Effect of gabapentin on sexual function in vulvodynia: a randomized, placebo-controlled trial

Sexual dysfunction is common in women with vulvodynia. The 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 pel...

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Published inAmerican journal of obstetrics and gynecology Vol. 220; no. 1; pp. 89.e1 - 89.e8
Main Authors Bachmann, Gloria A., Brown, Candace S., Phillips, Nancy A., Rawlinson, Leslie A., Yu, Xinhua, Wood, Ronald, Foster, David C., Dawicki, Diane, Bonham, Adrienne, Dworkin, Robert, Balabathula, Pavan, Bachour, Candi, Brooks, Ian, Dulin, Turid, Horton, Frank, Sakauye, Mark, Thoma, Laura, Villa, Emanuel, Wang, Jiajing, Ling, Frank, Nyirjesy, Paul, Fosbre, Sue, Hartmann, Dianne, Queenen, John, Pulsinelli, William, Taylor, Deanne, Wesselmann, Ursula
Format Journal Article
LanguageEnglish
Published United States Elsevier Inc 01.01.2019
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Abstract Sexual dysfunction is common in women with vulvodynia. The 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. As 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. From 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). Gabapentin 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.
AbstractList Sexual dysfunction is common in women with vulvodynia. The 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. As 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. From 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). Gabapentin 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.
Sexual dysfunction is common in women with vulvodynia.BACKGROUNDSexual dysfunction is common in women with vulvodynia.The 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.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.As 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.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.From 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).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).Gabapentin 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.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.
Author Dawicki, Diane
Nyirjesy, Paul
Balabathula, Pavan
Pulsinelli, William
Fosbre, Sue
Dworkin, Robert
Taylor, Deanne
Brown, Candace S.
Dulin, Turid
Queenen, John
Bonham, Adrienne
Wood, Ronald
Horton, Frank
Sakauye, Mark
Bachmann, Gloria A.
Brooks, Ian
Thoma, Laura
Bachour, Candi
Villa, Emanuel
Yu, Xinhua
Ling, Frank
Hartmann, Dianne
Phillips, Nancy A.
Wesselmann, Ursula
Wang, Jiajing
Rawlinson, Leslie A.
Foster, David C.
AuthorAffiliation 4 Department of Obstetrics and Gynecology, University of Rochester School of Medicine and Dentistry, Rochester, NJ
3 School of Public Health, Division of Epidemiology, Biostatistics & Environmental Health, University of Memphis, Memphis, TN
2 Department of Clinical and Translational Sciences, University of Tennessee Health Science Center, Memphis, TN
1 Department of Obstetrics, Gynecology and Reproductive Sciences, Rutgers-Robert Wood Johnson Medical School, New Brunswick, NJ
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BackLink https://www.ncbi.nlm.nih.gov/pubmed/30365922$$D View this record in MEDLINE/PubMed
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Dawicki, Diane
Nyirjesy, Paul
Balabathula, Pavan
Brooks, Ian
Thoma, Laura
Pulsinelli, William
Bachour, Candi
Villa, Emanuel
Fosbre, Sue
Ling, Frank
Hartmann, Dianne
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Taylor, Deanne
Wesselmann, Ursula
Dulin, Turid
Wang, Jiajing
Queenen, John
Bonham, Adrienne
Horton, Frank
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Copyright 2018 Elsevier Inc.
Copyright © 2018 Elsevier Inc. All rights reserved.
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Issue 1
Keywords vulvodynia
sexual function
pelvic floor
gabapentin
Language English
License Copyright © 2018 Elsevier Inc. All rights reserved.
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Snippet Sexual dysfunction is common in women with vulvodynia. The purpose of this study was (1) to evaluate whether extended-release gabapentin is more effective than...
Sexual dysfunction is common in women with vulvodynia.BACKGROUNDSexual dysfunction is common in women with vulvodynia.The purpose of this study was (1) to...
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StartPage 89.e1
SubjectTerms Adult
Confidence Intervals
Cross-Over Studies
Delayed-Action Preparations - therapeutic use
Double-Blind Method
Female
gabapentin
Gabapentin - therapeutic use
Humans
Middle Aged
Pain Measurement
Patient Satisfaction - statistics & numerical data
pelvic floor
Pelvic Floor - physiopathology
Prognosis
Reference Values
Risk Assessment
Severity of Illness Index
Sexual Dysfunction, Physiological - drug therapy
sexual function
Treatment Outcome
vulvodynia
Vulvodynia - drug therapy
Vulvodynia - prevention & control
Title Effect of gabapentin on sexual function in vulvodynia: a randomized, placebo-controlled trial
URI https://www.clinicalkey.com/#!/content/1-s2.0-S0002937818309050
https://dx.doi.org/10.1016/j.ajog.2018.10.021
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Volume 220
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