Prospective Evaluation of Acupuncture As Treatment For Glaucoma
Prospective Evaluation of Acupuncture As Treatment For Glaucoma
Prospective Evaluation of Acupuncture As Treatment For Glaucoma
SIMON K. LAW, STARRIE LOWE, SAMUEL M. LAW, JOANN A. GIACONI, ANNE L. COLEMAN, AND
JOSEPH CAPRIOLI
G
PURPOSE: To evaluate acupuncture as treatment for LAUCOMA MANAGEMENT IN WESTERN MEDICINE
glaucoma. is well established and its efficacy has been
DESIGN: Prospective double-masked randomized cross- demonstrated by a number of randomized clinical
over study. trials.1 However, despite medical and surgical therapies, a
METHODS: SETTING: Clinical practice. POPULATION: significant proportion of glaucoma patients continue to
One eye per patient with primary open-angle glaucoma go blind.2 Alternative therapies to reduce the progression
and stable intraocular pressure (IOP). INTERVENTION: rate of glaucoma have been actively sought, but as yet
Patients were randomized to receive 1 acupuncture series without much success. Acupuncture, a branch of Chinese
(12 sessions with either eye-related [eye-points] or non- traditional medicine used for over 2000 years in the treat-
eye-related [non-eye-points] acupoints) and then crossed ment of various illnesses, is one alternative therapy that has
over to receive the other series. OUTCOME MEASURES: IOP, garnered the attention of many glaucoma patients.3
blood pressure (BP), heart rate (HR), best-corrected Ocular effects associated with acupuncture have been
visual acuity (BCVA), visual field (VF), optic disc and studied in animal models and in small samples of human
peripapillary retinal nerve fiber layer (RNFL) measure- subjects. Some studies report beneficial effects such as
ments, compliance, and adverse reactions. Probability to intraocular pressure (IOP) reduction,4–10 improvement of
detect 3 mm Hg IOP difference between series was 90%. central visual acuity,10,11 and alterations of the visual
RESULTS: Twenty-two patients volunteered and 11 field.12 However, most of the clinical results are inconclu-
(50.0%) completed the study; 8 (36.4%) did not com- sive because of inadequate research design or incompletely
plete treatment owing to changes of health, moving described methodologies.13 In addition, variable locations
away, lack of transportation, or family crisis; and of acupoints and different acupuncture intensities, dura-
3(13.6%) were withdrawn owing to needle sensitivity tions, and frequencies of stimulation were studied. This
or IOP elevation (8 mm Hg) in the contralateral eye. Af- clinical heterogeneity makes scientific analyses or useful
ter an acupuncture session, mean IOP increased slightly comparisons of these acupuncture study results difficult, if
with both eye-points (from 12.9 ± 1.8 mm Hg to 13.6 not impossible.13,14
± 2.0 mm Hg, P [ .019) and non-eye-points (from The purpose of this investigation was to prospectively
13.0 ± 1.5 mm Hg to 13.5 ± 1.7 mm Hg, P [ .073) evaluate the effects of acupuncture as glaucoma treatment.
series. HR, diurnal IOP, and BCVA showed no statisti- In particular, IOP, central visual acuity, visual field status,
cally significant changes after 12 sessions of either series. and optic nerve and retinal nerve fiber structure were stud-
Systolic and diastolic BP were reduced after 12 sessions of ied in patients with primary open-angle glaucoma.
non-eye-points series (P [ .040, P [ .002, respec-
tively). Optic disc, RNFL, and VF showed no statistically
significant changes.
CONCLUSIONS: Acupuncture has no overall effect on METHODS
diurnal IOP or BCVA but may temporally increase the
IOP immediately after a treatment session. BP is lowered THIS WAS A PROSPECTIVE, DOUBLE-MASKED, RANDOMIZED
by acupuncture with non-eye-points, but not with eye- crossover comparative study approved by the Institutional
points. Compliance and adverse event rates were Review Board of the University of California Los Angeles.
low. (Am J Ophthalmol 2015;160(2):256–265. The study was conducted according to the tenets of the
Ó 2015 by Elsevier Inc. All rights reserved.) Declaration of Helsinki and all applicable HIPAA rules.
Informed consent was obtained from subjects prior to
screening and study enrollment. Flyers explaining the na-
ture of the study were available to patients who visited
Accepted for publication Apr 21, 2015. the Glaucoma Division of the Stein Eye Institute. Patients
From the Glaucoma Division, Stein Eye Institute, David Geffen School who expressed interest in the study underwent a screening
of Medicine, University of California Los Angeles, Los Angeles, visit for eligibility. Eligibility criteria were primary open-
California.
