Use of leuprolide acetate plus tibolone in the treatment of severe premenstrual syndrome.
OBJECTIVE
To evaluate the effectiveness of GnRH agonist (GnRH-a) plus tibolone in the treatment of severe premenstrual syndrome (PMS).


METHODS
Prospective, double-blind, placebo-controlled clinical trial.


METHODS
Department of Obstetrics and Gynecology, University of Naples Federico II, Naples, Italy. PATIENT(S); Thirty patients affected by severe PMS, aged 23-29 years (mean age +/- SD, 25.3 +/- 2.9 years).


METHODS
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).


METHODS
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.


CONCLUSIONS
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.
Di Carlo
C
C
Department of Obstetrics and Gynecology, University Federico II of Naples, Via S. Pansini, 5, 80131 Naples, Italy.
Palomba
S
S
Tommaselli
G A
GA
Guida
M
M
Di Spiezio Sardo
A
A
Nappi
C
C
D000328:Adult; D045930:Anabolic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D019584:Hot Flashes; D006801:Humans; D016729:Leuprolide / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D009652:Norpregnenes / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D010919:Placebos; D011293:Premenstrual Syndrome / Q000188:drug therapy*; D011446:Prospective Studies
D045930:Anabolic Agents; D009652:Norpregnenes; D010919:Placebos; D016729:Leuprolide; C027385:tibolone