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

PLoS One. 2016 Apr 12;11(4):e0153037. doi: 10.1371/journal.pone.0153037. eCollection 2016.

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.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Amines / economics
  • Amines / therapeutic use*
  • Analgesics / economics
  • Analgesics / therapeutic use*
  • Chronic Pain / drug therapy
  • Chronic Pain / economics
  • Cost-Benefit Analysis
  • Cyclohexanecarboxylic Acids / economics
  • Cyclohexanecarboxylic Acids / therapeutic use*
  • Female
  • Gabapentin
  • Humans
  • Models, Statistical
  • Outcome Assessment, Health Care
  • Pain Management / methods
  • Pelvic Pain / drug therapy*
  • Pelvic Pain / economics
  • Pilot Projects
  • Prospective Studies
  • Young Adult
  • gamma-Aminobutyric Acid / economics
  • gamma-Aminobutyric Acid / therapeutic use*

Substances

  • Amines
  • Analgesics
  • Cyclohexanecarboxylic Acids
  • gamma-Aminobutyric Acid
  • Gabapentin

Associated data

  • ISRCTN/ISRCTN45178534