Indian Journal of Research in Homoeopathy

Official Publication of Central Council for Research in Homoeopathy

Print ISSN: 0974-7168

E-ISSN: 2320-7094

Editorial Board
Editor-In-Chief
Dr. R. K. Manchanda, MD (Hom.), MBA (Health Care)
Editors
Dr. Vikram Singh, MD (Hom.)
Dr. Bindu Sharma, MD (Hom.)
Dr. Anil Khurana, MD (Hom.)
Associate Editors

Assistant Editors
Dr. Shaji Kumar R. T., MD (Hom.)
Dr. V. Roja, MD (Hom.)
Dr. Hima Bindu, MD (Hom.)
Dr. Amulaya Ratna Sahoo, MD (Hom.)
Dr. Sindhu Mary Jacob, BHMS, R. C. (Hom.)
Dr. Ritika Hassija Narula, MD (Hom.)

Dr. O. P. Verma, M.A., M.L.I.Sc., PhD.

Dr. K. R. Janardanan Nair, MD (Hom.)
Dr. Ch. Raveender, MD (Hom.)
Dr. P. S. Chakraborty, MD (Hom.)
Dr. K. C. Muraleedharan, MD (Hom.)
Dr. Pritha Mehra, MD (Hom.)

Editorial Advisory Board

Dr. Peter Fisher
Clinical Director and Director of Research,
Royal London Hospital for Integrated Medicine, London,
United Kingdom
Dr. Michel Van Wassenhoven
Coordinator, European Committee for Homeopathy,
Brussels, Belgium
Dr. Flavio Dantas
Professor of Homeopathy, University of Uberlandia,
Uberlandia, Brazil
Dr. Robert T. Mathie
Research Development Advisor, British Homoeopathic
Association & Member, Faculty of Homoeopathy,
London, United Kingdom
Prof. Robert Jutte
Director, Institute for the History of Medicine of the
Robert Bosch Foundation and Adjunct Professor of
History, University of Stuttgart, Stuttgart, Germany
Dr. Michel Teut
Medical Director, Charit Outpatient Clinic for
Preventive and Integrative Medicine, Berlin, Germany
Prof. (Dr.) Martin Dinges
Deputy Director, Institute for History of Medicine of
Robert Bosch Foundation, Stuttgart, Germany
Dr. Clare Relton
Research Fellow, School of Health and Related Research,
University of Sheeld, Sheeld, United Kingdom
Dr. Silvia Waisse
Professor, Post Graduate Program in History of Science,
PUC-SP, Brazil
Dr. Renzo Galassi
President, LMHI, Macerata, Italy
Dr. Gabor Fruzsina
Pharmacy Subcommittee Co-ordinator, European Committee for Homeopathy, National Vice President for LMHI,
Hungary

Padmashree Dr. V. K. Gupta

Former Principal, Nehru Homoeopathic Medical
College & Hospital, New Delhi, India
Dr. M. P. Arya
Member, Scientic Advisory Committee, CCRH,
New Delhi, India
Dr. P. N. Varma
Chairman, Special Committee for Drug
Standardization, CCRH, New Delhi, India
Dr. Girish Gupta
Member, Special Committee for Human
Pathogenetic Trial (Drug Proving) CCRH, New Delhi,
India
Prof. (Dr.) C. Nayak
Member, Scientic Advisory Committee, CCRH &
Former Director General, CCRH, New Delhi, India
Dr. Rathin Chakravarty
Member, Scientic Advisory Committee, CCRH, New
Delhi, India Member, Faculty of Homoeopathy,
London, United Kingdom

Dr. N. Mohanty
Chairman, Special Committee for Human
Pathogenetic Trial (Drug Proving), CCRH, New
Delhi, India
Dr. Arvind Kothe
Principal & Medical Superintendent, Shri
Kamaxidevi Homoeopathic Medical College &
Hospital, Shiroda, Goa, India
Dr. K. K. Singh
Scientist G & Head, Human Resource Planning
and Development, Indian Council of Medical
Research, New Delhi, India
Dr. R. J. Yadav
Scientist G, National Institute of Medical Statistics,
Indian Council of Medical Research, New Delhi,
India
Dr. N. C. Jain
Scientist F & Editor, Indian Journal of Medical
Research, Indian Council of Medical Research, New
Delhi, India

Prof. L. K. Nanda
Member, Scientic Advisory Committee, CCRH,
New Delhi, India

Prof. (Dr.) Asha Choudhary

Professor & Head, Dept. of Anatomy,
Dr. B. R. Sur Homoeopathic Medical College
Hospital and Research Centre, New Delhi, India

Dr. Eswara Das

Former Director, National Institute of
Homoeopathy, Kolkata,India

Prof. Anu Kapoor

Professor, Nehru Homoeopathic Medical College &
Hospital, New Delhi, India

Dr. Alok Kumar

Deputy Advisor (Homoeopathy), Department
of AYUSH, Ministry of Health & Family Welfare,
Government of India

Dr. S. R. Sharma
Consultant Homoeopath, Former Sceintist-3, CCRH,
New Delhi, India

Dr. Harsh Nigam

Member, Special Committee for Clinical Research,
CCRH, New Delhi, India
Dr. Alok Pareek
Member, Special Committee for Clinical Research,
CCRH, New Delhi, India

Dr. Todd Hoover

President, American Institute of Homeopathy,
Alexandria, USA

Dr. S. K. Nanda
Director, National Institute of Homoeopathy,
Kolkata, India

Dr. V. T. Augustine
Chairman, Scientic Advisory Committee, CCRH, New
Delhi, India

Dr. Surender Singh

Associate Professor, Department of Pharmacology,
All India Institute of Medical Sciences, New Delhi, India

Indian Journal of Research in Homoeopathy / Vol. 7 / Issue 2 / Apr-Jun 2013

Dr. Rajeev K. Sharma

Director, Homoeopathic Pharmacopoeia
Laboratory,Ghaziabad ,India
Prof. (Dr.) Rajendra Kumar Saxena
Ex. Professor of Biomedical Engineering, IIT Delhi,
New Delhi, India

Indian Journal of Research in Homoeopathy

Official Publication of Central Council for Research in Homoeopathy

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Indian Journal of Research in Homoeopathy / Vol. 7 / Issue 2 / Apr-Jun 2013

Indian Journal of Research in Homoeopathy

Official Publication of Central Council for Research in Homoeopathy

| Volume 7 | Issue 2 | April-June 2013 |

CONTENTS

Editorial
R. K. Manchanda........................................................................................................................................................................ 39

Original Articles
Standardization of homoeopathic drug: Buxus sempervirens L.

P. Subramanian, P. Padma Rao, T. Sheshashena Reddy, P. Sudhakar, P. Ramachandra Reddy.................................................... 41

Hydroquinone: Homoeopathic Pathogenetic Trial

Rajesh Shah................................................................................................................................................................................ 47

Individualized homoeopathy versus placebo in essential hypertension: Adoubleblind

randomized controlled trial

Subhranil Saha, Munmun Koley, Seikh Intaj Hossain, Malay Mundle, Shubhamoy Ghosh, Goutam Nag,
Achintya Kumar Datta, Prasanta Rath....................................................................................................................................... 62

Effect of homoeopathic LM potencies in acute attacks of haemorrhoidal disease:

A multicentric randomized singleblind placebocontrolled trial

P. S. Chakraborty, Roja Varanasi, A. K. Majumdar, Kishan Banoth, Sunil Prasad, M. S. Ghosh, M. N. Sinha,
G. Ravi Chandra Reddy, Vikram Singh, Chaturbhuja Nayak....................................................................................................... 72

Antidiabetic effect of Cephalandra indica Q in diabetic rats

Arindam Pal, Biswapriya B. Misra, Shibendu S. Das, Samiran S. Gauri, Moumita Patra, Satyahari Dey.................................... 81

Case Report
Treatment of postburn hypertrophic scar with homoeopathic medicine

Bhopal Singh Arya, Vaqar A. Siddiqui, Rupali P. Dixit................................................................................................................. 91

Reminiscences
Glimpses from the past, CCRH quarterly bulletin review, volume 6(14), 1984

Chaturbhuja Nayak, Harleen Kaur.............................................................................................................................................. 95

Book Review
Samuel Hahnemann: The Founder of Homoeopathy

R. K. Manchanda, Pritha Mehra................................................................................................................................................. 98

Indian Journal of Research in Homoeopathy / Vol. 7 / Issue 2 / Apr-Jun 2013

iii

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I J R H

Editorial
Access this article online
Website:
www.ijrh.org
DOI:
10.4103/0974-7168.116616
Quick Response Code:

Assuring the quality of homoeopathic dilutions is a

challenging task. Nevertheless, the true physician
must be provided with genuine medicines of
unimpaired strength so that he may be able to rely
upon their therapeutic powers, he must be able
himself to judge their genuineness, as mentioned
in the Aphorism 264 of Organon of Medicine.[1]
The quality of a drug depends not only on the way
the drug is manufactured after extracting the used
part(s) of the original material, but also in the way
the plant medicines are cultivated.
The Council has carried out standardization of
many drugs and in this issue we present a paper on
standardization markers of Buxus sempervirens. The
drug is known for its medicinal properties for treating
rheumatism, malaria, and gastrointestinal disorders.[2]
Pharmacognostic study and highperformance thin
layer chromatography fingerprinting of Buxus make
available the information regarding morphology,
powder microscopy, organoleptic characters,
and physicochemical studies, which will help
in identification, authentication, and proper
standardization of the drug.[3]
Dr.S. C. Ghosh introduced Cephalandra indica to
Homoeopathy in 1905. He proved this drug on
four healthy volunteers and published the data in
his book Drugs of Hindoosthan, 9thedition. The
Council carried out a Clinical Verification study
on the hypoglycaemic effect of Cephalandra indica
on the symptoms mentioned by Dr.Ghosh. The
study was encouraging and showed its efficacy in
reducing blood glucose level and also symptoms of
diabetic retinopathy in tincture form.[4] Fortyone
percent alcoholic abstract of Cephalandra indica,
on regular administration in doses ranging from
25 to 75mL/100g of body weight by oral or
Indian Journal of Research in Homoeopathy / Vol. 7 / Issue 2 / Apr-Jun 2013

intraperitoneal route produced a significant fall in

blood sugar level in alloxaninduced diabetes in rats.[5]
In the featured study, there was a significant reduction
of blood glucose level, regain of body weight, and
regeneration of beta cells in pancreas in mother
tincturetreated rats, further verifying the antidiabetic
effects of the drug.
Another paper featured in this issue assesses the role of
individualized homoeopathy in essential hypertension.
Afew trials conducted earlier used specific remedy
or combination formulae for treating hypertension
rather than an individualized approach.[6] This paper
observes statistically significant reduction of blood
pressure in the verum group as compared with the
control group through individualized homoeopathic
treatment, within a period of 6months. Natrum
muriaticum, Calcarea carbonica, Sulphur, Thuja occidentalis,
Nitric acid and Medorrhinum were among the frequently
prescribed medicines.
Furthermore, despite their established clinical efficacy,
evidencebased studies on LM potencies are limited
to only a few. Today, the LM potencies take up a
small, but not insubstantial share of the market of
homoeopathic remedies, which are prescribed by
physicians and practitioners. Although this by no
means indicates that the highpotency debate has
come to an end, the gentle power of the small dosage
convinces an increasing number of people. However,
the kind of evidence required is still not available.[7] In
a paper where he shares his clinical experiences with
LM potencies, Dr.Luc de Shepper expresses that the
use of LM potencies call for more investigations so
that this treasure of the 6thedition of Organon is not
lost.[8] One of our featured papers explores the effect
of homoeopathic LM potencies in acute attacks of
haemorrhoidal disease in a placebocontrolled trial.
39

Manchanda: Editorial

A Homoeopathic Pathogenetic Trial on Hydroquinone,

which evaluated the data using the Quantitative and
Qualitative Pathogenetic Indices is also featured
in the issue. Besides its use as an antioxidant in
the rubber industry and a developing agent in
photography, Hydroquinone and products containing
Hydroquinone are used as depigmenting agents to
lighten skin.[9] The paper unveils the homoeopathic
therapeutic effects of this substance through this
pathogenetic trial.
It is my appeal to all the readers to use the
information provided in this journal and share their
experiences with the professionals.

References
1.
2.

3.

Samuel H. Organon of Medicine. 5th and 6th ed. New Delhi: B. Jain
Publishers; 1994.
Barceloux DG. Boxwood (Buxus sempervirens L.) in medical toxicology
of natural substances: Foods, fungi, medicinal herbs, plants, and
venomous animals. New Jersy: John Wiley and Sons Inc; 2008.
Subramanian P, Padma Rao P, Sheshashena Reddy T, Sudhakar
P, Ramachandra Reddy P. Standardization of homoeopathic drug
Buxus sempervirens L. Indian J Res Homoeopathy 2013;7(2):41-46.

4.

Rastogi DP. Clinical verification of hypoglycaemic effect of

Cephalandra indica in patients of DM. CCRH Quarterly Bulletin
1990;12:20.
5. Rastogi DP, Saxena AC and Kumar Sunil. Pancreatic beta-cell
regeneration a novel anti-diabetic action of Cephalandra indica
mother tincture. Br Homoeopath J 1988;77:147.
6. Saha S, Koley M, Seikh IH, Mundle M, Ghosh S, Nag G, et
al. Individualized Homoeopathy versus placebo in essential
hypertension: A doubleblind randomized controlled trial. Indian J
Res Homoeopathy 2013;7(2):62-71.
7. Jtte R. The LM potencies in homoeopathy: From their beginnings
to the present day. Vol. 78. Stuttgart: Institute for the History of
Medicine of the Robert Bosch Foundation; 2007. p. 78.
8. De Schepper L. LM potencies: One of the hidden treasures of the
sixth edition of the Organon. Br Homeopath J 1999;88:12834.
9. Kari FW. Toxicology and carcinogenesis studies of hydroquinone
in rats and mice, Vol. 3. National Toxicology Program. USA: U.S.
Department of Health and Human Services, NTP TR 366; NIH;1989.

R. K. Manchanda

Editor in Chief
Director General, Central Council for Research in Homoeopathy,
61-65, Institutional Area, Janakpuri, New Delhi, India.
Email: [email protected]

How to cite this article: Manchanda RK. Editorial. Indian J Res

Homoeopathy 2013;7(2):39-40.

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Indian Journal of Research in Homoeopathy / Vol. 7 / Issue 2 / Apr-Jun 2013

I J R H

Original Article
Access this article online

Standardization of homoeopathic drug:

Buxus sempervirens L.

Website:
www.ijrh.org
DOI:
10.4103/0974-7168.116618
Quick Response Code:

P. Subramanian, P. Padma Rao1, T. Sheshashena Reddy, P. Sudhakar1,

P. Ramachandra Reddy2

ABSTRACT
Background: Buxus sempervirens L. (Buxaceae), is a small tree, used in Homoeopathy
for acute pain, increase in pulse rate and nausea. Leaves and stems are used in the
preparation of medicine.
Objective: The pharmacognostic and physico-chemical studies are carried out to
facilitate use of correct species and standard raw materials.
Material and Methods: Pharmacognostic studies of leaf and stem of authentic samples
of Buxus sempervirens have been carried out. Physico-chemical parameters of the raw
drug, namely, extractive values, ash value, formulation besides weight per milliliter, total
solids, alcohol content, High Performance Thin Layer Chromatography (HPTLC) and
Ultraviolet (UV) studies are given for the mother tincture.
Results: The leaves are nearly sessile, opposite, entire, narrowly lanceolate or ovate
and up to 2.5 cm. The stomata are paracytic and confined to the abaxial side. Unicellular
conical hair and peltate scaly hair occur on the adaxial side near the base. The midvein
is ribbed on either sides. Crystalliferous idioblasts occur towards the abaxial side at the
midvein and lamina. Secretory canals occur in the mesophyll. A single vascular bundle
is present in the midvein. The stem is quadrangular. The vascular tissue is present as
a cylinder with four cortical bundles, one each in the angles. The microscopical and
organoleptic characteristics of the powder are provided.
Conclusion: The powder microscopic features and organoleptic characters along with
anatomical and physico-chemical studies are diagnostic to establish the standards for
ensuring quality and purity of the drug.

Chemistry Section, 1Pharmacognosy

Section, Drug Standardisation Unit,
O.U. B.32, Road No.4, Habsiguda,
Hyderabad, 2Department of Botany,
Osmania University, Hyderabad,
India.
Address for correspondence:
Dr. P. Subramanian,
O.U.B. 32, Road No. 4, Habsiguda,
Hyderabad - 500 007, Andhra
Pradesh, India.
E-mail: [email protected]
Received: 29012013
Accepted: 28062013

Keywords: Buxus sempervirens L., High performance thin layer chromatography,

Homoeopathy, Pharmacognosy, Physicochemical, Spectroscopy, Standardization

INTRODUCTION
Buxus sempervirens L., popularly known as
boxwood in English; Bachsbaum in German;
Chikri in Punjab and Kashmir; Shamshad in
Urdu and Persian, is a small tree belonging to the
family Buxaceae.[1] It is a native of Western and
Southern Europe and also occurs in Western Asia
and North. Africa. In India, it is found in Himalayas
and Punjab.[2] In Himalayas, it is found in Kumaon to
Shimla, Punjab and Bhutan.[3] It is also cultivated as
a hedge in gardens at Kodaikanal in Tamil Nadu.[1]
Indian Journal of Research in Homoeopathy / Vol. 7 / Issue 2 / Apr-Jun 2013

Since it is grown at an altitude of 16002800 m, it is

not found in other states.
The tincture of the young leaves and twigs are used
as medicine in homoeopathy in the treatment for
forcing pains (e.g., labor), frequent desire to urinate,
increase in pulse rate and slight nausea.[4] In unani
system of medicine, the leaves are used for the
treatment of headache, pain and prolapse ani. The
leaves are bitter, purgative, diaphoretic and useful in
rheumatism and syphilis.[2]
In homoeopathy, its authority was mentioned in
41

Subramanian, etal.: Standardization of Buxus sempervirens L.

Br. Jour. Hom. 11, 158, for the effects of an infusion

taken for the purpose of producing an abortion
which it failed to do.[4]
Chemically the leaves are reported to contain
buxenineG (an alkaloid), sitosterol, stigmasterol,
cycloartenol,
lupeol,
germanicol,
amyrin,
(+)semperviramidine, () buxadienine (steroidal
alkaloid),
(+)sempervirine,
()31acteyl
cyclomicrophyllineA and ()benzoylbuxidienine
from this plant.[58]
A review of the literature reveals that no
pharmacognostic standards have been recorded for
the drug except for the anatomical review.[9] In view
of the importance of the drug, pharmacognostic
and physicochemical studies of leaves and stem are
carried out to lay down standards.

MATERIAL AND METHODS

Plant Material

The plant material of Buxus sempervirens L., was

supplied by the Survey of Medicinal Plants and
Collection Unit, The Nilgiris, Tamil Nadu. The leaves
and young stems were fixed in formaldehydeacetic
acidalcohol, dehydrated through the alcoholxylene
series, embedded in paraffin wax. Sections cut
between 8 and 10 m were stained in crystal violet
basic fuchsin combination.[10] The epidermal peels
were obtained by gently scraping and peeling with a
razor blade. The microscopic characters of powder
were studied by boiling the powdered drug in
distilled water, stained in saffranin and mounted in
glycerine.

Preparation of Extracts

The air dried leaves and twigs of the drug were

coarsely powdered to 10/44 (sieve size) and were
subjected to the determination of moisture content
(loss on drying at 105C), total ash, water soluble
ash, acid insoluble ash, extractability in different
solvents, physicochemical constants, thin layer
chromatography (TLC) and ultraviolet aspects of
mother tincture following official methods.[11]
Mother tincture was prepared as per Homoeopathic
Pharmacopoeia of India. 100 g of coarse powder
of the drug was suspended in 680 mL of 95%
alcohol and 350 mL of purified water for 24 hour
at room temperature. It was filtered and made up
to 1000 mL using same solvent ratio. Percolation
method[11,12] was used for the preparation of mother
tincture.
42

High Performance Thin Layer Chromatography

(HPTLC) Analysis
25 mL mother tincture was evaporated on water
bath to remove alcohol. The residue was extracted
with 3 mL 25 mL chloroform. Concentrated
chloroform extract was used for the HPTLC study.
The concentrated chloroform extract was spotted
in the form of the band of width 4 mm with a
Camag microliter syringe on precoated silica gel
aluminium plate 60F254, (5 cm 10 cm with 0.25
mm thickness; Merck, Darmstadt, Germany) using
a Linomat IV sample applicator (Camag, Muttenz,
Switzerland, Supplied by Anchrom Technologists,
Mumbai). A constant application rate of 6 mL/s was
employed. The slit dimension was kept at 4 mm
0.45 mm and 20 mm/s scanning speed was employed.
The mobile phase consisted of chloroform: methanol
(9:1 v/v) and 10 mL of mobile phase was used for
chromatography. Linear ascending development was
carried out in a 10 cm 10 cm twin trough glass
chamber (Camag, Muttenz, Switzerland) saturated
with the mobile phase at room temperature for 20
minutes. The length of the chromatogram run was
8 cm and subsequent to the development, the TLC
plates were dried in a current of air with the help
of hot air dryer in a wooden chamber with adequate
ventilation. Densitometric scanning was performed
(Camag TLC scanner III) at 254 nm and 366 nm by
reflectance scanning and operated by Win Cats
software (v 4.05, Camag) resident in the system.[1315]

OBSERVATIONS AND RESULTS

Morphology

A much branched shrub or small tree. Leaves are

nearly sessile, opposite, narrowly lanceolate or
ovate, up to 2.5 cm, entire, usually obtuse. Flowers
small, yellow to green, strongly scented in small
axillary heads or spikes. The terminal flowers are
usually female, others being male. Capsule ovoid,
1.3 cm long, 3horned, seeds 36, small.[2]

Macroscopy

Leaves nearly sessile, opposite, narrowly lanceolate

or ovate, up to 2.5 cm entire, usually obtuse, dark
green above and pale beneath, glabrous. Stem
quadrangular, 1.61.8 mm thick, covered by conical
and occasionally few peltate scaly hair.

Microscopy
Leaf

In surface view, epidermal cells are polygonal

Indian Journal of Research in Homoeopathy / Vol. 7 / Issue 2 / Apr-Jun 2013

Subramanian, etal.: Standardization of Buxus sempervirens L.

isodiametric in outline and have sides thin to slightly

thick and straight to curved [Figure 1ac]. The cells
show scanty to slightly dense contents and are
5130/mm2 (abaxial) and 7260/mm2 (adaxial). The
costal cells are anisodiametric to linear, parallelly
oriented and are present on primary and secondary
veins. The stomata are paracytic [Figure 1c], and
260/mm2 with stomatal index: 4.8; size 1625 m
(19) long and 1116 m (14) wide.
Trichomes are of two types: (1) Unicellular conical hair
and (2) peltate scaly hair. The former are confined to
the base, midvein and margins on adaxial [Figure 1a]
and the latter are few and present more towards base,
sides of midvein and near margins [Figure 1a].
In a Transverse Section (TS), the midvein is ribbed
on either sides and 216346 m (305) thick. The
lamina is dorsiventral, 184216 m (200) thick
[Figure 2a]. The margins are pointed and slightly
bent inwards.
Epidermis is singlelayered and composed of mostly
barrel shaped cells, some isodiametric, oval to

spherical. The epidermal cells are covered by a

thick cuticle. Stomata are confined to lower surface
of the leaf and flushed with epidermis. Unicellular
trichomes are present on the adaxial surface and
restricted to the base. Mesophyll is dorsiventral.
Palisade is twolayered but at places threelayered,
extending into midvein, cells 2038 m (30) long and
1422 m (17) wide, walls thin, contents dense with
chloroplasts, occasionally with sphaeraphides. Spongy
parenchyma is predominant with upper 34 layers of
closely packed and lower portion loosely arranged
with large intercellular spaces often interspersed with
sphaeraphidal idioblasts. Some large secretory pores
also occur in the mesophyll [Figure 2a and b].
The ground tissue at midvein consists of 12 layered
collenchyma on abaxial followed by 45 layers of
parenchyma while the collenchyma on adaxial as a
group of cells followed by 34 layers of parenchyma.
Collenchyma cells are 816 m (13) in diameter and
angular. Parenchyma cells 825 m (18) in diameter,
often contain chloroplasts and interspersed with
sphaeraphidal idioblasts mostly towards abaxial near

c
c
Figure 1: (a) Upper epidermis at the base with trichomes 417. (b) Upper
epidermis in surface (enlarged) 364. (c) Lower epidermis in surface (enlarged)
630 (Psh: Peltate scaly hair, uc: Unicellular conical hair, ps: Paracytic stomata)

Indian Journal of Research in Homoeopathy / Vol. 7 / Issue 2 / Apr-Jun 2013

Figure 2: (a)Transverse section (TS) of leaf at midvein 162. (b) TS of

leaf lamina 132. (c)TS of stem 145 (c: Cuticle, ue: Upper epidermis,
le: Lower epidermis, p: Palisade tissue, vb: Vascular bundle, x: Xylem,
ph: Phloem, cr: Crystal, sp: Spongy tissue, e: Epidermis, cb: Cortical bundle, pi: Pith,
sc: Secretory canal)

43

Subramanian, etal.: Standardization of Buxus sempervirens L.

vascular bundle, 1436 m (27) in diameter. Besides,

few cells contain rhombic or hexagonal prismatic
crystals of calcium oxalate [Figure 2a].
The vascular bundle is single, large, oval, 227281
m (254) long and 162205 m (181) wide,
endarch, conjoint, collateral and capped by lignified
sclerenchyma. A layer of endodermis and pericycle
encloses the vascular bundle. The xylem elements
are numerous and arranged in radial rows. Phloem is
extensive on the abaxial [Figure 2a].
Stem

In TS, the stem is quadrangular with winged

angles, covered by unicellular conical hair,
papillate hair and peltate scales. The epidermis is
singlelayered covered by thick cuticle; hypodermis
is collenchymatous as a group of cells, angular or
lamellar in few with chloroplasts. Cortex is 810
layered in the interangles and 1216 at the angles;
cells polygonal to spherical and tangentially long;
those at periphery collenchymatous, few with
yellowish contents. Crystalliferous idioblasts occur in
the phloem besides few in cortex. Cortical spherical
vascular bundles are present one each in the angles
[Figure 2c].
Vascular tissue is in the form of thick secondary
xylem cylinder. It is enclosed by an endodermis
followed by pericycle. The phloem is precocious,
external, encloses the xylem. A small amount
of primary xylem is present close to pith. The
xylem consisting of vessels or tracheids, fibres
and xylem parenchyma are arranged in radial
rows. In longisection, the vessels and tracheids
show helical thickenings, besides few scalariform
and bordered pits. Pith parenchyma is centrally
present. Prismatic and rhombic crystals of calcium
oxalate occur in the cortex close to cortical
bundles while sphaeraphidal cells are close to the
phloem [Figure 2c].

