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Short-term administration of tibolone plus GnRH analog before laparoscopic myomectomy
Stefano Palomba1, Michele Morelli, Roberto Noia
1Department of Obsterics and Gynecology, University of Messina, Italy.
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 I).
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, 1 week before, and 1 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.