The Prophylactic Effect of Acupuncture for Migraine Without Aura: A Randomized, Sham‐Controlled, Clinical Trial

OBJECTIVE: Acupuncture is recognized as an effective migraine treatment, but the comparative long-term efficacy of different acupuncture methods at identical acupoints remains unclear. This study investigates the prophylactic effects of manual acupuncture (manual penetrating acupuncture, MPA) versus sham acupuncture (non-penetrating acupuncture, NPA) at the same acupoints. METHODS: In this multicenter, single-blind randomized controlled trial conducted across four Chinese clinical centers (May 2020 to September 2022), 192 migraineurs without aura (International Classification of Headache Disorders 3rd edition criteria) were randomized 1:1 to 12 sessions of MPA or NPA. Primary outcome was the change from baseline in migraine attack frequency at week 16; secondary outcomes included migraine attack frequency, responder rates, migraine days, and pain intensity (every 4 weeks), etc. Trial registration: No. ChiCTR2000032308. RESULTS: A total of 198 participants were randomly allocated to either MPA or NPA groups, 99 in each group. At 16 weeks, the change in MPA showed a greater reduction in migraine attacks versus NPA (mean difference [MD] = -0.6, 95% confidence interval [CI] -1.5 to 0.05; p = 0.069). MPA demonstrated superior responder rates (risk difference = 17.2%, 95% CI 5.2 to 29.1; p = 0.007) and pain reduction (MD = -0.6, 95% CI -1.1 to -0.2; p = 0.003) after treatment. At follow-up, MPA improved all migraine symptoms and some quality of life compared with NPA. Adverse events occurred in 5.1% of MPA participants. CONCLUSIONS: Although MPA and NPA showed comparable preventive effects, MPA provided sustained symptom relief and quality-of-life improvements. Therefore, suitable acupoint selection establishes therapeutic potential, whereas acupuncture methods critically determine long-term clinical benefits.