Acupuncture Research Team, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.
South China Research Center for Acupuncture, Guangzhou University of Chinese Medicine, Guangzhou, China.
Eur J Pain. 2022 May;26(5):1006-1020. doi: 10.1002/ejp.1924. Epub 2022 Feb 19.
In prospective experimental studies of neck pain patients, it is difficult to determine whether responses to sham acupuncture differ from responses to real acupuncture due to the heterogeneous methodologies in control/sham interventions. Here we aim to compare the specific and nonspecific effects of electroacupuncture with four types of sham acupuncture.
In this double-blind, sham-controlled study, we randomly assigned 175 patients with neck pain to receive 10 sessions of electroacupuncture, shallow puncture, nonacupoint deep puncture, nonacupoint shallow puncture, or nonpenetration acupuncture. We used the Northwick Park Neck Pain Questionnaire (NPQ) as our primary outcome, and Short-form McGill Pain Questionnaire, visual analog scale (VAS), and Pain Threshold as secondary outcomes to measure the changes from baseline to a 3-month follow up.
All groups, except nonacupoint shallow puncture, had significant improvement in all outcome measurements. Electroacupuncture only showed superior improvements than the shallow puncture, nonacupoint shallow puncture, and nonpenetration groups when compared using the NPQ and VAS scale (*p < 0.001). Interestingly, the nonacupoint shallow puncture produced even less placebo response than nonpenetration acupuncture.
Our study demonstrates the high variability of placebo response among different types of sham controls depending on the depth of needle insertion and the puncture location. An important implication of our results is nonacupoint deep puncture produced similar analgesic effects as electroacupuncture. Our study may shed a new light on the predominant underlying mechanisms among different types of sham acupuncture controls, which can help with interpreting the effect of acupuncture in other studies.
Chinese clinical trial registry (ChiCTR-IOR-15006886).
This study compared the observed specific and nonspecific analgesia effect in four different types of sham acupuncture stimulation with neck pain patients, assessed by four outcomes. Although all of the sham controls produced significant reduction in neck pain, electroacupuncture had superior significant improvement. Importantly, placebo responses differed significantly between the sham controls and responses were inconsistent according to different outcome assessments. This study emphasizes the importance of taking into consideration which sham control and method of outcome measurement were used in a pain research study when evaluating its results.
在颈痛患者的前瞻性实验研究中，由于对照/假干预措施的方法学存在差异，因此很难确定假针刺的反应是否与真针刺的反应不同。在这里，我们旨在比较电针与四种类型的假针刺的特异性和非特异性效应。
在这项双盲、假对照研究中，我们将 175 名颈痛患者随机分为电针、浅刺、非穴位深刺、非穴位浅刺和非穿透针法组，接受 10 次治疗。我们使用 Northwick Park 颈痛问卷（NPQ）作为主要结局，并用简化 McGill 疼痛问卷、视觉模拟量表（VAS）和疼痛阈值作为次要结局来衡量从基线到 3 个月随访的变化。
除非穴位浅刺组外，所有组在所有结局测量中均有显著改善。与浅刺、非穴位浅刺和非穿透针法组相比，电针仅在 NPQ 和 VAS 量表上显示出更好的改善（*p<0.001）。有趣的是，非穴位浅刺比非穿透针法产生的安慰剂反应更小。
我们的研究表明，不同类型的假对照之间的安慰剂反应存在高度变异性，这取决于针刺的深度和针刺的位置。我们研究结果的一个重要启示是，非穴位深刺产生的镇痛效果与电针相似。我们的研究可能为不同类型的假针刺对照之间的主要潜在机制提供新的认识，这有助于解释其他研究中针刺的效果。
中国临床试验注册中心（ChiCTR-IOR-15006886）。
本研究比较了四种不同类型的假针刺刺激对颈痛患者的观察到的特异性和非特异性镇痛效果，通过四种结局进行评估。尽管所有的假对照都显著减轻了颈痛，但电针的显著改善更为明显。重要的是，安慰剂反应在假对照之间存在显著差异，并且根据不同的结局评估，反应不一致。本研究强调了在评估疼痛研究结果时，考虑使用哪种假对照和结局测量方法的重要性。