Inquiries to Simon K. Law, 100 Stein Plaza #2-235, Stein Eye Institute, angle glaucoma, age 18 years or older, stable intraocular
Los Angeles, CA 90095; e-mail: [email protected] pressures (less than 2 mm Hg variation in the last 2
follow-up visits over a period of at least 3 months and reaction evaluation, (3) central corneal thickness measure-
without alteration of glaucoma therapy for 6 months), no ment, (4) ocular motility evaluation, (5) external and peri-
use of any alternative therapy including cannabis, no his- orbital evaluation, (6) anterior segment examination with
tory of surgical or laser intervention for glaucoma or failed slit-lamp biomicroscopy, (7) gonioscopic evaluation of
interventions within the prior 3 years, no cardiovascular or anterior chamber drainage angle, (8) optic disc evaluation,
neurologic diseases or bleeding disorders, and no retinal and (9) dilated retinal examination. The visual field was
abnormalities or nonglaucomatous optic neuropathy. One tested with achromatic automated perimetry (Humphrey
eye per patient was enrolled; if both eyes qualified for Field Analyzer [HFA] II; Carl Zeiss Meditec, Dublin, Cal-
enrollment, only the right eye was enrolled. Diagnosis of ifornia, USA) with the 24-2 Standard Swedish Interactive
primary open-angle glaucoma was made when glaucoma- Threshold Algorithm (SITA-standard). Optic disc and
tous visual field defects and glaucomatous optic neuropathy RNFL measurements were obtained with confocal scan-
were diagnosed by the treating physician (a glaucoma ning laser ophthalmoscopy (Heidelberg Retinal Tomogra-
specialist) in the setting of an open angle. Secondary glau- phy [HRT]; Heidelberg Engineering, Carlsbad, California,
comas were excluded, including pigmentary dispersion, USA) and spectral-domain OCT (Cirrus SD OCT; Carl
pseudoexfoliation, uveitic, steroid-induced, or traumatic Zeiss Meditec), respectively.
glaucomas. After the baseline examination, patients were scheduled
A separate baseline examination was scheduled after to undergo acupuncture treatment. Acupuncture was
screening to obtain baseline measurements, which performed by an experienced, licensed acupuncturist
included blood pressure (BP) and heart rate (HR), a com- (S.L.). Two groups of acupuncture points were evaluated.
plete ophthalmic examination, visual field testing, optic One group of points was related to the eye or used to treat
disc and peripapillary retinal nerve fiber layer (RNFL) eval- eye diseases according to traditional Chinese acupuncture
uation, and diurnal IOP measurements (measured with theory (eye-points). The 4 eye-points were UB2, GB37,
Goldmann tonometry every 2 hours from 8 AM to 4 Liv3, and LI415,16 (Figure 1). The second group of
PM). A complete ophthalmic examination consisted acupuncture points was not eye related and is traditionally
of (1) Snellen visual acuity measurement, (2) pupillary used to treat nonocular disease (non-eye-points). The 4
non-eye-points were St36, St38, Sp6, and UB60. These acupuncture needles left in place for 20 minutes while
non-eye-points are typically used for pain control, stress the patient rested on a 45-degree-reclined examination
management, fatigue, and treatment of insomnia and diges- chair, without electric or laser stimulation of the needle
tive illnesses15,16 (Figure 2). There is no consensus among or moxibustion. (Moxibustion is the application of heat
acupuncturists on a set of acupuncture points for treating resulting from the burning of herbs, or moxa, to acupoints
any particular ocular disease. Literature on acupuncture to facilitate the acupuncture effect.) The examination door
and Chinese medicine suggests that one cause of ocular dis- was closed to avoid noise or disturbance; no music was
ease is an imbalance of body energy flow along the gall- played.
bladder (GB) and liver (Liv) meridians. Two eye-points Patients were randomly assigned (by flipping a coin) to
chosen in this study (GB37 and Liv3) belong to these me- receive 1 acupuncture series, either the eye-points or
ridians. Eye-points GB37, Liv3, and LI4 were studied in a non-eye-points, for 12 sessions over 6–12 weeks (1–2 ses-
prospective case series of acupuncture treatment in patients sions per week) and then were crossed over to receive the
with glaucoma or ocular hypertension.8 Eye-point UB2, other acupuncture series (12 sessions over 6–12 weeks)
located on the medial end of the eyebrow, belongs to a with a washout period of 4 weeks in between. Glaucoma
group of acupuncture points surrounding the orbit that is medical therapy was not altered at any time during the
believed to have a stronger therapeutic effect in treating study.
