Authors:
Di Carlo C. Palomba S. Tommaselli GA. Guida M. Di Spiezio Sardo A. Nappi C.
Institution:
Dr. C. Di Carlo, Clinica Ostetrica/Ginecologica, Via S. Pansini 5, 80131 Naples; Italy.
Title Use of leuprolide acetate plus tibolone in the treatment of severe premenstrual syndrome (2001-3261).
Source:
Fertility and Sterility. Vol 75(2) (pp80-384), 2001.
Abstract:
Objectives:
To evaluate the effectiveness of GnRH agonist (GnRH-a) plus tibolone in the treatment of severe premenstrual syndrome (PMS).
Design:
Prospective, double-blind, placebo-controlled clinical trial.
Setting:
Department of Obstetrics and Gynecology, University of Naples 'Federico II,' Naples, Italy.
Patients:
Thirty patients affected by severe PMS, aged 23-29 years (mean age +/- SD, 25.3 +/- 2.9 years). Intervention(s): Treatment for two cycles with leuprolide acetate depot (3.75 mg IM for 28 days) in association with tibolone (2.5 mg/d orally) or placebo (1 tablet per day orally).
Main Outcome Measure(s):
The mean severity of each symptom and sign of PMS was evaluated using a visual analog scale during the last 7 days of each treatment cycle in comparison with the last 7 days of the cycle before treatment.
Results:
Mean scores for each of the adverse psychological/physical and positive psychological symptoms were significantly improved during treatment. No statistically significant difference was detected between patients treated with tibolone and placebo. A significantly lower number of hot flushes per day was observed in groups treated with GnRH-a and tibolone in comparison with GnRH-a and placebo.
Conclusion(s):
Tibolone administered in association with GnRH-a does not reduce the therapeutic effect of GnRH-a in women affected by PMS. Tibolone used in association with GnRH-a may provide long-term medical treatment for women with PMS. Copyright (copyright) 2001 American Society for Reproductive Medicine.
   
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