Ovarian suppression with the gonadotrophin-releasing hormone agonist goserelin (Zoladex) in management of the premenstrual tension syndrome.

The objective of this study was to determine the effectiveness of ovarian suppression by a GnRH agonist analogue in 32 women with prospectively confirmed severe premenstrual tension. The design was a randomized, double-blind study comparing goserelin 3.6 mg with placebo, both given as a monthly s.c. injection for 3 months. Self-assessment was by daily visual analogue scales (VAS) for anxiety and depression, daily quantitative symptom rating for breast discomfort, swelling, irritability, tension, depression and by monthly Hospital Anxiety and Depression (HAD) scales. Of the 16 women in each group, 15 completed active and 12 completed placebo therapy. Median symptom scores for whole cycles showed a significant reduction of breast discomfort and swelling during active treatment, with no significant improvement in psychological symptoms. Analysis by cycle phase showed that for individual subjects, pre-treatment differences in VAS scores for anxiety and depression were abolished in a significantly greater proportion of actively treated cycles. Within-group comparisons showed a marked placebo effect and, comparing the two groups, differences reached significance only during treatment cycle 1 and the first post-treatment cycle for anxiety with no significant differences for depression. It was concluded that while suppression of ovarian activity with a gonadotrophin-releasing hormone analogue dampens down cyclical mood swings, it has a more marked effect on the physical components of the premenstrual syndrome. Results reconfirm the positive role of placebo in the management of this condition.

RCT Entities:   Population Interventions Outcomes