S Palomba1, M Pellicano, P Affinito, C Di Carlo, F Zullo, C Nappi. 1. Department of Gynecology, Obstetrics and Pathophysiology of Human Reproduction, University of Naples Federico II, Naples, Italy. stefano.palombal@tin.it
Abstract
OBJECTIVE: To evaluate whether administration of tibolone changes the effectiveness of GnRH analogue administered before laparoscopic myomectomy. DESIGN: Prospective, randomized, open, placebo-controlled clinical trial. SETTING: Department of Gynecology and Obstetrics, University of Naples Federico II, Naples, Italy. PATIENT(S): 66 women with symptomatic uterine leiomyomas. INTERVENTION(S): Treatment for 2 months with leuprolide acetate and iron tablets, plus tibolone (group A) or placebo tablets (group B); or with leuprolide acetate and iron tablets (group C). MAIN OUTCOME MEASURE(S): Laparoscopic myomectomy at the end of treatment. Operative time and blood loss during surgery were recorded. Uterine volume, volume and number of uterine leiomyomas, volume and echogenicity of the largest uterine leiomyomas, hematologic data, and myoma-related symptoms were evaluated at baseline and 1 week before and after surgery. RESULT(S): Uterine and leiomyomata volume and myoma-related symptoms were significantly reduced and hematologic variables improved significantly in groups A and B, compared with baseline values and with group C. Operative time and blood loss were significantly less in groups A and B than in group C. After surgery, hematologic variables were significantly worse in group C compared with groups A and B. During the study no significant difference was detected between groups A and B. CONCLUSIONS: Administration of tibolone administration in patients treated with GnRH analogue before laparoscopic myomectomy does not change the effectiveness of the analogue administered alone.
RCT Entities:
OBJECTIVE: To evaluate whether administration of tibolone changes the effectiveness of GnRH analogue administered before laparoscopic myomectomy. DESIGN: Prospective, randomized, open, placebo-controlled clinical trial. SETTING: Department of Gynecology and Obstetrics, University of Naples Federico II, Naples, Italy. PATIENT(S): 66 women with symptomatic uterine leiomyomas. INTERVENTION(S): Treatment for 2 months with leuprolide acetate and iron tablets, plus tibolone (group A) or placebo tablets (group B); or with leuprolide acetate and iron tablets (group C). MAIN OUTCOME MEASURE(S): Laparoscopic myomectomy at the end of treatment. Operative time and blood loss during surgery were recorded. Uterine volume, volume and number of uterine leiomyomas, volume and echogenicity of the largest uterine leiomyomas, hematologic data, and myoma-related symptoms were evaluated at baseline and 1 week before and after surgery. RESULT(S): Uterine and leiomyomata volume and myoma-related symptoms were significantly reduced and hematologic variables improved significantly in groups A and B, compared with baseline values and with group C. Operative time and blood loss were significantly less in groups A and B than in group C. After surgery, hematologic variables were significantly worse in group C compared with groups A and B. During the study no significant difference was detected between groups A and B. CONCLUSIONS: Administration of tibolone administration in patients treated with GnRH analogue before laparoscopic myomectomy does not change the effectiveness of the analogue administered alone.
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
Authors: Inge de Milliano; Judith A F Huirne; Andreas L Thurkow; Celine Radder; Marlies Y Bongers; Huib van Vliet; Jonas van de Lande; Peter M van de Ven; Wouter J K Hehenkamp Journal: Acta Obstet Gynecol Scand Date: 2019-09-27 Impact factor: 3.636