Institute of Medical Informatics, China Academy of Chinese Medical Sciences, Beijing 100700, China.
J Tradit Chin Med. 2013 Jun;33(3):403-7. doi: 10.1016/s0254-6272(13)60187-9.
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.
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.
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.
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.
研究德国关于针灸与假针灸治疗效果的对照临床试验，以发现假针灸与针灸无显著差异的结论是否存在问题。
我们重点关注 2002 年至 2011 年间 PubMed 上发表的德国针灸与假针灸对照临床试验的文献。总结了假针灸中应用的方法，并分析了针灸组和假针灸组之间的差异。我们根据以下标准衡量效果：针灸有效且优于假针灸、针灸有效但与假针灸相似、两种疗法的治疗效果不确定、或无显著效果。最后，我们回顾了不同学者对假针灸的假设，并分析了他们的结果。
在分析的 57 篇文章中，包括非传统中医穴位的假针灸、非穴位的微针刺、安慰剂针和假激光针灸等 4 种类型的对照临床试验，结果各异。一些研究表明针灸的效果优于假针灸，而另一些研究则表明针灸和假针灸的效果相似。在所有使用非治疗穴位、假电极和假电针的假针灸试验中，假针灸的疗效均优于假针灸。其中 37 项试验表明针灸的效果优于假针灸。仅有 9 项试验发现针灸与假针灸之间无显著差异。两个由不同德国研究所进行的针对同一病症（颈部疼痛）的对照试验使用了相同的对照方法，但得出了相互矛盾的结论。
我们发现德国关于假针灸对照临床试验结果的结论存在问题。因此，目前尚无足够证据支持“针灸与假针灸在治疗效果上无差异”和“针灸只是一种安慰剂效应”的说法。德国使用的假针灸对照方法可能不规范，不适合针灸临床试验研究。我们建议在未来的针灸试验设计中，应优先研究假针灸的方法学。
