Migraine without aura affects hundreds of millions of people worldwide and remains underdiagnosed and undertreated in most health systems. A randomized clinical trial published in JAMA Network Open shows modest superiority of real acupuncture over sham acupuncture in reducing migraine days (effect of around 1 day per month), and advances into a methodologic territory not previously explored: identification of baseline brain connectivity patterns — measurable before treatment initiation — capable of predicting with statistical significance which patients will achieve therapeutic response. This convergence of clinical efficacy and predictive neuroimaging represents a relevant advance for evidence-based medical acupuncture.
CLINICAL TRIAL NUMBERS
Study design
The trial, conducted between 2021 and 2023 at the Beijing Hospital of Traditional Chinese Medicine, recruited 120 participants with established diagnosis of migraine without aura. After a four-week baseline period, patients were randomized to receive real acupuncture at acupoints established for migraine or sham acupuncture — with needles inserted at clinically inactive sites — across twelve sessions distributed over four weeks. A subsample underwent functional magnetic resonance imaging (fMRI) before treatment initiation, allowing the application of predictive modeling based on individual connectome.
Clinical results
Real acupuncture produced significantly greater reduction in monthly migraine days compared with sham (median difference: −1.0 day; p=0.02). In addition to pain days, the real group demonstrated superiority in monthly headache days, days of rescue medication use, pain intensity scores, and measures of functional disability. Patient satisfaction was considerably higher in the group that received real acupuncture (96.7% vs. 73.3%; p=0.01). The safety profile was favorable in both groups, with only mild and self-limited adverse events (4.2% overall), with no records of serious events.
The connectome as a predictive biomarker
The most innovative aspect of the study was the application of connectome-based predictive modeling to identify, before treatment initiation, patterns of functional brain connectivity associated with therapeutic response. The resting-state fMRI data revealed two distinct predictive patterns: low connectivity between the default mode network and subcortical structures predicted significant pain relief (r=0.23; p=0.04), while high connectivity between subcortical, cerebellar, and motor regions predicted disability reduction (r=0.29; p=0.02).
These findings suggest that migraine is not a homogeneous condition from the standpoint of brain organization, and that certain profiles of functional connectivity may identify subgroups of patients with greater likelihood of response to acupuncture. The possibility of stratifying patients by neuroimaging before treatment initiation represents a step toward precision medicine applied to medical acupuncture.
Implications for medical practice
The publication of this trial in JAMA Network Open confers visibility to a level of methodologic rigor that is frequently absent in the acupuncture literature. The use of fMRI to map predictors of response, combined with the controlled design and adequate sample size for an exploratory study, positions this work as a reference for larger-scale confirmatory trials. The results are particularly relevant for neurologists and pain medicine specialists who treat patients with chronic or episodic migraine of difficult pharmacologic control.
Frequently Asked Questions
The results of this trial indicate that real acupuncture produces significant reduction in migraine days compared with sham, with clinical relevance. However, medical acupuncture is best understood as a complementary strategy to pharmacologic treatment, not as a substitute. The physician — neurologist or pain specialist — should individually evaluate each patient’s profile to indicate the most appropriate therapeutic combination.
Sham acupuncture consists of inserting needles at clinically inactive sites, unrelated to the established acupoints for the condition being treated. It is used as an active control in clinical trials to control for the placebo effect of needle insertion and interaction with the practitioner. The superiority of real acupuncture over sham in this study indicates that the observed therapeutic effect goes beyond placebo response.
Fonte Original
JAMA Network Open(em inglês)Founded in 1989 by physicians trained at the University of São Paulo (USP) and specialized in China, CEIMEC is a Brazilian national reference in the teaching and practice of medical acupuncture. With more than 3,000 physicians trained over 35 years, it collaborates with HC-FMUSP and is recognized by the Brazilian Medical College of Acupuncture (CMBA/AMB).
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