Abstract

Background

Placebo control plays an important role in evaluating the effectiveness of interventions. Specifying differential effects of various placebo controls on migraine prevention would be essential in the explanation of preventive treatment for migraine and the indirect comparison between different prophylactic therapeutics.

Objectives

To access the impact of different non-pharmacologic placebo types on different outcomes in migraine patients.

Methods

We searched PubMed, Cochrane Controlled Register of Trials, Embase, and Web of Science databases from the date of creation to June 19, 2023. Randomized controlled trials of migraine that included sham intervention of acupuncture or cognitive behavioural therapy (CBT) or non-invasive Vagus Nerve Stimulation (nVNS) or repetitive Transcranial Magnetic Stimulation (rTMS) or transcranial Direct Current Stimulation (tDCS) were conducted. The primary outcome was the migraine days, and the secondary outcomes were the number of migraine attacks, headache days, headache frequency, and responder’s rate. Placebo effects were assessed using five individual placebos for network meta-analysis, using mean differences to measure the relative effect of pair-wise comparisons between interventions.

Result

A total of 50 trials with 4880 subjects were included. Twenty-seven trials were evaluated for low risk of bias. The results of indirect comparisons show that sham rTMS and sham tDCS had optimal and similar effects in reducing migraine days; sham acupuncture has the greatest effect on reducing the number of migraine attacks and relieving headache frequency; sham rTMS had a highly significant advantage in reducing headache days compared with the other placebo controls.

Conclusion

Based on the network meta-analysis results, we found that sham acupuncture had the greatest effect on migraine prophylaxis. The strong placebo effect of sham acupuncture should be considered when assessing the therapeutic effect.

中文翻译：

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不同非药物安慰剂治疗对偏头痛预防的影响：随机对照试验的网络荟萃分析

摘要

背景

安慰剂对照在评估干预措施的有效性方面发挥着重要作用。明确各种安慰剂对照对偏头痛预防的不同作用对于解释偏头痛的预防性治疗以及不同预防性治疗之间的间接比较至关重要。

目标

了解不同非药物安慰剂类型对偏头痛患者不同结局的影响。

方法

我们检索了从创建之日到 2023 年 6 月 19 日的 PubMed、Cochrane 对照试验注册库、Embase 和 Web of Science 数据库。偏头痛的随机对照试验，包括针灸或认知行为疗法 (CBT) 或非侵入性的假干预进行迷走神经刺激（nVNS）或重复经颅磁刺激（rTMS）或经颅直流电刺激（tDCS）。主要结局是偏头痛天数，次要结局是偏头痛发作次数、头痛天数、头痛频率和缓解率。使用五种单独的安慰剂进行网络荟萃分析来评估安慰剂效应，使用平均差异来衡量干预措施之间成对比较的相对效果。

结果

总共纳入了 50 项试验，涉及 4880 名受试者。对二十七项试验进行了低偏倚风险评估。间接比较结果表明，假rTMS和假tDCS在减少偏头痛天数方面具有最佳且相似的效果；假针灸对减少偏头痛发作次数、缓解头痛频率效果最大；与其他安慰剂对照相比，假 RTMS 在减少头痛天数方面具有非常显着的优势。

结论

根据网络荟萃分析结果，我们发现假针灸对偏头痛的预防效果最大。在评估治疗效果时应考虑假针灸的强烈安慰剂效应。