Summary of findings for the main comparison. Ursodeoxycholic acid (UDCA) versus no intervention for primary biliary cholangitis.
| UDCA versus no intervention for primary biliary cholangitis | |||||
|
Patient or population: people with primary biliary cholangitis Settings: secondary or tertiary care Intervention: UDCA Comparison: no intervention | |||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of participants (trials) | Quality of the evidence (GRADE) | |
| Assumed risk | Corresponding risk | ||||
| No intervention | UDCA | ||||
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Mortality at maximal follow‐up Follow‐up: 12 to 89 months |
208 per 1000 | 206 per 1000 (136 to 301) | OR 0.99 (0.60 to 1.64) | 734 (6 trials) | ⊕⊝⊝⊝ Very low1,2 |
|
Serious adverse events (proportion) Follow‐up: 12 to 41 months |
There were no events in either group | 380 (3 trials) | ⊕⊝⊝⊝ Very low1,2,3 | ||
| Serious adverse events (number of events) | None of the trials reported this outcome. | ||||
| Health‐related quality of life | None of the trials reported this outcome. | ||||
| *The basis for the assumed risk is the mean control group proportion across all the trials. 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; UDCA: ursodeoxycholic acid. | |||||
| 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 Risk of bias in the trial(s) was high (downgraded by two levels). 2 Sample sizes were small and 95% confidence intervals overlapped clinically significant and clinically insignificant or no effect (downgraded by two levels).
3 There was moderate heterogeneity (downgraded by one level).