Eighty-two women with complaints of moderate to severe premenstrual symptoms were recruited for a double-blind, controlled trial of a triphasic oral contraceptive (o.c.). Subjects made daily ratings of symptoms for at least one baseline cycle and were then randomly assigned to receive either placebo or o.c. for three months. Twenty-three women dropped out of the study (18 o.c., 5 placebo), 13 failed to show prospective confirmation of moderate to severe premenstrual symptoms, and one placebo subject had an anovulatory cycle. Forty-five women with prospectively-confirmed premenstrual changes (20 o.c., 25 placebo) completed the study. Premenstrual breast pain and bloating were significantly reduced with active treatment compared to placebo (p less than 0.03) but there were no beneficial effects of the o.c. over placebo for any of the mood symptoms. Women who received o.c.s reported decreased sexual interest after starting treatment and this effect was independent of any adverse influence on mood.
PIP: A placebo-controlled, double-blind study of triphasic oral contraceptives for prospectively confirmed premenstrual syndrome (PMS) was conducted with 82 subjects, 59 of whom completed the study and who were later confirmed to have moderate to severe premenstrual symptoms. 212 subjects were recruited between April 1987 - June 1988, and completed a menstrual history form and a 95-item retrospective questionnaire on premenstrual symptoms. Subjects took Synphasic (Syntex, Mississauga, Canada) containing 35 mcg ethinyl estradiol and 0.5 mg, 1.0 mg, and 0.5 mg norethindrone. Subjects were monitored for 1 menstrual cycle for baseline, then took triphasic or placebo for 3 cycles. 23 oral contraceptive taking and 36 placebo subjects completed the trial: completers had higher status occupations and lower symptom severity scores than dropouts. Both pill and placebo groups showed significant clinical improvement on every symptom except headache. Symptom scores decreased significantly between baseline and 3rd treatment cycle, and between menstrual phase scores and the variables "mood swings," "more sleep," "unhappy," and "tense" in the 2nd treatment cycle compared with the 1st treatment cycle in both groups. In the pill group ratings of premenstrual breast pain were significantly lower in the 3rd treatment cycle compared with baseline (p0.05), and to the 1st treatment cycle (p0.01). No significant changes in breast pain were found in the placebo group. Some pill cycles showed significant reduction in edema. Those in the pill group who were initially rated as "depressed" showed greater improvement in work impairment, sleep requirements, and energy level premenstrually. The pill group, however, reported significantly lower sexual interest during treatment. This is the 1st reported double-blind, placebo-controlled, prospectively confirmed study of oral contraceptives for PMS.