2008 Volume 3 Issue 1 Full

Australian Journal of
Acupuncture and
Chinese Medicine
CONTENTS
01
Editorial
C Zaslawski
02 Letters to the Editor
03 Acupuncture for Migraine: A Systematic Review of Chinese Literature
YY Wang, Z Zheng and CCL Xue
17 Chinese Medicine and the Yi Jing’s Epistemic Methodology
LF Qu and M Garvey
25 Modern Applications of Modified Ban Xia Xie Xin Tang and Their Development
H Xu and WX Zhang
31 SOPE: A Model for Developing Online Materials in Chinese Herbal Medicine Education
Q Wu, AWH Yang, S Mansu, A Radloff, AL Zhang, CCL Xue
37 Chinese Herbal Medicine for Primary Dysmenorrhoea: A Systematic Review
XS Zhu, M Proctor, A Bensoussan, C Smith and E Wu
53 Current Research and Clinical Applications
57 Research Snapshots
60 Book Reviews
65 Conference Reports
68 Upcoming International Conferences
2008 VOLUME 3 ISSUE 1

Australian Journal of
Acupuncture and Chinese Medicine
A PEER-REVIEWED JOURNAL
EDITOR-IN-CHIEF
Zhen Zheng, PhD, BMed
RMIT University, Australia
The Australian Journal of Acupuncture and

Chinese Medicine (AJACM) is the official journal DEPUTY EDITOR
of the Australian Acupuncture and Chinese
Medicine Association Ltd (AACMA). It is Christopher Zaslawski, PhD, DipAcu, PGDipCHM, BAppSc(Physio), MHlthScEd
Australia’s only peer-reviewed journal for the University of Technology, Sydney, Australia
acupuncture and Chinese medicine profession.
All articles, other than Current Research &
Clinical Applications, Conference Reports, Book
Reviews, Standards & Guidelines and National EDITORIAL BOARD
and International News, have undergone the
John Deare, MAppSc(Acu), BHSc(CompMed) Damien Ryan, PhD, BA(Theol), BA(Phil),
peer-review process. AJACM is indexed in the
Australian Acupuncture and Chinese Medicine DipAcu, DipHerbMed(Nat), MEd(Res)
Australasian Medical Index.
Association Ltd Riverina Institute of TAFE, Australia
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John Deare, AACMA Vice-President GradDipHerbMed, MA(Res) University of Western Sydney, Australia
Judy James, AACMA CEO Victoria University, Australia
Ke Li, AACMA Director
Managing editor and staff

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ISSN 1833-9735 University of York, United Kingdom
Australian Journal of Acupuncture
and Chinese Medicine
CALL FOR SUBMISSION OF MANUSCRIPTS
The Australian Journal of Acupuncture and Chinese Medicine is the official journal of the Australian
Acupuncture and Chinese Medicine Association Ltd. It seeks to foster intellectual endeavour and
academic exchange about the research and clinical practice of acupuncture and Chinese medicine
and to promote quality in the provision of acupuncture and Chinese medicine clinical services.
The primary focus of the Journal is publishing peer-reviewed articles that will enhance quality
and diversity in acupuncture and Chinese medicine clinical practice and/or research and stimulate
the exchange of ideas about clinical practice and the role of acupuncture and Chinese medicine
in contemporary health care.
Peer-reviewed papers include research articles, clinical trials, systematic reviews, case reports and case
series, as well as general and theoretical papers. The Journal also publishes brief reports on current
research, book reviews, conference reports and other articles relevant to the Journal’s objectives.
Researchers, educators and practitioners in the fields of acupuncture, Chinese medicine and related
areas are invited to submit manuscripts to be considered via peer review for publication in future
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Editorial
This issue of AJACM (volume 3, issue 1) is packed with potential patients of the ability of herbal medicine and
systematic reviews, articles, research summaries, conference acupuncture to treat many common conditions.
reports and book reviews and is one of our biggest issues yet.
Our aim is to provide our readers and subscribers with the Central to the development of a profession is education. To
latest in research findings, clinical practice and professional this end, the next article directs readers to the growing use of
issues, an aim which I believe the Journal is achieving. To computer technology. The paper describes the four-stage quality
this end, we will be distributing an anonymous survey at the assurance model SOPE and how it is used in the development
next Australasian Acupuncture and Chinese Medicine Annual of online materials for a subject on herbal pharmacology at an
Conference (AACMAC) at Sydney in May, in order to get Australian university.
some detailed feedback on what you want in the Journal.
There are also book reviews, conference reports and clinical
The first article in this issue is a systematic review of the research summaries that will keep you up to date on the
Chinese literature on research of the effect of acupuncture Australian and international scene.
on migraine, co-authored by our editor, Zhen Zheng. While
there is a global expansion of Chinese medicine, access by Since the last issue in December 2007, we have had a number of
English speakers to the wealth of Chinese research literature important events occur in Australia. On the conference front,
has been minimal. This paper represents, I believe, one of the an international conference, the Third International Congress
first studies to specifically address that issue in the format of a of Complementary Medicine Research (ICCMR) was held
systematic review. in Sydney in March. While the scope of the conference was
broad, Chinese medicine and acupuncture were an integral
The second article is an exploration of Chinese medicine component of the program. On the research front, the
epistemics (knowledge systems). The authors, one Chinese and National Health and Medicine Research Council (NHMRC)
one Australian, contest some of the assumptions in the West complementary medicine grants were recently released. In the
concerning early notions of reality and being, and how these area of Chinese medicine and acupuncture, Professor Alan
affected the early developments of Chinese medical concepts Bensoussan (University of Western Sydney) was successful in
and methods. Those interested in a scholarly understanding receiving a grant of $590 200 for the clinical and physiological
of Chinese medical thought will find this article thought evaluation of Chinese herbal medicine for constipation
provoking. predominant irritable bowel syndrome. The other recipient
was Associate Professor Patricia Armati (University of Sydney),
The next paper, by Hong Xu and her colleague, has a clinical who will receive $326 207 to investigate the neural mechanism
focus. The well-known Shang Han Lun formula – Ban Xia Xie of laser acupuncture in pain relief using rat peripheral nervous
Xin Tang for treating glomus – is evaluated for its clinical usage tissue models. Also released were the National Institute of
and further modification. The ability of master practitioners Complementary Medicine (NICM) Collaborative Centre
to use a few formulae with the knowledge to modify them for grants, a State and Commonwealth venture to increase the
a range of specific complaints is integral to developing clinical capacity for research into complementary medicine. The
skill. University of Sydney (representing a consortium of eight
universities) was successful in obtaining $734 000 to establish
The fourth article is a condensed version of a Cochrane a national approach to evaluating Chinese medicine, including
Systematic Review on the Chinese herbal research on primary acupuncture and Chinese herbal medicine.
dysmenorrhea that was published in late 2007. Xiaoshu Zhu
and co-authors have permitted us to reproduce the review of Finally, congratulations to the Division of Chinese Medicine
this very commonly presented clinical condition. Reviews such at RMIT University, one of the only two organisations
as this and the previous acupuncture study give us confidence globally that have been recognised through the Wang Ding Yi
in treating such conditions, and are also useful in informing Cup International Prize by the World Federation of Chinese
Australian Journal
of Acupuncture and Chinese Medicine 2008 VOLUME 3 ISSUE 1 1
Editorial
Medicine Societies (WFCMS). The conferring ceremony was as we need your support to continue to make the Journal a
held at the Great Hall of the People (the Chinese Parliament) valuable resource for professional and clinical knowledge. I think
on 15 April 2008. This award is recognition of RMIT’s I have accosted you in this editorial with enough acronyms to
contribution to Chinese medicine education, research, clinical last a lifetime! Please read and enjoy, and we look forward to
training and promotion of the internationalisation of Chinese publishing an even bigger and better issue in late 2008.
medicine over a period of 15 years.
Chris Zaslawski
Readers are reminded to consider submitting manuscripts to Deputy Editor
the Journal, including letters to the editor and case studies,
Letters to the Editor

One of our readers recently contacted Sherman Gu regarding his case report, ‘Thoracic Outlet Syndrome Treated with Acupuncture,
Manual Techniques and Self-stretching Exercises’, which was published in volume 2, issue 1 (2007) of AJACM. The reader had
utilised some of the treatments decribed by Gu and enquired whether he could recommend any additional treatment for thoracic
outlet syndrome (TOS). Gu’s response is reprinted below.
Dear —,
I am pleased to hear that your patient is benefiting from the toward the affected side or neutral position (face up). The
article I wrote. stretching can be repeated three or four times in each direction
and performed in two or three sessions daily until the the
You might instruct the patient to perform the following patient is pain free.
stretch exercises adapted from Travell and Simons, one of the
references listed at the end of my article. The details of the stretch can be obtained from the following:
The patient is in the supine position; if the TOS is on the left Travell J, Simons D. Myofascial pain and dysfunction: the trigger
side, then anchor his affected side arm by placing it behind point manual (Vol. 1). Baltimore, MD: Williams & Wilkins; 1983.
the trunk. Put his other hand on the back of the head with p. 362–63.
the head in 45° rotation away from the affected side, and
stretch the neck and shoulder gently and slowly. Repeat the Regards,
same manoeuvre with the head in the position of 45° rotation Sherman Gu
Australian Journal
2 of Acupuncture and Chinese Medicine 2008 VOLUME 3 ISSUE 1
Acupuncture for Migraine:
A Systematic Review of
Chinese Literature
Yanyi Wang BMed
Zhen Zheng* PhD
Charlie Changli Xue PhD
Division of Chinese Medicine, School of Health Sciences, RMIT University, Melbourne, Australia
ABSTRACT
Introduction: Acupuncture is widely used for the treatment of migraine, but its effectiveness is
inconclusive based on findings of two recent systematic reviews. However, these reviews included
very few studies conducted in Asian countries. Research papers published in Chinese are yet to
be reviewed to determine their role in the overall understanding of the effectiveness and safety
of acupuncture for migraine. Objectives: Is acupuncture more effective than no treatment,
sham/placebo acupuncture, or as effective as other interventions for migraine? Methods: Search
Strategies: Electronic search was performed in the two most comprehensive Chinese e-databases, Vi
Pu and Wan Fang. Keywords used were a combination of acupuncture, headache, migraine, Chinese
medicine, electroacupuncture and point-stimulation. Selection Criteria: Randomised, controlled
trials comparing acupuncture with any type of control interventions and reporting at least one of
the clinically related outcome measures for migraine were selected. Data Collection and Analysis:
Characteristics of the studies were extracted by two independent reviewers. Reporting quality and
validity were assessed using the Jadad Scale, Internal Validity Scale and Oxford Pain Validity Scale.
STRICTA was used to assess the reporting quality of acupuncture treatment. RevMan 4.2 was
used for data analysis. Results: Seventeen studies with a total of 2097 participants (median 91;
range 62–216) met the inclusion criteria. Ten studies compared acupuncture alone with western
medications. The remaining seven trials compared a combined therapy of acupuncture and other
therapies with western medications. None of the studies compared acupuncture with no-treatment
control or sham/placebo acupuncture. None of the 17 studies was considered of high quality.
Studies indicated that acupuncture alone was superior to western medications (RR 1.55, 95% CI
1.27 to 1.88). In comparison to studies included in the other two reviews, the Chinese studies in
this review had a larger sample size and acupuncture treatments were more frequent. Conclusion:
There is moderate evidence that acupuncture is more effective than western pharmacotherapy. Due
to the poor quality and validity of included studies, this conclusion requires further assessment.
Data from Chinese literature should be included in future systematic reviews.
K E Y W O R D S systematic review, acupuncture, migraine, headache.
* Correspondent author; e-mail: [email protected] Aust J Acupunct Chin Med 2008;3(1):3–16.
Australian Journal
of Acupuncture and Chinese Medicine 2008 VOLUME 3 ISSUE 1
Acupuncture for Migraine YY Wang, Z Zheng and CCL Xue
Introduction Studies that did not separate migraine patients from those with
other types of headache, such as tension-type headache, were
Migraine is a common, disabling, and typically unilateral excluded.
headache disorder with symptoms such as nausea, vomiting,
phonophobia or photophobia. Approximately 16% of TYPES OF INTERVENTION
Australians suffer from migraine.1 Direct and indirect costs Studies that involved needle insertion at acupuncture points,
of migraine as a whole in Australia from 1989 to 1990 were tender points, or trigger points, and other invasive methods
estimated to be between 302 and 721 million dollars.2 of stimulating these points (e.g. electroacupuncture) were
included. Studies examining non-invasive acupuncture, such as
Current treatments for migraine focus on symptomatic laser acupuncture or acupressure, were excluded, so were studies
management using anti-inflammatory medications, opioids utilising point-injection alone. Studies comparing a combined
and ergots. These western medications have provided some therapy of acupuncture and Chinese herbal medicine or Tuina
relief, but not without risks, such as drug overuse with resultant with a control group were included because acupuncture was
headache exacerbation. More and more migraine sufferers often used together with other therapies in clinical practice.
seek complementary therapies, including acupuncture, for
relief. A recent Italian study reported that the percentages of Control interventions considered were:
complementary and alternative medicine users in chronic and • no treatment,
episodic migraine sufferers were 50% and 27%, respectively.3 • sham or placebo acupuncture, or
• other active treatments.
The role of acupuncture in migraine treatment, however,
remains uncertain.4 Currently available systematic reviews Studies comparing different modalities of acupuncture were
(SRs) on this topic have focused on published studies from excluded, for instance, those comparing manual acupuncture
western countries, with few studies in Asian languages.4-6 with electroacupuncture. Studies without a valid control group,
Thus, the majority of Asian studies were neglected, possibly meaning that the effect of acupuncture could not be assessed
due to language difficulties and a lack of access to the relevant (for instance, comparing acupuncture with acupuncture plus
databases.4 In China, acupuncture is widely used and data from Qigong), were also excluded.
this region need to be taken into consideration in determining
the effectiveness and safety of acupuncture for migraine. TYPES OF OUTCOME MEASURES
Included studies should report at least one clinically related
Objectives outcome for migraine, such as frequency or intensity of

migraine or number of respondents. Trials reporting only
Through systematically reviewing Chinese literature, the physiological or laboratory parameters as outcome measures,
objectives of this review were to determine whether acupuncture such as electroencephalogram, were excluded.
was:
1. more effective than no treatment; We extracted data of the ‘global response’ to treatment.
2. more effective than ‘sham/placebo’ acupuncture; and Response was defined as at least 50% improvement in our
3. as effective as other interventions for migraine. review. We estimated whether 50% improvement was met
from the description provided by the authors. For instance,
Lao9 recorded the reduction of migraine index (MI) during the
Methods third month after the end of the treatment. The MI reduction
CRITERIA FOR CONSIDERING STUDIES between 90% and 100% was considered as ‘cured’, between
FOR THIS REVIEW 55% and 89% as ‘marked improvement’, between 20% and
TYPES OF STUDIES 54% as ‘improvement’ and less than 20% as ‘no effect’. The
Studies with a randomised and controlled design were included. participants in the first two groups were considered to be
Quasi-randomised studies (e.g. by the order of admission or respondents in our review. Most studies did not report the
date of birth) were also included. Ongoing or unpublished immediate and the long-term effects separately. For instance
studies were excluded. Zhou10 defined ‘improvement’ as more than 50% reduction
of MI in the three months after the end of the treatment.
TYPES OF PARTICIPANTS Consequently, the 50% improvement in our review refers to
Participants were migraine patients diagnosed according to the global response to acupuncture at 0–12 months after the
standard criteria, such as those recommended by the Ad Hoc treatment, and is not specific to either the immediate effect or
Committee of the National Institute of Neurological Diseases the long-term effect. Relative risks and their 95% confidence
and Blindness7 or the International Headache Society (IHS).8 intervals were calculated.
Australian Journal
SEARCH STRATEGY FOR IDENTIFICATION OF DATA EXTRACTION

STUDIES
Information on participants, randomisation, blinding
‘Acupuncture (针灸)’, ‘electroacupuncture (电针)’, ‘Chinese interventions, outcome measures and results were extracted
medicine (中医药疗法)’, ‘point-stimulation (穴位刺激)’, using the standard form adopted by Melchart and colleagues.4
‘headache (头痛)’ and ‘migraine (偏头痛)’ were the keywords One reviewer (YYW) extracted the data. Another reviewer
searched in the two largest Chinese electronic databases, Vi Pu (ZZ) checked the extraction according to the pre-defined
(重庆维普, www.cqvip.com, inception 1989) and Wan Fang form. Differences between the reviewers were resolved through
(万方数据, www.wanfangdata.com.cn, inception 1982) for discussion.
papers published from the inception of the databases to August
2006. ASSESSMENT OF QUALITY
The quality of included studies was assessed independently
METHODS by two reviewers using the Jadad Scale,11 the Internal Validity
ELIGIBILITY Scale (IVS),12 and the Oxford Pain Validity Scale (OPVS).13
Of 266 papers found, 177 were either not RCTs, used Chinese The former two scales have been used in several SRs on
herbs as the active intervention, or did not have a valid control acupuncture.4,14 Studies scoring three or more points on the
intervention. A further 55 papers were excluded because they Jadad scale are considered of high quality, which is 60% of the
reported other types of headache. Two authors (YYW and ZZ) maximum score. OPVS was designed specifically to examine
assessed the remaining 34 papers. Two were excluded because the internal validity of trials in the field of pain research.13
non-invasive acupuncture was used and seven were excluded Points awarded for each item of the Jadad Scale, IVS and
due to the use of point-injection alone as the treatment. A OPVS are listed in order for each trial in Table 1. In addition,
further eight were eliminated for not providing any clinically the Standards for Reporting Interventions in Controlled Trials
relevant outcome measures. Finally, a total of 17 studies were of Acupuncture (STRICTA) were used to assess the reporting
included and analysed. The following flowchart illustrates the quality of acupuncture interventions.15
process of identifying studies (Figure 1).
Concealment of allocation is the process of concealing
assignments of the interventions. We adopted the method
recommended by the Cochrane Collaboration to assess whether
266 studies allocation concealment was adequate, uncertain, inadequate or
177 excluded for not being RCTs,
using Chinese herbs as the not mentioned, and scored A, B, C and D, appropriately.16
study intervention, or not having This method has been used by other systematic reviews.4,17-19
a valid control intervention ‘A’ refers to studies adopting correct concealment methods,
89 studies
such as using centralised randomisation or sequentially
55 excluded for reporting other numbered, sealed, opaque envelopes. If studies do not report
types of headache
any concealment approach, ‘B’ should be coded. Category C
34 studies includes the use of case record numbers, dates of birth or days
2 excluded for using non- of the week, and any procedure that is entirely transparent
invasive acupuncture treatment before allocation, such as an open list of random numbers. ‘D’
refers to studies that clearly state that allocation concealment
32 studies was not used.
7 excluded for using point-
injection alone as the studied DATA ANALYSIS
intervention
25 studies RevMan 4.2 was used for meta-analysis. If significant
8 excluded for not providing heterogeneity among the trials was detected with the I2 statistic
clinically relevant outcome (I2 ≥ 50%), a random-effects model was used. Otherwise, a
measures fix-effects model was used. For continuous data, weight or
17 studies standard mean difference was used; for dichotomy data, relative
risk was used.
FIGURE 1 A flowchart illustrating the process
We adopted the method described by van Tulder and colleagues
of study identification
in 2003 for the qualitative assessment of the overall evidence.
This method classifies the evidence into strong, moderate,
limited, conflicting or no evidence, depending on the quality,
number and results of the studies.20
Australian Journal
TABLE 1 Characteristics of included studies
Author and date Intervention Sample population* Outcomes# Follow-up Drop-out
Zhou JH Acupuncture vs western Acu: n = 35 ▲ 6 months No

(2005) medication WM: n = 35
Wang B Acupuncture vs western Acu: n = 125 ▲ N/A No

Cui R, et al. Acupuncture vs western Acu: n = 48 ▲ 3 months No

Feng SL, et al. Acupuncture vs western Acu: n = 35 ▲ 2 months No

Zhang YC, et al. Acupuncture vs western Acu: n = 106 ■ 1 year No

Liu KY, et al. Acupuncture vs western Acu: n = 43 ▲ and 1 month No

(2001) medication WM: n = 43 frequency and
duration
Li W, et al. Acupuncture vs western Acu: n = 70 ▲ N/A Yes

Chen XS Acupuncture vs western Acu: n = 45 ■ 6 months No

Zhou LS Acupuncture vs western Acu: n = 43 ▲ 3 months No

Lao JX Electronic acupuncture vs Acu: n = 87 ▲ 2 months No

(2003) western medication WM: n = 61
Wang JL, et al. Acupuncture plus Chinese Acu: n = 60 ■ 6 months No

(2004) medicine injection vs WM: n = 60
western medication
Liu Y, et al. Acupuncture plus acupoint Acu: n = 54 ■ 8 weeks No

(2002) injection vs western WM: n = 52
medication
Lu ZQ Acupuncture plus massage Acu: n = 54 ■ 6 months Yes (16)

(2004) vs western medication WM: n = 30
Australian Journal
Number and percentage of Allocation

Quality
respondents: Treatment vs Control concealment†
Treatment: 21/35, 60% Jadad: 1-0-0-0-1 C
Control: 9/35, 25.7% IVS: 0.5-0-0.5-0-0-1
OPVS: 0-3-2-0-1-1-0-1
Treatment: 100/125, 80% Jadad: 1-0-0-0-1 B
Control: 36/61, 59% IVS: 0.5-0-1-0-0-1
OPVS: 0-3-2-0-1-1-0-1
Treatment: 28/48, 58.3% Jadad: 1-0-0-0-1 C
Control: 17/38, 44.7% IVS: 0.5-0-1-0-0-1
OPVS: 0-3-2-0-1-0-0-1
Treatment: 23/35, 65.7% Jadad: 1-0-0-0-1 B
Control: 7/27, 25.9% IVS: 0.5-0-0.5-0-0-1
OPVS: 0-3-2-0-1-0-0-1
Control: 24/110, 21.8% IVS: 0.5-0-0-0-0-1
OPVS: 0-3-2-0-1-1-0-1
Control: 25/43, 58.1% IVS: 0.5-0-1-0-0-1
Frequency: 0.3 ± 1.4 vs 2.6 ± 1.6 OPVS: 0-3-2-0-1-1-1-1
Duration: 2.54 ± 1.37 vs 14.7 ± 15.6
Control: 15/32, 46.9% IVS: 0.5-0-0-0-0-0.5
OPVS: 0-3-2-0-1-1-0-1
Control: 16/30, 53.3% IVS: 0.5-0-1-0-0-1
OPVS: 0-3-2-0-1-1-0-1
Treatment: 40/43, 93% Jadad: 1-0-0-0-1 B
Control: 15/20, 75% IVS: 0.5-0-0.5-0-0-1
OPVS: 0-3-2-0-1-0-0-1
Control: 14/61, 23% IVS: 0.5-0-0.5-0-0-1
OPVS: 0-3-2-0-1-1-0-1
Control: 19/60, 31.7% IVS: 0.5-0-0.5-0-0-1
OPVS: 0-3-2-0-1-0-0-1
Control: 32/52, 61.5% IVS: 0.5-0-0.5-0--0-1
OPVS: 0-3-2-0-1-1-0-1
Control: 12/26, 46.2% IVS: 0.5-0-0.5-0-0-0.5
OPVS: 0-3-2-0-1-1-0-1
continued on next page
Australian Journal
TABLE 1 Characteristics of included studies (continued)
Author and date Intervention Sample population* Outcomes# Follow-up Drop-out
Shao Y, et al. Electronic acupuncture Acu: n = 35 ▲ 6 months No

(2005) plus massage vs western WM: n = 33
medication
Wang LQ, et al. Acupuncture plus Acu: n = 63 ● 1 year No

(2004) hyperbaric oxygen vs WM: n = 28
western medication
Liu XL, et al. Acupuncture plus Acu: n = 256 ■ N/A No

(2002) hyperbaric oxygen vs WM: n = 158
western medication
Zhang YK Acupuncture plus Acu: n = 60 Headache No No

(2005) medication vs western WM: n = 60 index
medication
* Acu: acupuncture, WM: western medications

# ▲ refers to four categories of self-defined ‘global response’, named ‘cured’, ‘marked improvement’, ‘improvement’ and ‘no effect’. According to
the definition, the participants in the ‘cured’ and ‘significantly improved’ categories had more than 50% improvement when compared with the
baseline and were considered as respondents in this review. ■ refers to three categories of self-defined ‘global response’, named ‘cured’, ‘effective’
and ‘ineffective’. According to the definition, the participants in the ‘cured’ category had more than 50% improvement, and were considered as
respondents in this review. ● refers to four categories of self-defined ‘global response’, named ‘cured’, ‘marked improvement’, ‘improvement’
and ‘no effect’. According to the definition, the participants in the ‘cured’, ‘significantly improved’ and ‘improved’ categories had more than 50%
improvement, and were considered as respondents in this review.
METHODOLOGICAL ASSESSMENT All 17 trials were described as randomised studies. Six studies
DESCRIPTION OF THE STUDIES in which the method of randomisation was briefly mentioned
Table 1 summarises the characteristics of the 17 studies. Sixteen used the order of admission or date of birth to allocate
trials adopted the IHS criteria for the diagnosis of migraine, participants, and can be considered as quasi-randomised studies.
and one trial used the Ad Hoc Committee’s criteria.21 A total Consequently, ‘C Inadequate’ was coded for these six studies.
of 2097 participants (median 91; range 62–414) were included The remaining twelve studies were in Category B because it is
in our review. unclear if and how the allocation concealment was conducted.
Detailed information about allocation concealment was absent
All studies compared acupuncture with western medication in eleven studies, one trial only merely stated that the sortition
treatments. Ten studies used acupuncture alone. Six studies method was used.9
used a combined therapy of acupuncture with acupoint
injection,22 with intravenous injection of a purified Chinese Furthermore, no study reported details regarding the process of
herb,23 with Chinese Tuina,24,25 or with hyperbaric oxygen.26,27 blinding. The participants were not blinded to the treatment
The remaining study compared acupuncture plus western allocation because western medications were the control
medication with western medication alone.23,28 None of the intervention. The blinding of assessors was not reported in
studies compared acupuncture with no-treatment control or any of the studies. All studies gained one point for reporting
sham/placebo acupuncture. drop-outs. In two studies, a drop-out rate of less than 10%
was reported.21,25 The remaining studies did not have any
QUALITY ASSESSMENT drop-outs.
The median Jadad score was 2 (range 1–2) out of a possible
score of 5; the median IVS was 2.0 (range 1.5–2.5) out of 6; Only two trials28,29 presented means and standard deviations
and the median OPVS was 8 (range 7–9) out of 16. None of of the outcome measures and were awarded one point for data
the 17 studies had more than 60% of a maximum score of presentation in OPVS.
Jadad, IVS or OPVS.
Australian Journal
Number and percentage of Allocation

