A RANDOMIZED, PLACEBO-CONTROLLED, CROSSOVER TRIAL OF DANAZOL FOR THE TREATMENT OF PREMENSTRUAL-SYNDROME

To investigate whether danazol is more effective than placebo for the treatment of premenstrual syndrome (PMS), we conducted a randomized, d ouble-blind, crossover study comparing three successive cycles of dana zol (200 mg bid) to three cycles of placebo. Thirty-one women meeting rigorous criteria for a diagnosis of severe PMS over two pretreatment cycles were enrolled; 28 of these subjects completed at least one cycl e of treatment with symptom recordings, which were entered into the an alysis. A significant period effect confounded the planned within-subj ect analysis and therefore, the main treatment comparisons were confin ed to the first period only. Symptom scores on the Premenstrual Tensio n Self-Rating Scale (PMTS), Beck Depression Inventory (BDI), and a Vis ual Analogue Scale (VAS) were compared for the premenstrual week in th e last cycle of treatment. For the 16 patients on danazol, scores on t he PMTS decreased by an average of 14.0 (10.7) (standard deviation) po ints from a baseline of 25.4 (5.6) points. For the 12 patients on plac ebo, PMTS scores decreased by an average of 3.6 (9.5) points from a ba seline of 23.5 (5.8) points (14.0 vs. 3.6; p = .0133, unpaired t-test) . Seven (43.8%) of the subjects on danazol achieved a clinically relev ant reduction of symptoms into the asymptomatic range (PMTS scores les s than or equal to 5) as compared to one (8.3%) of the subjects on pla cebo. Thus, danazol (200 mg bid) provided greater relief from severe P MS during the premenstrual week than did placebo.