Randomized placebo controlled trial of lofexidine hydrochloride for chronic pelvic pain in women

R W Stones, William Stones, L Bradbury, D Anderson
Human Reproduction · 2001 · vol. 16(8) , pp. 1719–1721 · doi:10.1093/humrep/16.8.1719 · PMID:11473971 · W2096019576
RCT OA: bronze CC0 ⤵ 11 in-corpus citations
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This randomized placebo-controlled trial found that lofexidine hydrochloride was not effective for treating chronic pelvic pain in women.

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Abstract

BACKGROUND: We hypothesised that the orally-active alpha(2)-adrenoceptor agonist lofexidine hydrochloride would ameliorate chronic pelvic pain in women. METHODS: A randomized placebo-controlled parallel group trial was undertaken in the University Hospital Gynaecology Clinic. Women with pelvic pain of at least 6 months duration were eligible, and were randomized using a sealed envelope system to receive up to 600 mg lofexidine hydrochloride twice daily over 8 weeks or placebo. Outcome measures were summary and daily diary visual analog scales for pain (VAS) and a 5 point self rating scale. RESULTS: 9/19 women randomized to lofexidine completed the study compared to 14/20 of those randomized to placebo. Intention-to-treat analysis showed that 4/19 in the lofexidine group achieved 50% or greater reduction in VAS compared with 8/20 in the placebo group (OR 2.5, 95% CI 0.6--10.3). Summary and diary VAS were closely correlated. CONCLUSIONS: Within the limits of a small study with power to detect only a substantial effect, we conclude that lofexidine hydrochloride is not effective for the treatment of chronic pelvic pain.

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Outcome instruments

VAS-pain

Condition tags

chronic_pelvic_pain

MeSH descriptors

Adrenergic alpha-Agonists Clonidine Codeine Pelvic Pain Acetaminophen Acetaminophen Acetaminophen Adrenergic alpha-Agonists Adrenergic alpha-Agonists Adrenergic alpha-Agonists Anti-Inflammatory Agents, Non-Steroidal Anti-Inflammatory Agents, Non-Steroidal Anti-Inflammatory Agents, Non-Steroidal Body Mass Index Chronic Disease Clonidine Clonidine Clonidine Clonidine Codeine

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