Gabapentin for the Treatment of Vulvodynia: A Randomized Controlled Trial.
Gabapentin for the Treatment of Vulvodynia: A Randomized Controlled Trial.
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DOI：
10.1097/aog.0000000000002617
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发表时间：
2018-06
影响因子：
7.2
通讯作者：
Gabapentin (GABA) Study Group
中科院分区：
文献类型：
--
作者：
Brown CS;Bachmann GA;Wan J;Foster DC;Gabapentin (GABA) Study Group
To evaluate whether extended-release gabapentin is more effective than placebo among women with vulvodynia. In a multicenter double-blind, placebo-controlled randomized crossover trial, gabapentin (1200 – 3000 mg/day) was compared to placebo. The primary outcome was mean pain intensity (0, no pain at all to 10, worse pain ever)on the tampon test (a standardized tampon insertion and removal test used as a surrogate marker for dyspareunia) during the last 7 days of the maintenance phase. Secondary outcomes included sexual intercourse pain and daily pain. A sample size of 53 provided 90% power to detect a one-point reduction on the tampon test (.05 level, two-sided) between the two treatment phases. From August 2012 to January 2016, 230 women were screened at three academic institutions and 89 (mean age: 37; 66% black) were randomized: 45 to gabapentin first and then placebo; and 44 to placebo first and then gabapentin. Tampon pain with gabapentin was not different compared to placebo (adjusted mean: 4.0 [95% confidence interval, CI, 3.0–4.9] vs. 4.3 [95% CI, 3.4–5.2], difference: -0.3 [95% CI, -0.7–0.0]; P=.07). Gabapentin also did not improve pain over placebo for sexual intercourse pain (adjusted mean: 3.9 [95% CI, 2.4–5.3] vs. 4.0 [95% CI, 2.5–5.4], difference: -0.1 [95% CI, -0.9–0.6]; P=.76) and daily pain (adjusted mean: 2.7 [95% CI, 1.8–3.6] vs. 2.9 [95% CI, 2.0–3.8], difference: -0.2 [95% CI, -0.5– -0.2]; P=.36). Subset analyses found that longer pain duration and oral contraceptive nonuse were associated with minimal improvement in tampon testpain with gabapentin. In this cohort, extended-release gabapentin, as compared with placebo did not reduce tampon pain. These data do not support the recommendation of gabapentin alone as treatment for vulvodynia.