Powder Microscopy

1. Pieces of adaxial epidermis.

2. Pieces of abaxial epidermis with stomata.
3. Unicellular hairs, broken, few.
4. Rhombic and prismatic crystals of Calcium oxalate.
5. Pieces of stem epidermis with parallelly oriented
cells and attached unicellular hairs.
6. Fragments of tracheary tissue with fibres.
7. Fragments of leaf with epidermis and underlying
palisade.
8. Few sphaeraphidal crystals broken.
44

Organoleptic Characters
Colour: Moss green.
Touch: Smooth.
Odour: Slightly pungent.
Taste: Bitter.

Physicochemical Studies

The determined data under the physicochemical

study for the raw drug is summarized in Table 1
and that of mother tincture preparation and its
standardization in Tables 2 and 3 respectively.
Results of physicochemical studies are summarized
in Tables 13.
Table 1: Standardisation of raw drug

Parameters

Quantitative values (% w/w)

Moisture content
(loss on drying at 105 C)

Not more than 4.5

Total ash

Not more than 6.6

Acid insoluble ash

Not more than 0.49

Water soluble ash

Not more than 0.94

Alcohol soluble extractive

Not less than 17.5

Water soluble extractive

Not less than 21.9

Extractive values in
Hexane

Not less than 2.8

Chloroform

Not less than 5.9

Methanol

Not less than 20.6

Table 2: Formulation of mother tincture

(Percolation technique used)
Alcohol

65% v/v

Drug strength

1/10

Preparation

Buxus sempervirens in coarse powder

100 g

Strong alcohol

680 mL

Purified water

350 mL

To make 1,000 mL of the mother tincture

Table 3: Standardization of the mother tincture

Parameters

Observations

Organoleptic profile
Appearance

Clear, nonviscous, foam on shaking

Colour

Blackish brown

Odour

Characteristic

Sediments

Absent

Weight per mL

Not more than 0.89 g

Total solids

Not less than 1.9% w/v

Alcohol content

6165% v/v

pH

5.0-6.0

max

318 (0.20), 278 (0.25), 202 (1.06)

Indian Journal of Research in Homoeopathy / Vol. 7 / Issue 2 / Apr-Jun 2013

Subramanian, etal.: Standardization of Buxus sempervirens L.

Figure 3: High performance thin layer chromatography densitogram

(chloroform: methanol [9:1 v/v]) of Buxus sempervirens mother tincture
scanned at 254 nm

Figure 4: High performance thin layer chromatography finger printing

(chloroform: methanol [9:1 v/v]) of Buxus sempervirens mother tincture
scanned at 254 nm and 366 nm

HPTLC Finger Printing

the present species. Idioblasts containing prismatic

crystals and sphaeraphides occur more on the abaxial
side and also in the midvein as also reported earlier.[9]
Some secretory canals are present in the mesophyll as
also reported.[9]

The profile of chromatographic separation scanned

at 254 nm, reveals seven spots [Figures 3 and 4] out
of which seven, six and four spots possess maximum
composition with Rf at 0.86, 0.74 and 0.38 respectively.
On the other hand scanned chromatogram at 366 nm
revealed seven spots with seven, six and five spots
showing maximum composition at Rf 0.89, 0.85 and
0.72 respectively. It is evident from the data that these
are characteristic for the studied drug, which will help
in the identification and authentication of the mother
tincture. This is considered as valuable standards in
pharmacopoeia. At 254 nm, seven spots appeared at
Rf 0.15, 0.22, 0.29, 0.38, 0.52, 0.74 and 0.86 [Figures
3 and 4] with various concentrations while at 366 nm,
seven spots at Rf 0.13, 0.27, 0.38, 0.51, 0.72, 0.85 and
0.89.

DISCUSSION
Leaf

The stomata have been reported to be confined

to the lower surface and surrounded by rosettes
of subsidiaries in Buxus.[9] However, presently they
are hypostomatic as has been reported earlier
but presently they are distinctly paracytic in Buxus
sempervirens studied. Further, the guard cells are
strongly crested as also reported earlier.[9] The number
of stomata are 260/mm2 and the stomatal index is 4.8.
The trichomes in Buxus were reported as unicellular
conical[9] which is presently confirmed and are found
restricted to the basal region near the midvein on
the adaxial side. Besides, a few peltate scaly hairs
are also found near the base on the adaxial side in
Indian Journal of Research in Homoeopathy / Vol. 7 / Issue 2 / Apr-Jun 2013

Stem

In TS, the stem is quadrangular with winged angles.

The epidermis is reported as thickly cutinized and
papillate[9] which is presently confirmed. Besides,
the epidermis possesses unicellular conical hair
and rarely peltate scaly hair over its surface. The
cortex is chlorenchymatous in its outer layer as also
reported earlier.[9] The vascular tissue is a continuous
vascular cylinder with four cortical bundles, one each
in the angular wings. The presence of 12 layers of
sclerenchyma fibres enclosing the cortical bundles has
been described,[9] which is now confirmed. The xylem
is a continuous cylinder exhibiting some secondary
growth. The phloem is external and often possesses
idioblasts with prismatic, rhombic and cluster crystals
as also earlier reported.[9] The pith is quite abundant
with thick walled pitted cells [Figure 2c] as also been
reported earlier.[9]

PhysicoChemical

Herbal medicines are composed of many constituents,

therefore, amenable to variation. The physicochemical
analysis of Buxus sempervirens is presented in Tables
13. HPTLC fingerprinting is a precise and accurate
method for herbal identification and can be used in
authentication and characterization of this important
medicinal plant. Hence, it is very important to obtain
reliable chromatographic fingerprints that represent
therapeutically active and chemically characteristic
45

Subramanian, etal.: Standardization of Buxus sempervirens L.

components of the herbal medicines. Thus, the

developed chromatogram will be specific with
selected solvent system and Rf value and serve as a
good standardization tool for Buxus sempervirens.
Physical parameters include colour, appearance,
odour, viscosity, moisture content, pH, sedimentation
and ash values. Chemical parameters include limit
tests, extractive values, chemical assays, etc. These
standards along with the preparation of mother
tincture furnished in Homoeopathic Pharmacopeia of
India have been meticulously adhered to in our study.

CONCLUSION
The macro and microscopical, organoleptic characters
along with the anatomical and methodology used
for the studies are diagnostic and establish the
standards. HPTLC analysis of Buxus sempervirens L.
leaves and twigs can provide standard finger prints
and will be used as reference tool for identification,
authentication, quality control and standardization
of this important medicinal plant.

Bishen Singh Mahendrapal Singh; 1980. p. 22112.

3. Hooker JD. The Flora of British India. London: L. Reeve and
Co.;1890. p. 267.
4. Allen TF. The Encyclopedia of Pure Meteria Medica. Reprint ed.,
Vol.2. New Delhi: B. Jain Publishers; 1982. p. 320.
5. Atta-ur-Rahman, Dildar Ahmed, Asif S Erfan, Arshad Jamal, Iqbal
Choudhary M, Bilge Sener, et al. Steroidal alkaloids from leaves of
Buxus Sempervirens. Phytochemistry 1991;30(4):1295-8.
6. Puckett RT, Sim GA. The structure of buxenineG. Tetrahedron Lett
1966;32:38158.
7. Atta-ur-Rahman, Dildar Ahmed, Bilge Sener, Songul Turkoz.
Steroidal alkaloids from Buxus Sempervirens. Phytochemistry 1989;
28(4);1293-4.
8. Abramson D, Goad JL, Goodwin TW. Triterpenes and sterols of Buxus
sempervirens and local variations in their levels. Phytochemistry
1973;12:22116.
9. Metcalfe CR, Chalk L. The Anatomy of the Dicotyledons. Vol. 2.
Oxford: Clarendon Press; 1950. p. 12367.
10. Johansen DA. Plant Microtechnique. New York: Macgraw Hill Book
Co.; 1940.
11.
Homoeopathic
Pharmacopeia
Laboratory.
Homoeopathic
Pharmacopoeia of India. New Delhi: Controller of Publications; 1971.
12. American Institute of Homoeopathy. Homoeopathic Pharmacopoeia
of United States Convention: Chicago: Duncan Bros.;1993.
13. Stahl E. Thin Layer Chromatography: A Laboratory Hand Book.
Berlin: SpringerVerlag; 1969.
14. Wagner H, Bladt S, Zgainski EM. Plant Drug Analysis: A Thin Layer
Chromatography Atlas. Berlin: SpringerVerlag; 1996.
15. Sethi PD. High Performance Thin Layer Chromatography.
New Delhi: CBS Publishers and Distributers; 1996.

REFERENCES
1.

2.

Baburaj DS, editor. A Check List of Homoeopathic Medicinal Plants

of India. Rev. ed. New Delhi: Central Council for Research in
Homoeopathy; 2003. p. 43.
Kirtikar KR, Basu D editors. Indian Medicinal Plants. Vol. 3. Dehradun:

How to cite this article: Subramanian P, Rao PP, Reddy TS,

Sudhakar P, Reddy PR. Standardization of homoeopathic drug:
Buxus sempervirens L.. Indian J Res Homoeopathy 2013;7(2):41-6.
Source of Support: Nil, Conflict of Interest: None declared.

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46

Indian Journal of Research in Homoeopathy / Vol. 7 / Issue 2 / Apr-Jun 2013

I J R H

ORIGINAL ARTICLE
Access this article online

Hydroquinone: Homoeopathic Pathogenetic

Trial

Website:
www.ijrh.org
DOI:
10.4103/0974-7168.116621
Quick Response Code:

Rajesh Shah

ABSTRACT
Background: A doubleblind, randomized, placebocontrolled Homoeopathic
Pathogenetic Trial (HPT/Drug Proving) of Hydroquinone was conducted, using the
accepted guidelines, ethical approval and scientific documentation The potentization
method was standardized. Toward enhancing the quality of HPT, the investigator
proposed and evaluated the data using the Quantitative Pathogenetic Index and
Qualitative Pathogenetic Index. Usable symptoms were derived from the study. The
medicine was suggested for the treatment of vitiligo, based on its known toxicological
effects.
HPT of a new medicinal substance, using the established parameters, to evaluate
symptoms in healthy volunteers was carried out using a controlled experiment.
Aims: The aim of the study was to conduct a HPT using the accepted and scientific
guidelines to derive clinically usable symptoms.
Material and Methods: A doubleblind, randomized, placebocontrolled homoeopathic
pathogenetic trial was conducted in 22 volunteers (provers), out of whom 15 received
Hydroquinone in 30C potency, thrice daily, for four weeks, while seven received the
placebo. The volunteers symptoms during the initial seven days of the runin period
were carefully noted, and these were used as a filter, by elimination of the same
symptoms in that volunteer during the verum phase. Thorough documentation such as
Informed Consent Form, approval by the Ethics Committee, laboratory investigations,
and safety and ethical measures, were taken care of. The volunteers were trained to
write data in the prescribed diaries which was analyzed at the end. The investigator
introduced Quantitative and Qualitative Pathogenetic Indices as parameters in the
evaluation of the data derived from the HPT.
Results: The HPT of Hydroquinone exhibited qualitatively distinct symptoms, which
could be applied in clinical practice. Safe use was documented. An anecdotal study
supported the proposed efficacy of Hydroquinone for the treatment of vitiligo and
further exploration could be carried out.
Conclusion: The HPT of Hydroquinone brought in qualitative symptoms. It was noted
that a potentized preparation could produce many functional symptoms, but could not
produce degenerative pathological symptoms such as vitiligo. The preparation could
be used by the profession for vitiligo on the basis of its toxicological effects, supported
by the anecdotal study. The Quantitative and Qualitative Pathogenetic Indices could
further be used in future HPTs as a tool.

Director, Life Force Homoeopathy,

Chembur, Mumbai 400 089,
Maharashtra, India
Address for correspondence:
Dr. Rajesh Shah,
Life Force, 411 Krushal Commercial
Complex, GM Road,
Chembur, Mumbai 400 089,
Maharashtra, India.
Email: [email protected]
Received: 22-03-2013
Accepted: 15-04-2013

Keywords: Double blind, Hydroquinone, Homoeopathic pathogenetic trial,

Placebo control, Quantitative pathogenetic index, Qualitative pathogenetic index,
Randomization, Vitiligo

Indian Journal of Research in Homoeopathy / Vol. 7 / Issue 2 / Apr-Jun 2013

47

Shah: Hydroquinone: Homoeopathic Pathogenetic Trial

INTRODUCTION
Hydroquinone is a phenol compound that is known

to have melanocytespecific cytotoxicity,[1] used in

conventional medicine as a topical therapeutic agent
to lighten pigmentation on skin, in conditions such
as melasma.[2,3] Based on the Law of Similars, the
investigator used potentized Hydroquinone in many
patients having vitiligo or hypopigmentation in 1998,
and later, with encouraging results. Subsequently,
a doubleblind, randomized, placebocontrolled
homoeopathic pathogenetic trial was conducted to
investigate this effects of the substance on healthy
volunteers.

General Information

Hydroquinone is a type of phenol, which is an

aromatic organic compound.[2] It can be considered
a simple polyphenol. It is a white granular solid
substance. Substituted derivatives of this parent
compound are also referred to as hydroquinones.[2]
Specifications

Hydroquinones chemical structure has two hydroxyl

groups bonded to a benzene ring in a para position.
Some specifications[4] of hydroquinone are as follows:
Ballandstick model
of the trans rotamer
of hydroquinone[2,5]

Structure of
hydroquinone[2,6]

Other names

Quinol, Benzene1,4diol

Chemical formula

C6H4(OH)2

Molecular formula

C6H6O2

Relative molecular mass

110.11

Chemical and physical

properties

Hexagonal prisms (Verschueren,

1996)

Boilingpoint

287C (Lide, 1997)

Meltingpoint

172.3C (Lide, 1997)

Solubility

Soluble in water (5.9 g/100 mL

(15C),
ethanol, and diethyl ether
(Lewis, 1993)

Vapor pressure

532 Pa at 150C; relative vapor

density (air=1), 3.81 (Verschueren,
1996)

Flashpoint

165C, closed cup (American

Conference of Governmental
Industrial Hygienists, 1992)

Conversion factor

mg/m3=4.5ppm

CAS Number

123319

Hydroquinone: Use in conventional medicine

Hydroquinone is an important industrial chemical. It is

an ubiquitous chemical, readily available in cosmetic
and nonprescription forms as a skin lighten agent.[7] It
48

is considered one of the most effective inhibitors of

melanogenesis in vitro and in vivo. It causes reversible
inhibition of cellular metabolism by affecting both the
DNA and RNA syntheses[8] and can be considered a
potent melanocyte cytotoxic agent with relatively high
melanocytespecific cytotoxicity.[1] In turn, it produces
loss of pigment, which is comparable with vitiligo.
Two percent Hydroquinone is readily available over the
counter in various cosmetic preparations in various
countries. Evidence of improvement in the cases of
hyperpigmentation with Hydroquinone (monotherapy)
is usually observed in fourtosix weeks, with the
improvement appearing to plateau at approximately
four months. Concentrations as high as 10% can be
compounded extemporaneously for refractory cases.[9]
Hydroquinone: Known effects on humans and animals

In animals, the acute oral toxicity (LD50) is 320

mg/kg in rats. Acute dermal toxicity (LD50): 5970
mg/kg in mammals.[10] The toxicological effects of
hydroquinone on humans and animals are known and
may be summarized as under:
1. Hypopigmentation[1,2,4,7,11]
2. Skin irritation,[12,13] mild rash and burning,[12] and
ulceration[11]
3. Exogenous ochronosis: [3,14] A condition where
there is accumulation of homogentisic acid in the
connective tissues
4. Longterm feeding of Hydroquinone to rats has led
to aplastic anaemia, liver cordcell atrophy, and
ulceration of the gastric mucosa[4]
5. A single high dose was reported to induce renal
tubule necrosis in rats[4]
6. Cancer: Hydroquinone has been suspected to be
a carcinogen.[15] In skin painting studies in mice,
Hydroquinone was inactive as an initiator of skin
carcinogenesis. Oral ingestion of Hydroquinone did
not produce cancer of the stomach or bladder in a
study on mice.[4]
7. Eyes: Conjunctivitis, keratitis, and discolouration
of the conjunctiva.[11,16] Causes eye irritation and
possible burns. May cause redness, pain, blurring of
vision and possible eye and cornea[13] damage.[11]
8. May cause dizziness, nausea, sense of suffocation,
increased respiratory rate, vomiting, pallor, muscle
twitching, cyanosis (bluish discolouration of skin
due to deficient oxygenation of the blood), delirium,
and collapse. May cause liver damage leading to
jaundice. May cause harmful nervous system effects,
including tremors and convulsions.[11]
Indian Journal of Research in Homoeopathy / Vol. 7 / Issue 2 / Apr-Jun 2013

Shah: Hydroquinone: Homoeopathic Pathogenetic Trial

9. May cause respiratory tract irritation. Inhalation may

be fatal as a result of spasm, inflammation, oedema
of the larynx and bronchi, chemical pneumonitis,
and pulmonary oedema. Central nervous system
effects may include confusion, ataxia (failure of
muscular coordination), vertigo, tinnitus, weakness,
disorientation, lethargy, drowsiness, and finally
coma. May be harmful if inhaled. May cause burning
sensation, coughing, wheezing, laryngitis, shortness
of breath, headache, nausea, and vomiting. Pure
hydroquinone does not readily form a vapour at room
temperature. The dust my cause irritation of the
nose, throat, and upper respiratory tract.[11]
10. Tinnitus, nausea, dizziness, a sense of suffocation[11]
11. Dizziness, sense of suffocation, increased rate of
respiration, vomiting, pallor, muscular twitching,
headache, dyspnoea, cyanosis, and collapse.[1719]
Hydroquinone: A new medicine proposed in homoeopathy

Hydroquinone (Investigational Product IP) as a new

homoeopathic medicine is proposed as a single
constituent formulation based on the simple logic that
since it has a capacity to produce hypopigmentation
(comparable with leucoderma or vitiligo), it could
be applied homoeopathically as a remedy to treat
hypopigmentation or vitiligo; and some other
conditions presenting with hypopigmentation.
It has been understood that the application of the
homoeopathic medicine is based on (1) Drug proving
(2) Toxicological effects, and (3) Clinical use. There
are a number of homoeopathic medicines, which
are prescribed largely on the basis of their ability to
produce certain symptoms or diseases; which may
not have been proved in the pathogenetic trials. For
example, the use of Tuberculinum in Tuberculosis, use
of Arsenic in Cancer, use of Phosphorus and Nitric acid
for vitiligo, and so on, where the said medicines have
never produced the respective diseases in drug proving,
but they are popularly used for those conditions
based on their toxicology. Similarly, there are many
remedies introduced on the basis of provings on the
sick (clinical provings), which have also served a useful
purpose.[20] The proposed use of Hydroquinone is one
such application of the homoeopathic principle, based
on clinical proving, where the investigator has studied
this preparation in a good number of cases of vitiligo.
Of course, there will be indications besides vitiligo,
based on the homoeopathic pathogenetic trial and
other indications.

Indian Journal of Research in Homoeopathy / Vol. 7 / Issue 2 / Apr-Jun 2013

HOMOEOPATHIC Pathogenetic Trial

Objective
This protocol is designed to conduct a homoeopathic
pathogenetic trial for evaluating the effects of
potentized Hydroquinone on healthy human volunteers.

MATERIAL AND METHODS

The HPT of Hydroquinone was conducted by the author
(Principal Investigator - PI), through a doubleblind,
randomized, placebocontrolled study, at the Life Force
Research Center. The Life Force Research Center has
a research staff of one principal investigator having
28 years of clinical practice (Hahnemannian style)
and research experience; supported by five study
members including four homoeopaths and one clinical
trial expert, who had over 10 years of experience in
research.
The IP was prepared as per the homoeopathic
potentization method. The drug was proved in 30c
potency on 22 volunteers with a randomization ratio
of 2:1, wherein, 15 volunteers were given IP and
seven volunteers were given a matching placebo,
according to a pregenerated (through a software)
random number table. The study involved 4 females
and 18 males, out of 22 volunteers, three females
were on the drug and one female was on placebo.
The dose and frequency of the investigational product
was designed as 30C potency, six pills three times a
day, for four weeks. The volunteers and investigator
were blinded from the drug name and its allocation.
The volunteers signed the Informed Consent Forms.
The blind for randomization was maintained till
the completion of the proving period. The proving
volunteers were selected based on the inclusion
and exclusion criteria, as per the protocol of the
Hydroquinone study. The volunteers were in the age
group of 18 to 45 years, mean age being 26.5 years,
from different walks of life, from different locations,
such as urban and various suburbs of Mumbai, having
a different socioeconomic status, and having different
occupations, including homoeopathic students
and homoeopaths. The volunteers underwent
preobservation and postobservation investigations.
Detailed present and past clinical histories of the
volunteers were recorded in case record forms. Each
volunteer had completed the intake of the doses as
per the protocol schedule and the oneweek doses

49

Shah: Hydroquinone: Homoeopathic Pathogenetic Trial

of placebo as a runin period. Each volunteer visited

the Life Force Center for screening and six weekly
followup visits. At each visit, the volunteers were
examined by the PI and study doctors. The symptoms
generated during the trial period were noted (up to
six weeks) by the volunteers in the diary provided
to them and they were crossexamined and the
symptoms were elaborated by the proving master.
The proving master (investigator) had compiled the
data after decoding (opening the blind).

Source

Hydroquinone is available commercially in the

pharmaceutical and research market, with a purity
of about 99.5%. The inventor procured six grams of
Hydroquinone.

Vehicle Used for Dilution

Sterile water for injection was used to prepare up

to 10C potency. Subsequently, higher potencies
were prepared using dispensing alcohol (alcohol
content 90% v/v), especially for storage and
dispensing purpose.
Six grams of Hydroquinone was dissolved in 100 ml
of water; 0.03 ml of solution was then mixed with
2.97 ml of water for injection (600 micrograms per
ml) in a clean glass vial, using a micropipette, and
labeled as HQM (Hydroquinone mother preparation).

Potentization

HQM was potentized using an electromechanical

potentizer
machine,
with
the
following
considerations:
i. Machine standardization
Weight of arm: 7.5 kg
Arm length: 55 cm
Angle: 90 degrees
ii. Force = Weight Gravitational acceleration

=7.5 kg 9.8 = 73.5 Newton
iii. Impact: Torque (Moment of Force)
iv. Torque = (tau) = = r F = 0.55 73.5 = 40.43
Nm
(Newton meter) 10 strokes = 404.3 Nm
v. Strokes: Number of strokes applied at each step
of potentization was 10, which was counted with
a digital device attached to the machine, avoiding
human errors.
It may be noted that even if there is a change in
the above parameters while preparing any new
preparation or potency, it is scientifically indicated to
have the documentation in place. Uniformity of the

50

impact is possible with the mechanical device, which

can never be achieved with handmade potencies.

Centesimal and Decimal Scale Potency

Preparation

HQM of 0.03 ml was mixed with 2.97 ml water

for the injection (600 micrograms per ml) in a
clean glass vial, using a micropipette, and labeled
as Hydroquinone, for making Hydroquinone 1C
potency. The proportion of 1: 99 was maintained;
0.03 mL of HQM 1C was then mixed with 2.97
mL water, and subjected to the above process
of potentization to arrive at the Hydroquinone 2C
potency. Likewise, Hydroquinone10C, 17C, 20C,
30C, 50C, 100C, 200C, 500C, and 1000C potencies
were prepared as per the Hahnemannian multivial
dilution method and labeled accordingly. Similarly,
the decimal potencies were prepared using a 1: 10
ratio. The potencies were prepared, labelled, and
safely stored for use.

Placebo

Identical (same size, shape, colour, taste) placebo

pills provided were prescribed to the volunteers who
were on placebo.

Guidelines, Ethics, Compliance, and Approvals

The HPT was based on the guidelines advocated

by Dr. Samuel Hahnemann, MD, in the Organon of
Medicine, aphorisms 110145,[21] the Central Council
for Research in Homoeopathy (CCRH), Government
of India,[22] and the European Committee for
Homoeopathy (ECH) guidelines.[23] The project was
reviewed and approved on 16 January, 2012, by
the Institutional Ethics Committee, Homoeopathy
India Pvt. Ltd., Mumbai, constituted as per
the Indian Council of Medical Research (ICMR)
guidelines.[24] The requirements regarding the
obligations of investigators as per the Guidance
on Good Clinical Practice as per the International
Conference
on
Harmonization
of
Technical
Requirements for Registration of Pharmaceuticals for
Human Use Independent Ethics Committee (ICH)[25]
were met with. The drug proving project has been
registered (Number: CTRI/2012/03/002506) with the
Clinical Trials RegistryIndia (CTRI),[26] set up by the
ICMRs National Institute of Medical Statistics (NIMS).
When writing the manuscript, data reporting has been
done in accordance with the Consolidated Standards
of Reporting Trials (CONSORT) (RedHot) guidelines.[27]

Indian Journal of Research in Homoeopathy / Vol. 7 / Issue 2 / Apr-Jun 2013

Shah: Hydroquinone: Homoeopathic Pathogenetic Trial

Investigations

Pre and Post drug administration investigations

included complete blood count, erythrocyte
sedimentation rate (ESR), blood biochemistry, urine
routine analysis, pregnancy test, Xray chest, and
Electrocardiogram (ECG). Due care was taken to
confirm that every female volunteer had a negative
pregnancy test, before sending her for Xray chest.
Other investigations, if indicated, were done at the
last visit.

Inclusion, Exclusion and Withdrawal Criteria

Preferably homoeopathic doctors or students, who

had knowledge of drug proving, were included in the
study. However, nonmedico participants were also
included, after giving adequate training with regard
to the proving and symptom recording method.

Inclusion Criteria

1. Healthy volunteers of both sexes in the age group of

18-45 years without significant psychic or physical
symptoms, confirmed by history and physical
examination. A careful record of the volunteer's
present health status, symptoms and reports was
maintained in case record.
2. The ppersons who were trustworthy, able and ready
to express and describe their experiences during the
study.
3. Volunteers with no plans for important life changes
like relocating, change of job, marriage, medical or
surgical treatment. The usual habits and conduct
of life continued.
4. Volunteers were in such a mental and legal that they
were able to exercise fully their choice and written
consent.
5. Their ECG and Xray reports were within normal
limits.

Exclusion Criteria

1. Current medical treatments or Homoeopathy

drugs in the preliminary observation period or
during the study.
2. Consumption of prescribed drugs (including
Homoeopathy) in the past four weeks (to be judged
by the PI).
3. Contraceptive pills in the past three months.
4. Surgical treatment within the past two months.
5. Pregnancy, breastfeeding.
6. Persons suffering from allergic manifestations
particularly pertaining to the respiratory system
and skin should not be included in proving (to be
judged by the PI).
Indian Journal of Research in Homoeopathy / Vol. 7 / Issue 2 / Apr-Jun 2013

7. Volunteers with a history of diabetes, hypertension,

and hypothyroidism should not be included in
proving.
8. Volunteers who are drug addicts should not be
included in proving.

