Gabapentin for prevention of hypobaric hypoxia-induced headache: randomized double-blind clinical trial.

BACKGROUND High-altitude headache (HAH) is a hypobaric hypoxia-induced symptom that is commonly experienced by newcomers to high-altitude areas. OBJECTIVE To assess the efficacy of gabapentin in the prevention of HAH. METHODS A placebo-controlled randomised trial was performed at an altitude of 3500 m. Two hundred and four unacclimatised 15-65-year-old (mean age (+/-SD), 31.5 (SD 11.7)) hotel guests were randomly assigned to a 600 mg single-dose of gabapentin capsule or identical placebo. HAH incidence and intensity were measured to assess gabapentin efficacy. Intention-to-treat analysis was performed. RESULTS HAH incidence was not significantly different between subjects under gabapentin (44 (43.1%)) compared with placebo (56 (54.9%); p = 0.09). In contrast, moderate/severe HAH had a lower incidence in the gabapentin group (27 (26.5%)) versus the placebo group (42 (41.2%)), showing that gabapentin reduced HAH attack intensity (p = 0.03). CONCLUSIONS Gabapentin was effective for the prevention of HAH and had satisfactory tolerability. TRIAL REGISTRATION NUMBER ISRCTN26123577.