The International Journal of Romanian Society of Endocrinology / Registered in 1938

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January - March 2008, Volume 4, Issue 1
Endocrine Care

Zervoudis S, Vladareanu R, Galazios G, Liberis V, Tsikouras P, Veduta A

Oral contraceptives with and without drospirenone in the treatment of premenstrual syndrome and premenstrual dysphoric disorder a multicentric study of 92 cases

Acta Endo (Buc) 2008, 4 (1): 47-58
doi: 10.4183/aeb.2008.47

Aim. The efficacy of various treatment regimens in severe premenstrual syndrome, (PMS), and premenstrual dysphoric disorder, (PMDD).\r\nStudy design. The study group of 92 patients, aged 20-36 years, was assessed for 2 months before and at the end of one of the following 4 months treatment regimens, randomly assigned: A - combined oral contraceptives with drospirenone; B - oral contraceptives without drospirenone; C - selective serotonin reuptake inhibitors; D - EPO and vitamin B6. A not blinded control group of 92 age-matched patients with severe PMS, without medication, was used.\r\nMethods. All 184 patients completed the Prospective Record of the Impact and Severity of Mastodynia (PRISM) calendar published in 1985 (11) for every of the 6 months of the study. We did not manage or analyze PMDD separately from severe PMS. Simple t test of the initial PRISM results was used, as well as Student t test, or the chi2 test / Fisher test for qualitative data for subgroup analysis.\r\nResults. Oral contraceptives with drospirenone (treatment A) significantly improved the breast tenderness (average severity score was 14.5 ? 0.6 before and 8.9 ? 0.7, p< 0.05, after treatment) and the lack of self-control (average severity score was 14.3 ? 0.7 before and 9.1 ? 0.5, p< 0.05 after treatment). However, oral contraceptives without drospirenone (treatment B) also significantly improved the same parameters of PMS: breast tenderness (average severity score was 15.3 ? 0.4 before and 9.2 ? 0.5, p< 0.05 after treatment) and the lack of self-control (average severity score was 15.5 ? 0.5 before and 9.8 ? 0.7, p< 0.05 after treatment). The subgroup on drospirenone oral contraceptives did not show any premenstrual weight gain, unlike the other subgroups. SSRIs (treatment C) significantly improved the lack of self-control (p< 0.01), but without significant effect on breast tenderness and without any effect on the weight gain. EPO and vitamin B6 (treatment D) showed no significant effects.\r\nConclusion. Concerning the number of patients, drospirenone containing oral contraceptives showed effective improvement of PMS in 67.9% (remission) versus 35.9% (remission in the control group without any medication). However, the authors suggest that SSRIs (and not oral contraceptives with or without drospirenone) might be the treatment of choice in cases where mood / behavioral symptoms prevail over physical symptoms.

Keywords: PMS, PMDD, oral contraceptives for PMS, drospirenone

Correspondence: Professor S. Zervoudis, Lito Maternity Hospital, Dept of Mastology, 7-13 Mouson street, 11524. Athens, Greece, phone: 30 6944 308777, e-mail: