Research Protocol Homoeopathy in polycystic ovarian syndrome: A randomized placebo-controlled pilot study

Abstract

Background: Polycystic ovarian syndrome (PCOS) is an emerging health problem in young females characterized by ovarian dysfunction and hyperandrogenism. Existing information indicates a positive role of homoeopathy but more rigorous studies are desirable. This protocol has been developed to undertake a pilot study to evaluate the efficacy of homoeopathic intervention using established diagnostic criteria.
Methods/Design: It will be a multi-centric, randomized, placebo controlled pilot study with a 6-month intervention and follow up period. Minimum 60 cases fulfilling the eligibility criteria will be enrolled and randomized to receive either the homoeopathic intervention or the identical placebo. Both the arms follow lifestyle modification for weight reduction. Primary endpoint will be the establishment of regular menstrual cycle along with improvement in either ultrasonology or hirsutism/acne. Secondary endpoints will be to compare the changes in total and individual domain scores of PCOS questionnaire at monthly interval and the changes in ultrasound of polycystic ovaries. For the primary outcome and each of the secondary outcomes, both per protocol and modified intention to treat analysis will be done.
Discussion: This pilot study has been planned considering the varied presentation of PCOS as per international diagnostic criteria and accordingly the composite endpoints have been kept for evaluation. The outcome of this pilot study will help in planning a definite study.
Trial registration: CTRI/2013/09/003983 [Registered on: 16/09/2013].

Full text

Indian Journal of Research in Homoeopathy / Vol. 8 / Issue 1 / Jan-Mar 2014 3
ABSTRACT
Background: Polycystic ovarian syndrome (PCOS) is an emerging health problem in
young females characterized by ovarian dysfunction and hyperandrogenism. Existing
information indicates a positive role of homoeopathy but more rigorous studies are
desirable. This protocol has been developed to undertake a pilot study to evaluate the
efficacy of homoeopathic intervention using established diagnostic criteria.
Methods/Design: It will be a multi‑centric, randomized, placebo controlled pilot study
with a 6‑month intervention and follow up period. Minimum 60 cases fulfilling the
eligibility criteria will be enrolled and randomized to receive either the homoeopathic
intervention or the identical placebo. Both the arms follow lifestyle modification for
weight reduction. Primary endpoint will be the establishment of regular menstrual
cycle along with improvement in either ultrasonology or hirsutism/acne. Secondary
endpoints will be to compare the changes in total and individual domain scores of
PCOS questionnaire at monthly interval and the changes in ultrasound of polycystic
ovaries. For the primary outcome and each of the secondary outcomes, both per
protocol and modified intention to treat analysis will be done.
Discussion: This pilot study has been planned considering the varied presentation of
PCOS as per international diagnostic criteria and accordingly the composite endpoints
have been kept for evaluation. The outcome of this pilot study will help in planning a
definite study.
Trial registration: CTRI/2013/09/003983 [Registered on: 16/09/2013].
Keywords: Anovulation, Homoeopathy, Hyperandrogenism, Insulin resistance,
Oligomenorrhoea, Polycystic ovarian syndrome, Polycystic ovary syndrome
questionnaire
BACKGROUND
Polycystic ovarian syndrome (PCOS) is a complex
metabolic, endocrine and reproductive disorder
affecting approximately 5-10% of the female
population in developed countries. The developing
countries like China and India, undergoing rapid
nutritional transitions due to westernised diets and
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DOI:
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lifestyle also indicate similar prevalence (9.13%).[1,2]
Its clinical characteristics include hyperandrogenism,
chronic anovulation, insulin resistance and infertility.
