1. A first-choice combined oral contraceptive influences general well-being in healthy women: a double-blind, randomized, placebo-controlled trial.
- Author
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Zethraeus, Niklas, Dreber, Anna, Ranehill, Eva, Blomberg, Liselott, Labrie, Fernand, von Schoultz, Bo, Johannesson, Magnus, and Hirschberg, Angelica Lindén
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WELL-being , *DEPRESSED persons , *ORAL contraceptives , *UNIVERSITY hospitals , *CLINICAL trials , *PREVENTION of mental depression , *COMPARATIVE studies , *MENTAL depression , *DRUG side effects , *HEALTH status indicators , *RESEARCH methodology , *MEDICAL cooperation , *PATIENT satisfaction , *PLACEBOS , *PSYCHOLOGICAL tests , *QUESTIONNAIRES , *REFERENCE values , *RESEARCH , *WOMEN'S health , *EVALUATION research , *RANDOMIZED controlled trials , *TREATMENT effectiveness , *DISEASE incidence , *BLIND experiment , *PSYCHOLOGY , *THERAPEUTICS - Abstract
Objective: To determine whether there is a causal effect of oral contraceptive (OC) treatment on general well-being and depressed mood in healthy women.Design: Double-blind, randomized, and placebo-controlled trial.Setting: University hospital.Patient(s): Three hundred and forty healthy women aged 18-35 years randomized to treatment, of whom 332 completed the data collection at follow-up evaluation.Intervention(s): A combined OC (150 μg levonorgestrel and 30 μg ethinylestradiol) or placebo for 3 months of treatment.Main Outcome Measure(s): Primary outcome measures: global score of Psychological General Well-Being Index (PGWBI) and the Beck Depression Inventory (BDI); secondary outcome measures: six separate dimensions of the PGWBI.Result(s): The OC treatment statistically significantly decreased general well-being compared with placebo -4.12 (95% CI, -7.18 to -1.06). Furthermore, OC decreased the following PGWBI dimensions compared with placebo: positive well-being -3.90 (95% CI, -7.78 to -0.01), self-control -6.63 (95% CI, -11.20 to -2.06), and vitality -6.84 (95% CI, -10.80 to -2.88). The effect of OC on depressive symptoms and on the PGWBI dimension depressed mood were not statistically significant.Conclusion(s): This study demonstrates a statistically significant reduction in general well-being by a first-choice OC in comparison with placebo in healthy women. We found no statistically significant effects on depressive symptoms. A reduction in general well-being should be of clinical importance. [ABSTRACT FROM AUTHOR]- Published
- 2017
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