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A Randomized Double-Blind Placebo-Controlled Trial of Thioctic Acid in Migraine Prophylaxis

Authors

  • Delphine Magis MD,

  • Anna Ambrosini MD, PhD,

  • Peter Sándor MD,

  • Jean Jacquy MD, PhD,

  • Patrice Laloux MD, PhD,

  • Jean Schoenen MD, PhD


  • From Headache Research Unit, Neurology Department, University of Liège, Liège, Belgium (Drs. Magis, Ambrosini, and Schoenen); University Hospital Zurich—Headache & Pain Unit, Department of Neurology, Zurich, Switzerland (Dr. Sándor); Neurology Department—Hôpital Civil, Charleroi, Belgium (Dr. Jacquy); University Department of Neurology, Cliniques Universitaires de Mont-Godinne, Yvoir, Belgium (Dr. Laloux); and Department of Molecular Neurobiology Research Center—University of Liège, Liège, Belgium (Dr. Schoenen).

Address all correspondence to Dr. Delphine Magis, University of Liège—Headache Research Unit, Department of Neurology, CHR Citadelle, Boulevard du 12ème de Ligne 1, 4000 Liège, Belgium.

Abstract

Background.—Impaired mitochondrial phosphorylation potential may play a role in migraine pathogenesis. Metabolic enhancers, such as riboflavin or coenzyme Q, are effective in migraine prophylaxis and quasi-devoid of adverse effects. Thioctic acid (-lipoïc acid) is another substance known to enhance energy metabolism in mitochondria and to be beneficial in diabetic neuropathy.

Objective.—After an open pilot study suggesting its therapeutic antimigraine potentials, we embarked therefore in a randomized controlled trial of thioctic acid (Thioctacid) in migraine prophylaxis steered by the Belgian Headache Society.

Methods.—Five Belgian centers recruited 54 migraineurs (43 migraine without aura, 11 with aura; mean age 38 ± 8 years; 7 males). After a 1-month single-blinded run-in period, 44 patients received either placebo (n = 18) or thioctic acid 600 mg p.o./day (n = 26) for 3 months.

Results.—Statistical analysis was carried out on an intention-to-treat basis. Monthly attack frequency tended to be reduced between run-in and the 3rd month of treatment in the thioctic acid group compared to placebo (P= .06). The proportion of 50% responders was not significantly different between thioctic acid (30.8%) and placebo (27.8%). Within-group analyses showed a significant reduction of attack frequency (P= .005), headache days (P= .009), and headache severity (P= .03) in patients treated with thioctic acid for 3 months, while these outcome measures remained unchanged in the placebo group. No adverse effects were reported. For logistical reasons this trial was interrupted before the planned 80 patients were enrolled.

Conclusion.—Albeit underpowered, this study tends to indicate that thioctic acid may be beneficial in migraine prophylaxis. Before any firm conclusion can be drawn, however, a large multicenter trial is necessary.

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