Summary of findings 2. Levonorgestrel‐releasing intrauterine device compared to oral progestogen (norethisterone acetate) for uterine fibroids.
| Levonorgestrel‐releasing intrauterine device compared to oral progestogen (norethisterone acetate) for uterine fibroids | ||||||
| Patient or population: women with uterine fibroids Setting: university hospital Intervention: levonorgestrel‐releasing intrauterine device (LNG‐IUS) Comparison: oral progestogen (norethisterone acetate (NETA)) | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Risk with NETA | Risk with LNG‐IUS | |||||
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Uterine fibroid‐related symptoms (change in abnormal uterine bleeding, measured from baseline to 6 months, with a visual bleeding score (VBS); lower = better) |
The mean change in VBS with NETA was 56.71 | The mean change in VBS with LNG‐IUS was 23.75 lower (1.26 lower to 46.24 lower) | ‐ | 48 (1 RCT) | ⊕⊝⊝⊝ Very lowa,b | MD ‐23.75 (95% CI ‐1.26 to ‐46.24); skewed data |
|
Uterine fibroid‐related symptoms (change in haemoglobin level, from baseline to 3 months; higher = better) |
The mean change in haemoglobin with NETA was 2.37 g/dL | The mean change in haemoglobin with LNG‐IUS was 4.53 g/dL higher (1.46 higher to 7.60 higher) | ‐ | 48 (1 RCT) | ⊕⊝⊝⊝ Very lowa,b | MD 4.53 g/dL (95% CI 1.46 to 7.60); reported data were inconsistent; skewed data |
|
Uterine fibroid‐related symptoms (change in haemoglobin level, from baseline to 6 months; higher = better) |
The mean change in haemoglobin with NETA was 5.95 g/dL | The mean change in haemoglobin with LNG‐IUS was 10.14 g/dL higher (5.57 higher to 14.71 higher) | ‐ | 45 (1 RCT) | ⊕⊝⊝⊝ Very lowa,b | MD 10.14 (95% CI 5.57 to 14.71); reported data were inconsistent; skewed data |
| Fibroid size | ‐ | ‐ | ‐ | ‐ | ‐ | Study did not report |
|
Adverse events (spotting at 3 and 6 months) |
At 3 months, 18 (64.3%) women with a LNG‐IUD and 30% of the women on NETA (absolute numbers not available) reported spotting. At 6 months, 7 (25.9%) women with a LNG‐IUD and 22.2% of the women on NETA (absolute numbers not available) reported spotting. |
‐ | 45 (1 RCT) | ⊕⊝⊝⊝ Very lowa,b | No clear information about total number of women at 3 and 6 months | |
| *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; MD: mean difference | ||||||
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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. | ||||||
aDowngraded by one level due to risk of bias; unclear allocation concealment, unclear blinding, and high risk of attrition bias. bDowngraded by two levels due to imprecision; one study with small sample size