Summary of findings for the main comparison. Bezafibrate compared with no intervention for primary biliary cirrhosis.
| Bezafibrate compared with no intervention for primary biliary cirrhosis | ||||||
| Patient or population: patients with primary biliary cirrhosis. Settings: out‐patients. Intervention: bezafibrate. Comparison: no intervention. | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of Participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| No intervention | Bezafibrate | |||||
| All‐cause mortality | Study population | RD 0.00 (‐0.11 to 0.11) | 60 (3 trials) | ⊕⊝⊝⊝ very low2,3 | ||
| 0 per 1000 | 0 per 1000 (0 to 0)1 | |||||
| Liver morbidity | Study population | RD 0.00 (‐0.11 to 0.11) | 60 (3 trials) | ⊕⊝⊝⊝ very low2,3 | ||
| 0 per 1000 | 0 per 1000 (0 to 0)1 | |||||
| Adverse events | Study population | RR 5.4 (0.69 to 42.32) | 60 (3 trials) | ⊕⊝⊝⊝ very low2,3 | ||
| 0 per 1000 | 0 per 1000 (0 to 0) | |||||
|
Serum alkaline phosphatases (U/L) |
The mean serum alkaline phosphatases activity in the intervention groups was 186.04 lower (249.03 to 123.04 lower) | 79 (4 trials) | ⊕⊕⊝⊝ low4,5,6 | |||
|
Serum alkaline phosphatases (U/L) ‐ duration of administration 6 months |
The mean serum alkaline phosphatases activity (duration of administration 6 months) in the intervention groups was 141.97 lower (228.3 to 55.64 lower) | 38 (2 trials) | ⊕⊝⊝⊝ very low4,6,7 | |||
|
Serum alkaline phosphatases (U/L) ‐ duration of administration 12 to 13 months |
The mean serum alkaline phosphatases activity (duration of administration 12 to 13 months) in the intervention groups was 236.23 lower (328.35 to 144.1 lower) | 41 (2 trials) | ⊕⊕⊝⊝ low6,8 | |||
| Serum bilirubin (mg/dl) | The mean serum bilirubin concentration in the intervention groups was 0.19 lower (0.38 lower to 0 higher) | 34 (2 trials) | ⊕⊝⊝⊝ very low3,8 | |||
| *The basis for the assumed risk (eg, the median control group risk across studies) is provided in footnotes. 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; RR: Risk 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 Dichotomous outcome was expressed as risk difference (RD) with 95% confidence intervals (CI). 2 The main limitations in design was the lack of clarity of reporting on adverse events, the lack of clarity of the generation of allocation sequence, concealment of allocation, blinding, and the length of follow‐up. 3 Included trials in our meta‐analysis include few patients and few events indicating that we have little knowledge about the intervention effect, and that further information is needed. 4 The main limitations in design was the lack of clarity of the generation of allocation sequence, concealment of allocation, blinding, and the length of follow‐up. 5 Statistical heterogeneity I2 = 34%. 6 According to the results of trial sequential analysis there is a evidence for a beneficial effect of bezafibrate versus no intervention on the activity of serum alkaline phosphatases when the cumulative meta‐analysis is adjusted for sparse data and multiple testing on accumulating data. Therefore there is no risk for random error. 7 Statistical heterogeneity I2 = 56%. 8 The main limitations in design was the lack of clarity of the generation of allocation sequence and concealment of allocation in one trial. One trial was unblinded and another was likely unblinded.