While reproductive features are prominent, it
has potential for major metabolic consequences
including obesity, type2 diabetes and cardiovascular
disease.[3] It remains a syndrome and, as such, no
single diagnostic criterion(such as hyperandrogenism
RESEARCH PROTOCOL
Homoeopathy in polycystic ovarian
syndrome: A randomized
placebo‑controlled pilot study
Central Council for Research in Homoeopathy
Address for correspondence:
Dr. Raj K. Manchanda,
Central Council for Research in
Homoeopathy, New Delhi, India
E-mail: rkmanchanda@gmail.com
Received: 18-02-2014
Accepted: 19-02-2014
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Homoeopathy in polycystic ovarian syndrome‑A randomized placebo controlled pilot study
Indian Journal of Research in Homoeopathy / Vol. 8 / Issue 1 / Jan-Mar 2014 4
or PCO) is sufficient for diagnosis. It also remains
a diagnosis of exclusion. Known disorders such as
late-onset congenital adrenal hyperplasia that mimic
the PCOS phenotype should be excluded.[4]
Although there are more than 5,000 scientific
publications, majority relates to pathophysiology and
treatment of PCOS but assessment of psychological
impact has largely been ignored. Only recently has
the complexity of the symptomatology of PCOS
begun to be investigated in a comprehensive manner
to address the psychosocial implications. It has been
concluded that depression and anxiety are common
in patients with PCOS as compared with healthy
women. Depression in PCOS is often associated
with obesity and metabolic abnormalities.[5,6] The
depression and anxiety did not show a significant
change in PCOS after treatment with oral
contraceptive pills.[7] Homoeopathic prescription
being holistic might help in these aspects, hence,
polycystic ovary syndrome questionnaire (PCOSQ),
which evaluates emotional aspects along with body
hair, weight, infertility and menstrual problems for
the assessment of quality of life is being used in the
study.[8]
Lifestyle modification is the first line of treatment
and it is known that even 5-10% weight loss
has led to significant clinical benefits improving
psychological outcomes, reproductive and metabolic
features.[9,10] In conventional medical system,
metformin, oral contraceptives, anti-androgens,
clomiphene citrate and thiazolidinediones are used
for the management of different presentations of
PCOS. Metformin is commonly used either alone
or in combination with other medicines for the
treatment of most of the clinical manifestations
of PCOS.[11] In a study, metformin reduced
hyperinsulinaemia and hyperandrogenaemia,
independently of changes in body weight. In a large
number of subjects these changes were associated
with striking, sustained improvements in menstrual
abnormalities and resumption of ovulation[12] but
it causes gastrointestinal intolerance (nausea,
abdominal pain and/or diarrhoea) in 30% of patients.
It is contraindicated in liver disease and certain
other clinical conditions. Other medicines also have
their side effects.[11]
There are few reports indicating the usefulness
of homoeopathic treatment. Sanchez et al.,[13] and
Gupta et al.,[14] reported symptomatic as well as
ultrasonological improvement but more studies are
required with proper rigor. Council has developed
this protocol for a pilot study. The primary objective
of the study shall be to determine the feasibility of
the study to evaluate the efficacy of homoeopathic
intervention in PCOS in establishing the menstrual
regularity with either ultrasonological improvement
of PCO or improvement in hirsutism/acne and the
secondary objective shall be to assess the changes
in ultrasound reports of polycystic ovaries and
to assess the changes in the total and individual
domain scores of PCOSQ.
METHODS/DESIGN
Study Design
The study shall be multi-centric, randomized,
placebo controlled with 6-month intervention and
follow up period.
Eligibility Criteria
The inclusion criteria for the study are:
(1) female aged 18-36 years (2) oligomenorrhoea
(intermenstrual period of more than 35 days for 3
consecutive cycles)/ amenorrhoea for more than
3 months (2 years after menarche)(3) ultrasound
findings of polycystic ovaries [The PCO should
have at least one of the following: either 12 or
more follicles measuring 2 ± 9 mm in diameter
or increased ovarian volume (>10 cm3). If there
is evidence of a dominant follicle (>10 mm) or a
corpus luteum, the scan should be repeated during
the next cycle. Only one ovary fitting this definition
or a single occurrence of one of the above criteria is
sufficient to define the PCO.[15](4) clinical evidence
of hirsuitism (Ferriman score 8 and above)[16] and/
or acne (acne global severity scale score 1 and
above)[17]; (5) Body Mass Index (BMI) 23 and above
(6) participants willing to adopt healthy diet and to
take regular exercise(at least 30minutes of exercise
for at least 5 days a week) (7) written informed
consent from the patient.
The exclusion criteria includes: (1) diabetes
mellitus, Cushing’s disease, hyper-prolactinemia;
(2) untreated hypo or hyperthyroidism (3) adrenal
hyperplasia and adrenal tumour (4) ovarian
tumour (5) hyperthecosis (6) significant renal
impairment (7)history of intake of drugs aldactone/
metformin or history of oral contraceptive pills
(OCP) use or intake of drugs known to interfere
with carbohydrate metabolism 4 weeks prior to
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Homoeopathy in polycystic ovarian syndrome ‑A randomized placebo controlled pilot study
Indian Journal of Research in Homoeopathy / Vol. 8 / Issue 1 / Jan-Mar 2014 5
enrolment (8) pregnancy, breast feeding (9) cases
with any systemic disease.
