Leuprolide acetate treatment with and without coadministration of tibolone in premenopausal women with menstrual cycle-related irritable bowel syndrome

Objective: To evaluate the effectiveness of gonadotropin-releasing hormone agonists (GnRH-a) with or without coadministration of tibolone in women with menstrual cycle-related irritable bowel syndrome (IBS). Design: Prospective, randomized, placebo-controlled clinical trial. Setting: Universities of Catanzaro and Naples. Patient(s): One hundred twenty young premenopausal women with menstrual cycle-related IBS (Rome II criteria). Intervention(s): Administration of leuprolide acetate depot (LAD, 11.25 mg IM/3 months) plus tibolone (group A), LAD plus placebo tablets (group B), and injection of a placebo solution plus placebo tablets (group C). Main Outcome Measure(s): Severity of bowel symptoms or signs of IBS and quality of life (QoL), at baseline and after 6 months of treatment. Result(s): In all groups, the mean scores for each symptom or sign of IBS and for QoL were significantly improved after treatment. A significant difference was observed between group C and groups A and B. No difference between these last groups was detected in symptoms or signs of IBS. The QoL scores were significantly higher in group A than in group B. Conclusion(s): Gondotropin-releasing hormone agonist administration is effective in women with menstrual cycle-related IBS. The addition of tibolone does not reduce effectiveness compared with agonist alone and increases QoL.