Background: Acupuncture has shown benefit in preventing migraine attacks, but there has been no clear recommendation about the number of treatment sessions that should be provided.

Objectives: The aim of this study was to examine whether 5 sessions of acupuncture treatment is non-inferior to 10 sessions for migraine.

Methods: We performed a multicenter, open-label, randomized, controlled clinical trial across five hospitals in Thailand. Migraine patients were randomly assigned into two groups: treatment with 5 sessions of acupuncture (group A) or 10 sessions of acupuncture (group B). Acupuncture was performed twice a week. We measured the number of migraine days, average pain severity according to a 0-10 numeric pain rating scale (NPRS) and quality of life using the EQ-5D-5L questionnaire, comparing 4 weeks after treatment versus baseline.

Results: Of 156 patients, 83 and 73 patients were assigned to groups A and B, respectively. Comparing 4 weeks after treatment with baseline, the mean reduction in the number of headache days in groups A and B was 6.4 (95% confidence interval [CI] 4.8 to 7.9) days and 6.4 (95% CI 4.5 to 8.4) days, respectively (p = 0.97). The mean difference between the reduction in headache days of the two groups was -0.1 (95% CI -2.5 to 2.4) days, which included the pre-specified non-inferiority limit of -1. The mean reduction of NPRS scores in groups A and B was 4.5 (95% CI 3.8 to 5.1) and 3.8 (95% CI 3.1 to 4.5), respectively (p = 0.17). Both groups showed an improvement in quality of life.

Conclusion: Both 5 and 10 sessions of acupuncture were associated with apparent benefits in terms of preventing migraine attacks, reducing the severity of the headache and improving quality of life, based on comparisons between baseline and follow-up in both study groups. Although we were unable to demonstrate non-inferiority of 5 sessions versus 10 sessions of acupuncture, the effects in the two groups were not significantly different and the temporal effects appeared to last for at least 1 month.

Trial registration number: TCTR20170612002 (Thai Clinical Trials Registry).