Summary of findings 2. LNG‐IUS compared to endometrial ablation for heavy menstrual bleeding.
| IUS compared to endometrial ablation for heavy menstrual bleeding | |||||||
| Patient or population: heavy menstrual bleeding Setting: any Intervention: LNG‐IUS Comparison: endometrial ablation | |||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Certainty of the evidence (GRADE) | Comments | ||
| Risk with endometrial ablation | Risk with IUS | ||||||
| Bleeding | PBAC score at 12 months | ‐ | see comment | not estimable | 122 (2 studies) | ⊕⊝⊝⊝ VERY LOW123 | Substantial heterogeneity so trials not combined. The trial at high risk of bias reported no difference between treatments and the trial with a lower risk of bias reported that PBAC score was lower with endometrial ablation |
| Improvement in HMB within 12 months: amenorrhoea | 186 per 1000 | 224 per 1000 (158 to 319) | RR 1.21 (0.85 to 1.72) | 431 (8 RCTs) | ⊕⊕⊝⊝ LOW 1 2 | ||
| Improvement in HMB within 12 months: hypomenorrhoea | 462 per 1000 | 452 per 1000 (337 to 614) | RR 0.98 (0.73 to 1.33) | 200 (4 RCTs) | ⊕⊕⊝⊝ LOW 1 2 | ||
| Improvement in HMB within 12 months: eumenorrhoea | 269 per 1000 | 148 per 1000 (81 to 269) | RR 0.55 (0.30 to 1.00) | 160 (3 RCTs) | ⊕⊝⊝⊝ VERY LOW 1 3 4 | ||
| Satisfaction with treatment | Within 1‐year follow‐up | 811 per 1000 | 770 per 1000 (689 to 868) | RR 0.95 (0.85 to 1.07) | 317 (5 RCTs) | ⊕⊕⊝⊝ LOW 1 2 | |
| Quality of life | Within 12 months' follow‐up ‒ General health (SF‐36) | The mean quality of life (SF‐36) within 12 months' follow‐up ‒ General health was 54.9 | MD 14.4 lower (22.63 lower to 6.17 lower) | ‐ | 33 (1 RCT) | ⊕⊝⊝⊝ VERY LOW 1 2 4 | |
| Adverse events | Total proportion of women with any adverse events | 277 per 1000 | 571 per 1000 (399 to 815) | RR 2.06 (1.44 to 2.94) | 201 (3 RCTs) | ⊕⊕⊕⊝ MODERATE 1 | |
| Treatment failure | Discontinuation of initial treatment, adjunct medical therapy or persistent HMB at 12 months | 131 per 1000 | 234 per 1000 (143 to 381) | RR 1.78 (1.09 to 2.90) |
320 (5 RCTs) | ⊕⊕⊝⊝ LOW 1 2 | |
| Requirement for surgery (hysterectomy) at 12 months | 78 per 1000 | 200 per 1000 (116 to 345) | RR 2.56 (1.48 to 4.42) |
400 (3 RCTs) | ⊕⊕⊝⊝ LOW 1 2 | ||
| Cost | According to 1 study, the cost per woman of the LNG‐IUS is about 50% of the endometrial ablation. | ||||||
| *The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk 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 1 level for high risk of bias (performance and detection bias)
2 Downgraded 1 level for risk of bias (attrition)
3 Downgraded 1 level for substantial heterogeneity
4 Downgraded 1 level for imprecision