Use of Ayurvedic Diagnostic Criteria in Ayurvedic Clinical Trials: A Literature Review focused on Research Methods

Objective: The objective of this literature review was to evaluate whether Ayurvedic diagnostic criteria or western medicine diagnostic criteria have been used in published clinical trials testing Ayurvedic treatments. Methods: The Pubmed, Embase, and Allied and Complementary Medicine (AMED) databases were searched to identify relevant articles on Ayurvedic clinical trials published in English from 1980 to 2009. Animal studies, systematic reviews, literature review articles, Phase I, Phase II and pilot studies were not included in this review. A total of 45 Ayurvedic Phase III clinical trials were identified and grouped into two time periods: pre- and post-2000 periods. Each article was independently reviewed by two calibrated reviewers. Results: Analysis revealed that not one of these 45 clinical trials reported ‘only-and-full' use of the 23 available Ayurvedic diagnostic criteria. In fact, 24.4% of these 45 articles never specified any diagnostic criteria at all. While the percentage of articles using Ayurvedic diagnostic criteria (either as ‘only use' or ‘combined use with Western Medicine diagnostic criteria') doubled over the two time periods (27.7% to 59%), rarely were more than 2 of the 23 Ayurvedic diagnostic criteria ever used. Conclusion: This observed near total failure to used Ayurvedic diagnostic criteria in the design of the existing body of clinical studies to date calls all their findings into question as to whether they were, indeed, valid tests of Ayurvedic treatments. To improve confidence in findings, future studies should use Ayurvedic diagnostic criteria in the designing of Ayurvedic clinical trials to ensure valid assessments.