College of Acupuncture and Orthopedic, Hubei University of Chinese Medicine, Wuhan, 430065, China.
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, 100700, China.
Front Med. 2021 Oct;15(5):767-775. doi: 10.1007/s11684-020-0785-6. Epub 2021 Apr 19.
Acupuncture is a promising treatment for relieving pain and improving lower back function in clinical practice. However, evidence from randomized clinical trials (RCTs) remains controversial. Most RCTs conclude that acupuncture procedures for chronic low back pain (CLBP) had no significant difference in efficacy and belonged to placebo. We carefully reviewed and analyzed the methodology and implementation of sham acupuncture in RCTs. Controversial evidence of acupuncture for CLBP is only a microcosm of the evaluation methodological limitation of acupuncture. Inappropriate selection of sham acupuncture controls, rigorous RCT research models, and incorrect interpretation of results may contribute to negative evidence. Evaluating and disregarding the holistic efficacy of acupuncture with an explanatory RCT model based on evaluation drugs may be unwise. Moreover, sham acupuncture is often proven to be non-inert, unreasonable, and with low fidelity. Pitfalls of the explanatory RCT model and sham acupuncture design should be avoided. Establishing a new evaluation system that is in line with the clinical characteristics of acupuncture and obtaining high-quality evidence are difficult but promising tasks.
针刺在临床上是一种有前途的缓解疼痛和改善下腰痛功能的治疗方法。然而,来自随机对照试验(RCT)的证据仍然存在争议。大多数 RCT 得出的结论是,慢性下腰痛(CLBP)的针刺程序在疗效上没有显著差异,属于安慰剂。我们仔细审查和分析了 RCT 中假针刺的方法学和实施情况。针刺治疗 CLBP 的有争议的证据只是针刺评价方法局限性的一个缩影。假针刺对照的选择不当、严格的 RCT 研究模式以及对结果的错误解释可能导致负面证据。用基于药物评估的解释性 RCT 模型来评估和忽视针刺的整体疗效可能是不明智的。此外,假针刺通常被证明是非惰性的、不合理的,而且保真度低。应避免解释性 RCT 模型和假针刺设计的陷阱。建立一个符合针刺临床特点并获得高质量证据的新评价体系是困难但有希望的任务。