Quality
respondents: Treatment vs Control concealment†
Short-term: Treatment: 26/35,74.3% Jadad: 1-0-0-0-1 C
Control: 25/33, 75.8% IVS: 0.5-0-0.5-0-0-1
After 6 months: Treatment: 26/35, 74.3% OPVS: 0-3-2-0-1-1-0-1
Control: 17/33, 51.5%
Control: 33/56, 58.9% IVS: 0.5-0-0.5-0-0-1
OPVS: 0-3-2-0-1-1-0-1
Control: 50/158, 31.6% IVS: 0.5-0-1-0--0-1
OPVS: 0-3-2-0-1-1-0-1
Treatment: 9.1 ± 2.07 Jadad: 1-0-0-0-1 B
Control: 11.7 ± 3.04 IVS: 0.5-0-0.5-0-0-1
OPVS: 0-3-2-0-1-1-0-1
† A: indicates adequate concealment of the allocation (e.g. by telephone randomisation, or use of consecutively
numbered, sealed, opaque envelopes). B: indicates uncertainty about whether the allocation was adequately
concealed (e.g. where the method of concealment is not known). C: indicates that the allocation was definitely not
adequately concealed (e.g. open random number lists or quasi-randomisation, such as alternate days, odd/even date
of birth, or hospital number). D: indicates the score was not assigned, i.e. allocation concealment was not used.
In contrast to the poor reporting quality of study designs, The top five acupoints used in the 17 trials were GB 8 Shuaigu,
most of the studies achieved satisfactory results in STRICTA, GB 20 Fengchi, LI 4 Hegu, LR 3 Taichong, and Ex-HN 5
reporting quality of intervention, which is not assessed by any Taiyang.
other measurements. All 17 trials gave detailed information for
acupuncture rationale, needling techniques, treatment regimes, CONTROL INTERVENTION
co-interventions and control interventions; however, none of All 17 trials used western medications as the control
the studies gave details of practitioner backgrounds (Table 2). intervention. Participants took prophylactics daily. These
drugs were categorised as Ca++ channel blocker (Nimodipine),
ACUPUNCTURE INTERVENTION antihistamines (Flunarizine), anticonvulsants (Carbamazepine)
Twelve trials used formula acupoints. One trial employed and analgesics (Rotudin, a combination of analgesics and
formula acupoints plus Ashi points.21 The remaining four used unnamed herbs). In two studies, participants were instructed to
semi-structured acupuncture treatment, including formula use NSAID (Indomethacin and Brufen) daily,25,28 which is not
plus complementary acupoints based on traditional Chinese a standard western pharmacotherapy for prophylactic treatment
medicine (TCM) syndrome differentiation.9,25,26,30 The of migraine. They were excluded from the meta-analysis.
principles of acupuncture point selection were clearly stated in
16 studies, including dispelling wind,22,23,25 dredging meridian In six trials, Ergotamine, Cafergot or Ibuprofen was used for
and activating Qi and blood,27,28,31-33 and regulating the acute attacks in the control group only.10,21,22,24-26,31
liver.9,10,21,24,26,29,34,35 Deqi (a feeling of numbness, heaviness,
distension or radiation) was reported in all 17 studies. OUTCOME MEASURES
All studies reported the use of at least one of the clinical-related
The median treatment period was 30 days (range 5–56 days) outcome measures, such as frequency, intensity, and duration
with an average of 30 treatment sessions (range 5–40). In of migraine. However, apart from two studies which presented
13 studies, participants were treated with acupuncture daily. the means and standard deviations of clinical data,28,29 the
Three studies gave five or six treatment sessions weekly21,30,35 remaining fifteen reported the number of participants in the
and in the remaining study, treatment was given once every ‘cured’, ‘marked improvement’, ‘improvement’ and ‘no effect’
three days.31 categories. None of the studies mentioned the use of a diary to
record patients’ migraine.
Australian Journal
FOLLOW-UP were randomised into two groups with 1:1 ratio. After 30
Follow-up was not clearly mentioned in three studies, and treatment days, the acupuncture group (9.1 ± 2.07) was
one trial did not include a follow-up period. Fourteen studies found to be statistically significantly better than the western
had a follow-up period ranging from one month to one year medication alone group (11.7 ± 3.04) in headache index, a
after treatment with a median of 4.5 months. Performance of combined measure of frequency and intensity of headache.
the participants during the follow-up period was not reported
separately from that immediately after acupuncture. ACUPUNCTURE PLUS OTHER TCM
THERAPIES VS WESTERN MEDICATIONS
Side effects of acupuncture and western medications were not Four studies compared a combined therapy of acupuncture and
reported. other Chinese medicine (CM) therapies, including acupoint
injection,22 intravenous injection of a purified Chinese herb23
and Tuina24,25, respectively, with western medications. Lu25
Results combined acupuncture with Chinese Tuina to compare with
ACUPUNCTURE VS WESTERN treatment with Indomethacin (NSAID) (25 mg twice a day for
MEDICATIONS 30 days), an invalid pharmacological treatment for migraine.
In total, ten studies with 1094 participants were included in In fact, frequent use of NSAIDs could lead to migraine from
this analysis. All 10 studies reported positive results (Figure 2); medicine overuse.36 Consequently, this study was not included
however, the I2 statistic (61.4%) indicated significant in the meta-analysis.
heterogeneity. Thus, a random-effects model was applied in the
data analyses. The results significantly favoured acupuncture as Shao24 is the only study that presented both short-term data
an intervention (RR 1.55; 95% CI 1.27 to 1.88). Only one and the six-month follow-up data. The results indicated that
study29 presented the details of frequency and duration of acupuncture with massage produced a long-term effect, although
migraine in mean and SD (frequency per month: 0.3 ± 1.4 the short-term effect was not better than western medications.
vs 2.6 ± 1.6; duration in hours: 2.54 ± 1.37 vs 14.7 ±1.56). To be consistent with the data extracted from other studies, the
This study also provided the number of participants in the follow-up data were included in the meta-analysis.
sub-groups of ‘cured’, ‘marked improvement’, ‘improvement’
and ‘no effect’. The number of respondents in the study was The fixed-effects model was used because the I2 statistic was
chosen for the meta-analysis. 43.1%. Figure 3 shows that acupuncture plus other CM
therapies were significantly better than western medications
ACUPUNCTURE PLUS WESTERN control (RR 1.48, 95% CI 1.22 to 1.81).
MEDICATION VS WESTERN
MEDICATION ACUPUNCTURE PLUS OTHER THERAPY
There was only one study in the comparison. Zhang (2005)
VS WESTERN MEDICATION
compared acupuncture plus western medication with the same Two studies of 503 participants combined acupuncture with
western medication alone (Brufen). In total, 120 participants hyperbaric oxygen to compare with western medication.26,27
FIGURE 2 Global responses to the treatments – acupuncture versus western medications
Australian Journal
FIGURE 3 Global responses to the treatments – acupuncture with other traditional Chinese medicine
versus western medications
Significant heterogeneity was indicated by the I2 statistic Trials published in English and European languages used
(84.7%), and a random-effects model was applied. Figure sham/placebo acupuncture, waiting list, western medicine
4 indicates that the combined therapy was not statistically or physiotherapy as the control interventions; blinding of
significantly better than the western medication controls (RR participants was common in the sham acupuncture–controlled
1.22, 95% CI 0.87 to 1.7). trials. All of the 17 Chinese studies used western medications
as a control. Except for two studies,25,28 all drugs used in these
A COMPARISON OF OUR REVIEW WITH 17 trials were recommended migraine medication37 and were
THE OTHER TWO SRS similar to those of trials in the other SRs
A comparison of findings from our review with those in the two
previous SRs4,6 is presented in Table 3. The majority of studies
included in the two existing SRs were published in English
Discussion
or European languages. In general, studies published in China This review of Chinese literature was conducted to determine
had larger sample sizes, were of poorer quality, had acupuncture the effect of acupuncture on migraine when compared with
treatment more frequently and had pharmacotherapy controls sham acupuncture, no treatment and other therapies. No
only. All studies included in our review emphasised that the relevant studies were identified for the first two comparisons.
Deqi sensation was achieved during treatment. Only 9 out of There is moderate evidence from Chinese literature supporting
26 trials reported Deqi in Melchart et al’s review,4 and 10 out the value of acupuncture for the treatment and prevention
of 25 in Scott and Deare’s review.6 of migraine when compared with western medications.
Furthermore, combining acupuncture with other modalities of
Twenty three percent of the Chinese trials (four out of 17 Chinese medicine is superior to western medications.
studies) used semi-standardised acupuncture treatment based
on Chinese medicine syndrome differentiation. In comparison, The major limitation of our SR is that we were not able to
44% of the trials reported in English and European literature identify papers published prior to the 1980s because the
adopted this method. inceptions of the two databases – Vi Pu (重庆维普) and Wan
FIGURE 3 Global responses to the treatments – acupuncture and other therapy versus western medications
Australian Journal
TABLE 2 Study and control interventions of included studies
Author and date Study intervention Type of acupuncture treatment Acupuncture points and needling
Zhou JH Acupuncture alone Formula acupuncture (dredging meridian GB 8, GB 19, TE 20. Deqi mentioned.
(2005) and activating Qi and blood)
Wang B Acupuncture alone Formula acupuncture (dredging meridian GV 15, GV 16, GV 17; dividing the distance between GV 16 and
(2004) and activating Qi and blood) GB 12 into 6 equal sections, then needling the points dividing the
sections. Deqi mentioned.
Cui R, et al. Acupuncture alone Formula acupuncture (regulating the liver) GB 8, GB 20, GB 39, GB 41, LI 4, LR 3, KI 12. Deqi mentioned.
(2004)
Feng SL, et al. Acupuncture alone Formula acupuncture plus complementary Empirical points: 1st point: 0.5 cun above GB 8; 2nd/3rd points:
(2003) point based on TCM syndrome 1 cun left or right of the 1st point. Complementary points: BL 23,
differentiation KI 3 ,LR 3, or SP 9, ST 8, ST 40 or GB 20, GB 34, LR 3. Deqi
mentioned.
Zhang YC, et al. Acupuncture alone Formula acupuncture (dredging meridian TE 21. Deqi mentioned.
(2002) and activating Qi and blood)
Liu KY, et al. Acupuncture alone Formula acupuncture (regulating the liver) Ex-HN 5, GB 8, GB 20, GB 34, GB 41, LR 3, TE 5, ST 36, start
(2001) and end points of lower sensory area in Head acupuncture. Deqi
mentioned.
Li W, et al. Acupuncture alone Formula acupuncture (regulating the liver) GV 20, GB 20, GB 39, LR 2. Complementary points: Ashi points.
(1998) plus Ashi points Deqi mentioned.
Chen XS Acupuncture alone Formula acupuncture Ex-HN 5, GB 20, LR 3, ST 8, TE 5. Deqi mentioned.
(1997) (regulating the liver)
Zhou LS Acupuncture alone Formula acupuncture (regulating the liver) TE 5, GB 8, GB 41, GB 44, TE 3, TE 19. Deqi mentioned.
(2003)
Lao JX Electrical acupuncture Formula acupuncture (regulating the liver) GB 4, TE 23. Complementary points: Ex-HN 5, GB 20, LU 7, or
(2003) alone plus complementary point based on TCM KI 3, LR 3 or LI 4, LR 2, or GB 8, ST 40. Deqi mentioned.
syndrome differentiation
Wang JL, et al. Acupuncture plus Formula acupuncture (dispelling wind) Ex-HN 5, GB 8, GB 20, LI 4, LR 3, TE 3. Deqi mentioned.
(2004) intravenous injection of a
purified Chinese herb
Liu Y, et al. Acupuncture plus Formula acupuncture (dispelling wind) GV 20, Ex-HN 5, GB 8, GB 20, LI 4, LU 7, ST 8, TE 23. Deqi
(2002) acupoint injection mentioned.
Lu ZQ Acupuncture plus massage Formula acupuncture (dispelling wind) Ex-HN 5, GV 14 GV 20, GB 20. Complementary points:
(2004) plus complementary point based on TCM LI 4, ST 40 or KI 3, LR 3 or LI 4, SP 6 or LU 9, ST 36. Deqi
syndrome differentiation mentioned.
Shao Y, et al. Electrical acupuncture plus Formula acupuncture (regulating the liver) Ex-HN 5, GB 4, GB 20, GB 38, GB 41, LR 3, PC 6 , TE 23. Deqi
(2005) massage mentioned.
Wang LQ, et al. Acupuncture plus Formula acupuncture (regulating the liver) GB 4, GB 20, TE 19, TE 23. Complementary points: BL 17,
(2004) hyperbaric oxygen plus complementary point based on TCM SP 10, or BL 12, BL 60, or SP 6, ST 40, or BL 23, KI 3. Deqi
syndrome differentiation mentioned.
Liu XL, et al. Acupuncture plus Formula acupuncture (dredging meridian Ex-HN 5, LI 4, LI 11, LU 4. Deqi mentioned.
(2002) hyperbaric oxygen and activating Qi and blood)
Zhang YK Formula acupuncture plus Formula acupuncture (dredging meridian GB 8, GB 20, LI 4, LR 3. Deqi mentioned.
(2005) medication and activating Qi and blood)
Key: bid = twice per day; tid = three times per day; qd = four times per day.
Australian Journal
Practitioner
Other treatment Treatment regime Control intervention
background
No 1/day for 30 days N/A Nimodipine (Ca channel blocker) 40 mg, tid
No 1/3 days for 30 days N/A 1. Cafergot 2 tabs for acute migraine attacks; if not effective within 30
mins, take another 1–2 tablets; max 6 tab/day.
2. Nimodipine 30 mg bid for 30 days.
No 6/week for 3 weeks N/A Nimodipine 40 mg, tid and oryzanol 20 mg, tid
No 5/week for 8 weeks N/A Nimodipine 40 mg, t.i.d
No 1/day for 5 days N/A Flunarizine (antihistamines) 10 mg, q.d for 5 days
No 1/day for 30 days N/A Nimodipine 30 mg, tid for 30 days
No 6/week for 3 weeks N/A Carbamazepine (anticonvulsants) 100 mg, tid for 21 days
No 1/day for 20 days N/A Nimodipine 30 mg, tid for 20 days
No 1/day for 40 days N/A Ergotamine 1 mg for acute migraine attacks; if not effective, take
another 2 mg after 30 mins; maximal dose 6 mg/day
No 1/day for 10 days, then N/A Rotudin 30 mg tid for 10 days, then rest 5 days; totally repeat 3 times
rest 5 days; totally repeated
3 times
Ligustrazine Hydrochloride (川芎嗪) 100 1 /day for 15 days N/A Flunarizine 5 mg, qd
mL i.v. drip qd for 15 days
Acupoint injection using stauntoniae (野 1/day for 10 days, then N/A Flunarizine 5 mg, qd for 8 weeks; cafergot for acute migraine attacks.
木瓜皂甙) on Ex-HN 5 or GB 16, 2 mL rest 2 day, lasting 8 weeks
for 8 weeks
Tuina 1/day for 30 days N/A 1. Ergotamine 1–2 mg for acute migraine attacks, if not effective, take
another 2 mg after 30 mins; max 6 mg/day.
2. Indomethacin (NSAID) 25 mg bid for 30 days.
Tuina along the gallbladder meridian on the 1/day for 10 days, then N/A Flunarizine 5 mg, qd Acute migraine attack, take ibuprofen 1–2
head for 15 min rest 3 days, totally 3 tablets.
phases.
Hyperbaric oxygen 1/day for 10 days N/A 1. Cafergot (1–2 tabs for first symptoms).
2. Nimodipine 40 mg tid and Flunarizine (antihistamines) 5 mg, tid
for 10 days.
Hyperbaric oxygen 1/day for 10 days N/A Somiton (a combination of analgesics and unnamed herbs) 500 mg,
tid, oryzanol 10 mg, tid, and VB1 10 mg, tid for 7 days
Brufen 400 mg, t.i.d for 30 days 1/day for 30 days N/A Brufen 400 mg, tid for 30 days
Australian Journal
Fang (万方数据) – were 1989 and 1982 respectively. These (Zhongguo Zhenjiu) was indexed in PubMed (from 2005). Three
two databases are the most comprehensive Chinese e-databases studies16-18 in our review were published in this journal before
and include all the academically credible journals and theses 2005 and so were not included in PubMed. This confirms the
published in China in the area of science and technology. view expressed by the authors of the other two SRs that there is
Although studies published before the 1980s are not included a lack of access to the Asian literature.4,6
in these databases, it is unlikely we have missed many published
papers in this area. Apart from two of the 17 papers being In this review, we encountered the same difficulty that faced
published in 1997 and 1998, the remaining fifteen studies the authors of the other two SRs. Ideally, we should use the
were published after 2001. number of days with migraine per month or changed intensity
or duration of migraine at the end of the treatment as the main
None of the 17 studies in our review were included in the other outcome measure for quantitative analyses as recommended
two SRs,4,6 indicating that a large body of research was not by the IHS.38 Only two papers presented means and standard
considered when the conclusions were drawn. Given that the deviations of these outcome measures.28,29 Due to detailed
Chinese studies have larger sample sizes than those conducted clinical data being unavailable, the number of respondents was
in western countries, potentially yielding a higher weighting used for meta-analyses. There are differences in the definition of
in a meta-analysis, it is even more important to include such respondents; 50% was used in our and Melchart et al’s reviews,
studies. and 33% in Scott and Deare’s review. Such a reduction of data
limits our understanding of the exact effects of acupuncture on
A search indicated that only one journal included in our review the frequency, intensity and duration of migraine.
TABLE 3 A comparison of our review (overall data) and two other systematic reviews of
acupuncture for migraine
Our review Melchart et al. Scott and Deare
Sample size 91 37 63
(median)
Frequency of treatment 5–7 1–2 mostly 1–2
(sessions per week)
Deqi sensation 17/17 trials reported 9/26 trials reported 10/25 trials reported
Jadad, median 2 (1–2) 1.5 (1–4) 2.3 (1–5)

(range)
IVS 2 (1.5–2.5) 2.5 (1–4) 3 (0.5–6)
Acupoint selection 23% of the studies chose N/A 44% of the studies chose
acupoints according to acupoints according to
Chinese medicine individual Chinese medicine individual
syndrome differentiation syndrome differentiation
Control intervention Western medications Physiotherapy (massage and Physiotherapy (massage and
relaxation), sham/placebo relaxation), sham/placebo
acupuncture, waiting list, acupuncture, waiting list,
western medications, standard western medications, standard
GP care. GP care
Respondent rate 50% 50% 33%
Relative risk 1.55 (1.27–1.88) N/A 1.38 (1.08–1.76)

(acupuncture vs Favours acupuncture Favours acupuncture
western medications)
Australian Journal
Similar pharmacological treatments were used as the control

interventions in our review and Scott and Deare’s. The effect Clinical Commentary
size identified in our review (1.55) is comparable with the value
reported by Scott and Deare (1.38). Considering the different
definitions for respondents, Chinese trials have a higher success This review indicates that acupuncture alone or
rate. It is unknown whether the higher success rate is due to when combined with other therapies is 1.2 to 1.5
publication bias reported by Vickers and colleagues,39 lower times more effective than western medications
quality, or the differences in acupuncture treatment protocol. for the treatment of migraine. Formula-based
acupuncture is used in the majority of studies. The
The reporting quality and internal validity are generally poor, most frequently used acupoints are GB 8 Shuaigu,
as confirmed by three different scales. All 17 studies compared GB 20 Fengchi, LI 4 Hegu, LR 3 Taichong and Ex-
acupuncture with western medications, and participants HN 5 Taiyang. The findings of this review need to be
could not be blinded to treatment allocation. Furthermore, interpreted with caution as the quality of the included
no trial described whether the acupuncturists were blinded studies is poor.
to outcome assessment or whether an independent assessor/
evaluator was employed. No trials reported the detailed process
of randomisation or the reasons for drop-out. studies should improve the reporting quality and trial design
and present detailed data of the outcome measures. Profiles
Another major shortcoming of the Chinese literature is the of the side effects of acupuncture should also be recorded.
assessment of the outcomes. First, the effect of acupuncture Furthermore, it is important to include trials published in
on acute attacks was not investigated. Second, the Chinese Chinese in meta-analyses.
trials neither presented detailed clinical data nor separated the
immediate effect from the long-term effect. As a result, we IMPLICATIONS FOR CLINICAL PRACTICE
cannot determine the duration of the effect of acupuncture on Acupuncture might be an effective prophylactic treatment for
migraine. Third, although many included studies claimed that migraine. It can be used either alone or in conjunction with
they assessed the time-profile and intensity of migraine, none western medications.
of the studies described either the use of a diary, a method
recommended by the IHS,40 or how the data were recorded.
The poor reporting quality and lower internal validity might
Acknowledgments
have contributed to the over-estimation of the effect size. POTENTIAL CONFLICTS OF INTEREST
None. The authors recently completed a randomised, controlled
Most Chinese trials implemented nearly daily treatment, clinical trial of acupuncture for migraine.
which is much more frequent than the treatments provided in
studies included in the other two SRs.4,6 It is unknown whether CONTRIBUTION OF REVIEWERS
frequent treatment is associated with better results. Except YYW and ZZ contributed to the development of the protocol,
for one study using empirical points alone, the remaining 16 paper selection, data extraction and assessment of quality.
trials selected traditional acupoints and provided the basis for YYW, ZZ and CX contributed to interpretation of the data
point selection. All of them are in accordance with the classic and writing of the manuscript.
literature. From the available data, we cannot conclude how
frequent the treatment should be and which formula is the
best. The ideal acupuncture treatment, in terms of frequency
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Chinese Medicine and the
Yi Jing ’s Epistemic Methodology
Lifang Qu MMed
Shanghai University of Traditional Chinese Medicine, Shanghai, China
Mary Garvey* MHSc

College of TCM, University of Technology, Sydney, Australia
ABSTRACT
Traditional Chinese medicine and contemporary biomedicine have developed methodologies
that observe and investigate the human body from different epistemological perspectives. Their
conceptual differences have been a recurring topic in the West. The contribution of our article
to this topic draws on the ontological and epistemological insights found in the Yi Jing (Book
of Changes). Readers will already be familiar with the argument that Chinese medicine has been
profoundly influenced by the Yi Jing’s use of yin-yang theory. This paper offers a fresh perspective
by examining the Great Commentary’s dao-xiang-qi cosmology. ‘Dao-xiang-qi’ stands for abstract
principles, emergent manifestations, and concrete objects, respectively, and this triadic conception
of reality leads to an analysis of the human body from a holistic, process-oriented epistemology.
The interpretations of reality and being contained in the Yi Jing were developed by careful and
detailed observation over time, and have deeply influenced China’s philosophical and scientific
traditions, including medicine. The effect of the dao-xiang-qi (way-image-vessel) triad on Chinese
medicine has lead to its characteristic dao xiang epistemic: investigations of human health and
illness focus on the living body and result in a more functional or process-oriented epistemic.
Relatively speaking, biomedical investigations are guided by a qi-vessel epistemic that places more
importance on objective, physicalist information and on quantitative and concrete data. The
purpose of this paper is to explore the Yi Jing’s influence on medical epistemics and the influence
of dao-xiang-qi for Chinese medical investigations and methodologies. The paper does not attempt
an analysis of biomedical epistemics but inevitably the discussion touches on issues pertaining
to the integration of Chinese medicine and biomedicine occurring in recent times. Integration
presupposes some degree of philosophical and methodological commonality and to that extent we
draw attention to the ontological and epistemological assumptions of both medicines.
K E Y W O R D S biomedicine, Chinese medicine, epistemology, integration, materialism,

methodology, ontology, Yi Jing (Book of Changes).
Introduction
During the nineteenth and early twentieth centuries, the scientific medicine and traditional medicines has become
survival of China’s traditional medical practices seemed part of a global health strategy promoted by the World
doubtful as they struggled to compete with the evidence, Health Organization as recently as 2002,1 and in China the
advances and technologies of the emerging western medical integration of Chinese medicine and biomedicine has already
sciences. But then, in the late 1950s, Mao Zedong declared occurred to a large extent.2,3 Since 1958 the highest levels of
Chinese medicine ‘a great treasure house’ and its continued Chinese government have actively pursued unification, or
existence was ensured. The integration of contemporary more recently, integration, as ‘national policy . . . backed by
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Yi Jing’s Epistemic LF Qu and M Garvey
Methodology
strong public support’.4,5 Official government policy has also its dao xiang qi (道象器, way-image-vessel) cosmology, and
encouraged modernisation and scientisation, so that today the consequent theories of being (ontology) and of knowing
Chinese medicine must highlight its status as an icon of (epistemology) that connect all phenomena. Dao-xiang-qi has
Chinese culture and at the same time, measure up to scientific important epistemological and methodological consequences
scrutiny.6 for investigating the world and human life. References to
contemporary scientific medicine are given to highlight those
Western sciences pursue the investigation of material and consequences and some of the problems for integration.
objective phenomena and the label ‘scientific materialism’
defines this endeavour. Scientific enquiry uses empirical and The Yi Jing investigates material and immaterial reality using
analytic-deductive methods that rely on objective technologies symbols and metaphors that afford insight into the principles
and quantifiable data, and favour reductionism and linear governing life and the cosmos. The text’s yin-yang method,
causality. Scientific observations therefore tend to deal with with its analogic-inductive reasoning, is a more appropriate
phenomena that can be recorded and quantified in an objective tool for this enterprise than the analytic-deductive logic of
way. Its methods of investigation attempt to reduce variables, the Greek tradition and contemporary sciences. The Yi Jing’s
utilise repeatable experiments, and apply measurement and symbols, metaphors and interpretations are based on guan (观,
analysis to isolated factors and individual components. Some comprehensive observation). Guan requires the observation
recent scientific theories (systems, quantum, complexity, bio- and contemplation of nature’s ‘organic relationships . . . [and] a
coherence) may challenge these broad principles, but in the long period of time to make correct adjustment and to achieve
meantime, biomedicine also utilises scientific methods of a neatness and simplicity that would cover the totality of nature
investigation and analysis. and life’.9
The qualitative nature of early Chinese sciences, including The early forms of Daoism, Confucianism and medicine
medicine, generally emphasised relational and functional that arose in China before the Qin Dynasty (221–206 BCE)
patterns rather than quantitative or physicalist information. developed in distinct ways over the next two millennia, but all
Being less concerned with the physical details of body three drew from the Yi Jing’s onto-cosmological assumptions
organs and tissues, medical investigations instead produced a and methods. Historically, Chinese medical texts frequently
‘sophisticated analysis of how functions were related on many acknowledge the importance of the Yi Jing for medicine. In the
levels, from the vital processes of the body to the emotions Tang Dynasty (618–906 CE), Sun Si-Miao said: ‘If you don’t
to the natural and social environment of the patient, always understand the changes, you cannot practice medicine.’ [不知
with therapy in mind’.7 Chinese medical theories codified 易，不足以言太医.]10 In 1624 Zhang Jie-Bin said:
these relational qualities. They assumed principles of holism
embracing complexity, the connectedness and interaction of Medicine and the Yi Jing are the same. [This is because] Nature/
all things, and the non-separability of body and mind. As for heaven and the human body conform to the same laws, namely, the
contemporary biomedicine, Chinese medicine’s methodologies principles of yin-yang. And though medical practice is complicated,
were largely empirical. But the Chinese were concerned with we can use yin-yang to summarise and analyse all its permutations.
whole systems, dynamic complexity over time, interactivity, [医易相同。天人一理也，一此阴阳也。医道虽繁，而可
and subjectivity. They were also concerned as to whether 一言以蔽之者，曰：阴阳而已.] 11
nature could be fully comprehended by rational, empirical
investigation and this led to an abiding interest in the idea The high regard traditionally accorded Yi Jing is more than
that the scale of nature and the cosmos is too large, its texture convention. In the next section, we examine the influence of its
too subtle and fine, too closely intermeshed for phenomena to dao-xiang-qi triad for the philosophical assumptions concerning
be fully predictable. ‘This proposition denies that the physical the nature of reality and being, and the approach to ‘knowing’.
world can be fully penetrated by study, or fully described in Following that, we explore how these assumptions and concepts
words or numbers’.8 have influenced the Chinese medical tradition.
Yin-yang theory is the core of early Chinese philosophy, and

