Sodium valproate in migraine without aura and medication overuse headache: a randomized controlled trial.

Abstract

OBJECTIVE:

To assess the efficacy, safety and tolerability of sodium valproate (800mg/die) compared with placebo in medication-overuse headache patients with a history of migraine without aura.

METHODS:

This is a multicenter, randomized, double-blind, placebo-controlled study enrolled medication-overuse headache patients for a 3-month treatment period with sodium valproate (800mg/day) or placebo after a 6 day outpatient detoxification regimen, followed by a 3-month follow-up. Primary outcome was defined by the proportion of patients achieving ≥50% reduction in the number of days with headache per month (responders) from the baseline to the last 4 weeks of the 3-month treatment. Multivariate logistic regression models were used on the primary endpoint, adjusting for age, sex, disease duration, comorbidity and surgery. The last-observation-carried-forward method was used to adjust for missing values.

RESULTS:

Nine sites enrolled 130 patients and, after a 6-day detoxification phase, randomized 88 eligible patients. The 3-month responder rate was higher in the sodium valproate (45.0%) than in the placebo arm (23.8%) with an absolute difference of about 20% (p=0.0431). Sodium valproate had safety and tolerability profiles comparable to placebo.

CONCLUSIONS:

The present study supports the efficacy and safety of sodium valproate in the treatment of medication overuse headache with history of migraine after detoxification.

• Authors: Paola Sarchielli, Paolo Messina, Letizia M Cupini, Gioacchino Tedeschi, Vittorio Di Piero, Paolo Livrea, Luigi A Pini, Giorgio Bernardi, Giorgio Bono, Giorgio Sandrini, Stefano Caproni, Ilenia Corbelli, Francesco Pisani, Ettore Beghi, Paolo Calabresi, SAMOHA Study Group
• Journal: European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology (Eur Neuropsychopharmacol) Vol. 24 Issue 8 Pg. 1289-97 (Aug 2014) ISSN: 1873-7862 [Electronic] Netherlands
• PMID: 24862255 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2014 Elsevier B.V. and ECNP. All rights reserved.

Chemical References

• Antimanic Agents
• Valproic Acid

Topics

• Adolescent
• Adult
• Age Factors
• Analysis of Variance
• Antimanic Agents (therapeutic use)
• Disability Evaluation
• Double-Blind Method
• Drug Overdose (complications)
• Female
• Follow-Up Studies
• Headache (drug therapy, etiology)
• Humans
• Logistic Models
• Male
• Middle Aged
• Migraine Disorders (complications, drug therapy)
• Pain Measurement
• Quality of Life
• Surveys and Questionnaires
• Valproic Acid (therapeutic use)
• Young Adult