Gabapentin for the Management of Chronic Pelvic Pain in Women (GaPP1): A Pilot Randomised Controlled Trial

Steff Lewis, Siladitya Bhattacharya, Olívia Wu, Katy Vincent, Stuart Jack, Hilary Critchley, Maureen Porter, Denise Cranley, John A. Wilson, Andrew W. Horne
In: PLOS ONE · 2016 · vol. 11(4) , pp. e0153037 · doi:10.1371/journal.pone.0153037 · PMID:27070434 · PMC4829183 · W2339871018
article OA: gold CC0 ⤵ 31 in-corpus citations
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⚙ AI-generated summary by claude@2026-06, 2026-06-07 ⓘ

This pilot trial found that gabapentin in women with chronic pelvic pain reduced pain and improved mood compared to placebo, with good participant retention and acceptability.

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⚙ AI-generated deep summary by claude@2026-06, 2026-06-07 ⓘ

This two-centre UK pilot randomized controlled trial evaluated gabapentin versus placebo for chronic pelvic pain in women without obvious pelvic pathology, focusing primarily on feasibility outcomes—recruitment and 6-month retention—while estimating pain/mood changes, acceptability, and cost-effectiveness. Women aged 18–50 with CPP for over six months and negative laparoscopy within a defined window were randomized to escalating gabapentin (300–2700 mg daily) or placebo, with intention-to-treat analyses and additional participant interviews. Of 47 randomized participants (34% of eligible), 25 (53%) completed six-month follow-up, and women assigned to gabapentin reported less pain and improved mood at six months; however, uncertainty remains due to the small sample size and attrition, consistent with a feasibility study. Relevance to endometriosis: the study excludes known pelvic pathology such as endometriosis yet cites prior CPP gabapentin work that included women with endometriosis, so it is indirectly informative for endometriosis-associated chronic pelvic pain management trials.

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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 (300-2700 mg 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.

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chronic_pelvic_pain

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