Withdrawal Criteria (i.e. terminating drug proving)

1. If a volunteer has to be withdrawn because of a
severe adverse event like accident or hospitalization,
the data recorded until the event occurrence for
such volunteers will be considered for analysis,
depending on the investigators discretion, and the
volunteers will be marked as withdrawal
2. No replacement of withdrawn volunteers
3. Volunteer lost to follow up
4. Volunteer withdraws consent to continue in the
drug proving study by himself/herself
5. If a volunteer experiences Serious Adverse Events or
serious symptoms due to the drug proving.

Cointerventions

Volunteers were advised to continue the routine

lifestyle and avoid any Complementary and Alternative
Medicine (CAM) or mainstream interventions.
However, volunteers requiring any interventional
treatment were documented. None of the volunteers
required an antidote during the study period.

Training

Volunteers were trained to note down the symptoms

in the diaries provided to them, as soon as possible.
The proving coordinator was trained to study cases,
review symptoms, and coordinate with the volunteers.

Data Handling and Record Keeping

Records have been maintained in the original

handwritten diaries filled in by the volunteers. Data
is organized in excel sheets and word documents,
subsequently.

RunIn Period, dose, and Repetition

Every volunteer was given doses of placebo, six pills,

three times a day, for one week, and observed for
the symptoms. The first week was a runin period.
The symptoms experienced during the runin
period were documented carefully. Two volunteers
produced the same symptoms during the runin
period as well as after the intake of the medicine;
these symptoms were not incorporated in the final
analysis. The dose of six pills (30c potency), three
times a day, was administered to every volunteer,
for four subsequent weeks; unless there were severe
symptoms or Serious Adverse Events (SAE).
51

Shah: Hydroquinone: Homoeopathic Pathogenetic Trial

Adverse Event and Withdrawal of Volunteers

An adverse event is defined as any untoward medical

occurrence in a volunteer administered a proving
substance, which does not necessarily have a causal
relationship with the action of the substance. None
of the volunteers developed adverse events during
the course of the trial.

Serious Adverse Events

No volunteer reported Serious Adverse Event or

Serious Adverse Drug Reaction during the course of
drug proving.
The Pathogenetic Effect[28]

The Pathogenetic effect is defined as any change in

Graph 1: Number of symptoms (Verum vs. Placebo)

Graph 2: Number of provers (Verum vs. Placebo)

Graph 3: Qualitative analysis (intensity-wise, in IP, run-in, and placebo groups)

52

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Shah: Hydroquinone: Homoeopathic Pathogenetic Trial

clinical events and laboratory findings reported by

volunteers during a homoeopathic pathogenetic trial
and recorded in the final report.[28]

= Number of volunteers who had at least one

reported pathogenetic effect/Total number of
volunteers taking the medicine and who contributed
to the symptoms or signs.

The overall incidence of pathogenetic effects[28] and

the incidence of pathogenetic effects per volunteer
were calculated as under

The incidence of pathogenetic effects per

volunteer[28] = total number of findings claimed in
the trial/total number of subjects using the medicine
and included in its final pathogenetic description.

The overall incidence of pathogenetic effects[28]

Table 1: Quantitative symptom analysis [Graph 1 and 2]

Volunteers with
intensity

Main
symptoms

Sub symptoms

Total number of
symptoms

Volunteers

Volunteers with
intensity

Main
symptoms

Volunteers

Volunteers with
intensity

1++

Dreams

18+

Head

10

11

4+, 7+++, 13++,

16++, 18++, 19+,
22++

Eyes

4++, 13++

9++, 22+

6+, 9++, 10++,

13++, 16+,
19+

14++, 23++

13++

14+, 17+

Ears

Nose

4+++, 9++, 16+,

18+, 22+

22+

Throat

18+, 19+

Larynx, cough,
expectoration

16+

11++, 21+

Chest

16+

22+

11+

Stomach

5 , 19

10

Abdomen

8+, 10++, 16+,

19+, 20++, 22+

8+, 20+

11++

Rectum

6+

Stool

Urine

13+

10++, 16+,
20+

12+, 14+,
15+

Neck

20+

10++

11+, 12+

Back

19

12+

Extremities

7 , 19

Sleep

18+, 24+++

18+

Fever

10+, 22+

Skin

9 , 13 , 16 ,
22+

13 , 22

19+++

0
14

Generalities

Total symptoms

24

30

47

Total number of
symptoms

Volunteers

Mind

Placebo group (n=7)

(Duration=6 weeks)

Sub symptoms

Total number of
symptoms

Runin period (n=15)

(Duration=1 week)

Sub symptoms

IP group (n=15)
(Duration=5 weeks

Main
symptoms

Organ

++

++

21

12

26

++

17+

17+

17

Incidence of
Pathogenetic effect
(IPE) per volunteer

3.357

1.857

2.429

Incidence of
Pathogenetic effect
(IPE) volunteer per
day

0.096

0.265

0.067

Indian Journal of Research in Homoeopathy / Vol. 7 / Issue 2 / Apr-Jun 2013

53

Shah: Hydroquinone: Homoeopathic Pathogenetic Trial

Table 2: Qualitative symptom Intensity wise

Location

Group I (IP)
++ +++ ++++ Total

Group II (RUNIN)
++
+++ ++++ Total

Group III (Placebo)

++ +++ ++++ Total

Mind

Dreams

Head

11

Eyes

Ears

Nose

Throat

Stomach

Abdomen

Rectum, stool

Urinary organ

Neck

Back

Extremities

Sleep

Fever

Skin

Generalities

Larynx, cough, expectoration

Chest

Total

29

15

47

17

26

13

17

13

3.357

1.857

2.429

0.035 0.285 0.142 0.016

0.111 0.052 0.019

0.018

No. of volunteers
Qualitative pathogenetic
Index

0.063 0.047 0.028

Table 3: Qualitative analysis (Intensity wise)

Total symptom Total symptom in Total symptom in
in group I (IP)
group II (Runin) group III (placebo)
+ ++ +++ ++++ + ++ +++ ++++ + ++ +++ ++++
29 15

17

13

Quantitative and Qualitative Pathogenetic Indices

The incidence of the pathogenetic effect[28] is a useful

index for a systematic review. However, the author
proposes two more indices for enhanced evaluation
of the data by accounting (a) the number of days
and (b) strength of each symptom. The author has
used these indices in the evaluation of three more
HPTs (data not yet published).
1. Quantitative Pathogenetic Index
2. Qualitative Pathogenetic Index
Qualitative Pathogenetic Index is an index where
in every symptom is given a qualitative grade,
namely, mild (+), moderate (++), severe (+++),
and very severe (++++), for all organ locations.
The Qualitative Pathogenetic Index [Graph 3] =
54

Graph 4: Quantitative pathogenetic index

Total number of symptoms for a particular intensity/

Number of volunteers contributing the symptoms/
Number of days. As it can be seen in Table 1, the
indices in the verum group are found to be higher
than in the placebo group.
A = Quantitative Pathogenetic Index, [Graph 4]
Indian Journal of Research in Homoeopathy / Vol. 7 / Issue 2 / Apr-Jun 2013

Shah: Hydroquinone: Homoeopathic Pathogenetic Trial

B = Total number of findings claimed in the trial,

C = Total number of subjects using the medicine
and included in its final pathogenetic description,
and D = Number of days.
Quantitative Pathogenetic Index (A) = (B/C)/D
a = Qualitative Pathogenetic Index, [Graph 6 and Tables
2,3] b = Total number of symptoms for a particular
intensity, c = Number of volunteers who contributed
the above symptoms, d = Number of days.
Qualitative Pathogenetic Index (a) = (b/c)/d

Similarly, the incidence of pathogenetic effects of

placebo per volunteers is calculated as 17 symptoms/
number of volunteers (7*) =17/7 = 2.429.
The author proposes to compute the pathogenetic
effect of the verum and placebo per volunteer, per
day, [Graph 5] by dividing the Pathogenetic effect
per volunteer by the number of day doses taken:
Verum group: 3.357/35 = 0.095
Placebo group: 2.429/42 = 0.067

Methodological Quality Index

The incidence of pathogenetic effects of verum per

volunteer = Total number of findings claimed in the
trial, 47/Total number of subjects using the medicine
and included in its final pathogenetic description
(14) =47/14 = 3.357

It is based on the key components of methodological

quality, including internal and external validity
items. The Methodological Quality Index (MQI)[28]
includes aspects such as randomization, inclusion and
exclusion criteria, blinding, and criteria for selection
of pathogenetic effects, with values ranging from 1

Graph 5: Pathogenetic effect of the verum and placebo per volunteer per day

Graph 6: Qualitative pathogenetic index

Flow chart: Volunteers screening, recruitment, randomization, and study completion

Indian Journal of Research in Homoeopathy / Vol. 7 / Issue 2 / Apr-Jun 2013

55

Shah: Hydroquinone: Homoeopathic Pathogenetic Trial

to 4 for each component, giving a range from 4 to

16. The scores were divided into four methodological
classes, where class I is the worst and class IV is the
best, with arbitrary cut off points. (6 for Class I;
7-10 for Class II; 11-13 for Class III; >14 for Class IV).
I. Randomization: Pregenerated (computerized
program) Random number table was used to
allocate the randomization kits to the volunteers
as per the recruitment sequence.(Score: 4)
II. Blinding: Doubleblind, the participant and
investigator were blinded. The blind for
randomization was maintained till the completion
of the proving period. The blind was opened post
trial and verified by the volunteers for drug and
placebo. (Score: 4)
III. Inclusion and exclusion criteria: Inclusion and
exclusion criteria were clearly defined in the
protocol. (Score: 4)
IV. Criteria for selection of effects: Six criteria were
defined:
1. 
All the symptoms produced during the runin
period and if repeated by the same volunteer in
subsequent weeks (first week, with placebo) were
excluded.
2. 
Symptoms produced, if any, by the volunteers
who were dropped out from study due to adverse
events, symptoms of such volunteers were
excluded.
3. Symptoms produced by placebo group, for five
weeks and symptoms produced by volunteer on
the drug were analyzed quantitatively as well
as qualitatively. If the placebo and drug groups
experienced the same symptom, they were
evaluated on the basis of intensity and duration.
For example, if the symptom of headache in the
placebo group was reported to be of mild (+)
intensity, while of severe (+++) intensity in the
drug group, it was not eliminated.
4. All symptoms were reported quantitatively, day
wise, with duration and frequency, for example,
dull headache with heaviness of head all over
<14 pm associated with sleepiness. (Number of
volunteer: 1) [9+ (day 22 for 2-3 hours)]
5. Every symptom described by the volunteers has
been graded as +(mild), ++(moderate), +++ (severe)
and ++++ (very severe). This method allowed
qualification grading.
6. Volunteers who had exhibited some symptoms
prior to the HPT, (as per the history), were
eliminated, if the volunteer also exhibited same
or similar symptoms as an effect of the medicine.
56

Based on the above criteria, the MQI = 4 + 4 + 4

+ 4 = 16.

RESULTS
The flow chart of volunteers screening, recruitment,
randomization, and study completion is shown here.

Hydroquinone HPT Symptoms (Verum Group)

Mind

Mind: (Number of volunteers: 1) [1++]

1. Mind, mood swings, getting angry without reasons
[1+ (day 12, 13 for a day)]
2. Mind, sometimes without any reason feeling upset
does not like to do anything, feeling sleepy [1++
(day 16 for a day)][2]
Dreams

Dreams: (Number of volunteers: 1) [18+]

3. Dreams, going to his native place [18+ (day 9)][3]
Head

Head: (Number of volunteers: 7) [4+, 7+++, 13++,

16++, 18++, 19+, 22++]
4. Head: Aching pain (Number of volunteers: 2) [4+,
7+++]
a. Aching pain in the right temporal region, in
afternoon [4+ (day 9 for 1-2 hours)]
b. Aching pain in forehead from 5 pm to 7 pm,
<evening [7+++ (day 33 for 2 hours)]
5. Head, throbbing pain, >pressure [16++ (day 24
for a day)
6. Headache (Number of volunteers: 5) [13++, 16+,
18++, 19+, 22++]
a. Headache, from 10 am to 10.30 am, > after
sleep [13++ (day 15, 16 for halfanhour)
b. 
Headache, for 1 hour (10 am to 11 am),
< sunlight [18++ (day 11 for one hour)]
c. Headache, from 3 pm to 3.30 pm, >after sleep
[13++ (day 20, 21 for halfanhour)
d. Headache, for 10-15 minutes, <afternoon [16+
(day 15 for 10-15 minutes)]
e. Headache, for halfanhour at night [18++ (day
17, 26 for halfanhour)]
f. Headache, in afternoon at 12 noon, >rest [22+
(day 11 for 1-2 hours)]
g. Headache [22++ (day 18, 33 for halfanhour)]
h. Headache, for a day [19+(day 25, for a day)][14]
Eyes

Eyes (Number of volunteers: 2) [4++, 13++]

7. Eyes, itching, wants to rub eye, lachrymation,
< cold [4+ (day 8, 9, 10 for a day)].
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Shah: Hydroquinone: Homoeopathic Pathogenetic Trial

8. Eye, pain (Number of volunteers: 2) [4++, 13++]

a. Eye, pain since morning to night for 8-10 hours
< cold [4++ (day 21 for 810 hours)].
b. Eye, pain [13++ (day 13 for a day][17]
Ears

Ears (Number of volunteers: 1) [4++]

9. Ear, pain in both ears, 2-3 hours at night [4++ (day
21 for 2-3 hours)][18]
Nose

Nose (Number of volunteers: 5) [4+++, 9++, 16+, 18+,

22+]
10. 
Nose, running nose (Number of volunteers: 5)
[4+++, 9++, 16+, 18+, 22+]
a. Running nose, watery secretions with redness,
<cold, <dust [4+++ (day 8, 9, 10, 21 for a day)]
b. Running nose, watery secretion, from afternoon
till evening, <cold drinks, <ice cream [9++ (day
16, 24 for two days)]
c. Running nose [16+ (day 15 for a day)]
d. Running nose, watery secretions with sneezing,
<cold water [18+ (day 13, for 2-3 hours in
evening)]
e. Running nose < cold food < ice cream [22+
(day 20 for a day)]
11. Nose, sneezing three to four times [18+ (day 20 for
1-2 hours)][24]
Throat

Throat, (Number of volunteers: 2) [18+, 19+]

12. Dryness in throat, with thirst, had to drink water
every 10 to 15 minutes, >drinking water [18+ (day
29, for a day)]
13. Dryness of throat with irritation [19+ (day 24 for
a day)][26]
Chest

Chest (Number of volunteers: 1) [16+]

14. Chest pain, aching pain, both sides of the chest for
5-10 minutes, <morning, >cold water, >pressure
[16+ (day 16 for 510 minutes, day 23 for a day)][27]
Stomach

Stomach (Number of volunteers: 2) [5+, 19+]

15. Burning sensation in stomach with gases and acidic
taste in mouth in the morning [(5+ (day 9 for a day)]
16. Vomiting four to five times a day, pain in abdomen,
after eating outside food, <drinking water, <sight
of food [19+ (day 33 for a day)][29]
Abdomen

Abdomen (Number of volunteers: 6) [8+, 10++, 16+,

19+, 20++, 22+]
17. 
Abdomen, pain (Number of volunteers: 6) [8+,
10++, 16+, 19+, 20++, 22+]
Indian Journal of Research in Homoeopathy / Vol. 7 / Issue 2 / Apr-Jun 2013

a. Pain in abdomen in the right iliac fossa, pain

radiates toward back, sudden pain, needle
prick sensation, <coughing, <sitting for long,
<standing up suddenly [8+ (day 8, 9, 10, 11, 12,
13, 14 for entire day)]
b. Pain in abdomen in the afternoon <after food
[10++ (day 9, 16 for entire day)]
c. Pain in abdomen with discomfort for 2-3 hours
[10++ (31 for 2-3 hours)]
d. 
Pain, discomfort, feeling of fullness of
abdomen, in the evening, urge for stool even
after defaecation [16+ (day 22 for a day)]
e. Pain, at 12 noon [20++ (day 11 for one to
oneandahalfhours)]
f. Pain in the right iliac fossa, >diverting mind to
work [20+ (day 12 for 1 hour)]
g. Pain, in the epigastric region, >passing flatus
[19+ (day 34 for a day)]
h. Pain, <fasting, >after meal [22+ (day 20 for a
day)].[37]
Urine

Urine (Number of volunteers: 1) [13+]

18. Urine burning, more at night (may be due to less
intake of water as he moved out in the sun on the
previous day) [13+ (day 11, 14 for a day)][38]
Neck

Neck (Number of volunteers: 1) [20+]

19. Neck Pain, mild stiffness, <morning [20+ (day 33
for one to oneandahalfhours)][39]
Sleep

Sleep (Number of volunteers: 2) [18+, 24+++]

20. Disturbed sleep, could sleep around 12 midnight
[18+ (day 15 for a night)]
21. Feeling sleepy in the morning [24+++ (day 22 for
one hour)][41]
Fever

Fever (Number of volunteers: 2) [10+, 22+]

22. Fever (Number of volunteers: 2) [10+, 22+]
a. Fever, mild at night 10.30 pm [10+ (day 12 for a
night)]
b. Fever, mild at night 12 midnight [22+ (day 16
for a day)][43]
Skin

Skin (Number of volunteers: 4) [9+, 13++, 16+,22+]

23. Skin, pimples (Number of volunteers: 3) [9+, 16+, 22+]
a. Face, pimples, slightly painful on cheeks [16+
(day 32 for a day)]
b. Pimples on right cheek, painful [22+ (day 33,
35 for a day)]
c. Chest, red eruptions, 2-3 spots on it with mild
burning, <sunlight [9+ (day 25 for a day)] [46]
24. 
Face, itching on cheeks with mild rash <after
shave [13++ (day 12, 28, 32 for a day][47]
57

Shah: Hydroquinone: Homoeopathic Pathogenetic Trial

Note:
Analysis strategies: A systematic review of the
symptoms was done and the symptoms exhibited
by the volunteers were reported organwise from
head to toe, including the general symptoms, under
different headings (as per the Kent Analysis Method
and based on the above criteria for selection of
effects mentioned in the MQI). The symptoms were
numbered as the main symptom, based on distinction
within the particular organ/location, for example, Mind
(heading) (1) Mind, irritability, (2) Mind, depressed
(Main symptoms).
The main symptoms were followed by subsymptoms,
described in detail, (e.g. Mind (heading) (1) Mind,
irritability (a) irritable by noise (b) irritable, when
asked something (subsymptoms), and so on.
The total number of symptoms was counted by
eliminating the recurrence of the symptom as the main
symptom. That is, in the cases where subsymptoms
were observed, the counting of the main symptom
was eliminated, and thus, the cumulative total number
of symptoms (represented at the end of each heading
in a square bracket, in bold) was considered for the
calculation of different indices.

Prominent and Clinically Applicable Symptoms

Chief symptoms from the HPT may be shortlisted here:

1. Mind: [1++] Mood swing, anger, feels upset. No
desire to do anything feeling sleepy
2. Head [4++, 7+++, 13++, 16++, 18++, 19+, 22++]
Headache. [13++, 16+, 18++, 19+, 22++] <10 am to
11 am
3. Eyes [4++, 13++] Pain in eyes. Itching, rubbing,
lachrymation
4. Ears [4++] Earache, at night
5. Nose [4+++, 9++, 16+, 18+, 22+] Coryza, Running
nose. <Cold food, ice cream. Watery discharge,
sneezing
6. Throat, Larynx [18+, 19+] Dryness of throat (with
irritation), >drinking water.
7. Chest (Number of volunteers: 1) [16+] Pain
8. Stomach [5+, 19+] Burning with acidic taste in
mouth, in the morning. Thirst, drinks often with
dryness in throat. Vomiting.
9. Abdomen [8+, 10++, 16+, 19+, 20+, 22+] Pain in
abdomen. Pain in the right iliac fossa. Fullness.
<Afternoon
10. Urine [13+] Burning
11. Neck [20+] Pain, mild stiffness, <morning
12. Sleep [18+, 24+++] Disturbed sleep. Feeling sleepy
in the morning
13. Fever [10+, 22+] Fever, mild, before midnight
58

14. Skin [9+, 13++, 16+, 22+] Face, acne, and red
eruptions on cheeks. Itching.

Deviations in Laboratory Reports

One volunteer was found to have an increase

in Serum Glutamic Pyruvic Transaminase (SGPT)
(normal range: 30-65 U/l) from 88 to 116, while
another volunteer had a reduction in SGPT from 157
to 117. Both were clinically asymptomatic before
as well as after the trial. There were no clinically
significant changes after the HPT, with respect to
complete blood count, liver function tests, renal
function tests, urine analysis and ECG. All pre and
postinvestigation reports were documented.

Safety Report

Safety of volunteers was evaluated based on

preinvestigation at screening and postdrug
administration investigations. There were no adverse
events reported during the proving period.

DISCUSSION
Hydroquinone,
a
homoeopathic
potentized
preparation was made with the substance being
sourced with precise information of the chemical
properties,
using
welldefined
potentization
parameters, inclusive of standardized force
parameters applied in potentization; which would
allow the making of standardized and reproducible
homoeopathic medicine, now and in the future. A
doubleblind, randomized, placebocontrolled HPT
of Hydroquinone exhibited distinct symptoms, which
could be applied in clinical practice. Hydroquinone (in
potency) intake proved to be safe for the volunteers.
Fourteen volunteers from the IP group (n = 15)
produced 47 symptoms (numbers super scripted at
end of last symptom under each system/anatomical
part) in five weeks; the placebo group (n = 7)
produced 17 symptoms in six weeks, while the
runin period (n = 15) produced 26 symptoms in
one week. It must be noted that symptoms with
description of location, sensation, modality, and
concomitants, along with the duration, days, and
intensity, have been listed as subsymptoms. The
volunteers (with prior training), coordinator, and
principal investigator carefully noted and verified
the intensity of each symptom, with every detail.
The outcome was 47 symptoms produced by verum,
which was quantitatively more than the symptoms
produced in comparative groups, which could be
Indian Journal of Research in Homoeopathy / Vol. 7 / Issue 2 / Apr-Jun 2013

Shah: Hydroquinone: Homoeopathic Pathogenetic Trial

appreciated by examining the higher intensity of

symptoms in the verum group.
Hydroquinone was selected for exploring its
homoeopathic use based on the preknowledge that
it has a capacity to induce hypopigmentation, and
should, in turn, have a capability to treat the same.
Also, the investigator used the potentized preparation
of Hydroquinone in a series of patients having
hypopigmentation (vitiligo), with encouraging and
verifying results, calling for a larger clinical application.
Careful appraisal of symptoms produced during the
verum phase, placebo, and runin period was carried
out observing the following filters in determining
the prominence of symptoms.
a. Those observed in more than one volunteer
b. Those that lasted for a significant period
c. Those, which were very intense, without the
volunteer having experienced similar symptoms
in the past one year; and without any apparent
(causal) reason
d. The symptoms should finally be compared with the
symptoms based on the known effects of the source
substance, which was adequately established.
Crude Hydroquinones effects on humans and animals
is known; it produces skin irritation, rash, burning,
gastritis, and ulceration, ochronosis, aplastic
anaemia, and of course, vitiligo. It is exciting to
document that the effects of an ultra small dose
of potentized Hydroquinone in 30C potency, in a
controlled trial, were comparable with that of
its crude effects, such as skin rash, burning in
epigastrium, vomiting, and earnosethroat irritation.
Symptoms pertaining to the mind and dreams have
not been found to be prominent. Similarly, symptoms
of generalities have not been produced. The substance
has produced a limited number of symptoms, as its
effects on humans have also been found to be limited
to certain symptoms. Its effects on blood related
to aplastic anaemia and on the kidney, producing
tubular necrosis, were obviously not reflected in the
symptomatology; as the potentized dose would not
produce pathological symptoms to that extent.
It must be noted that Hydroquinone did not produce
any hypopigmentation or vitiligo in the HPT. The
investigator did not expect vitiligo as a symptom or
sign as potentized dose is not expected to produce
such pathological symptoms. It may be recalled
that none of commonly used medicines for vitiligo,
namely, Phosphorus,[29] Arsenicsulphuricum flavum,[30]
Indian Journal of Research in Homoeopathy / Vol. 7 / Issue 2 / Apr-Jun 2013

Nitricum acidicum,[29] Kali carbonicum,[31] and Sepia[32]

ever produced vitiligo in drug proving. This common
observation should also stimulate another discussion
on, how important is it to conduct a homoeopathic
pathogenetic trial for new substances having
wellestablished pathogenesis or scope of action.
The process of new homoeopathic drug discovery
may be boosted by allowing the introduction of
new medicines on the basis of known toxicological
effects and clinical evidence, and not only on the
basis of the homoeopathic pathogenetic trial.
Clinically, based on the sphere of action of
hydroquinone, its use may be explored in the cases
of vitiligo, gastritis, peptic ulcer, upper respiratory
tract affections, headache, aplastic anaemia, renal
necrosis, and ochronosis.
The Quantitative Pathogenetic Index and Qualitative
Pathogenetic Index indices proposed and used here
by the investigator, add a new dimension toward
developing the method of qualitative and quantitative
research in systematic reviews, aimed at minimizing
the bias, and are not to be considered as mandatory
in terms of application for the study of a HPT.

CONCLUSION
Hydroquinone was identified for exploring its effects on
human volunteers in a homoeopathic, potentized dose.
The potentization was carried out with documented
force parameters. A doubleblind, randomized,
placebocontrolled HPT, as per the accepted guidelines,
with 15 volunteers and seven controls, with an initial
seven days of runin period, led to 47 symptoms,
quantitatively and qualitatively higher than the placebo
groups; comparable with the toxicological symptoms,
and with documented safety in the healthy volunteers,
and thus, clinically usable data was generated.
The Quantitative Pathogenetic Index and Qualitative
Pathogenetic Index proposed by the investigator are
important parameters, which may help in deciding
the quality of data produced by the HPT.
The HPT has produced clear symptomatology, which
can easily be applied in clinical practice for a set of
symptoms. As potentized preparations are known
for not producing significant pathological symptoms
such as vitiligo, it is seen that hydroquinone has not
produced any hypopigmentation; which is not to be
considered as a limitation of the trial.
Further research on similar lines may help in
59

Shah: Hydroquinone: Homoeopathic Pathogenetic Trial

homoeopathic drug discovery. Further clinical trials

and evaluation can enhance the strength of the
current experiment and its outcome.

ACKNOWLEDGMENTS
The author extends thanks and appreciation to the members
of the Institutional Ethics Committee, subject experts for
their technical, ethical, legal, and medical inputs; and the
volunteers for their participation in the study.

