Clinical research on acupuncture - Concepts and guidance on efficacy and effectiveness research.

Over the last few years a number of large acupuncture trials have been carried out in western countries. carried out in western countries. The following article draws on the experience from these recent large-scale trials on acupuncture to outline the way randomized trials could be used to answer questions on efficacy, effectiveness and efficiency. It will provide guidance, firstly on the underlying concepts of both efficacy and effectiveness and secondly on designing both types of trials. In addition, the controversy over specific and non-specific effects of acupuncture, emerging from the results of the above-mentioned trials, will be highlighted. Suggestions for future clinical research on acupuncture include: greater reflection on the complex approach of Chinese medicine, and transparent and detailed reporting according to CONSORT and STRICTA guidelines. The current data on acupuncture point-specific effects do indeed have relevance, however for valid decision-making on acupuncture, further clinical trials on effectiveness and cost-effectiveness are required to provide realistic benefit estimates for future health care.