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).