Gabapentin for the treatment of vulvodynia

A randomized controlled trial

Candace Brown, Gloria A. Bachmann, Jim Wan, David C. Foster

Research output: Contribution to journalArticle

8 Citations (Scopus)

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 20.3, 95% CI 20.7 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 20.1, 95% CI 20.9 to 0.6; P5.76) and daily pain (adjusted mean 2.7, 95% CI 1.8-3.6 vs 2.9, 95% CI 2.0-3.8, difference 20.2, 95% CI 20.5 to 20.2; 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.

Original languageEnglish (US)
Pages (from-to)1000-1007
Number of pages8
JournalObstetrics and gynecology
Volume131
Issue number6
DOIs
StatePublished - Jun 1 2018

Fingerprint

Vulvodynia
Randomized Controlled Trials
Pain
Placebos
Therapeutics
Coitus
gabapentin
Dyspareunia
Oral Contraceptives
Sample Size

All Science Journal Classification (ASJC) codes

  • Obstetrics and Gynecology

Cite this

Gabapentin for the treatment of vulvodynia : A randomized controlled trial. / Brown, Candace; Bachmann, Gloria A.; Wan, Jim; Foster, David C.

In: Obstetrics and gynecology, Vol. 131, No. 6, 01.06.2018, p. 1000-1007.

Research output: Contribution to journalArticle

Brown, Candace ; Bachmann, Gloria A. ; Wan, Jim ; Foster, David C. / Gabapentin for the treatment of vulvodynia : A randomized controlled trial. In: Obstetrics and gynecology. 2018 ; Vol. 131, No. 6. pp. 1000-1007.
@article{f81a99a71cd64fde83fb26ab475d6643,
title = "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 20.3, 95{\%} CI 20.7 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 20.1, 95{\%} CI 20.9 to 0.6; P5.76) and daily pain (adjusted mean 2.7, 95{\%} CI 1.8-3.6 vs 2.9, 95{\%} CI 2.0-3.8, difference 20.2, 95{\%} CI 20.5 to 20.2; 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.",
author = "Candace Brown and Bachmann, {Gloria A.} and Jim Wan and Foster, {David C.}",
year = "2018",
month = "6",
day = "1",
doi = "10.1097/AOG.0000000000002617",
language = "English (US)",
volume = "131",
pages = "1000--1007",
journal = "Obstetrics and Gynecology",
issn = "0029-7844",
publisher = "Lippincott Williams and Wilkins",
number = "6",

}

TY - JOUR

T1 - Gabapentin for the treatment of vulvodynia

T2 - A randomized controlled trial

AU - Brown, Candace

AU - Bachmann, Gloria A.

AU - Wan, Jim

AU - Foster, David C.

PY - 2018/6/1

Y1 - 2018/6/1

N2 - 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 20.3, 95% CI 20.7 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 20.1, 95% CI 20.9 to 0.6; P5.76) and daily pain (adjusted mean 2.7, 95% CI 1.8-3.6 vs 2.9, 95% CI 2.0-3.8, difference 20.2, 95% CI 20.5 to 20.2; 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.

AB - 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 20.3, 95% CI 20.7 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 20.1, 95% CI 20.9 to 0.6; P5.76) and daily pain (adjusted mean 2.7, 95% CI 1.8-3.6 vs 2.9, 95% CI 2.0-3.8, difference 20.2, 95% CI 20.5 to 20.2; 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.

UR - http://www.scopus.com/inward/record.url?scp=85056253556&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85056253556&partnerID=8YFLogxK

U2 - 10.1097/AOG.0000000000002617

DO - 10.1097/AOG.0000000000002617

M3 - Article

VL - 131

SP - 1000

EP - 1007

JO - Obstetrics and Gynecology

JF - Obstetrics and Gynecology

SN - 0029-7844

IS - 6

ER -