REFERENCES
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for melanocytederived cells is mediated by tyrosinase activity but
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12. Noreen Kassem. Adverse Effects of hydroquinone. Demand Media,
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article/207531-adverse-effectsofhydroquinone/.
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MD: Williams and Wilkins; 1992. p. 1098.

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14. Merola JF, Meehan S, Walters RF, Brown L. Exogenous ochronosis.

Dermatol Online J 2008;14:6.
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Inc. 2011. [Cited 2012 Oct 21]. Available from: http://www.
safecosmetics.org/article.php?id=289 .
16. Pattys Industrial Hygiene and Toxicology: Toxicology. 3rd ed, Vol.
2A, 2B, 2C. New York: John Wiley Sons; 19811982. p. 2591.
17. International Labour Office. Encyclopedia of Occupational Health
and Safety, Vol. 1 and 2. Geneva: International Labour Office; 1983.
p. 1675.
18. Budavari S, editor. The Merck IndexEncyclopedia of Chemicals,
Drugs and Biologicals. New Jersy: Merck and Co. Inc; 1989. p. 763.
19. Clayton GD, Clayton FE, editors. Pattys Industrial Hygiene and
Toxicology. Toxicology. 3rd ed. Vol. 2A, 2B, 2C. New York: John
Wiley Sons; 19811982. p. 2591.
20. Diwan HC. Microdoses Mega results. Vol. 1. New Delhi: National
Homoeopathic Pharmacy; 2008.
21. Hahnemann S. Organon of Medicine, 6th ed. New Delhi: B. Jain
Publishers; 1979.
22. CCRH.Central Drug Proving Cum Data Processing Cell, and Pre and
Post trial medical report proforma. New Delhi: Central Council for
Research in Homoeopathy.
23. European committee for Homoeopathy. Homoeopathy Drug
Proving Guidelines. Vol. 1. [Cited 2010 Mar 11].Available
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homoeopathicprovings/ECH.
24. Indian Council of Medical Research. Ethical Guidelines for Biomedical
Research on Human Participants New Delhi: 2006. [Cited 2012 Sep
2]. Available from: http://icmr.nic.in/ethical_guidelines.pdf.
25. ICH Harmonised Tripartite Guideline, Guideline for good clinical
practice. International Conference on Harmonisation of technical
requirements for registration of pharmaceuticals for human use, E6
(R1), Current Step 4 version. June 1996.
26. CTRI/2012/02/002449 [Registered on: 24/02/2012]. [Cited 2012 Mar
21]. Available from: http://ctri.nic.in.
27. Reporting data on homoeopathic treatments (RedHot): A supplement
to CONSORT. J Altern Complement Med 2007;13:1923.
28. Dantas F, Fisher P, Walach H, Wieland F, Rastogi DP, Teixeira H, et
a. A systematic review of the quality of homoeopathic pathogenetic
trials published from 1945 to 1995. Homoeopathy 2007;96:416.
29. Allen TF. The Encyclopedia of pure Materia Medica, Vol. 7. New
Delhi: B. Jain Publishers; 1988.
30. Hering C. The guiding symptoms of our materia medica, Vol. 2. New
Delhi: B. Jain Publishers; 1989.
31. Allen TF. The Encyclopedia of pure Materia Medica, Vol. 5. New
Delhi: B. Jain Publishers; 1988.
32. Allen TF. The Encyclopedia of pure Materia Medica, Vol 8. New
Delhi: B. Jain Publishers; 1988.

How to cite this article: Shah R. Hydroquinone : Homoeopathic

pathogenetic trial. Indian J Res Homoeopathy 2013;7(2):47-60.
Source of Support: Nil, Conflict of Interest: Homoeopathy India
Pvt. Ltd. sponsored the HPT. The sponsor has played no role in
data collection, analysis, or data interpretation. An independent
team did the investigations and assessment of the symptoms;
and independent, accredited laboratories carried out all the safety
assessments.

Indian Journal of Research in Homoeopathy / Vol. 7 / Issue 2 / Apr-Jun 2013

Shah: Hydroquinone: Homoeopathic Pathogenetic Trial

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Indian Journal of Research in Homoeopathy / Vol. 7 / Issue 2 / Apr-Jun 2013

61

I J R H

Original Article
Access this article online

Individualized homoeopathy versus

placebo in essential hypertension:
Adoubleblind randomized controlled trial

Website:
www.ijrh.org
DOI:
10.4103/0974-7168.116629
Quick Response Code:

Subhranil Saha, Munmun Koley, Seikh Intaj Hossain1, Malay Mundle2,

Shubhamoy Ghosh3, Goutam Nag4, Achintya Kumar Datta5, Prasanta Rath6

ABSTRACT
Background: Hypertension is the most common cardiovascular disorder posing a
major public health challenge to the population. Homoeopathy, although widely used
in hypertension, is assumed to have nothing but placebo effects and its specific clinical
effects are frequently ascribed as implausible.
Aims: To evaluate whether individualized homoeopathy can produce any significant
effect different from placebo in essential hypertension by comparing the lowering of
blood pressure between groups.
Settings and Design: A prospective, doubleblind, randomized, placebocontrolled,
parallelarm clinical trial was conducted at the Outpatient Clinic of the Mahesh
Bhattacharyya Homoeopathy Medical College and Hospital, West Bengal.
Material and Methods: Out of 233hypertensives assessed for eligibility, 150 were
enrolled and randomized(verum/homoeopathy 70, control/placebo 80). Atotal of 18
dropped out and 132 were regular(verum 64, control 68). The outcome measures
were assessed after three months and six months.
Statistical Analysis: The intentiontotreat population was subjected to statistical
analysis. Group differences were tested using the 2 test and independent t test.
Repeated measure(ANOVA) was performed to compare the data of two groups
obtained longitudinally at baseline, three months and six months.
Results: The baseline data were not significantly different between the groups. After six
months, mean Systolic Blood Pressure (SBP) reduction was 26.6 mm Hg (95% CI 21.5,
31.7) in the homoeopathy group and SBP increased by 3.6 mm Hg (95% CI 8.7, 1.5) in the
placebo group. Similarly, the mean Diastolic Blood Pressure (SBP) in the homoeopathy
group reduced by 11.8 mm Hg (95% CI 9.2, 14.4) and increased by 1.6 mm Hg (95%
CI 3.6, 0.4) in the placebo group. Repeated measures ANOVA also showed significant
difference (P=0.0001) between the groups. Natrum muriaticum, Calcarea carbonica,
Sulphur, Thuja occidentalis, Nitric acid and Medorrhinum were frequently prescribed.
Conclusion: Individualized homoeopathy produced a significantly different hypotensive
effect than placebo.

Senior Research Fellow

(Homoeopathy), Clinical Research
Unit (Homoeopathy), Siliguri,
Central Council for Research in
Homoeopathy, Government of India;
1
Former House Staff, 3Departments
of Pathology and Microbiology,
4
Forensic Medicine and
Toxicology; Mahesh Bhattacharyya
Homoeopathy Medical College and
Hospital, Howrah, West Bengal,
India; 2Department of Community
Medicine, Medical College,
Kolkata, West Bengal, India,
5
Former Visiting Physician, Howrah
District Hospital, West Bengal,
India; 6Department of Community
Medicine, National Institute of
Homoeopathy, Kolkata, West
Bengal, India
Address for correspondence:
Dr.Subhranil Saha,
Clinical Research Unit
(Homoeopathy),
Siliguri, Gokhel Road,
Arabindopally, Siliguri734006,
West Bengal, India.
Email:[email protected]
Received: 05022013
Accepted: 04062013

Keywords: Essential hypertension, Homoeopathy, Placebo, Randomized controlled

trial, Systolic and diastolic blood pressure

INTRODUCTION
Cardiovascular diseases (CVD) accounted for
1.5million deaths[1] (29% of the deaths)[2] and 11%
of all Disability Adjusted Life Yearsin India(all ages,
62

2005),[3] and it is estimated that by 2020, CVDs will

be the largest cause of mortality and morbidity in
India.[4] Hypertension is a major risk factor for CVDs
and its burden is increasing disproportionately in
developing countries as they undergo demographic
Indian Journal of Research in Homoeopathy / Vol. 7 / Issue 2 / Apr-Jun 2013

Saha, etal.: Homoeopathy in hypertension

transition.[57] The World Health Organization(WHO)

rates hypertension as one of the most important
causes of premature death worldwide.[8] It is directly
responsible for 57% of all stroke deaths and 24% of
all coronary heart disease deaths in India.[9] Recent
studies from India have shown the prevalence
of hypertension to be 25% in urban and 10% in
rural subjects in India.[10] The prevalence rate of
hypertension in urban India is 29-45% in men and
25-38% in women,[1114] and these are projected to go
up to 22.9 and 23.6% for Indian males and females,
respectively, by 2025.[15] However, only about 25.6% of
the treated patients had their blood pressure under
control.[16] Systolicand diastolic blood pressures(BP)
have a strong, continuous, graded, and positive
association with CVD outcomes or lifetime risk of
CVD, with no indication of a critical value.[17]

Bhattacharya Homoeopathy Medical College and

Hospital, Howrah, West Bengal, India, between April
2011 and February 2012, as per the Reporting Data
on Homoeopathy Treatments(ReDHoT) guidelines.[26]
Screening and enrollment was continued for the first
six months followed by intervention and followup
for the next six months[Figure1]. The study
protocol was completely in accordance with the
Helsinki declaration on human experimentation[27]
and Good Clinical Practice,[28] in India. Clearance
was obtained from the Ethics Committee of the
institution. Consequently, each participant was
verbally explained about the study, with the help
of the Patient Information Sheet, and thereafter, a
written consent was obtained from them. However,
they were free to withdraw from the study at any
point in time.

According to the statistics of the WHO, homoeopathy

is the second most useful health care system in
the world.[18] However, a metaanalysis in 2005 by
Shang etal.,[19] concluded that the clinical effects
of homoeopathy are nothing but placebo effects;
although a conflicting conclusion was arrived at
earlier by another metaanalysis by Linde etal.[20]
In the two doubleblind, randomized controlled
trials on hypertension, homoeopathy could not
generate statistically significant results. However,
none of the trials tried individualized homoeopathy
instead of the used specific remedy or combination
formulae.[21,22] Afew observational studies, although
methodologically inadequate, revealed some efficacy
of individualized homoeopathy in the management
of essential hypertension and overall cardiovascular
mortality.[2325]

Patient selection

The aim of this trial was to evaluate whether

individualized homoeopathy could produce any
significant hypotensive effect different from placebo
in patients with essential hypertension by comparing
the lowering of blood pressure between groups.
To the best of the authors knowledge, this was
the first randomized controlled trial conducted to
compare individualized homoeopathy with placebo
in essential hypertension.

MATERIAL AND METHODS

Study Setting and Design

The study was a randomized, placebocontrolled,

parallelarm trial, conducted at the Outpatient
Clinic for hypertensive patients at the Mahesh
Indian Journal of Research in Homoeopathy / Vol. 7 / Issue 2 / Apr-Jun 2013

This trial is registered with the Clinical Trial

Registry India vide CTRI/2012/02/002464 with
Universal
Trial Number (UTN) U1111-1128-2447 and Protocol
Identification No. 1343/MBHMCH/CH/H/01/11.
The study inclusion criteria consisted of patients
(1)
suffering
from
essential
hypertension
(prehypertensives: SBP 120-139 mm Hg, DBP
80-89 mm Hg, stage I hypertensives: SBP 140-159
mmHg, DBP 90-99 mmHg; and stage II hypertensives:
SBP 60 mm Hg, DBP 100 mm Hg);[29] (2) aged
18-65 years; (3) of both sexes; (4) with at least a
sixmonth history of suffering; (5) whose history,
examination, and routine investigations revealed no
evidence of obvious secondary causes; and (6) giving
written informed consent.
Cases were considered excluded where (1) diagnosis
or findings from the history were uncertain;
(2) physical examination or routine investigations
produced suspicion of a secondary cause for
hypertension; (3) the cases were diagnosed
(provisional/confirmatory) cases of secondary
hypertension; (4) there was any kind of continued
antihypertensive therapy for at least six months;
(5) the cases were of malignant hypertension
(SBP>200mmHg and DBP>140 mmHg) with
clinical features of hypertensive encephalopathy
(severe headache, vomiting, visual disturbances,
transient paralysis, convulsion, stupor and
coma), cardiac decompensation(heart failure),
and rapidly declining renal function(oliguria);
63

Saha, etal.: Homoeopathy in hypertension

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Figure 1: CONSORT Study flow diagram

(6)patients were suffering from isolated

systolic hypertension (SBP 140 mm Hg and/
or DBP<90 mmHg), as was mostly found
in elderly patients;[29](7) patients were with
labile(sometimes, but not always, arterial pressure
in the hypertensive range, i.e.not sustained)
hypertension;[29](8) patients were not strictly
conforming to the criteria given by the Joint
National Committee7(although variation of10
mmHg in SBP and/or DBP was considered);[29](9)
there was a presence of severe concomitant
disease(s);(10) there was a failure of vital organs/
systems, for example, heart, lungs, liver, kidney,
and the like, as detected clinically; (11)there was a
presence of any systemic(endocrinal/cardiovascular/
locomotor/neurological/hematological/psychiatric,
etc.) or infectious disease(s) the patients were
already diagnosed or detected clinically or by
routine laboratory investigations;(12) there were
immunocompromised patients;(13) diagnosed
cases of developmental defects or congenital
64

abnormalities;(14) pregnant patients, patients

who were breast feeding and/or with likelihood of
pregnancy; and(15) patients with a history of drug
and/or alcohol abuse.

Intervention(Medicine)/Comparator(Placebo)

A range of homoeopathic potencies were used as per

the requirement, decided by the treating physicians.
All the medicines used were manufactured by a
Good Manufacturing Practicecertified homoeopathy
pharmaceutical company and were prepared strictly
in adherence with the regulations/instructions of the
Homoeopathic Pharmacopoeia of India. Medicines in
all forms and placebo were dispensed in Good Clinical
Practice environment. Each dose, administered orally,
either medicine(in centesimal potencies) or placebo,
identical in appearance, consisted of a single drop
of medicine or comparator placebo in 83.1% ethanol
in 10ml distilled water and was served in identical
ambercoloured glass vials. These were directed
to be taken once daily, that is, every 24hours.
For 50 millesimal potencies, a single medicated/
Indian Journal of Research in Homoeopathy / Vol. 7 / Issue 2 / Apr-Jun 2013

Saha, etal.: Homoeopathy in hypertension

nonmedicated globule No.10 was dissolved in 60ml

of distilled water, with addition of two drops of 83.1%
ethanol, divided into 10 equal doses. Each dose
was directed to be taken after 10equal downward
strokes into half a cup(45ml) of normal water, from
which a single teaspoon(5ml) was to be taken and
the rest discarded. Successive doses were continued
in a similar fashion until a mild homoeopathic
aggravation, as per homoeopathic principles, took
place. During intercurrent acute illness, the medicines
were prescribed in either centesimal or 50 millesimal
potencies, as appropriate for the case.

Outcomes

The outcome measures were changes in the systolic

and/or diastolic blood pressure at a timeline of
three months and six months. The effect size
was considered as the lowering of systolic and
diastolic BP by a minimum of 15mm and 6 mmHg,
respectively. Thus, cases where this lowering in
systolic and diastolic BP was observed were ascribed
as improved and the rest as not improved. The
study endpoint was lowering of BP following
intervention. The primary safety endpoint was
any adverse event during the study in any of the
groups. The stopping guidelines were, a marked
deterioration of health condition and/or constant
increase in BP among subjects in either group,
constant progress of disease with appearance of
complications, and adverse events(if any).

Sample size

The effect size calculated from the study on

hypertension conducted by CCRH[23] was 0.6[SBP:
157.6513.05 versus 143.4112.41, Cohens
d=1.13, effect size=0.5; DBP: 100.774.04 versus
89.137.75, Cohens d=1.88, effect size=0.7;
overall effect size=0.6; calculated at UCCS Effect
Size Calculators; http://www.uccs.edu/~lbecker/;
1998, 1999 Dr.Lee A Becker, University of Colorado,
Colorado Springs]. Taking into account the effect
size (Standardized difference) of 0.6, power 90%, and
significance level() of 5%, the required sample size
determined was 118 by the Altmans nomogram.
Keeping a provision for dropouts of about 27%, the
targeted sample size became 150.
The hypertensive status of the study population
was initially confirmed by taking the average
of the measured blood pressure twice on two
separate occasions in two contralateral arms in
a supine position during rest, using a mercury
Indian Journal of Research in Homoeopathy / Vol. 7 / Issue 2 / Apr-Jun 2013

sphygmomanometer of standard cuff size,

throughout the study. Every case was subjected
to detailed screening by a specified eligibility
criteria followed by recruitment in the trial.
After recruitment, all were subjected to baseline
assessments. The preentry and postintervention
laboratory investigations performed were as follows:
Blood for routine investigation(haemoglobin%,
White Blood Cells(WBC)/WBC total count(TC) and
differential count(DC), Erythrocyte Sedimentation
Rate(ESR) first hour, fasting and postprandial
sugar, urea, creatinine, total cholesterol, High
Density Lipoprotein cholesterol/HDLc, Low Density
Lipoprotein cholesterol/LDLc, Very Low Density
Lipoprotein cholesterol/VLDLc and triglyceride),
urine analysis(albumin, blood, WBC or pus
cells), chest xray PA(posteroanterior) view, and
electrocardiogram(ECG) were performed before and
after an intervention of six months.
Data were extracted from the reports directly and
independently. Predesigned proforma were used
by the investigators. All these were compiled at the
end; data were extracted and analyzed.
Out of 233 hypertensive patients assessed for the
eligibility criteria, 150 were enrolled. Then individual
treatment was prescribed to all the enrolled
participants by the treating physicians. The treating
physicians were free to decide the homoeopathy
medicines, dosage, and repetitions to be applied.
Following prescription, a random allocation
sequence was generated by a cointoss method and
dividing the sample into two groups. Randomization
codes (h =heads, t = tail) were mentioned on
the prescription of each participant by the treating
physicians and were sent to the pharmacist. The
pharmacist was instructedto serve either medicine
or placebo to the groups as per the mentioned codes
on the prescription. The treating physicians were
kept blinded from the code of allocation, in strict
confidentiality, throughout the study. The codes were
broken after the end of the trial when the dataset
was frozen. Thus, 70 participants were found to be
randomized to verum(homoeopathy) and 80 to
control(placebo). Atotal of 18 were dropouts and
132 were regular(subjects 64, control 68). Double
blinding was checked early and also during the
trial(by MM) by asking the patients in which group
they believed they were during the trial. If necessary,
the prescription was changed in the course of time,
65

Saha, etal.: Homoeopathy in hypertension

and of course, the patients who started on placebo

stayed on placebo, except during intercurrent acute
illness.
Treating physicians were housestaffs in the
Department of Medicine of the hospital. Of them,
two had masters in dietetics and all of them had a
practicing experience of one year in the hospital.
Necessary inputs regarding the selection of medicine
were taken from experts, who had enough expertise
and 10years of experience in hospital practice. All
the participants were given additional instructions
regarding the diet(DASH diet; i.e.,Dietary Approach
to Stop Hypertension) and regimen, keeping in mind
their socioeconomic status and level of education.
The usual measures included avoiding tobacco and
alcohol, restricting salt and saturated fat in the daily
diet, increasing fruit and fibre content in the diet,
and encouragement to undertake more physical
activity. These additional measures were advised to
all the participants to minimize bias.
A detailed case recording of each patient was done
by the investigators as per the guidelines laid
down by Hahnemann in Organon of Medicine[30]
and Kents philosophy.[31] Repertorization was done
on the basis of the totality of symptoms by Kent,
Boenninghausen, and Synthesis repertories using the
RADAR software. After repertorization, the medicine
was selected on the basis of the Homoeopathy
Materia Medica.[32,33] In either group, patients were
followed up in person on every fourteenth day and
finally after six months, by measurement of blood
pressure. In either group, all followups were done
as per the guidelines laid down for the second
prescription in the protocol, that is, increasing the
potency and change of medicine depending on the
outcome of the first prescription. Amaximum of
two changes in the prescription were permitted. Any
acute complaint arising during the followup was
prescribed the indicated remedy as the prevailing
symptomatology suggested. During the sixmonth
trial, all data were measured and analyzed at entry,
after three months, and after six months of the
study by the outcome assessor(blinded, AD).

Statistical analysis

Intention to treat(ITT) population was subjected

to statistical analysis. Comparable baseline
characteristics and potential variables were
matched to evaluate whether the samples
originated from the same distribution and whether
66

they differed statistically significantly or not.

Missing values were calculated by the maximum
likelihood method of estimation of the lambda
parameter of normal distribution. Various statistics
computational websites, for example, Vassar
University statistical software(http://vasarstats.
net), GraphPad software(http://www.graphpad.com/
quickcalcs/), Jumk.de statistics calculator(http://
jumk.de/statisticcalculator), WessaNet statistics
software(http://www.wessa.net/rwasp_), and Jeromy
Stangrooms social science statistics(http://www.
socsscistatistics.com/tests) were used for statistical
calculations. Repeated measures ANOVA was done
using SPSS version20. The data were checked for
normal/nonnormal distribution using descriptive
statistics of skewness and kurtosis and appropriate
tests(parametric/nonparametric) were performed
accordingly. The analysis was planned to be
performed on demographic data and treatment
outcomes, to test the group differences, using
the Chisquare(2) test and independent t test.
If significant difference was obtained, repeated
measure(ANOVA) was planned to perform to
compare the data of two groups obtained at
different points of time, that is, at baseline, after
three months, and after six months.

RESULTS
Out of 233 hypertensive subjects assessed for the
eligibility criteria, 83 were excluded and 150 were
randomized into two groupsverum(homoeopathy)
and placebo. Sixtyfour participants in the
homoeopathy group out of 70 were allocated, and
68 out of 80participants in the placebo group were
included in the final analysis. There was a total dropout
of 18cases in the trial(verum 6, placebo 12). In the
verum group, two subjects withdrew themselves from
the study, three failed to continue regular followup for
the minimum required duration/investigations for the
conduct of analysis, and one developed hepatitis during
the course of study and attended other treatment. In
the placebo group, eight subjects withdrew themselves
from the study; three were irregular, and one needed
active therapeutic intervention for sudden deterioration
of condition[Figure1].
The available data was subjected to assessment of
skewness and kurtosis as descriptive analysis to
determine normal/nonnormal distribution. Skewness
ranged from 0.27 to 0.47 and kurtosis around
three in both verum and control indicating an
Indian Journal of Research in Homoeopathy / Vol. 7 / Issue 2 / Apr-Jun 2013

Saha, etal.: Homoeopathy in hypertension

approximate normal distribution.

Table1: Baseline data(n=150)

Baseline demographic characteristics, clinical

indices, and pathologicalbiochemical parameters
were tested using the independent ttest and
Chisquare test. They were found to be similar and
no statistically significant difference existed between
the groups[Table1].

Baseline demographic data

Sociodemographic
Homoeopathy
characteristics
(n=70)

Placebo
(n=80)

P
value

Age; MSD; n(%)

After six months of intervention, change in blood

pressure showed a statistically significant trend
in favour of homoeopathy. Blood pressure was
lowered significantly in fiftyfour(84.4%) and nine
patients(13.2%) in the verum and control groups,
respectively,(12 = 64.06; P=0.000, twotailed).
BP remained unimproved(static or deteriorated)
in 10(15.63%) patients in the verum group and
59(86.76%) patients in the control group.

Gender; n(%)

After three months, mean SBP and DBP reduction

was 16.6(95% CI 9.9, 23.3) and 7.3(95% CI 4.1, 10.5)
mmHg respectively in the homoeopathy group.
Contrarily, mean SBP and DBP raised by 2.2(95%
CI7.2, 2.8) and 1.6(3.6, 0.4) mmHg respectively
in the placebo group. Again after six months, mean
SBP and DBP reduction was 26.6(95% CI 21.5, 31.7)
and 11.8(95% CI 9.2, 14.4) mmHg respectively in
the homoeopathy therapy group. The mean SBP and
DBP increased by 3.6(95% CI8.7, 1.5) and 1.6(3.6,
0.4) mmHg respectively in the placebo group.
Repeated measures ANOVA was performed comparing
data obtained at baseline, at 3 months and 6 months,
which also revealed significant difference between
the two groups, both in SBP[F=77.2]; P=0.0001 and
DBP[F=63.2]; P=0.0001.
Post hoc independent t test was carried out
comparing three months and six months values which
showed a statistically significant difference between
groups, both in SBP (mean difference = -17.8, t =
-6.2 and mean difference= -29.2, t = -10.38, P =
0.001) after 3 months and 6 months respectively
and DBP (mean difference = -7.4, t = -6.1
and mean difference = -11.8, t = -11.47; P = 0.001)
after 3 and 6 months respectively. (Table 2, Figure 2)
The most frequently prescribed homoeopathic
medicines
in
both
groups
were
Natrum
muriaticum(n=19, 15), Calcarea carbonica(n=9, 9),
Sulphur(n=9, 7), Thuja occidentalis(n=6, 6), and Nitric
acid (n=3, 5) in varied potencies[Table3]. Among
incurrent antimiasmatics, Medorrhinum, Nitric acid and
Thuja occidentalis were frequently used; Bacillinum,
Indian Journal of Research in Homoeopathy / Vol. 7 / Issue 2 / Apr-Jun 2013

52.410

51.110.8

0.488

18-35years

5(7.14)

9(11.25)

0.561

36-50years

27(38.57)

28(35)

0.777

51-65years

38(54.29)

43(53.75)

0.922
0.884

Male

27(38.57)

31(38.75)

Female

43(61.43)

49(61.25)

0.884

Weight(kg); MSD

62.15.8

61.66.1

0.022*

Height(cm); MSD

160.77.2

1626.4

0.069

Body mass index; MSD

23.12.7

24.32.9

0.509

25(35.71)

29(36.25)

0.919

F/H of Hypertension;
n(%)
Marital status; n(%)
Married

61(87.14)

65(81.25)

0.448

Unmarried

9(12.86)

15(18.75)

0.448

Habitat; n(%)
Urban

56(80)

64(80)

0.838

Rural

14(20)

16(20)

0.838

Risk factors; n(%)

Stress

45(64.29)

51(63.75)

0.919

Sedentary habits

32(45.71)

36(45)

0.939

Rich food

37(52.86)

47(58.75)

0.575

High salt intake

50(71.43)

54(67.5)

0.732

21(30)

26(32.5)

0.878

9(12.86)

13(16.25)

0.723

Placebo
(n=80)

P
value

Smoking
Alcohol

Baseline clinical data

Clinical indices
Homoeopathy
(n=70)
Respiratory rate; MSD

19.71.6

19.91.4

0.849

Heart rate; MSD

82.711.8

84.510.9

0.343

Hypertension stages; n(%)

6(8.57)

11(13.75)

0.459

Stage I

Prehypertension

22(31.43)

20(25)

0.489

Stage II

42(60);

49(61.25)

0.991

161.721.1

160.716.9

0.692

Systolic blood pressure;

MSD
Prehypertension

129.46.1

131.55.7

0.709

Stage I

151.55.4

150.55.4

0.767

Stage II

173.38.7

171.59.6

0.684

100.210.7

98.76.9

0.684

Prehypertension

87.24.4

88.25.6

0.692

Stage I

99.66.3

98.65.0

0.713

Stage II

100.15.2

101.15.4

0.742

Diastolic blood pressure;

MSD

Comorbid conditions; n(%)

Hyperlipidemia

15(21.43)

14(17.5)

0.689

Hyperglycaemia

20(28.57)

23(28.75)

0.875

8(11.43)

9(11.25)

0.823

22(31.43)

20(25)

0.925

Renal insufficiency
Menopause

(contd)...
67

Saha, etal.: Homoeopathy in hypertension

Table1: Contd...

