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. 2019 Dec 17;2019(12):CD013505. doi: 10.1002/14651858.CD013505

Summary of findings 3. Metformin compared with clomiphene citrate for women with polycystic ovary syndrome.

Metformin compared with clomiphene citrate for women with polycystic ovary syndrome
Population: women with polycystic ovary syndrome
 Setting: outpatient
 Intervention: metformin
 Comparison: clomiphene citrate
Outcomes Anticipated absolute effects* (95% CI) Relative effect
 (95% CI) № of participants
 (studies) Quality of the evidence
 (GRADE) Comments
Risk with CC Risk with metformin
Live birth rate per woman
aParticipants with BMI < 30 kg/m2 or ≤ 32 kg/m2
256 per 1000 371 per 1000
(256 to 503)
OR 1.71 (1.00 to 2.94) 241
(3 studies)
⊕⊝⊝⊝
very lowb,c,d
High heterogeneity (I2 = 78%)
76 events
Live birth rate per woman
aParticipants with BMI ≥ 30 kg/m2
216 per 1000 76 per 1000
(45 to 125)
OR 0.30
(0.17 to 0.52)
500
(2 studies)
⊕⊝⊝⊝
 very lowb,c,d 73 events
Adverse events
(gastrointestinal)
Not reported by any of the included studies
Clinical pregnancy rate per womanaParticipants with BMI < 30 kg/m2 or ≤ 32 kg/m2 258 per 1000 352 per 1000 (270 to 444) OR 1.56
 (1.06 to 2.29) 530
 (6 studies) ⊕⊕⊝⊝
 lowb,e 160 events
Clinical pregnancy rate per woman
aParticipants with BMI ≥ 30 kg/m2
276 per 1000 115 per 1000 (74 to 173) OR 0.34
 (0.21 to 0.55) 500
 (2 studies) ⊕⊕⊝⊝
 lowb,c 98 events
Ovulation rate per woman
fParticipants with BMI < 30 kg/m2
650 per 1000 597 per 1000 (491 to 699) OR 0.80
 (0.52 to 1.25) 352
 (5 studies) ⊕⊕⊝⊝
 lowb,c 220 events
Ovulation rate per woman
fParticipants with BMI ≥ 30 kg/m2
516 per 1000 236 per 1,000
 (176 to 314) OR 0.29
 (0.20 to 0.43) 500
 (2 studies) ⊕⊕⊝⊝
 lowb,c 188 events
Miscarriage rate per woman
aParticipants with BMI < 30 kg/2
57 per 1000 83 per 1000 (36 to 182) OR 1.51 (0.62 to 3.71) 281
(4 studies)
⊕⊕⊝⊝
 lowb,c 20 events
Miscarriage rate per pregnancy: OR 1.02 (0.41 to 2.54)
Miscarriage rate per woman
aParticipants with BMI ≥ 30 kg/m2
64 per 1000 40 per 1000 (18 to 86) OR 0.61 (0.27 to 1.38) 500 (2 studies) ⊕⊕⊝⊝
 lowb,c 26 events; only 1 study with events
Miscarriage rate per pregnancy: OR 1.92 (0.72 to 5.12)
*The risk in the intervention group (and its 95% confidence interval) is based on the median risk in the comparison group and the relative effect of the intervention (and its 95% CI).
 
 CI: confidence interval; OR: odds ratio
GRADE Working Group grades of evidenceHigh 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.

aData subgrouped by BMI, as pooling of BMI groups resulted in high heterogeneity (I2 > 85%) with differing directions of effect.
 bEvidence downgraded one level for risk of bias.
 cEvidence downgraded one level for serious imprecision: low event rate and/or wide confidence intervals.
 dEvidence downgraded for high heterogeneity.
 eEvidence downgraded for serious imprecision; many small studies with wide confidence intervals.
 fData subgrouped by BMI, as pooling of BMI groups resulted in high heterogeneity (I2 = 74%), though direction of effect was consistent.