The patients presenting with PCOS will be
screened for eligibility and will undergo pelvic
ultrasound, complete blood count with erythrocyte
sedimentation rate, fasting glucose, thyroid
function test, serum prolactin, basal morning
17α-hydroxyprogesterone (17OHP), complete urine
examination and urine pregnancy test in case
of married women with amenorrhoea prior to
enrolment.
Types of Intervention
Patients fulfilling the eligibility criteria will be
enrolled and randomized as per computer generated
randomization chart[18] to receive either the
homoeopathic intervention or the identical placebo
as illustrated in Figure 1. Medicine shall be given
in Q, 6C, 30C, 200C or 1M potency as per the
prescribing totality. Mother tincture shall only be
prescribed in persistent amenorrhoea. The medicine
will be repeated depending on the potency and
complaints of the patient in accordance with the
principles of homoeopathy.[19] All the participants
will be asked to follow healthy diet and to take up
regular exercise (at least 30 minutes of exercise at
least 5days a week).
Criteria for Baseline Assessment and Follow Up
All the enrolled subjects will undergo complete
case taking along with clinical examination,
baseline investigations for sex hormone binding
globin, Luteinizing Hormone/Follicle Stimulating
Hormone (LH/FSH) ratio, total Testosterone,
Dehydroepiandrosterone sulphate (DHEAS), serum
insulin, glucose insulin ratio, triglycerides and
High-Density Lipoprotein (HDL)-cholesterol at
baseline and shall fill PCOSQ.
Patient will be assessed at monthly intervals (or
earlier as per the need) for 6 months. Symptomatic
assessment and clinical examination will be
done every month and PCOSQ will be filled. Any
inter-current complaint arising during the treatment
period is to be managed as per the acute totality
in both the groups. Prescription will be changed
and selection of the medicine will be based on the
characteristic symptoms including exciting cause,
mental and physical generals and qualified particular
symptoms modified as a consequence of acute
disease. Previously prescribed medicine/placebo is
to be discontinued as per the need of the case till
acute phase is over. Record of any such event is to
be maintained in follow up sheet for acute phase.
If the case does not respond to the homoeopathic
intervention, patient shall be referred accordingly
for the conventional treatment. The patient will be
encouraged to revert back after the acute phase
gets over. Such cases will be followed up as per the
protocol subsequently.
At completion of the study, symptomatic assessment,
clinical examination and pelvic ultrasound will
be done. All patients will fill PCOSQ. Only those
investigations will be repeated at 6 months, which
were out of range at baseline.
Study Endpoints
Primary study endpoint is the establishment of
regular menstrual cycle along with either ultra
sonological improvement of PCO or improvement
in hirsutism/acne. Secondary study endpoints are
to compare the changes in total and individual
domain scores of PCOSQ(consists of five domains,
each relating to a common symptom of PCOS;
emotions, body hair, weight, infertility and menstrual
problems. Each question on the PCOSQ is associated
with a 7-point scale in which 7 represents optimal
function and 1 the poorest function) in verum and
placebo groups at monthly interval for 6 months
and to compare the changes in ultrasound reports
of polycystic ovaries at entry and 6months in verum
and placebo groups.
Randomization
Separate sets of random numbers have been
generated for the two study sites(each site is strata)
using stratified randomization method.
Allocation
The patients fulfilling the eligibility criteria shall
be enrolled and randomized as per computer
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Figure 1: Flow chart of the study groups
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Homoeopathy in polycystic ovarian syndrome‑A randomized placebo controlled pilot study
Indian Journal of Research in Homoeopathy / Vol. 8 / Issue 1 / Jan-Mar 2014 6
generated randomization chart to receive either the
homoeopathic intervention or the identical placebo.
Blinding
The patients will remain blinded to the identity of
the treatment group.
Sample Size Calculation
In the initial stage of the study, 30cases of PCOS
in verum and 30 cases in placebo group shall be
enrolled. After the analysis of the data, the sample
size shall be revisited and according to the outcome
of this study, further study shall be continued or
discontinued.
