Authors:
Palomba S. Affinito P. Tommaselli GA. Nappi C.
Institution
Dr. S. Palomba, Cattedra di Ginecologia e Ostetricia, Facolta di Medicina e Chirurgia, Universita degli Studi Napoli, Via Pansini, 5, 80131 Naples; Italy.
Title:
A clinical trial of the effects of tibolone administered with gonadotropin-releasing hormone analogues for the treatment of uterine leiomyomata. (1998 2933)
Source:
Fertility and Sterility. Vol 70(1) (pp11-118), 1998.
Abstract:
Objectives:
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.
Design:
A prospective, randomized, double-blind, placebo-controlled, clinical trial.
Setting:
Department of Gynecology and Obstetrics, University of Naples 'Federico II,' Naples, Italy.
Patients:
Fifty women with symptomatic uterine leiomyomata.
Interventions:
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).
Main Outcome Measure(s):
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.
Conclusion(s):
Administration of tibolone in association with GnRH-a reduces vasomotor symptoms and prevents bone loss, without compromising the therapeutic efficacy of GnRH-a alone.
   
Please click on the required question.
Do you have an unanswered women's health question?
Please let us have your general question on our
NEW FORUM
/ MESSAGE BOARDS facility and we will try
to answer it for you. I am sure that you will appreciate that we cannot offer advice on the management of an individual's specific problem.
DISCLAIMER
The aim of this web site is to provide a general guide and it is
not intended as a substitute for a consultation with an appropriate specialist
in respect of individual care and treatment.
Thank you for your visiting us at 2womenshealth.com.
This is the personal website of David A Viniker MD FRCOG, Consultant Obstetrician and Gynaecologist at Whipps Cross University Hospital, London.
I do hope that you find the answers to your questions in the patient information and medical advice provided.
If you still have unanswered questions, please consider entering them into one of our forums and I will try to assist you.
 | | 
