Randomised controlled trial of gabapentin for chronic pelvic pain in women
The Lancet(2020)
摘要
Background Chronic pelvic pain (CPP) affects 2-24% of women worldwide and evidence for medical treatments is limited. Gabapentin is effective in treating some chronic pain conditions. We aimed to determine the efficacy and safety of gabapentin in women with CPP and no obvious pelvic pathology.
Methods We performed a multicentre placebo-controlled randomised trial in 39 UK hospital centres. Participants were randomised to receive gabapentin (titrated to a maximum dose of 2700mg daily) or matching placebo for 16 weeks. The online randomisation system minimised allocations by presence of dysmenorrhea, psychological distress, current hormone use and centre. The dual primary outcome measures were worst and average pain scores assessed separately on a numerical rating scale in weeks 13-16 post-randomisation, in the intention-to-treat population. This trial is registered in the ISRCTN registry, ISCRTN77451762.
Findings 306 women underwent randomisation (153 gabapentin, 153 placebo) between 22nd January 2016 and 6th March 2019. The mean worst pain score 13-16 weeks post-randomisation was 7·1 (standard deviation [SD] 2·6, n=124) in the gabapentin group and 7·4 (SD 2·2, n=122) in the placebo group (adjusted mean difference, -0.20; 97·5% confidence interval [CI] -0.81 to 0·42; p=0·47). The mean average pain score was 4·3 (SD 2·3, n=123) in the gabapentin group and 4·5 (SD 2·2, n=121) in the placebo group (adjusted mean difference, -0·18; 97·5% CI -0·71 to 0·35; p=0·45). More women experienced a serious adverse event in the gabapentin compared to the placebo group (10/153 vs. 3/153; p=0·04). Dizziness, drowsiness and visual disturbances were more common in the gabapentin than in the placebo group (66/122 vs. 32/114 p [less than] 0·001, 64/124 vs. 34/116 p=0·002 and 25/113 vs. 12/110 p=0·01, respectively).
Interpretation In this adequately powered, blinded study, treatment with gabapentin did not result in significantly lower pain scores and was associated with more side effects.
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