all China’s ancient sciences were formed from and deeply
Yi Jing epistemics: dao-xiang-qi
influenced by it. The pragmatic application of relational, The Yi Jing’s triadic analysis guides its investigation of all
contingent concepts such as yin-yang is characteristic of the phenomena. The result is a sophisticated synthesis, or ‘natural
Chinese medical tradition, a tradition that is closely related to law’, that applies to all of creation. The Yi Jing categorises the
the onto-cosmological framework of the Yi Jing (易经, Book essences of the myriad beings, and a being’s behaviour in the
of Changes), the oldest and most famous of China’s ancient world is largely determined by the category (类, lei) to which it
classics. To further examine the Yi Jing’s influence, we discuss belongs. The concept of lei also plays a significant role in the Nei
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Jing Su Wen, where phenomena are systematically associated becomes apparent and can be seen,’14 meaning: the observable
with the five phases (五行, wuxing) by, for example, describing indications of yin-yang law are called xiang.
things as ‘of the category of fire’ (类火, lei huo).12 In the Yi
Jing, lei is linked to the notion of a common origin, meaning Xiang reveals the existence of the dao’s governing potentials
the dao. In both cases these are not logical statements of fact so and activities, including yin-yang law; it is the bridge linking
much as probabilistic or analogic-inductive observations. invisible (道, dao) and visible (器, qi). So when the changes
and transformations of yin and yang become apparent, this
DAO 道 : ‘WHAT IS ABOVE THE FORM IS produces xiang. Xiang (象) means manifestation, image and
CALLED THE DAO.’ symbol, and since the Song Dynasty (960–1279 CE), the term
The Yi Jing achieves its ‘penetrating syntheses’9 of categories, has been used in its modern sense of ‘phenomenon’.13
changes and natural law by the application of its dao-xiang-
qi onto-epistemic and yin-yang analytic method. Its analysis All macrocosmic and microcosmic phenomena are modelled
of categories, changes and transformations connects and on the xiang-manifestations. Heaven and earth are associated
integrates all of creation, and its methods and interpretations with two kinds of xiang: ‘images’ and ‘symbols’ (象, xiang)
have served as primary resources for the investigation of all belong to heaven, and ‘forms’ (形, xing) belong to earth. The
phenomena, material and immaterial. For the Yi Jing and early Great Commentary says:
Chinese onto-cosmology, nothing is greater than heaven and
earth, and in all areas of early Chinese theorising, nothing is In heaven perfecting symbols 象; on earth perfecting forms
bigger and nothing is smaller than yin-yang. 形: change and transformation become apparent. . . . What is
above form is called the ‘Way’; what is below form is called the
According to the Nei Jing, yin and yang are the ‘way’ (dao, or ‘vessel’.13,15
‘natural law’) of heaven and earth. In Su Wen (chapter 5: Yin
Yang Ying Xiang Da Lun – ‘Great Treatise on the Interactions QI 器 : ‘WHAT IS BELOW THE FORM IS
and Manifestations of Yin and Yang’), the comprehensiveness
CALLED THE QI-VESSEL’
of yin-yang theory for cosmology, the environment, human According to the Great Commentary: ‘What may be seen is
physiology, diet, emotions, illness, ageing, and so on, is spoken of as [象, xiang]. What has physical form is spoken of
explained. This is yin-yang natural law as it applies to human as [器, qi].’16
life, including the relationships, manifestations and interactions
within and between macrocosmic (nature) and microcosmic Whilst the dao (道) is without substance and before time, qi
(human life) phenomena. Because human life is one kind of (器) is substantial and subsequent in time, and the binome,
natural phenomena it must also follow the way of yin-yang. daoqi (the way and vessel), expresses the relationship of
So yin-yang has provided an effective guiding principle for that between the abstract and concrete. In the Yi Jing, qi-
Chinese medicine since earliest times. In the Nei Jing it is used vessel refers to ‘everything that does not depend on human
extensively to discuss the connections between nature and consciousness but is the objective object of all sensation and
human life and health (also see, for example, Su Wen, chapter awareness. . . . [The] Chinese notion of qi-vessel is very close
3: Sheng Qi Tong Tian Lun – ‘On Human Life’s Union with to . . . the Western notion of matter [except that it] lacks the
Heaven/Nature’). traditional Western mechanistic interpretation of matter’.13
While xiang-manifestation and qi-vessel are both perceptible
When arranged in the earlier heaven (先天, xian tian) things in the world, the qi-vessel has a determined shape and
sequence, the Yi Jing’s eight trigrams (八卦, ba gua) represent can be seen and felt. The xiang, as emergent manifestation or
the universal potential before space, time, and movement – the process-event, does not have a determined shape.
dao. The xian tian arrangement is the cosmogenic principle and
the source of the later heaven sequence. Similarly, the relation Early Chinese philosophy tends to assume that the dao (abstract
of the dao-way to qi-vessels is that of universal principles to principles) exists before and produces the material world, and
local particulars, abstract to concrete.2,13 all phenomena come from the dao.17 So in the Yi Jing, the
dao is the governor, qi is the result, and xiang is the interface
According to the Yi Jing and its Great Commentary (大传, Da between dao and qi – if there is no dao there can be no xiang
Zhuan), the dao (道, the way) is not visible – it is before time and and no qi. Conversely, it is difficult to maintain that the dao
without substance; the qi (器, vessel, tool or container) is visible exists independently of phenomena. In other words, if there
– it is subsequent in time, it has substance and a determined can be no abstract principle apart from concrete phenomena,
shape. The xiang (象, image) can be observed but does not then from qi-vessel the xiang must appear, and the xiang must
have a determined shape; it is the emergent manifestation of have the dao working behind it. Whilst Chinese philosophy
the dao. Wang Bing (8th c. CE) said: ‘Xiang means something emphasises the first direction, our understanding in fact comes
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from the second because it is based on the observation of XIANG: ZANG XIANG XUE
natural phenomena. As the PRC Marxist historian Fan Wenlan The differences between zang qi (脏器) and zang xiang (脏象)
(1893–1969) explained: ‘The dao is the rule of nature extracted research objects and methodologies are fundamental. Reductive
from all physical things.’18 physicalism and zang qi investigations have little to do with the
xiang, and of course no need for the dao. As an example of zang
In any case, dao-xiang-qi cannot be separated: they are not qi methodology, the biomedical anatomy tradition reflects the
independent, they are not divisible entities or parts of existence, onto-epistemic of scientific materialism – anatomical research
and the Yi Jing’s epistemic tradition recognises all three aspects methods provide knowledge of objective physical structures.
(dao, xiang and qi), and both levels (above and below the
‘form’). To that extent, the clear differentiation between the Historically, however, the object of enquiry is the corpse without
physical and the metaphysical made by Aristotle is much less life phenomena. Lu Mao-xiu’s (1818–1886) famous rebuttal
distinct in the Chinese tradition. of Wang Qing-ren’s (1768–1831) Correcting the Errors in the
Forest of Medicine decried the ‘moral turpitude and medical
Guided by the Yi Jing’s onto-epistemic, Chinese medical irrelevance of direct anatomical investigations’.19 Although
traditions explore human life phenomena, including visceral Wang’s criticisms of the medical classics in favour of anatomical
(脏, zang) functions and manifestations (脏象, zang xiang). The investigations could be viewed as the beginning of ‘modern’
zang are deep inside the body and the xiang are their observable Chinese medicine, his revisions in fact seem ill-informed and
manifestations. Over time, comprehensive observation and the redundant today.20 Lu gave voice to the prevailing (traditional)
understanding of reality, including xiang-manifestation, meant attitude towards the zang qi level of inquiry, noting the obvious
that Chinese medical methodologies are characterised by zang problems of examining lifeless body structures.
xiang xue (脏象学) – medical investigation with a functional
perspective based on observable phenomena – rather than by a Although the methods and technologies of today’s medical
zang qi xue (脏器学) – the reductive physicalist perspective of sciences are so much more advanced and successful, the
anatomical and micro-anatomical investigations. zang-qi onto-epistemic still operates to guide research issues,
interpretations and outcomes. From the point of view of the dao-
Dao-xiang-qi and Chinese xiang-qi onto-epistemic, it is not possible to acquire knowledge

of human life by relying on qi-vessel data alone because the
medicine’s epistemic methods investigation of isolated body structures and substances remains
at the level of zang-qi physicalism, where the essence (精, jing)
DAO: YIN-YANG METHOD
is exhausted, qi movement (气机, qi ji) has ceased, and both
From the discussion so far, we see China’s early theories of being the body form and consciousness (形神, xing-shen), and yin
and knowing propose the dao as the undifferentiated potential and yang have separated.
behind all of creation, and yin and yang as the expression of the
dao in nature. On the human scale, yin and yang are unified The term ‘zang-qi’ is not much used in Chinese medicine and
to form a new individual at conception; disease arises when mention of it in the Nei Jing is very rare, but Chinese medicine
yin and yang are disordered, and death occurs when essence qi does recognise all three aspects of the dao-xiang-qi model. Its
(精气, jing qi) is exhausted and yin and yang separate. Today, investigations, however, are focused primarily on the zang xiang
Chinese medicine’s basic theories, diagnostic frameworks and aspect – the emergent manifestations of the integrated systems
therapeutic methods still embrace the yin-yang epistemic and processes of human life. Specifically, traditional Chinese
method. But its encounters with external knowledge systems medicine’s human systems and processes include the five viscera
and advances have forced Chinese medicine to undertake (五脏, wu zang) and their associated hollow organs (腑, fu), the
extensive revisions to scientise and systematise its methods and five offices or sense organs (五官, wu guan), five body tissues
practices. Additionally, there are the political pressures to unify, (五体, wu ti), five spirits (五神, wu shen), and five minds (五志,
merge, or integrate with its biomedical counterpart.5 wu zhi). In health, all the body’s systems and processes are well-
integrated, and all aspects of qi movement, including the five
Traditional Chinese medicine and contemporary biomedicine phase relationships of engendering (生, sheng) and restraining
both observe and investigate human physiology and pathology, (克, ke), are appropriate and orderly. Orderly qi movement
but their philosophical assumptions and methodologies are produces the harmonious function of yin and yang and unifies
fundamentally different. Here we will distinguish the two by the body form (形, xing) and mind (神, shen). Zang xiang
the epistemic methods identified above: the zang xiang xue and theory therefore applies not only to internal organs, but also to
zang qi xue. their systemic influences, structures, and substances, external
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senses and tissues, consciousness, perceptions, movements and

transformations. In other words, zang xiang leads to a holistic
Conclusion
analysis of the living body and whole person. The scale and complexity of nature, its fine textures and
subtleties, were the subject of investigation in China before
QI: ANCIENT ANATOMY recorded history. In addressing these issues, the Yi Jing’s
We know the Chinese performed detailed anatomical sophisticated analyses and syntheses provide an onto-
dissections because even in the Nei Jing the body’s internal hermeneutic framework that has profoundly influenced
structures are described along with their positions, size, length, Chinese thinking. Furthermore, the Yi Jing is the philosophical
capacity, and so on. Many of the organs and measurements root of Chinese medicine, and historically its dao-xiang-qi
given in the Nei Jing Ling Shu (chapters 31 and 32) are the same onto-epistemic is embedded in the development of Chinese
or very close to those we observe today. Why Chinese medicine medicine’s theoretical and clinical methodologies. Chinese
did not pursue a materialist-physicalist (zang-qi) approach medicine recognises all three aspects of the dao-xiang-qi triad,
to its investigations is a question that Joseph Needham and not only zang-qi physicalism, and even today, the Yi Jing’s yin-
Nathan Sivin have frequently approached and refined. Readers yang methodology deeply penetrates its theoretical concepts
will be familiar with the arguments that China’s socio-political and clinical practices.
structures stymied technological and scientific innovation to
some extent, and that traditions respecting one’s ancestors and The Yi Jing’s yin-yang epistemic method encompasses and
parents meant that one’s body should not be dismembered or connects all phenomena because it contains the dao and expresses
dissected. Sivin has challenged the relevance of the question ‘natural law’. In light of the Yi Jing’s onto-hermeneutics, the
itself for an unbiased enquiry into Chinese ‘sciences’. nature and activities of life may be observed at the point of
emergence (xiang) between the dao and qi aspects of reality, and
In our opinion, the Yi Jing’s onto-hermeneutic perspective medicine must account for basic and essential life categories
served as a guiding principle in the Nei Jing and has been a and activities (the yin-yang balance, unified xing-shen, the
critical influence for the epistemic methodologies informing jingluo, qi movement, mingmen, and so on). In this paper we
Chinese medicine’s theoretical developments. Today, Chinese have argued that, comparatively speaking, a biomedical focus
medicine still observes the living body as integrated process- is primarily within the parameters of zang-qi physicalism, and
systems that depend on orderly qi movement, the harmonious its epistemic methods therefore emphasise information on
interaction of qi and blood, and the dynamic balance of yin material structures and components. Inevitably, zang xiang
and yang. Its interventions attempt to restore and maintain (脏象) functional and zang qi (脏器) physicalist perspectives
those movements and interactions. Therapeutic adjustments have developed different theories about health and disease, and
at that level are believed to create optimum circumstances herein lies the difficulty in comparing and integrating the two
whereby xing (形) and shen (神) are unified, the jing-qi-shen medical traditions.
(精气神) are strong and well integrated, the wu xing (五行)
relationships are orderly, and human life unfolds. Guided by their onto-hermeneutic traditions, Chinese medical
and biomedical researchers and practitioners employ different
Clinical Commentary
This paper does not discuss particular disease states, treatment strategies or prescriptions. Instead it raises some
of the epistemological and methodological issues faced by Chinese medicine as it appraises its place in the
contemporary healthcare industry, absorbs the impact of biomedical advances and technologies, and realigns
its traditional assumptions to conform to a more scientised investigation of human health and disease. The paper
notes that the ‘integration’ of Chinese medicine into contemporary healthcare delivery systems consists of the
‘biomedicalisation’ of its interventions and conceptual frameworks.
The onto-cosmological frameworks of medicine have important methodological consequences for investigating
the human form, the object of treatment. The changes and revisions Chinese medicine has undergone in recent
decades have caused a shift away from the more process-oriented and contingent methods that developed early
in its history and are closely related to its traditional view of being and reality.
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TABLE 1 Glossary of terms 易经 Yi Jing or

Book of Changes, I Ching
(易經) I Ching
八卦 ba gua eight trigrams ‘Great Treatise on the Interactions
阴阳应象 Yin Yang Ying
大传 Da Zhuan the Yi Jing’s Great Commentary and Manifestations of Yin and
大论 Xiang Da Lun
Yang’
道 dao the way, or law of nature 脏 zang internal yin viscera
道器 dao qi the way and vessel medical investigation with a
脏器学 zang qi xue
道象器 dao xiang qi quantitative-materialist perspective
way image vessel
medical investigation with a
腑 fu yang (hollow) organs 脏象学 zang xiang xue
functional-processual perspective
观 (觀) guan comprehensive observation
精 jing essence
methodologies appropriate to their favoured perspectives of
经络 jing luo channels and collaterals
reality. But today, the criteria and methodologies of biomedicine
精气 jing qi essence Qi are applied to investigate, evaluate and validate Chinese
medicine. Science is used to research Chinese medicine’s
精气神 jing-qi-shen essence-Qi-spirit
therapeutic interventions and to correct and modernise its
克 ke restrain, check theoretical content. Thus, the integration of biomedicine and
类 (類) lei kind, category Chinese medicine in reality means that biomedicine is practised
according to its own epistemic methods, whereas Chinese
灵枢 Ling Shu ‘Miraculous Pivot’ medicine is practised according to biomedical and Chinese
命门 ming men life gate epistemic methods – despite their fundamental differences.
内经 Nei Jing (Huangdi’s) Internal Classics
If we employ the Yi Jing’s dao-xiang-qi onto-epistemic to
气 (氣) qi Qi evaluate biomedicine, we find it is primarily concerned with
器 qi vessel, container developing our knowledge of human anatomy, physiology and
pathology at the level of qi-vessel physicality. Even though
气机 qi ji Qi movement; Qi dynamic biomedical research is advancing rapidly, it remains conceptually
认识方法 renshi fangfa epistemic method bound to materialist-physicalist ontologies and interpretations,
and in our opinion, research that neglects the xiang (象) and
认识论 renshilun epistemology
shen (神) cannot reflect the complexity and subtlety of human
三宝 san bao three gems/treasures; jing-qi-shen life. This is why some areas of zang-xiang xue (such as 三宝,
san bao; 命门, mingmen; and 经络, jingluo) are unlikely to be
生 sheng life, movement, engendering
investigated, or have proved so difficult to investigate, using
生气通 Sheng Qi Tong ‘On Human Life’s Union with scientific methods.
天论 Tian Lun Heaven/Nature’
素问 Su Wen ‘Plain Questions’ The fundamental differences between Chinese medicine and
五官 wu guan five offices or sense organs biomedicine constitute the basis for on-going intellectual and
political tensions between the two, and to some extent within
五神 wu shen five spirits our medical and healthcare industries.21 We contend that
五体 wu ti five body tissues the dissimilarity of their respective epistemic and ontological
assumptions is significant, and that the ‘modernisation’ and
五脏 wu zang five viscera
‘integration’ of Chinese medicine cannot be realised by simply
五志 wu zhi five minds discarding its philosophical underpinnings and adopting
biomedical epistemics and technologies.
五行 wu xing five phases
先天 xian tian earlier heaven
image, manifestation,
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Modern Applications of
Modified Ban Xia Xie Xin Tang
and Their Development
Hong Xu* PhD
Faculty of Health, Engineering and Science, Victoria University, Melbourne, Australia
Wen-Xuan Zhang PhD

Department of Wen Bing, Beijing University of Chinese Medicine, Beijing, China
ABSTRACT
Traditional Chinese medicine (TCM) classic formulae have evolved over hundreds of years; however,
their applications and modifications can be further developed. The classic formula Ban Xia Xie Xin
Tang (Pinellia Decoction to Drain the Epigastrium; BXXXT), which was originally prescribed by
Zhang Zhong-Jing in the Han dynasty (150–219), can be modified and used flexibly in treating
various abdominal disorders. In the Qing dynasty (1644–1911), Wu Ju-Tong (1758–1836) wrote
the book Wen Bing Tiao Bian (Systematised Identification of Warm Pathogen Diseases), outlining
his eight modifications to BXXXT based on Ye Tian-Shi’s (1667–1746) clinical applications of
BXXXT and its patterns. Ye applied BXXXT in two main ways. The first involved the use of
bitter, pungent, dispersing and purging herbs to treat damp heat; the second was used to purge
jue yin and unblock yang ming in order to treat various symptoms caused by Liver wood attacking
Stomach earth. Wu followed Ye’s methodology and developed eight modifications to BXXXT.
These can treat summer heat-damp (shu shi), lurking summer heat (fu shu) and damp-warm
(shi wen) conditions. They can also treat jue yin Liver conditions or Liver Qi attacking Stomach
patterns. This article discusses the use of Wu Ju-Tong’s eight modifications. Modern clinical cases
including nausea, vomiting, abdominal distension, stomach ache, diarrhoea and infertility have
been used as examples to illustrate the flexible use of BXXXT.
K E Y W O R D S Chinese herbal formula, Ban Xia Xie Xin Tang, Wen Bing, abdominal
disorders, patterns of disharmony.
Introduction
Ban Xia Xie Xin Tang (BXXXT) is derived from the Shang Han as pi syndrome (痞, gastric stuffiness). Jin gui yao lue – nausea,
Lun (‘Treatise on Cold Damage Diseases’, clause 149) and vomiting and diarrhoea (clause 10) – indicate that nausea,
is used for shang han chai hu syndrome, where purging was intestinal rumbling and pi can be treated with BXXXT.
wrongly applied.1 It was originally developed to regulate focal According to Ye Tian-Shi’s (1667–1746) Wen Bing Lun
distension and epigastric fullness due to the accumulation of (‘Treatise on Warm Pathogen Diseases’), the pathogenesis of
endogenous pathogenic cold and heat in the gastrointestinal wen bing damp-heat stasis in the middle jiao can be treated with
organs, with an underlying deficiency of Spleen and Stomach. bitter and purging herbs. The formula BXXXT treats exterior
Appearance of glomus below the heart with no pain is defined damp-heat. In Lin Zheng Zhi Nan Yi An (‘Guide to Clinical
Australian Journal
Modern Applications of H Xu and WX Zhang
Cases’), BXXXT was frequently used for treating summer- heat, the movement of Qi is disrupted, resulting in dry retching
damp, damp-heat, malaria and dysentery. Wu Ju-Tong edited or nausea and vomiting. Abdominal pain, intestinal rumbling
Ye Tian-Shi’s cases and in his Wen Bing Tiao Bian developed and diarrhoea also occur. Cold and heat need to be removed,
eight BXXXT modifications based on Ye’s basic methods of ascending and descending Qi function needs to be restored and
applying BXXXT.2 the Spleen and Stomach must be tonified.5
Wu Ju-Tong (1758–1836) made a significant contribution to The formula uses the bitter, cold, descending and purging
Wen Bing Xue (the Study of Warm Pathogen Diseases) and is natures of Huanglian (Rhizoma Coptidis) and Huangqin
renowned for his formulae and San Jiao Bian Zheng (Triple (Radix Scutellariae) to remove the heat; the pungent and
Energizer Pattern Identification). A devoted follower, he studied warm qualities of Ganjiang (Rhizoma Zingiberis officinalis) and
and further developed Ye Tian-Shi’s theory. His modifications Banxia (Rhizoma Pinelliae ternatae) to unblock stasis and to
of BXXXT provide a different therapeutic perspective to the disperse the cold; the sweet and warm nature of Renshen (Radix
Cold Damage Diseases of the era of Zhang Zhong-Jing (150– Ginseng), Gancao (Radix Glycyrrhizae uralensis) and Dazao
219), some 1500 years earlier.3 (Fructus Zizyphi jujubae) to benefit Qi and to tonify deficiency.
The seven herbs, which utilise cold and hot, bitter descending
BXXXT and the eight and pungent dispersing to tonify Qi and harmonise the middle
jiao, naturally reset the balance.
modifications
The herbal compositions of the eight modifications of BXXXT6
The original formula BXXXT is from Shang Han Lun: are listed in Table 1. The frequencies of the use of specific
Banxia (Rhizoma Pinelliae ternatae), 9 g; Huangqin (Radix herbs in the original and eight modified formulae are listed
Scutellariae), 9 g; Ganjiang (Rhizoma Zingiberis officinalis), 9 g; in Table 2. Their indications are illustrated in Figure 1. These
Renshen (Radix Ginseng), 9 g; Zhigancao (Radix Glycyrrhizae modifications reflect the understanding and methodology of
uralensis, prepared), 9 g; Huanglian (Rhizoma Coptidis), 3 g; Ye, including Wu Ju-Tong’s personal understanding. All have
Dazao (Fructus Zizyphi jujubae), 4 pieces.4 Formula actions been successfully applied clinically.
include harmonising Stomach and descending rising Stomach
Qi, dispersing stasis and removing pi. The pattern treated
is Stomach Qi disharmony. Symptoms and signs include pi
Case studies
below the heart that is painless, dry retching or nausea and CASE 1: USING BXXXT TO TREAT
vomiting, intestinal rumbling and diarrhoea, thin yellow and PHLEGM QI STAGNATION 7
greasy tongue coating, wiry rapid pulse.4 A 36-year-old male had consumed excessive alcohol for a
long time, resulting in alcohol-damp damaging the Spleen
Pi is Qi that is blocked, with fullness but no pain, and a soft and Stomach, which inturn weakened the transport and
sensation when pressed. Due to the accumulation of cold and transformation functions of Spleen and led to disharmony
TABLE 1 The composition of Ban Xia Xie Xin Tang (BXXXT) and its eight modifications
Original BXXXT formula herbs Added herbs
Rx Ban Huang Huang Ren Gan Da Gan Zhi Sheng Bai
Others
No.* Xia Lian Qin Shen Jiang Zao Cao Shi Jiang Shao
Xinren
M1    
M2     
M3      
Muli
M4     
M5      
Jinyinhua, Charcoaled
M6     Shanzha, Muxiang
M7       
M8      
* Rx No. = Case study formulae as outlined in Figure 1
Australian Journal
TABLE 2 The frequencies of use of specific herbs in the original Ban Xia Xie Xin Tang
and eight modified formulae
BXXXT M1 M2 M3 M4 M5 M6 M7 M8 F*
Huanglian          9
Huangqin         8
Zhishi       7
Banxia       6
Ganjiang       6
Renshen      5
Shengjiang     4
Baishao    3
Xinren  1
Dazao  1
Gancao  1
Muli  1
Jinyinhua  1
Charcoaled Shanzha  1
Muxiang  1
* M1–8 = Case study formulae as outlined in Figure 1. F = frequencies of use of specified herbs.
of middle jiao Qi, generating phlegm. The phlegm further in the morning the food consumed the night before. He also
affected lifting and descending functions of the middle jiao complained of recent, frequent nausea and vomiting once
Qi, and resulted in pi with nausea, vomiting and diarrhoea daily or every second day. Apart from food, he also vomited
three to four times a day. He had no significant improvement a large amount of acid. Normally he experienced tastelessness
after receiving previous treatments. The tongue body was red, and had no appetite. He felt depressed and had abdominal
tongue coating white, pulse wiry and slippery. bloating after food, acid regurgitation, lower back pain, cool
extremities, frequent and excessive urination. He had deep-red
The symptoms were due to phlegm Qi blockage resulting in pi. lips, red tongue body, thin white and slippery tongue coating,
BXXXT can be used. Modified BXXXT was prescribed, using and deep-weak-thready pulse.
Banxia (Rhizoma Pinelliae ternatae), 12 g; Ganjiang (Rhizoma
Zingiberis officinalis), 6 g; Huanglian (Rhizoma Coptidis), The diagnosis was earth deficiency with wood attacking and
6 g; Huangqin (Radix Scutellariae), 6 g; Dangshen (Radix adversely affecting the movement of Stomach Qi. Treatment
Codonopsitis pilosulae), 9 g; Dazao (Fructus Zizyphi jujubae), 7 principles were to control the Liver and harmonise the
pieces; Zhigancao (Radix Glycyrrhizae uralensis, prepared), 9 g. Stomach. Four doses of formula BXXXT were prescribed,
After taking one dose, the patient passed lots of white sticky containing Zuojinwan (Left Metal Pill), 9 g; Banxia (Rhizoma
mucus in his stools. Nausea and vomiting reduced significantly. Pinelliae ternatae), 9 g; Renshen (Radix Ginseng), 9 g; Huanglian
After taking the second dose, the pi and diarrhoea were both (Rhizoma Coptidis), 6 g; Huangqin (Radix Scutellariae), 6 g;
reduced. After taking four doses he completely recovered. Ganjiang (Rhizoma Zingiberis officinalis), 6 g; Wuzhuyu (Fructus
Professor Liu Du-Zhou commented that this was a case of tan- Evodiae rutaecarpae), 6 g; Zhigancao (Radix Glycyrrhizae
qi-pi (phlegm-Qi-pi), traditionally treated with BXXXT.7 uralensis, prepared), 3 g; Dazao (Fructus Zizyphi jujubae), 3
pieces. Once the treatment started, the patient only had mild
CASE 2: USING BXXXT TO TREAT nausea and vomiting twice, vomiting clear fluid, phlegm,
REFLUX 8,9 saliva and a small amount of food. No acid taste or acid reflux
For two years, a 32-year-old male had suffered from vomiting in occurred but he regularly experienced excessive saliva. It took a
the evening the food consumed the same morning, or vomiting long time for his extremities to become warmer; his urination
Australian Journal
bitter taste in the mouth, stomach and abdominal fullness and

M1*: Jue yin distension after food, dry retching and bad breath, abdominal
heat stasis, bloating that was more severe in the afternoon, difficulty with
phlegm-damp in
Stomach and damp- flatulence, irritability, a wariness of speaking and engaging in
M2*: Both
heat accumulation external and outdoor activities, poor sleep (only sleeping two to four hours
M8*: damp- in middle jiao internal disorders per night) and occasionally pain in the area of the liver. He
heat blocked in (nausea, vomiting,
middle jiao was short and obese. The tongue coating was white/yellow with
abdominal pi and
stomach ache) moisture, and the pulse was deep and strong though slightly
weak at the right guan position.
M7*: M3*: Damp- The diagnosis was chronic stomach and intestinal functional
BXXXT: heat accumulation
Dysentery or
damp diarrhoea
Cold and heat or Stomach yang disorder but with mixed cold and heat, yin/yang disharmony
accumulation, deficiency, yin and lifting/descending disharmony. Zhang Zhong-Jing’s
with additional
Stomach Qi turbid and jue yin
middle jiao pi BXXXT was used to harmonise. Contents of prescription were
disharmony Liver heat stasis
stasis
Dangshen (Radix Codonopsitis pilosulae), 9 g; Banxia (Rhizoma
Pinelliae ternatae, Qing), 9 g; Ganjiang (Rhizoma Zingiberis
M6*: Damp-
officinalis), 4.5 g; Zhigancao (Radix Glycyrrhizae uralensis,
heat dysentery, M4*: Stomach prepared), 4.5 g; Huangqin (Radix Scutellariae), 9 g; Huanglian
severe damp- Qi and Liver
Gallbladder Qi
(Rhizoma Coptidis), 3 g; Dazao (Fructus Zizyphi jujubae), 4
heat, deficient
Stomach yang
M5*: Liver up-rising pieces. After taking the formula, the patient gradually improved.
and Stomach After finishing forty doses over a few months he identified
disharmony
and severe five areas of improvement. The first improvement was better
Liver heat appetite, no stomach bloating and stuffiness after food and
with mild abdominal bloating occurring only occasionally.
* M1, M2, M3, M4, M5, M6, M7, M8 = Modified formulae 1, 2, 3, 4, 5, 6, 7, 8.
The second improvement was enhanced energy levels, with
the patient enjoying walking and participating in outdoor
FIGURE 1 BXXXT and its modifications in relation to activities without feeling tired. The third was improved bowel
patterns of disharmony movements, which were lessened to once a day and in most
cases with lots of wind passing out with the bowel movement.
was still excessive and frequent. His lip and tongue colour The fourth was that pain in the area of the liver disappeared in
changed to normal, but his tongue coating was still thin, general, with mild pain occurring occasionally but disappearing
white and wet. The BXXXT formula was modified to exclude quickly. The fifth was improved sleep with the ability to sleep
Huangqin (Radix Scutellariae) and Huanglian (Rhizoma for more hours each night. A chronic disorder for so many years
Coptidis); and the following were added: Fuzi (Radix lateralis had benefited from this treatment. Later the patient was given
Aconiti carmichaeli, prepared) [Note: this herb is currently a formula to nourish Heart and calm shen (spirit), due to a
not legally available to Australian TCM practitioners – Ed.], difficulty in falling asleep.
9 g; Chaobaizhu (Rhizoma Atractylodis macrocephalae), 9 g;
Buguzhi (Fructus Psoraleae corylifoliae), 9 g; Roudoukou (Semen CASE 4: BXXXT TREATMENT FOR
Myristicae fragrantis, Wei), 6 g; Rougui (Cortex Cinnamomi
INFERTILITY 9
cassiae), 1.2 g (separate pack); Renshen (Radix Ginseng), 9 g. A female, 29 years old, had had a miscarriage three years ago,
With the treatment of one dose every three days continuing for following a three-month pregnancy and without any clear
ten doses, the patient recovered. cause. She had not been pregnant since. Western medical
examinations could not identify any pathology. No significant
CASE 3: USING BXXXT TO TREAT abnormality was found for her or her husband. She had taken
CHRONIC HEPATITIS WITH PI AND Spleen tonifying and Kidney jin nourishing herbs without
BLOATING 10
success. She often experienced lower abdominal coldness,
A male, 42 years old, suffered from poor appetite, fatigue stomach fullness with acid regurgitation, and diarrhoea 1–2
and tiredness, two to four sticky and loose bowel movements times daily. Her menstrual cycle was normal. Tongue body was
per day, abdominal bloating and flatulence. He had been red, coating thin, yellow and greasy.
previously diagnosed with chronic hepatitis. Current lab tests
showed relatively normal liver function. The patient had been Diagnosis was accumulated cold and heat and blocked bao
taking different western medicines and herbs for the symptoms mai. Treatment principles were to remove cold and heat,
with no effect. Current symptoms were poor appetite, slightly regulate Qi and warm the channels. Modified BXXXT was
Australian Journal
prescribed, including Banxia (Rhizoma Pinelliae ternatae), CASE 6: BXXXT AND WU LING SAN (FIVE-
12 g; Dangshen (Radix Codonopsitis pilosulae), 12 g; Xiangfu INGREDIENT POWDER WITH PORIA) TO
(Rhizoma Cyperi rotundi), 12 g; Huangqin (Radix Scutellariae),
TREAT DIARRHOEA
9 g; Ganjiang (Rhizoma Zingiberis officinalis), 9 g; Chenpi (From WXZ’s clinical record.)
(citrus peel), 9 g; Huanglian (Rhizoma Coptidis), 3 g; Zhigancao A male, 35 years old, experienced diarrhoea for a year. The
(Radix Glycyrrhizae uralensis, prepared), 3 g; Dazao (Fructus western medical diagnosis was colitis. Watery diarrhoea
Zizyphi jujubae), 3 pieces. After taking five doses of herbs the occurred 3–4 times every morning; this was aggravated with
patient’s acid regurgitation reduced significantly, the tongue work-related stress. The patient could not drink beer or
coating became thin, yellow and slightly greasy, and other cold drinks as watery diarrhoea occurred immediately after.
symptoms remained unchanged. The above formula was then Abdominal pain occurred before the diarrhoea. There was
modified, removing Huangqin (Radix Scutellariae) and adding Stomach pi and the patient was tired with irritability, dry
Baizhu (Rhizoma Atractylodis macrocephalae) and Sangjisheng mouth, deep red tongue, yellow and slightly greasy tongue
(commonly used dosage: 9–15 g). After a few months the coating, and deep, wiry and slightly rapid pulse. Li Zhong Tang
patient informed the doctor that her period had not come for (Decoction to regulate the middle jiao), Ge Gen Qin Liang
more than 40 days and a test showed that she was pregnant. A Tang (Decoction with Radix Puerariae, Radix Scutellariae and
boy was born after a full-term pregnancy. Rhizoma Coptidis) and Bu Zhong Yi Qi Tang (Decoction to
tonify the middle jiao and augment the Qi) granule formulae
CASE 5: BXXXT PLUS XIAO CHAI HU TANG were used and the diarrhoea increased.
(MINOR BUPLEURUM DECOCTION) TO
TREAT STOMACH ACHE
Diagnosis was depressed wood attacking earth and Liver heat
(From Wen-Xuan Zhang’s (WXZ) clinical record.) with Stomach cold. This was a BXXXT and Wu Ling San
A female, 31 years old, had stomach ache occurring regularly pattern. Five doses were prescribed of Banxia (Rhizoma Pinelliae
for two years due to work-related stress, family issues and a ternatae), 12 g; Ganjiang (Rhizoma Zingiberis officinalis),
long-term unstable mood state. The pain always started when 10 g; Shengjiang (Rhizoma Zingiberis officinalis recens), 10
the patient was hungry or experiencing negative emotions. g; Huanglian (Rhizoma Coptidis), 6 g; Huangqin (Radix
Stomach ache had occurred daily recently, sometimes occurring Scutellariae), 3 g; Zhishi (Fructus immaturus Citri aurantii),
as spasm pain. There was Stomach pi, no appetite, and nausea 10 g; Fuling (Sclerotium Poriae cocos), 15 g; Guizhi (Ramulus
upon waking in the morning. Other symptoms included Cinnamomi cassiae), 10 g. After taking five doses he only had
irritability and a bitter taste in the mouth, chest fullness and one bowel movement per day, which tended to be loose but not
discomfort, and sleeplessness; the tongue was red, coating thin watery and his abdominal pain and pi symptoms disappeared.
yellow, pulse wiry and slightly rapid. His tongue was red, coating greasy and slightly yellow; pulse
was wiry and slightly rapid. A modified formula was given,
This was a typical BXXXT and Xiao Chai Hu Tang pattern, including Banxia (Rhizoma Pinelliae ternatae), 12 g; Ganjiang
with emotional depression, accumulated heat in the Liver (Rhizoma Zingiberis officinalis), 10 g; Huanglian (Rhizoma
Gallbladder attacking the Stomach and Stomach Qi blockage. Coptidis), 6 g; Huangqin (Radix Scutellariae), 3 g; Fuling
Five doses of the following were prescribed: Banxia (Rhizoma (Sclerotium Poriae cocos), 15 g; Guizhi (Ramulus Cinnamomi
Pinelliae ternatae), 12 g; Shengjiang (Rhizoma Zingiberis cassiae), 10 g. Bowel movements became normal after taking
officinalis recens), 10 g; Huanglian (Rhizoma Coptidis), 6 g; 14 doses. Two months later, watery diarrhoea occurred three to
Huangqin (Radix Scutellariae), 10 g; Zhishi (Fructus immaturus four times a day after drinking a lot of beer. He was given the
Citri aurantii), 10 g; Chaihu (Radix Bupleuri), 10 g; Baishao first formula for seven doses and the diarrhoea stopped. He was
(Radix Paeoniae lactiflorae), 12 g; Zhigancao (Radix Glycyrrhizae prescribed BXXXT plus Li Zhong Tang (Decoction to regulate
uralensis, prepared), 6 g. The patient reported that, after taking the middle jiao). He then fully recovered.
the first dose, her stomach ache was relieved and after taking
five doses, the above-mentioned symptoms all disappeared.
Her appetite also increased. She was advised to control her
Discussion
mood and avoid eating too much at each meal. The following THE COMPOSITION OF BXXXT AND ITS
simplified formula was given, including Banxia (Rhizoma EIGHT MODIFICATIONS
Pinelliae ternatae), 12 g; Shengjiang (Rhizoma Zingiberis The herbs commonly used by Wu Ju-Tong for treating pi and
officinalis recens), 10 g; Huanglian (Rhizoma Coptidis), 6 g; its related pattern are: Huanglian (Rhizoma Coptidis), Huangqin
Zhishi (Fructus immaturus Citri aurantii), 10 g; Chaihu (Radix (Radix Scutellariae) (to clear heat and dry damp), Zhishi
Bupleuri), 10 g; Baishao (Radix Paeoniae lactiflorae), 12 g; (Fructus immaturus Citri aurantii) (to regulate and descend
Zhigancao (Radix Glycyrrhizae uralensis, prepared), 6 g. Qi), Banxia (Rhizoma Pinelliae ternatae) (to dispel damp and
descend Qi), Ganjiang (Rhizoma Zingiberis officinalis), Renshen
Australian Journal
Stomach Qi and the Stomach not sending Qi downwards. The

