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Non-specific effects of different sham acupuncture methods and their impact on true acupuncture effectiveness in migraine: a protocol for systematic review and network meta-analysis.

BMJ open·August 2025·Qilin Liu, Jiahui Yang, Meng Lin et al.
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Key Finding

Different sham acupuncture methods produce varying non-specific effects that complicate accurate assessment of true acupuncture effectiveness in migraine treatment, necessitating network meta-analysis to distinguish real therapeutic benefits from placebo responses.

What This Means For You

Researchers are planning a comprehensive study to better understand how acupuncture works for migraine relief and why different types of fake acupuncture (called "sham acupuncture") used in research studies can make it difficult to measure acupuncture's true effectiveness. Migraine affects about one billion people worldwide and creates significant personal and economic burdens. While many patients turn to acupuncture for migraine management, scientific debates continue about how well it actually works. The challenge is that research studies use different types of fake acupuncture as comparison treatments, and these fake treatments can have their own effects that complicate understanding the real benefits of acupuncture. This planned study will review all available research trials comparing real acupuncture to various types of sham acupuncture for migraine treatment. The researchers will examine multiple databases of medical research from their earliest records through November 2024. They'll look at how often migraines occur, how severe the pain is, how much medication patients need, and overall quality of life measures. By comparing different types of sham acupuncture used in studies, the researchers hope to identify which fake treatments have the strongest placebo effects and what factors influence these effects. This information could help design better future studies and give clearer answers about acupuncture's true effectiveness for migraine sufferers. The results will be published in medical journals and presented at academic conferences. If you're considering acupuncture for migraines, consult with a licensed acupuncturist who has experience treating headache disorders.

Clinical Notes for Practitioners

This protocol describes a systematic review and network meta-analysis examining acupuncture effectiveness for migraine while evaluating differential non-specific effects of various sham acupuncture (SA) methodologies. The study will search 12 databases through November 2024 for RCTs comparing acupuncture to SA controls in migraine patients, excluding those with exclusively chronic migraine (≥15 headache days/month). Primary outcome will be standardized mean difference (SMD) in migraine frequency measures. Secondary outcomes include response rate (≥50% frequency reduction), acute medication usage, monthly migraine days, pain intensity (VAS/NRS), and migraine-specific questionnaire scores. Cochrane RoB 2 tool will assess bias. Frequentist network meta-analysis using Stata 18.0 will synthesize continuous outcomes via SMD with 95% CI, with meta-regression and subgroup analyses as needed. The study aims to: (1) evaluate acupuncture effectiveness versus SA controls; (2) compare effect sizes across different SA methods; and (3) identify factors influencing sham intervention outcomes. No sample size reported as this is a protocol for future systematic review. Results may clarify acupuncture's true therapeutic effects beyond placebo.

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