Acupuncture for Migraine Without Aura and Connection-Based Efficacy Prediction: A Randomized Clinical Trial
Abstract
Importance: Connectome-based predictive modeling (CPM) uses a data-driven whole-brain framework to identify connectivity patterns predicting clinical outcomes. However, CPM's application to acupuncture in migraine without aura (MWOA) remains novel.
Objective: To evaluate the clinical efficacy of real acupuncture and sham acupuncture in MWOA, and to identify acupuncture-response brain connectivity patterns using CPM analysis of baseline functional magnetic resonance imaging (fMRI) data.
Design, setting, and participants: This single-blinded randomized clinical trial was conducted from June 2021 to June 2023 at Beijing Hospital of Traditional Chinese Medicine in China. It enrolled participants aged 18 to 65 years who met the MWOA criteria of the International Classification of Headache Disorders, 3rd edition. Eligible participants were randomly assigned to receive real acupuncture or sham acupuncture, and underwent baseline clinical assessments and baseline fMRI scans. Data analyses were performed between October 2024 and March 2025 following intention-to-treat and per-protocol principles.
Interventions: Both treatment groups received 12 sessions of 30-minute acupuncture over 4 weeks. Real acupuncture involved 8 acupoints with deqi sensation, while sham acupuncture used sham acupoints without deqi.
Main outcomes and measures: Primary outcome was the change from baseline in monthly migraine days (MMDs) during weeks 1 to 4. Secondary outcomes included 50% or greater reduction in…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 120 participants or records.
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