Summary of findings 6. Antifibrinolytics compared to levonorgestrel intrauterine system.
| Antifibrinolytics compared with levonorgestrel for heavy menstrual bleeding | ||||||
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Patient or population: heavy menstrual bleeding Settings: all Intervention: antifibrinolytics Comparison: levonorgestrel intrauterine system (IUS) | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of Participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Risk with levonorgestrel IUS | Risk with TXA | |||||
| Menstrual blood loss: median difference in PBAC score ‐ after 6 months Rx Assessed with: PBAC4 Follow‐up: outcomes measured at end of treatment |
−252.0 (IQR 124.5) 1 | −126.5 (IQR 104.5) | 42 (1 RCT) | ⊕⊝⊝⊝ VERY LOW2 3 | ||
| Menstrual blood loss: improvement in mean blood loss (PBAC score < 100) Assessed with: PBAC4 Follow‐up: outcomes measured at end of treatment |
850 per 1000 | 364 per 1000 (204 to 655) | RR 0.43 (0.24 to 0.77) | 42 (1 RCT) | ⊕⊝⊝⊝ VERY LOW2 3 | |
| Adverse events (any) | 500 per 1000 | 455 per 1000 | RR 0.83 (0.25 to 2.80) | 42 (1 RCT) | ⊕⊝⊝⊝ VERY LOW2 3 | |
| Thromboembolic events | The study did not measure any thromboembolic events. | |||||
| *The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (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; IQR: Interquartile Range; OR: Odds Ratio; RR: Risk Ratio | ||||||
| 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 Unable to calculate 'X per 1000 women', as the data are not in a normal distribution, but are skewed.
2 Quality downgraded 2 levels due to the one trial being at high risk of: performance and detection bias; and attrition bias.
3 Quality downgraded a further level because of imprecision (single small trial).
4Some authors consider 100 points in the Pictorial Blood Assessment Chart (PBAC) equivalent to 80 mL of menstrual blood loss (i.e. heavy menstrual bleeding); some 150 points.