A randomized double-blind placebo-controlled trial of thioctic acid in migraine prophylaxis.
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 (-lipoic 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.


CONCLUSIONS
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.
Magis
Delphine
D
Headache Research Unit, Neurology Department, University of Liège, Liège, Belgium.
Ambrosini
Anna
A
Sándor
Peter
P
Jacquy
Jean
J
Laloux
Patrice
P
Schoenen
Jean
J
D000328:Adult; D001530:Belgium; D004311:Double-Blind Method; D004734:Energy Metabolism / Q000502:physiology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D008881:Migraine Disorders / Q000517:prevention & control*; D008928:Mitochondria / Q000378:metabolism; D012720:Severity of Illness Index; D008063:Thioctic Acid / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D014803:Vitamin B Complex / Q000009:adverse effects / Q000627:therapeutic use*
D014803:Vitamin B Complex; D008063:Thioctic Acid