Abstract
Combined oral contraceptives are often considered a treatment option for women with premenstrual syndrome or premenstrual dysphoric disorder also seeking contraception, but evidence for this treatment is scarce. We aimed to determine (1) the level of evidence for the efficacy of combined oral contraceptives in managing premenstrual depressive symptoms and overall premenstrual symptomatology and (2) the comparative efficacy of combined oral contraceptives (the International Prospective Register of Systematic Reviews registration number CRD42020205510). We searched Cochrane Central Register of Controlled Trials, PubMed, Web of Science, PsycINFO, EMCare, and Embase from inception to June 3,2021. All randomized clinical trials that evaluated the efficacy of combined oral contraceptives in women with premenstrual syndrome or premenstrual dysphoric disorder were considered eligible for inclusion in this meta-analysis. A random effect Bayesian pairwise and network meta-analysis was conducted with change in premenstrual depressive symptoms and overall premenstrual symptomatology between baseline and 3 cycles as outcome. Certainty of the evidence was assessed using the Grading of Recommendations, Assessment, Development, and Evaluation approach. Of 3664 records, 9 eligible trials were included that studied 1205 women with premenstrual syndrome or premenstrual dysphoric disorder (mean age per study range, 24.6-36.5 years). The pairwise meta-analysis revealed that combined oral contraceptives were more efficacious than placebo in treating overall premenstrual symptomatology (standardized mean difference, 0.41; 95% credible interval, 0.17-0.67), but not premenstrual depressive symptoms specifically (standardized mean difference, 0.22; 95% credible interval,-0.06 to 0.47). However, none of the combined oral contraceptives were more effective than each other in reducing premenstrual depressive symptoms and overall premenstrual symptomatology. Combined oral contraceptives may improve overall premenstrual symptomatology in women with premenstrual syndrome or premenstrual dysphoric disorder, but not premenstrual depressive symptoms. There is no evidence for one combined oral contraceptive being more efficacious than any other.
Highlights
Symptoms that occur in the luteal phase of the menstrual cycle and resolve after the onset of menstruation characterize the premenstrual syndrome (PMS) and its more severe variant premenstrual dysphoric disorder (PMDD).1e4 A broad range of physical and affective symptoms may be present, but in women with PMDD, severe affective symptoms such as depression are the primary complaint.[1]
This approval was based on the results of 2 randomized clinical trials in women with PMDD reporting that the use of this formulation reduced overall premenstrual symptomatology compared with placebo.[9,10]
We originally aimed to investigate whether studies with a greater proportion of women with PMDD reported larger effect sizes compared with placebo than those that included a smaller proportion of women with PMDD, using meta-regression analyses
Summary
Symptoms that occur in the luteal phase of the menstrual cycle and resolve after the onset of menstruation characterize the premenstrual syndrome (PMS) and its more severe variant premenstrual dysphoric disorder (PMDD).1e4 A broad range of physical and affective symptoms may be present, but in women with PMDD, severe affective symptoms such as depression are the primary complaint.[1]. The evidence for their efficacy remains scarce. Ethinylestradiol drospirenone (20 mg, 3 mg) in a 24-day regimen is the only combined oral contraceptive that has been approved by the US Food and Drug Administration for the treatment of PMDD.[8] This approval was based on the results of 2 randomized clinical trials in women with PMDD reporting that the use of this formulation reduced overall premenstrual symptomatology compared with placebo.[9,10] other trials showed that the same ethinylestradiol drospirenone combination in a different treatment regimen in women with PMS11 and the same combination but with a slightly higher ethinylestradiol dosage (30 mg) in women with PMDD were not effective.[12] Notably, 2 trials investigating the continuous use of ethinylestradiol levonorgestrel (20 mg, 90 mg) in women with
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