Short-term administration of tibolone plus GnRH analog before laparoscopic myomectomy

Study Objective. To evaluate whether tibolone modifies the effectiveness of gonadotropin-releasing hormone (GnRH) analog administered before laparoscopic myomectomy. Design. Prospective, randomized, open, placebo-controlled clinical trial (Canadian Task Force classification 1). Setting. University-affiliated hospital. Patients. Sixty-six women with symptomatic leiomyomas. Interventions. Patients received 2 months of treatment with GnRH analog and iron plus tibolone (group A) or placebo (group B); group C received only iron. Laparoscopic myomectomy was performed after medical treatment. Measurements and Main Results. Uterine volume, number and volume of leiomyomas, echogenicity and volume of the largest leiomyomas, hematologic values, and myoma-related symptoms were evaluated at baseline, I week before, and I week after surgery We observed significant (p <0.05) reductions in uterine and leiomyomata volume, myoma-related symptoms, and improvement in hematologic values before surgery in groups A and B, without significant difference between groups compared with baseline values and group C. Operating time and blood loss were significantly (p <0.05) lower in groups A and B, without significant difference compared with group C. After surgery, significant numbers of women in group C had worsening of hematologic values (p <0.05). Conclusion. Adding tibolone to the GnRH analog regimen before laparoscopic myomectomy does not modify the effectiveness of GnRH analog administered alone.