Enhancing chronic migraine preventive therapy: low-level 810 nm laser acupuncture as an add-on treatment for patients with unsatisfactory pharmacological effect, a pilot single-blind randomized controlled trial.
Study Goal
The researchers aimed to investigate the efficacy and safety of laser acupuncture as an add-on preventive therapy for chronic migraine in adults with unsatisfactory pharmacological effects.
Results Summary
Laser acupuncture significantly reduced monthly migraine days and acute headache medication usage compared to sham treatment, with effects becoming more pronounced over time. No serious adverse events were reported in either group.
Population
Adults with chronic migraine who had unsatisfactory pharmacological effects.
Effective Dosage
8 sessions over 4 weeks (frequency not specified).
Duration
4 weeks of intervention, with follow-up evaluations up to 12 weeks from baseline.
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
laser acupuncture | decrease | monthly migraine days | chronic migraine patients with unsatisfactory pharmacological effects | 5.2 vs. 1.5 days at 8th week | significant reduction | #1 |
laser acupuncture | decrease | monthly migraine days | chronic migraine patients with unsatisfactory pharmacological effects | 7.3 vs. 1.8 days at 12th week | significant reduction | #2 |
laser acupuncture | decrease | acute headache medications usage days per month | chronic migraine patients with unsatisfactory pharmacological effects | 3.1 vs. 0.4 days at 4th week | significant reduction | #3 |
laser acupuncture | decrease | acute headache medications usage days per month | chronic migraine patients with unsatisfactory pharmacological effects | 3.2 vs. 0.0 days at 8th week | significant reduction | #4 |
laser acupuncture | decrease | acute headache medications usage days per month | chronic migraine patients with unsatisfactory pharmacological effects | 3.9 vs. 0.0 days at 12th week | significant reduction | #5 |
laser acupuncture | no change | safety | chronic migraine patients with unsatisfactory pharmacological effects | - | no serious adverse event was observed | #6 |
BACKGROUND: Laser acupuncture is a proven non-invasive treatment with effects comparable to traditional acupuncture in different types of headaches, but there is still insufficient evidence for chronic migraine (CM) in adults. We aim to investigate the efficacy and safety of laser acupuncture (LA) as an add-on preventive therapy on CM. METHODS: A single-blind randomized controlled trial was conducted from January 2022 to November 2023. CM patients with unsatisfactory pharmacological effects were randomly assigned in a 1:1 ratio to receive either LA or sham treatment over a course of 8 sessions spanning 4 weeks. The co-primary outcomes were changes in monthly migraine days (MMD) and acute headache medications usage days per month from baseline. Evaluations were taken at baseline (12 weeks before randomization), at 4th week (treatment completed), 8th week and 12th week from baseline. RESULTS: A total of 60 patients (30 in each group) were included in the intention-to-treat analyses. Baseline headache characteristics between trial groups were similar. Compared with the sham group, the LA group had a significant reduction in MMD (5.2 vs. 1.5 days at 8th week, p = 0.015; 7.3 vs. 1.8 days at 12th week, p = 0.001), and acute headache medications usage days per month (3.1 vs. 0.4 days at 4th week, p = 0.007; 3.2 vs. 0.0 days at 8th week, p = 0.005; 3.9 vs. 0.0 days at 12th week, p < 0.001). No serious adverse event was observed in both groups. CONCLUSIONS: Laser acupuncture was effective in reducing MMD and acute headache medications usage with promising safety. Specifically, the efficacy of LA exhibited a progressively more pronounced effect within the follow-up period. We suggested that LA is a promising add-on preventive therapy for CM, and trials focused on investigating the mechanism of LA's effect and its long-term effects on CM prevention are justified. TRIAL REGISTRATION: The study was retrospectively registered at ISRCTN.org Identifier: ISRCTN11208146 ( https://doi.org/10.1186/ISRCTN11208146 ). The registration date: 19, January, 2024. The date of first participant registration: 04, May, 2022.