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

Stefano Palomba, Francesco Orio, Francesco Manguso, Tiziana Russo, Angela Falbo, Gaetano Lombardi, Patrizia Doldo, Fulvio Zullo

Research output: Contribution to journalArticle

29 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)1012-1020
Number of pages9
JournalFertility and Sterility
Volume83
Issue number4
DOIs
Publication statusPublished - Apr 2005

Fingerprint

tibolone
Leuprolide
Irritable Bowel Syndrome
Menstrual Cycle
Placebos
Quality of Life
Signs and Symptoms
Tablets
Therapeutics
Gonadotropin-Releasing Hormone
Randomized Controlled Trials

Keywords

  • GnRH analogue
  • Irritable bowel syndrome (IBS)
  • Menstrual cycle
  • Quality of life
  • Sex hormones

ASJC Scopus subject areas

  • Obstetrics and Gynaecology

Cite this

Leuprolide acetate treatment with and without coadministration of tibolone in premenopausal women with menstrual cycle-related irritable bowel syndrome. / Palomba, Stefano; Orio, Francesco; Manguso, Francesco; Russo, Tiziana; Falbo, Angela; Lombardi, Gaetano; Doldo, Patrizia; Zullo, Fulvio.

In: Fertility and Sterility, Vol. 83, No. 4, 04.2005, p. 1012-1020.

Research output: Contribution to journalArticle

Palomba, Stefano ; Orio, Francesco ; Manguso, Francesco ; Russo, Tiziana ; Falbo, Angela ; Lombardi, Gaetano ; Doldo, Patrizia ; Zullo, Fulvio. / Leuprolide acetate treatment with and without coadministration of tibolone in premenopausal women with menstrual cycle-related irritable bowel syndrome. In: Fertility and Sterility. 2005 ; Vol. 83, No. 4. pp. 1012-1020.
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AB - 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.

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