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

• Published in: Fertility and sterility Vol. 83; no. 4; p. 1012
• Main Authors: Palomba, Stefano, Orio, Jr, Francesco, Manguso, Francesco, Russo, Tiziana, Falbo, Angela, Lombardi, Gaetano, Doldo, Patrizia, Zullo, Fulvio
• Format: Journal Article
• Language: English
• Published: United States 01-04-2005
• Subjects: Adult; Antineoplastic Agents, Hormonal - administration & dosage; Antineoplastic Agents, Hormonal - adverse effects; Drug Therapy, Combination; Female; Humans; Irritable Bowel Syndrome - drug therapy; Leuprolide - administration & dosage; Leuprolide - adverse effects; Menstrual Cycle; Norpregnenes - administration & dosage; Norpregnenes - adverse effects; Patient Dropouts; Premenopause; Quality of Life; Treatment Outcome
• ISSN: 1556-5653
• DOI: 10.1016/j.fertnstert.2004.12.007

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).
Prospective, randomized, placebo-controlled clinical trial.
Universities of Catanzaro and Naples.
One hundred twenty young premenopausal women with menstrual cycle-related IBS (Rome II criteria).
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).
Severity of bowel symptoms or signs of IBS and quality of life (QoL), at baseline and after 6 months of treatment.
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.
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.