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.
Acupuncture ; methods ; Acupuncture Therapy ; methods ; Biomedical Research ; methods ; Clinical Trials as Topic ; methods ; Concept Formation ; Efficiency ; Humans ; Models, Biological ; Research Design ; Treatment Outcome

In clinical research on complementary and integrative medicine, experts and scientists have often pursued a research agenda in spite of an incomplete understanding of the needs of end users. Consequently, the majority of previous clinical trials have mainly assessed the efficacy of interventions. Scant data is available on their effectiveness. Comparative effectiveness research (CER) promises to support decision makers by generating evidence that compares the benefits and harms of best care options. This evidence, more generalizable than evidence generated by traditional randomized clinical trials (RCTs), is better suited to inform real-world care decisions. An emphasis on CER supports the development of the evidence base for clinical and policy decision-making. Whereas in most areas of complementary and integrative medicine data on CER is scarce, available acupuncture research already contributes to CER evidence. This paper will introduce CER and make suggestions for future research.
Comparative Effectiveness Research ; Integrative Medicine ; Randomized Controlled Trials as Topic ; Research Design

In clinical research on complementary and integrative medicine, experts and scientists have often pursued a research agenda in spite of an incomplete understanding of the needs of end users. Consequently, the majority of previous clinical trials have mainly assessed the efficacy of interventions. Scant data is available on their effectiveness. Comparative effectiveness research (CER) promises to support decision makers by generating evidence that compares the benefits and harms of the best care options. This evidence, more generalizable than the evidence generated by traditional randomized controlled trials (RCTs), is better suited to inform real-world care decisions. An emphasis on CER supports the development of the evidence base for clinical and policy decision-making. Whereas in most areas of complementary and integrative medicine data on comparative effectiveness is scarce, available acupuncture research already contributes to CER evidence. This paper will introduce CER and make suggestions for future research.
Comparative Effectiveness Research ; Decision Support Systems, Clinical ; Humans ; Integrative Medicine ; Medicine, Chinese Traditional ; Practice Guidelines as Topic ; Randomized Controlled Trials as Topic