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

Stones, R. William, Bradbury, Lucy and Anderson, Denise (2001) Randomized placebo controlled trial of lofexidine hydrochloride for chronic pelvic pain in women. Human Reproduction, 16 (8), 1719-1721.

Abstract

Background: We hypothesised that the orally-active 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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