Is sham laser a valid control for acupuncture trials?
Is sham laser a valid control for acupuncture trials?
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DOI：
10.1093/ecam/neq009
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发表时间：
2011
期刊：
影响因子：
--
通讯作者：
Fleckenstein J
中科院分区：
文献类型：
--
作者：
Irnich D;Salih N;Offenbächer M;Fleckenstein J
针灸试验的方法学问题集中在充分的安慰剂对照。在这项试验中，我们评估了使用假激光针灸作为对照程序。34名健康志愿者采用随机、双盲、交叉试验设计，分别在三个穴位（LI 4、LU 7和LR 3）接受真激光（45 s，1 J/穴）和假激光（红光）治疗。主要结果测量是每次治疗后立即进行的正确与不正确治疗评级的比率。次要结局指标是在10倍视觉模拟量表（VAS; 10为最强可感觉）上，穴位处的德气样感觉的发生及其强度。我们汇总了之前三项试验的结果，以评估假激光针灸与针刺相比的可信度。34名健康志愿者（年龄：28 ± 10.7岁）中有15名（44%）在第一次治疗后识别出使用过的激光器械，14名（41%）在第二次治疗后识别出使用过的激光器械。因此，两种治疗方法无法区分（P = 0.26）。活动激光束组（2.34 VAS）和假激光束组（2.49 VAS）分别有46%和49.0%的患者出现类似德气的感觉。假激光的可信度与针刺没有区别。在激光针灸研究中，假激光针灸可以作为有效的安慰剂对照。由于类似的可信度和缺乏对周围神经系统的感觉输入，假激光针灸也可以作为针灸试验的假对照，以评估针刺效应本身。
Methodological problems of acupuncture trials focus on adequate placebo controls. In this trial we evaluated the use of sham laser acupuncture as a control procedure. Thirty-four healthy volunteers received verum laser (invisible infrared laser emission and red light, 45 s and 1 J per point) and sham laser (red light) treatment at three acupuncture points (LI4, LU7 and LR3) in a randomized, double-blinded, cross-over design. The main outcome measure was the ratio of correct to incorrect ratings of treatment immediately after each session. The secondary outcome measure was the occurrence of deqi-like sensations at the acupuncture points and their intensity on a 10-fold visual analog scale (VAS; 10 being the strongest sensible sensation). We pooled the results of three former trials to evaluate the credibility of sham laser acupuncture when compared to needle acupuncture. Fifteen out of 34 (44%) healthy volunteers (age: 28 ± 10.7 years) identified the used laser device after the first session and 14 (41%) after the second session. Hence, both treatments were undistinguishable (P = .26). Deqi-like sensations occurred in 46% of active laser (2.34 VAS) and in 49.0% of sham laser beams (2.49 VAS). The credibility of sham laser was not different from needle acupuncture. Sham laser acupuncture can serve as a valid placebo control in laser acupuncture studies. Due to similar credibility and the lack of sensory input on the peripheral nervous system, sham laser acupuncture can also serve as a sham control for acupuncture trials, in order to evaluate needling effects per se.
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影响因子：
105.7
作者：
Irnich, D;Behrens, N;Schöps, P
通讯作者：
Schöps, P
影响因子：
168.9
作者：
Streitberger, K;Kleinhenz, J
通讯作者：
Kleinhenz, J
影响因子：
--
作者：
Hui, Kathleen K S;Nixon, Erika E;Kennedy, David N
通讯作者：
Kennedy, David N
DOI：
10.1073/pnas.95.5.2670
发表时间：
1998-03-03
影响因子：
11.1
作者：
Cho, ZH;Chung, SC;Min, BI
通讯作者：
Min, BI
影响因子：
5.7
作者：
Park, H;Park, J;Lee, H
通讯作者：
Lee, H