Summary of findings 2. Metformin compared to metformin combined with oral contraceptive pill (OCP) for hirsutism, acne, and menstrual pattern in adult women with polycystic ovary syndrome (PCOS).
| Metformin compared to metformin combined with OCP for hirsutism, acne, and menstrual pattern in adult women with PCOS | |||||||
| Patient or population: adult women with PCOS Setting: Hospital or University Clinics Intervention: metformin Comparison: metformin combined with OCP | |||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Quality of the evidence (GRADE) | Comments | ||
| Risk with Metformin combined with OCP | Risk with metformin | ||||||
| Hirsutism ‐ Clinical F‐G score | The mean hirsutism ‐ Clinical F‐G score was 5.6 | MD 1.36 higher (0.62 higher to 2.11 higher) | ‐ | 135 (3 RCTs) | ⊕⊕⊝⊝ LOW 1,2 | ||
| Adverse events ‐ Severe | Gastro‐intestinal | 74 per 1 000 | 56 per 1 000 (17 to 168) | OR 0.74 (0.21 to 2.53) | 171 (3 RCTs) | ⊕⊕⊝⊝ LOW 1,3 | |
| Others | 60 per 1 000 | 35 per 1 000 (7 to 153) | OR 0.56 (0.11 to 2.82) | 109 (2 RCTs) | ⊕⊕⊝⊝ LOW 1,3 | ||
| Adverse events ‐ Minor | Gastro‐intestinal | No trials reported on outcome "Adverse events ‐ Minor ‐ Gastro‐intestinal" | |||||
| Others | No trials reported on outcome "Adverse events ‐ Minor ‐ Others" | ||||||
| Improved menstrual pattern | Shortening of intermenstrual days | No trials reported on outcome "Improved menstrual pattern (i.e. shortening of intermenstrual days)" | |||||
| An initiation of menses or cycle regularity | No trials reported on outcome "Improved menstrual pattern (i.e. an initiation of menses or cycle regularity)" | ||||||
| Acne ‐ Visual analogue scale/Clinical acne score | No trials reported either on outcome "Acne ‐ Visual analogue scale" or "Acne ‐ Clinical acne score" | ||||||
| BMI (kg/m2) | The mean Body Mass Index (kg/m2) was 25.49 | MD 1.47 lower (2.27 lower to 0.66 lower) | ‐ | 199 (5 RCTs) | ⊕⊕⊝⊝ LOW 1,2 | ||
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). BMI: Body mass index; CI: Confidence interval; F‐G: Ferriman‐Gallwey score; MD: Mean difference; OR: Odds ratio; RCT: Randomised controlled trial. | |||||||
| GRADE Working Group grades of evidence High quality: further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: we are very uncertain about the estimate. | |||||||
1 Evidence downgraded by one level for serious risk of bias ‐ the majority of the RCTs have unclear risk of bias 2 Evidence downgraded by one level for serious imprecision – low number of participants (total number of participants < 400) 3 Evidence downgraded by one level for serious imprecision – low number of events (total number of events < 300) and 95% CI includes both appreciable benefit and harm