Abstract: OBJECTIVE: To examine German controlled clinical trials on the therapeutic effects of acupuncture vs sham acupuncture, and to find whether there are problems with the conclusion that sham acupuncture has no significant deviation from acupuncture. METHODS: We focused on literature from the last ten years (2002-2011) included in PubMed about controlled clinical trials on acupuncture vs sham acupuncture carried out in Germany. The methods applied in sham acupuncture are summarized, and the difference between the acupuncture and sham groups were analyzed. We measured effects based on the following criteria: acupuncture is effective and superior to sham, acupuncture is effective but similar to sham, both of them have uncertainty regarding treatment effect, or no significant effect. Finally, we reviewed the hypotheses of different scholars on sham acupuncture and analyzed their results.RESULTS: Four types of controlled clinical trials including sham acupuncture on non-Traditional Chinese Medicine acupoints, minimal acupuncture on non-acupoints, placebo needle and sham laser acupuncture had varying results in the 57 articles analyzed. Some showed that acupuncture had a better effect than sham, while some suggest acupuncture and sham had similar effects. In all studies using sham acupuncture on non-therapeutic points, sham electrodes, and sham electro-acupuncture, the therapeutic effect was better than sham. Of the trials, 37 demonstrated that acupuncture had a better effect than sham acupuncture. Only nine trials found no significant difference between acupuncture and sham. Two controlled trials for the same condition (neck pain) conducted by two different German research institutes used the same control method, but reached contradictory conclusions. CONCLUSION: We found problems in conclusions based on results of controlled clinical trials of sham acupuncture in Germany. Therefore, there is still not enough evidence to support the statements that "acupuncture and sham acupuncture have no difference in treatment effect" and "acupuncture is just a placebo effect." The control methods of sham acupuncture used in Germany may not be standardized and may not be suitable for acupuncture clinical trial research. We suggest that research on the methodology of sham acupuncture should be given priority in the design of acupuncture trials in the future.

Key words: Acupuncture therapy, Placebos, Controlled clinical trials, Germany