Premenstrual syndrome (PMS) constitutes a real health problem in France. Its etiology is still poorly understood. A national multicenter study has recently been devoted to this problem. The results are reported here.
Study objectives: to improve awareness of the epidemiology of PMS and evaluate the therapeutic activity, on an open-label basis, of a micronized purified flavonoid fraction (Daflon 500 mg).
Methods: the features of PMS were determined prior to the commencement of any treatment by using a daily self-assessment diary consisting of 24 items. The same diary was used for the 3 cycles during which patients were treated with Daflon 500 mg at the dose of 2 tabs/day without interruption. Weight and circumferential measurements were noted at least twice per cycle. Monitoring included telephone contact after one cycle and a final clinical evaluation after 3 cycles under treatment.
Results: of the 1,908 women selected by 887 gynecologists throughout the country, 1,724 contributed to the epidemiological study. It was confirmed that problems related to PMS were significant in 35% of cases and led to time off work in 7.4% of cases. One thousand four hundred and seventy three women completed the therapeutic trial. PMS disappeared completely in 37,4% of patients. The duration of PMS decreased on average by 2.6 days (p < 0.0001). Symptoms of congestion gradually lessened in terms of both frequency and severity by about 60%, the same applying to weight gain (-29% in comparison with the pre-treatment cycle). The safety/acceptability of Daflon 500 mg was considered to be very good by both patients and gynecologists.
Conclusion: the diagnosis and management of PMS require precise evaluation. This study, the results of which require confirmation, justifies the inclusion of Daflon 500 mg among potential treatments offered to women suffering from PMS with a congestive component.