A clinical trial of the effects of tibolone administered with gonadotropin-releasing hormone analogues for the treatment of uterine leiomyomata.

OBJECTIVE

To evaluate the effects of tibolone therapy in association with GnRH-a on uterine leiomyomata, on climacteric-like symptoms, on bone metabolism, and on the lipid profile.

METHODS

A prospective, randomized, double-blind, placebo-controlled, clinical trial.

METHODS

Department of Gynecology and Obstetrics, University of Naples "Federico II," Naples, Italy.

METHODS

Fifty women with symptomatic uterine leiomyomata.

METHODS

Six months of treatment with leuprolide acetate (3.75 mg every 28 days IM) combined with daily placebo tablets (group A) or with 2.5-mg of tibolone per os (group B).

METHODS

Uterine and uterine leiomyomata sizes, lumbar spine bone mineral density, biochemical markers of bone metabolism, lipid profile, and myoma-related symptoms were measured at baseline and after 6 months of treatment. Daily symptom diary in which hot flushes and vaginal bleeding episodes were recorded.

RESULTS

No differences between the 2 groups in uterine and uterine leiomyomata size and myoma-related symptoms were detected. After 6 months of treatment, there were statistically significant changes from baseline in bone mineral density and in biochemical markers of bone metabolism in group A but not in group B. Vasomotor symptoms were significantly lower in group B than in group A. There was a statistically significant increase (P<.01) in serum total cholesterol, high-density lipoprotein cholesterol, and triglycerides in group A after 6 months of treatment in comparison with baseline values. The difference in serum total cholesterol and triglyceride levels after 6 months of treatment in group B was not statistically significant in comparison with baseline values, but was statistically significant in comparison with group A values (P<.01). In group B, levels of high-density lipoprotein cholesterol were significantly lower after 6 months of therapy in comparison with baseline values and in comparison with group A values (P<.01). There were no statistically significant changes at baseline and after 6 months of treatment in the level of low-density lipoprotein cholesterol in either group.

CONCLUSIONS

Administration of tibolone in association with GnRH-a reduces vasomotor symptoms and prevents bone loss, without compromising the therapeutic efficacy of GnRH-a alone.