Gabapentin for the management of chronic pelvic pain in women (GaPP1): a pilot randomised controlled trial

Lewis, Steff C., Bhattacharya, Siladitya ORCID: https://orcid.org/0000-0002-4588-356X, Wu, Olivia, Vincent, Katy, Jack, Stuart A., Critchley, Hilary O. D., Porter, Maureen A., Cranley, Denise, Wilson, John A. and Horne, Andrew W. 2016. Gabapentin for the management of chronic pelvic pain in women (GaPP1): a pilot randomised controlled trial. PLoS ONE 11 (4) , e0153037. 10.1371/journal.pone.0153037

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Abstract

Chronic pelvic pain (CPP) affects 2.1–24% of women. Frequently, no underlying pathology is identified, and the pain is difficult to manage. Gabapentin is prescribed for CPP despite no robust evidence of efficacy. We performed a pilot trial in two UK centres to inform the planning of a future multicentre RCT to evaluate gabapentin in CPP management. Our primary objective was to determine levels of participant recruitment and retention. Secondary objectives included estimating potential effectiveness, acceptability to participants of trial methodology, and cost-effectiveness of gabapentin. Women with CPP and no obvious pelvic pathology were assigned to an increasing regimen of gabapentin (300-2700mg daily) or placebo. We calculated the proportion of eligible women randomised, and of randomised participants who were followed up to six months. The analyses by treatment group were by intention-to-treat. Interviews were conducted to evaluate women’s experiences of the trial. A probabilistic decision analytical model was used to estimate cost-effectiveness. Between September 2012–2013, 47 women (34% of those eligible) were randomised (22 to gabapentin, 25 to placebo), and 25 (53%) completed six-month follow-up. Participants on gabapentin had less pain (BPI difference 1.72 points, 95% CI:0.07–3.36), and an improvement in mood (HADS difference 4.35 points, 95% CI:1.97–6.73) at six months than those allocated placebo. The majority of participants described their trial experience favorably. At the UK threshold for willingness-to-pay, the probabilities of gabapentin or no treatment being cost-effective are similar. A pilot trial assessing gabapentin for CPP was feasible, but uncertainty remains, highlighting the need for a large definitive trial.

Item Type:	Article
Date Type:	Publication
Status:	Published
Schools:	Medicine
Publisher:	Public Library of Science
ISSN:	1932-6203
Date of First Compliant Deposit:	28 August 2018
Date of Acceptance:	21 March 2016
Last Modified:	05 May 2023 02:12
URI:	https://orca.cardiff.ac.uk/id/eprint/114411

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