P05.28 LB
Purpose: With the recent developments in evidence-based complementary medicine, the Indian systems of medicine (ISM) with its multimodal individualized treatment, perceives many challenges in conducting randomized controlled trials (RCTs). A clear understanding of these challenges is a basic step in determining the feasibility of RCTs and development of research methods in this field. The aim of our study was to identify the important methodological considerations specific for ISM (Ayurveda and Siddha) in conducting a RCT and to review systematically all currently undertaken controlled trials of ISM regarding these features.
Methods: We formulated a 18 point checklist in a PICO (Population Intervention Comparison Outcomes) format including usage of ISM concepts in diagnosis and outcome assessment, whole treatment package or integrated treatment as intervention, choice of comparison groups, a non-inferiority hypothesis with the benefit of safety, etc. For the systematic review, we identified all controlled trials published between January 2000 and December 2012. Basic and design specific characteristics of the trials were extracted and analyzed.
Results: The searches retrieved 295 articles, of which 70 controlled trials were identified. Only about 20 to 30% of the trials used ISM concept in diagnosis and outcome assessment. About 20% tested integrated interventions. There were 11 different types of comparison groups used. All the trials studied a superiority hypothesis and only 29% involved an active surveillance for safety outcome. However, RCTs adopting ISM principles, using relevant comparison groups, and further high methodological qualities could be found.
Conclusion: Our research showed that there is ample room for improvement of ISM clinical trial designs. The formulated checklist of specific methodological features can help ISM trialists plan better RCTs. Though current RCTs about ISM often show deficiencies in methodological considerations, we could find examples of successful adaptation of RCT methodologies and hence evidence for its feasibility in ISM.
Contact: Primrose Beryl, beryl@imbi.uni-freiburg.de
