Gabapentin for the Management of Chronic Pelvic Pain in Women (GaPP1): A pilot randomised controlled trial

Lewis, S. C., Bhattacharya, S., Wu, O. , Vincent, K., Jack, S. A., Critchley, H. O.D., Porter, M. A., Cranley, D., Wilson, J. A. and Horne, A. W. (2016) Gabapentin for the Management of Chronic Pelvic Pain in Women (GaPP1): A pilot randomised controlled trial. PLoS ONE, 11(4), e0153037. (doi: 10.1371/journal.pone.0153037) (PMID:27070434) (PMCID:PMC4829183)

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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:Articles
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:Wu, Professor Olivia
Authors: Lewis, S. C., Bhattacharya, S., Wu, O., Vincent, K., Jack, S. A., Critchley, H. O.D., Porter, M. A., Cranley, D., Wilson, J. A., and Horne, A. W.
College/School:College of Medical Veterinary and Life Sciences > Institute of Health and Wellbeing > Health Economics and Health Technology Assessment
Journal Name:PLoS ONE
Publisher:Public Library of Science
ISSN:1932-6203
ISSN (Online):1932-6203
Published Online:12 April 2016
Copyright Holders:Copyright © 2016 Lewis et al.
First Published:First published in PLoS ONE 11(4):e0153037
Publisher Policy:Reproduced under a Creative Commons License

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