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. 2017 Nov 2;2017(11):CD001511. doi: 10.1002/14651858.CD001511.pub3

Summary of findings for the main comparison.

Glucocorticosteroids for people with alcoholic hepatitis

Glucocorticosteroids for people with alcoholic hepatitis
Patient or population: participants with alcoholic hepatitis at high risk of mortality and morbidity
Settings: hospitals and clinics
Intervention: glucocorticosteroids
Comparison: placebo or 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
Placebo or no intervention Glucocorticosteroids
All‐cause mortality: 3 months following randomisation 298 per 1000 278 per 1000 RR 0.90
(0.70 to 1.15)
1861
(15 RCTs)
⊕⊝⊝⊝1 very low The Trial Sequential Analysis‐adjusted CI was 0.36 to 2.32
Health‐related quality of life: up to 3 months
(measured withEuropean Quality of Life ‐ 5 Dimensions‐3 Levels (EQ‐ 5D‐3L) scale)
The mean value is 0.592 The mean value is 0.553 MD ‐0.04; (‐0.11 to 0.03) 377
(1 RCT)
⊕⊕⊝⊝2
low
We did not perform Trial Sequential Analysis
Serious adverse events during treatment 361 per 1000 389 per 1000 RR 1.05
(0.85 to
1.29)
1861
(15 RCTs)
⊕⊕⊝⊝3 low The Trial Sequential Analysis‐adjusted CI was 0.60 to 1.82
Liver‐related mortality: up to 3 months following randomisation 298 per 1000 277 per 1000 RR 0.89
(0.69 to 1.14)
1861
(15 RCTs)
⊕⊕⊝⊝4 low The Trial Sequential Analysis‐adjusted CI was 0.32 to 2.45
Any complication: up to 3 months following randomisation 443 per 1000 474 per 1000 RR 1.04
(0.86 to 1.27)
1861
(15 RCTs)
⊕⊕⊝⊝5 low The Trial Sequential Analysis‐adjusted CI was 0.67 to 1.63
Number of participants with non‐serious adverse events: up to 3 months' follow‐up after end of treatment 51 per 1000 120 per 1000 RR 1.99
(0.72 to 5.48)
160
(4 RCTs)
⊕⊝⊝⊝6 very low The Trial Sequential Analysis‐adjusted CI was 0.01 to 249.60
*The basis for the assumed risk (e.g. 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; RCT: randomised controlled trial; RR: risk 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.

1Downgraded 3 levels: 1 level due to within‐study risk of bias (high overall risk of bias in all the trials); 1 level due to inconsistency of the data (there is wide variation in the effect estimates across studies; there is little overlap of confidence intervals associated with the effect estimates; presence of moderate heterogeneity: I² = 45%; heterogeneity could be explained with selection bias); 1 level due to imprecision of effect estimates (the trial sequential analysis showed that additional evidence is needed and that we have not yet reached the required information size). 2Downgraded 2 levels: 1 level due to within‐study risk of bias (high overall risk of bias in the trial); 1 level due to imprecision of effect estimates. 3Downgraded 2 levels: 1 level due to within‐study risk of bias (high overall risk of bias in all the trials); 1 level due to inconsistency of the data (there is wide variation in the effect estimates across studies; there is little overlap of confidence intervals associated with the effect estimates; presence of moderate heterogeneity: I² = 36%; heterogeneity could be explained with selection bias). 4Downgraded 2 levels: 1 level due to within‐study risk of bias (high overall risk of bias in all the trials); 1 level due to inconsistency of the data (there is wide variation in the effect estimates across studies; there is little overlap of confidence intervals associated with the effect estimates; presence of moderate heterogeneity: I² = 46%; heterogeneity could be explained with selection bias). 5Downgraded 2 levels: 1 level due to within‐study risk of bias (high overall risk of bias in all the trials); 1 level due to inconsistency of the data (there is wide variation in the effect estimates across studies; there is little overlap of confidence intervals associated with the effect estimates; presence of moderate heterogeneity: I² = 41%; heterogeneity could be explained with selection bias). 6Downgraded 4 levels: 1 level due to within‐study risk of bias (high overall risk of bias in all the trials); 1 level due to inconsistency of the data (there is little overlap of confidence intervals associated with the effect estimates);1 level due to imprecision of effect estimates (the Trial Sequential Analysis showed that additional evidence is needed and that we have not yet reached the required information size); 1 level due to publication bias (only 4 trials with a small number of participants reported on non‐serious adverse events).