OBJECTIVE: To assess whether tibolone can prevent the bone loss and symptomatic side effects normally associated with GnRH agonist (GnRH-a) use and whether tibolone modifies the effect of GnRH-a on endometriosis. DESIGN: Prospective, double-blind, placebo-controlled, group comparative study. SETTING:Gynecological research unit in a London teaching hospital. PATIENTS: Twenty-nine patients with endometriosis and two with fibroids. INTERVENTIONS: Six months of treatment with 3.75 mg/mo IM triptorelin combined with daily tablets of either placebo or 2.5 mg tibolone. MAIN OUTCOME MEASURES: Daily symptom diary for hot flushes and bleeding episodes, laparoscopic scoring of endometriosis, endocrine and biochemical changes, and bone mineral density scans. RESULTS:Lumbar spine bone mineral density decreased significantly from baseline in the placebo group (-5.1%) but not in the tibolone group (-1.1%). The frequency of hot flushes and sweating episodes was reduced significantly by tibolone. There was no difference between the two treatment groups with regard to the endometriosis scores. CONCLUSIONS: The addition of tibolone to GnRH-a treatment reduces the bone loss and vasomotor symptoms that normally occur with GnRH-a, thus making long-term treatment with GnRH-a safer and more acceptable. It does not negate the therapeutic effect of GnRH-a on endometriosis.
RCT Entities:
OBJECTIVE: To assess whether tibolone can prevent the bone loss and symptomatic side effects normally associated with GnRH agonist (GnRH-a) use and whether tibolone modifies the effect of GnRH-a on endometriosis. DESIGN: Prospective, double-blind, placebo-controlled, group comparative study. SETTING: Gynecological research unit in a London teaching hospital. PATIENTS: Twenty-nine patients with endometriosis and two with fibroids. INTERVENTIONS: Six months of treatment with 3.75 mg/mo IM triptorelin combined with daily tablets of either placebo or 2.5 mg tibolone. MAIN OUTCOME MEASURES: Daily symptom diary for hot flushes and bleeding episodes, laparoscopic scoring of endometriosis, endocrine and biochemical changes, and bone mineral density scans. RESULTS: Lumbar spine bone mineral density decreased significantly from baseline in the placebo group (-5.1%) but not in the tibolone group (-1.1%). The frequency of hot flushes and sweating episodes was reduced significantly by tibolone. There was no difference between the two treatment groups with regard to the endometriosis scores. CONCLUSIONS: The addition of tibolone to GnRH-a treatment reduces the bone loss and vasomotor symptoms that normally occur with GnRH-a, thus making long-term treatment with GnRH-a safer and more acceptable. It does not negate the therapeutic effect of GnRH-a on endometriosis.
Authors: Rafael M Moroni; Wellington P Martins; Rui A Ferriani; Carolina S Vieira; Carolina O Nastri; Francisco José Candido Dos Reis; Luiz Gustavo Brito Journal: Cochrane Database Syst Rev Date: 2015-03-20