Summary of findings 6. Colchicine plus ursodeoxycholic acid (UDCA) versus UDCA for primary biliary cholangitis.
| Colchicine plus UDCA versus UDCA for primary biliary cholangitis | |||||
|
Patient or population: people with primary biliary cholangitis Settings: secondary or tertiary care Intervention: colchicine + UDCA Comparison: UDCA | |||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of participants (trials) | Quality of the evidence (GRADE) | |
| Assumed risk | Corresponding risk | ||||
| UDCA | Colchicine + UDCA | ||||
|
Mortality at maximal follow‐up Follow‐up: 24 months in 1 trial; not reported in 1 trial |
110 per 1000 | 185 per 1000 (45 to 524) | OR 1.84 (0.38 to 8.91) | 158 (2 trials) | ⊕⊝⊝⊝ Very low1,2 |
|
Serious adverse events (proportion) Follow‐up: not stated |
14 per 1000 | 42 per 1000 (2 to 526) | OR 3.08 (0.12 to 78.14) | 74 (1 trial) | ⊕⊝⊝⊝ 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).