Baseline pathological-biochemical data

Indices
Homoeopathy Placebo
(n=70)
(n=80)

P
value

Blood sugar; MSD

Fasting

105.829.2

107.127.3

0.284

Postprandial

141.228.1

140.440.5

0.436

Blood urea; MSD

28.69.8

29.18.9

0.192

Serum creatinine; MSD

0.90.2

0.80.1

0.490

Lipid profile; MSD

222.728.1

219.232.5

0.107

HDLc

Total cholesterol

46.98.1

47.16.1

0.176

LDLc

141.721.8

138.222.7

0.108

VLDLc

32.812.9

32.511.6

0.362

Triglycerides

195.065.4

202.775.5

0.227

Albuminuria

4(5.71)

5(6.25)

1.000

Hematuria

3(4.29)

3(3.75)

1.000

Urine microscopy; n(%)

Abnormal ECG findings;

n(%)
Ischemic heart disease

6(8.57)

7(8.75)

0.801

Left ventricle enlargement

4(5.71)

4(5)

1.000

Heart block

2(2.86)

2(2.5)

1.000

Chisquare and Independent t test applied; Fishers exact Pvalue; *P<0.05

two-tailed considered as statistically significant, ECG: Electrocardiogram,
HDLc: High density lipoprotein cholesterol, LDLc: Low density lipoprotein
cholesterol, VLDLc: Very low density lipoprotein cholesterol

Sulphur, and Syphilinum each were used in single cases.

No serious adverse events were reported during
the study period, except a single case of hepatitis
in the verum group and one case of deterioration
of condition in control group; however, those
cannot be attributed to causality. Mildtomoderate
homoeopathic aggravation, as per homoeopathic
principles, was observed.

DISCUSSION
Individualized homoeopathy definitely produced
some hypotensive effects different from placebo.
Homoeopathic prescriptions in our study were based
on homoeopathic principles. Mildtomoderate
hypertension in many cases is asymptomatic,
emphasizing the need for a holistic approach.
The trial was made doubleblind by the blinding
participants, the outcome assessor, and treating
physicians. Doubleblind studies on individualized
homoeopathy where physicians are given a free hand
for prescriptions are rare, probably due to the inherent
problems in the methodology of treatment, that is,
the individualization procedure, treatment by multiple
68

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Figure 2: Mean changes of blood pressure over time

remedial agents in various potencies prepared under

various scales for a single clinical diagnosis, and so on.
We followed the instructions of Kleijnen etal.,[34] for
making the study double blind, that is, an individual
treatment is prescribed, and then the patients are
randomly allocated to homoeopathy or placebo
treatment. Double blinding was checked early in
the trial, before the treatment was expected to take
effect by asking the patients in which group they
believed they were in during the trial. Otherwise, any
positive effect would break the code, especially when
chances of diffusion of treatment(contact between
verum and control subjects) could not be removed
completely. However, the quasirandomization by
the cointoss method may be improved by adopting
computergenerated random number lists, in future
researches. As the randomization was a bit different
from the usual procedures, traditional allocation
concealment
mechanisms(e.g.,consecutively
numbered drug containers, sequentially numbered,
opaque, sealed envelopes etc.) were not followed.
Bias was tried to be minimized by blinding of
participants, treating physicians, and the outcome
assessor(AD, expert of conventional system of
medicine, who was neutral about homoeopathy and
did not participate in the treatment); randomization
of participants into subject and control groups; and
matching for comparable baseline characteristics and
potential variables.
Also, although explained extensively to the
participants, chances of threats to external validity
could not be completely avoided, due to chances of
interaction with other forms of therapy and interaction
of testing and treatment(evidence that testing might
be related to the treatment so that subjects complete
the tests differently after treatment). The best
possible effort was made to minimize chances of any
compensatory work to equalization(evidence that
Indian Journal of Research in Homoeopathy / Vol. 7 / Issue 2 / Apr-Jun 2013

Saha, etal.: Homoeopathy in hypertension

Table2: Blood pressure changes in the two groups over different points in time

Group(s)

Baseline

SBP(meanSD)
At 3 months

At 6 months

Within group
F
P
value
value

Homoeopathy(n=70)

161.721.3

145.119.0

135.118.3

71.90

0.0001

Placebo(n=80)

160.716.9

162.915.3

164.315.8

7.50

0.001

0.001

0.001

P value

NS

Group(s)
Baseline
Homoeopathy(n=70)
Placebo(n=80)
P value

DBP((meanSD)
At 3 months
At 6 months

Within group
F
P
value
value

100.210.7

92.88.5

88.36.7

57.62

0.001

98.66.8

100.16.1

100.15.8

6.12

0.003

NS

0.001

0.001

Between groups
F
P value
value
77.2

0.0001

Between groups
F
P value
value
63.2

0.0001

Repeated measures ANOVA was carried out with time as factor to show any difference in each group. Repeated measures ANOVA was carried out with time as
factor versus group for showing difference between the groups, *Independent t test was carried out for showing the difference between the groups at each time
point i.e.,at 3 months and at 6 months. Post hoc Bonferonni corrections in Pvalue were done for multiple comparison(due to two comparisons, Pvalue <0.025
were taken as statistically significant)

Table 3: Most often prescribed homoeopathic

medicines

Medicine

Homoeopathy
Placebo
Pvalue
number of
number of
prescriptions prescriptions

Natrum muriaticum

19

15

0.639

Calcarea carbonica

0.936

Sulphur

0.959

Thuja occidentalis

0.985

Nitric acid

1.000()

Causticum

1.000()

Medorrhinum

1.000()

Staphysagria

1.000()

Digitalis

1.000()

Glonoine

1.000()

Chisquare test; Pvalue twotailed at 95% CI; Fishers exact Pvalue; P<0.05
considered as statistically significant

groups are knowledgeable about design and might

equal things out), compensatory rivalry(evidence that
groups are knowledgeable about design and might
compete with other group members), and resentful
demoralization(evidence that one group feels
disadvantaged through a group assignment process);
however, these cannot be warranted.[35] Attempts
were made to minimize threats to construct validity
by minimizing chances of inadequate explication,
monomethod bias, hypothesis guessing, evaluation
apprehension, and experimenter bias.[35]
Besides, due to limited infrastructure and absence of
an Intensive Care Unit, malignant hypertension cases
were excluded from this study. Also, retinoscopic
examination was not possible on account of want of
faculty.
A larger sample size was considered in this trial
Indian Journal of Research in Homoeopathy / Vol. 7 / Issue 2 / Apr-Jun 2013

in comparison to two other published randomized

trials.[21,22] Also, individualized homoeopathy was
tested in this study revealing a positive outcome
and a significantly different effect from the placebo.
Furthermore, the objective of this study was not to
suggest any single homoeopathy remedy for essential
hypertension. Larger trials in future, in multicentric
design, may suggest a subgroup of remedies that are
more frequently indicated in this clinical condition.
The final differentiation of the remedies was made
after referencing drug pictures of different Materia
Medica, and a remedy matching the totality was
chosen, taking care that it also corresponded to
the predominant miasmatic influence in the case.
Natrum muriaticum, Calcarea carbonica, and Sulphur
were indicated in most of the cases; however, these
remedies were chosen strictly on the principles of
homoeopathy and should never be used specifically
or blindly to control hypertension. In some cases,
especially where characteristic symptomatology and
precise prescribing totality were lacking, remedy
selection was influenced by constitutional attributes,
generalities, and the fundamental cause, that is,
the chronic miasm in the background. Treatment
was often difficult due to this fundamental
miasm; sometimes improvement ceased even after
administration of a wellselected remedy; sometimes,
remedies failed to make any impression in spite of
certain indications; occasionally they completely
obscured the symptomatology. These cases required
intercurrent antimiasmatic remedies to remove
the block. Prescription in such instances became
presumptive rather than a certainty, and success
or failure of the selected remedy was indicated
69

Saha, etal.: Homoeopathy in hypertension

only on a serial repetition of BP measurement,

in the absence of a demonstrable aberration in
health. During the followup visits, the remedy was
repeated only when necessary, in the same potency
or with a change in potency, as indicated. Likewise,
a change in remedy also was considered only when
essential, after careful evaluation of the follow up. In
cases where both were not necessary, only placebo
was prescribed. Some individuals in the placebo
group experienced improvement, probably due to
individual variation by adaptation of and meticulous
adherence to the additional lifestyle modification
measures concerning diet and regimen that were
advised to all, to eliminate the bias.
Homoeopathic principles were not followed in the
two randomized controlled trials on hypertension
performed to date; and quite obviously, the findings
were negative. No statistically significant differences
were found between the effects of placebo and active
drug(Baryta carbonica 15cH) on the blood pressure.[21]
The earlier study concluded that a blood pressure
lowering effect under pharmacotherapy was clearly
superior to that under homoeopathy, where it was
negligible and statistically not significant.[22] However,
the observational studies, although methodologically
inadequate, yielded positive outcomes favouring
homoeopathy.[2325] Our study findings generated
conflicting evidence in the outcomes of the previous
two RCTs and confirmed that homoeopathic
medicines, when applied as per principle, can
definitely produce significant effects different from
placebo. Finally, in order to build credibility within
the medical research field, multiple replications and/
or extensions using the same or similar approaches
to treat the different diseases are necessary. Multisite
research with larger sample sizes is essential to
improve the confidence level and generalizability of
the study findings.

Conclusion
Finally our data suggest that individualized
homoeopathy treatment may have significantly
beneficial effects different from placebo in patients
suffering from essential hypertension. It may be
adopted as an alternative public health approach in
curbing the increasing prevalence of hypertension
throughout the globe. However, further research in
multicentric design is required on larger sample size
before making firm recommendations.
70

ACKNOWLEDGMENTS
The authors would like to thank Prof. Amitava Biswas,
Principal, Mahesh Bhattacharyya Homoeopathy Medical
College and Hospital, Government of West Bengal, for
giving permission to conduct the trial in his institution;
and also Mr. Suman Khatua for his outstanding technical
support and assistance.

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20. Linde K, Clausius N, Ramirez G, Melchart D, Eitel F, Hedges LV,
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metaanalysis of placebocontrolled trials. Lancet 1997;350:83443.
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www.similima.com.
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on Prevention, Detection, Evaluation and Treatment of High Blood
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1991;302:31623.
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How to cite this article: Saha S, Koley M, Hossain SI, Mundle M,

Ghosh S, Nag G, et al. Individualized homoeopathy versus placebo
in essential hypertension: A double-blind randomized controlled trial.
Indian J Res Homoeopathy 2013;7(2):62-71.
Source of Support: Nil, Conflict of Interest: None declared.

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Indian Journal of Research in Homoeopathy / Vol. 7 / Issue 2 / Apr-Jun 2013

71

I J R H

Original Article
Access this article online

Effect of homoeopathic LM potencies in

acute attacks of haemorrhoidal disease:
A multicentric randomized singleblind
placebocontrolled trial
P. S. Chakraborty, Roja Varanasi, A. K. Majumdar1, Kishan Banoth2,
Sunil Prasad3, M. S. Ghosh4, M. N. Sinha5, G. Ravi Chandra Reddy6, Vikram Singh,
Chaturbhuja Nayak

ABSTRACT
Background and Objectives: Anecdotal data on the usefulness of homoeopathic
medicines in acute haemorrhoids shows grade V evidence. So, the efficacy of
individualized homoeopathic medicines in LM potencies, in Acute Haemorrhoidal
Attacks (AHAs), was investigated in this study against placebo.
Material and Methods: In a multicenter randomized controlled singleblind parallel
group trial conducted at six centers under the Central Council for Research in
Homoeopathy, patients who presented with any symptom such as bleeding, pain,
discharge, heaviness, and itching were included. The patients were randomized to
receive either individualized homoeopathic medicine or placebo for a period of 90
days. Changes in haemorrhoidal symptoms were the main outcome measures.
Results: Two hundred and seventyeight patients (Homoeopathy: n = 140, placebo: n
= 138) were analyzed. After 90 days of treatment, a significant difference (P = 0.0001)
was found in the median area under the curve (AUC) for bleeding {difference: 64.0
[95% confidence interval (CI): 90.0, 31.4]}, pain [243.0 (280.9, 202.4)], heaviness
[208.0 (95% CI: 245.5, 174.9)], and itching [198.5 (246.4, 158.5)] between the
Homoeopathy and placebo groups. Significant differences (P < 0.001) were also found
in the World Health Organization Quality of LifeBREF (WHOQOLBREF) physical
domain [difference 7.0 (95% CI: 6.0, 12.0)], psychological domain [7.0 (6.0, 12.0)],
and environmental domain [6.0 (0.001, 11.9)]. However, no difference was found in
discharge [0.0 (21.0, 0.0); P = 0.1386] and social domain of the WHOQOLBREF
[0.0 (0.001, 5.9; P = 0.0803)].
Conclusion: In this study, homoeopathic intervention relieved acute haemorrhoidal
symptoms early compared to the placebo group. Randomized controlled trials with
double blinding are suggested further.

Website:
www.ijrh.org
DOI:
10.4103/0974-7168.116630
Quick Response Code:

Central Council for Research

in Homoeopathy, New Delhi,
1
Dr. Anjali Chatterjee Regional
Research Institute (Homoeopathy),
Kolkata, 4Clinical Research Unit
(Homoeopathy), Siliguri, West
Bengal, 2Regional Research Institute
(Homoeopathy), Gudivada, 6Clinical
Research Unit (Homoeopathy),
Tirupathi, Andhra Pradesh, 3Clinical
Research Unit (Homoeopathy),
Agartala, Tripura, 5Regional
Research institute (Homoeopathy),
Jaipur, Rajasthan, India
Address for correspondence:
Dr. Roja Varanasi,
Research Officer (H)Scientist 1,
Central Council for Research in
Homoeopathy, 6165 Institutional
Area, Janakpuri, New Delhi, India.
Email: [email protected]
Received: 20022013
Accepted: 09072013

Keywords: Acute haemorrhoidal attacks, Haemorrhoids, Homoeopathy,

Randomized controlled trial

INTRODUCTION
Haemorrhoids have been referred to in the literature
dating back to the preChristian era and are a
common condition. Prevalence in western population
72

statistics varies from 4.4% in the general population

to 36.4% in general practice.[1] In India with the
advent of western culture and diet, the scenario is
no better despite the diet being richer in fibre, that
is, 2.4 to 40%.[2,3]
Indian Journal of Research in Homoeopathy / Vol. 7 / Issue 2 / Apr-Jun 2013

Chakraborty, et al.: Homoeopathic LM potencies for acute attacks of haemorrhoidal disease

Haemorrhoids may be internal or external in nature

depending on its location above or below the dentate
line in the anal region. Internal haemorrhoids are
the symptomatic, exaggerated, submucosal vascular
tissue located above the dentate line and covered
by transitional and columnar epithelium. It can be
divided into four categories. Grade 1: These bulge
into the lumen of the anal canal and may produce
painless bleeding. Grade 2: These protrude at the
time of a bowel movement but reduce spontaneously.
Grade 3: These protrude spontaneously or at the
time of a bowel movement and require manual
replacement. Grade 4: These are permanently
prolapsed and irreducible despite attempts at manual
replacement. In a classic case, bleeding is bright red
and painless and occurs at the end of defaecation.
The patient complains of blood dripping or squirting
into the toilet bowl. External haemorrhoids comprise
the dilated vascular plexus that is located below
the dentate line and covered by the squamous
epithelium.[1]
Controversies and lack of agreement still exist on
treatment strategies. On the one hand, nonsurgical
treatment modalities such as rubber band ligation,
injection schlerotherapy, photocoagulation, and
cryotherapy are well established and acceptable
to patients. However, they are not suitable for
all grades of haemorrhoids and have recognized
complications.[48] On the other hand, surgical
haemorrhoidectomy is associated with a significant
morbidity, complications, and may lead to delays in
return to work. It is worth noting that 26% of the
patients who require a haemorrhoidectomy may
have a recurrence, and 11% need further treatment.
Similarly, approximately half of those who undergo
office procedures may require further treatment or
surgery in 5 to 10 years.[1,9] Laxatives and a highfibre
diet help to some extent in reducing the symptomatic
haemorrhoids.[1012] The cost to the community, both
financial and in lost working days is great and by any
standards this condition must be considered a major
health hazard.[2]
Homoeopathic literature shows anecdotal data
on the efficacy of homoeopathic medicines in
haemorrhoids. Although various practitioners and
clinicians quote brilliant cure of haemorrhoids with
homoeopathic medicines, there is low evidence[1319]
and lacks controlled studies.
Homoeopathic dynamized medicines are given in
Indian Journal of Research in Homoeopathy / Vol. 7 / Issue 2 / Apr-Jun 2013

uncommonly small doses. Hahnemann, the father

of Homoeopathy aimed at achieving a rapid,
gentle and permanent restoration of the health,
which seemed to him easier to achieve with his
last dynamization method, known as 50 millesimal,
Quinquagintamillesimal
(Qpotencies),
or
LM
potencies, in which the medicine is diluted 50,000
times at each step (potency) of the dynamizing
process.[20]
There is no controlled study of the homoeopathic
use of LM potencies in acute attacks of
haemorrhoidal disorders. Nevertheless, LM potencies
have been recently tested in randomized, controlled
studies showing therapeutic effects in fibromyalgia,
attention deficit hyperactivity disorder, and
depression as compared to placebo/active control.
[2123]

The present study was aimed at investigating

the effectiveness of individualized homoeopathic
medicines (LM potencies) in Acute Haemorrhoidal
Attack (AHA), as compared to placebo in a
prospective, randomized, singleblind, parallel trial,
and secondary changes in quality of life.

MATERIAL AND METHODS

Trial Design

This is a multicenter randomized placebocontrolled

parallel group study. Six investigators from six
study centers participated in the trial for screening,
treating patients, and collecting data. Investigators
were trained in the protocol before initiation of the
study. Consultant surgeons were engaged at each
study center to assess the patients as per protocol.
All patients gave their written informed consent
before enrollment in the study. The study protocol
was approved by the ethical committee of the
council. The study has been registered in the Clinical
Trials Registry India, CTRI/2012/04/002541.

Patients and Setting

Inclusion criteria for patients were: Male and

female patients between 25 and 60 years suffering
from internal haemorrhoids presenting with any of
the symptoms, namely, bleeding, pain (including
discomfort and tenesmus during defaecation or any
other time), heaviness, pruritus, and mucus discharge
with or without anitis. Patients with controlled
diabetes (HbA1C < 8%) and controlled hypertension
and thyroid disorders were also eligible for the
73

Chakraborty, et al.: Homoeopathic LM potencies for acute attacks of haemorrhoidal disease

study. Patients using topical agents for haemorrhoids

were included after a washout period of one week,
subject to persistence of symptoms and signs of
haemorrhoids.
Patients with the following conditions were
excluded: Anal fissure, fistula in ano, inflammatory
bowel disease, chronic alcoholism, recreational drug
abuse, coagulation disorders, external haemorrhoids,
previous history of surgery for haemorrhoids,
hypertrophic anal papillae, haemoglobin of <7
gm/dL, malignancies of the rectum, history of
leukemic disorders, patients with obstruction of
portal circulation, pregnancy leading to obstruction
of the portal circulation, lactating mothers, patients
with psychiatric diseases, and inability to comply
with the study protocol.
The study was conducted at six centers under
the Central Council for Research in Homoeopathy
which was decided. Regional Research Institute
for Homoeopathy, Jaipur, Rajasthan, Regional
Research Institute for Homoeopathy, Gudivada,
Andhra Pradesh, Dr. Anjali Chatterjee Regional
Research Institute for Homoeopathy, Kolkata, West
Bengal, Clinical Research Unit for Homoeopathy,
Siliguri, West Bengal, Clinical Research Unit for
Homoeopathy, Agartala, Tripura, and Clinical
Research Unit for Homoeopathy, Tirupathi, Andhra
Pradesh.

Study Interventions

The homoeopathic medicines in LM potencies were

procured from a Good Manufacturing Practices
(GMP)certified company. The investigators were
instructed to have an indepth interview with
the patient, as per the guidelines laid down by
Hahnemann S[20] in the sixth edition of the Organon
of Medicine and followup of all the patients were
done as per homoeopathic principles. However, the
final decision was taken after consultation with the
Materia Medica.
All the participants, irrespective of the medicine or
placebo group, were encouraged to correct constipation
and unhealthy defaecation habits such as ignoring the
need to pass stools, irregular meals, spending a long
time in the lavatory, straining, and lack of exercise.
They were also advised about the importance of a
fibrerich diet in health and encouraged to consume
food rich in natural fibre such as unpeeled fruits,
vegetables, and wholegrain bread, and so on, and
prohibited from high consumption of spices.
74

Homoeopathic Intervention

Patients randomized to the intervention group

received individualized homoeopathic medicine
and the same was selected as per homoeopathic
principles[20] for 90 days customized to each patient
which started with 0/1 potency, followed by the next
higher potency, serially, as per need of the case. The
investigator or the pharmacist on instruction from
the investigator dispensed the medicine/placebo as
follows: One globule (poppy seed size) of the desired
potency was dissolved in 120 mL of distilled water,
containing 2.4 mL (2% v/v) of dispensing alcohol,
premixed in it, followed by 10 uniformly forceful
downward strokes given against the bottom of the
phial. The medicine was given two to six hourly,
even oftener: six hourly in mild cases, four hourly in
moderate cases, two hourly in severe cases, and less
than two hourly for very intense conditions. Each
patient was advised to give 10 uniformly forceful
downward strokes to the bottle with the hand on
a hard surface and to take three teaspoonfuls (15
mL) of this solution and mix it in eight teaspoonfuls
(40 mL) of water in a clean glass after stirring the
solution for each dose of medicine taken. One
teaspoonful (5 mL) of this solution constituted
one dose. If any change was triggered after
administration (improvement/deterioration), change
of remedy followed homoeopathic principles.

Control Group

Patients randomized to the control group received

placebo for the duration of the study (90 days). It
constituted unmedicated poppysized sugar globules
impregnated with dispensing alcohol. Mode of
dispensing of the placebo was similar to that of the
medicine. Any change triggered after administration
(improvement) was followed by placebo only.
However, if a patient worsened after 14 days of
taking placebo, the investigator was instructed to
give these patients rescue homoeopathic medicine
due to ethical reasons.

Outcomes

The primary outcome measure was changes in

symptoms of haemorrhoids, that is, bleeding
followed by pain, heaviness, discharge, and
itching.[24,25] The secondary outcome measure was
changes in quality of life using the World Health
Organization Quality of LifeBREF (WHOQOLBREF).
Followup period was of a duration of three months
(90 days). Symptomatic assessments were done
at baseline, day 0 (before treatment), 3rd, 7th, 14th,
Indian Journal of Research in Homoeopathy / Vol. 7 / Issue 2 / Apr-Jun 2013

Chakraborty, et al.: Homoeopathic LM potencies for acute attacks of haemorrhoidal disease

28th, 60th, and 90th day by the study investigator

and consultant surgeons at the respective centers.
Bleeding was assessed on a scale of 0-3:[25] A score
of 3 was considered as severe if it occurred more
than five times a week, a score of 2 was considered
moderate if it occurred less than three to five times
a week, a score of 1 was considered as mild if it
occurred one to less than three times a week, and if
the bleeding did not occur at all, then it was scored
as zero. Pain, heaviness, discharge, and itching were
measured on a Visual Analogue Scale ranging from 0
to 10, where zero corresponded to no symptoms and
10 corresponded to the worst possible symptoms
as described by previous researchers.[24,25] However,
due to ethical considerations, on the 14th day of
assessment, if symptoms of a patient were worsened,
the investigator was instructed to give the patient in
the placebo group a rescue homoeopathic medicine.
Investigators were allowed to followup the patients
telephonically if required.
Anoscopic examination was done by consultant
surgeons at baseline, 7th, 14th, 28th, 60th, and 90th
day, on a scale of 0 to 2 as follows:[25] 0 = no
signs of inflammation, 1 = a rather active grade,
haemorrhoids without overt inflammatory findings
(mild anitis), and 2 = an actively or easily bleeding
haemorrhoids with overt signs of inflammation and
oedema (severe anitis).
Haemoglobin (Hb), packed cell volume (PCV), mean
cell volume (MCV), mean cell haemoglobin (MCH),
and mean cell haemoglobin concentration (MCHC)
were done at baseline and every month to assess
changes during treatment, if any. The WHOQOLBREF
questionnaire has been designed to be applicable
to people living in different conditions or cultures.
This questionnaire has been validated in the Indian
population. It contains 26 items divided into four
domains: physical, psychological, social relationships,
and environmental. All the patients were assessed
on this scale for their quality of life at baseline and
at end of study (90th day).

Sample Size

From various clinical records, it was found that AHAs

can be managed with homoeopathic medicines.[1419]
The natural history of symptomatic haemorrhoids
suggests the selflimiting nature of this disease.[26]
With this in mind, it was assumed that there would
be 50% change in signs and symptoms in patients
taking placebo and that a further 20%, that is, 70%
Indian Journal of Research in Homoeopathy / Vol. 7 / Issue 2 / Apr-Jun 2013

patients would improve in symptoms and signs in

the Homoeopathy group, with an a - 0.05 and power
of 85%. A samplesized table by Fleiss[27] was used
for estimating the sample. A total of 250 patients
(125 patients in each group) were needed to prove
or disprove the hypothesis. Therefore, a total of 280
patients were considered including 12% dropouts.

Randomization and Blinding

Random
numbers
were
generated
from a computerbased software available at
www.randomizer.org. Twentythree sets of two
unique numbers per set were generated using block
design. The same set of random numbers was used
in each center. Both placebo and homoeopathic
medicines were made identically so that they were
indistinguishable. Due to the individualized nature
of homoeopathic prescription, blinding of the
investigator was not done. The investigator was
aware of the intervention given to enrolled patients.
Only the patients were blinded to the intervention.