Clinical Commentary Liver attacking the Stomach causes these symptoms; therefore,
BXXXT is used to treat the Liver.
The classic formula Ban Xia Xie Xin Tang (BXXXT) was designed to treat
the mixed pattern of heat and cold which results in Qi moving up and Shang Han academics generally believe that BXXXT is the
down incorrectly and damp heat accumulation. This treatment method main formula for regulating Stomach and Intestine cold and
is particularly useful for treating Liver/Stomach disharmony. The common heat mixed disorder. Based on Ye’s cases in the use of BXXXT
causes of this disharmony are stress and improper diet, which cause to purge the Liver and unblock the Stomach, Wu Ju-Tong
Qi stagnation and damp heat and/or cold accumulation. By comparing determined that BXXXT should be used for jue yin disease as
the original and modified formulae and analysing modern cases, it is a standard method. This is an important development of the
clear that Ban Xia Xie Xin Tang can be modified and used flexibly in traditional view and makes a substantial contribution to clinical
treating a variety of abdominal disorders, including nausea and vomiting, practice.
abdominal distension, infertility, stomach ache and diarrhoea.
WU JU-TONG’S APPLICATIONS OF
YE TIAN-SHI’S BXXXT
(Radix Ginseng) and Shengjiang (Rhizoma Zingiberis officinalis After reviewing Ye’s cases, Wu Ju-Tong, in his book Wen Bing
recens) (to warm and tonify the middle). The main patterns of Tiao Bian, developed Renshen XXT (clause 54) and then San
pi are cold and heat accumulation and Stomach Qi disharmony Ren Tang (Three Kernels Decoction, clause 55). He wrote that,
(see Figure 1). while Renshen XXT uses heavy herbs to remove evils from the
lower jiao, the San Ren Tang uses light herbs to remove evils from
BXXXT AS A FORMULA FOR TREATING the upper jiao. He further commented that in cases of wen bing
JUE YIN DISEASE summer damp-heat, these formulae could be utilised. Banxia
Wu Ju-Tong put a note under the modified Renshen XXT, (Rhizoma Pinelliae ternatae) is the key herb for treating phlegm-
stating that the formula included strong pungent and warm, damp turbidity. Herbs that clear damp-heat and regulate Qi
together with strong bitter and cold herbs, and should have are essential in modified BXXXT formulae, indicating that
been used as a standard method for treating jue yin channel damp-heat is the main pathogen associated with the modified
disorder. The Liver and Gallbladder are close in location, formulae.
which is different to the other zang and fu in TCM. The
Liver prefers warmth and the Gallbladder prefers cold. Zhang
Zhong-Jing’s Wu Mei Wan (Prunus Mume pill) and XXT
References
provided a good basis for future development. Wu Ju-Tong’s 1. Zhang ZJ. Treatise on febrile disease caused by cold with 500 cases.
Luo XW, translator. Beijing: New World Press; 1993.
notes indicate that BXXXT and Wu Mei Wan (Mume pill)
should be in one category because they used the basic rule of 2. Zhang WX. Wen Bing Fang Zheng Yu Za Bing Bian Zhi (温病方
证与杂病辨治). Beijing: Ren Min Wei Sheng Chu Ban She (人
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pungent and warm herbs to treat shao yang disease and treat 4. Xu, JQ, Wang MZ. Formulae (方剂学). Higher medical education
both the Liver and Gallbladder. text book. Beijing: Ren Min Wei Sheng Chu Ban She (人民卫生
出版社); 1995.
Given that BXXXT is a formula for jue yin disease, how do 5. Xu, JQ. Formulae (方剂学). Higher medical education text book.
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Wei Sheng Chu Ban She (人民卫生出版社); 1963.
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TCM is nue (malaria) with a disturbed Stomach that causes 7. Chen M. Liu Du Zhuo Shang Han Lin Zheng Zhi Yao (刘渡舟
伤寒临证指要). Beijing Xue Yuan Chu Ban She (学苑出版
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fu dependant on yin. It should be sending the Qi downwards,
8. Yu CR. Shang Han Lun Hui Yao Fen Xi (伤寒论汇要分析). Fu
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considered a Stomach symptom. Wu Ju-Tong believed that 10. China Academy of Chinese Medicine. Yue Mei Zhong Yi An Ji (岳
nausea, vomiting and pi were caused by a blockage of the 美中医案集). Beijing: Xue Yuan Chu Ban She (学苑出版社);
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Australian Journal
Acupuncture
SOPE: for Migraine:
A Systematic Review
A Model for Developing Online
Materials in Chinese Herbal
Sean W Scott* MBBS(Hons), MMed
Department of Emergency Medicine, Gold Coast Hospital, Southport, Australia
Medicine Education John C Deare BHSc(CompMed), MAppSc(Acu)

Compmed Health Institute, Southport, Australia
Qing Wu1,2 MAppLing Alex Radloff 3 PhD

Angela WH Yang2 PhD Anthony L Zhang2 PhD
Suzi Mansu2 MAppSc Charlie Changli Xue*2 PhD
1. School of Humanities, Beijing University of Chinese Medicine, Beijing, China

2. RMIT Chinese Medicine Research Group, WHO Collaborating Centre for Traditional Medicine,
RMIT University, Melbourne, Australia
3. Pro Vice Chancellor (Academic Services), Central Queensland University, Rockhampton, Queensland, Australia
ABSTRACT
The application of online materials to support classroom teaching may increase the flexibility
of students’ access to course information and facilitate communication between teachers and
students. Quality assurance is the key to the development of online materials. Chinese medicine
degree training has recently been introduced into higher education systems of the western world.
We have recently adapted a four-stage model (SOPE), including strategic planning, operational
practice, product implementation, and evaluation, into the development of online materials
for a Chinese medicine subject – Pharmacology of Chinese Medicine. Following this model,
information on 350 individual Chinese herbs has been presented at RMIT’s Distributed Learning
System to facilitate learning and teaching. This paper describes the process of this development
with a focus on activities and their quality criteria at the four stages. Findings from this study
demonstrate the applicability of the SOPE model in the development of online materials for
primary healthcare practitioner training, such as Chinese medicine. Further study is required
to conduct formal evaluation of the proposed model and its effective implementation in other
educational disciplines.
K E Y W O R D S quality assurance, case study, Chinese medicine education.
Australian Journal
The SOPE Model for Chinese Q Wu, AWH Yang, S Mansu,
Herbal Medicine Education A Radloff, AL Zhang, CCL Xue
Introduction and online learning.10-14 The essential elements for designing

online teaching materials include gathering data (e.g. learner
The application of information technology (IT) in education characteristics and needs), developing materials (e.g. selecting
has had a significant impact on educational practice. Online materials), producing materials (e.g. instructional methodology
materials are particularly important to support classroom combined with technology) and evaluating materials (e.g.
teaching. Online materials may increase students’ access to checking and revising for the fitness of purpose).10,11,14
the course information and facilitate communication between
teachers and students outside of class time.1 However, issues The process of planning, developing and evaluating is frequently
concerning the cost-effectiveness, quality of learning, and discussed in the literature related to online material design.10,15
value-adding in learning are yet to be fully addressed.2 Such The SOPE model is an improved system representing strategic
concerns have negatively impacted on the acceptance of online planning (S), operational practice (O), product implementation
resources,3 particularly for primary healthcare practitioner (P), and evaluation (E). The accessibility of IT is essential for
training such as Chinese medicine. this process. The requirements of IT in the SOPE development
include access to a knowledge base for construction, suitability
Chinese medicine has a long history dating back thousands of of the learning context, and usability as a management tool.16,17
years4 and has been introduced into higher education systems This four-stage process has been used in the online material
of western countries. In Australia alone, four publicly funded development for a Chinese medicine course – Pharmacology
universities offer degree programs in acupuncture and Chinese of Chinese Medicine. This course is designed to teach students
herbal medicine.5 However, Chinese medicine education has the principles of Chinese materia medica and the characteristics
encountered some difficulties in accessing English resources, of a number of individual Chinese herbs, which consist of
as the majority of Chinese medicine literature is in Chinese. actions, meridians entered, dosage range, processing, and
There are limited high-quality online resources that can be contraindications/cautions. This paper attempts to provide a
used in these programs. case study on the development of online materials for the course
of Pharmacology of Chinese Medicine at RMIT University to
The term ‘quality’ has various definitions that need to be illustrate the SOPE model.
interpreted within specific contexts.6,7 Within the context of
education, quality is a multi-faceted, multi-level, and dynamic
description that reflects the specific objectives of a program.7
Methods
Educational quality assurance involves a number of sequential The implementation of the SOPE model into Pharmacology of
steps that contribute to the overall learning outcome.8 It is an Chinese Medicine involved the development team identifying
ongoing and continuous process of management and evaluation the activities for each stage and their relevant quality criteria.
to ensure consistency and to meet stated targets and anticipated The four stages of this model are shown in Figure 1 and are
outcomes by an institution.7,9 Specifically, for the development elaborated below.
of online materials, the steps may include determining learning
objectives, understanding student needs, and developing course STRATEGIC PLANNING
materials that address relevant pedagogic requirements. Much Aspects of educational mode, teaching objectives, learner
has been written about quality assurance of higher education characteristics/needs, and instructional strategy (i.e. methods
Evaluation (E)
Strategic planning (S) Operational practice (O) Product implementation (P)
FIGURE 1 The SOPE model for the development of online materials
Australian Journal
to support students in pursuing learning goals) should all DATA MANAGEMENT

be taken into account throughout the process. At this stage, 1. Structural template10: is the format of structure standardised
the team developed strategies to achieve teaching objectives to increase user satisfaction?
with consideration of students’ characteristics. The quality 2. Presentation template10: is information to be presented in a
criteria considered included capability-oriented curriculum, consistent format to simplify the learning process?
attainability and adaptability. 3. Material formatting10: what font, colour and background
texture are chosen for the presentation?
OPERATIONAL PRACTICE
This stage involved five steps: classifying thematic topics (i.e. PRODUCT IMPLEMENTATION
categorising herbs), selecting materials, producing materials The main task at this stage is the presentation of materials.
(i.e. writing introductions and summaries of categorised The following criteria were used to facilitate the online
herbs), producing media objects (i.e. taking pictures of presentation:
individual herbs), and managing data. The peer review process
was involved at every step. The quality criteria for each step are 1. Consistency of web/content layout: the instructional
described below. material for each unit is in the same format to improve
user-friendliness.
TOPIC SELECTION 2. Sequence of content15: content within each instructional
1. Appropriateness: does each unit (topic) contribute to the topic is in logical order for learning enhancement.
learning objectives of the subject? 3. Clarity of material presentation: all the texts, graphics and
2. Sequence12: are the topics sequenced in the order of subject pictures are well organised and clearly presented.
knowledge development? 4. Minimisation of human errors: particular efforts should be
made to reduce human errors, such as making wrong links
MATERIAL SELECTION or typographical or other mistakes.
1. Readability10: is the chosen material appropriate to the
students’ level? As RMIT University provides all the enrolled students with
2. Relevancy: is the material related to the core theme of the access to the Distributed Learning System (DLS), DLS is
subject? selected as the media for delivery of online teaching materials.
3. Reliability: is the material retrieved from a reliable source?
4. Currency: is the chosen material of interest to learners and is EVALUATION
the information up-to-date? Evaluation is an essential component of every stage of the
development. This is an ongoing process that includes expert
SCRIPT PRODUCTION review, staff appraisal within or across institutions, as well as
1. Accuracy: is the information accurately presented and is the student feedback. In the current project, informal evaluation
language error-free? from students and staff was used to assess the application of
2. Clarity: is the material logically sequenced and presented in online materials to support classroom teaching as an outcome
an organised manner? from the SOPE process.
3. Strategy-oriented format: is the material written in a way
that embodies a target instructional strategy or a learning
strategy?10
Results
STRATEGIC PLANNING
MEDIA SELECTION AND PRODUCTION The purpose of the development of online materials for
1. Types of media object: are the chosen media objects most Pharmacology of Chinese Medicine was to facilitate study in
appropriate to facilitate learning? the Double Degree Program of Bachelor of Applied Science
2. Quality of the media: are the colour, size, and sound quality (Chinese Medicine/Human Biology) at RMIT University. The
of the media object suitable for specific topics and intended online learning process was developed to supplement face-
learning activities? to-face learning as opposed to replacing class learning. The
3. Size of images: has quality IT access been made readily development of the online material for Pharmacology of Chinese
available to learners? Medicine has successfully addressed the following criteria: (a)
4. Practicality: are students able to access the online material Capability-oriented curriculum by offering hyper-links to the
using different IT platforms? herbs for the purpose of herb identification; (b) Attainability
5. Learning support: have media objects been designed to by providing a user-friendly learning environment; and, (c)
facilitate efficient and effective learning? Adaptability by giving the opportunity of self-development
and catering to different learning styles.
Australian Journal
FIGURE 2 DLS introductory page for Pharmacology of Chinese Medicine
OPERATIONAL PRACTICE
As part of the capability-driven curriculum development, Currently, essential information, including high quality
online material needs to contribute to the building of graduate digital images of 350 commonly used Chinese herbs, has been
capabilities. Besides the provision of major course content, constructed as online materials. Figure 2 and Figure 3 illustrate
other subject matters such as images, graphics, and external how the design of lecture notes was integrated with computer
links to additional information require deliberation to ensure technology to provide students the maximum learning outcome
that such elements are coherent with the overall design. During through a more flexible and self-paced learning process. All
this stage, peer reviews8 were conducted to ensure quality of students enrolled in the Pharmacology of Chinese Medicine
the materials prepared. This was undertaken by peers in the course are provided with access to the course materials through
program team, including two key academic staff for the course, the DLS at RMIT University. All the online information has
an IT expert and the Head of Division of Chinese Medicine, been presented at the DLS Learning Hub website: https://dls.
who provided comments and feedback. Their comments were rmit.edu.au/learninghub/hub.asp (login required).
reflected in the revision of the relevant online materials.
EVALUATION
PRODUCT IMPLEMENTATION Informal feedback on the online materials has been gathered
The third stage is to focus on uploading the developed from students and staff, and it was indicated that such online
materials to the RMIT intranet via a File Transfer Protocol materials are effective complements to classroom learning
(FTP). The online materials have been presented with a user- and teaching, particularly to enhance the learning of herbal
friendly interface. Students and staff are able to obtain easy identification at students’ own pace and in their own time.
access to the desired information. Online tutorials (i.e. user’s Students and staff also made a number of suggestions for further
guide) and technical support are available. Provisions have been improvements, which have been taken into consideration for
made to ensure two-way teacher–student communication via more effective use of the online materials in both classroom
e-mail, forum or other forms of communication. A specific and outside scheduled teaching time. A formal and systematic
staff member has been appointed to update and maintain the evaluation will be undertaken to determine student and staff
currency of the materials, to provide technical support for staff views on the value and effectiveness of using these online
and students as well as to maintain technology stability. materials in Chinese medicine learning and teaching.
Australian Journal
FIGURE 2 DLS sample page for individual herbs
Comments and conclusion development. This will be a valuable contribution to the

The increasing popularity of complementary and alternative profession as many of the practitioners have limited time to
medicine, including Chinese medicine, has resulted in the undertake professional development activities during business
introduction of numerous degree programs in the tertiary hours. Obviously, the information and resources in this format
education systems of western countries. Significant efforts have are not intended to be used by consumers independently, as
been made to address challenges to this development, including they do not have adequate background to make appropriate
appropriate application of teaching technology such as IT into clinical judgment for the use of herbal medicines.
Chinese medicine education. This paper describes the process
that has been developed and applied in the development of Online materials have been successfully used as supplements to
online Chinese herbal medicine teaching materials. traditional learning and teaching in healthcare education, such
as dental18 and histology19 courses. Within the blended learning
This project showed that online materials with an appropriate context, online materials provide students with a flexible,
and user-friendly interface can be an effective supplementary non-linear and diverse learning environment. This emerging
learning and teaching method for the subject area of Chinese educational mode creates unlimited potential for access to
medicine pharmacology. It is clearly demonstrated that the education. However, rigorous quality assurance procedures
information and standardised images of herbal medicine, with are prerequisites for the fulfilment of these potentials. The
convenient student accessibility, are of great benefit to learning development of the SOPE model was an attempt to address
in this topic, either during self-directed learning hours, tutorials, quality assurance concerns associated with online material
attending a teaching clinic for supervised clinical practice, or development. A case study on the course Pharmacology of
preparation for the assessments. The project is a pilot to build Chinese Medicine was presented to illustrate the quality
such a platform which will have the capacity and technical assurance process that was embedded into this development
capability for the development of other online teaching, such by creating a set of practical criteria as check-lists throughout
as incorporation of recent research findings on specific herbal a four-stage process. The SOPE model may serve as a point of
medicine into this information portal and multi-site real- reference for health education online material development.
time real case studies for student training and professional
Australian Journal
Evaluation is a critical stage of the SOPE model and 5. Xue CCL, Story DF. Chinese medicine in Australia. Asian Pac
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To date, informal feedback on the online materials from the 6. Campbell C, Rozsnyai C. Quality assurance and the development
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stakeholders, including undergraduate students and academic
UNESCO-CEPES; 2002 [cited 13 Oct 2005]. Available from:
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formal evaluation has yet to be conducted. This may hinder 7. Vlăsceanu L, Grünberg L, Pârlea D, editors. Quality assurance
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application of the SOPE model to other courses. Therefore, on Higher Education. Bucharest: UNESCO-CEPES; 2004 [cited
further study will be extended to the following three areas. 13 Oct 2005]. Available from: www.cepes.ro/publications/papers.
htm.
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Secondly, formal evaluation from students and staff will need 8. Valenti S, Panti M, Leo T. Quality assurance issues for a web-based
degree in motor disability assessment. In: Albalooshi F, editor.
to be conducted through a structured and systematic approach. Virtual education: cases in learning and teaching technologies.
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other subject areas of health education. 9. Fallows S, Bhanot R. Quality in ICT-based higher education: some
introductory questions. In: Fallows S, Bhanot R, editors. Quality
Acknowledgments issues in ICT-based higher education. London: Routledge Falmer;

2005. p. 1–6.
This study was partially sponsored by the Chinese Government’s 10. Jolliffe A, Ritter J, Stevens D. The online learning handbook:
China Scholarship Council for Q Wu and the Division of developing and using web-based learning. London: Kogan Page;
2001.
Chinese Medicine at RMIT University. We are grateful to the
11. Khan BH. The people-process-product continuum in e-learning:
constructive comments from Mr Michael Owens.
the e-learning p3 model. Educ Technol 2004;44(5):33–40.
AUTHORS’ CONTRIBUTION 12.

Montilva JA, Sandia B, Barrios J. Developing instructional
web sites: a software engineering approach. Educ Inf Technol
QW, AY, AR and CX conceived and executed the project, 2002;7(3):201–24.
participated in the interpretation of data and drafted the 13. Smith C, Cha J, Puno F, Magee J, Bingham J, van Gorp M. Quality
manuscript. SM participated in the design of the online assurance processes for designing patient education web sites.
component of the study and contributed to drafting the Comput Inform Nurs 2002;20(5):191–200.
manuscript. AZ contributed to the conception of the study 14. Frydenberg J. Quality standards in eLearning: a matrix of analysis.
and to the revision of intellectual contents of the manuscript. Int Rev Res Open Distance Learn 2002;3(2). Available from: www.
irrodl.org/index.php/irrodl/article/view/109/189.
All authors read and approved the final manuscript.
15. Morrison GR, Ross SM, Kemp JE. Designing effective instruction.
COMPETING INTERESTS 3rd ed. New York: John Wiley; 2001.
16. Jonassen DH, Peck KL, Wilson BG, Pfeiffer WS, editors. Learning
The authors declare that they have no competing interests.
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NJ: Lawrence Erlbaum; 1998.
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Australian Journal
Chinese Herbal Medicine for
Primary Dysmenorrhoea:
A Systematic Review
Xiaoshu Zhu*1 MMed Caroline Smith1 PhD
Michelle Proctor2 MA Emily Wu3 MTCM
Alan Bensoussan1 PhD
1. CompleMED, University of Western Sydney, Australia

2. Psychological Services, Department of Corrections, New Zealand
3. Private practice, Sydney, Australia
This paper is based on a Cochrane Review published in The Cochrane Library 2008, Issue 2. Cochrane
Reviews are regularly updated as new evidence emerges and in response to feedback, and The Cochrane
Library should be consulted for the most recent version of the review (see www.thecochranelibrary.com for
information).
ABSTRACT
Background: Conventional treatment for primary dysmenorrhoea has a failure rate of 20% to 25%
and may be contraindicated or not tolerated by some women. Chinese herbal medicine may be a
suitable alternative. Objectives: To determine the efficacy and safety of Chinese herbal medicine
for primary dysmenorrhoea when compared with placebo, no treatment, and other treatment.
Main results: Thirty-nine randomised controlled trials involving a total of 3475 women were
included in the review. A number of the trials were of small sample size and poor methodological
quality. Results for Chinese herbal medicine compared to placebo were unclear as data could
not be combined (3 RCTs). Chinese herbal medicine resulted in significant improvements in
pain relief (14 RCTs; RR 1.99, 95% CI 1.52 to 2.60), overall symptoms (6 RCTs; RR 2.17,
95% CI 1.73 to 2.73) and use of additional medication (2 RCTs; RR 1.58, 95% CI 1.30 to
1.93) when compared to use of pharmaceutical drugs. Self-designed Chinese herbal formulae
resulted in significant improvements in pain relief (18 RCTs; RR 2.06, 95% CI 1.80 to 2.36),
overall symptoms (14 RCTs; RR 1.99, 95% CI 1.65 to 2.40) and use of additional medication (5
RCTs; RR 1.58, 95% CI 1.34 to 1.87) after up to three months of follow-up when compared to
commonly used Chinese herbal health products. Chinese herbal medicine also resulted in better
pain relief than acupuncture (2 RCTs; RR 1.75, 95% CI 1.09 to 2.82) and heat compression (1
RCT; RR 2.08, 95% CI 2.06 to 499.18). Reviewers’ conclusions: The review found promising
evidence supporting the use of Chinese herbal medicine for primary dysmenorrhoea; however,
results are limited by the poor methodological quality of the included trials.
K E Y W O R D S traditional Chinese medicine, dysmenorrhoea, review.
Australian Journal
Chinese Herbal Medicine XS Zhu, M Proctor, A Bensoussan,
for Primary Dysmenorrhoea C Smith and E Wu
Background Objectives
Dysmenorrhoea is a common gynaecological complaint among To determine the efficacy and safety of CHM in the treatment
adolescent girls and women of reproductive age and refers of primary dysmenorrhoea when compared with a placebo,
to the occurrence of painful cramps in the lower abdominal no treatment, conventional medical treatments (for example
region during menstruation. It is usually classified into two NSAIDs), heat compression or other TCM therapy (such as
subcategories: primary dysmenorrhoea occurs in the absence of acupuncture, Chinese massage).
an identifiable pathological condition;1 when the period pain
is associated with organic pathology such as endometriosis, it
is defined as secondary dysmenorrhoea.2
Criteria for considering studies
for this review
Dysmenorrhoea can have a significant impact on women’s lives.
It can affect as many as 50% of women of reproductive age,3 Any RCTs involving CHM for the treatment of primary
although, using different measurement methods and study dysmenorrhoea were considered for inclusion in the review.
populations, prevalence estimates vary from 60% to 85% of Interventions could include, but were not limited to, placebo,
adolescent girls.4-6 no treatment, conventional therapy, another type of CHM,
acupuncture and heat compression.
The aetiology or cause of primary dysmenorrhoea has been the
source of some debate. Experimental and clinical research has At least one of the following primary outcomes was measured
identified the over-production of uterine prostaglandins and for a trial to be included. Data from each of the following
vasopressin as contributing factors to the painful cramps.7,8 outcomes were recorded, where available.
Principal pharmacological therapies include drugs that inhibit PRIMARY OUTCOMES

prostaglandins, such as non-steroidal anti-inflammatory drugs i. Change in menstrual pain intensity – measured by a
(NSAIDs); or that regulate hormones, such as oral contraceptive visual analogue scale (VAS), or other validated scales, or
pills (OCPs). NSAIDs reduce myometrial activity (contraction measured as dichotomous outcomes.
of the uterus) by inhibiting prostaglandin F2 (PGF2) synthesis
and reducing vasopressin secretion. This may effectively reduce SECONDARY OUTCOMES
menstrual pain. However, these drugs provide no long-term i. Changes in overall severity of symptoms (other
relief as the treatment relieves symptoms on an episode-by- menstruation-related symptoms) – measured by changes
episode basis only. In addition, the failure rate of NSAIDs is in dysmenorrhoeic symptoms, treatment effectiveness
often 20 to 25%9 and these drugs may be contraindicated or that was either self-reported or observed or other similar
not tolerated by some women.10 In addition, gastrointestinal measures;
side effects can be particularly troublesome.3,11,12 Emerging ii. Adverse effects – measured by any relevant incident and
documents suggest many women are seeking alternatives to duration of any side effects;
conventional medicine, including herbal medicine.13 iii. Use of additional medication – measured as the proportion
of women requiring no analgesics and continued routine
Chinese herbal medicine (CHM) has been used for centuries activities;
in China. Recently, the practice of CHM has significantly iv. Satisfaction of treatment as reported by patients – measured
permeated a broad cross-section of the western community.14 as the proportion of women who reported improvements
CHM is currently used in public hospitals in China for or satisfaction, or both, with their treatment;
the treatment of primary dysmenorrhoea. Case studies v. Quality of life – measured by a validated scale, for example
suggest that CHM may be effective in treating primary SF 36.
dysmenorrhoea; herbs may improve general wellbeing and also
reduce recurrence of the condition over a three-month follow-
up period.15 However, the evidence describing the safety and
Search strategy for identification
efficacy of CHM for the treatment of primary dysmenorrhoea of studies
is important and there is a need for a systematic review of the
available literature. The Cochrane MDSG search strategy was adopted. The
following electronic databases were searched from their
This review aims to identify randomised, controlled trials inception to the date given: Cochrane Central Register of
(RCTs) of CHM as treatment for women with primary Controlled Trials (CENTRAL) (The Cochrane Library 2006,
dysmenorrhoea in order to establish the efficacy and safety of Issue 4), MEDLINE (1950 to January week 2 2007), EMBASE
CHM.
Australian Journal
(1980 to January week 2 2007), CINAHL (1982 to January Statistical heterogeneity between trials was tested using a
week 1 2007), AMED (1985 to January week 1 2007). standard chi-squared test. Inconsistency across trials included
in meta-analysis was measured using I2. This describes the
Three electronic Chinese databases were examined. These were percentage of the variability in effect estimates that is due to
the China National Knowledge Infrastructure (CNKI) (1990 to heterogeneity rather than sampling error. As a general rule, I2
January week 1 2007), Traditional Chinese Medicine Database values of up to 25% provide evidence of low heterogeneity, a
System (TCMDS) (1990 to December 2006) and Chinese value of 50% is considered moderate heterogeneity and 75%
BioMedicine Database (CBM) (1990 to December 2006). The or above is considered as high heterogeneity. In the presence
search identified a large number of trials on the use of CHM of significant heterogeneity, the causes of heterogeneity
in the treatment of primary dysmenorrhoea. However, search were examined by pre-specified sub-group analysis and also
results from the individual databases overlapped significantly. sensitivity analysis, if possible. Where sub-group analysis failed
Only search results from CNKI were reported in this review as to explain the heterogeneity, data were analysed using the
it is regarded as having wide coverage with full-text access. random-effects model.
Methods of the review Description of studies

