The Institute of Ayurveda and Integrative Medicine (I-AIM) collaborated with the South
Asian Cochrane Network to organize a workshop to develop standards for reporting Ayurveda
clinical trials, during the South Asian CONSORT meeting held at Christian Medical
College, Vellore, India, on 12 January, 2010.
Guidelines for reporting scientific research have enhanced transparency and improved
the quality of evidence.[1] In particular, the CONSORT (Consolidated Standards for
Reporting Trials) statement has benefited planning and publications of clinical trials.[2]
Many different initiatives have attempted to develop standards of reporting research.[3]
It is generally agreed that individual standards of a similar nature are needed for
all systems of traditional complementary and alternative medicine, including Ayurveda.
The workshop was Chaired by Darshan Shankar, Hon. Adviser for Indian Systems of Medicine
to the Member (Health), Planning Commission of India. In his overview, Shankar summarized
the background, emphasizing the need to retain comprehensiveness of Ayurveda interventions
in research. He requested the gathering to develop standards for reporting Ayurveda
research as current standards need modification to incorporate Ayurvedic principles.
He discussed the IAIM initiative to do so, and called for united efforts in this endeavor.
Girish Tillu, Ayurveda physician and researcher, explained the poster “Systems Ayurveda.”[4]
He elaborated Ayurveda interventions’ comprehensiveness and complexity in light of
the overall seminar theme. Bhushan Patwardhan, Director-Designate, Institute of Ayurveda
and Integrative Medicine, reviewed paradigms of Ayurveda research against the “Systems
Ayurveda” background. He added that planning and reporting research should adopt comprehensive
approaches, and Ayurveda principles of diagnosis and management.
David Moher, Director of the Chalmers Research Group and CONSORT Scientist, said that
more than 75 sets of guidelines for reporting experiments exist, but when analyzed,
most of them fail the definition of “good” guidelines. He suggested undertaking a
cross-sectional review of Ayurvedic clinical trials to justify the need for developing
guidelines. He recommended following principles described in his recent publication
on developing guidelines for reporting research,[5] also suggesting that larger stakeholders
should become involved early to have a buy-in.
Moher gave more detailed advice. Several years are normally necessary making it an
ideal project for a graduate thesis. Guidelines should incorporate Ayurveda-specific
interventions and outcomes. The Delphi, peer consultative process is an effective
way to set about such a problem where knowledge is incomplete.[6] In response to a
plea from Patwardhan, he assured the group of assistance in developing guidelines
for Ayurveda.
Doug Altman, Professor in Statistics in Medicine at Oxford University, re-iterated
Moher's points and urged everyone to read revised STRICTA guidelines, which aim at
reporting of Chinese Medicine Trials. Revisions were driven by the need to improve
quality of reporting acupuncture interventions, emerging from collaboration between
STRICTA, CONSORT, and the Chinese Cochrane Centre. He felt that a similar collaboration
may be needed to develop Ayurvedic guidelines, involving experts in Ayurveda and guidelines
development. Altman shared his experiences about methodological aspects of developing
guidelines.
Bian Xiao Zheng, Chinese Medicine expert, laid out the process and achievements of
CONSORT-like statements for Traditional Chinese Medicine, resulting in publications
standardizing reporting of TCM trials.[7] Emphasis was on the quality of herbal products
and associated guidelines, Chinese Government rules on agricultural products helped
in their formulation. Trials are classified according to whether they (a) use traditional
TCM definitions of disease and cure; (b) use modern definition of disease and cure;
or (c) use a combination of modern and traditional definitions. Correspondence between
traditional and modern is evaluated.
Senior Statistician Ashwini Mathur gave a short presentation on the need for standardization
of Ayurvedic trials, and basic principles to be followed in developing guidelines
for them. These followed his previous suggestions.[8]
A possible name was suggested in the form of CONSORT-like standards for reporting
Ayurveda clinical trials (STRACT).