Statistical Methods

Reporting adhered to the Consolidated Standards

of Reporting Trials statement for reports of parallel
group randomized designs. Data are presented as
number (%) or median [interquartile range (IQR)]
as appropriate. As the data did not follow normal
distribution, all the analyses were done using
nonparametric tests. Baseline characteristics between
the groups are presented. MedCalc version 11 was
used for calculation of Area Under the Curve (AUC),
Minitab version 16 for calculating 95% confidence
intervals (CIs) of median, and SPSS version 20 for
descriptive statistics. Where telephonic followup
was not possible or the patient was not available
for it, their missing values were replaced by last
observation. AUC was calculated at seven time
points (baseline, 3rd day, 7th day, 14th day, 28th day,
60th day, and 90th day) for bleeding, pain, heaviness,
discharge, and itching. AUC for anitits score was
calculated at six time points (baseline, 7th day, 14th
day, 28th day, 60th day, and 90th day). Patients who
entered early escape were counted in the treatment
regimen to which they were originally assigned.
Efficacy data and changes in WHOQOLBREF are also
presented by actual treatment received based on
the early escape status. In all analyses, if a patient
entered early escape at day 14, the baseline values
were carried forward to impute missing values. P <
0.05 was considered as significant.
75

Chakraborty, et al.: Homoeopathic LM potencies for acute attacks of haemorrhoidal disease

RESULTS
Between June 2009 and September 2010, 501
patients were screened for the trial. Treatment
and followups of the patients were completed by
December 2010. Figure 1 shows the patient flow in
the study. The baseline characteristics of the patients
were almost similar in the two groups [Table 1].
Male:Female ratio was 2:1 in both the groups; 83%
of the patients were nonvegetarians.
After 90 days of treatment, the median AUC bleeding
was 18.0 (95% CI: 15.4; 26.0) in the Homoeopathy
group which was significantly better (P = 0.0001)
than for the placebo group, which had a median AUC
of 90.0 (56.5; 146.9). The results were similar for AUC
pain [Homoeopathy: 105.0 (82.2; 121.0) vs. placebo:
342.7 (304.5; 423.8); P = 0.0001)], AUC heaviness
[Homoeopathy: 82.5 (69.0; 103.0) vs. placebo: 292.2
(270.0; 343.4; P = 0.0001], AUC itching [Homoeopathy
57.5 (41.9; 69.0) vs. placebo: 270.0 (216.0; 332.9; P
= 0.0001]. However, no difference was found in AUC
discharge (Homoeopathy 21.0 (10.4; 37.1) vs. placebo
30.7 (0.0 to 57.0); P = 0.1386] [Table 2].
$VVHVVHGIRUHOLJLELOLW\Q 

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Time to bleeding and pain clearance was analyzed

by survival methods [Figures 2 and 3]. The median
bleeding clearance time was 14 days and 90 days
and median pain clearance was 60 days and 90
days for the Homoeopathy and placebo groups,
respectively. Log rank test showed significant
difference between the groups (P = 0.0001). At
day 90, bleeding clearance in Homoeopathy group
was found in 97% patients, much higher than in the
placebo group, that is, 38.4%. Similar results were
found for pain clearance (75 vs. 13.7%).
The WHOQOLBREF physical domain, psychological
domain, and environmental domain were significantly
better (P < 0.001) in Homoeopathy compared to
placebo group [Table 2]. In parallel with symptomatic
healing, the median AUC for anitis rated through
anoscopy was significantly better (P = 0.0001) in
the Homoeopathy group: 21.0 (95% CI: 10.5; 25.5)
compared to placebo 90.0 (95% CI: 75.0; 90.0) [Table 2].
19 medicines were used to treat 140 patients
randomized homoeopathic group. They are mentioned
in the descending order of their prescription: Phosphorus
(n = 30), Sulphur (n = 25), Nux vomica (n = 22),
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Figure 1: CONSORT flow chart of the patients in the study

76

Indian Journal of Research in Homoeopathy / Vol. 7 / Issue 2 / Apr-Jun 2013

Chakraborty, et al.: Homoeopathic LM potencies for acute attacks of haemorrhoidal disease

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Table 1: Baseline characteristics of intention

totreat population

Variable

Homoeopathy
(n=140)

Placebo
(n=138)

38 (30,47.7)

38.5 (30,48)

Male

96 (68.6)

85 (61.6)

Female

44 (31.4)

53 (38.4)

2 (1;3)

2 (1;3)

Age (years)



Sex



Duration of haemorrhoids
in years



Food habits











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23 (16.4)

22 (15.9)

Nonvegetarian

117 (83.6)

116 (84.1)

Grade 1

61 (43.6)

67 (48.6)

Grade 2

69 (49.2)

59 (42.8)

Grade 3

25 (17.8)

28 (20.2)

Grade 4

01 (0.7)

3 oclock

93 (66.4)

92 (66.7)

5 oclock

25 (17.9)

25 (18.1)

7 oclock

86 (61.4)

83 (60.1)

Grade of haemorrhoids

Figure 2: Kaplan Meir curve of timetobleeding clearance



Vegetarian

Position of haemorrhoids

9 oclock

01 (0.7)

11 oclock

79 (56.4)

66 (47.8)

Bleeding (0-3)

137 (97.8), 2
(1,2)

127 (91.0), 2 (1,2)

Pain (VAS: 0-10)

137 (97.8), 6
(5,8)

135 (97.8), 6
(3.7,7)

Discharge (VAS: 0-10)

74 (52.8), 1 (0,5)

51 (36.9), 0 (0,3)

Heaviness (VAS: 0-10)

133 (95), 5 (3,6)

129 (93.4), 5 (3,6)

Itching (VAS: 0-10)

119 (85), 5 (2,6)

130 (94.2), 5 (3,6)

100 (71.4),1 (0,1)

90 (65.2), 1 (0,1)

Symptoms/signs present


        
'D\VVLQFHUDQGRPL]DWLRQ

Figure 3: Kaplan Meir curve of timetopain clearance

Nitric acid (n = 17), Lycopodium clavatum (n = 9),

Arsenicum album (n = 7), Pulsatilla pratensis (n = 6),
Ignatia (n = 5), Aesculus hippocastanum (n = 4), Carbo
vegetabilis (n = 2), Calcarea carbonica (n = 2), Chamomilla
(n = 2), Fluoric acid (n = 2), Natrum muriaticum (n =
2), Aloes socotrina (n = 1), Graphites (n = 1), Kalium
carbonicum (n = 1), Lachesis (n = 1) and Mercurius
solubilis (n = 1).
Table 3 demonstrates the improvement, status quo,
and worsening of patients on 90th day of treatment
cum followup for bleeding, pain, discharge, heaviness,
and itching. The proportion of patients with bleeding
improvement was higher in the homoeopathy group
(94.3%) versus placebo (43.5%). Similarly for status
quo, it was 8 (5.7) versus 65 (47.1) and for worsened
status, 0 (0) versus 13 (9.4%) which is statistically
significant (2 = 84.5, P = 0.0001).

DISCUSSION
To the best of our knowledge, this is the
first randomized trial evaluating the effect of
Indian Journal of Research in Homoeopathy / Vol. 7 / Issue 2 / Apr-Jun 2013

Anitis (0-2)
WHOQOLBREF
Physical domain

56 (44,63)

50 (38,63)

Psychological domain

50 (44,56)

44 (31,56)

Social domain

50 (44,73.5)

50 (40.7,69)

Environmental domain

50 (39.5,63)

47 (38,56)

Blood parameters
Hb

12.4 (11.2,13.7)

12.2 (11.2,13.6)

PCV

39 (36, 43)

39 (35, 43.2)

MCV

90 (85.2,96.7)

90 (84,102)

32 (29.2,33)

32 (30,33)

29 (26,31)

29 (25,32)

MCHC
MCH

WHOQOL: World health organization quality of life; VAS: Visual analogue

scale, Values are presented in n (%), median (Q1, Q3), haemoglobin (Hb) in
mg/dL, packed cell volume (PCV) in %, mean cell volume (MCV) in fl, mean
cell haemoglobin concentration (MCHC) in g/dL, mean cell haemoglobin
(MCH) in pg; the values under position of haemorrhoids and grade of
haemorrhoids may not correspond to total number of patients as one patient
may have more than one position or grade of haemorrhoids

individualized homoeopathic treatment in AHA. We

observed statistically significant differences in AHA
patients who received individualized Homoeopathy
for 90 days compared to patients who took placebo
77

Chakraborty, et al.: Homoeopathic LM potencies for acute attacks of haemorrhoidal disease

Table 2: Outcome variables at the end of study

Variable

Homoeopathy
Placebo (n=138)
(n=140)
Median (95% CI)

Median diff (95% CI)*

P
value

Primary outcome
AUC bleeding

18.0 (15.4; 26.0)

90.0 (56.5; 146.9)

64.0 (90.0, 31.4)

0.0001

105.0 (82.2; 121.0)

342.7 (304.5;
423.8)

243.0 (280.9, 202.4)

0.0001

AUC discharge

21.0 (10.4; 37.1)

30.7 (0.0 to 57.0)

0.0 (21.0, 0.0)

0.1386

AUC heaviness

82.5 (69.0; 103.0)

292.2 (270.0;
343.4)

208.0 (245.5, 174.9)

0.0001

AUC itching

57.5 (41.9; 69.0)

270.0 (216.0;
332.9)

198.5 (246.4, 158.5)

0.0001

21.0 (10.5; 25.5)

90.0 (75.0; 90.0)

25.5 (46.0, 14.9)

0.0001

Physical domain

63.0 (63.0; 69.0)

56.0 (56.0; 56.0)

7.0 (6.0, 12.0)

0.0001

Psychological domain

56.0 (56.0; 63.0)

50.0 (44.0; 56.0)

7.0 (6.0, 12.0)

0.0001

Social domain

53.0 (50.0; 56.0)

50.0 (44.0; 55.9)

0.0 (0.001, 5.9)

0.0803

Environment domain

50.0 (50.0; 56.0)

44.0 (38.0; 50.0)

6.0 (0.001, 11.9)

0.0005

Hb

12.4 (12.2; 12.8)

12.2 (12.0; 12.6)

0.2 (0.0, 0.6)

0.1268

PCV

40.0 (38.0; 41.0)

40 (38.0; 40.9)

0.0 (1.0, 2.0)

0.4876

MCV

92.0 (90.0; 94.4)

90 (89.0; 93.0)

1.0 (0.9, 3.6)

0.2242

MCHC

32.0 (31.0; 32.2)

32 (31.4; 32.0)

0.0 (0.9, 0.7)

0.9976

MCH

29.0 (28.7; 29.7)

29 (28.7; 30)

0.0 (0.7, 1.0)

0.7408

AUC pain

Secondary outcome
AUC anitis score
WHOQOLBREF

Blood parameters

WHOQOL: World health organization quality of life, CI: Confidence interval, Hb: Haemoglobin, PCV: Packed cell volume, MCV: Mean cell volume, MCHC: Mean
cell haemoglobin concentration, MCH: Mean cell haemoglobin, AUC: Area under the curve, *MannWhitney U test was used for comparing between the groups

Table 3: Proportion of patients improved/status quo/worsened in primary outcome variables at the end
(90th day)
Symptoms/
signs

Homoeopathy (n=140) n (%)

Improved
Status
Worsened
quo

Placebo (n=138) n (%)

Improved
Status
Worsened
quo

Chi square**

Bleeding

132 (94.3)

8 (5.7)

0 (0)

60 (43.5)

65 (47.1)

13 (9.4)

84.5

Pain

130 (92.9)

7 (5.0)

3 (2.1)

70 (50.7)

51 (37.0)

17 (12.3)

61.2

Heaviness

125 (89.3)

13 (9.3)

2 (1.4)

59 (42.8)

62 (44.9)

17 (12.3)

67.5

Discharge

70 (50.0)

68 (48.6)

2 (1.4)

35 (25.4)

81 (58.7)

22 (15.9)

29.4

Itching

115 (82.1)

23 (16.4)

2 (1.4)

66 (47.8)

48 (34.8)

24 (17.4)

40.6

**P value is highly significant at <0.0001, Improved: score became zero or decreased from baseline, status quo: Score remained same with baseline, worsened:
Score increased from baseline

in most of the outcome measures after 90 days.

This study was done at six centers in five states of
India, encompassing a population from various walks
of life in a primary healthcare setting. The findings
show a significant (P = 0.0001) symptomfree
state or improvement in virtually all haemorrhoidal
symptoms and physical, psychological, and
environmental domains of WHOQOlBREF after 90
days of treatment, having both internal and external
validity and creating a strong supportive evidence
for case reports of a lower evidence level.[1419]
78

The planned sample size was 250 with 50%

improvement in the placebo group and 70%
improvement in the homoeopathy group with a
power of 85%. The analysis supports the difference
of 20% which further gives strength to the study
design. On the other hand, advice about a fibrerich
diet and avoiding irregular bowel habits may
be the confounding factors but these practical
recommendations were required for patients to
adopt a healthy lifestyle as 83.8% of the patients,
irrespective of the intervention, were on a lower
Indian Journal of Research in Homoeopathy / Vol. 7 / Issue 2 / Apr-Jun 2013

Chakraborty, et al.: Homoeopathic LM potencies for acute attacks of haemorrhoidal disease

fibre diet before commencement of treatment and

might have adopted the changed lifestyle. So, the
improvement can be attributed to a change in lifestyle
also. Further, we find it inappropriate and unethical
to not instruct them and only to create control
groups. Our ethical committee too was against this
restriction. The investigators were trained to teach a
healthy lifestyle to all the patients. Another strength
was involvement of surgeons, who were responsible
for anoscopic scoring, adding credibility to the study.
One potential limitation of the study is lack of
investigator blinding which was not possible due
to the individualized nature of the intervention;
one could, therefore, argue that our results might
have been biased by a lack of sufficient blinding.
Although this bias cannot be ruled out, a major bias
seems unlikely to us because patients were informed
in a manner suggesting that two different types of
treatment would be compared. And, due to the nature
of dispensing, the homoeopathic medicine and placebo
were indistinguishable to the patient in taste and
colour, favouring homoeopathic clinical trials. Another
limitation of the study is advice for lifestyle changes,
which the investigators might have given differently to
the homoeopathic and placebo groups. These biases
can be removed in a doubleblind study design.
The results of our study shows improved benefit
of 93.4% in bleeding with no adverse events from
the homoeopathic therapy. There are at present no
studies in the homoeopathic field to compare these
findings; however, a doubleblind placebocontrolled
study by Mentes et al.,[25] with Calcium dobesilate
showed 86.2% success rate after two weeks of
treatment with few adverse events.
India is a country with a diverse population and with
52% people constituting a labor force occupied in
agriculture and 25% people below the poverty line.[28]
So, a therapy with no side effects for patients coming
to outpatient departments of dispensaries in the
primary healthcare setting will be immensely helpful.
This will cut the cost of medication as well as prevent
suffering from invasive techniques which can lead to
considerable side effects and complications.[48]

trials with doubleblind design are suggested further.

ACKNOWLEDGMENTS
The authors acknowledge Dr. R. K. Manchanda, Director
General, Central Council for Research in Homoeopathy
(CCRH) for his valuable support, consultant surgeons of
the respective centers for help in conducting physical
examination of the patients, Dr. Chetna Deep Lamba,
Research Officer (H) for verification of case records from
centers during the study, Dr. Syed Afsar Ali, Senior Research
Fellow, CCRH for verification of data before analysis, Dr.
R.M. Pandey, Head, Department of Biostatistics, All India
Institute of Medical Sciences, Ms. Maya Padmanabhan,
Statistical Assistant, CCRH for guidance in statistical
analysis, Dr. Debadatta Nayak, Research Officer (H), CCRH
for technical input, Ms. Bindu Shaji T for secretarial
assistance, and finally the patients for their participation
to make this study successful.

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How to cite this article: Chakraborty PS, Varanasi R,

Majumdar AK, Banoth K, Prasad S, Ghosh MS, et al. Effect of
homoeopathic LM potencies in acute attacks of haemorrhoidal
disease: A multicentric randomized single-blind placebo-controlled trial.
Indian J Res Homoeopathy 2013;7(2):72-80.
Source of Support: Nil, Conflict of Interest: None declared.

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80

Indian Journal of Research in Homoeopathy / Vol. 7 / Issue 2 / Apr-Jun 2013

I J R H

Original Article
Access this article online

Antidiabetic effect of Cephalandra indica

Q in diabetic rats

Website:
www.ijrh.org
DOI:
10.4103/0974-7168.116632
Quick Response Code:

Arindam Pal, Biswapriya B. Misra, Shibendu S. Das, Samiran S. Gauri,

Moumita Patra, Satyahari Dey

Abstract
Background: Diabetes mellitus is an emerging global epidemic, taking its toll in
developing countries as India. Presently, the treatment for diabetes using allopathic
drugs gives only a temporary relief. A combination of right medicine and potency, on
other hand has given Homoeopathy a high success rate in the treatment of this disease.
Objective: The aim of this study was to investigate the effects of Cephalandra indica
mother tincture and potencies on blood glucose level, cholesterol level, body weight,
and beta-cells of pancreatic islets of Langerhans, in streptozotocin (STZ)-induced
diabetic Wistar rats.
Material and Methods: Glucose uptake was monitored in mother tincture-treated
mouse fibroblast cell line. Diabetes mellitus was induced by intraperitoneal injection of
STZ (55 mg/kg body weight) in adult male rats. After three days of injection, diabetic
rats received mother tincture orally (750 L/kg body weight) daily for three weeks.
Results: There was a significant reduction of blood glucose level, regain of body
weight, and regeneration of beta-cells in the pancreas of the mother tincture-treated
rats. Mother tincture-treated 3T3 cells also showed reduced uptake of glucose in
comparison to normal cells.
Conclusion: The present study clearly indicates a significant antidiabetic effect of
Cephalandra indica and lends support for its usage as a homoeopathic medicine.

Department of Biotechnology, Indian

Institute of Technology Kharagpur,
Kharagpur, West Bengal, India
Address for correspondence:
Prof. Satyahari Dey,
Department of Biotechnology,
Indian Institute of Technology
Kharagpur, Kharagpur 721302,
West Bengal, India.
Email: [email protected]
Received: 02062013
Accepted: 29-07-2013

Keywords: Antidiabetic, Cephalandra indica mother tincture, Diabetes mellitus,

Wistar rat

INTRODUCTION
Diabetes mellitus (DM) refers to a group of common
metabolic disorders that share the phenotype
of hyperglycaemia arising as a consequence of
relative or absolute deficiency of insulin secretion,
resistance to insulin action, or both. The International
Diabetes Federation has estimated that the total
number of cases of diabetes would be about
350 million by 2030.[1] Hyperglycaemic conditions
result in increased glycosylation. This leads further
to biochemical abnormalities due to altered protein
structure which over a period of time develops
into diabetic complications such as nephropathy,
Indian Journal of Research in Homoeopathy / Vol. 7 / Issue 2 / Apr-Jun 2013

retinopathy, neuropathy, and cardiomyopathy.[2]

Pharmacotherapies for the treatment of diabetics
include oral hypoglycaemic agents and insulin. These
are however, not free from side effects.[3] The World
Health Organization (WHO) has recommended
the evaluation of traditional plants used for the
treatment of diabetics as they are effective, nontoxic
with fewer or no side effects, and are considered
to be excellent candidates for oral therapy.[4]
There are also several reviews on medicinal plants
possessing antidiabetic activity that have been used
as traditional medicines.[5,6]
The present study was carried out to evaluate
81

Pal, et al.: Antidiabetic effect of Cephalandra indica

the antidiabetic activity of Cephalandra indica

[mother tincture (MT) and potencies] belonging
to the family of Cucurbitaceae. The medicine is
used in biliousness, bilious complaints, poisonous
boils, abscesses, carbuncles, blood poisoning,
inflammation, and glandular swelling of the neck.
Cephalandra indica has been acknowledged for its
wound healing ability.[7] It also finds use in the
traditional system of Ayurveda to treat diabetes,
jaundice and dysentery.

Recording of body weight, blood glucose, and cholesterol

MATERIAL AND METHODS

Group VIII: Diabetic rat with 6C (C= Centicimal

Potency)

Sources of Reagents, Medicines, Model

Animals, and Cell Lines

All chemicals and reagents were purchased from

SigmaAldrich,
unless
mentioned
otherwise.
Cephalandra indica MT and potencies (6C, 24X, 12C
and 30C) were brought from Hahnemann Publishing
Company Private Ltd. (HAPCO), Kolkata. Healthy
male Wistar rats were procured from M/s SC Ghosh,
Kolkata. The rats were housed in polypropylene cages
and were maintained in ventilated caging (Citizen
Industries Ltd., India) conditions (temperature: 22
2 C, relative humidity: 57 10%, and 12:12 light:
dark cycle) at the Indian Institute of Technology,
Kharagpur. The rats were put on a standard diet
and had free access to water. The experiments were
performed after approval of the protocol by the
Institutional Animal Ethics Committee (IAEC) and
were carried out in accordance with the current
guidelines for the care of laboratory animals. Mouse
fibroblast 3T3 cells were purchased from the National
Centre for Cell Science, Pune, India. The cells were
maintained at the Indian Institute of Technology,
Kharagpur. The experiments were also conducted in
the Indian Institute of Technology, Kharagpur from
September 2009 to December 2011.

Design of Animal Experiments

Induction of diabetes mellitus

Diabetes mellitus was induced in healthy male Wistar

albino rats by a single intraperitoneal injection of
freshly prepared streptozotocin (STZ; in 0.1 M citrate
buffer pH 4.5) at a dose of 55 mg/kg body weight.
After three days of STZ injection, animals with fasting
blood glucose above 400 mg/dL were considered as
diabetic and included in the study. After three days
of injection, diabetic rats received MT/potencies orally
(750 L/kg body weight) daily for three weeks.
82

The animals were randomly assigned into following

groups and given the following treatments:
Group I: Normal control with citrate buffer
Group II: Placebo control (40% ethanol)
Group III: Normal rats with MT
Group IV: Diabetic control with 40% ethanol
Group V: Diabetic negative control without medicine
Group VI: Diabetic positive control with glibenclamide
Group VII: Diabetic rat with MT (75 L/ 100 g body
weight)
Group IX: Diabetic rat with 24X (X= Decimal Potency)
Group X: Diabetic rat with 12C
Group XI: Diabetic rat with 30C
Doses: Glibenclamide - 1mg/ kg body weight. 40%
ethanol, MT, 6C, 24X, 12C and 30C - 75 L/ 100 g
body weight. Data were recorded at the end of each
week for four weeks.
MT, placebo, and glibenclamide were administered
orally. Body weight, cholesterol, and blood glucose
analyses were done weekly on overnight fasted
animals. At the end of the experimental period, the
animals were sacrificed by cervical decapitation.
Organs like liver and pancreas were dissected,
immediately rinsed in liquid nitrogen, and stored at
80 C for further studies.
Determination of blood glucose and cholesterol

Blood samples were taken from the tail vein

[according to Guideline 9 (3/10/99) of the Institutional
Animal Care and Use Committee (IACUC)] before oral
administration of MT or the vehicle. Twentytwo
microliters of blood were used for each assay; the
glucose concentration was measured in plasma
serum with a glucometer (AccuChek Compact,
Roche). Cholesterol estimations were done
spectrophotometrically
(Chemito
Technologies,
India) using standard kits (Merck, India). Additional
analyses were done for crosschecking using
Transasia semiautomated analyzer.
Liver and pancreatic biopsy

Tissue specimens of the liver and pancreas of

STZinduced treated and untreated rats (stored at
80C) were fixed in Bouins fluid for 24 hours and
dehydrated through alcohol gradient series up to
absolute ethanol. These were transferred to xylene and
saturated with wax overnight for block preparation.
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Pal, et al.: Antidiabetic effect of Cephalandra indica

Microsections were cut and mounted on clean

slides at 37C. The sections were deparaffinized by
two changes in xylene, 10 minutes each time. The
sections were rehydrated by two changes in absolute
ethanol (5 minutes each) followed by passage through
95% and 70% ethanol for two minutes each time.
Finally, these were washed in distilled water. The
sections were stained in Mayers hematoxylin solution
(0.1%) for eight minutes. The stained sections were
washed in running tap water and finally rinsed
in distilled water. They were counterstained
in 1% Eosin Y solution for 45 seconds. The
doublestained sections were finally mounted
in dinbutylphthalatepolystyrenexylene (DPX)
mounting medium after following reverse dehydration
up to 100% ethanol. The sections were
photographed by an Olympus microscope, with
magnification 400.
Glucose uptake assay

The 3T3 cells were maintained in Dulbeccos

modified Eagles medium (DMEM) (Invitrogen, USA)
with 15 mM HEPES [HEPES: (4(2hydroxyethyl)1
piperazineethanesulfonic acid)] buffer supplemented
with 10% heatinactivated (30 minutes, 56C) fetal
bovine serum (FBS) (Invitrogen) and antibiotics (100
U/mL penicillin, 100 g/mL streptomycin, HiMedia).
They were incubated in a 5% carbon dioxide (CO2)
atmosphere incubator (Heracell 150i, Thermo
Fisher Scientific Inc., USA) at 37C. Subculturing
was done after the cells reached confluence
level by detaching cells from flasks using 0.25%
trypsin0.02% ethylenediaminetetraacetic acid (EDTA)
solution in a 1:4 splitting ratio. The cell viability was
measured using trypan blue (0.4%) dye exclusion
method and cells with >95% viability were used for
further experiments.
The 3T3 cells were incubated in serumfree
medium for a short period and then incubated
in
phosphatebuffered
saline
(PBS)containing
insulin. After washing, the cells were incubated
in PBS containing 2deoxyglucose and 2 mCi/mL
2deoxyD[3H/14C] glucose. 3Hglucose uptake was
detected using liquid scintillation counter (Beckman
Coulter, USA). About 5 106 cells were taken in
microcentrifuge tubes. The cells were centrifuged
at 250 g for five minutes. The supernatant was
discarded and 1 mL assay buffer (37C) was added
and recentrifuged to wash the cells. This step was
repeated thrice. Then 14C glucose was added into
the reaction mixture and incubated for 20 minutes at
37C. The reaction mixture was vacuumfiltered with
Indian Journal of Research in Homoeopathy / Vol. 7 / Issue 2 / Apr-Jun 2013

0.1 m porosity nitrocellulose filter membrane disc.

Then, 3 mL of ice cold assay buffer, 1mL at a time,
was added to wash by vacuum filtration. Thereafter,
3 mL icecold 5% trichloroacetic acid (TCA), 1 mL at a
time, was added to the filtration device and filtered.
After the liquid from the disc was totally filtrated, the
filter disc was dried in room temperature. The filter
discs were put in a liquid scintillation counting (LSC)
vial containing 3 mL of LSC cocktail and the count
was taken.

Statistical Analysis

Each data point represents the mean and standard

deviation of three samples. Analysis was performed
using a Students ttest designed by GraphPad
Software QuickCalcs. The significance and P values
are indicated in data tables.