SELECTION OF STUDIES TRIALS
The selection of trials for inclusion in the review, or exclusion Using the search strategy described above, 39 RCTs involving
from the review, was performed by two review authors (XZ treatment for primary dysmenorrhoea with CHM were
and MP) employing the search strategy described previously. identified. Figures 1 and 2 summarise the numbers of trials
Since the majority of references were published in Chinese, two included in and excluded from the review. A description of the
bilingual review authors (XZ and EW) translated the reports included trials can be found in Table 1.
and extracted data onto hard-copy data sheets independently.
Most of the studies were conducted in mainland China,
QUALITY ASSESSMENT AND DATA except for one which was conducted in Taiwan, one in Japan
EXTRACTION and another in the Netherlands. Thirty-six of the included
All assessments on the quality of trials and further data trials were published in Chinese and three were published in
extraction were performed independently by two review English.18-20
authors (XZ and MP). Any discrepancies were to have been
resolved by a third review author (AB or CS); however, this was PRINCIPLE OF HERBAL TREATMENT
not necessary due to the lack of discrepancies. In this review, nineteen of the included trials considered the
traditional approach by making individualised treatment based
All trials were assessed for methodological quality using the on differentiated pattern(s) in TCM diagnosis. The criteria
Jadad scale.16 Furthermore, allocation concealment was for differentiating the patterns of symptoms in most included
scored according to the categories used by the Cochrane trials were referred to the Traditional Chinese Medicine
Collaboration: allocation concealment was adequate (A), Professional Statute: Criteria of Diagnosis and Therapeutic Effect
unclear (B), inadequate (C) or allocation concealment was not of Diseases/Syndromes, published by the State Administration
used (D). of Traditional Chinese Medicine, China.21 A number of other
references, such as textbooks, were supplemented.22-25
ANALYSIS
Statistical analysis was performed in accordance with the HERBAL INTERVENTION IN THE
guidelines developed by the Cochrane MDSG. Where possible,
EXPERIMENTAL GROUP
intention-to-treat data were extracted from trials and used in The majority of included trials used complicated formulae
the analysis. with more than five or six herbs. However, two included trials
tested a single herb, either in the form of a decoction or as a
Statistical analysis was performed using the Review Manager herbal extraction.20,26
software.17 For dichotomous data, relative risk (RR) and
associated 95% confidence interval (CI) were calculated using Regardless of the variations in formulation, the herbs were
a fixed-effect model. Weighted mean difference (WMD) and mostly chosen from the following categories, which are set out
95% CI were calculated for continuous data using a fixed- in the Chinese herbal pharmacopoeia and textbooks: herbs
effect model. ‘regulating the Qi and Blood’, ‘warming the Interior’, ‘tonifying
the Kidney and Liver’ and ‘reinforcing Qi and Blood’.27,28
Australian Journal
39
Included studies
36 studies 1 study 1 study 1 study

Mainland China Taiwan Japan The Netherlands
Published in Chinese Published in English Published in English Published in English
FIGURE 1 Trials included in the review
OUTCOME MEASURES
The most frequently evaluated herbs were: Danggui (Radix Outcome measures of change in pain intensity varied. Most
Angelicae sinensis, Chinese angelica root), Chuanxiong included studies measured the pain intensity rating on an ordinal
(Chuanxiong Rhizoma, Szechuan lovage root), Chishao scale (for example, from poor to excellent) in combination with
(Paeoniae Radix rubra, red peony root), Baishao (Paeoniae a dichotomous measure (for example, complete relief or ongoing
Radix alba, white peony root), Yimucao (Leonuri Herba, pain). Pain relief was measured as the number of women with
Chinese motherwort), Puhuang (Typhae Pollen, cattail pollen), pain relief, reduced pain or no improvement compared with
Wulingzhi (Trogopterori Faeces, flying squirrel faeces), Niuxi the total number of women in the treatment or control group;
(Radix Achyranthis bidentatae, achyranthes root), Danshen whether or not there was a relapse during the follow-up was
(Radix Salviae miltiorrhizae, salvia root), Chaihu (Radix also taken into consideration. The majority of trials that were
Bupleuri, Chinese thorowax root), Xiangfu (Rhizoma Cyperi, conducted in mainland China fell into this group, which
nut-grass rhizome), Yanhusuo (Rhizoma Corydalis, corydalis indicates such practice was compliant with the statute enacted
rhizome), Aiye (Folium Artemisiae argyri, mugwort leaf ), by the State Administration of Traditional Chinese Medicine
Wuzhuyu (Fructus Evodiae, evodia fruit), Huixiang (Fructus for measuring therapeutic efficacy of herbs in the treatment of
Foeniculi, fennel fruit), Rougui (Cortex Cinnamomi, cinnamon primary dysmenorrhoea.21
bark), Dihuang (Radix Rehmanniae, rehmannia root), Gouqizi
(Fructus Lycii, lycium fruit), Dangshen (Radix Codonopsis, A continuous numerical scale such as a visual analogue scale
codonopsis root), Baizhu (Rhizoma Atractylodis macrocephalae, was rarely used in mainland China, but was used in three
atractylodes rhizome) and Gancao (Radix Glycyrrhizae, included studies from other countries or regions.18-20 Tseng and
liquorice root). colleagues used multiple scales to rate the degree of pain, such as
the Short-form McGill Pain Questionnaire and the Menstrual
Most trials considered timing of the clinical intervention Distress Questionnaire Short Form.
based on phase of menstrual cycle. Herbal interventions were
usually introduced from five to seven days prior to the onset Only eight out of 39 included trials reported adverse effects.
of menstruation and continued for a period of approximately Seven trials18,19,30-34 provided a thorough report, including data
10 to 15 days, which was until the first or second day of in the experimental and control groups. However, the rest had
menstruation or throughout the whole bleeding period. One incomplete data. One trial18 mentioned that headache was the
trial specified that the herbs should be given three days prior to most frequently reported side effect, with equal frequency in
bleeding and continued for a period of five days.29 both experimental and control groups. The adverse effects were
usually self-reported.
26
Excluded studies
3 studies 4 studies 1 study 18 studies

