Background: In our systematic review and meta-analysis we aim to summarize and evaluate user satisfaction, body weight control and general well-being of estetrol (E4) in combination with drospirenone (DRSP).
Methods: We followed the standard methods of Cochrane Handbook of Systematic Reviews for interventions and the PRISMA statement guidelines 2020 when conducting and reporting this study. A computer literature search of PubMed, Scopus, Web of Science, and Cochrane Central Register of Controlled Trials was conducted from inception until January 31, 2022. We selected randomized controlled trials (RCTs) assessing the efficacy of Estetrol (E4) when combined with drospirenone (DRSP) on women Safety and menopausal bleeding as well as general well-being, and all relevant outcomes were pooled in the meta-analysis using Review Manager Software
Results: We included ten RCTs in our study with only five RCTs included in the meta-analysis. In the fixed-model effect and the random-effect model there was significant difference with the use of E4 in combination with DRSP regarding all our outcomes as following: abdominal pain [2.2%, CI 95% (1.7,2.7), P< 0.001], acne [3.7%, CI 95% (3.1,4.3), P< 0.001], metrorrhagia [5%, CI 95% (4.2,5.7), P< 0.001], nausea [3.8%, CI 95% (2.9,4.7), P< 0.001], weight increase [2.4%, CI 95% (1.9,2.9), P< 0.001], treatment related adverse events [34.9%, CI 95% (27.2,42.6), P< 0.001], any adverse event lead to discontinuation [6.9%, CI 95% (2.6,11.2), P= 0.002], breast pain [3.6%, CI 95% (1.5,5.4), P< 0.001], dysmenorrhea [3.6%, CI 95% (1.9,5.3), P< 0.001], headache [6.8%, CI 95% (4.3,9.4), P< 0.001], and anxiety [2%, CI 95% (1.4,2.6), P< 0.001]. For absence of scheduled bleeding after second, third and sixth menopausal cycles there was no significant difference as following: [6.3%, CI 95% (-4.3,17), P= 0.243], [7.5%, CI 95% (-4.5%,17%), P=0.243], and [8.3%, CI 95% (-2.1,18.7), P=0.117]. While there was no significant difference in the percentage of occurrence of unscheduled bleeding after first: [1.3%, CI 95% (0,2.7), P=0.05], second [4.4%, CI 95% (1.7,7), P= 0.001], third [3.1%, CI 95% (0.8,5.3), P=0.007], sixth [2.6%, CI 95% (0.6,4.6), P=0.012], and twelfth [1.1%, CI 95% (0.7,1.5), P< 0.001].
Conclusion: In conclusion, our meta-analysis showed that use of E4 in combination with DRSP was associated with decrease abdominal pain, acne, metrorrhagia, nausea, and weight increase treatment related adverse events, any adverse event led to discontinuation, breast pain, dysmenorrhea, headache, and anxiety. On the other hand, it’s not associated with decrease unscheduled bleeding after first, second, third, sixth, and twelfth month of menstrual cycle.
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