Metabolite Profiling

Phenolics and terpenoids were isolated from MT

as mentioned elsewhere.[8] MT was extracted with
methanol (1:4 w/v). The extract was filtered and
dried to concentrate. The extract was then acidified
with 2N H2SO4 and further extracted with three
volumes of chloroform. The chloroform extract was
dried and used for analysis by High Performance
Thin Layer Chromatography (HPTLC) and liquid
chromatographymass spectrometry (LCMS).

Identification of Phenolics by HPTLC

The extracts were subjected to HPTLC[9] on a Linomat

5 (Camag, Switzerland) system using toluene: ethyl
acetate: acetic acid (3:1:1) as the mobile phase.
TLC silica gel 60 F254 plates (Merck, Germany)
with fluorescent indicator (254 nm) were used for
normalphase HPTLC and Rf value determination.
Each time, 20 l of the sample was spotted on the
silica gelcoated plates.
LCMS/MS analyses of extracted phenolics

LCMS/MS analyses were performed[10] using a

Waters 2695 separation module coupled with
Quattro microTM API mass spectrometer (Waters,
USA). The liquid chromatographic (LC) system
equipped with quaternary pump, online vacuum
degasser, autosampler and thermostatic column
compartment was connected to a photo diode
array (PDA) detector (model no: Waters 2998).
Data acquisition and analyses were carried out in
Waters MassLynx 4.1 software. The sample (10 uL)
was injected into the LC system by the autosampler
and separation was performed on a XTerra MS
C18 reversedphase column (2.1 100 mm
83

Pal, et al.: Antidiabetic effect of Cephalandra indica

Internal Diameter (ID), 5 um particle size, Waters).

The mobile phase comprised 0.1% aqueous formic
acid and acetonitrile 0.3 mL/minute, and column
temperature was maintained at 25C. All the
compounds were detected within the range of
230-360 nm in the PDA detector.
The LCeluted samples were introduced into the
electrospray ionization (ESI) source in a postcolumn
splitting ratio of 3:1. An ES source with negative
ionization mode (source block temperature: 130C,
desolvation temperature: 300C, capillary voltage:
3 kV, cone voltage: 30 V) was used for mass analysis.
The desolvation and cone gas were 650 and
50 L h-1, respectively. The data were recorded in
the MS scanning mode with a scan range of 100-600
(m/z); the scan time was 0.5 seconds, and interscan
delay time was 0.1 seconds.

RESULTS
Evaluation of Blood Glucose Levels

At the end of four weeks, blood glucose level

for the MTtreated animals was found to be
269 mg/dL, whereas rats treated with glibenclamide
showed a blood glucose concentration of
278 mg/dL [Table 1]. In comparison to diabetic
control animals (blood glucose level 486 mg/dL), this
is a significant reduction. MT therefore compares
very well with glibenclamide in therapeutic effect.
For all the potencies, the blood glucose levels
remained significantly higher (in the range of
390-485 mg/dL) and were therefore not effective
antidiabetically.

Variations in Body Weight

The body weight of the rats were measured every

week up to four weeks. Variations in body weight

Table 1: Measure of blood glucose level in diabetic rats

Group (#)

Before treatment
(mg/dL)

1st week
(mg/dL)

2nd week
(mg/dL)

3rd week
(mg/dL)

4th week
(mg/dL)

Normal control

864.2

883.3

864.4

882.1

874.2

Placebo control

783.3

8142

793.4

855.2

862.1

Normal rat with MT

892.2

903.2

895.5

914.2

914.2

Diabetic control with ethanol

957.2

48711.2

48613.2

39810.3

48610.7

Diabetic control without medicine

9311.1

48718.7*

48313.8*

48216.2*

47913.1*

Diabetic positive control with glibenclamide

905.2

36911.6

27215.6*

27613.1*

27810.2*

Diabetic with MT

916.2

21611.5*

22711.4*

2649.2*

2699.4*

Diabetic with 6C

872.2

38521.3

38411.2

48111.9

48510.2

Diabetic with 24X

911.9

38915.2

38712.5

39217.2

38413.2

Diabetic with 12C

921.7

39121.4

38712.2

38912.4

39014.7

Diabetic with 30C

944.3

38713.4

38214.2

40111.8

39717.2

(#) Each group with six rats as replica, Values have been rounded to the nearest integer; Data are mean of six replicatesstandard error (SE), *The result obtained
from the above test for MT and glibenclamide were found to be statistically significant (P<0.05) compared to that of diabetic control without medicine, MT: Mother
tincture

Table 2: Measure of body weight in diabetic rats

Group (#)

Before treatment (g)

1st week (g)

2nd week (g)

3rd week (g)

4th week (g)

Normal control

1161.2

1181.3

1161.4

1181.1

1171.2

Placebo control

1121.3

1131.2

1121.4

1121.2

1161.1

Normal rat with MT

1091.2

1101.2

1091.5

1111.2

1111.2

Diabetic control with ethanol

1151.2

871.2

861.2

851.3

861.7

Diabetic control without medicine

1131.1

871.7

831.8

821.9

791.9

Diabetic positive control with glibenclamide

1101.2

691.6*

721.6*

761.2*

781.2*

Diabetic with MT

1111.2

1161.5*

1171.4*

1141.2*

1191.4*

Diabetic with 6C

1101.2

851.3

841.2

811.9

851.2

Diabetic with 24X

1111.2

891.2

871.5

921.2

841.2

Diabetic with 12C

1121.2

911.4

871.2

891.4

901.7

Diabetic with 30C

1141.2

871.4

881.2

911.8

971.2

(#) Each group with six rats as replica, Values have been rounded to nearest integer; data are mean of six replicatesstandard error (SE), *The result obtained
from the above test for MT was found to be statistically significant (P<0.05) compared to that of diabetic positive control with glibenclamide, MT: Mother tincture

84

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Pal, et al.: Antidiabetic effect of Cephalandra indica

The serum cholesterol levels were not altered

significantly between treatment groups and control.
They all ranged within 183-234 mg/dL [Table 3].

diabetic rats. However, liver biopsies of MTtreated

diabetic rats showed a partial recovery [Figure 3].
Histopathology of normal rat pancreas is shown in
Figure 4. Pancreatic biopsy showed no recovery of
beta cells of the islets of Langerhans and interlobular
duct in untreated diabetic animals [Figure 5] whereas
MTtreated diabetic rats [Figure 6] showed maximum
recovery.

Liver and Pancreatic Biopsy of Normal,

Diabetic, and MTTreated Rats

Inhibition of Glucose Uptake in MTTreated

3T3 Cells

are presented in Table 2. In the treated animals, MT

resulted in regain in body weight to normalcy. The
glibenclamidetreated animals lost body weight to
the extent of 30%.

Evaluation of Serum Cholesterol

Tissue biopsy of treated and untreated rats showed

partial recovery of liver and islets of Langerhans for
MTtreated STZinduced diabetic rats. Figure 1 shows
the liver of normal rat with a prominent central vein
and symmetrical spokewheel appearance of other
veins. Figure 2 shows deformed liver of STZinduced

Experiments with radiolabeled glucose in cultured

3T3 cell line are presented in Table 4 and
Figures 79 show that both glibenclamide and MT
showed reduced count per minute (CPM), indicating
reduced glucose uptake in comparison to dimethyl
sulfoxide (DMSO)treated control.

Table 3: Measure of blood cholesterol level in diabetic rats

Group (#)

Before treatment
(mg/dL)

1st week
(mg/dL)

2nd week
(mg/dL)

3rd week
(mg/dL)

4th week
(mg/dL)

Normal control

1864.2

1883.3

1864.4

1582.1

1874.2

Placebo

1788.3

18142

1793.4

1855.2

1862.1

Normal rat with MT

1895.2

1903.2

1895.5

1914.2

2014.2

Diabetic control with ethanol

1957.2

20711.2

18613.2

19810.3

19610.7

Diabetic control without medicine

19311.1

19718.7

19313.1

18216.2

19913.1

Diabetic positive control with glibenclamide

1905.2

21911.6*

20211.6*

19613.1

19810.2

Diabetic with MT

2116.2

19611.5*

18711.4*

1849.2

1999.4

Diabetic with 6C

1875.2

21511.3

21411.2

21111.9

21514.2

Diabetic with 24X

1917.9

19915.4

21717.5

21217.2

21413.4

Diabetic with 12C

2028.7

22521.4

21312.6

21912.4

19015.7

Diabetic with 30C

1946.2

19712.4

20816.2

21111.1

21717.2

(#) Each group with six rats as replica, Values have been rounded to nearest integer; data are mean of six replicatesstandard error (SE), *The result obtained
from the above test for MT was found to be statistically significant (P<0.05) compared to that of glibenclamide, MT: Mother tincture

Figure 1: Simple microscopic image (400) of rat liver control, stained

with eosin

Indian Journal of Research in Homoeopathy / Vol. 7 / Issue 2 / Apr-Jun 2013

Figure 2: Simple microscopic image (400) of streptozotocintreated diabetic

rat liver; central vein and spokewheel appearance altered

85

Pal, et al.: Antidiabetic effect of Cephalandra indica

Figure 3: Si mpl e mic rosc op ic image ( 4 0 0 ) of MT t re at e d

streptozotocininduced diabetic rat liver, showing partial recovery

Figure 4: Histopathology of normal rat pancreas

Figure 5: Histopathology of pancreas of streptozotocintreated diabetic rats

showing altered islets of Langerhans and interlobular duct

Figure 6: Pancreas of streptozotocintreated rats also treated with MT;

picture shows partial recovery of the islets of Langerhans and interlobular duct

Figure 7: Blank 3T3 cells treated with radioactive glucose

Figure 8: 3T3 cells treated with glibenclamide with radioactive glucose

Metabolite Profiling

corresponding mass, as indicated within parentheses,

in MT but not detectable in the potencies.

The HPTLC and LCMS/MSbased phytochemical

analyses revealed [Figures 1012] the presence
of phenolics protocatechuic acid (154.9), gallic
acid (171.1), syringic acid (198.3), pcoumaric acid
derivatives (205.1), and gallocatechin (305.1), with their
86

LCMS/MSanalyzed phenolics in MT (m/z values in

parentheses) are as follows:
Protocatechuic acid (154.9)
Gallic acid (171.1)
Indian Journal of Research in Homoeopathy / Vol. 7 / Issue 2 / Apr-Jun 2013

Pal, et al.: Antidiabetic effect of Cephalandra indica

Figure 9: 3T3 cells treated with mother tincture with radioactive glucose

Figure 11: Highperformance thinlayer chromatography (HPTLC) of

Cephalandra indica mother tincture (1), 6C (2), 12C (3), 30C (4), and standard
phenolics (5)

Syringic acid (198.3)

pcoumaric acid derivative (205.1)
Gallocatechin (305.1)
Unidentified mass values 140.8; 386.9; 227.1
The fresh leaf extract had many more numbers of
known and unidentified phenolics (data not presented).
Table 4: Reduced glucose uptake in
MTtreated 3T3 cells

Experiment details

Only DMSO+14C glucose

CPM
5755171

Glibenclamide (100 M) in DMSO+14C glucose

66333

10 L MT+14C glucose

411089

Data are mean of 3 replicatesSE, MT: Mother tincture; DMSO: Dimethyl

sulfoxide, CPM: Count per minute

DISCUSSION
This investigation revealed that Cephalandra indica
Indian Journal of Research in Homoeopathy / Vol. 7 / Issue 2 / Apr-Jun 2013

Figure 10: Highperformance thinlayer chromatography (HPTLC) profile

of A) mother tincture and B) 24 dilution

Figure 12: Liquid chromatographymass spectrometry (LCMS) profile of

highperformance thinlayer chromatography (HPTLC) separated phenolics
from mother tincture.

MT is a potential antidiabetic medicine. The testing

of biological activities in vivo in rats and in vitro in
3T3 cell lines has indicated that Cephalandra indica
MT reduced the blood sugar level in diabetic rats
significantly and inhibited the uptake of radioactive
glucose, respectively. The partial recovery of altered
islets of Langerhans and interlobular ducts in the
pancreas of STZ and Cephalandra indica MTtreated
rats also support this observation.
Evaluation of antidiabetic activity of Cephalandra indica
MT was conducted in STZinduced diabetic rats. The
blood glucose level for diabetic rats untreated with
any drug reached up to ~485 mg/dL at the end of
the fourth week, whereas diabetic rats treated with
glibenclamide at a concentration of 1mg/kg body
weight showed a blood glucose concentration of
~278 mg/dL. The oral administration of MT for 28
87

Pal, et al.: Antidiabetic effect of Cephalandra indica

days (75 L/100 g) showed a much lower glucose

(~269 mg/dL) at the end of the fourth week. The
characteristic loss of body weight associated with
diabetes is due to increased muscle wasting or loss of
muscle proteins due to hyperglycaemia.[11,12]
The body weight of diabetic rats (secondary
complication resulting from diabetes) treated with MT
also did not show much variation, whereas those of
untreated and glibenclamidetreated rats decreased
considerably, suggesting that MT has a protective role
against muscle wasting. The body weight of diabetic
untreated rats decreased from ~115 to ~86 g,
whereas those of glibenclamidetreated rats decreased
from ~110 to ~78 g. Reports on the change in body
weight in diabetic rats treated with glibenclamide
and the extracts of antihyperglycaemic herbs varied
widely. In sandalwood oiltreated rats, the weight
gain was 59.2% above normal in rats treated with
vehicles, whereas glibenclamidetreated rats recovered
weight to the extent of 3.5% below normal.[13] In an
investigation, diabetic rats treated with Momordica
charantia (bitter melon, karela) showed an increase of
46% of body weight over control but no net gain of
body weight was observed for glibenclamide-treated
ones.[14] While comparing hypoglycemic activities of
Syzygium cumini (jamun) and Tinospora cordifolia (giloi)
to those of glibenclamide, all animals regained body
weight to the extent of 12% above normal rats.[15,16] In
fenugreektreated rats, there was no change in body
weight.[17]
Liver and pancreatic biopsy of the MTtreated rats
showed partial recovery in comparison to untreated
and glibenclamidetreated rats. Glucose uptake assay
also confirmed that MTtreated 3T3 cells uptake
less glucose in comparison to untreated cells. In
conclusion, the present study supported the use
of Cephalandra indica in the treatment of diabetes.
Cephalandra indica MT could reverse the effect of
STZinduced glucose levels indicating antidiabetic
activity. The antidiabetic activity may be due to
the restoration of liver and pancreatic tissue,
thus reducing the risk of secondary complications
associated with diabetes. Further detailed activity
of isolated molecules of Cephalandra indica MT
may unveil the constituents responsible for the
antidiabetic activity. The active constituents of
Cephalandra indica were identified by HPTLC and
LCMS. There were no terpenoids identified in MT,
whereas all other dilutions (6 to 30C) were found
88

to have nondetectable levels of active constituents.

Although specific molecules responsible for weight
increment in MTtreated rats were not identified,
it may be suggested that as MT is rich in phenolics
[Figures 1012]; these molecules may have a
contributory role, possibly by preventing protein and
lipid catabolism.
This is the first ever study on Cephalandra indica MT,
identifying several molecules in it. The results will
induce further research in exploring the usefulness of
specific molecules responsible for antidiabetic effects.
A systematic review on 108 clinical studies[17] on
wellknown herbs (used commonly in glycemic control)
such as ivy gourd (Cephalandra indica), ginseng, garlic,
tulsi, fenugreek, gurmar, karela, and aloe indicated
that all these herbs have efficacies similar to
conventional drugs. These investigations, however,
lacked uniformity with regard to experimental
design, methods, molecular constituents, and doses.
The evidence was therefore termed as preliminary
and warranted indepth study.
The efficacy of Cephalandra indica MT as an antidiabetic
homoeopathic medicine was reported[18] as early
as 1988. Pancreatic betacell regeneration was also
observed. Further progress through subsequent
research was not evident in the literature. The present
investigation on the same homoeopathic medicine,
using both in vivo and in vitro model experiments with
similar observations of reduced blood sugar levels
as well as STZ treatmentaltered central vein and
spokewheel appearance in the liver as well as islets
of Langerhans and interlobular duct in the pancreas,
and the treatments with MT toward partial recovery
of both, records a more concrete information for its
therapeutic role. Hypoglycaemic herbal constituents
reportedly have an insulinsecretagogue role in
stimulating skeletal muscles, preventing neurological
deficits, suppressing stressactivated protein kinase,
regenerating betacells in the islets of Langerhans, and
many phenolics compounds in them may modulate
signal transduction pathways.[19] Several antidiabetic
herbal products are available in the market globally. But
the United Kingdom has issued a warning in using such
medicines due to concerns over safe dosage and due
to lack of information on actual bioactive compounds.
This investigation revealed that Cephalandra indica
MT is rich in many phenolics that are important for
health care. On the whole, it is reaffirmed that the
efficacy of Cephalandra indica MT could be supported
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Pal, et al.: Antidiabetic effect of Cephalandra indica

by modern biological experiments as reported

here. Glibenclamide was reported as an antidiabetic
drug for typeII diabetes as early as 1966. But its
newer mechanism of action and usefulness were
established over the last 40 years,[20] establishing
it as an irreplaceable molecule. The only other
widely used alternative is metformin. It is therefore
imperative that more research must be promoted
for a greater market share of homoeopathic
medicines for important diseases like diabetes. As
homoeopathic medicines are much cheaper, this
effort will come as a boon to poorer sections of the
Indian population. In response to the increasing use
of complementary and alternative medicines, even
the rich nations like the United States (US Preventive
Services Task Force; American Diabetes Association
Guidelines) recommended more studies on Coccinia
indica (Cephalandra indica) based on encouraging
results from randomized controlled trials using
Cephalandra indica powder displaying insulinmimetic
properties of a magnitude similar to conventional
medicines.[17] Cephalandra indica, like Gymnema
sylvestre, has no side effects on liver and kidney.
One prerequisite for attracting the global market
for such lowcost medicine is specifying actual
bioactive compounds and their doses. This is likely
to boost the economic health of the manufacturers
of homoeopathic medicine in India.

ACKNOWLEDGMENTS
The authors thank the department of AYUSH, Government
of India, for the financial support for this investigation
through the extramural research scheme. They also thank
Dr. DS Bhar, HAPCO, Kolkata, for providing ultrahigh diluted
potencies.

REFERENCES
1. Kumar S, Kumar V, Prakash OM. Antidiabetic and hypolipidemic
activities of Kigelia pinnata flowers extract in streptozotocin induced
diabetic rats. Asian Pac J Trop Biomed 2012;2:5436.
2. Arky RA. Clinical correlates of metabolic derangements of diabetes
mellitus, In: Kozak GP, editors. Complications of diabetes mellitus,
Philadelphia: W.B. Saunders; 1982. p. 1620.
3. Bandawane D, Juvekar A, Juvekar M. Antidiabetic and

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antihyperlipidemic effect of Alstonia scholaris Linn bark

in streptozotocin induced rats. Indian J Pharm Educ Res
2011;45:11420.
Patel K, Srinivasan K. Plant foods in the management of diabetes
mellitus: Vegetables as potential hypoglycemic agents. Nahrung
1997;41:6874.
Day C. Traditional plant treatments for diabetes mellitus:
Pharmaceutical foods. Br J Nutr 1998;80:2038.
Mankil J, Moonsoo P, Hyun CL, YoonHo K, Eun SK, Sang
KK. Antidiabetic agents from medicinal plants. Curr Med Chem
2006;13:120318.
Ghose SC. Drugs of Hindoosthan. Kolkata: Hahnemann Publishing
Co. Pvt. Ltd.; 2003.
Harborne JB. Phytochemical Methods. 3rd ed. New Delhi: Springer
(India) Pvt. Ltd.;2005.
Pothala P, Dutta Majumdar D, Dey S. Phenylpropanoid profiling
in the elicited sandalwood culture. J Med Aromatic Plant Sci
2010;32:4326.
Mandal S, Dey S. LCMALDITOF MSbased rapid identification of
phenolic acids. J Biomol Tech 2008;19:11621.
Russell ST, Rajani S, Dhadda RS, Tisdale MJ. Mechanism of
induction of muscle protein loss by hyperglycaemia. Exp Cell Res
2009;315:1625.
Haldar PK, Kar B, Bhattacharya S, Bala A, Kumar RB. Antidiabetic
activity and modulation of antioxidant status by Sansevieria
roxburghiana rhizome in streptozotocininduced diabetic rats.
Diabetol Croat 2010;39:11523.
Misra BB, Dey S. Evaluation of in vivo antihyperglycemic and
antioxidant potentials of santalol and sandalwood oil. Phytomedicine
2013;20:40916.
Virdi J, Sivalami S, Shahani S, Suthar AC, Banavalikar MM, Biyani
MK. Antihyperglycemic effects of three etracts from Momordica
charantia. J Ethnopharmacol 2003;88:10711.
Prince PS, Menon VP, Pari L. Hypoglycemic activity of Syzigium
cumini seeds: Effect on lipid peroxidation in alloxan diabetic rats. J
Ethnopharmacol 1998;61:17.
Prince PSM, Menon VP. Hypoglycemic and other related actions
of Tinospora cordifolia roots in alloxaninduced diabetic rats. J
Ethnopharmacol 2000;70:915.
Yeh GY, Eisenberg DM, Kaptchuk TJ, Phillips RS. Systematic review
of herbs and dietary supplements for glycemic control in diabetes.
Diabetes Care 2003;26:127794.
Rastogi DP, Saxena AC, Kumar S. Pancreatic betacell regeneration:
A novel antidiabetic action of Cephalandra indica mother tincture. Br
Homoeopath J 1988;77:14751.
Joseph B, Jini D. Antidiabetic effects of Momordica charantia
(bitter melon) and its medicinal potency. Asian Pac J Trop Dis
2013;3:93102.
Luzi L, Pozza G. Glibenclamide: An old drug with a novel mechanism
of action? Acta Diabetol 1997;34:23944.

How to cite this article: Pal A, Misra BB, Das SS, Gauri SS,
Patra M, Dey S. Antidiabetic effect of Cephalandra indica Q in
diabetic rats. Indian J Res Homoeopathy 2013;7(2):81-90.
Source of Support: Department of AYUSH (Grant No.
1761/200910/CCRH/TECH/EMR/5759 dated 07.08.2009),
Government of India., Conflict of Interest: None declared.

89

Pal, et al.: Antidiabetic effect of Cephalandra indica

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orZeku esa e/kqesg ds mipkj esa ,yksiSfFkd nokvksa ds iz;ksx ls rks dsoy ,d vLFkk;h jkgr feyrh gSA nwljh vksj gksE;ksiSFkh
esa lgh nok vkSj iksVsUlh ds vuqdwy la;kstu ls bl jksx ds mipkj esa mPp lQyrk nj izkIr gqbZ gSA
mn~ns;% bl v/;;u dk ms; LVsVkstksVksflu ,lVhtsM& mRlkgh e/kqesg ihfM+r pwgksa esa lsQkysaMjk bafMdk dqanzq
enjfVapj vkSj mldh iksVsUlh dk] muds jDr kdZjk Lrj] dksysLVkWy Lrj] kjhj ds out vkSj ysaxjgsUl ds vXukk;
vkbysV~l dh chVk dksfkdkvksa ij gq, izHkko dh tkap djuk FkkA
lkexzh vkSj i)fr;k% enjfVapj mipkfjr QkbczksCykLV lsy ykbu jskdksjd dksfkdk oak ds Xywdkst mn~xzg.k ij utj
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e/kqesg ihfM+r fd;k x;kA batsDku nsus ds rhu fnuksa ds ckn] e/kqesgh pwgksa dks enjfVapj 750 ekbdzksfy-@fdxzk kjhj ds
otu rhu lIrkg ds fy, nSfud lsou djk;k x;kA
ifj.kke% enjfVapj ls mipkfjr pwgksa ds jDr kdZjk Lrj esa egRoiw.kZ deh ns[kh xbZ] kjhj dk otu iqu% c<+us yxk vkSj
muds vXU;kk; esa chVk dksfkdkvksa dk iqu% mRiknu gksus yxkA enjfVapj mipkfjr 3Vh3 dksfkdkvksa esa Hkh lkekU;
dksfkdkvksa dh rqyuk esa kdZjk dh de ek=k ns[kh xbZA
fudkZ% orZeku v/;;u ls ;g LiV gksrk gS fd lh- bafMdk dk e/kqesg izfrjks/ku esa egRoiw.kZ izHkko gksrk gS vkSj ,d
gksE;ksiSfFkd nok ds :i esa blds mi;ksx dh laHkkouk gSA

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I J R H

Case Report
Access this article online

Treatment of postburn hypertrophic scar

with homoeopathic medicine

Website:
www.ijrh.org
DOI:
10.4103/0974-7168.116634
Quick Response Code:

Bhopal Singh Arya, V. A. Siddiqui1, Rupali P. Dixit1

ABSTRACT
Hypertrophic scar (HSc) is a dermal fibro proliferative disorder that occurs following
trauma, inflammation, surgery, burns, and sometimes spontaneously. This is a case
report of a 23 year old male with post-burn HSc after acid burn injury on his left jaw.
The homoeopathic medicine Silicea was prescribed in 30th potency on the basis of the
totality of symptoms followed by repertorization; though only three doses of Silicea
were prescribed at baseline during the course of treatment followed by placebo, there
was a marked improvement in HSc as well as in associated complaints.
Keywords: Burn scar, Hypertrophic scar, Homoeopathy, Silicea

INTRODUCTION
Annually about two million people suffer from
various modes of burn injuries worldwide, of whom
more than a lakh die. In India, about 60,000 people
suffer from burns annually, more than 50,000 are
treated in hospitals, and about 10,000 succumb to
thermal injury. Every year, a substantial proportion
of deaths in India occur due to burn injuries.
Prolonged morbidity as well as temporary and
permanent disability due to burns results in a heavy
economic loss. Scarring secondary to burns leads
to a multitude of adverse medical consequences
including loss of function, restriction of joint
mobility, restriction of growth, altered appearance,
and adverse psychological effects.[1]
HSc scarring after burns remains a major problem and
is considered to be common. Although hypertrophic
scarring commonly occurs following burns, many
aspects such as incidence of and optimal treatment
for scar hypertrophy remain unclear.[2] Pressure
garments are commonly used as treatment even
though there is little sound data that they reduce the
prevalence or magnitude of the scarring.[3]
Indian Journal of Research in Homoeopathy / Vol. 7 / Issue 2 / Apr-Jun 2013

Homoeopathic Treatment
Center, Safdarjung Hospital,
1
Central Council for Research
in Homoeopathy, Headquarters,
NewDelhi, India
Address for correspondence:
Dr.V.A. Siddiqui,
Scientist4, Central Council for
Research in Homoeopathy, Hqrs,
NewDelhi, India.
Email:[email protected]
Received: 26042013
Accepted: 26-07-2013

Homoeopathic
medicines
like
Arnica
and
Staphysagria have demonstrated a significant role in
wound healing and cicatrization process, concluded
in a recent animal model study.[4] As per the
literature available, it is seen that homoeopathic
medicines had positive effects on scar resolution but
the scientific studies for showing its effectiveness
are rarely found. Acase report of post-burn HSc
is presented here with a positive effect of the
homoeopathic medicine Silicea in reducing the HSc.
This case is an attempt to document the usefulness
of homoeopathic treatment in post-burn scars.
An increasing number of such cases will create
an adequate database to enable a welldesigned
research study in this area.

