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. 2017 Nov 3;2017(11):CD011564. doi: 10.1002/14651858.CD011564.pub2

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
  • High quality: this research provides a very good indication of the likely effect; the likelihood that the effect will be substantially different is low.

  • Moderate quality: this research provides a good indication of the likely effect; the likelihood that the effect will be substantially different is moderate.

  • Low quality: this research provides some indication of the likely effect; however, the likelihood that it will be substantially different is high.

  • Very low quality: this research does not provide a reliable indication of the likely effect; the likelihood that the effect will be substantially different is very high.

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.