title: Simvastatin and vitamin D for migraine prevention: A randomized, controlled trial.
abstract: OBJECTIVE
  The aim of this work was to assess efficacy and tolerability of simvastatin plus vitamin D for migraine prevention in adults with episodic migraine.
  
  
  METHODS
  We performed a randomized, double-blind, placebo-controlled trial with a 12-week baseline period and 24-week intervention period in 57 adults with episodic migraine. Participants were randomly assigned to simvastatin 20 mg tablets twice-daily plus vitamin D3 1,000 international units capsules twice-daily or matching placebo tablets and capsules.
  
  
  RESULTS
  Compared to placebo, participants using simvastatin plus vitamin D3 demonstrated a greater decrease in number of migraine days from the baseline period to intervention weeks 1 to 12: a change of -8.0 (interquartile range [IQR]: -15.0 to -2.0) days in the active treatment group versus +1.0 (IQR: -1.0 to + 6.0) days in the placebo group, p < 0.001; and to intervention weeks 13 to 24: a change of -9.0 (IQR: -13 to -5) days in the active group versus +3.0 (IQR: -1.0 to + 5.0) days in the placebo group, p < 0.001. In the active treatment group, 8 patients (25%) experienced 50% reduction in the number of migraine days at 12 weeks and 9 (29%) at 24 weeks postrandomization. In comparison, only 1 patient (3%) in the placebo group (p = 0.03) experienced such a reduction. Adverse events were similar in both active treatment and placebo groups.
  
  
  CONCLUSIONS
  The results demonstrate that simvastatin plus vitamin D is effective for prevention of headache in adults with episodic migraine. Given statins' ability to repair endothelial dysfunction, this economical approach may also reduce the increased risk for vascular diseases among migraineurs.
authors.affiliation: Department of Medicine, Beth Israel Deaconess Medical Center, and Harvard Medical School, Boston, MA.
authors.forename: Catherine
authors.initials: C
authors.lastname: Buettner
authors.affiliation: Department of Neurology, Rambam Health Care Campus, and Faculty of Medicine, Technion-Israel Institute of Technology, Haifa, Israel.
authors.forename: Rony-Reuven
authors.initials: RR
authors.lastname: Nir
authors.affiliation: Department of Medicine, Beth Israel Deaconess Medical Center, and Harvard Medical School, Boston, MA.
authors.forename: Suzanne M
authors.initials: SM
authors.lastname: Bertisch
authors.affiliation: Department of Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, and Harvard Medical School, Boston, MA.
authors.forename: Carolyn
authors.initials: C
authors.lastname: Bernstein
authors.affiliation: Department of Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, and Harvard Medical School, Boston, MA.
authors.forename: Aaron
authors.initials: A
authors.lastname: Schain
authors.affiliation: Department of Epidemiology, Harvard School of Public Health, Department of Medicine, Beth Israel Deaconess Medical Center, and Harvard Medical School, Boston, MA.
authors.forename: Murray A
authors.initials: MA
authors.lastname: Mittleman
authors.affiliation: Department of Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, and Harvard Medical School, Boston, MA.
authors.forename: Rami
authors.initials: R
authors.lastname: Burstein
mesh_terms: D000328:Adult; D002762:Cholecalciferol / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D008297:Male; D008875:Middle Aged; D008881:Migraine Disorders / Q000517:prevention & control*; D017063:Outcome Assessment, Health Care; D019821:Simvastatin / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D055815:Young Adult
chemical_list: D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D002762:Cholecalciferol; D019821:Simvastatin