CASE REPORT
A young male of 23years of age, an unmarried cloth
merchant, suffered from acid burn on the left side of
the face and left shoulder seven months previously
when walking on the road. It was 4.5% burn as
per the past reports of the Burn Department of
Safdarjung Hospital, NewDelhi. He was treated by
91

Arya, etal.: Post burn hypertrophic scar

allopathy with minimal improvement. Subsequently,

he developed HSc on the left jaw since one month.
He consulted at the outpatient department of
the Homoeopathic Treatment Centre, Safdarjung
Hospital, NewDelhi. Presenting complaints were
HSc post-burn scar since one month on the left jaw
with severe itching, worsening at night and during
perspiration. Pain was of a stitching type along with
marked redness of the region[Figure1].

Selection of medicine was based on totality of

symptoms of the patient and the final medicine was
selected after repertorization in consultation with
homoeopathic materia medica. Three doses of Silicea 30
were prescribed the first day followed by placebo twice
a day for 15days before the first followup. Placebo
was continued, as improvement continued after the
first followup. The following rubrics were selected for
repertorization(chart is attached in Table2):

The patient had a history of pneumonia in childhood

and was treated with conventional medicines. Family
history revealed nothing except filariasis in his
mother. The patient was thin and tall in appearance
with decreased thirst and appetite. He was habitually
constipated with constant desire for defaecation.
During physical and systemic examination, nothing
abnormal was found. He lacked confidence in his work.
When angry, he threw things. He sweated profusely
during the daytimespecially in morning leaving
white stains on his cloths; he had disturbed sleep till
midnight. In general, heat aggravated the patients
symptoms.

MINDANGERviolent
MINDCONFIDENCEwant of selfconfidence
STOMACHTHIRSTLESS
STOMACHAPPETITEdiminished
RECTUMCONSTIPATIONconstant desire
PERSPIRATIONPROFUSEmorning
PERSPIRATIONSTAINING the linen
PERSPIRATIONODOURoffensive
SLEEPSLEEPLESSNESSnightmidnightbefore
SKINCICATRICESpainfulstitching
SKINITCHINGnight
SKINITCHINGperspirationagg.

The Vancouver Scar Scale(VSS) , an internationally

accepted scale for assessing scars, was used
during pre and posttreatment assessment of
HSc in this case. VSS[Table1] consists of four
variables: Vascularity, height(thickness), pliability,
and pigmentation. In this case report, Patients
VSSwas used for the assessment of symptom
of Itching. Each variable has four to six possible
scores. The total score ranges from 0 to 16, where
score 0 reflects normal skin. VSS score of this
patient was 13 at baseline on October 23, 2010 and
this reduced to 2 on February 4, 2011 during three
months of followup with seven visits[Table1].
[5]

Figure1: Before the treatment

92

RESULTS
The patient was followed up on every 15thday and the
VSS score was filled after observation of the scar and
measurement of its height. The score reduced from
13 to 2 in three months of followup and showed
84.6% improvement(marked improvement) in the
scar[Figure2]. Followup schedule is shown in Table1
as per the VSS score. This result shows the usefulness
of the homoeopathic medicine Silicea in HSc. Redness,
itching, and height of scar are reduced as shown post
treatment[Figure2] after the prescription of Silicea
compared to the pretreatment stage[Figure1].

Figure2: After the treatment

Indian Journal of Research in Homoeopathy / Vol. 7 / Issue 2 / Apr-Jun 2013

Arya, etal.: Post burn hypertrophic scar

Table1: Followup chart as per vancouver scar scale

Sign/
Score
Symptoms at entry
231010

2nd visit
51110

Score at follow up visits

3rd visit 4th visit 51210 5th visit 151210 6th visit 301210 7th visit
201110
4111

8th visit
15111

Pigmentation Mixed
2

Mixed
2

Mixed
2

Hypopigmentation
1

Hypopigmentation
1

Hypopigmentation
1

Normal
0

Normal
0

Height

2-5 mm
2

2-5 mm
2

2-5 mm
2

2-5 mm
2

<2 mm
1

<2 mm
1

Flat
0

Flat
0

Pliability

Ropes
4

Firm
3

Yielding
2

Yielding
2

Yielding
2

Supple
1

Supple
1

Supple
1

Vascularity

Red
2

Red
2

Red
2

Red
2

Pink
1

Pink
1

Normal
0

Normal
0

Patients
VSS

Severe
3

Severe
3

Occasional Occasional itching

itching
2
2

Occasional itching
2

Sometimes itching
1

Sometimes Sometimes
itching
itching
1
1

10

Itchy
sensation
Total score

13

12

Treatment
schedule

Silicea 30
3 doses1
day;
placebo
BD15days

Improvement Placebo
started;
BD*15
placebo
days
continued

Placebo
BD15days

Placebo
BD15days

Placebo
BD15days

Placebo
BD15
days

Placebo
BD15
days

*BD: Twice daily,VSS: Vancouver Scar Scale

Table 2: Repertorization chart

Indian Journal of Research in Homoeopathy / Vol. 7 / Issue 2 / Apr-Jun 2013

93

Arya, etal.: Post burn hypertrophic scar

DISCUSSION AND CONCLUSION

It is known that Arnica is a useful remedy in injuries
and in after effects of injuries. In the literature
on burn cases, the usefulness of homoeopathic
medicines like Cantharis and Aconite is found.[6] One of
the studies conducted to see the effects of Cantharis
as an analgesic in 34cases of minor burn found that
Cantharis was effective in alleviating pain.[7]
Strong evidence of homoeopathic treatment for HSc
burn scar is not found in the literature, except in one
article by Dr.Foubister, Homoeopathy and Scar Tissue,[8]
where he discusses his experience and the comments
of stalwarts in such cases. In homoeopathic materia
medica, medicines like Graphites, Silicea, Nitric acid
and so on are described for use in scar dissolution.[6]
In this case report, the patient showed improvement
after the homoeopathic medicine not only in the
scar but also in other associated complaints; stools
became satisfactory, appetite and sleeping pattern
improved, and so on. Only three doses of Silicea 30
were prescribed at baseline during the whole period
of treatment. Pigmentation, height, vascularity,
pliability, and itching of HSc improved markedly with
the homoeopathic medicine.
In the conventional system, silicone gel or sheath are
used for the treatment of HSc;[9] coincidentally, in this
case, potentized Silicea was prescribed on the basis of
the totality of symptoms with marked improvement.
It is interesting to know that the silica as a substance
is useful in HSc scar treatment in a crude form like
gel as well as in homoeopathic potency. However,
phases of scar evolution can be protracted, and a
tremendous range exists between the time that a
scar becomes hypertrophic in the first few months
to the time that it completely resolves with little or
no treatment.[10] In this case report also, we cannot
exclude the chances of spontaneous resolution
of scar or resolution due to delayed response to
allopathic treatment. Though the homoeopathic
treatment has shown favourable results in this case,

in the future, randomized controlled trials with larger

sample size are required for validation of the effects
of the homoeopathic treatment.

ACKNOWLEDGMENTS
The authors express their heartfelt gratitude to the
former Director General Prof.(Dr.) C. Nayak and the
present Director General of the Central Council for
Research in Homoeopathy(CCRH), Dr.R. K. Manchanda
for their continued guidance and encouragement. They
also gratefully acknowledge the patient who cooperated
wholeheartedly during the treatment.

REFERENCES
1.

Meenakshi J, Jayaraman V, Ramakrishnan KM, Babu M. Keloid and

hypertrophic scar: A review. Indian J Plast Surg 2005;38:1759.
2. Bloemen MC, van der Veer WM, Ulrich MM, van Zuijlen PP,
Niessen FB, Middelkoop E. Prevention and curative management of
hypertrophic scar formation. Burns 2009;35:46375.
3. Bombaro KM, Engrav LH, Carrougher GJ, Wiechman SA, Faucher
L, Costa BA, et al. What is the prevalence of hypertrophic scarring
following burns? Burns 2003;29:299302.
4. Alecu A, Alecu M, Mrcus G. Effect of thehomoeopathic remedies
Arnica montana and Staphysagria on the time of healing of surgical
wounds. Cultura Homeoptica 2007;20:1921.
5. Draaijers LJ, Tempelman FR, Botman YA, Tuinebreijer WE,
Middelkoop E, Kreis RW, et al. The patient and observer scar
assessment scale: A reliable and feasible tool for scar evaluation.
Plast Reconstr Surg 2004;113:19605.
6. Boericke W. Pocket Manual of Homoeopathic Materia medica and
repertory. Rep. ed. New Delhi: B Jain Publishers; 1998.
7. Leaman AM, Gorman D. Cantharis in the early treatment of minor
burns. Arch Emerg Med 1989;6:25961.
8. Foubister DM. Homoeopathy and scar tissue observations on
the influence of certain potentized substance on scar tissue. Br
Homoeopath J 1975; 6064.
9. Van den Kerckhove E, Stappaerts K, Boeckx W, Van den Hof B,
Monstrey S, Van der Kelen A, et al. Silicones in the rehabilitation of
burns: A review and overview. Burns 2001;27:20514.
10. Atiyeh BS. Nonsurgical management of hypertrophic scars:
Evidancebased therapies, standard practices, and emerging
methods. Aesthetic Plast Surg 2007;31:46892.

How to cite this article: Arya BS, Siddiqui VA, Dixit RP. Treatment
of post-burn hypertrophic scar with homoeopathic medicine. Indian
J Res Homoeopathy 2013;7(2):91-4.
Source of Support: Central Council for Research in Homoeopathy,
Conflict of Interest: None declared.

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ds ipkr~ vkSj dHkh&dHkh Lor% gh gks tkrh gSA ;g 23 okZ ds ,d ,sls vkneh dh dsl fjiksVZ gS] ftls mlds ck,a tcMs+
ij ,flM ls tyus ls gqbZ {kfr ds ipkr~ ,p ,llh gks x, FksA laxzg }kjk vuqofrZr lay{k.kksa dh lexzrk ds vk/kkj ij
30 dh iksVsalh esa gksE;ksiSfFkd vkSk/k lhfyfl;k nh xbZA gkykafd] Iykflcks ds ckn ds nkSjku cslykbu ij lhfyfl;k dh
dsoy rhu [kqjkd nh xbZ Fkha ijarq ,p ,l lh esa vkSj blls tqM+h fkdk;rksa esa vPNk [kklk lq/kkj ik;k x;kA
94

Indian Journal of Research in Homoeopathy / Vol. 7 / Issue 2 / Apr-Jun 2013

I J R H

Reminiscences
Access this article online

Glimpses from the past, CCRH Quarterly

Bulletin review, volume 6(14), 1984

AUTHORS NOTE
Study of indigenous drugs has been one of the
major thrust areas of the Council, be it through
Drug Standardization, Drug Proving or Clinical
Verification. However, 30years hence, most of the
drugs studied continue to be underutilized by the
homoeopathic profession. Such vital research studies
need to be reposted through appropriate channels
for wider appreciation and knowledge sharing. The
following review is an attempt in this regard.

EDITORIAL
The Editorial of the issue begins on a thoughtprovoking
note, The applied science thrives on continuous
research, otherwise, it stagnates and dies. The
editor, Dr.V.P. Singh, lays down the importance of the
objective of the research in science. It highlights that
good results are outcomes of good research studies,
which in turn, are based on good objectives.

PROVINGS PLANNING AND PROTOCOL

The author Dr.V.M. Nagpaul reveals in this article
how provings provide knowledge about the
instruments that homoeopaths used in combating
human sickness. However, provings need a lot of
preplanning and laying of protocols to achieve
scientific validity. The author informs us that
Dr. Hahnemann gave credit to the physician Albrecht
Von Haller for observing before him the method
of proving drugs, to elicit their pure and peculiar
effects, by altering the sensorial condition of man.
However, credit goes to Hahnemann for enunciating
the fundamental theoretical basis of the proving
of drugs on healthy persons. The author then
Indian Journal of Research in Homoeopathy / Vol. 7 / Issue 2 / Apr-Jun 2013

Website:
www.ijrh.org
DOI:
10.4103/0974-7168.116637
Quick Response Code:

explains how the discovery of Homoeopathy took

place through the proving of the Cinchona bark by
Hahnemann. Ranging from aims and objectives of
homoeopathic proving to various elements of the
protocol, like investigators, volunteers, the test
substance, and its dosage, involved in a drug proving
process, the author explains the points succinctly
and lucidly. Other aspects of proving, like the time
scale for the process, nature of trials, precautions
to be observed, proforma layout and recording, as
also other legal and ethical considerations, are also
described in the article.
The author stresses upon the need for adequate
preplanning of a proving program, while warning
that an inappropriately planned proving might be
worse than no proving at all.

HOMOEOPATHIC REPERTORIAL INDEX FOR

EPILEPSY
Authors, Drs. V.P. Singh and Gulraj Kaur, share in
this feature a vital Repertorial Index for epilepsy.
Introducing the condition as more of a symptom
than a disease in itself, and its causes and features,
they mention the prevalence rate of the condition to
be about 0.5%, with a male to female ratio of 10:8,
with most patients having their first attack before
the age of 20. Touching upon the classification
of epilepsy and its general management and
conventional treatment, the authors then introduce
the objective of their article, that of indexing
the available data in the form of a homoeopathic
repertory, on the basis of pathognomonic or
nonpathognomonic(uncommon) symptoms, with
the view of offering to physicians a ready reference
for epilepsy cases. The authors take Kents and
95

Nayak and Kaur: CCRH quarterly bulletin review, volume 6(14), 1984

Boerickes repertories as the source material. Even

as the rubric convulsions, epileptic was taken from
Kents, Epilepsy was taken from Boerickes as a
reflection of the main pathognomonic symptom. The
related medicines were placed in alphabetic order,
with the gradings from each repertory remaining
intact. The denotations(K) and(B) were used for the
rubrics of Kents repertory and Boerickes repertory,
respectively. In all 27 common signs and symptoms
were considered, covering 125 medicines. This
laborious study was reflected in a comprehensive
chart published alongside.

Clinical Trials with Holarrhena

Antidysenterica and Glycosmis
Pentaphylla(Atista Indica): the
Indigenous Homoeopathic Remedies
The authors, Drs. B.N. Dutta and S. Das,
highlighted in the article, the usefulness of the
two drugs, Holarrhena antidysenterica and Glycosmis
pentaphylla (Atista indica), in amoebiasis and other
gastrointestinal disorders, by verifying some
earlier proven symptoms, and finding some new
symptoms during the trials. They also revealed
that the drugs were shortacting in nature
and more effective in Q and 3 potencies, in
repeated doses. Despite the fact that the utility
of these drugs in amoebiasis was known during
fragmentary proving by Dr.M. L. Sarkar(1973) and
Dr.K. K. Bhattacharjee(1917), these drugs were not
used in the homoeopathic profession due to lack of
authentic clinical verification data, which inspired
the authors to take up clinical trials on these drugs
at the Calcutta Unit of the Council during the period
1972-1977. Atotal of 77cases were enrolled, with
39cases of Holarrhena antidysenterica and 38cases of
Glycosmis pentaphylla. The cases were placed under
three groups, acute, chronic, and chronic with acute
exacerbations. The already available symptoms in
the literature were taken as the guiding symptoms
for selecting the drugs.
The results revealed that the majority of the cases
belonged to the age group of 1130years, and
most of them were chronic in nature. It was noticed
that the cases improved faster with Holarrhena
antidysenterica than with Glycosmis pentaphylla. The
authors concluded that the drugs had the power

96

to relieve various symptoms of amoebiasis and

other gastrointestinal disorders. Astriking feature
of Glycosmis pentaphylla that was revealed by the
authors was that it proved to be of great value in
cases of amoebiasis associated with itching around
the anus, passing of pin worms, and hyperacidity.

Preliminary Acute and Subacute Toxicity

Study of some Homoeopathic Drugs
Drs. K. P. Singh and P. N. Varma, in this article,
present the study of 13 homoeopathic drugs for their
preliminary acute and subacute toxic effects on 181
albino mice. These 13 drugs were, Acidum formicum,
Aegle folia, Azadirachta indica, Calotropis gigantea,
Cannabis indica, Cannabis sativa, Cassia fistula, Cuprum
oxydatum nigrum, Ficus religiosa, Hydrocotyle asiatica,
Solanum xanthocarpum, Thymol, and Tylophora indica.
Except for Thymol, which was used in 3 potency, the
rest of the drugs were used in the mother tincture
form(1). Of the 13 drugs, Calotropis gigantea
and Acidum formicum were found to be quite toxic,
resulting in the death of all the mice within six days.
However, Cannabis indica, Cannabis sativa, Azadirachta
indica, and Cassia fistula produced drowsiness, which
was more pronounced in the Cannabis group. As the
mice responded to the tactile stimuli, it was inferred
that the drugs had a tranquilizing effect rather than
them acting as a sedative. Aegle folia, Ficus religiosa,
Tylophora indica, and Thymol were found to be devoid
of any observable effect. In case of Cuprum oxydatum
nigrum, one mouse died, however, its death was not
considered to be related, owing to the fact that the
other mice who received higher concentrations of the
drug survived. Also, such mortality was noticed in a
control mouse given lactose alone on the same doses.
In case of Solanum xanthocarpum, it was found that
the drug prepared from berries or a whole plant,
using the percolation method, had a strong protective
effect against alcohol lethality, with five of the six
mice dying within six days. No mortality was noted
when the drug prepared solely from berries through
percolation was administered, whereas, only one
mortality was found when it was prepared from the
whole plant through the same method. However,
this protective effect against alcohol lethality was
less marked when the drug was prepared by the
maceration technique. The physicochemical study of

Indian Journal of Research in Homoeopathy / Vol. 7 / Issue 2 / Apr-Jun 2013

Nayak and Kaur: CCRH quarterly bulletin review, volume 6(14), 1984

the drug also indicated that the tincture prepared by

the percolation technique had higher alkaloid content.
The authors, in the end, caution against the use of
Calotropis gigantea and Acidum formicum in tincture
form and suggest a further study for the proving of
Solanum xanthocarpum for alcohol intoxication.

Sulphur(References of, in Kents

Repertory)
In a series of articles, the authors Dr.Vishal Chawla
and Dr.V. P. Singh wanted to reflect the various
rubrics related to Sulphur in Kents Repertory. In
this issue, such rubrics of Sulphur pertaining to the
chapters Nose, Face, and Mouth, are reflected
along with their gradations.

Abstracts
This bulletin covered 18 abstracts from international
publications on various aspects of diabetes.

The Bulletin Ends with a Beautiful

Quote by Sir Robert Platt
The conventional picture of the research worker is that of
a rather austere man in a white coat with a background
of complicated glassware. My idea of a research worker,
on the other hand, is a man who brushes his teeth on the
left side of his mouth only so as to use the other side as
a control and see if toothbrushing has any effect on the
incidence of caries.
Chaturbhuja Nayak, Harleen Kaur1

Director-Professor, Department of Materia Medica, Bakson Homoeopathic

Medical College and Hospital, Greater Noida and Former Director General,
Central Council for Research in Homoeopathy, New Delhi, 1Senior Research
Fellow (H), Central Research Institute for Homoeopathy,
Noida, Uttar Pradesh, India
Email: [email protected]

How to cite this article: Nayak C, Kaur H. Glimpses from the past,
CCRH Quarterly Bulletin review, volume 6 (1-4), 1984. Indian J Res
Homoeopathy 2013;7(2):95-7.
Source of Support: Nil, Conflict of Interest: None declared.

Author Institution Mapping (AIM)

Please note that not all the institutions may get mapped due to non-availability of the requisite information in the Google Map. For AIM of other
issues, please check the Archives/Back Issues page on the journals website.
Indian Journal of Research in Homoeopathy / Vol. 7 / Issue 2 / Apr-Jun 2013

97

I J R H

Book Review

Samuel Hahnemann: The Founder of Homoeopathy

Name of the book: Samuel Hahnemann: The Founder of Homoeopathy
Author: Robert Jutte
Language: Originally published in the German language. English translation by: Margot Saar
Published by: Robert Bosch Foundation, Germany. Available online at http://www.igm-bosch.de

The life history of Dr.Hahnemann has always

attracted historians and persons in the field of
medicine; the reason being the distinctive manner
and approach with which he discovered the
homoeopathic system of medicine. He had the
audacity to tell the medical world of his time that
they needed to be modest in their conduct and
approach in giving relief to the sufferer rather than
increasing their suffering, and that he could establish
this system of medicine, which today is considered
as the safest system of treatment.
There are many authors who have written
about his life, namely, Bradford(1895), Richard
Haehl(1922), Ross Waugh Waugh Hobhouse(1933),
Trevor M.Cook(2000), Fernando Dario
FrancoisFlores(2002), Prof.(Dr.) Diwan Harish
Chand, Dr.Pritha Mehra(2011) and so on. Each one
of these books provides glimpses of the personal
and professional life or his contributions in the field
of medicine. This book is the latest in the series
and is published by one of the most prestigious
institutes of Homoeopathy, the Institute for the
History of Medicine, run by the renowned Robert
Bosch Foundation, Germany. The research library in
this institute provides the homoeopathic archives
with the assets of Dr. Samuel Hahnemann and
his important pupils and successors. Thus, this
book is unique, as the information available is
Access this article online
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Website:
www.ijrh.org

98

wellresearched and authentic. The book had been

originally published in the German language and it
is good to have its English edition.
History of Medicine is one of the subjects that is
taught in most of the postgraduate medical colleges.
Whenever the name of Hippocrates comes, there
are narrations about him and his contributions.
Dr.Hahnemann holds the same respectful position
in the homoeopathic fraternity and it is crucial
that the generations to come should not forget his
contributions toward the betterment of mankind.
The book is divided into eight chapters. The first
chapter describes the status of the medical world
in the late eighteenth century and how the death
of the Austrian Emperor Leopold II raised questions
regarding the available standards of medical
treatment. Chapter two narrates the controversy
about the date of birth of Dr.Hahnemann, his
schooling, and his medical education. The third
chapter gives details about his voyage to twenty
odd places in Germany and also to parts of Europe,
for establishing his medical practice, and finally
settling at Torgau in 1805. During these 25years,
starting from 1780, he developed his skills, attained
knowledge and experience in the field of Chemistry,
Metallurgy, and so on. The minutest description of
his life has been narrated here.
The next six years, elaborated in the next chapter
are the most important, as this was the time when
he concentrated on his medical practice and started
documenting the cases he treated. It was for the first
time he brought out his concept of medicine in the
form of a booklet, Medicine of Experience. In this
tenure, he also conducted drug provings on healthy
human beings to bring out their therapeutic effects.
Indian Journal of Research in Homoeopathy / Vol. 7 / Issue 2 / Apr-Jun 2013

Book Review

This he overtly mentions in the book, Fragmenta de

viribus, which was equivalent to a pharmacopoeia at
that time, and was published in 1805. Subsequently,
he went a step ahead and started experimenting with
medicines after diluting them. In 1807, he used the
word Homoeopathy for the system of medicine he
found, and in 1810, the first edition of Organon was
published. This chapter also talks about the other
editions of Organon, certain important sections, and
the spirit behind their publication.
With a firm belief in the system of medicine that
he had discovered and to propagate it, he moved
to Leipzig, and thought of teaching this science to
academically trained physicians. How his vision came
true and what efforts he had put in are elaborated
in the fifth chapter of this book.
Court physician and pioneer of homoeopathy in
Kothen is the next chapter, which elaborates the next
fifteen years of his stay in Kothen. He got political
recognition as a physician and was allowed to practice,
prepare, and dispense homoeopathic medicines.
Although he was appointed as a privy councilor,
the challenges and troubles were not over and he
moved out of this place also. Another interesting
part that has been mentioned in this chapter is his
daily regimen, his eating habits, his likes and dislikes
regarding food, rather his own conviction about the
diet that he followed strictly, and also recommended
to his patients. His daily routine other than attending
the patients included wide correspondence. He
adhered to his routine till his old age.
It was interesting to note that he led a healthy life
and never suffered from any serious illness. In his
seventies also he looked young, as people who
met him have expressed his eyes betrayed the
scientist; they shine with youthful enthusiasm; his
features are sharp and animated. Furthermore,
having five editions of the Organon of Medicine
during his lifetime reflected that he was a real
researcher and always looked forward to improve
upon his studies.
In the sixth chapter, the turmoil that he faced in his
personal and professional life during this phase has
been illustrated and the interaction and contributions
of his followers and pupils is also reflected. He
analyzed his study in terms of success and failure
retrospectively and published a treatise on Chronic
diseases: Their nature and homoeopathic treatment,
in 1828, and introduced the theory of miasms. In 1831,
homoeopathy emerged as an established medical
Indian Journal of Research in Homoeopathy / Vol. 7 / Issue 2 / Apr-Jun 2013

discipline after combating the cholera epidemic and

his dream of establishing a homoeopathic hospital
and teaching institute came true.
The subsequent chapter talks about his life in
Paris with his second wife, the developments that
transpired in his life, and also his interaction with the
homoeopaths from world over and also politicians
in France. Many homoeopathic associations and
societies came up with the increasing popularity of
homoeopathy and Dr.Hahnemann was honored by
them at different occasions. His extensive medical
practice continued, along with scientific research
and publishing of his studies till his death.
The last chapter is titled, The Honor of a Monument:
The Hahnemann Cult. It reports the love, gratitude,
and admiration of homoeopaths all over the world
for the founder of homoeopathy. He is considered
to be undoubtedly the authority and exerted
power even from beyond the grave. Carl Orff
has expressed that, It is the best monument for a
physician if his work remains part of the repertoire.
The book has been well written with all the narrations
and original wordings by which one can feel that he/
she knows Dr.Hahnemann from the core. Although
the writing pattern is very interesting and one will
not get bored, yet it is suggested that a few pictures
of places, persons, writings, and so on, related to
him, may be incorporated. The font and spacing are
good enough for comfortable reading. All said and
done, this piece of work is worth reading and can be
downloaded free of cost from the virtual library at the
website of the Institute for the History of Medicine,
Robert Bosch Foundation(http://www.igmbosch.de).
This book is a source of reference reading for a
student, a professional, a physician, a historian or a
common man who is interested to know about the
life of a man who has inspired many.
There is a need to publish this book in print form,
with inclusion of the Preface or Introductory
chapter, which should give a brief about the
book and also how the references are to be read.
The referencing is very important and is to be
understood well so that one can go back to the
source from where the information has been
gathered.
R. K. Manchanda, Pritha Mehra1

Director General, Central Council for Research in Homoeopathy,

New Delhi, Research Officer (H), 1Central Council for Research in
Homoeopathy, New Delhi, India
E-mail: [email protected]
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