Niklas Zethraeus1, Anna Dreber2, Eva Ranehill3, Liselott Blomberg4, Fernand Labrie5, Bo von Schoultz6, Magnus Johannesson2, Angelica Lindén Hirschberg7. 1. Department of Learning, Informatics, Management and Ethics, Karolinska Institutet, Stockholm, Sweden. 2. Department of Economics, Stockholm School of Economics, Stockholm, Sweden. 3. Center for Economic Research, ETH, Zurich, Switzerland; Department of Economics, University of Gothenburg, Gothenburg, Sweden. 4. Department of Obstetrics and Gynecology, Karolinska University Hospital, Stockholm, Sweden. 5. Laval University, Quebec City, Montreal, Canada. 6. Department of Economics, University of Gothenburg, Gothenburg, Sweden; Department of Obstetrics and Gynecology, Karolinska University Hospital, Stockholm, Sweden. 7. Department of Obstetrics and Gynecology, Karolinska University Hospital, Stockholm, Sweden; Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden. Electronic address: angelica.linden-hirschberg@sll.se.
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.
RCT Entities:
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.
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