Clinical trials in the premenstrual syndrome

Abstract

Patient selection, assessment of symptoms and the variable nature of the condition makes it difficult to organize effective clinical trials in the treatment of the premenstrual syndrome. The trials described in this report have been of a special single-blind, placebocontrolled design suited to the condition. Accepting the limitations of this form of assessment, a 73% and 63% sustained improvement was found after dydrogesterone and pyridoxine treatment, respectively. The dydrogesterone trial also included a 43% improvement with placebo and this should be considered us a positive result. No serious side-effects were reported. The dose of dydrogesterone was 10 mg b.d. from Days 12 to 26 and long-acting pyridoxine 100 mg daily from Day 10 to Day 3 of the following cycle. The effect of counselling as compared with active treatment and placebo is discussed.