Study Duration
The duration of the study will be 2years(1year for
enrolment, 6months for follow up and 6months for
data compilation).
Data Collection
Each case will be followed up for 6months to assess
the outcome results of the treatment. Study data will
be collected at baseline, every follow up(monthly or
early if required) and at final/termination visit. The
patients will be evaluated for symptomatic, clinical
assessment, laboratory parameters and adverse
events, if any, as per the study protocol.
Statistical Analysis
Data obtained during the study would be verified
and analyzed using Statistical Package for Social
Sciences(SPSS) version20. Chisquare test shall be
applied for checking the improvement in menstrual
cycle and acne. Pre and post analysis (paired t
test) shall be applied for checking the changes in
hirsutism, ultrasound assessment of ovaries and
laboratory investigations. Repeated measure analysis
of variance(ANOVA) and pre and post analysis(paired
t test) shall be applied for checking the difference
in the total score and individual domain score of
PCOSQ. Hereditary factor, socio-economic status,
stress, etc., would be considered as potential
confounders in PCOS.
For the primary outcome and each of the secondary
outcomes, both per protocol and modified intention
to treat (mITT) analysis will be done. mITT analysis
will be done on the patients completing a minimum
of three scheduled follow up visits.
Regulatory and Ethical Approval
The study protocol is in accordance with the latest
revision of the Helsinki declaration[20] on human
experimentation and Good Clinical Practices India.[21]
Although, medicines proposed to be used during
the study are known homoeopathic pharmacopoeal
preparations, yet necessary clearance of the Ethical
Committee and Scientific Advisory Committee has
been obtained before undertaking the study.
DISCUSSION
As the PCOS is a multi-faceted problem with
reproductive, endocrine and metabolic dysfunction;
therefore, the study has been planned keeping
in view the multi-factorial evaluation of the
intervention. Accordingly, to establish the diagnosis
of PCOS, the criteria laid down by 2003 Consensus
Statement on PCOS[4] and 2006 Androgen Excess
Society have been followed.[22] It is reported that
Lifestyle modification should be the first line of
treatment and is effective in reducing the signs and
symptoms of PCOS,[13] therefore, the study has been
designed as placebo controlled trial with both the
arms following Lifestyle modification so that the
effect of Lifestyle modification and homoeopathy
can be evaluated.
As the investigations are only suggestive and not
fully confirmatory, therefore, the outcome will be
assessed on composite endpoints, namely, menstrual
regularity, ultrasonological improvement of PCO[15]
and hyperandrogenism (hirsutism and/or acne as
per Ferriman–Gallwey scoring system[16] and/or
acne global severity scale[17]). PCOSQ, a validated
questionnaire, will be used for evaluation of quality
of life in cases of PCOS.[8]
Conventional treatment varies as per the symptoms
and also has some side effects. Studies in
homoeopathy[14,15] have indicated a positive role
but these studies primarily evaluated menstrual
irregularity and PCO through ultrasonography.
Hyperandrogenism and effect of Lifestyle
modification was not evaluated and statistical rigor
was also lacking. Due consideration has been given
to all these aspects while drafting this protocol.
High quality protocols facilitate proper conduct,
reporting and external review of clinical trials. This
study protocol is in accordance with the SPIRIT
2013[23] and covers all the domains of model validity
of homoeopathic trials (MVHT).[24] The protocol
shall generate data that can be reported as per
CONSORT guidelines for reporting randomised trials
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Homoeopathy in polycystic ovarian syndrome ‑A randomized placebo controlled pilot study
Indian Journal of Research in Homoeopathy / Vol. 8 / Issue 1 / Jan-Mar 2014 7
with parallel groups[25] and the Reporting data on
Homoeopathic Treatments (RedHot) supplement
to CONSORT.[26] The overall risk of bias appears
to be minimal as only one domain (allocation
concealment) out of six has high risk of bias.[27] The
study is not double-blind due to nature of disease,
which may require multiple prescriptions in
different potencies depending on the presentation,
and moreover the outcome measures are not likely
to be influenced by lack of blinding. The outcome
of this pilot study will help in planning a definite
study subsequently.
Trial Status
Participant recruitment has been initiated in
February 2014.
