Summary of findings for the main comparison. Vitamin D compared to placebo or no intervention for chronic liver diseases in adults.
Vitamin D compared to placebo or no intervention for chronic liver diseases in adults | ||||||
Patient or population: adults with chronic liver diseases. Setting: inpatients and outpatients from Austria, China, Egypt, Iran, Israel, Italy, Japan, USA. Intervention: vitamin D Comparison: placebo or no intervention | ||||||
Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (trials) | Quality of the evidence (GRADE) | Comments | |
Risk with placebo or no intervention | Risk with vitamin D | |||||
All‐cause mortality at the end of follow‐up Follow‐up: 0.1 to 1.4, mean 0.6 years |
Study population | OR 0.70 (0.09 to 5.38) | 1034 (15 RCTs) | ⊕⊝⊝⊝ Very low1,2,3 | Trial Sequential Analyses‐adjusted CI was 0.00 to 2534. | |
4 per 1.000 | 3 per 1.000 (0 to 21) | |||||
Liver‐related mortality Follow‐up: mean 1 year |
Study population | RR 1.62 (0.08 to 34.66) | 18 (1 RCT) | ⊕⊝⊝⊝ Very low1,3 | Due to few data, we did not conduct Trial Sequential Analysis which would only have revealed larger imprecision. | |
0 per 1.000 | 0 per 1.000 (0 to 0) | |||||
Serious adverse events ‐ hypercalcaemia Follow‐up: mean 1 year |
Study population | RR 5.00 (0.25 to 100.80) | 76 (1 RCT) | ⊕⊝⊝⊝ Very low1,3 | Due to few data, we did not conduct Trial Sequential Analysis which would only have revealed larger imprecision. | |
0 per 1.000 | 0 per 1.000 (0 to 0) | |||||
Serious adverse events ‐ myocardial infarction Follow‐up: 0.2 to 1, mean 0.6 years |
Study population | RR 0.75 (0.08 to 6.81) | 86 (2 RCTs) | ⊕⊝⊝⊝ Very low1,3 | Due to few data, we did not conduct Trial Sequential Analysis which would only have revealed larger imprecision. | |
25 per 1.000 | 19 per 1.000 (2 to 170) | |||||
Serious adverse events ‐ thyroiditis Follow‐up: mean 0.2 years |
Study population | RR 0.33 (0.01 to 7.91) | 68 (1 RCT) | ⊕⊝⊝⊝ Very low1,3 | Due to few data, we did not conduct Trial Sequential Analysis which would only have revealed larger imprecision. | |
29 per 1.000 | 10 per 1.000 (0 to 233) | |||||
Failure of sustained virological response Follow‐up: 0.3 to 1.4, mean 0.9 years |
Study population | RR 0.59 (0.28 to 1.21) | 422 (5 RCTs) | ⊕⊝⊝⊝ Very low 1,2,3,6 |
The trial sequential monitoring boundary is ignored due to little information use (0.6%). | |
465 per 1.000 | 275 per 1.000 (130 to 563) | |||||
Acute cellular rejection in liver transplant recipients Follow‐up: mean 0.08 years |
Study population | RR 0.33 (0.04 to 2.62) | 75 (1 RCT) | ⊕⊝⊝⊝ Very low 1,3,7 |
The trial sequential monitoring boundary is ignored due to little information use (0.84%). | |
120 per 1.000 | 40 per 1.000 (5 to 314) | |||||
*The risk in the intervention group (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; RCT: randomised clinical trial; OR: Odds ratio. | ||||||
GRADE Working Group grades of evidence
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1 Downgraded one level due to risk of bias: all trials were at high risk of bias. 2 Downgraded one level due to inconsistency of evidence: intertrial heterogeneity was significant. 3 Downgraded one level due to imprecision of evidence: Trial Sequential Analysis of vitamin D trials shows that we had insufficient information. 4 Downgraded one level due to indirectness of evidence: rapid virological response is a surrogate outcome. 5 Downgraded one level due to indirectness of evidence: early virological response is a surrogate outcome. 6 Downgraded one level due to indirectness of evidence: sustained virological response is a surrogate outcome. 7 Downgraded one level due to indirectness of evidence: acute cellular rejection is a surrogate outcome.