| Methods |
Open‐label, randomized controlled trial conducted in 50 practices in Germany and the Netherlands; 6 treatment cycles. According to correspondence from the author, the block size was 2 for randomization. |
| Participants |
1027 women. Inclusion criteria 18 to 45 years of age, good physical and mental condition, sexually active, with body mass index from 18 to 29 kg/m2.
Exclusion criteria: menstrual cycle < 24 days or > 35 days, being older than 35 years and smoking, taking concomitant medications or addictive drugs, or having a mental or psychiatric disorder or depression that might interfere with the trial, using OCs, IUD. Also excluded were those who had contraceptive implant within past month or injectable contraceptive within past 6 months. |
| Interventions |
Group 1: DSG 150 µg plus 20 µg EE
Group 2: LNG 100 µg plus EE 20 µg |
| Outcomes |
Acne lesion count (comedones, papules, pustules, nodules) by investigators; subject judgment (no, mild, moderate, severe); Psychological General Well‐Being Index; Profile of Mood States.
Report had limited data for analysis. Author provided some data via correspondence for outcomes that had been presented in figures: numbers and percents with worsening or improvement of comedones, papules, pustules, and nodules (not clear how these were calculated for an individual) and mean scores for Psychological General Well‐Being Index. |
| Notes |
Losses were 22% in DSG Group and 25% for LNG group according to the report. However, change data for the main outcomes indicated losses of 47% and 48%, respectively. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Unclear risk |
No information on allocation concealment. |
