Dataset Information

Gabapentin for the Treatment of Vulvodynia: A Randomized Controlled Trial.

ABSTRACT: 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.

SUBMITTER: Brown CS

PROVIDER: S-EPMC6020139 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature

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Gabapentin for the Treatment of Vulvodynia: A Randomized Controlled Trial.

Brown Candace S CS Bachmann Gloria A GA Wan Jim J Foster David C DC

Obstetrics and gynecology 20180601 6

<h4>Objective</h4>To evaluate whether extended-release gabapentin is more effective than placebo among women with vulvodynia.<h4>Methods</h4>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 ...[more]

PMID: 29742655

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Project description:BackgroundSexual dysfunction is common in women with vulvodynia.ObjectiveThe purpose of this study was (1) to evaluate whether extended-release gabapentin is more effective than placebo in improving sexual function in women with provoked vulvodynia and whether there is a relationship between treatment outcome and pelvic pain muscle severity that is evaluated by palpation with standardized applied pressure and (2) to evaluate whether sexual function in women with provoked vulvodynia would approach that of control subjects who report no vulvar pain either before or after treatment.Study designAs a secondary outcome in a multicenter double-blind, randomized crossover trial, sexual function that was measured by the Female Sexual Function Index was evaluated with gabapentin (1200-3000 mg/d) compared with placebo. Pain-free control subjects, matched by age and race, also completed Female Sexual Function Index for comparison.ResultsFrom August 2012 to January 2016, 230 women were screened at 3 academic institutions, and 89 women were assigned randomly to treatment. Gabapentin was more effective than placebo in improving overall sexual function (adjusted mean difference, 1.3; 95% confidence interval, 0.4-2.2; P=.008), which included desire (mean difference, 0.2; 95% confidence interval, 0.0-3.3; P=.04), arousal (mean difference, 0.3; 95% confidence interval, 0.1-0.5; P=.004), and satisfaction (mean difference, 0.3; 95% confidence interval, 0.04-0.5; P=.02); however, sexual function remained significantly lower than in 56 matched vulvodynia pain-free control subjects. There was a moderate treatment effect among participants with baseline pelvic muscle pain severity scores above the median on the full Female Sexual Function Index scale (mean difference, 1.6; 95% confidence interval, 0.3-2.8; P=.02) and arousal (mean difference, 0.3; 95% confidence interval, 0.1-0.6; P=.01) and pain domains (mean difference, 0.4; 95% confidence interval, 0.02-0.9; P=.04).ConclusionGabapentin improved sexual function in this group of women with provoked vulvodynia, although overall sexual function remained lower than women without the disorder. The most statistically significant increase was in the arousal domain of the Female Sexual Function Index that suggested a central mechanism of response. Women with median algometer pain scores >5 improved sexual function overall, but the improvement was more frequent than the pain domain. We hypothesize that gabapentin may be effective as a pharmacologic treatment for those women with provoked vulvodynia and increased pelvic muscle pain on examination.

Project description:ImportanceApproved medications for alcohol dependence are prescribed for less than 9% of US alcoholics.ObjectiveTo determine if gabapentin, a widely prescribed generic calcium channel/γ-aminobutyric acid-modulating medication, increases rates of sustained abstinence and no heavy drinking and decreases alcohol-related insomnia, dysphoria, and craving, in a dose-dependent manner.Design, participants and settingA 12-week, double-blind, placebo-controlled, randomized dose-ranging trial of 150 men and women older than 18 years with current alcohol dependence, conducted from 2004 through 2010 at a single-site, outpatient clinical research facility adjoining a general medical hospital.InterventionsOral gabapentin (dosages of 0 [placebo], 900 mg, or 1800 mg/d) and concomitant manual-guided counseling.Main outcomes and measuresRates of complete abstinence and no heavy drinking (coprimary) and changes in mood, sleep, and craving (secondary) over the 12-week study. RESULTS Gabapentin significantly improved the rates of abstinence and no heavy drinking. The abstinence rate was 4.1% (95% CI, 1.1%-13.7%) in the placebo group, 11.1% (95% CI, 5.2%-22.2%) in the 900-mg group, and 17.0% (95% CI, 8.9%-30.1%) in the 1800-mg group (P = .04 for linear dose effect; number needed to treat [NNT] = 8 for 1800 mg). The no heavy drinking rate was 22.5% (95% CI, 13.6%-37.2%) in the placebo group, 29.6% (95% CI, 19.1%-42.8%) in the 900-mg group, and 44.7% (95% CI, 31.4%-58.8%) in the 1800-mg group (P = .02 for linear dose effect; NNT = 5 for 1800 mg). Similar linear dose effects were obtained with measures of mood (F2 = 7.37; P = .001), sleep (F2 = 136; P < .001), and craving (F2 = 3.56; P = .03). There were no serious drug-related adverse events, and terminations owing to adverse events (9 of 150 participants), time in the study (mean [SD], 9.1 [3.8] weeks), and rate of study completion (85 of 150 participants) did not differ among groups.Conclusions and relevanceGabapentin (particularly the 1800-mg dosage) was effective in treating alcohol dependence and relapse-related symptoms of insomnia, dysphoria, and craving, with a favorable safety profile. Increased implementation of pharmacological treatment of alcohol dependence in primary care may be a major benefit of gabapentin as a treatment option for alcohol dependence.Trial registrationclinicaltrials.gov Identifier: NCT00391716.

