Oral contraceptives containing drospirenone for premenstrual syndrome.

BACKGROUND: Premenstrual syndrome (PMS) is a common problem. Premenstrual dysphoric disorder (PMDD) is a severe form of PMS. Combined oral contraceptives (COCs), which have both progestin and estrogen, have been examined for their ability to relieve premenstrual symptoms. A COC containing drospirenone and low estrogen has been approved for treating PMDD in women who choose COCs for contraception.

OBJECTIVES: To review all randomized controlled trials comparing combined oral contraceptives containing drospirenone versus a placebo or another COC for effect on premenstrual symptoms.

SEARCH STRATEGY: We searched the computerized databases MEDLINE, POPLINE, CENTRAL, EMBASE, LILACS, PsycINFO, and CINAHL for studies of drospirenone and premenstrual syndrome. We also examined references lists of relevant articles, and wrote to known investigators to find other trials.

SELECTION CRITERIA: We included randomized controlled trials in any language that compared a COC containing drospirenone versus a placebo or another COC for effect on premenstrual symptoms. Primary outcome was the prospective recording of premenstrual symptoms (affective and physical). Adverse events related to COC use were examined.

DATA COLLECTION AND ANALYSIS: Two review authors independently abstracted data and assessed study quality.

MAIN RESULTS: We included five trials with a total of 1600 women. Two placebo-controlled trials of women with PMDD showed less severe premenstrual symptoms after three months with drospirenone (plus ethinyl estradiol (EE) 20g) than with the placebo (WMD -7.83; 95% CI -10.91 to -4.75). The drospirenone group had greater decreases in impairment of productivity (WMD -0.42; 95% CI -0.64 to -0.20), social activities (WMD -0.39; 95% CI -0.62 to -0.15), and relationships (WMD -0.38; 95% CI -0.61 to -0.51). Side effects more common with COC use were nausea, intermenstrual bleeding, and breast pain. Little effect was found on less severe symptoms when comparing drospirenone plus more estrogen to another COC. A six-month study showed fewer symptoms with drospirenone, while a two-year trial found the groups to be similar.

AUTHORS' CONCLUSIONS: Drospirenone plus EE 20 mug may help treat premenstrual symptoms in women with PMDD. The placebo also had a large effect. We do not know whether the COC works after three cycles, for women with less severe symptoms, or better than other COCs. Larger and longer trials of higher quality are needed to address these issues. Trials should follow CONSORT reporting guidelines.