Efficacy of tibolone as "add-back therapy" in conjunction with a gonadotropin-releasing hormone analogue in the treatment of uterine fibroids

Objective: To assess the efficacy of tibolone add-back therapy with Goserelin treatment of uterine fibroids. Design: Randomized placebo-controlled study. Setting: Gynecology department of an inner-city teaching hospital. Patient(s): Seventy-five women of reproductive age with uterine fibroids. Intervention(s): All women were given monthly SC implants of 3.6 mg goserelin and were randomized to take 3 months of placebo followed by 3 months of tibolone 2.5 mg daily (delayed administration), tibolone 2.5 mg daily for 6 months, or placebo for 6 months. Main Outcome Measure(s): Changes in bone mineral density (BMD) at the hip and spine, fibroid and uterine size, and patient symotomatology. Result(s): In the tibolone group, 2% loss of BMD at the spine was observed compared with 5.5% loss in the placebo group. For total hip, tibolone led to a 0.7% gain in BMD compared with a loss of 1.7% in the placebo group. Tibolone did not affect GnRH analogue-induced fibroid shrinkage. Vasomotor symptom scores in women taking tibolone were 2.2 and were significantly lower than those taking placebo or in the delayed administration groups (mean scores 2.9 and 2.7, respectively), Conclusion(s): Tibolone appears to be a safe and effective add-back therapy which can be given from the commencement of GnRH analogue treatment for fibroids. (Fertil Steril (R) 2008;89:421-8. (c) 2008 by American Society for Reproductive Medicine.)