SU M M A R Y

Background: Consumers want to know the recent evidences on Ayurveda treatments

despite of over 10,000 written volumes (Bhagel MS 2009). Progress in any discipline of

science often judged by the number of publications (Arunachalam S 2002). English

language journals always highlight the difficulty in locating research publication on

Ayurveda. Unpublished research works (e.g. theses) and journal volumes are scattered all

over India denying easy accessibility. Since funding agencies list the name o f projects that

they support there ought to have many publication on Ayurveda. However no attempts were

made to systematically search and collect research publications on Ayurveda. This helps to

conduct systematic reviews and offer recommendations for patient treatment and further

research .

Objective:

1. To develop a search strategy to identify vast majority o f published and

unpublished clinical studies in any subject on Ayurveda

2. To develop structured protocol to conduct systematic reviews on research

publications to recommend on treatment & further research

3. To E-publish search methodologies, protocols, systematic reviews and journal

abstracts

Methods: The first meeting of Local Project Advisory Committee (LPAC) decided to

structure a model to implement the project objectives over one disease: Switra (called

Vitiligo or Leucoderma).

The project was implemented in three steps:

1. Developed protocol and search strategy to identify research publications

2. Conducted systematic review o f pooled research works. Recommendations are

made on the basis o f available publications for evidence based treatment of

Switra

3. E published the outcome o f project work with a scope to expand the database

to provide easy access to the information on evidence based treatment in

Ayurveda.

We searched all articles (1975-2008) pertaining to one disease: Switra. The Protocol was

developed ( Page No 74 to 111) .We are grateful to Prof Shreekumaran Nair (Manipal),

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Dr. Unnikrishnan (Mangalore ) and Dr. Muralidharan (Kasaragod) for their continuous

guidance during protocol development .

Search strategy to identify research works included developing a PICO table (Page No

41) listing controlled vocabulary of Sanskrit ( AyuSH - Ayurveda Subject Headings) as key

words (Page no 207)

Hand Searching was achieved the through Baghel MS (2006). During the search strategy

we had to list the databases that host Ayurveda articles. At this stage search strategy

was supported by search option and descriptions o f various web sites (page No 39). We

also visited the offices o f a few of them to learn on their experiences.

Pooled research publications were reviewed independently by PI- allopathy (Dr. S R

Narahari) and SRF - Ayurveda (Dr. Guruprasad Aggithaya). Both attempted to extract the

data through integrated data extraction sheet ( Page No 104). A standard methodology

article against which the reviews could be compared did not exist. Hence at this stage

we synthesized clinical trial methodology out o f Ayurvedic principles and structured that

using CONSORT model.

Based on the review a questionnaire was developed to assess the knowledge level of

Ayurveda investigators. This was sent to four referees. The questionnaire was then further

improved through pre-testing in two Ayurveda Medical colleges: SDM College Udupi,

Karnataka (Dr. Muralidhara Sharma & Colleagues), Parassinikkadavu Ayurveda Medical

College, K.annur, Kerala (Dr. Rashmitha & Colleagues). This questionnaire was sent through

email (1631) and by post (445). 58 investigators participated. (Page No 308)

Summary of the project activities are then E-published

(www.systematicreviewinayurveda.org)

Results:

41 databases were identified that host authentic research publication from Ayurveda.

Baghel MS (2006) listed 71 theses works on Switra in 27 institutions. This formed 0.9 %

o f total theses work all Ayurveda Medical Colleges in the country during 1975-2008.34

Articles were identified in 41 databases and 64% could be procured. We could procure 32.4

% o f theses on Switra. Many studies identified in Ayurveda Medical Colleges could not be

procured despite a personal visit or sending an emissary. 112 combinations or single

formulations to treat Switra were listed from classical literature. 39 of them were studied

through 24 clinical trials till 2008. Each o f 39 medicines has undergone only one trial. Most

o f them had methodological issues and o f small sample size. Case series studies were eleven.

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Five trials used industrial products that are not described in classical Ayurveda. One

classical formulation (Katuki) was used along with biomedical drugs. This was classified

as integrative medicine trial. Details o f the trials conducted and medicines used are

described in tables (Page No 278)Trials on industrial products gave no details on

conducting mandatory preclinical tests. 20.7 % studies performed after 2000 AX) obtained

ethical approval.

A questionnaire based assessment o f knowledge level of investigators on Ayurveda was

done . 58 responses were obtained from 2076 people contacted. 60% did not know the

correct method of literature search. None developed a search strategy. They frequently

accessed PUBMED for research studies. None mentioned Baghel MS (2006) for hand

searching. Percentage of incorrect answers to important issues in clinical trials were listed

( Page No316, Table no 4) 74% o f investigators on Ayurveda who receive grants for their

research did not receive training for research.