Mixed I and II* No mention of Mixed interventions Not true randomised
dysmenorrhoea randomisation trials
* I = primary, II = secondary
FIGURE 2 Trials excluded from the review
Australian Journal
TABLE 1 Description of included studies
Study Methods Participants Interventions
Deng Allocation concealment n (experimental) = 33; n (control) = 30; Self-designed formula (Jia Wei Muo Jie Pian) vs OTC (Yue Yue Shu).
and randomisation: Drop-outs/withdrawals: unstated;
(2003) Jia Wei Muo Jie Pian: Xuejie (Sanguis Draconis), Moyao (Myrrha), Puhuang (Pollen
method unstated; Blinding: Diagnosis of dysmenorrhoea: stated; Typhae), Wulingzhi (Excrementum Trogopteri seu Pteromi), Sanleng (Rhizoma
unstated; Trial design: Age (experimental): 16–33; Age Sparganii stoloniferi), Erzhu (Rhizoma curcumae), etc. 4 tablets, tid. 2 weeks prior
parallel; Duration: 3 cycles (control): 15–33. to bleeding till 1st day of cycle.
of intervention + 3 cycles of
follow-up. Yue Yue Shu: 1 sachet (10 g), bid. 1 week prior to bleeding till 1st day of cycle.
Deng Allocation concealment n (experimental) = 70; n (control) = 70; Folker formula (Jiang Ji Jiu) vs OTC (Tian Qi Tong Jing Jiao Nang).
and randomisation: method Drop-outs/withdrawals: unstated; Age:
(2005) Jiang Ji Jiu: rice wine 200 mL, Shengjiang (Rhizoma Zingiberis officinalis
unstated; Blinding: unstated; 15–37 y. TCM Pattern: both groups recens) 200 g, Aiye (Folium Artemisiae argyri) 200 g, Yimucao (Herba Leonuri
Trial design: parallel; were diagnosed as ‘retention of cold’, heterophylli) 50 g, Hen 1000 g; modification of formula may be required. Stewing
Duration: 3–5 cycles of ‘stagnation of Qi and blood’, ‘deficiency all ingredients, taking the soup and the chicken meat, one dose for 3 days. 3 days
intervention + 3 cycles of of liver and kidney’, ‘retention of prior to bleeding, no chicken soup during menstruation, then started again on
follow-up. dampness and heat’. day 2 of cycle for 6 days.
Tian Qi Tong Jing Jiao Nang: 6 pills, tid. 2 days prior to bleeding for 6 days.
Fan Allocation concealment n (experimental) = 50; n (control) = 48; Self-designed formula (Huo Xue Zhen Tong Tang) vs Indomethacin + Atropome.
and randomisation: method Drop-outs/withdrawals: unstated;
(1999) Huo Xue Zhen Tong Tang: Puhuang (Pollen Typhae) 15 g, Wulingzhi (Excrementum
unstated; Blinding: unstated; Age: 15–26 y. TCM Pattern: specified, Trogopteri seu Pteromi) 15 g, Yanhusuo (Rhizoma Corydalis) 30 g, Danshen (Radix
Trial design: parallel; ‘stagnation of blood Qi and blood’, Salviae miltrorrhizae) 12 g, Honghua (Flos Carthami tinctorii) 12 g, Baishao
Duration: 3 cycles + 3 cycles ‘retention of cold’, ‘deficiency of kidney (Radix Paeoniae latiflorae) 30–45 g, Chaihu (Radix Bupleuri) 12 g. Modification
of follow-up. deficiency’. might be required. Herbal decoction, one dose/day, 5 days prior to bleeding for
a period of 7 days.
Indomethacin: 25 mg, tid; Atropome: 0.3 mg, tid. 20th day of cycle for a period
of 7 days.
Guo Allocation concealment n (experimental) = 35; n (control) = 31; Self-designed formula (Tong Jing San) vs OTC formula (Yue Yue Shu).
(1997) Tong Jing San: Xuejie (Sanguis Draconis), Rougui (Cortex Cinnamomi cassiae), in a
unstated; Blinding: unstated; Diagnosis of dysmenorrhoea: ratio of 3:1 and a form of powder, 3 g, bid. Mixed and dissolve with warm water,
Trial design: parallel; stated; Age: 15–26 y. TCM Pattern: starting 24 hours prior to bleeding, till 3rd day of cycle.
Duration: 3 cycles + 3 cycles unspecified, but mentioned the
of follow-up. common reasons as ‘stagnation of blood Yue Yue Shu (powder): 10 g, bid. 1 week prior to bleeding till day 3 of cycle
Qi and blood, retention of cold’ etc.
Huang Allocation concealment n (experimental) = 33; n (control) = 25; Self -designed formula (modified Si Wuo Tang) vs Indomethacin.
(2000) Modified Si Wuo Tang based on patterns.
unstated; Blinding: unstated; Diagnosis of dysmenorrhoea:
Trial design: parallel; Parallel stated; Age: 15–33 y. TCM Pattern: Stagnation of Qi and Blood: Danggui (Radix Angelicae sinensis) 15 g, Chuanxiong
performance: no; Duration: unspecified, only common patterns (Radix Ligustici) 10 g, Baishao (Radix Paeoniae latiflorae) 10 g, Shudi (Radix
2 cycles of intervention + 2 were ‘stagnation of Qi and blood in the Rehmanniae glutinosae conquitae) 10 g, Xiangfu (Rhizoma Cypri rotundi) 10 g,
cycles of follow-up. channels’ and ‘retention of cold in the Taoren (Semen Persicae) 15 g, Honghua (Flos Carthami tinctorii) 10 g.
channels’. Retention of Cold and Blood Stasis: Danggui (Radix Angelicae sinensis) 15 g,
Chuanxiong (Radix Ligustici) 10 g, Baishao (Radix Paeoniae latiflorae) 10 g, Shudi
(Radix Rehmanniae glutinosae conquitae) 10 g, Taoren (Semen Persicae) 15 g,
Honghua (Flos Carthami tinctorii) 10 g, Guizhi (Ramulus Cinnamomi cassiae)
6 g, Wuzhuyu (Fructus Evodiae rutaecorpae) 6 g. Herbal decoction, one dose/day,
as soon as bleeding started, for a period of 3 days.
Indomethacin: 25mg, as soon as bleeding started, for a period of 3 days.
Jiang Allocation concealment n (experimental) = 40; n (control) = 36; Self-designed formula (Li Qi Huo Xue Tang) vs Indomethacin.
and randomisation: Drop-outs/withdrawals: unstated;
(2000) Li Qi Huo Xue Tang: Dihuang (Radix Rehmanniae glutinosae) 12 g, Yanhusuo
method unstated; Blinding: Age: 14–25 y. TCM Pattern: (Rhizoma Corydalis) 12 g, Gegen (Radix Puerariae) 12 g, Danggui (Radix
unstated; Trial design: unspecified, but the common pattern Angelicae sinensis) 10 g, Chishao (Radix Paeoniae rubrae) 10 g, Zelan (Herba
parallel; Duration: 3 cycles was ‘stagnation of Qi and blood with Lycopi lucidi) 10 g, Xiangfu (Rhizoma Cypri rotundi) 10 g, Huluba (Semen
of intervention + 3 cycles of retention of cold’. Trigonellae foenigraeci) 10 g, Danshen (Radix Salviae miltrorrhizae) 15 g, Wuyao
follow-up. (Radix Linderae strychnifoliae) 6 g, Sharen (Fructus Amomi) 6 g, Wuzhuyu (Fructus
Evodiae rutaecorpae) 5 g. Herbal decoction, one dose daily, starting from 3 days
prior to bleeding till bleeding ended, plus OCT (Wu Ji Bai Feng Wan) started as
soon as bleeding stopped for a period of 10 days.
Indomethacin: 25mg, bid. 3 days before bleeding till bleeding ends.
Australian Journal
Kennedy Allocation concealment n (experimental) = 17; n (control) = 19; Self-designed formula vs Placebo.
and randomisation: method Drop-outs/withdrawals: stated, 3
(2006) Self-designed formula: Danggui (Radix Angelicae sinensis), Baishao (Radix
stated (computer-generated dropped out before randomisation, Paeoniae latiflorae), Chishao (Radix Paeoniae rubrae), Yanhusuo (Rhizoma
opaque sealed envelope); 2 dropped out after randomisation Corydalis), in a ratio of approximately 1:1.5:1.
Blinding: double blinded; due to either irregular menstruation
Trial design: parallel; or personal reasons. Their data Placebo: sugar beet fibre and maltodextrin indistinguishable in appearance.
Duration: 3 cycles of were excluded (no intention-to- Both groups took 3 tablets, bid, 2 days prior to bleeding for a period of 7 days.
intervention + 1 cycles of treatment performed). Diagnosis of Rescue medication: Ibuprofen, 200 mg, 6 tablets/day maximum.
follow-up. dysmenorrhoea: stated; Age: 18–45 y.
TCM Pattern: unspecified.
Kotani Allocation concealment n (experimental) = 20; n (control) = 20; Classic Chinese formula (Tao Hong Si Wuo San) vs Placebo.
(1997) Tao Hong Si Wuo San: Danggui (Angelicae sinensis radix); Chishao (Paeoniae rubrae
unstated; Blinding: double Age: 14–45 y. TCM Pattern: stated, radix); Fuling (Sclerotium Poriae cocos); Cangzhu (Atractylodis lanceae rhizoma);
blind; Trial design: parallel; only included ‘stagnation blood’, Zexie (Alismatis rhizoma); Chuanxiong (Chuanxiong rhizome), in a ratio of
Duration: 2 cycles of ‘deficiency’, ‘yin’, and ‘cold’. 3:4:4:4:4:3.
observation + 2 cycles of
intervention + 2 cycles of Placebo: no details.
follow-up. Both groups took study materials 7.5 g, daily, for two cycles. Rescue medication:
Diclofenac sodium 25 mg, 4 tablets/day maximum.
Li Allocation concealment n (experimental) = 44; n (control) = 36; Self-designed formula (Fu Ke Qian Jin Pian) vs OTC Chinese herbal formula
and randomisation: method Drop-outs/withdrawals: unstated; (Tian Qi Jiao Nang).
(1999)
unstated; Blinding: unstated; Age: 14–45 y. TCM Pattern: stated, Fu Ke Qian Jin Pian: no details stated.
Trial design: parallel; Parallel ‘stagnation of Qi and Blood’.
performance: yes.Duration: Tian Qi Jiao Nang: no details stated.
3 cycles of intervention + 3 Both group took 5 tablets of each study material, tid. 4–5 days prior to bleeding
cycles of follow-up. till day 2 of cycle.
Li Allocation concealment n (experimental) = 50; n (control) = 50; Self-designed formula (Tong Jing Wan) vs OTC Chinese herbal formula (Yuan Hu
and randomisation: method Drop-outs/withdrawals: unstated; Zhi Tong Pian).
(2001)
unstated; Blinding: single Diagnosis of dysmenorrhoea: stated; Tong Jing Wan: Xiaohuixiang (Fructus Foeniculi vulgaris), Rougui (Cortex
blinded; Trial design: Age (experimental): 15–35 y; Age Cinnamomi cassiae), Sanqi (Radix Notoginseng), Wulingzhi (Excrementum
parallel; Duration: 3 cycles (control): 15–33 y. TCM Pattern: Trogopteri seu Pteromi), Puhuang (Pollen Typhae), Chenxiang (Lignum Aquitariae),
of intervention + 3 cycles of unstated. Yanhusuo (Rhizoma Corydalis), Muxiang (Radix Aucklandiae lappae), Baizhu
follow-up. (Rhizoma Atractylodis macrocephalae), made with certain ratio into pills. 2 g, tid.
Yuan Hu Zhi Tong Pian: 5 tablets, tid.
Both groups started from 5 days prior to bleeding till day 2 of cycle.
Li Allocation concealment n (experimental) = 40; n (control) = 40; Self-designed formula (Nuan Gong Zhi Tong Tang) vs OTC (Yue Yue Shu).
and randomisation: Drop-outs/withdrawals: unstated; Age
(2004) Nuan Gong Zhi Tong Tang: Rougui (Cortex Cinnamomi cassiae) 5 g, Zhifuzi
method unstated; Blinding: (experimental): 12–33 y; Age (control): (Radix lateralis Aconiti carmichaeli praeparata) 3 g, Zishiying (Fluoritum) 10 g,
unstated; Trial design: 13–32 y. TCM Pattern: stated, only the Sanleng (Rhizoma Sparganii stoloniferi) 10 g, Erzhu (Rhizoma Curcumae) 10 g,
parallel; Duration: 3 cycles pattern of ‘retention of cold and blood Danggui (Radix Angelicae sinensis) 10 g, Xiangfu (Rhizoma Cypri rotundi) 10 g,
of intervention + 3 cycles of stasis’. Chuanxiong (Radix Ligustici) 6 g, Chishao (Radix Paeoniae rubrae) 12 g, Yanhusuo
follow-up. (Rhizoma Corydalis) 12 g. 150 mL, bid.
Yue Yue Shu: 1 sachet (10 g), bid.
Both groups started from 5 days prior to bleeding for a period of 7 days.
Liu Allocation concealment n (experimental) = 40; n (control) = 38; OCT Chinese herbal formula (Xiao Yao Wan) + Piroxicam vs Prioxicam.
and randomisation: Drop-outs/withdrawals: unstated; Age:
(2000) Xiao Yao Wan: Danggui (Radix Angelicae sinensis), Baishao (Radix Paeoniae
method unstated; Blinding: 14–31 y. TCM Pattern: unspecified. latiflorae), Chaihu (Radix Bupleuri), Fuling (Sclerotium Poriae cocos), Baizhu
unstated; Trial design: (Rhizoma Atractylodis macrocephalae), Gancao (Radix Glycyrrhizae uralensis),
parallel; Duration: 3 cycles Weijiang (Rhizoma Phragmitis communis), Bohe (Herba Menthae haplocalcis). 9 g,
of intervention + 3 cycles of bid, in combination with Piroxicam, 20 mg, once daily.
follow-up.
Piroxicam: 20 mg, once daily.
Both groups started from 2 days prior to bleed for a period of 3 days.
Australian Journal
Liu Allocation concealment n (experimental) = 52; n (control) = 38; Self-designed formula (Wen Jing Tang oral administration + Xin Jie San external
and randomisation: method Drop-outs/withdrawals: unstated; administration) vs Indomethacin + Vit B6 + Hot water bottle.
(2003)
unstated; Blinding: unstated; Age: 15–30 y. TCM Pattern: specified, Wen Jing Tang: Rougui (Cortex Cinnamomi cassiae) 3 g, Chuanxiong (Radix
Trial design: parallel; Parallel pattern of ‘stagnation of blood’ only. Ligustici) 8 g, Dangshen (Codonopsis radix) 20 g, Danggui (Radix Angelicae
performance: yes; Duration: sinensis) 10 g, Erzhu (Rhizoma Curcumae) 10 g, Danshen (Radix Salviae
2–3 days prior to bleeding miltrorrhizae) 15 g, Chuanniuxi (Radix Cyathulae officinalis) 10 g, Baishao (Radix
or 1st day of bleeding Paeoniae latiflorae) 10 g, Yanhusuo (Rhizoma Corydalis) 10 g, Gancao (Radix
for 7 days × 3 cycles of Glycyrrhizae uralensis) 6 g. Herbal decoction, one dose daily.
intervention + 3 cycles of
follow-up. Xin Jie San: Xixin (Asari herba) 30 g, Baijiezi (Sinapis semen) 30 g, Mangxiao
(Natrii sulfas) 30 g. All ingredients mixed, ground into powder and packed into
20 × 30 cm bag, sealed. Warmed up in microwave oven before applied on the
lower abdominal region.
Indomethacin: 25 mg, tid. Vit B6 20 mg, tid. Hot water bottle in the lower
abdominal region. Both groups started from 2–3 days prior to bleeding or 1st
day of bleeding for a period of 7 days.
Liu Allocation concealment n (experimental) = 45; n (control) = 40; Self-designed formula administrated externally vs Classic formula (Wen Jing
and randomisation: Drop-outs/withdrawals: unstated; Age: Tang) administrated orally.
(2004)
method unstated; Blinding: 14–18 y. TCM Pattern: retention of Zi Ni Wai Fu Tong Jing Zhi Tong Fan: Rougui (Cortex Cinnamomi cassiae) 30 g,
unstated; Trial design: coldness and stagnation of blood. Yanhusuo (Rhizoma Corydalis) 30 g, Ruxiang (Gummi Olibanum) 30 g, Moyao
parallel; Duration: 3 cycles (Myrrha) 30 g, Dibiechong (Eupolyphaga seu Opisthaplatia) 30 g, Wuyao (Radix
of intervention + 3 cycles of Linderae strychnifoliae) 30 g. All ingredients were dried and powdered, 20 g each
follow-up. time, mixed with rice wine as paste for external use on navel. Change once daily.
Wen Jing Tang: no details. One dose daily.
Liu Allocation concealment n (experimental) = 30; n (control) = 30; Self-designed formula (Wen Jing Zhi Tong Yin) vs OTC Chinese herbal formula
and randomisation: Drop-outs/withdrawals: unstated; (Ai Fu Nuan Gong Tang).
(2005)
method unstated; Blinding: Age: 14–30 y. TCM Pattern: stated, Wen Jing Zhi Tong Yin: Paojiang (Quick-fried Rhizoma Zingiberis officinalis),
unstated; Trial design: retention of coldness and stagnation Rougui (Cortex Cinnamomi cassiae), Danggui (Radix Angelicae sinensis),
parallel; Duration: 3 cycles of blood. Chuanxiong (Radix Ligustici), Wulingzhi (Excrementum Trogopteri seu Pteromi),
of intervention + 3 cycles of Puhuang (Pollen Typhae), Baishao (Radix Paeoniae latiflorae), Yanhusuo (Rhizoma
follow-up. Corydalis), Huainiuxi (Radix Achyranthis bidentatae), Xiaohuixiang (Fructus
Foeniculi vulgaris), Xiangfu (Rhizoma Cypri rotundi), Gancao (Radix Glycyrrhizae
uralensis), etc. No dosage stated in detail. Herbal decoction. 5 days prior to
bleeding for a period of 7 days.
Ai Fu Nuan Gong Tang: No dosage stated in detail. 3 days prior to bleeding for a
period of 6 days.
Luo Allocation concealment n (experimental) = 31; n (control) = 31; Self-designed formula (Tong Jing San) vs Indomethacin.
(2002) Tong Jing San: Puhuang (Pollen Typhae) 15 g, Wulingzhi (Excrementum Trogopteri
method unstated; Blinding: 13–40 y. TCM Pattern: Stagnation of seu Pteromi) 12 g, Yanhusuo (Rhizoma Corydalis) 15 g, Xiangfu (Rhizoma Cypri
unstated; Trial design: Qi and blood. rotundi) 10 g, Chuanniuxi (Radix Cyathulae officinalis) 10 g, Paojiang (Quick-
parallel; Duration: 3 cycles fried Rhizoma Zingiberis officinalis) 6 g, Xixin (Herba cum radice Asari) 3 g. Herbs
of intervention + 3 cycles of were soaked for one hour, cooked for one hour, extracted into 200 mL decoction,
follow-up. 100ml, bid. Started from 7 days prior to bleeding till 1st day of cycle.
Indomethacin: 25 mg, tid. 3 days prior to bleeding till 1st day of cycle
Miao Allocation concealment n (experimental) = 36; n (control) = 27; Self-designed formula (Niu Xi San) vs Acupuncture (LI 4, and SP 6 only)
(2003) Niu Xi San: Niuxi (Chuan Niuxi (Radix Cyathulae officinalis) or Huai Niuxi
method unstated; Blinding: 12–20 y. TCM Pattern: believed all (Radix Achyranthis bidentatae) (not clear), Rougui (Cortex Cinnamomi cassiae),
unstated; Trial design: clinical patterns related to ‘deficiency of Chishao (Radix Paeoniae rubrae), Taoren (Semen Persicae), Yanhusuo (Rhizoma
parallel; Duration: 3 cycles kidney and liver’. Corydalis), Danggui (Radix Angelicae sinensis), Muxiang (Radix Aucklandiae
of intervention + 3 cycles of lappae), Danpi (Cortex Mouten radicis), in a ration of 3:1:1:1:1:1:1:1:1,
follow-up. powdered, 9 g, mixed with warm water or wine, for a period of 5 days (unclear
when the intervention started).
Acupuncture: needles remained for 30 min at each point, for a period of 5 days
(unclear when the intervention started).
Niu Allocation concealment n (experimental) = 32; n (control) = 21; Single herb (Glycyrrhiza uralensis) vs OTC (Yuan Hu Zhi Tong Pian)
and randomisation: method Drop-outs/withdrawals: unstated; Age
(1996) Glycyrrhiza uralensis: no dosage details stated.
unstated; Blinding: single (experimental): 17–47 y; Age (control):
blinded; Trial design: 18–42 y. TCM Pattern: unstated. Yuan Hu Zhi Tong Pian: 6 tablets, tid.
parallel; Duration: 3 of Both groups took the herb as soon as pain started, for 3 days.
intervention + 3 follow-up.
Australian Journal
Qin Allocation concealment n (experimental) = 60; n (control) = 60; Self-designed formula (Du Yi Wei Jiao Nang) vs OTC Formula (Yuan Hu Zhi
and randomisation: Drop-outs/withdrawals: unstated; Age Tong Jiao Nang) or added pain-relieving medication if required.
(2003)
method unstated; Blinding: (average): 14–40 y. TCM Pattern: Du Yi Wei Jiao Nang: no details given; 3 pills, tid.
unstated; Trial design: unstated
parallel; Duration: 3 cycles Yuan Hu Zhi Tong Jiao Nang: no details given.
of intervention + 3 cycles of Both groups started the herb from 1st day of cycle/bleeding for 7 days.
follow-up.
Shen Allocation concealment n (experimental) = 60; n (control) = 60; Self-designed formula (Wen Jing Jian Tong Jiao Nang) vs OCT formua (Jiu Qi
and randomisation: Drop-outs/withdrawals: unstated; Age Jian Tong Wan).
(2001)
method unstated; Blinding: (mean experimental): 26.63 y; Age Wen Jing Jian Tong Jiao Nang: Rougui (Cortex Cinnamomi cassiae), Jiuxiangchong
unstated; Trial design: (mean control): 25.1 y. TCM Pattern: (Aspongopus), Xiaohuixiang (Fructus Foeniculi vulgaris), Danggui (Radix Angelicae
parallel; Duration: 3 cycles stated, ‘the retention of cold and sinensis), Wulingzhi (Excrementum Trogopteri seu Pteromi), Xiangfu (Rhizoma
of intervention + 3 cycles of stagnation of blood’. Cypri rotundi), Yanhusuo (Rhizoma Corydalis), Bingpian (Borneol), ratio of herbal
follow-up. ingredients unstated; 4 pills, bid.
Jiu Qi Jian Tong Wan: no details of herbal ingredients stated; 9 g, bid.
Both groups started herbs 7 days prior to period for a period of 5 days.
Song Allocation concealment n (experimental) = 50; n (control) = 50; Self-designed formula (Tong Jing Jiao Nang) vs Indomethacin.
(2003) Tong Jing Jiao Nang: Xuejie (Sanguis Draconis), Puhuang (Pollen Typhae),
unstated; Blinding: single (experimental): 15–35 y; Age (control): Wulingzhi (Excrementum Trogopteri seu Pteromi), Chuanniuxi (Radix Cyathulae
blinding; Trial design: 14–36. TCM Pattern: stated, only the officinalis), Xiangfu (Rhizoma Cypri rotundi), Yanhusuo (Rhizoma Corydalis),
parallel; Duration: 3 cycles pattern of ‘stagnation of Qi and Blood’ Danggui (Radix Angelicae sinensis), Baishao (Radix Paeoniae latiflorae), Xixin
of intervention + 3 cycles of was included. (Herba cum radice Asari), etc. as a capsule (no detailed dosage); 4 capsules, tid.
follow-up. 5 days prior to period for a period of 7 days.
Indomethacin: 25 mg, tid. 3 days prior to period for a period of 6 days.
Sun Allocation concealment n (experimental) = 46; n (control) = 45; Self-designed formula (Tao Jing Ding Tong Tang) vs OTC Chinese herbal formula
and randomisation: Drop-outs/withdrawals: unstated; Age (Tian Qi Tong Jing Jiao Nang)
(2006)
method unstated; Blinding: (experimental): 13–35y; Age (control): Tao Jing Ding Tong Tang: Guizhi (Ramulus Cinnamomi cassiae) 15 g, Xiaohuixiang
unstated; Trial design: 12–35 y. TCM Pattern: specified, only (Fructus Foeniculi vulgaris) 10 g, Danggui (Radix Angelicae sinensis) 10 g,
parallel; Duration: 3 cycles the pattern of ‘stagnation of blood and Chuanxiong (Radix Ligustici) 15 g, Xiangfu (Rhizoma Cypri rotundi) 15 g, Chaihu
of intervention + 3 cycles of retention of cold’. (Radix Bupleuri) 10 g, Yimucao (Herba Leonuri heterophylli) 15 g, Zelan (Herba
follow-up. Lycopi lucidi) 15 g, Wangbuliuxing (Semen Vaccariae segetalis) 20 g, Lulutong
(Fructus Liquidambaris taiwanianae) 15 g, Baishao (Radix Paeoniae latiflorae)
15 g, Gancao (Radix Glycyrrhizae uralensis) 5 g. Herbal decoction, bid.
Tian Qi Tong Jing Jiao Nang: 4 pills, tid, half an hour before meals.
Both groups took herbs from 5 days prior to period for a period of 6 days.
Sun Allocation concealment and n (experimental) = 30; n (control) = 30; OTC formula (Gui Zhi Fu Ling Wan no. 1) vs Placebo.
randomisation: randomised Drop-outs/withdrawals: unstated; Age:
(2004a) Gui Zhi Fu Ling Wan no. 1: Guizhi (Ramulus Cinnamomi cassiae), Fuling
based on a random-number 15–23 y. TCM Pattern: unstated. (Sclerotium Poriae cocos), Chishao (Radix Paeoniae rubrae), Danpi (Cortex Mouten
table, double-blinding; Trial radicis), Taoren (Semen Persicae); 3 pills, tid.
design: parallel; Duration:
3 cycles of intervention + 3 Placebo: 3 pills, tid; no further details.
cycles of follow-up. Both groups started herbs/placebo 3 days prior to period for a period of 7 days.
Sun Allocation concealment and n (experimental) = 30; n (control) = 30; OTC formula (Gui Zhi Fu Ling Wan no. 2) vs Placebo.
randomisation: randomised Drop-outs/withdrawals: unstated; Age:
(2004b) Gui Zhi Fu Ling Wan no. 2: Guizhi (Ramulus Cinnamomi cassiae), Fuling
based on a random number 15–23 y. TCM Pattern: unstated. (Sclerotium Poriae cocos), Baishao (Radix Paeoniae latiflorae), Danpi (Cortex
table, double-blinding; Mouten radicis), Taoren (Semen Persicae); 3 pills, tid.
Duration: 3 cycles of
intervention + 3 cycles of Placebo: 3 pills, tid; no further details.
follow-up. Both groups started herbs/placebo 3 days prior to period for a period of 7 days.
Tseng Allocation concealment n (experimental) = 70; n (control) = 60; Rose tea vs No treatment.
and randomisation: method 21 out of 130 dropped out because of
(2005) Rose tea: 2 teacups per day made from 6 dry rosebuds steeped in 300 mL of hot
unstated; Blinding: open irregular course of menstruation, failure water, taken for 12 days from one week prior to their menstrual period to the
trial; Trial design: parallel; of compliance, withdrawal of school; fifth menstrual day.
Age: significant difference Age: adolescents/boarding school
in mean age and PSS girls, age unspecified. TCM Pattern:
scores (variable) between unstated, only mentioned stagnation
two groups, but adjusted; Qi and blood as general condition.
Duration: 6 cycles of
intervention; no follow-up.
Australian Journal
Wang Allocation concealment n (experimental) = 23; n (control 1) Self-designed formula (Tong Jing Ling) rectal administration vs 1 OCT Chinese
and randomisation: based = 21; n (control 2) = 16; Drop-outs/ herbal formula (Tian Qi Tong Jing Jiao Nang) oral administration vs 2 Self-
(1996)
on random number table; withdrawals: unstated; Age: high-school designed formula (Tong Jing Ling) oral administration.
Blinding: single blinded; girls. TCM Pattern: specified, ‘retention Tong Jing Ling: Guizhi (Ramulus Cinnamomi cassiae), Wuyao (Radix Linderae
Trial design: parallel; of cold and stagnation of Qi’. strychnifoliae), Xiangfu (Rhizoma Cypri rotundi), Yanhusuo (Rhizoma Corydalis),
Duration: 3 cycles + 3 cycles Muxiang (Radix Aucklandiae lappae), Kuncao, Wulingzhi (Excrementum
of follow-up. Trogopteri seu Pteromi), Chuanxiong (Radix Ligustici), etc. Either in suppository
administration, 1 piece, rectal administration, bid. or in oral administration in
capsule form, 5 pills, tid.
Tian Qi Tong Jing Jiao Nang: 5 pills, tid. All groups started from 4–5 days prior
to bleeding till day 2 of cycle (approximately 7 days).
Wang Allocation concealment and n (experimental) = 50; n (control) = 50; Self-designed formula (Bu Shen Hua Yu Tang) vs OCT formula (Yue Yue Shu)
randomisation: Randomised, Drop-outs/withdrawals: unstated; Age
(2000) Bu Shen Hua Yu Tang: Bajietian (Radix Morindae officinalis) 15 g, Gouqizi
method unstated; Blinding: (experimental): 14–35 y; Age (control): (Fructus Lycii) 15 g, Xianlingpi (Herba Epimedii) 15 g, Shudi (Radix Rehmanniae
unstated; Trial design: 15–32 y. TCM Pattern: unspecified. glutinosae conquitae) 15 g, Baishao (Radix Paeoniae latiflorae) 20 g, Danggui
parallel; Duration: 3 cycles (Radix Angelicae sinensis) 12 g, Honghua (Flos Carthami tinctorii) 12 g, Puhuang
of intervention + 3 cycles of (Pollen Typhae) 12 g, Wulingzhi (Excrementum Trogopteri seu Pteromi) 12 g,
follow-up. Chuanxiong (Radix Ligustici) 6 g, Xiangfu (Rhizoma Cypri rotundi) 9 g, Zhiqiao
(Fructus Aurantii) 9 g, Gancao (Radix Glycyrrhizae uralensis) 6 g. Modification of
formulation might be required. Herbal decoction, one dose daily, starting from
5 days prior to bleeding for a period of 7 days.
Yue Yue Shu: no details of formula stated. 10 g, bid, started from 7 days prior to
bleeding for a period of 10 days.
Wang Allocation concealment n (experimental) = 52; n (control) = 51; Tailored formulae based on clinical manifestation vs Acupuncture.
(2003)
unstated; Blinding: open (experimental): 14–35 y; Age (control):
labelled comparison; 15–32 y. TCM Pattern: specified.
Duration: 3 cycles
Wang Allocation concealment n (experimental) = 172; n (control) OCT Chinese herbal formula (Su Xiao Jiu Xin Wan) vs Indomethacin.
and randomisation: = 168; Drop-outs/withdrawals:
(2006a) Su Xiao Jiu Xin Wan: sublingual administration, 2–5 pills, tid, as soon as pain
method unstated; Blinding: unstated; Age: 14–23 y. TCM Pattern: started for 4 days.
unstated; Trial design: unspecified.
parallel; Duration: 3 cycles Indomethacin: 25 mg, tid, as soon as pain started for 4 days.
Wang Allocation concealment n (experimental) = 32; n (control) = 24; Modified self-designed formula (Tong Jing Ling) vs Indomethacin.
(2006b) Tong Jing Ling: Danggui (Radix Angelicae sinensis) 15 g, Baishao (Radix Paeoniae
method unstated; Blinding: (experimental): 14–29 y; Age (control): latiflorae) 15 g, Shengdi (Radix Rennanniae glutinosae) 15 g, Danshen (Radix
unstated; Trial design: 15–30 y. TCM Pattern: unspecified Salviae miltiorrhizae) 15 g, Chuanxiong (Radix Ligustici) 12 g, Honghua (Flos
parallel; Duration: 3 cycles Carthami tinctorii) 12 g, Taoren (Semen Persicae) 9 g, Xiaohuixiang (Fructus
of intervention + 3 cycles of Foeniculi vulgaris) 9 g, Guangmuxiang (Radix Aucklandiae lappae) 6 g.
follow-up. Modification of formulation might be required. Herbal decoction, 1 dose daily,
3 days prior to bleeding for a period of 6 days.
Indomethacin: 50 mg, bid, as soon as pain started for a period of 6 days.
Wu Allocation concealment n (experimental) = 45; n (control) = 45; Self-designed formula (Jia Wei Dang Gui Shao Yao San) vs Ibuprofen.
(2006) Jia Wei Dang Gui Shao Yao San: Danggui (Radix Angelicae sinensis) 10–20 g,
method unstated; Blinding: (experimental): 13–27 y; Age (control): Chuanxiong (Radix Ligustici) 30 g, Baishao (Radix Paeoniae latiflorae) 15–30 g,
unstated; Trial design: 14–29 y. TCM Pattern: no specific Chishao (Radix Paeoniae rubrae) 10–20 g, Fuling (Sclerotium Poriae cocos) 10–20
parallel; Duration: 3 cycles statement. g, Zexie (Rhizoma Alismatis orientalis) 10–20 g, Baizhu (Rhizoma Atractylodis
of intervention + 3 cycles of macrocephalae) 10–20 g, Wuyao (Radix Linderae strychnifoliae) 10–20 g, Xiangfu
follow-up. (Rhizoma Cypri rotundi) 10–20 g, Yanhusuo (Rhizoma Corydalis) 10–20 g,
Gancao (Radix Glycyrrhizae uralensis) 5–10 g. Herbal decoction, 150 mL, bid.
Ibuprofen: 200 mg, tid.
Ye Allocation concealment and n (experimental) = 30; n (control) = 28; Self-designed formula (Nv Jin Jiao Nang) vs Indomethacin.
randomisation: unstated; Drop-outs/withdrawals: unstated; Age
(2004) Nv Jin Jiao Nang: Danggui (Radix Angelicae sinensis), Baishao (Radix Paeoniae
Blinding: unstated; Trial (experimental): 15–27 y; Age (control): latiflorae), Chuanxiong (Radix Ligustici), Shudi (Radix Rehmanniae glutinosae
design: parallel; Duration: 14–28 y. TCM Pattern: unstated. gonquitae), Rougui (Cortex Cinnamomi cassiae), etc. 23 herbs in total, in pill-
3 cycles of intervention + 3 form; 3 pills, bid, 7 days prior to bleeding until the end of bleeding.
cycles of follow-up.
Indomethacin: 50 mg, tid, 1 day prior to bleeding until the end of bleeding.
Australian Journal
Yu Allocation concealment and n (experimental) = 35; n (control) = 30; Self-designed formula (Fu Mei Tong Jing Fang) vs OTC formula (Tian Qi Tong
randomisation: unstated; Drop-outs/withdrawals: unstated; Age Jing Jiao Nang).
(2003)
Blinding: unstated; Trial (experimental): 12–32 y; Age (control): Fu Mei Tong Jing Fang: Zhifuzi (Radix lateralis Aconiti carmichaeli praeparata)
design: parallel; Duration: 13–30 y. TCM Pattern: both groups 6 g, Yanhusuo (Rhizoma Corydalis) 12 g, Danggui (Radix Angelicae sinensis) 12 g,
3 cycles of intervention + 3 were diagnosed as ‘retention of cold Moyao (Myrrha) 9 g, Erzhu (Rhizoma Curcumae) 9 g,Wulingzhi (Excrementum
cycles of follow-up. with blood stasis’. Trogopteri seu Pteromi) 9 g, Puhuang (Pollen Typhae) 9 g, Rougui (Cortex
Cinnamomi cassiae) 5 g. Herbal decoction, extracted as 200 mL, bid.
Tian Qi Tong Jing Jiao Nang: no details of formulation provided; 4 pills, tid.
Zhang Allocation concealment and n (experimental) = 35; n (control) = 20; Self-designed formula (modified Si Wu Tang) vs Heat compression.
randomisation: unstated; Drop-outs/withdrawals: unstated; Age
(2000) Modified Si Wu Tang: Danggui (Radix Angelicae sinensis), Chishao (Radix Paeoniae
Blinding: unstated; Trial (experimental): 16–22 y; Age (control): rubrae), Shendi, Chuanxiong (Radix Ligustici), etc. 2–3 days prior to bleeding for
design: parallel; Duration: 15–23 y. TCM Pattern: unspecified, a period of 10 days.
3 cycles of intervention + 3 common patterns mentioned were
cycles of follow-up. ‘deficiency of blood, blood stasis’. Heat compression: as soon as pain started till pain disappeared.
Zhang Allocation concealment and n (experimental) = 60; n (control) = 40; Self-designed formula (oral administration) + self-designed formula (external
randomisation: unstated; Drop-outs/withdrawals: unstated; Age: administration) vs Two different OTC formulae (Yuan Hu Zhi Tong Pian and
(2001)
Blinding: unstated; Trial 14–26 y. TCM Pattern: unstated. Tong Jing Wan, oral administration).
design: parallel; Duration: Self-designed formula (oral administration): Guizhi (Ramulus Cinnamomi cassiae)
3–5 cycles of intervention + 9 g, Ruxiang (Gummi Olibanum) 9 g, Chishao (Radix Paeoniae rubrae) 9 g, Zelan
3 cycles of follow-up. (Herba Lycopi lucidi) 9 g, Gancao (Radix Glycyrrhizae uralensis) 9 g, Xixin (Herba
cum radice Asari) 6 g, Xiaohuixiang (Fructus Foeniculi vulgaris) 6 g, Chuanxiong
(Radix Ligustici) 6g, Yanhusuo (Rhizoma Corydalis) 6 g, Yimucao (Herba Leonuri
heterophylli) 15 g, Danggui (Radix Angelicae sinensis) 15 g, Xiangfu (Rhizoma
Cypri rotundi) 15g. Herbal decoction, one dose daily, 7 days prior to period till
post menstruation.
Self-designed formula (external administration): Baizhi (Radix Angelicae) 6 g,
Danggui (Radix Angelicae sinensis) 6 g, Chishao (Radix Paeoniae rubrae) 6 g,
Dahuang (Radix et rhizoma Rhei) 6 g, Huangdan (Minium) mixed with sesame
oil, in a paste, applied on ‘Guan Yuan’ outpoint during menstruation.
Yuan Hu Zhi Tong Pian: 4 tablets, bid, 1st OCT started from 7 days prior to
period for 7 days.
Tong Jing Wan: 10 pills, bid, 2nd OCT in menstruation period for 3–5 days.
Zhu Allocation concealment and n (experimental) = 78; n (control) = 39; Self-designed formula (Dong Gui Ai Ye Tang) vs Indomethacin and vitamin B6.
randomisation: methods Drop-outs/withdrawals: unstated; Age
(2001) Dong Gui Ai Ye Tang: Danggui (Radix Angelicae sinensis) 30 g, Aiye (Folium
unstated; Blinding: (experimental): 12–30 y; Age (control): Artemisiae argyri) 15 g, Hongtang (Caulis Sargentodoxae cuneatae) 60 g; 600 mL
unstated; Trial design: 12.5–28 y. TCM Pattern: stated, herbal decoction daily, 3 days prior to bleeding for a period of 6 days.
parallel; Duration: 3 cycles ‘stagnation of Qi and Blood, retention
of intervention + 3 cycles of of cold, deficiency of Qi and Blood, Indomethacin: 25 mg, tid; vitamin B6, 20 mg, tid; 3 days prior to bleeding till
follow-up. deficiency of Liver and Kidney’. bleeding stopped.
Zhu Allocation concealment and n (experimental) = 70; n (control) = 62; Self-designed formula vs Indomethacin.
randomisation: unstated; Drop-outs/withdrawals: unstated; Age:
(2002) Self-designed formula: Danshen (Radix Salviae miltiorrhizae) 30 g, Xiangfu
Blinding: unstated; Trial 16–32 y. TCM Pattern: unstated. (Rhizoma Cypri rotundi) 10–15 g, Shengjiang (fresh Rhizoma Zingiberis officinalis)
design: parallel; Duration: 6 g. Herbs were cooked and extracted into 300 mL decoction, mixed with brown
3 cycles of intervention + 3 sugar (no dose provided), bid, 1 day prior to bleeding until 3rd day of cycle.
cycles of follow-up.
Indomethacin: 50 mg, tid, 3 days prior to bleeding until 3rd day of cycle.
Zhu Allocation concealment and n (experimental) = 42; n (control) = 42; Self-designed formula (Hua Yu Tong Mai Zhi Tong Tang) vs OCT (Yuan Hu Zhi
randomisation: blinding Drop-outs/withdrawals: unstated; Age: Tong Jiao Nang).
(2003)
unstated; Trial design: 14–32 y. TCM Pattern: unspecific, but Hua Yu Tong Mai Zhi Tong Tang: Danggui (Radix Angelicae sinensis) 10 g, Shishao
parallel; Duration: 3 cycles mentioned ‘stagnation of blood in the 12 g, Baishao (Radix Paeoniae latiflorae) 12 g, Taoren (Semen Persicae) 10 g,
of intervention or 6 cycles medians’ was most common pattern. Chuanxiong (Radix Ligustici) 10 g, Honghua (Flos Carthami tinctorii) 10 g,
or 9 cycles + 3 cycles of Xiangfu (Rhizoma Cypri rotundi) 12 g, Yanhusuo (Rhizoma Corydalis) 15 g,
follow-up. Yimucao (Herba Leonuri heterophylli) 20 g, Zelan (Herba Lycopi lucidi) 15 g,
Xuejie (Sanguis Draconis) 3 g, Wulingzhi (Excrementum Trogopteri seu Pteromi)
15 g, Gancao (Radix Glycyrrhizae uralensis) 6 g. Herbal decoction, one dose daily.
Yuan Hu Zhi Tong Jiao Nang: 3 pills, tid.
Australian Journal
METHODOLOGICAL QUALITY OF medicine also resulted in better pain relief than acupuncture (2
INCLUDED STUDIES RCTs; RR 1.75, 95% CI 1.09 to 2.82) and heat compression
ALLOCATION CONCEALMENT AND (1 RCT; RR 2.08, 95% CI 2.06 to 499.18). For detailed and
RANDOMISATION comprehensive analysis, please see the original publication at
Only two of the included trials described adequate methods www.thecochranelibary.com.
of randomisation and allocation concealment, receiving an
allocation score of A.18,32 All other included trials received
allocation scores of B or C. Poor compliance during clinical
Discussion
intervention was also noted.35 The review found promising evidence in the form of RCTs for
the use of CHM in reducing menstrual pain in the treatment
BLINDING of primary dysmenorrhoea, with up to three months of
Four included trials were single blinded;26,36-38 three trials effectiveness. No significant adverse effects were identified
were double blinded.18,19,32 The other included trials did not from the studies included in this review.
mention blinding at all.
IMPACT OF AN INDIVIDUALISED
POWER CALCULATION APPROACH TO THE ROUTINE PRACTICE
OF CHM
Only one included trial mentioned power calculation and
stated that no formal statistical sample size calculation was A key primary requirement of traditional treatment with
made because this was a pilot study; it estimated a sample size CHM is that treatment needs to be tailored according
for future study.18 to different patterns. Nineteen out of 39 included trials
considered an inclusion criterion in relation to the TCM
INTENTION-TO-TREAT (ITT) ANALYSIS AND diagnostic pattern(s), and another 23 trials considered the
FOLLOW-UP
influence of the pattern(s) (for example, a pattern was only
Only two included trials clearly reported the number of drop- treated by one correlating experimental herbal formula).
outs and withdrawals,18,20 although ITT analysis was not In other words, the majority of included trials paid specific
implemented, nor was it used in the other included trials. One attention to the role of differentiated patterns defined in
trial reported that the exclusion of data from analysis was due TCM diagnosis for primary dysmenorrhoea, because the
to poor compliance and incomplete data; nevertheless, the patterns of primary dysmenorrhoea in TCM inform selection
information about drop-outs was unclear.39 of treatment formulation. The patterns of ‘stagnation of Qi
and Blood’, ‘retention of Cold’, ‘deficiency of the Kidney and
Most included trials had two to three months of follow-up after Liver’ were the common diagnostic classifications of primary
the cessation of clinical intervention; four out of the 39 included dysmenorrhoea in TCM diagnosis. In addition, ‘stagnation
trials did not report on any further follow-up.20,33,40,41 of Blood’ was the fundamental aetiology and pathological
condition for primary dysmenorrhoea in TCM. This was in
Results agreement with the majority of published diagnostic protocols

in TCM.21,22,42,43
In summary, 39 randomised, controlled trials involving a total
of 3475 women were included in the review. A number of Overall, 23 trials used modified experimental Chinese herbal
the trials were of small sample size and poor methodological formulae in order to fit the different TCM diagnostic patterns,
quality. Results for Chinese herbal medicine compared to or selected a standard formula based on a defined specific
placebo were unclear as data could not be combined (3 RCTs). pattern, that is, the individualised (tailored) treatment approach
Chinese herbal medicine resulted in significant improvements was employed. The results demonstrated promising evidence
in pain relief (14 RCTs; RR 1.99, 95% CI 1.52 to 2.60), of effective pain relief for primary dysmenorrhoea. Whilst
overall symptoms (6 RCTs; RR 2.17, 95% CI 1.73 to 2.73) 16 trials did not consider a possible variation in patterns, the
and use of additional medication (2 RCTs; RR 1.58, 95% CI results still demonstrated the effectiveness of CHM in pain
1.30 to 1.93) when compared to use of pharmaceutical drugs reduction with statistical significance. However, this review
(Figure 3). Self-designed Chinese herbal formulae resulted in was unable to provide an explicit answer as to whether tailored
significant improvements in pain relief (18 RCTs; RR 2.06, treatment was more beneficial than standard formulae in the
95% CI 1.80 to 2.36), overall symptoms (14 RCTs; RR treatment of primary dysmenorrhoea.
1.99, 95% CI 1.65 to 2.40) and use of additional medication
(5 RCTs; RR 1.58, 95% CI 1.34 to 1.87) after up to three ADVERSE EFFECTS
months of follow-up when compared to commonly used Generally, the reviewed trials reported that CHMs for primary
Chinese herbal health products (Figure 4a–c). Chinese herbal dysmenorrhoea were safe when compared with conventional
Australian Journal
FIGURE 3a Meta-analysis results of Chinese herbal medicine for primary dysmenorrhoea when
compared with conventional therapy (NSAIDs or over-counter products): Effects on pain reductions.
FIGURE 3b Meta-analysis results of Chinese herbal medicine for primary dysmenorrhoea when
compared with conventional therapy (NSAIDs or over-counter products): Overall symptoms.
Australian Journal
FIGURE 3c Meta-analysis results of Chinese herbal medicine for primary dysmenorrhoea when
compared with conventional therapy (NSAIDs or over-counter products): Use of additional medication.
medicines. However, the attention to the safety of CHM in the majority of trials reported positive effects of CHM in the
clinical practice was not addressed adequately in the reviewed treatment of primary dysmenorrhoea.
trials. The measurement and reporting of adverse effects were
poor; most trials neglected the fact that herbs are not risk free. Overall, the review has found that an attempt towards evidence-
based TCM practice has been made. However, more research
METHODOLOGICAL WEAKNESSES trials with high-quality design are needed.
The methodological quality of many trials included in this
review was poor calibre. Only three out of the 39 trials clearly
described their methods of randomisation and allocation
Reviewers’ conclusions
concealment. The rest either did not state the methods or the The review found promising evidence for the use of Chinese
methods were inadequate. herbal medicine in reducing menstrual pain in the treatment
of primary dysmenorrhoea, compared to conventional
A consistent weakness of all the trials was their small sample medicine such as NSAIDs and the oral contraceptive pill,
size. Only one trial had more than one hundred participants. acupuncture and heat compression. No significant adverse
The small size reduces the likelihood of detecting any effect effects were identified in this review. However, the findings
of an intervention in a single study, but given the similarities should be interpreted with caution due to the generally low
between studies, it makes meta-analysis of the data particularly methodological quality of the included studies.
valuable.
Placebo was seldom used in the trials (only three trials compared
Acknowledgments
CHM with placebo). The lack of placebo trials affects the The authors wish to acknowledge the University of Western
results, since typically a medicine’s efficacy is established with Sydney for its financial support through the doctoral scholarship
placebo trials before comparisons are made with other drugs. program; the editorial board of Cochrane Menstrual Disorders
With CHM this has not been the case. In addition, the lack of and Subfertility Group for guidance in the preparation of the
blinding in some trials had the potential to affect the results as review; and Professor Chunxiang Zhou (Nanjing University
it may give skewed results, if participants were aware of their of Traditional Chinese Medicine, China) and Professor Jin Yu
treatment. (Fudan University, China), who advised on data searches in
the Chinese literature and strategic planning at an early stage
The measurement outcomes were generally subjective. Most of of the review.
the trials collected the data by using descriptions of symptoms
with no quantitative standards. Only four trials used numerical POTENTIAL CONFLICT OF INTEREST
scales. Xiaoshu Zhu recently completed a randomised, controlled
trial of CHM for primary dysmenorrhoea. There are no other
A possible publication bias has not excluded for this review as known potential conflicts of interest.
Australian Journal
FIGURE 4a Meta-analysis results of self-designed Chinese herbal medicine for primary

dysmenorrhoea when compared with over-counter or standard Chinese medicine herbal products:
Effects on pain reduction.
FIGURE 4b Meta-analysis results of self-designed Chinese herbal medicine for primary

