Gabapentin for the Treatment of Vulvodynia: A Randomized Controlled Trial
Autor: | David C. Foster, Jim Y. Wan, Candace Brown, Gloria Bachmann |
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Rok vydání: | 2018 |
Předmět: |
medicine.medical_specialty
030219 obstetrics & reproductive medicine Gabapentin Surrogate endpoint business.industry Obstetrics and Gynecology General Medicine Placebo medicine.disease Crossover study Article law.invention Clinical trial 03 medical and health sciences 0302 clinical medicine Randomized controlled trial law Internal medicine Cohort medicine Vulvodynia 030212 general & internal medicine business medicine.drug |
Zdroj: | Obstetrical & Gynecological Survey. 73:525-527 |
ISSN: | 1533-9866 0029-7828 |
Popis: | Objective To evaluate whether extended-release gabapentin is more effective than placebo among women with vulvodynia. Methods In a multicenter double-blind, placebo-controlled randomized crossover trial, gabapentin (1,200-3,000 mg/d) was compared with a placebo. The primary outcome was mean pain intensity (0, no pain at all to 10, worst 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 1-point reduction on the tampon test (.05 level, two-sided) between the two treatment phases. Results From August 2012 to January 2016, 230 women were screened at three academic institutions and 89 (mean age 37 years; 65% black) were randomized: 45 to gabapentin first and then placebo and 44 to placebo first and then gabapentin. Tampon test pain with gabapentin was not different compared with the placebo (adjusted mean 4.0, 95% CI 3.0-4.9 vs 4.3, 95% CI 3.4-5.2, difference -0.3, 95% CI -0.7 to 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 to 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 to -0.2; P=.36). Subset analyses found that longer pain duration and oral contraceptive nonuse were associated with minimal improvement in tampon test pain with gabapentin. Conclusion In this cohort, extended-release gabapentin, as compared with a placebo, did not reduce tampon test pain. These data do not support the recommendation of gabapentin alone as treatment for vulvodynia. Clinical trial registration ClinicalTrials.gov, NCT01301001. |
Databáze: | OpenAIRE |
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