CONTRIBUTIONS
Study concept and design: Raj K. Manchanda, 1Chetna Deep Lamba
Expertise: 2Madhu Aggarwal, 3Neelam Aggarwal, 4Ajay Ajmani,
5Ravindra Mohan Pandey
Coordination: Raj K. Manchanda, 1Chetna Deep Lamba, 6VikramSingh,
7Anil Khurana, 8Jaya Gupta, 8PraveenOberai
Statistical planning: 9Maya Padmanabhan, 1Chetna Deep Lamba
Drafting of protocol with ethical and technical approval: 1Chetna Deep Lamba
Drafting and revision of manuscript: 1Chetna Deep Lamba
Critical review of manuscript: Raj K. Manchanda
Funding/ Support: Central Council for Research in Homoeopathy.
Contributor’s information
Director General, Central Council for Research in Homoeopathy
1Scientist-1, Central Council for Research in Homoeopathy
2Professor and Head, Dept. of Obstetrics and Gynaecology,
Dr. B. R. Sur Homoeopathic Medical College and Hospital, New Delhi
3Senior Consultant, Dept. of Obstetrics and Gynaecology, Post Graduate
Institute of Medical Education and Research, Chandigarh
4Senior Consultant, Dept. of Endocrinology, BLK Super Specialty Hospital,
New Delhi
5Professor and Head, Dept. of Biostatistics, All India Institute of Medical
Sciences, New Delhi
6Former Deputy Director (H), Central Council for Research in Homoeopathy
7Assistant Director (H)/ Scientist-4, Central Council for Research in Homoeopathy
8Scientist-4, Central Council for Research in Homoeopathy
9Statistical Assistant, Central Council for Research in Homoeopathy.
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Homoeopathy in polycystic ovarian syndrome‑A randomized placebo controlled pilot study
Indian Journal of Research in Homoeopathy / Vol. 8 / Issue 1 / Jan-Mar 2014 8
i`’BHkwfe% cgqiqfVd fMEcxzfUFk flUMªkse ¼ihlhvks,l½ ;qofr;ksa esa ,d mHkjrh gqbZ LokLF; leL;k gS tksfd fMEcxzfUFk f”kfFkyrk o mPp ,UMªkstsu }kjk
fpf=r dh tkrh gSA ekStwnk lwpuk bl leL;k esa gksE;ksiSFkh dh ldkjkRed Hkwfedk dh vksj ladsr djrh gS] ysfdu vkSj vf/kd dBksj v/;;uksa
dh vko”;drk gSA ;g izksVksdksy LFkkfir uSnkfud ekun.Mksa dk iz;ksx dj gksE;ksiSfFkd gLr{ksi dh izHkkfork dk vkdyu djus ds fy;s ,d
ik;yV v/;;u “kq: djus ds fy;s fodflr fd;k x;k gSA
fof/k% ;g N% ekg ds gLr{ksi o vuqlj.k dky ds lkFk cgqdsfUnd] ;kn`fPNd] Iykflcks fu;fU=r ik;yV v/;;u gksxkA ik=rk ds ekin.Mksa dks
iwjk djus okys de ls de 60 ekeyksa dks ukekafdr fd;k tk;sxk vkSj mudks ;k rks gksE;ksiSfFkd gLr{ksi ;k Iykflcks ds fy;s ;kn`fPNr fd;k
tk;sxkA nksuks gh “kk[kk;sa thou “kSyh la”kks/ku dks Hkkj de djus ds fy;s vuqlj.k djsaxhA izFke vUrfcUnq ;k rks vYVªklksuksyksth ;k eq¡gkls esa
lq/kkj ds lkFk fu;fer ekfld /keZ LFkkfir djuk gksxkA f}rh; vUrfcUnq ihlhvks,l iz”u i= ds dqy o O;fDrxr vuq{ks= Ldksj esa ifjorZuksa
dk ekfld vUrjky o cgqiqfVd fMEcxzfUFk;ksa esa vYVªklkm.M ifjorZu esa rqyuk djuk gksxkA izFke ifj.kke o izR;sd f}rh;d ifj.kkeksa ds fy;s]
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How to cite this article: Central Council for Research in
Homoeopathy. Homoeopathy in polycystic ovarian syndrome:
A randomized placebo‑controlled pilot study. Indian J Res
Homoeopathy 2014;8:3‑8.
Source of Support: Nil, Conflict of Interest: None declared.
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files/uploads/Risk%20of%20bias%20assessment%20tool.pdf [Last
accesseddateon2012Dec09].
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