Objectives We aimed to assess the methodological qual ity of RCT on acupuncture for migraine prophylaxis. Methods With the searching terms including acupuncture, migraine, prophylaxis and prevent, etc, the database of the Cochrane Library (Issue 4, 2007), MEDLINE (1966-2007), EMBase (1966-2007), CBM (1978-2007) and CMCC (1994-2007) were searched from their date of start publ ication. Chinese medical journals and relevant academic conference proceedings were hand searched as well. Several items in included trials were assessed, including methodology, diagnostic criteria, inclusion/exclusion criteria, acupuncture/control interventions, outcome measures and follow-up, etc. Result Among the 12 included trials, 9 trials overseas were high-qual ity and 3 in China were low-quality. Frequency or days of migraine attacks and SF-36/SF-12 were often evaluated as outcome measures in western countries, while headache index was used in China. Among the 12 trials, 9 reported the follow-up outcomes and 8 mentioned adverse events. Conclusion There was no high qual ity trial on acupuncture for migraine prophylaxis in China. The outcome measures in trials published in China by now can not evaluate the outcomes of acupuncture for migraine prophylaxis accurately. To study designs, advantages of trials oversea can be used for reference. To Chinese cl inical physicians, prophylactic therapy and abortive therapy of migraine should be distinguished in order to design high-qual ity study on acupuncture for migraine prophylaxis.
Based on the conclusion of recent clinical research conducted by foreign countries, there is no statistical difference in outcomes between real and placebo acupuncture. This paper analyzes the weaknesses of methods currently being used by foreign countries to compare the effects of real and placebo acupuncture, striving for a new way to test for the placebo effect; a way that is more scientific, more suitable for the current conditions of China, while at the same time capable of being recognized internationally. This paper describes a new acupuncture placebo-controlled method. Under the condition of complete patient trust, we may ensure an ideal placebo effect to the greatest extent by minimizing the potential curative effects in the placebo group. From the actual clinical practice, by randomized controlled trial comparing acupuncture and medicine, using the concept as the double-dummy clinical trail, this paper explores the “double-dummy – non-specific sites – random sampling” method in the clinical setting as a way to form a new acupuncture clinical research model of comparison between acupuncture and medicine.