Human Reproduction, Vol 13, 2402-2405, Copyright © 1998 by Oxford University Press
O Taskin, R Gokdeniz, A Yalcinoglu, A Buhur, F Burak, R Atmaca and U Ozekici
Central nervous system hormones have been linked to premenstrual syndrome
(PMS) and beta-endorphin (beta-EP) is thought to be involved in the
pathophysiology. We have tested the efficacy of the synthetic steroid Org
OD 14 (tibolone) in the treatment of PMS. This prospective, randomized,
placebo-controlled, double-blind cross-over study included 18 ovulatory
women with PMS as ascertained by a visual linear analogue scale (VLAS). The
women in each group received either 2.5 mg per day Org OD 14 (n = 9) or a
multi-vitamin pill as placebo (n = 9) for 3 months. Treatments were then
crossed over to a placebo for a further 3 months. VLAS ratings were
evaluated at the end of each menstrual cycle throughout the study.
Peripheral beta-EP concentrations were determined by radioimmunoassay on
days 7 and 25 of each menstrual cycle. Changes in VLAS score and beta-EP
concentrations from baseline were calculated and analysed by Student's
paired t-test. Improvements in VLAS scores and beta-EP concentrations were
evident during the second and third months of tibolone treatment. At the
end of the third month, there was a significant improvement in VLAS scores
of all symptom categories compared with pretreatment and placebo during
treatment with tibolone (P < 0.05). Similar results were obtained in the
first placebo group when switched to tibolone. Beta-EP concentrations were
not significantly different between the study groups at the initial cycle
(15.9 +/- 3.6 versus 17.2 +/- 2.3 pg/ml). The increase in beta-EP
concentration was significantly greater on day 25 of the menstrual cycle in
women treated with tibolone compared with baseline and placebo group (22.5
+/- 4.4 versus 15.9 +/- 3.6 and 17.2 +/- 2.3 pg/ml respectively, P <
0.05). Our data confirm the clinical efficacy of tibolone in PMS-related
symptoms, as well as its effects on serum beta- EP concentrations in
patients with PMS.
ARTICLES
Placebo-controlled cross-over study of effects of tibolone on premenstrual symptoms and peripheral beta-endorphin concentrations in premenstrual syndrome
Department of Obstetrics and Gynecology, Inonu University School of Medicine, Malatya, Turkey.
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