1. Randomized placebo controlled trial of lofexidine hydrochloride for chronic pelvic pain in women
- Author
-
Lucy Bradbury, R. William Stones, and Denise Anderson
- Subjects
Visual analogue scale ,Placebo-controlled study ,Placebo ,Pelvic Pain ,Clonidine ,Body Mass Index ,Placebos ,medicine ,Humans ,Completely randomized design ,Acetaminophen ,Intention-to-treat analysis ,business.industry ,Codeine ,Pelvic pain ,Rehabilitation ,Anti-Inflammatory Agents, Non-Steroidal ,Obstetrics and Gynecology ,LOFEXIDINE HYDROCHLORIDE ,Treatment Outcome ,Reproductive Medicine ,Anesthesia ,Lofexidine ,Chronic Disease ,Drug Therapy, Combination ,Female ,medicine.symptom ,business ,Adrenergic alpha-Agonists ,medicine.drug - 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.
- Published
- 2001