Simvastatin and vitamin D for migraine prevention: A randomized, controlled trial

Randomized controlled trial in adults with episodic migraine recruited from the greater Boston area. Participants were age 18 or older, had a diagnosis of episodic migraine with a baseline migraine-day burden, and could continue usual migraine medications; 28 participants were randomized to the active simvastatin plus vitamin D3 arm.

For the active arm, participants received oral simvastatin 20 mg twice daily plus vitamin D3 1,000 IU twice daily for 24 weeks. The comparison arm received matching placebo tablets and capsules.

Compared with placebo, simvastatin plus vitamin D reduced migraine days and increased 50% responder rates, with adverse events similar to placebo and good adherence. In the active arm, migraine days decreased by -8.0 (IQR: 215.0 to 22.0) days from baseline to weeks 1-12 (p < 0.001). Eight patients (25%) were responders at 12 weeks and 9 (29%) at 24 weeks. The authors concluded that the combination was effective for migraine prevention, but the independent contributions of simvastatin and vitamin D could not be separated.

Small, single-center trial with 28 participants in the active arm and a 24-week follow-up period. The sample was mostly women and non-Hispanic White adults from the greater Boston area, limiting generalizability. Because simvastatin and vitamin D were given together, the trial could not isolate the effect of either component alone.