Summary of findings 2. Gestrinone versus danazol for endometriosis.
Gestrinone versus danazol for endometriosis | ||||||
Patient or population: women with symptomatic endometriosis Settings: gynaecology clinic Intervention: progesterone receptor modulator (gestrinone) Comparison: danazol | ||||||
Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No. of participants (studies) | Quality of the evidence (GRADE) | Comments | |
Assumed risk | Corresponding risk | |||||
Danazol | Gestrinone | |||||
Pelvic pain: none or mild | 890 per 1000 | 852 per 1000 (727 to 927) |
OR 0.71 (0.33 to 1.56) |
230 (2) |
⊕⊕⊝⊝ Very lowa,b,c | |
Dysmenorrhoea: none or mild Follow‐up: 6 months |
721 per 1000 | 650 per 1000 (502 to 775) | OR 0.72 (0.39 to 1.33) | 214 (2) | ⊕⊝⊝⊝ Very lowa,b,c | |
Dyspareunia: none or mild Follow‐up: 6 months |
889 per 1000 | 869 per 1000 (748 to 937) | OR 0.83 (0.37 to 1.86) | 222 (2) | ⊕⊝⊝⊝ Very lowa,b,c | |
Side effects: hirsutism Follow‐up: 6 months |
248 per 1000 | 464 per 1000 (345 to 587) | OR 2.63 (1.60 to 4.32) | 302 (2) | ⊕⊝⊝⊝ Very lowb,c,d | I2 = 68% |
Decreased breast size Follow‐up: 6 months |
477 per 1000 | 360 per 1000 (257 to 472) | OR 0.62 (0.38 to 0.98) | 302 (2) | ⊕⊕⊝⊝ Lowb,c | |
Side effects: hot flushes Follow‐up: 6 months |
425 per 1000 | 368 per 1000 (270 to 482) |
OR 0.79 (0.50 to 1.26) |
302 (2 studies) |
⊕⊝⊝⊝ Very lowb,c,d | I2 = 72% |
Side effects: acne Follow‐up: 6 months |
556 per 1000 | 644 per 1000 (529 to 744) |
OR 1.45 (0.90 to 2.33) |
302 (2 studies) |
⊕⊕⊝⊝ Lowb,c | |
*The basis for the assumed risk is the mean control group risk across studies. 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; OR: odds 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 |
aAssessed in all randomised participants. Not all were symptomatic at baseline (although results show no significant differences in baseline symptoms between groups). Outcome therefore applies only to a select subgroup of participants: downgraded one level for serious indirectness
bDowngraded one level for serious risk of bias associated with poor reporting of study methods, high attrition in one study, and high risk of other bias in both studies
cImprecision of results (wide confidence intervals and/or few events), downgraded one level for serious imprecision
dDowngraded one level for serious inconsistency