Effectiveness and safety of GB20 acupoint pharmacopuncture with lidocaine 2% in migraine: A randomised clinical trial assessing headache characteristics and MIDAS-Ina score
Jeffry Alamsjah, Irma Nareswari, Ahmad Aulia Jusuf, Henry Riyanto SofyanBackground
Migraine is one of the three most disabling neurological disorders worldwide. Pharmacopuncture, the injection of pharmacological agents at acupuncture points, offers prolonged acupoint stimulation with a reduced treatment frequency, yet its efficacy in migraine has not been evaluated. We aimed to compare pharmacopuncture using 2% lidocaine at acupoint GB20 with propranolol pharmacotherapy in patients with migraine.
Methods
An open-label randomised clinical trial was conducted at the Neurology and Medical Acupuncture Outpatient Clinics of RSUPN Dr Cipto Mangunkusumo, Jakarta, Indonesia (August–December 2025). Thirty adults with migraine (ICHD-3 criteria; ≥3 attacks/month) were randomised 1:1 to pharmacopuncture (bilateral GB20 injection of 0.5 mL 2% lidocaine per point, once weekly for 4 weeks; n = 15) or medication (propranolol 20 mg twice daily for 28 days; n = 15). Outcomes including headache frequency, duration, intensity (Visual Analogue Scale), MIDAS-Ina score, most bothersome symptom (MBS) improvement, and adverse events were assessed at baseline, week 4 and week 8.
Results
No statistically significant between-group differences were detected in any headache characteristic or MIDAS-Ina change at either timepoint (all p > 0.05). Within the pharmacopuncture group, headache frequency (p = 0.013) and MIDAS-Ina score (p = 0.013 at week 4; p = 0.008 at week 8) decreased significantly; pain intensity reached significance at week 8 (p = 0.037). Within the medication group, intensity decreased significantly at both week 4 (p = 0.001) and week 8 (p = 0.036), and MIDAS-Ina at week 8 (p = 0.003). No significant between-group difference was found in MBS improvement (p = 0.748). Adverse events were mild in both groups with no significant intergroup difference (p = 0.264). A supplementary mixed-design (time × group) analysis of variance conducted to account for within-subject correlation across the three assessment timepoints showed no significant time × group interaction for any outcome (frequency: F(2,56) = 0.17, p = 0.845; duration: F(2,56) = 1.03, p = 0.363; intensity: F(2,56) = 1.41, p = 0.253; MIDAS-Ina: F(2,56) = 0.49, p = 0.615), corroborating the absence of a differential treatment trajectory between groups.
Conclusion
GB20 pharmacopuncture with 2% lidocaine produced reductions in migraine-related disability and headache frequency in the same direction as propranolol 20 mg twice daily, without evidence of a statistically significant between-group difference, and with a favourable safety profile. Pharmacopuncture may present as an alternative prophylactic modality for migraine.