Gabapentin for the Management of Chronic Pelvic Pain in Women (GaPP1)

A Pilot Randomised Controlled Trial

Steff C. Lewis, Siladitya Bhattacharya, Olivia Wu, Katy Vincent, Stuart A. Jack, Hilary O. D. Critchley, Maureen A. Porter, Denise Cranley, John A. Wilson, Andrew W. Horne

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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.
Original languageEnglish
Article numbere0153037
Pages (from-to)1-12
Number of pages12
JournalPloS ONE
Volume11
Issue number4
DOIs
Publication statusPublished - 12 Apr 2016

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Pelvic Pain
Chronic Pain
pain
Randomized Controlled Trials
placebos
cost effectiveness
Placebos
Pathology
Cost effectiveness
Cost-Benefit Analysis
willingness to pay
Pain
emotions
gabapentin
Pain Management
interviews
Health Care Costs
Uncertainty
uncertainty
planning

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Lewis, S. C., Bhattacharya, S., Wu, O., Vincent, K., Jack, S. A., Critchley, H. O. D., ... Horne, A. W. (2016). Gabapentin for the Management of Chronic Pelvic Pain in Women (GaPP1): A Pilot Randomised Controlled Trial. PloS ONE, 11(4), 1-12. [e0153037]. https://doi.org/10.1371/journal.pone.0153037

Gabapentin for the Management of Chronic Pelvic Pain in Women (GaPP1) : A Pilot Randomised Controlled Trial. / Lewis, Steff C.; Bhattacharya, Siladitya; Wu, Olivia; Vincent, Katy; Jack, Stuart A.; Critchley, Hilary O. D.; Porter, Maureen A.; Cranley, Denise; Wilson, John A.; Horne, Andrew W.

In: PloS ONE, Vol. 11, No. 4, e0153037, 12.04.2016, p. 1-12.

Research output: Contribution to journalArticle

Lewis, SC, Bhattacharya, S, Wu, O, Vincent, K, Jack, SA, Critchley, HOD, Porter, MA, Cranley, D, Wilson, JA & Horne, AW 2016, 'Gabapentin for the Management of Chronic Pelvic Pain in Women (GaPP1): A Pilot Randomised Controlled Trial', PloS ONE, vol. 11, no. 4, e0153037, pp. 1-12. https://doi.org/10.1371/journal.pone.0153037
Lewis, Steff C. ; Bhattacharya, Siladitya ; Wu, Olivia ; Vincent, Katy ; Jack, Stuart A. ; Critchley, Hilary O. D. ; Porter, Maureen A. ; Cranley, Denise ; Wilson, John A. ; Horne, Andrew W. / Gabapentin for the Management of Chronic Pelvic Pain in Women (GaPP1) : A Pilot Randomised Controlled Trial. In: PloS ONE. 2016 ; Vol. 11, No. 4. pp. 1-12.
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note = "Acknowledgments The authors thank Ann Doust for trial management, and Helen Dewart and Ros Campbell for patient recruitment. Funding: The study was funded by a project grant to AH SB OW HC MP JW and SL from the Chief Scientist's Office of Scotland, UK (CZH/4/688) (http://www.cso.scot.nhs.uk/grants).",
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N1 - Acknowledgments The authors thank Ann Doust for trial management, and Helen Dewart and Ros Campbell for patient recruitment. Funding: The study was funded by a project grant to AH SB OW HC MP JW and SL from the Chief Scientist's Office of Scotland, UK (CZH/4/688) (http://www.cso.scot.nhs.uk/grants).

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N2 - 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.

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