Discussion: Kessler C, Hannover Medical School, Germany observed that many Ayurvedic

publications are retrievable only by hand search as a comprehensive electronic database for

Ayurvedic publications do not exists. Popular western databases such as PUBMED and

CAM databases list only a small number o f Ayurvedic studies. Ayurvedic systematic reviews

often quote CCRAS database to search for publications. Two systematic reviews on vitiligo

published from Europe did not contain any Ayurveda research papers. Western scientists

commonly search AMED for CAM articles. This could not be accessed from India.

Facilities to search Ayurveda journal abstracts in the similar was as far biomedical journal

abstracts (PubMed) is not available in world wide web as far we could find.

This as background the project had the objective to develop protocols for evidence

based Ayurveda to treat dermatology and sexually transmitted disease. Creating a search

strategy, for ayurveda databases and publications, hand searching for unpublished research

work, systematic review o f the pooled literature all formed the part o f the work elements.

Since there was no previous experience in the field , we developed each area ‘de novo’.

To achieve this we have used the framework o f Cochrane protocols.

Comparative clinical trials used classical Ayurveda medicines on intervention and

comparison arms. However there was no mention of the non inferiority margin. Non

inferiority trials (NIT) test the hypothesis that one therapy is not worse than the other.

One o f the trials (Perugu 1992) compared Shamanoushadha with two arms o f shodhana

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karma (virechana and jalaukavacharana). Shamana group and virechana group were given to

19 patients each. Jalaukavacharana was given 14 patients. All showed repigmentation

except one patient in jalaukavacharana group. This study resembled equivalence trial (ET).

However these publications did not mentioned about NIT or ET. NIT and ET are o f recent

development and therefore Ayurveda studies may not discuss these designs in their

methodology. Since comparative trials resembled NIT we call them ‘quazi non inferiority

trials.’ There needs an elaborate discussion to develop clear guidelines on use o f non

inferiority trials on Indian Systems of Medicine before its adaptation to systematic reviews

of Ayurveda .

We found that in most trials non hairy areas o f the body had shown repigmentation.

Ayurveda and biomedicine claim that depigmentation affecting non hairy areas is mostly

not treatable. The findings in these primary studies give a lead that repigmentation

process may be influenced by factors other than melanocytes cell count done.

Total of 105 research works were undertaken on Switra during 1975-2008. 55/105 (52.4%)

could be procured. Among the procured studies 29/55 (52.7%) were eligible for analysis.

Our recommendation (Page No 8 to 11) are

• When shamanoushadha alone is used dhatryadi chuma or dhatryadi yoga is to be given

along with avalguja beejadi lepa on the basis o f individualized patient selection

• Any of the following Shamanoushadha can be used along with virechana on the basis of

individualized patient selection

1. shwetha aparajitha mula (oral) + Chitraka root (topical)

2. Gajalinda Kshara (oral) + Bakuchi beeja (topical)

As the part of the project knowledge level of investigators on Ayurveda were assessed.

60.3% o f the responders were Ayurvedic doctors, No one in 58 obtained full marks on

MCQ section of the questionnaire. MCQ questions dealt on available clear cut guidelines

with no scope for ambiguity . Incorrect answers to them indicate that clinical studies

carried out by such investigators are likely to have lower evidence level because of

the possibility o f confounders. 60% of the investigators did not know the correct

method o f literature search. None accessed all databases discussed in the project. There

was no search strategy. No one was aware of hand searching through Baghel MS (2006).

Among responders 77.6% were currently conducting research studies receiving funding

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from India’s major grant making agencies. However 74.1% am ong investigators did not

receive any structured training.

The above project used Switra as a model disease. This m ay be replicated to any

disease. We expect that in other diseases e.g. Kitibha, Amavatha, Vatarakta etc clinical

studies are likely to be more common on these diseases than vitiligo as latter is a difficult to

cure (Asadhya/ Kastasadhya) disease.

References:

1. Bhagel MS, Kori VK. International catalogue of Ayurvedic publications; Institute for

Postgraduate Teaching and Research in Ayurveda, Gujrat Ayurveda University,

Jamnagar; 2009.

2. Bhagel MS. Researches in Ayurveda 2005. Gandhinagar; M ridu Ayurvedic Publication

and Sales, 2006.

3. Perugu 1992 Evaluation o f kakodumbaradi yoga in the management o f shvitra

Department o f kayachikitsa, Govt. Ayurvedic M edical College Mysore.

4. Subbiah Arunachalam. Is science in India on the decline? Current science, 2002; 83:107-

108.

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