Use of additional medication.
Australian Journal
FIGURE 4c Meta-analysis results of self-designed Chinese herbal medicine for primary

Overall symptoms.
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Current Research and
Clinical Applications
Acupuncture as an Adjunct to Exercise-based
Physiotherapy Does not Improve the Pain of Knee
Osteoarthritis
Shu-Feng Zhou* PhD Charlie Changli Xue PhD
Division of Chinese Medicine, RMIT University Division of Chinese Medicine, RMIT University
Osteoarthritis is the most likely treatment, survey results, a consensus creating an illusion of insertion.
underlying reason for knee pain in workshop and recommendations from They meet the recommendations for
70% of community-dwelling adults traditional Chinese protocols.4 For acceptable controls for acupuncture
aged 50 or more.1 A recent summary of each individualised treatment session, research.5 No attempt was made to elicit
systematic reviews by Smidt et al.2 has six and ten acupuncture points from the Deqi sensation but participants were
concluded that exercise therapy, such as 16 commonly used local and distal told they may experience sensations and
strengthening, stretching, and functional points were selected. Local points were to report what they felt. Researchers
exercises, is effective for patients with SP 9 Yinglingquan, SP 10 Xuehai, ST 34 who collected, entered and analysed data
knee osteoarthritis compared with no Liangqiu, ST 35 Dubi, ST 36 Zusanli, were unaware of treatment allocation. By
treatment. The chronic use of oral Ex-LE 5 Xiyan, GB 34 Yanglingquan necessity the physiotherapists delivering
non-steroidal inflammatory drugs is and trigger points. Distal points the interventions were not blind to
discouraged because of their potential included LI 4 Hegu, TE 5 Waiguan, allocation.
gastrointestinal side effects. A recent SP 6 Sanyinjiao, LR 3 Taichong, ST 44
randomised, multi-centred and placebo- Neiting, KI 3 Taixi, BL 60 Kunlun and The primary outcome observed was
controlled clinical study by Foster et al.3 GB 41 Zulinqi. Sterilised disposable change in scores on the Western
indicates that the addition of acupuncture steel needles (30 × 0.3 mm) were used; Ontario and McMaster Universities
to a course of advice and exercise the depth of insertion was 5–25 mm, osteoarthritis index pain subscale
for knee osteoarthritis delivered by depending on the points selected. (Likert 3.0)6 at six months. Secondary
physiotherapists provides no additional Needles were manipulated to achieve outcomes included function, pain
improvement in pain. This study the Deqi sensation (e.g. aching, warm intensity and unpleasantness of pain at
recruited 352 adult patients aged 50 or or tingling sensation) and the therapists weeks 2 and 6, and months 6 and 12.
more with a clinical diagnosis of knee recorded the sensations in patients. The The researcher recorded the number of
osteoarthritis from 37 physiotherapy protocol permitted 25 to 35 minutes patients in each group that achieved a
centres accepting primary care patients between insertion of the last needle clinically significant response according
referred from general practitioners and stopping treatment. The therapists to criteria from the outcome measures
within the Midlands and Cheshire revisited and manipulated the needles as in the Rheumatology and Osteoarthritis
regions of the United Kingdom between appropriate. If the Deqi sensation was Research Society international initiative
November 2003 and October 2005. no longer present, the therapists were (OMERACT-OARSI). Side effects of
The patients were randomised to receive expected to use stronger manipulation, treatment, adverse events and use of co-
advice and exercise only (n = 116), advice either rotation or thrust-and-withdraw interventions were also recorded.7
and exercise plus true acupuncture techniques, to elicit it. Moxibustion,
(n = 117), or advice and exercise plus cupping, herbs or electroacupuncture The follow-up rate at month 6 was 94%
non-penetrating acupuncture (n = 119). were not allowed. The non-penetrating and the baseline pain score was 9.2 ± 3.8.
acupuncture was delivered through At six months, the reductions in pain
The acupuncture protocol was needles with a blunt tip. The shaft of score of patients receiving advice and
based on the concept of adequacy of these needles collapses into the handle, exercise only, advice and exercise plus
* Correspondent author; e-mail: [email protected]
Australian Journal
Current Research and Clinical Applications
true acupuncture, and advice and exercise McMaster Universities osteoarthritis few, minor adverse events; acupuncture
plus non-penetrating acupuncture were index at six and twelve months. This provided no additional improvement in
2.28 ± 3.8, 2.32 ± 3.6, and 2.53 ± 4.2, makes it different in several important pain scores compared with a course of six
respectively. Mean differences in change aspects from those in previous trials sessions of physiotherapy-led advice and
scores between advice and exercise alone of acupuncture for knee osteoarthritis exercise. Small benefits in pain intensity
and each acupuncture group were 0.08 which compared true acupuncture and unpleasantness were observed in
(95% confidence interval = −1.0 to with sham acupuncture (including both acupuncture groups, making it
0.9) for advice and exercise plus true off-point needling),12 ongoing stable unlikely that this was due to acupuncture
acupuncture and 0.25 (−0.8 to 1.3) for medication,13 waiting-list controls14,15 needling effects, manual stimulation
advice and exercise plus non-penetrating or education alone.16 throughout treatment, and elicitation of
acupuncture (p > 0.05, by χ2 test). the Deqi sensation. Further studies are
Similarly, non-significant differences Smidt et al.2 used fewer treatment warranted to investigate the underlying
were observed at other follow-up points. sessions: six acupuncture treatments mechanisms of acupuncture, particularly
However, there were small, statistically compared with 10–24 in previous the role of expectancy effects.
significant improvements in pain studies.12-15 The participants with a
intensity and unpleasantness at weeks clinical diagnosis of knee osteoarthritis REFERENCES
2 and 6 for true acupuncture and at all in this study are the patients seen in 1. Duncan RC, Hay EM, Saklatvala J,
Croft PR. Prevalence of radiographic
follow-up points for non-penetrating primary care, rather than those with a
osteoarthritis – it all depends on your
acupuncture compared with advice confirmed radiological diagnosis only, point of view. Rheumatology (Oxford)
and exercise alone. No adverse events as used in other trials. Importantly, they 2006;45(6):757–60.
occurred in the advice and exercise used the credible acupuncture control 2. Smidt N, de Vet HCW, Bouter LM,
group or in the advice and exercise plus of non-penetrating acupuncture at the Dekker J for the Exercise Therapy Group.
non-penetrating acupuncture group. same points as the true acupuncture Effectiveness of exercise therapy: a best-
evidence summary of systematic reviews.
Five adverse events were reported for rather than minimal depth needling at
Aust J Physiother 2005;51(2):71–85.
participants receiving true acupuncture predefined distant non-acupuncture
3. Foster NE, Thomas E, Barlas P, Hill JC,
(pain, sleepiness, fainting, nausea and points. There is much debate within Young J, Mason E et al. Acupuncture
swelling around the treated knee). the acupuncture literature about the as an adjunct to exercise based
validity of sham acupuncture,17 and physiotherapy for osteoarthritis of the
CLINICAL RELEVANCE given that a considerable proportion knee: randomised controlled trial. BMJ
Patients with knee osteoarthritis prefer of participants in the non-penetrating 2007;335(7617):436.
non-pharmacological options for pain acupuncture group reported sensations 4. White A, Foster NE, Cummings M, Barlas
P. Acupuncture treatment for chronic knee
relief and often choose complementary fitting the normal descriptions of Deqi,
pain: a systematic review. Rheumatology
medicine approaches.8 Acupuncture this intervention cannot be considered (Oxford) 2007;46(3):384–90.
is one of the most popular options. inert. 5. White AR, Filshie J, Cummings TM.
However, clinical trials of acupuncture Clinical trials of acupuncture: consensus
have been criticised for small sample However, as the authors have pointed out, recommendations for optimal treatment,
sizes, inadequate blinding and lack of a potential limitation of this trial lies in sham controls and blinding. Complement
credible sham controls and long-term its use of fewer treatment sessions than in Ther Med 2001;9(4):237–45.
follow-up. Systematic reviews have previous studies of acupuncture practice, 6. Bellamy N. WOMAC osteoarthritis index:
a user’s guide. London, ON: University of
concluded that acupuncture is more such as those from the United States16
Western Ontario; 1996.
effective than placebo for osteoarthritis and Germany.15,18 Nevertheless, the
7. Dougados M, Leclaire P, van der Heijde
of the knee.4,9-11 However, data on the acupuncture protocols were developed D, Bloch DA, Bellamy N, Altman RD.
benefits of adding acupuncture to other to fit within current physiotherapy Response criteria for clinical trials on
treatments, such as physiotherapy, for this practice in the United Kingdom and the osteoarthritis of the knee and hip: a report
population remain scant. In the present protocols met the minimum criteria for of the Osteoarthritis Research Society
International Standing Committee
study by Smidt et al.,2 acupuncture adequacy of acupuncture.
for Clinical Trials response criteria
delivered by physiotherapists as part of initiative. Osteoarthritis Cartilage
an integrated package of health care with CONCLUSIONS 2000;8(6):395–403.
advice and exercise, for older adults with The current study indicated that true 8. Breivik H, Collett B, Ventafridda V,
osteoarthritis of the knee, provided no acupuncture did not show any greater Cohen R, Gallacher D. Survey of chronic
additional improvement in pain scores therapeutic benefit than a credible pain in Europe: prevalence, impact on
compared with advice and exercise alone control procedure in patients with knee daily life, and treatment. Eur J Pain
2006;10(4):287–333.
measured on the Western Ontario and osteoarthritis; acupuncture was safe, with
Australian Journal
9. Ezzo J, Hadhazy V, Birch S, Lao of the knee: randomised controlled trial. 16.
Berman BM, Lao L, Langenberg P,
L, Kaplan G, Hochberg M et al. BMJ 2004;329(7476):1216. Lee WL, Gilpin AM, Hochberg MC.
Acupuncture for osteoarthritis of the 13.
Berman BM, Singh BB, Lao L, Effectiveness of acupuncture as adjunctive
knee: a systematic review. Arthritis Rheum Langenberg P, Li H, Hadhazy V et al. therapy in osteoarthritis of the knee: a
2001;44(4):819–25. A randomized trial of acupuncture as randomized, controlled trial. Ann Intern
10. Vas J, White A. Evidence from RCTs on an adjunctive therapy in osteoarthritis Med 2004;141(12):901–10.
optimal acupuncture treatment for knee of the knee. Rheumatology (Oxford) 17. Kaptchuk TJ, Stason WB, Davis RB,
osteoarthritis – an exploratory review. 1999;38(4):346–54. Legedza AR, Schnyer RN, Kerr CE et
Acupunct Med 2007;25(1–2):29–35. 14.
Williamson L, Wyatt MR, Yein K, al. Sham device v inert pill: randomised
11. Bjordal JM, Johnson MI, Lopes-Martins Melton JTK. Severe knee osteoarthritis: a controlled trial of two placebo treatments.
RAB, Bogen B, Chow R, Ljunggren randomized controlled trial of acupuncture, BMJ 2006;332(7538):391–7.
AE. Short-term efficacy of physical physiotherapy (supervised exercise) 18. Witt CM, Jena S, Brinkhaus B, Liecker B,
interventions in osteoarthritic knee pain. and standard management for patients Wegscheider K, Willich SN. Acupuncture
A systematic review and meta-analysis awaiting knee replacement. Rheumatology in patients with osteoarthritis of the knee
of randomised placebo-controlled trials. (Oxford) 2007;46(9):1445–9. or hip: a randomized, controlled trial
BMC Musculoskelet Disord 2007;8:51. 15. Witt C, Brinkhaus B, Jena S, Linde K, with an additional nonrandomized arm.
12. Vas J, Méndez C, Perea-Milla E, Vega E, Streng A, Wagenpfeil S et al. Acupuncture Arthritis Rheum 2006;54(11):3485–93.
Panadero MD, León JM et al. Acupuncture in patients with osteoarthritis of the
as a complementary therapy to the knee: a randomised trial. Lancet
pharmacological treatment of osteoarthritis 2005;366(9480):136–43.
Australian Journal
Acupuncture for Persistent Allergic Rhinitis

Chris Zaslawski PhD
University of Technology, Sydney
This Australian study1 was a randomised, Following eight weeks (two sessions present and the use of LI 4 Hegu, ST 36
single-blind, sham-controlled (sham per week) of treatment, results showed Zusanli and CV 6 Qihai be administered
needling) trial that investigated the effect that the verum acupuncture resulted if appropriate. Needle manipulation
of acupuncture on persistent allergic in a statistically significant reduction should be applied three times during the
rhinitis (PAR). Eighty participants were in the combined mean score of the 25-minute treatment session. Patients
randomised to either group and given nasal symptoms compared to the sham should expect a decrease in symptoms
16 sessions of either acupuncture or treatment at both the completion of the such as nasal obstruction, sneezing and
invasive sham acupuncture (nearby non- study and at follow-up of 12 weeks when nasal itch with a greater reduction in
acupoint sites with shallow needling). compared to the sham acupuncture nasal discharge (rhinorrhoea). These
The primary acupoints used were LI 20 group. There was a significant reduction effects become apparent after eight
Yingxiang, Ex-HN 3 Yintang (midway in use of PAR relief medication compared sessions (at week 4). Patients may need
between the medial eyebrows) and to baseline (within group comparison) to return for further treatment after a
GB 20 Fengchi. In addition, Chinese at completion and at 12 weeks follow- period of three months. Patients should
medicine pattern differentiation was up. This, however, was not significant also be informed that there may be some
used to provide secondary acupoints: when compared to the sham group discomfort associated with the needling
LI 4 Hegu for Lung Qi deficiency, ST 36 (between-group comparison). Reported at some acupoint sites and that they may
Zusanli for Spleen Qi deficiency and events included minor discomfort at the expect a reduction in the use of their
CV 6 Qihai for Kidney Qi deficiency needling sites for 11 verum and eight PAR relief medication
patterns. Needle manipulation involving sham acupuncture participants.
rotation (either supplementation or REFERENCES
reduction) was applied and repeated at 10 CLINICAL SUMMARY 1. Xue CC, An X, Cheung TP, Da Costa C,
Lenon GB, Thien FC et al. Acupuncture
minutes and prior to withdrawal of the Sixteen sessions (two sessions per week)
for persistent allergic rhinitis: a
needles. The primary outcome measure of needling should be administered to randomised, sham-controlled trial. Med J
was self-assessed symptoms scores for the acupoints LI 20 Yingxiang, Ex-HN 3 Aust 2007;187(6):337–41.
nasal obstruction, sneezing, nasal itch Yintang and GB 20 Fengchi. Pattern
and nasal discharge (rhinorrhoea). A differentiation should be used to
secondary outcome measure was use of determine whether Lung, Spleen or
PAR relief medication. Kidney Qi deficiency patterns are
Australian Journal
Research Snapshots
Caroline Smith PhD John Deare MAppSc Zhen Zheng PhD
University of Western Sydney AACMA Research Committee RMIT University
ACUPUNCTURE evidence suggests that acupuncture given dysmenorrhoea. STUDY DESIGN: The
ENHANCES IVF SUCCESS at the time of embryo transfer improves trial was undertaken in Germany. In a
RATE pregnancy and live births rates among randomised, controlled multi-centre
OBJECTIVES: To evaluate whether women undergoing IVF. Manheimer trial plus non-randomised cohort,
acupuncture improves rates of pregnancy reports a clinically relevant benefit and patients with dysmenorrhoea were
and live birth when used as an adjuvant estimates that the number needed to randomised to acupuncture (15 sessions
treatment to embryo transfer in women treat is 10 in order to bring about one over three months) or to a control
undergoing in vitro fertilisation. additional pregnancy. The subgroup group (no acupuncture) who received
DESIGN: Systematic review and meta- analysis of three trials with higher acupuncture after three months. Patients
analysis. Eligible studies were randomised pregnancy rates found a non-significant who declined randomisation received
controlled trials that compared needle trend, suggesting the relative added acupuncture treatment. All subjects were
acupuncture administered within value of acupuncture maybe reduced allowed to receive usual medical care.
one day of embryo transfer with where baseline pregnancy rates are high. Inclusion criteria included: age 18 or
sham acupuncture or no adjuvant However, the numbers of women and more years (age between menarche and
treatment, with reported outcomes trials included in the review is small, and menopause); primary dysmenorrhoea
of at least one of clinical pregnancy, further research is needed. This review from the start of the menarche onwards
ongoing pregnancy, or live birth. Two is important because it paves the way or secondary dysmenorrhoea (for at least
reviewers independently agreed on for future clinical research to further 12 months) with cramping pain during
eligibility, assessed methodological examine the effect of acupuncture on menstruation; written informed consent.
quality and extracted outcome data. pregnancy rates. Exclusion criteria were pain caused by
RESULTS: Seven trials with 1366 inflammatory or malignant diseases.
women undergoing in vitro fertilisation Manheimer E, Zhang G, Udoff L, Each patient received a maximum of
were included in the meta-analyses. Haramati A, Langenberg P, Berman BM, 15 acupuncture sessions. The number
There was little clinical heterogeneity. Bouter LM. Effects of acupuncture on of needles and the acupuncture points
Complementing the embryo transfer rates of pregnancy and live birth among used were chosen at the physicians’
process with acupuncture was associated women undergoing in vitro fertilisation: discretion. Only needle acupuncture
with significant and clinically relevant systematic review and meta-analysis. BMJ (with disposable single-use needles and
improvements in clinical pregnancy 2008;336(7643):545–9. manual stimulation) was allowed; other
(odds ratio 1.65, 95% confidence forms of acupuncture treatment such as
interval 1.27 to 2.14; number needed to ACUPUNCTURE REDUCES laser acupuncture were not permitted.
treat (NNT) 10 (7 to 17); seven trials),
DYSMENORRHOEA AND RESULTS: Of 649 women (mean age
IMPROVES QUALITY OF
ongoing pregnancy (1.87, 1.40 to 2.49; LIFE 36.1 ± 7.1 years), 201 were randomised.
NNT 9 (6 to 15); five trials), and live After three months, the average pain
birth (1.91, 1.39 to 2.64; NNT 9 (6 to Dysmenorrhoea is the leading cause intensity (NRS 0–10) was lower in the
17); four trials). The results were robust of time off school in adolescent girls acupuncture compared to the control
to sensitivity analyses on study validity and a common problem in women of group: 3.1 (95% CI 2.7; 3.6) vs 5.4
variables. A pre-specified subgroup reproductive age. The prevalence rates (4.9; 5.9), difference –2.3 (–2.9; –1.6);
analysis restricted to the three trials with ranged from 18 to 81% depending p < 0.001. In 11.8% of patients (n = 59)
the higher rates of clinical pregnancy in on the measurement method used. a total of 70 side effects were reported
the control group, however, suggested OBJECTIVES: The aim of this clinical after receiving acupuncture (74.3%
a smaller non-significant benefit of trial was to investigate the clinical minor local bleeding or haematoma,
acupuncture (odds ratio 1.24, 0.86 to effectiveness and cost-effectiveness 10% pain (e.g. needling pain), 4.3%
1.77). CONCLUSIONS: The preliminary of acupuncture in patients with vegetative symptoms, and 11.4%
Australian Journal
Research Snapshots
other). No life-threatening side effects IS IT ALL ABOUT SEX? of pelvic and back pain in pregnancy.
were reported. The acupuncture group A recent article in the journal Additional high-quality trails are needed
had better quality of life and higher Acupuncture in Medicine suggests that, to test the existing promising evidence
costs (overall ICER €3011 per QALY). because women experience repeated for this relatively safe and popular
CONCLUSION: Additional acupuncture painful visceral events such as menses complementary therapy.
in patients with dysmenorrhoea was and labour during their life, this could
associated with improvements in pain cause increased sensitivity and prevalence Ee CC, Manheimer E, Pirotta MV and
and quality of life as compared to to pain. The authors went on to explain White AR. Acupuncture for pelvic and
treatment with usual care alone and was that women exposed to experimental back pain in pregnancy review. Am J
cost-effective within usual thresholds. stimuli generally reported greater Obstet Gynecol 2008;198(3):254–9.
However, neither providers nor patients intensity than men did. They hypothesise
were blinded to treatment. Therefore, a that, due to this history of repeated BANXIA HOUPU TANG
bias due to unblinding cannot be ruled pain, this could be a contributing factor
PREVENTS PNEUMONIA
AND RELATED
out. for women and may be one of the MORTALITY IN ELDERLY
reasons they are more likely to suffer PEOPLE WHO HAD
Witt CM, Reinhold T, Brinkhaus B, Roll or experience painful conditions such DEMENTIA
S, Jena S, Willich SN. Acupuncture in as fibromyalgia, temporomandibular OBJECTIVES: In this prospective,
patients with dysmenorrhea: a randomized dysfunction, migraine, rheumatoid double-blinded, randomised, controlled
study on clinical effectiveness and cost- arthritis and IBS. trial, the authors evaluated whether the
effectiveness in usual care. Am J Obstet traditional Chinese herbal medicine
Gynecol. 2008;198(2):166.e1–8. Lund T, Lundeberg T. Is it all about sex? fomula Banxia Houpu Tang (BHT,
Acupuncture for the treatment of pain Banxia, Zhuling, Houpu, Zisu, Ganjiang)
NO DIFFERENCE from a biological and gender perspective. prevented pneumonia and related
BETWEEN DEEP OR Acupunct Med 2008;26(1):33–45. mortality in elderly people who had
SHALLOW NEEDLING
dementia. METHODS: Ninety-five
OBJECTIVES: The primary aim of this ACUPUNCTURE REDUCES participants (mean age 84.0) with
investigation was to compare the brain
PELVIC AND BACK PAIN IN dementia due to cerebrovascular disease,
PREGNANCY
activation in response to deep and Alzheimer’s disease, or Parkinson’s disease
shallow acupuncture needling by utilising OBJECTIVES: The objective of the from two long-term care hospitals in
fMRI scans. STUDY DESIGN: Seventeen study was to review the effectiveness Japan were randomly assigned to the
right-handed healthy volunteers were of needle acupuncture in treating the BHT treatment (n = 47) or the control
randomly allocated to receive either common yet disabling problem of pelvic group (n = 48) and took BHT or
deep (8–12 mm) or shallow (1–2 mm) and back pain in pregnancy. RESULTS: placebo for 12 months. The occurrence
needling with Deqi on LI 4 Hegu. Two Three studies met the inclusion criteria. of pneumonia, related mortality and
fMRI scans were conducted to measure Two trials with a small sample size the daily amount of self-feeding were
the increases (activations) and decreases examined mixed pelvic and back pain, recorded. RESULTS: Out of 92 patients
(deactivations) in the blood oxygen level and one larger trial was on pelvic pain who completed the study, four in the
dependent (BOLD). RESULTS: The only. The authors found in the two BHT group developed pneumonia, in
study demonstrated marked similarities smaller studies that acupuncture as comparison to 14 patients in the control
in BOLD signal responses between an adjunct to standard treatment was group. The number of patients who died
two groups. CONCLUSION: There was superior to standard treatment alone or from pneumonia was one and six in the
no significant difference between the physiotherapy in relieving mixed pelvic BHT and control groups, respectively.
groups. This result was consistant with and back pain. In the larger study, they There was a statistically significant
equivalent therapeutic outcomes claimed found that acupuncture in combination group difference. BHT reduced the
by the proponents of either Japanese or with standard care had greater relief risk of dementia patients developing
Chinese styles of acupuncture. than standard care alone or standard pneumonia by 50% (p = 0.008). No
care and stabilising exercises. Reported adverse events were observed from
MacPherson H, Green G, Nevado adverse events were minor and few. treatment with BHT. The BHT group
A, Lythgoe MF, Lewith G, Devlin R, The authors used a narrative synthesis also self-fed better than the control
Haselfoot R and Asghar AUR. Brain due to significant clinical heterogeneity group did (p = 0.006). CONCLUSION:
imaging of acupuncture: comparing between trials. CONCLUSION: The BHT reduced the risk of pneumonia
superficial with deep needling. Neurosci authors concluded that limited evidence and pneumonia-related mortality in
Lett 2008;434(1):144–9. supports acupuncture in the treatment older patients with dementia.
Australian Journal
Research Snapshots
Iwasaki K, Kato S, Monma Y, Niu K, life and reducing topical corticosteroid CONCLUSION: CQG is as effective and
Ohrui T, Okitsu R et al. A pilot study use in children with moderate-to-severe safe in treating acute upper respiratory
of Banxia Houpu Tang, a traditional AD. tract infection of wind heat syndrome
Chinese medicine, for reducing pneumonia as the commonly used Chinese herbal
risk in older adults with dementia. J Am Hon KLE, Leung TF, Ng PC, Lam MCA, medicine FSG.
Geriatr Soc 2007;55(12):2035–40. Kam WYC, Wong KY et al. Efficacy and
tolerability of a Chinese herbal medicine Chang J, Zhang Y, Mao B et al. A double-
CHINESE HERBAL concoction for treatment of atopic blind, randomized controlled trial of
MEDICINE ELIMINATES dermatitis: a randomized, double-blind, Chaige Qingre Granule in treating acute
LONG-STANDING
MODERATE-TO-SEVERE placebo-controlled study. Br J Dermatol. upper respiratory tract infection of wind
ATOPIC DERMATITIS IN 2007;157(2):357–63. heat syndrome [Article in Chinese]. Zhong
CHILDREN Xi Yi Jie He Xue Bao 2007;5(2):141–6.
OBJECTIVES: In this clinical study, the CHAIGE QINGRE GRANULE
authors aimed to assess the efficacy and
IS EFFECTIVE FOR ACUTE WUWEIZI CONTAINING
UPPER RESPIRATORY HERBAL FORMULA
tolerability of a Chinese herbal medicine TRACT INFECTION MAY HAVE A
concoction (TCHM, Jinyinghua, Bohe, (AURTI) OF WIND HEAT HEPATOPROTECTIVE
Mudanpi, Cangzhu and Huangbai) in SYNDROME EFFECT
children with long-standing moderate- OBJECTIVES: In this double-blinded,
to-severe atopic dermatitis (AD). randomised controlled trial, the authors OBJECTIVES: This study aimed to
METHODS: Following a two-week run- aimed to evaluate the safety and efficacy explore the immunomodulatory
in period, 85 children (mean age 11.7 of Chaige Qingre Granule (CQG), a effect of a Chinese herbal formula,
years) with AD were randomly allocated traditional Chinese compound herbal KY88 (Wuweizi, Chaihu, Yinchenhao,
to receive a 12-week treatment of either medicine, in treating acute upper Jinqiancao, Fuling, Zicao, Baishao,
TCHM or placebo. The SCORing of respiratory tract infection (AURTI) of Huangbai, Huangqin, Tianhuafeng),
Atopic Dermatitis (SCORAD) score, wind heat syndrome. METHODS: In on Hepatitis B surface antigen carriers.
Children’s Dermatology Life Quality phase II, 60 patients with AURTI of METHODS: Thirty-three asymptomatic
Index (CDLQI), allergic rhinitis wind heat syndrome were randomly Hepatitis B surface antigen carriers
score, and requirement for topical allocated to receive CQG (Chaihu, took two capsules of KY88 daily for
corticosteroid and oral antihistamine Gegan, Huangqin, Mahuang, Shigao, two weeks. Full blood tests and liver
were assessed at the baseline and at weeks Xinren, Gancao) or Fufang Shuanghua function tests were conducted before
4, 8, 12 and 16 after treatment. Adverse Granule (FSG, Jingyinhua, Lianqiao, and after. RESULTS: The circulating
events, tolerability, haematological Chuangxinlian, Banlangen). In phase III, monocyte count dropped significantly
and biochemical parameters were also 112 patients were randomly allocated after KY88 from 0.72 × 109/L at the
recorded during the study. RESULTS: to receive the two treatments. The two baseline to 0.57 × 109/L at the end of
The mean SCORAD score reduced groups were treated for three days and the two-week treatment. The count
significantly in both groups, from 58.3 four times daily. No other treatment stayed at a lower level for 8 weeks
to 49.7 in the TCHM group, and 56.9 was allowed. Clinical signs and after the treatment. White blood cell,
to 46.9 in the placebo group. However, symptoms, adverse effect, blood, urine neutrophil and lymphocyte, however,
there was no significant group difference. and stool test, hepatorenal function and did not change significantly after the
The CDLQI in TCHM-treated patients electrocardiogram were examined before treatment. CONCLUSION: The results
was significantly improved and the and after the treatment. RESULTS: After indicate that KY88 may reduce self-
amount of topical corticosteroid used was treatment, the percentage of patients inflicted host immune response to HBV
reduced by a third in the TCHM group, experiencing 75% reduction of fever and has a hepatoprotective effect.
significantly better than the placebo- and other symptoms were 93.10% and
control group. The results maintained 96.55% in the CQG group and the Yip AYS, Loo WTS, Chow LWC. Fructus
for one to three months after the end of control group, respectively, in phase Schisandrae (Wuweizi) containing
the treatment. No serious adverse effects II; and 92.11%, 92.59%, respectively, compound in modulating human
were reported CONCLUSIONS: The in phase III. There were no statistical lymphatic system – a Phase I minimization
TCHM concoction is well tolerated. differences between the two groups. No clinical trial. Biomed Pharmacother.
It is efficacious in improving quality of adverse effects were found in the trial. 2007:61(9):588–90.
Australian Journal
Book Reviews
Yin Lin Gai Cuo (Correcting the Errors in the Forest of Medicine)
Translated and commented on by Yuhsin Chung, Herman Oving and Simon Becker
Blue Poppy Press, 2007
ISBN 189184539X
Blood Stasis: China’s Classical Concept in Modern Medicine

