OBJECTIVE: To evaluate and introduce the current status of acupuncture clinical trials in Japan. METHODS: We performed a database search of controlled clinical trials (CCTs) published in Japan, using 'Igaku Chuo Zasshi (Japana Centra Revuo Medicina) CD-ROM version (between 1987 to 2000)' and an independent search. Parallel or crossover designed trials which assessed the efficacy of needle acupuncture were included. RESULTS: We located 32 published papers (24 full papers and eight abstracts), which reported 34 trials. Only two of these were listed in Medline or the Cochrane Library. Conditions examined were musculoskeletal pain (20 trials including 10 for low back pain and three for sciatica), neck and shoulder stiffness (four trials) and miscellaneous conditions (10 trials). Thirty-three trials were described as randomized, although seven trials employed a quasi-random method. Applying the 5-point Jadad quality assessment scoring system, the mean score was 1.85 +/- 1.16 (SD). Eighteen (53%) of the reports were conducted to determine a more effective procedure of acupuncture, these compared a certain type of acupuncture with another type of acupuncture or specific additional points. CONCLUSIONS: Japanese acupuncture CCTs, which are rarely listed in the Western databases, differ in several respects from Western reports. Systematic reviews including non-English papers with collaboration among authors representing different languages would promote more thorough scientific evaluation of complementary and alternative medicine.

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