Objective: To evaluate the effectiveness of GnRH agonist (GnRH-a) plus tibo
lone 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 "Fed
erico II," Naples, Italy.
Patient(s): 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 pla
cebo (I 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 tr
eatment cycle in comparison with the last 7 days of the cycle before treatm
ent.
Result(s): Mean scores for each of the adverse psychological/physical and p
ositive psychological symptoms were significantly improved during treatment
. No statistically significant difference was detected between patients tre
ated with tibolone and placebo. A significantly lower number of hot hushes
per day was observed in groups treated with GnRH-a and tibolone in comparis
on with GnRH-a and placebo.
Conclusion(s): Tibolone administered in association with GnRH-a does not re
duce the therapeutic effect of GnRH-a in women affected by PMS. Tibolone us
ed in association with GnRH-a may provide long-term medical treatment for w
omen with PMS. (C)2001 by American Society for Reproductive Medicine.