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

Randomized placebo controlled trial of lofexidine hydrochloride for chronic pelvic pain in women
Randomized placebo controlled trial of lofexidine hydrochloride for chronic pelvic pain in women
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.
chronic pelvic pain, lofexidine hydrochloride, women
1719-1721
Stones, R. William
cc80809c-04a3-4dc0-8771-820de97c312d
Bradbury, Lucy
b5cdf78e-a486-43c4-a46f-68d329fcb677
Anderson, Denise
7af6b389-1e50-4e5c-9497-679e8e55eb37
Stones, R. William
cc80809c-04a3-4dc0-8771-820de97c312d
Bradbury, Lucy
b5cdf78e-a486-43c4-a46f-68d329fcb677
Anderson, Denise
7af6b389-1e50-4e5c-9497-679e8e55eb37

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.

Record type: Article

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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More information

Published date: 2001
Keywords: chronic pelvic pain, lofexidine hydrochloride, women

Identifiers

Local EPrints ID: 37808
URI: http://eprints.soton.ac.uk/id/eprint/37808
PURE UUID: 9650c081-2b17-4225-8979-0be4a0d8e8ac

Catalogue record

Date deposited: 01 Jun 2006
Last modified: 08 Jan 2022 12:57

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Contributors

Author: R. William Stones
Author: Lucy Bradbury
Author: Denise Anderson

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