Workshop on a CONSORT statement for Ayuveda

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).