Summary of findings 3. Oral progestogen (dienogest, desogestrel) compared to goserelin acetate for uterine fibroids.
| Oral progestogen (dienogest, desogestrel) compared to goserelin acetate for uterine fibroids | ||||||
| Patient or population: women with uterine fibroids Setting: university hospital Intervention: oral progestogen (dienogest, desogestrel) Comparison: goserelin acetate | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Risk with goserelin acetate | Risk with oral progestogen (dienogest, desogestrel) | |||||
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Uterine fibroid‐related symptoms (duration of uterine bleeding, measured at 12 weeks; lower = better) |
The mean duration of uterine bleeding with goserelin acetate was 2.54 days | The mean duration of uterine bleeding with dienogest was 9.26 days longer (4.31 longer to 14.21 longer) | ‐ | 14 (1 RCT) | ⊕⊝⊝⊝ Very lowa,b | MD 9.26 (95% CI 4.31 to 14.21); skewed data |
| The mean duration of uterine bleeding with desogestrel was 6.61 days higher (5.14 higher to 8.08 higher) | ‐ | 16 (1 RCT) | ⊕⊝⊝⊝ Very lowa,b | MD 6.61 days (95% CI 5.14 to 8.08) | ||
|
Uterine fibroid‐related symptoms (abnormal uterine bleeding, measured at 12 weeks, with the pictorial blood assessment chart (PBAC); lower = better) |
The mean PBAC score with goserelin acetate was 18.0 points | The mean PBAC score with dienogest was 216.00 points higher (149.35 higher to 282.65 higher) | ‐ | 14 (1 RCT) | ⊕⊝⊝⊝ Very lowa,b | MD 216.00 points (95% CI 149.35 to 282.65) |
| The mean PBAC score with desogestrel was 78.00 points higher (28.94 higher to 127.06 higher) | ‐ | 16 (1 RCT) | ⊕⊝⊝⊝ Very lowa,b | MD 78.00 points (95% CI 28.94 to 127.06); skewed data | ||
| Fibroid size | ‐ | ‐ | ‐ | ‐ | ‐ | Study did not report |
|
Adverse events (vasomotor symptoms (e.g. hot flashes) |
55% of the women on goserelin acetate reported vasomotor symptoms | None of the women on dienogest reported vasomotor symptoms because progestogen does not induce them. | ‐ | 14 (1 RCT) | ⊕⊝⊝⊝ Very lowa,b | No data were reported for the dienogest group |
| None of the women on desogestrel reported vasomotor symptoms because progestogen does not induce them. | ‐ | 16 (1 RCT) | ⊕⊝⊝⊝ Very lowa,b | No data were reported for the desogestrel group | ||
| *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 selection, detection, attrition, and reporting bias bDowngraded by two levels due to imprecision; one study with small sample size