Abstract | BACKGROUND: 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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Authors | Delphine Magis, Anna Ambrosini, Peter Sándor, Jean Jacquy, Patrice Laloux, Jean Schoenen |
Journal | Headache
(Headache)
Vol. 47
Issue 1
Pg. 52-7
(Jan 2007)
ISSN: 0017-8748 [Print] United States |
PMID | 17355494
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)
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Chemical References |
- Vitamin B Complex
- Thioctic Acid
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Topics |
- Adult
- Belgium
- Double-Blind Method
- Energy Metabolism
(physiology)
- Female
- Humans
- Male
- Middle Aged
- Migraine Disorders
(prevention & control)
- Mitochondria
(metabolism)
- Severity of Illness Index
- Thioctic Acid
(adverse effects, therapeutic use)
- Treatment Outcome
- Vitamin B Complex
(adverse effects, therapeutic use)
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