Project description:OBJECTIVE:To evaluate the effect of oral gabapentin in conjunction with usual oral pain management regimens of lorazepam, ibuprofen, oxycodone, and acetaminophen for surgical abortion on pain 5 minutes postprocedure. METHODS:This was a randomized, double-blind, placebo-controlled trial of patients from 6 0/7-14 6/7 weeks of gestation scheduled to undergo surgical abortion at the Duke Family Planning Clinic. Participants were administered 600 mg of oral gabapentin compared with placebo with usual oral pain management. Pain score was assessed using a 100-mm visual analog scale, with the primary outcome being pain score 5 minutes after the procedure. The effect of gabapentin was assessed using a linear regression model controlling for baseline pain. We also measured pain perception 24 hours after the procedure. Secondary outcome measures included anxiety, side effects, and usage of opiate pain medication in the 24-hour postoperative period. RESULTS:Out of 113 women screened for this study; 96 women were recruited, enrolled, and randomized to study treatment arm from August 2016 to June 2018. Pain at 5 minutes after the procedure was similar between the gabapentin and placebo groups ((Equation is included in full-text article.)=3.40; 95% CI -8.20 to 15.0; P=.56). Gabapentin and placebo were well tolerated, with no statistically significant difference in side effects or anxiety levels. Although prescription of opioids after the procedure was not standardized among patients, 73% of women received a short-term prescription for oxycodone. A lower percentage of women in the gabapentin group self-reported taking opioids in the 24 hours postprocedure (18% vs 47%; odds ratio 0.26; 95% CI 0.09-0.75). CONCLUSION:The addition of gabapentin to usual oral pain management regimens with paracervical block did not reduce postoperative pain for patients undergoing outpatient surgical abortion. Although the addition of gabapentin was well tolerated and reduced oral opiate use 24 hours postprocedure, it did not affect the experience of pain during and immediately after the procedure. CLINICAL TRIAL REGISTRATION:ClinicalTrials.gov, NCT02725710.

Project description:BackgroundDespite advances in the development of pharmacotherapy for alcohol use disorder (AUD), there remains a need for medications that can be administered to actively drinking outpatients to promote a reduction in harmful alcohol consumption. The primary aim of this pilot study was to determine whether high-dose gabapentin (3600 mg/daily) is more effective than placebo in reducing harmful alcohol consumption in outpatients with AUD.MethodsForty patients (27 men) who met DSM-IV-TR criteria for alcohol dependence and reporting at least 4 heavy drinking days (HDD) per week were recruited at a single site. Participants were actively drinking at study entry and received double-blind gabapentin (3600 mg/day; n = 19) or placebo (n = 20) for 8 weeks. Study medication was titrated over 5 days and administered in three divided doses (1200 mg three times per day). The proportion of HDD (primary outcome) and percent days abstinent (PDA; secondary outcome) were analyzed using generalized longitudinal mixed models with the predictors being study arm, week, study arm by week interaction, and corresponding baseline drinking measure.ResultsThere was a significant interaction between study arm and week for the proportion of HDD per week, F (7, 215) = 3.33, p = 0.002 . There was also a significant interaction between study arm and week for PDA per week, F (7, 215) = 3.11, p = 0.004. The overall retention rate was 67.5% with no significant difference in time-to-dropout between treatment groups. There were no serious adverse events. No participants were removed from the trial due to the development of moderate-to-severe alcohol withdrawal (CIWA-Ar ≥ 13).ConclusionsGabapentin treatment rapidly titrated to a dosage of 3600 mg/day is associated with a reduction in the proportion of HDD per week and an increase in PDA per week in actively drinking outpatients with AUD. High-dose gabapentin is potentially a feasible approach to treating AUD and deserving of further study.

Dataset Information

Gabapentin for the Treatment of Vulvodynia: A Randomized Controlled Trial.

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Gabapentin for the Treatment of Vulvodynia: A Randomized Controlled Trial.

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