ocular diseases than distal acupuncture points.16 Acupunc- Patients and research personnel, except the licensed
ture needles were placed on points on both sides of the acupuncturist, were masked to the acupuncture points
body. Sterile stainless steel disposable acupuncture needles used, the therapeutic effects of the acupuncture points,
(1 inch 36 gauge needles and 1/2 inch 38 gauge needles) and the order of the acupuncture series (whether a patient
were used. A sensation of numbness and mild aching at was receiving the eye-points therapy or the non-eye-points
the acupoint (traditionally termed ‘‘De Qi’’) was elicited therapy).
as an indication of proper needle placement. Each BP, HR, and IOP were measured 15 minutes before and
acupuncture treatment session was conducted in an after each treatment session. Diurnal IOP measurement
assigned examination room with light dimmed and and automated visual field measurements were obtained
Patients who Completed the Study Patients who Did Not Complete the Study
Number of patients 11 11
Mean age, y (range) 63.7 6 14.3 (35.6–87.6) 64.5 6 10.0 (45.0–76.7)
Sex: female/male 8/3 8/3
Race: white/black/Hispanic/Asian 5/1/2/3 10/0/0/1
On systemic beta-blockers None None
Mean central corneal thickness (mm) 528.8 6 39.1 533.1 6 43.4
Lens status: phakic/pseudophakic 10/1 7/4
Previous laser trabeculoplasty 0 0
Previous trabeculectomy 2 1
Previous cataract surgery 1 4
TABLE 2. Blood Pressure, Heart Rate, and Intraocular Pressure Immediately Before and After Each Session of Eye-Related and Non-
Eye-Related Acupuncture Treatment in the Acupuncture as Treatment for Glaucoma Study
Before Individual Treatment Session After Individual Treatment Session P Value (Paired Student t Test)
TABLE 3. Blood Pressure, Heart Rate, Best-Corrected Visual Acuity, and Diurnal Intraocular Pressure Before and After 12 Sessions of
Eye-Related and Non-Eye-Related Acupuncture Treatments in the Acupuncture as Treatment for Glaucoma Study
at the baseline visit, within 1 week of completion of the first acupuncture series. Adverse reactions were recorded
series of 12 sessions, and within 1 week before and after throughout the study period.
the second series of 12 sessions. Optic disc (HRT) and In this pilot study, a sample size calculation was based on
RNFL measurements (SD OCT) were obtained at the base- IOP, which is the most important risk factor for glaucoma
line visit and within 1 week of completing the second and the primary parameter monitored in glaucoma therapy.
A treatment difference of 3 mm Hg was used based on the unrelated to glaucoma or acupuncture, 2 of the 8 moved
results of previous studies.4–10,17 Ten subjects were needed away, 3 had problems with transportation during the study,
for a 90% probability to detect a treatment difference of and 1 had a family crisis. An additional 3 patients (13.6%)
3 mm Hg with a 2-sided .05 significance level, assuming a were withdrawn from the study by one of the investigators
within-subject standard deviation of 1.5 mm Hg in a 2- owing to needle sensitivity (2 patients) and to clinically
treatment crossover study. Standard deviation of 1.5 mm significant elevated IOP (8 mm Hg) in the contralateral
Hg was chosen based on the IOP definition of stability in eye that required a change in glaucoma treatment for the
the inclusion criteria. patient. Table 1 summarizes the demographic characteris-
Primary outcome measurements included diurnal IOP, tics of patients who completed and did not complete the
best-corrected visual acuity (BCVA), visual field results, study.
and optic nerve and RNFL measurements. Secondary
outcome measurements included blood pressure, heart INTRAOCULAR PRESSURE: After each acupuncture ses-
rate, and rates of adverse reactions. BP, HR, and IOP sion, with either eye-points or non-eye-points, mean IOP
were compared before and after each individual acupunc- of the treatment groups exhibited a slight increase. After
ture treatment session. Diurnal IOP, BCVA, and visual treatment of the eye-points, mean IOP increased from
field indices (mean deviation and pattern standard devia- 12.9 6 1.8 mm Hg immediately before to 13.6 6 2.1 mm
tion) were compared before and after each series of 12 ses- Hg immediately after the treatment session (P ¼ .019,
sions. Snellen chart visual acuity was converted to the Table 2). A borderline statistically significant increase of
logMAR scale for analysis. Optic nerve and RNFL mea- mean IOP was noted with the non-eye-point sessions too
surements (linear cup-to-disc area ratio, cup shape mea- (from 13.0 6 1.5 mm Hg to 13.5 6 1.7 mm Hg, P ¼
sure, rim area, rim volume, RNFL height variation .073). This IOP effect appears to be temporary, as no signif-
contour, and mean RNFL thickness were measured with icant change of diurnal IOP was detected after 12 sessions
HRT; average RNFL thickness and RNFL thickness at su- of eye-related or non-eye-related acupuncture treatments
perior, nasal, inferior, and temporal quadrants were (Table 3). Mean diurnal IOPs were 12.9 6 2.0 mm Hg
measured with SD OCT) were compared between the before and 12.7 6 2.0 mm Hg after 12 sessions of eye-
baseline visit and after both 12-session series were related acupuncture treatment, and 13.1 6 1.8 mm Hg
completed. Paired Student t tests were used to compare before and 12.8 6 1.8 mm Hg after 12 sessions of non-
variables before and after interventions. Mean values eye-related acupuncture treatment (P ¼ .711 and P ¼
are reported with their standard deviations (6SD). .381, respectively).
