Placebo-controlled cross-over study of effects of tibolone on premenstrual symptoms and peripheral β-endorphin concentrations in premenstrual syndrome
Source: Human Reproduction, Volume 13, Number 9, September 1998 , pp. 2402-2405(4)
Publisher: Oxford University Press
Abstract:Central nervous system hormones have been linked to premenstrual syndrome (PMS) and β-endorphin (β-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 β-EP concentrations were determined by radioimmunoassay on days 7 and 25 of each menstrual cycle. Changes in VLAS score and β-EP concentrations from baseline were calculated and analysed by Student's paired t-test. Improvements in VLAS scores and β-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. β-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 β-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 β-EP concentrations in patients with PMS.
Keywords:β-endorphin/premenstrual syndrome/tibolone/ therapy
Document Type: Research Article
Affiliations: 1: Department of Obstetrics and Gynecology, Division of Reproductive Endocrinology, Inonu University School of Medicine, Malatya, Turkey 2: Firat University School of Medicine, Elazig, Turkey
Publication date: 1998-09-01
- Human Reproduction features full-length, peer-reviewed papers reporting original research, clinical case histories, as well as opinions and debates on topical issues. Papers published cover the scientific and medical aspects of reproductive physiology and pathology, endocrinology, andrology, gonad function, gametogenesis, fertilization, embryo development, implantation, pregnancy, genetics, genetic diagnosis, oncology, infectious disease, surgery, contraception, infertility treatment, psychology, ethics and social issues. The highest scientific and editorial standard is maintained throughout the journal along with a rapid rate of publication.