Traditional Chinese medicine versus flunarizine for the preventive treatment of episodic migraine: a randomized controlled clinical trial

Abstract Background The prophylactic effects of traditional Chinese medicine (TCM) for migraine without aura are uncertain. Aim This study aimed to evaluate the efficacy and safety of TCM compared with flunarizine as a prophylactic treatment for episodic migraine in adults. Design and Methods In this randomized clinical trial (4-week treatment and 12-week follow-up), participants were allocated in a 1:1 ratio to receive either TCM (acupuncture: three sessions/week; Chinese herbal medicine: two packets per day) or flunarizine (10 mg per day). The primary outcome was the mean change from baseline in monthly migraine days (MMDs) during weeks 1–4. Results and Conclusion Of 343 patients screened, with 212 (mean age, 46.1 [SD 8.9] years; 162 [76.4%] female) were included in the intention-to-treat analyses. Baseline characteristics were cpmparable between groups. The TCM group demonstrated a significantly greater reduction in MMDs than the flunarizine group during both weeks 1–4 and weeks 5–16, with a difference of –0.64 days (95% CI: –1.07 to –0.20; P = 0.004) during weeks 1–4. and –1.13 days (95% CI: –1.48 to –0.78; P < 0.001) during weeks 5–16. These findings indicate that TCM is effective in preventing episodic migraine, with superior efficacy to flunarizine after 4 weeks of treatment, and sustained benefits for 16 weeks. TCM may therefore be considered an optional preventive therapy for episodic migraine without aura. These results support its use in patients unwilling to take, or unresponsive to, prophylactic drugs, and suggest its consideration in future clinical guidelines.