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. 2017 Mar 28;2017(3):CD011648. doi: 10.1002/14651858.CD011648.pub2

Summary of findings 4. Ciclosporin versus no intervention for primary biliary cholangitis.

Ciclosporin versus no intervention for primary biliary cholangitis
Patient or population: people with primary biliary cholangitis
Settings: secondary or tertiary care
Intervention: ciclosporin
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 Ciclosporin
Mortality at maximal follow‐up
Follow‐up: 31 to 35 months
208 per 1000 188 per 1000 
 (118 to 283) OR 0.88 
 (0.51 to 1.50) 390 
 (3 trials) ⊕⊝⊝⊝
 Very low1,2
Serious adverse events (proportion) None of the trials reported this outcome.
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.
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).