Summary of findings for the main comparison. Antioxidants compared to placebo or no treatment for patients with male subfertility.
Antioxidants compared to placebo or no treatment for patients with male subfertility | ||||||
Patient or population: patients with male subfertility Setting: clinic Intervention: antioxidants Comparison: placebo or no treatment | ||||||
Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
Risk with placebo or no treatment | Risk with antioxidants | |||||
Live birth rate per couple randomised | 117 per 1000 | 192 per 1.000 (138 to 262) | OR 1.79 (1.20 to 2.67) | 750 (7 RCTs) | ⊕⊕⊝⊝ LOW 1 | |
Clinical pregnancy rate per couple randomised | 69 per 1000 | 180 per 1.000 (124 to 255) | OR 2.97 (1.91 to 4.63) | 786 (11 RCTs) | ⊕⊕⊝⊝ LOW 1 | |
Adverse events ‐ Miscarriage | 19 per 1000 | 33 per 1.000 (8 to 129) | OR 1.74 (0.40 to 7.60) | 247 (3 RCTs) | ⊕⊝⊝⊝ VERY LOW 1 2 | |
Adverse events ‐ Gastrointestinal | 18 per 1000 | 45 per 1.000 (23 to 86) | OR 2.51 (1.25 to 5.03) | 948 (11 RCTs) | ⊕⊝⊝⊝ VERY LOW 1 3 | |
*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). CI: Confidence interval; OR: Peto Odds ratio; | ||||||
GRADE Working Group grades of evidence High certainty: We are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect |
1 Downgraded two levels for serious risk of bias: lack of allocation concealment, lack of blinding and incomplete accounting of patients and outcome events
2 Downgraded one level for serious imprecision: crossing the line of no effect
3 Downgraded one level for serious imprecision: incomplete accounting of patients and outcome events