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The case of acupuncture for chronic low back pain: when efficacy and comparative effectiveness conflict.

机译:针灸治疗慢性下腰痛的情况:当疗效和比较效果发生冲突时。

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摘要

Efficacy signifies superiority over placebo controls in randomized controlled trials (RCTs). Effectiveness implies greater or equal clinical benefits compared to an already-established treatment. Two recent RCTs of acupuncture for chronic low-back pain (cLBP)-notable for their size, rigor, and innovative research designs that included both efficacy and effectiveness hypotheses-raise the interesting conundrum of what happens when these two forms of evidence conflict. In the first German trial, patients with cLBP (n = 1162) were randomized to acupuncture treatments, placebo acupuncture treatments, or optimal mainstream care.1 At 6 months, the primary endpoint, the proportion of positive clinical response was 47.6%, 44.2%, and 27.4% in acupuncture, placebo acupuncture, and conventional care, respectively. There was no statistical difference between acupuncture and placebo acupuncture (P = 0.39), but both acupuncture and placebo acupuncture were statistically and clinically superior to mainstream care that included physiotherapy, exercises, and nonsteroidal anti-inflammatory drugs (P < 0.001).
机译:在随机对照试验(RCT)中,疗效表明其优于安慰剂对照。与已经建立的治疗方法相比,有效性意味着更大或相等的临床收益。近期针对慢性腰背痛(cLBP)的两种针灸随机对照试验(RCT)均因其规模,严谨性和创新性研究设计而闻名,其中包括有效性和有效性假设,这引发了有趣的难题,即这两种形式的证据冲突时会发生什么。在德国的第一项试验中,cLBP(n = 1162)患者被随机分配到针灸治疗,安慰剂针灸治疗或最佳主流护理中。1在6个月(主要终点)时,临床阳性反应的比例分别为47.6%,44.2%在针灸,安慰剂针灸和常规护理中分别占27.4%。针灸和安慰剂针灸之间无统计学差异(P = 0.39),但针灸和安慰剂针灸在统计学和临床​​上均优于包括物理治疗,锻炼和非甾体抗炎药在内的主流护理(P <0.001)。

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