Adverse reactions were reported using descriptive statis-
tics. Microsoft Office Excel 2010 Analysis ToolPak VITAL SIGNS (BLOOD PRESSURE AND HEART RATE): BP
(Microsoft, Redmond, Washington, USA) was used for and HR responses were different after single eye-point
statistical analysis. and non-eye-point treatment sessions. The mean systolic
BP and HR of the entire group showed a significant reduc-
tion after a single non-eye-point session (Table 2). Mean
systolic BP decreased from 120.5 6 13.2 mm Hg immedi-
RESULTS ately before to 118.1 6 13.8 mm Hg immediately after a
treatment session (P ¼ .015), while mean HR decreased
TWENTY-TWO GLAUCOMA PATIENTS VOLUNTEERED TO from 67.6 6 10.5 beats per minute (bpm) immediately
participate in the study and 11 patients (50.0%) completed before to 64.3 6 8.5 bpm immediately after treatment
the study. Eight patients (36.4%) did not complete (P ¼ .006). In contrast, after an eye-point session, mean
the study; 2 of the 8 patients had changes in their health systolic BP increased from 118.5 6 17.3 mm Hg before
Before Eye-Related and Non-Eye-Related After Eye-Related and Non-Eye-Related P Value (Paired
Acupuncture Treatment Acupuncture Treatment Student t Test)
a
Heidelberg Retinal Tomography (HRT); Heidelberg Engineering, Carlsbad, California, USA.
TABLE 6. Retinal Nerve Fiber Layer Measurements With Spectral-Domain Optical Coherence Tomographya in Patients Before and
After Participation in the Eye-Related and Non-Eye-Related Acupuncture Treatment of the Acupuncture as Treatment for Glaucoma
Study (Mean Duration of Study: 8.02 6 2.44 Months)
a
Cirrus spectral-domain optical coherence tomography (SD OCT); Carl Zeiss Meditec, Dublin, California, USA.
to 121.6 6 18.0 mm Hg after the session (P ¼ .040). HR unchanged after 12 sessions of either treatment (0.084 6
went from 66.8 6 13.1 bpm before to 64.1 6 9.8 bpm after 0.138, 0.097 6 0.140, P >.999 and P ¼ .895, respectively,
an eye-point treatment (P ¼ .082). Mean diastolic BP did Table 3).
not change with either treatment.
The BP response observed after individual non-eye- HEIDELBERG RETINAL TOMOGRAPHY, SPECTRAL-
point treatment sessions appeared to be sustained. After DOMAIN OPTICAL COHERENCE TOMOGRAPHY, VISUAL
FIELD: The visual field was tested before and after 12 ses-
completion of the series of 12 sessions of non-eye-point
acupuncture, mean systolic BP decreased from 126.5 6 sions of eye-related and before and after 12 sessions of
19.7 mm Hg to 116.2 6 16.8 mm Hg and mean diastolic non-eye-related acupuncture treatments, while optic
BP was lowered from 78.4 6 7.4 mm Hg to 69.5 6 disc measurements with HRT and RNFL thickness with
9.7 mm Hg (P ¼ .040 and P ¼ .002, respectively). Changes SD OCT were obtained at baseline and after the last
in HR were not statistically significant (from 61.1 6 acupuncture treatment in the study. None of the visual
9.2 bpm to 62.4 6 10.4 bpm, P ¼ .565). For eye-point field indices (mean deviation and pattern standard devia-
acupuncture, no statistically significant changes were noted tion), optic disc, or RNFL thickness measurements
in the systolic BP, diastolic BP, or HR after 12 treatment demonstrated any statistically significant changes
sessions (Table 3). (Tables 4–6).
ALL AUTHORS HAVE COMPLETED AND SUBMITTED THE ICMJE FORM FOR DISCLOSURE OF POTENTIAL CONFLICTS OF INTEREST.
Financial Disclosures: None. Funding Support: Oppenheimer Seed Grants in Complementary, Alternative, and Integrative Medicine, University of Cal-
ifornia Los Angeles, David Geffen School of Medicine, Los Angeles, California. All authors attest that they meet the current ICMJE requirements to
qualify as authors.
The authors acknowledge Fei Yu, PhD, of the Biostatics Department of UCLA for providing statistical analysis.