Summary of findings 4. Metformin compared to oral contraceptive pill (OCP) for hirsutism, acne, and menstrual pattern in adolescent women with polycystic ovary syndrome (PCOS).
| Metformin compared to OCP for hirsutism, acne, and menstrual pattern in adolescent women with PCOS | |||||||
| Patient or population: adolescent women with PCOS Setting: Hospital or University Clinics Intervention: metformin Comparison: OCP | |||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Quality of the evidence (GRADE) | Comments | ||
| Risk with OCP | Risk with metformin | ||||||
| Hirsutism ‐ Clinical F‐G score | The mean hirsutism ‐ Clinical F‐G score was 8.6 | MD 0.40 lower (3.42 lower to 2.62 higher) | ‐ | 16 (1 RCT) | ⊕⊝⊝⊝ VERY LOW 1,2 | ||
| Adverse event ‐ Severe | Gastro‐intestinal | No trials reported on outcome "Adverse event ‐ Severe ‐ Gastro‐intestinal" | |||||
| Others | 150 per 1 000 | 100 per 1 000 (27 to 300) | OR 0.63 (0.16 to 2.43) | 80 (1 RCT) | ⊕⊝⊝⊝ VERY LOW 3,4 | ||
| Adverse event ‐ Minor | Gastro‐intestinal | 0 per 1 000 | 3 per 1 000 (0 to 0) | OR 11.67 (0.53 to 258.56) | 22 (1 RCT) | ⊕⊝⊝⊝ VERY LOW 1,5 | There were only 3 events in the arm metformin and 0 in the arm OCP |
| Others | No trials reported on outcome "Adverse event ‐ Minor ‐ Others" | ||||||
| Improved menstrual pattern | Shortening of inter menstrual days | No trials reported on outcome "Improved menstrual pattern (i.e. shortening of inter menstrual days)" | |||||
| An initiation of menses or cycle regularity | 1 000 per 1 000 | 1000 per 1 000 (1 000 to 1 000) | OR 0.10 (0.01 to 1.92) | 80 (1 RCT) | ⊕⊝⊝⊝ VERY LOW 3,6 | 40 out of 40 participants had improved menstrual patter in the OCP group compared to 36 out of 40 in the metformin group | |
| Acne ‐ Visual analogue scale or Clinical acne score | No trials reported either on outcome "Acne ‐ Visual analogue scale" or "Acne ‐ Clinical acne score" | ||||||
| BMI (kg/m2) | The mean BMI (kg/m2) was 36 | MD 1.45 lower
(5.08 lower to 2.17 higher) |
‐ | 69 (3 RCTs) | ⊕⊝⊝⊝ VERY LOW 7,8 | ||
| *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 – a single RCT which has unclear risk of bias 2 Evidence downgraded by two levels for very serious imprecision – very low number of participants (total number of participants < 400 i.e. n = 16 participants) and 95% CI includes both appreciable benefit and appreciable harm 3 Evidence downgraded by one level for serious risk of bias – a single RCT which has high risk of bias 4 Evidence downgraded by two levels for very serious imprecision – very low number of events (total number of events < 300 i.e. n = 10 events) and 95% CI includes both appreciable benefit and appreciable harm 5 Evidence downgraded by two levels for very serious imprecision – very low number of events (total number of events < 300 i.e. n = 3 events) and 95% CI includes both appreciable benefit and appreciable harm 6 Evidence downgraded by two levels for very serious imprecision – very low number of events (total number of events < 300 i.e. n = 76 events) and 95% CI includes both appreciable benefit and appreciable harm 7 Evidence downgraded by one level for serious risk of bias ‐ the majority of the RCTs have unclear risk of bias 8 Evidence downgraded by two levels for very serious imprecision – very low number of participants (total number of participants < 400 i.e. n = 69 participants) and 95% CI includes both appreciable benefit and appreciable harm