Gunter Neeb
Churchill Livingstone, 2007
ISBN 044210185X
Two recent related but different sections are a fascinating read, especially Chinese medical literature then follow
publications concern the Chinese when comparing these concepts to that bring to life the clinical complexity
medical concept of blood stasis. The first modern anatomy. There are numerous of each formula.
book is a complete translation of the Yi reproductions of the organs and ducts
Lin Gai Cuo (Correcting the Errors in the that assist the reader to understand A bibliography and glossary of comparative
Forest of Medicine), originally written Wang Qin-Ren’s developing thesis. terminology (Pinyin, Chinese character,
by Wang Qin-Ren, with the English Sections 8–11 introduce the herbal Eastland Press, ‘Practical Dictionary’
version being translated and commented therapy for blood stasis and outline the and Blue Poppy Press) complete the text
on by Yuhsin Chung, Herman Oving pathoconditions treated by the three and allow the reader to cross-reference
and Simon Becker. The book has two major herbal stasis-expelling formulae, technical medical concepts across
sections, the first being a translation of namely Tong Huo Xue Tang (Orifice- different publishing terminologies. The
the original text and the second being freeing Blood-quickening Decoction), translators have succeeded in producing
a review of the contemporary clinical Xue Fu Zhu Yu Tang (Mansion of Blood a very scholarly and detailed translation
uses of Wang Qin-Ren’s formulae. The Stasis-expelling Decoction) and Ge Xia of the text, with bilingual printing
original text, which was first published Zhu Yu Tang (Infradiaphragmatic Stasis- (Chinese and English in Book 1) for the
in 1830, is best understood as a expelling Decoction). Sections 12–35 adept readers of modern Chinese. The
‘foundational work in modern Chinese cover a variety of pathoconditions, ample commentaries and endnotes from
medicine’ that introduced a number of including hemiplegia, scourge toxin, the translators explain and elucidate
important Chinese herbal formulae for tugging wind, pox, pregnancy and many of the technical concepts and
treating blood stasis, such as Xue Fu Zhu impediment. theories in the text. It is evident that the
Yu (Mansion of Blood Stasis-expelling three translators bring together a unique
Decoction) and Bu Yang Huan Wu The text also has much to contribute to skill set that includes academic, clinical
Tang (Yang Supplementing Five [tenths] the clinical use of the herbal formulae, and English writing skills to produce
Returning Decoction). especially with the inclusion of Book 2. a text that sets the standard for future
Here the translators have collected a translations of Chinese medicine texts.
Book 1 has 35 sections, each relating variety of modern clinical reports that
to a specific issue. Sections 1–7 focus bring to life and explain in detail the Blood Stasis by Gunter Neeb covers very
on the anatomical revisions that Wang nuances associated with the use of eleven similar ground but is a lot broader in
Qin-Ren made after observing corpses of Wang Qin-Ren’s formulae. The outlook than the previous book. Whilst
and dismembered criminals. Wang composition, preparation and original acknowledging the integral contribution
Qin Ren theorised that the dried indications and modifications are given from Wang Qin-Ren to the concept of
blood (that collected in the area above for each formula. This is then followed blood stasis, the author draws on older and
the diaphragm, which he called the by modern functions and indications contemporary Chinese medicine texts to
mansion of blood) observed in corpses and an in-depth formula analysis and produce a clinical manual on the Chinese
was the source of most disease. These discussion. Several case reports from the condition of blood stasis. Section 1
Australian Journal
Book Reviews
relays the theoretical, historical and practitioners that further elucidate the and lists of Chinese medicinals and
background knowledge of the concept clinical usage of the blood stasis-expelling their western pharmacological actions.
of blood stasis both from a western and, formula. The author has contributed Appendices 4 and 5 consist of an index of
more importantly, a traditional Chinese a commentary for each case study that medicinals and formulae, a bibliography,
medicine perspective. The aetiology, further examines the clinical reasoning a listing of eminent Chinese physicians
diagnostic and syndrome differentiation, underlying each case. and their works, and a short bibliography
as well as principles of treatment, are of the author’s publications.
explained in a clear and rational manner. Section 3 (Chapter 10) again includes
Chapter 7 outlines 46 medicinals that a translation of Wang Qin-Ren’s Yi Together these two texts present a
are commonly used for blood stasis. Lin Gai Cuo. Whilst covering similar formidable foundation for the study
Tables are included, detailing the ground to the previous text, the lack of of blood stasis for the western Chinese
pharmacological effects of the medicinals, commentary precludes the reader from medicine practitioner. The importance
as well as the more traditional Chinese a comprehensive understanding of some of the first book lies in its ability to allow
medical concepts of their effect on of the technical concepts associated access to and an in-depth understanding
channels, organs and site of action. Also with the text. Indeed, it is interesting of an English translation of a primary
included are summaries of the effects to compare the two translations! Also medical text that has contributed to
of combining blood stasis medicinals included are excerpts from six other the contemporary practice of Chinese
(Pei Yao) with other medicinals, such as Chinese medical texts that contribute medicine. The second book amasses a
exterior-relieving and Qi-strengthening to the further understanding of the broader and more clinical perspective.
medicines. Chapter 8 then introduces concept. The author has also included Together these two books complement
32 commonly used formulae, outlining 63 colour tongue slides and sublingual each other and give a comprehensive and
their composition, application, action, photographs that exemplify blood stasis. authentic basis for the understanding
explanation and, where appropriate, and treatment of blood stasis.
suggested acupuncture treatment. Finally, there are nine appendices,
Chapter 9 follows with 20 cases studies including glossaries for both technical Reviewed by Chris Zaslawski
from famous ancient and modern TCM Chinese and western medicine terms,
Australian Journal
Book Reviews
Currents of Tradition in Chinese Medicine 1626–2006

Volker Scheid
Eastland Press, 2007
ISBN 9780939616565
Volker Scheid, in his second book, sets For those of us trained in the West, the sun. This was not because of some
out to look at the problem of tradition I believe that we are handicapped mystical force which they inherited, but
and Chinese medicine. He tackles during our training by not having the through hard work, a lot of study and, as
questions such as ‘how can a medical stories that make it all real. A lot of the Scheid shows us, through the ability to
tradition with cultural roots very concepts are new and very abstract. We carry out the project of what it is to be
different from those in the West survive have discussed theories without really human. Medicine was seen to be the art
and even thrive in places as far afield as knowing the people who were the bearers of compassion. Dripping through every
the US and the UK in the twenty-first of these traditions. This work makes page of this book is the idea that the
century?’ Scheid’s method is to look at it real. This is a story that humanises never-ending project of self-cultivation
how medicine was actually practised in Chinese medicine. or self-improvement sits at the heart of
imperial China. This study carries us what it is to be a good doctor. Ethics,
on a journey stretching from 1626 to Menghe is an area of China in morality and good old-fashioned virtue
2006. Jiangsu. Many of our Australia-trained were essential components of the project
practitioners would be familiar with of medical practice.
Scheid first provides as good an overall Nanjing, which abuts the Menghe area.
general picture of the development of Scheid goes on to show that the Menghe Part 2 deals with republican China
Chinese medicine from the Song period current had a huge influence on the (the period from the fall of the Qing
until now as you will find in the English development of the particular type of Imperial Court in 1911 until the end of
language. He draws on works in Chinese Chinese medicine that we are familiar the Nationalist Party rule in 1949). This
and English. His training as a historian with today. People as familiar to us as period sees Chinese medicine moving
means that he is able to tease out what is the recently departed and revered John into Shanghai. Scheid the historian gives
important for us to know. Scheid denies Shen claimed to be part of the Menghe us vignettes of the growth of Shanghai,
being a Sinologist, but I believe his lineage. now the largest city in China. We see
love of Chinese medicine and his deep the origins of its dynamism in these
attachment to China bring new depths The book comprises fourteen chapters, chapters.
of nuance to the areas of both Chinese being a weighty study of the area. It is
medicine studies and Chinese studies in divided into three parts. We learn a lot about that giant of his
general. time, Ding Ganren, and his medical clan
Part 1 deals with late imperial China, and lineage. This was an intense period
He then dives into a specific group of which formally came to an end in 1911. of questioning, not just in Chinese
practitioners in China. This group came This period is fascinating as it represents medicine, but Chinese thought in
to be known as the Menghe current. imperial China in its maturity. Scheid general. This was a period of turmoil in
This is where Scheid’s attention to detail shows us how the scholar-physicians intellectual circles, one in which Chinese
and his erudite scholarship really drew reached a position of pre-eminence in medicine nearly did not survive. We see
me in and stunned me. Scheid traces the Qing society. how the practitioners of Shanghai and
lineages in detail from primary sources. elsewhere cleverly negotiated the survival
He must have spent years going through Here we meet several families and learn of of Chinese medicine.
old records and diaries, which most the beginnings of the Menghe lineage as
people would have found boring. From embodied by people such as the famous Part 3 looks at contemporary China
these old pages he has made these revered Fei Boxiong. The scholar-physicians and how the Menghe practitioners of
and amazing practitioners of imperial were at their peak in terms of respect, Chinese medicine have managed the
China come to life and made them real status and wealth. This was the last time years of rule by the Communist Party,
characters who we can identify with, as that practitioners of Chinese medicine which took power in 1949. Maoist
well as picking out their faults. We see did not have to deal with the problem of China saw sharp twists and turns in
these people – warts and all – in their what to do with western medicine. The the fortunes of Chinese medicine and
daily practice and their daily lives, while scholar-physicians as paragons of virtue we see this through the stories of the
we learn how they actually practised. were confident and had their place in survivors of the Menghe lineage. From
Australian Journal
Book Reviews
difficult beginnings an institutional of how such an antiquated discipline This is not a clinical handbook. Rather,
infrastructure for TCM was established. is still valuable in a different place it provides an intellectual framework to
Scheid summarises the vicissitudes of and time. His analysis concludes that what it is that we are practising. It gives
medicine in China and brings us to medical practice stretches backwards us context, gives us a place and argues
the present day. Here we meet revered and forwards in place and time, that the how we can be potent practitioners and
practitioners such as Qin Bowei, Zhang practices of our forebears are as relevant effective members of our profession and
Cigong and Cheng Menxue. today as forever, and that we are part of our communities. Medicine is more
that tradition whether we may like it or than just a tool. It is also a ‘thread that
In the epilogue, Scheid signals a not. Lack of space means I cannot do allows people to establish connections, a
warning, and seems to be yearning for justice to his arguments in this review. tool for creating identities, and a strategy
the preservation of the ineffable. His for accumulating capital and extending
discussion is a poignant reflection on In his first book, Chinese Medicine in influence.’ Nathan Sivin, in the foreword,
the things that make Chinese medicine Contemporary China, Scheid argued points out that medical currents are not
valuable and precious. that diversity and plurality are essential just bodies of theory and method, but
features of medical practice. He was networks of people diversely motivated.
A lurch towards the ‘McDonaldisation’ able to show that modern-day TCM
of Chinese medicine would mean the has its origins in complex machinations The notion of the self, in relation to others
loss of diverse currents of practice. involving the very survival of Chinese and as an agency of transformation,
That this may have already happened medicine. generates potency as a practitioner and
is another debate. Paul Unschuld has as a human being.
already said that he thinks Chinese Scheid brings a new flavour to historical
medicine is dead. He argues that we have analysis as he is still a practitioner, seeing I believe this work is a beginning for
cut off the cultural roots, which means patients daily, fitting in his research more people in our field to do scholarly
we are as fossils fighting a losing battle. around his clinical work. This added research that looks at what we are really
Scheid shows that there may be ways to dimension obviates the shortcomings doing. There are so many unanswered
avoid this fate. in the work of some medical historians questions. Most of the history of Chinese
who do not actually understand Chinese medicine has not been analysed at the
This work is a very useful study for any medicine in depth. micro level – the level of human lives.
practitioner who wants to know where it This is a good start.
all came from. We can see where some of I found it such a fascinating read that I
our professional antecedents lie. Scheid am on my fifth go and still finding things Reviewed by James Flowers
also grapples intensely with the question to chew over.
Australian Journal
Book Reviews
The Practice of Chinese Medicine

Second Edition
Giovanni Maciocia
Churchill Livingstone, 2007
ISBN 9780443074905
The new edition of Giovanni Maciocia’s and important information related to substitutes. In addition, the names of
The Practice of Chinese Medicine arrived the subject, make this new edition more some chapters have been changed to
at the clinic the other day. On opening user friendly. reflect improved understanding of some
the package, the first thing I noticed clinical conditions.
was that this book is almost a third Also new are the fourteen additional
thicker than the first edition. For those chapters that include depression, The new edition is in hard cover and
who have not read the first edition, it anxiety, goitre, hypertension, nausea and printed on quality paper, which is the
covered aetiology, channels, diagnosis, vomiting, acid reflux, stomach ulcers, norm for this publisher and author. The
differentiation and treatment, prognosis urinary retention, interstitial cystitis, book is printed in a two-tone colour,
and prevention, western differential benign prostatic hyperplasia, prostatitis, making it easy and quick to identify
diagnosis with Chinese medicine fibromyalgia and erectile dysfunction. important areas.
treatment strategies using acupuncture The chapter on mental-emotional
and Chinese herbal therapy for various problems has been expanded, from This well laid-out book with excellent
common acute and chronic conditions. one chapter in the first edition to eight texts is easy to use, and suitable for Chinese
chapters in this edition, adding depth to medicine students and practitioners. To
This second edition is quite a shift from this important area of clinical practice. quote from another new book edited
the previous one, first published twelve by Hugh MacPherson, Acupuncture
years ago. Expanded and updated, Other changes include the removal of all Research, ‘One of the key characteristics
some of the chapters have new sections patent Chinese herbal products because of a profession is the ownership of a
on pathology, treatment strategies and the author is concerned with quality unique body of knowledge that informs
principles of point selection, as well as assurance and the use of banned or professional practice and is constantly
modern Chinese literature, reports of toxic contents or western drugs in some reviewed, renewed and augmented by
clinical trials and patient statistics from of the herbal products. Original herbal the profession itself.’ This beautifully
the author’s own clinic. These have all formulae containing banned products in presented text by Maciocia has clearly
added depth to the chapters. At the end some countries are however included, as achieved this outcome.
of each section are summaries clearly the author feels that listing them allows
outlining the important messages. the practitioners to see the functions of Reviewed by John Deare
Additional pictures and diagrams, as these herbs and gives them sufficient
well as boxes with updated clinical notes information to find appropriate
Australian Journal
Conference Reports
Third International Congress on Complementary Medicine
Research (ICCMR)
Sydney
29 to 31 March 2008
John Deare
On the last weekend of March 2008, I The vast volume of research on no strong or reliable evidence for its
represented the Australian Acupuncture complementary medicine was presented specific effect. The main problem was
and Chinese Medicine Association at the plenary sessions and the concurrent the definition of the term ‘meditation’,
(AACMA) at the Third International symposia during the two-day conference. inadequate statistical analyses and poor
Congress on Complementary Medicine On Sunday you could have chosen methodology in the design of sham
Research (ICCMR), held at the Sydney from any of the following areas: TCM medication. This reminded me of the
Convention and Exhibition Centre. and acupuncture, complementary and similar problems with acupuncture
Complementary medicine is a complex alternative medicine (CAM) and cancer, research.
and broad area, consisting of many safety and pharmaco-vigilance of herbal
modalities of health practice. The medicine, cross-disciplinary approaches At the closing session, Professor
organising committee did their best not to CAM evaluation, Ayurveda and other Bensoussan from the National Institute
to be biased towards any therapy. therapies for metabolic syndrome, the of Complementary Medicine outlined
international harmonisation of CAM, the main difficulties in complementary
The program was extensive, ranging or clinical trial methods. Monday medicine research in Australia.
across the complementary medicine continued the feast of choice with Evidence is what is needed; however,
spectrum, from research to policy. symposiums ranging from acupuncture less then 0.2% of the net sales of the
About 600 delegates and speakers from and TCM, chiropractic and mind- complementary medicine industries was
Australia, New Zealand, USA, Canada, body medicine, integrative medicine used for research. He praised the efforts
China, Hong Kong, India, Japan, Korea, in action, CAM practice, evidence, of AACMA in establishing research
Malaysia, Taiwan, UK, Germany, France, herbal medicine quality and efficacy, grants to stimulate studies into Chinese
Norway, Denmark, Austria, Switzerland, paediatric CAM, social and qualitative medicine in this country, and thought
Netherlands, Romania and Iran attended research, Tai Chi and exercise therapy, AACMA had set a good example for
the conference. pain/inflammation/psychobiology and other industries and complementary
integrating CAM into curricula and medicine professions.
The conference started with pre- post-graduate training.
conference workshops on Saturday As I got on the plane to come home, I
at a number of universities and a For me, perhaps the most interesting have to admit that the mind was full,
hospital around Sydney. The workshop presentation that I saw was ‘A review of and I was wiped out from trying to take
subjects covered herbal medicine and meditation RCTs – important insights it all in.
globalisation of traditional Chinese for future research’. Dr Manocha from
medicine (TCM), herbal medicines for the University of New South Wales
brain and behaviour (from bench to undertook a review of RCTs published
bedside), TCM practices and research, in English-language peer-reviewed
chiropractic and mind-body medicine. journals. He concluded that there was
Australian Journal
Conference Reports
The Status and Future of Acupuncture Research:

10 Years Post NIH Consensus Conference
Baltimore, Maryland, USA
8 to 11 November 2007
Zhen Zheng, Caroline Smith and Chris Zaslawski
GENERAL us agreed to summarise part of the may not serve acupuncture well. There
INTRODUCTION conference and provide a brief report. remains a need to consider the design
The Society for Acupuncture Research of treatment protocols that reflect
2007 Conference was held from the CLINICAL EFFICACY OF the everyday practice of acupuncture,
8th to the 11th of November 2007 in
ACUPUNCTURE and further careful consideration of
Baltimore, USA. The theme was to reflect The second day of the conference appropriate study designs.
on the achievements of acupuncture focused on the latest scientific evidence
research in the ten years since the from randomised controlled trials, BASIC RESEARCH
National Institutes of Health (NIH) systematic reviews and meta-analysis for The third day of the conference focused
published a consensus statement in 1997 a wide range of biomedical conditions. on basic research of acupuncture. Latest
on the safety and efficacy of acupuncture The scope was wide and included research presented included the effects of
for a range of clinical conditions. The presentations from key researchers in acupuncture on chronic inflammation
statement has since been considered the fields of osteoarthritis of the knee, (Prof LX Lao), high blood pressure (Prof
as a White Paper to support the use back pain, headache and neck pain, J Longhurst), female infertility (Dr E
of acupuncture in primary care and women’s health, cancer, mental health, Stener-Victorin) and brain imaging (Drs
promote acupuncture clinical research respiratory disorders, gastrointestinal Napadow and Harris).
in the United States and the world. disorders, some neurological disorders,
and a presentation from the German In animals, electroacupuncture (EA) of
Data presented at the conference showed acupuncture research programs. 2 Hz on ST 36 Zusanli, ST 37 Shangjuxu,
that since the publication of the Paper, PC 5 Jianshi and PC 6 Neiguan reduced
the number of physicians who favour A key approach was to provide an systolic blood pressure significantly
acupuncture in the US has increased overview of the evidence from clinical more effectively than EA of 40 Hz or
from 50% to 80%, and the percentage trials undertaken over the ten years since EA on LI 6 Pianli or LI 7 Wenliu did,
of insurance companies giving rebates the NIH consensus statement. Several indicating that the anti-hypertensive
to acupuncture treatments has increased common themes emerged from many effect of EA is specific to acupuncture
from 15% to 45%. More interestingly, in of the presentations. Firstly, conducting point and EA frequency. Frequency of
1997, only 30% of acupuncture projects rigorous, high quality and robust EA is also an important factor on chronic
funded by the NIH had an acupuncturist randomised controlled trials remains inflammation. EA of 100 Hz produced a
on the team; by 2006, 100% of projects a challenge. Secondly, we frequently transient analgesic effect, whereas EA of
had research acupuncturists. heard from the presenters of a lack of 10 Hz included a long-term analgesic as
a treatment effect between acupuncture well as anti-inflammatory effect.
The four-day conference was stimulating and a sham acupuncture control. The
and covered a range of topics, including majority of outcomes utilised in trials I am most fascinated by the results of
research into acupuncture’s mechanisms, are clinically focused, and there is an brain imaging research of acupuncture in
clinical efficacy and qualitative studies. absence of outcomes that reflect a more humans. In healthy humans, each digit
personal experience from treatment. of our hand has its clear presentation in
More than 300 delegates from 20 the somatosensory cortex of the brain.
countries took part in this special This stimulating day clearly In patients with carpel tunnel syndrome,
event. 250 abstracts were received by demonstrated the contribution such presentation is unclear and the areas
the conference organisers and 24 were researchers have made over the past ten are merged so that the brain could not
accepted for oral presentations and 200 years towards developing an evidence easily distinguish the sensation of one
for posters. Three Australian researchers, base for acupuncture. However, the finger from another. After a course of
all on the editorial board of this journal, challenge remains given in many areas acupuncture, patients reported reduced
presented at the conference. Each of that our current research methodology tingling and numbness and had enhanced
Australian Journal
Conference Reports
sensitivity in the affected hand. In such presenter, Dr Claire Cassidy, argued that when compared to the researcher’s
patients, the digit presentation in the while clinical research was important for aims. Charlotte also argued the need
brain became separated and mimicked understanding how acupuncture works, it for patient-centred outcomes in clinical
the brain imaging of healthy humans. did not reflect the everyday experience in trials, not just disease-focused measures.
a real clinical setting. She acknowledged
A PET study on fibromyalgia patients that measurable physiological changes The conference concluded with a
showed that although both real and were important, but the need to apply presentation of the future directions
sham acupuncture reduced pain in these a mix of qualitative and quantitative of acupuncture research by Richard
patients, the brain imaging induced methods in research would facilitate Hammerschlag from Oregon College
by the two types of acupuncture the whole exploration of the healing of Oriental Medicine. Richard painted
interventions was different. Real benefits of acupuncture. Both intention a futuristic picture of acupuncture
acupuncture enhanced the efficiency and expectation, she argued, must be research using an imaginary research
of opioids in the brain regions related factored into the design of studies. She institute. He then proceeded to extol the
to pain whereas sham acupuncture did then proceeded to layout a flow chart benefits of such an institute and said he
not. depicting the many ‘decision points hoped that such an institute would exist
inherent in the medical encounter even not too far in the future.
As we are all aware, recently a few before ”active” treatment begins and
large clinical trials have found that real which affect outcome well after “active” The conference closed with remarks from
acupuncture produces a similar amount treatment ceases.’ This perspective was Rosa Schnyer (Co-president of SAR)
of pain relief to sham acupuncture also echoed by Hugh MacPherson, who commented on the enormity of
(that is, needling shallowly on non- who argued the case for a ‘whole system organising the event and thanked all the
acupuncture points without Deqi). approach’ for evaluating acupuncture. participants for attending. In retrospect,
Results of such studies have led some From this perspective, not only the this was a ‘once in a lifetime’ event, where
people to believe that acupuncture is specific effects of acupuncture contribute leading researchers from not only western
merely a powerful placebo. The above- to the acupuncture effect, but also non- countries like America and Australia, but
mentioned PET study shows that the specific factors such as practitioner and also Korea, China and Japan, could meet,
underlying mechanisms of real and patient beliefs, the clinical setting and network and discuss the current state of
sham acupuncture are rather different the therapeutic relationship. Hugh is acupuncture research. The SAR is to be
and the effect of acupuncture cannot be also a strong advocate for pragmatic trials congratulated on undertaking such an
explained simply as placebo. which evaluate a treatment package, event. It also made us reflect on how
rather than parse out the specific effects the annual AACMA conference is also
Basic research not only helps us of needling. an important event for similar reasons.
understand how acupuncture works, Without interaction and peer discussion
but also guides our clinical practice by Charlotte Paterson also expressed a the acupuncture profession will stagnate.
identifying ideal treatment parameters. similar perspective. She presented some Rigorous research, lively discussion and
of the results of her research involving the generation of more questions than
QUALITATIVE RESEARCH qualitative research methodology. Her answers are sure indicators of a healthy,
The fourth and final day of the conference presentation explored the views of growing profession.
focused on the use of qualitative methods patients who were enrolled in a clinical
in acupuncture research. The first trial, and how dissimilar they were
Australian Journal
Upcoming International Conferences
2008
23–25 May Sydney, Australia
Australasian Acupuncture and Chinese Medicine Annual Conference (AACMAC)
Details: www.acupuncture.org.au/AACMAC_2008.cfm
20–22 June Wellington, New Zealand
New Zealand Register of Acupuncturists Annual Conference
Contact: [email protected]
27–29 June Göttingen, Germany
International Congress for Biological Lasertherapy and Acupuncture
Details: www.egla.de; contact: [email protected]
14–18 August Hong Kong, China
International Conference & Exhibition of the Modernization of Chinese
Medicine Health Products
Details: www.icmcm.com
14–17 October Macau, China
5th International Congress of Traditional Medicine
World Federation of Chinese Medicine Societies (WFCMS)
Details: www.2008ictm.com
16–20 October Chicago, USA
American Association of Acupuncture & Oriental Medicine Annual Conference
Details: www.aaaomonline.org
7–9 November Beijing, China
WHO Congress on Traditional Medicine
2009
22–24 May Melbourne, Australia
Australasian Acupuncture and Chinese Medicine Annual Conference (AACMAC)
Details: www.acupuncture.org.au/AACMAC_2009.cfm
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Australian Journal of

2008 VOLUME 3 ISSUE 1

The Australian Journal of Acupuncture and

Managing editor and staff

Hugh MacPherson, PhD, BSc

CALL FOR SUBMISSION OF MANUSCRIPTS

INSTRUCTIONS FOR AUTHORS

ADDRESS FOR SUBMISSION OF MANUSCRIPTS

Letters to the Editor

K E Y W O R D S systematic review, acupuncture, migraine, headache.

* Correspondent author; e-mail: [email protected] Aust J Acupunct Chin Med 2008;3(1):3–16.

Objectives outcome for migraine, such as frequency or intensity of

SEARCH STRATEGY FOR IDENTIFICATION OF DATA EXTRACTION

TABLE 1 Characteristics of included studies

Author and date Intervention Sample population* Outcomes# Follow-up Drop-out

Zhou JH Acupuncture vs western Acu: n = 35 ▲ 6 months No

Wang B Acupuncture vs western Acu: n = 125 ▲ N/A No

Cui R, et al. Acupuncture vs western Acu: n = 48 ▲ 3 months No

Feng SL, et al. Acupuncture vs western Acu: n = 35 ▲ 2 months No

Zhang YC, et al. Acupuncture vs western Acu: n = 106 ■ 1 year No

Liu KY, et al. Acupuncture vs western Acu: n = 43 ▲ and 1 month No

Li W, et al. Acupuncture vs western Acu: n = 70 ▲ N/A Yes

Chen XS Acupuncture vs western Acu: n = 45 ■ 6 months No

Zhou LS Acupuncture vs western Acu: n = 43 ▲ 3 months No

Lao JX Electronic acupuncture vs Acu: n = 87 ▲ 2 months No

Wang JL, et al. Acupuncture plus Chinese Acu: n = 60 ■ 6 months No

Liu Y, et al. Acupuncture plus acupoint Acu: n = 54 ■ 8 weeks No

Lu ZQ Acupuncture plus massage Acu: n = 54 ■ 6 months Yes (16)

Number and percentage of Allocation

continued on next page

TABLE 1 Characteristics of included studies (continued)

Author and date Intervention Sample population* Outcomes# Follow-up Drop-out

Shao Y, et al. Electronic acupuncture Acu: n = 35 ▲ 6 months No

Wang LQ, et al. Acupuncture plus Acu: n = 63 ● 1 year No

Liu XL, et al. Acupuncture plus Acu: n = 256 ■ N/A No

Zhang YK Acupuncture plus Acu: n = 60 Headache No No

* Acu: acupuncture, WM: western medications

Number and percentage of Allocation

FIGURE 2 Global responses to the treatments – acupuncture versus western medications

TABLE 2 Study and control interventions of included studies

No 5/week for 8 weeks N/A Nimodipine 40 mg, t.i.d

No 1/day for 30 days N/A Nimodipine 30 mg, tid for 30 days

No 1/day for 20 days N/A Nimodipine 30 mg, tid for 20 days

Our review Melchart et al. Scott and Deare

Jadad, median 2 (1–2) 1.5 (1–4) 2.3 (1–5)

Respondent rate 50% 50% 33%

Relative risk 1.55 (1.27–1.88) N/A 1.38 (1.08–1.76)

Similar pharmacological treatments were used as the control

Mary Garvey* MHSc

K E Y W O R D S biomedicine, Chinese medicine, epistemology, integration, materialism,

* Correspondent author; e-mail: [email protected] Aust J Acupunct Chin Med 2008;3(1):17–23.

Yin-yang theory is the core of early Chinese philosophy, and

Dao-xiang-qi and Chinese xiang-qi onto-epistemic, it is not possible to acquire knowledge

senses and tissues, consciousness, perceptions, movements and

TABLE 1 Glossary of terms 易经 Yi Jing or

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