A first-choice combined oral contraceptive influences general well-being in healthy women: a double-blind, randomized, placebo-controlled trial.
- Zethraeus N Department of Learning, Informatics, Management and Ethics, Karolinska Institutet, Stockholm, Sweden.
- Dreber A Department of Economics, Stockholm School of Economics, Stockholm, Sweden.
- Ranehill E Center for Economic Research, ETH, Zurich, Switzerland; Department of Economics, University of Gothenburg, Gothenburg, Sweden.
- Blomberg L Department of Obstetrics and Gynecology, Karolinska University Hospital, Stockholm, Sweden.
- Labrie F Laval University, Quebec City, Montreal, Canada.
- von Schoultz B Department of Economics, University of Gothenburg, Gothenburg, Sweden; Department of Obstetrics and Gynecology, Karolinska University Hospital, Stockholm, Sweden.
- Johannesson M Department of Economics, Stockholm School of Economics, Stockholm, Sweden.
- Hirschberg AL 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.
- 2017-04-24
Published in:
- Fertility and sterility. - 2017
Depression
oral contraceptives
quality of life
randomized clinical trial
well-being
Adolescent
Adult
Contraceptives, Oral, Combined
Depression
Double-Blind Method
Drug-Related Side Effects and Adverse Reactions
Female
Health Status
Humans
Incidence
Patient Preference
Placebo Effect
Pregnancy
Reference Values
Sweden
Treatment Outcome
Women's Health
Young Adult
English
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.
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.
- Language
-
- English
- Open access status
- bronze
- Identifiers
-
- DOI 10.1016/j.fertnstert.2017.02.120
- PMID 28433366
- Persistent URL
- https://folia.unifr.ch/global/documents/60664
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