A Cochrane review [Abstract] 1 included 6 RCTs with a total of 1009 subjects with migraine. Five trials were on gabapentin and one trial on its prodrug gabapentin enacarbil; no reports on pregabalin were identified. All six trials had a parallel-group design. The median duration of the treatment phase of the included trials was 12 weeks. One trial each of gabapentin 900 mg (n=53), and gabapentin titrated to 1200 mg (n=63) and 1800 mg (n=122) failed to show a statistically significant reduction in headache frequency when compared to the placebo group, whereas one trial of gabapentin titrated to 1800 to 2400 mg (n=113) demonstrated a small but statistically significant superiority of active treatment (MD -0.80; 95% CI -1.55 to -0.05). The pooled results do not demonstrate a significant difference between gabapentin and placebo (MD -0.44; 95% CI -1.43 to 0.56; 4 trials, n=351). One trial of gabapentin titrated to 1800 mg (n=122) failed to demonstrate a significant difference between active treatment and placebo in the proportion of responders (OR 0.97; 95% CI 0.45 to 2.11), whereas one trial of gabapentin titrated to 1800 to 2400 mg (n=113) demonstrated a small but statistically significant superiority of active treatment for this outcome (OR 2.79; 95% CI 1.09 to 7.17). The pooled results of these two studies (OR 1.59; 95% CI 0.57 to 4.46; n=235) do not demonstrate a significant difference between gabapentin and placebo. Comparisons from one study (n=135) suggest that gabapentin 2000 mg is no more effective than gabapentin 1200 mg. One trial of gabapentin enacarbil (n=523) failed to demonstrate a significant difference vs. placebo or between doses for gabapentin enacarbil titrated to between 1200 mg and 3000 mg with regard to proportion of responders; there was also no evidence of a dose-response trend. Five most prevalent adverse events with gabapentin were asthenia/fatigue, dizziness, flu syndrome, somnolence, and abnormal thinking.
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