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Study flow diagram
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Figure 1

Study flow diagram

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Risk of bias graph: review authors' judgements about each risk of bias domain presented as percentages across all included studies
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Figure 2

Risk of bias graph: review authors' judgements about each risk of bias domain presented as percentages across all included studies

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Risk of bias summary: review authors' judgements about each risk of bias domain for each included study
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Figure 3

Risk of bias summary: review authors' judgements about each risk of bias domain for each included study

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All‐cause mortality up to three months after randomisation. Fifteen trials provided data. The diversity‐adjusted required information size (DARIS) was calculated based on all‐cause mortality of 30% in the control group; risk ratio reduction in the glucocorticosteroid group of 20%; type I error of 1%; and type II error of 20% (80% power). Trial diversity was 62%. The required information size was 6734 participants. The cumulative Z‐curve (blue line) did not cross the trial sequential monitoring boundaries for benefit or harm (red inward sloping lines) and did not enter the trial sequential monitoring area for futility (inner‐wedge with red outward sloping lines). The green dotted lines show the conventional boundaries of the naive alpha of 5% equal to Z‐scores of +1.96 and ‐1.96.
Figuras y tablas -
Figure 4

All‐cause mortality up to three months after randomisation. Fifteen trials provided data. The diversity‐adjusted required information size (DARIS) was calculated based on all‐cause mortality of 30% in the control group; risk ratio reduction in the glucocorticosteroid group of 20%; type I error of 1%; and type II error of 20% (80% power). Trial diversity was 62%. The required information size was 6734 participants. The cumulative Z‐curve (blue line) did not cross the trial sequential monitoring boundaries for benefit or harm (red inward sloping lines) and did not enter the trial sequential monitoring area for futility (inner‐wedge with red outward sloping lines). The green dotted lines show the conventional boundaries of the naive alpha of 5% equal to Z‐scores of +1.96 and ‐1.96.

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Funnel plot of comparison 1. Glucocorticosteroids versus no intervention/placebo, outcome 1.1 all‐cause mortality
Figuras y tablas -
Figure 5

Funnel plot of comparison 1. Glucocorticosteroids versus no intervention/placebo, outcome 1.1 all‐cause mortality

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All‐cause mortality at the end of treatment (median 28 days (range 3 days to 12 weeks) (post hoc analysis). Fourteen trials provided data. The diversity‐adjusted required information size (DARIS) was calculated based on all‐cause mortality of 22% in the control group; risk ratio reduction in the glucocorticosteroid group of 20%; type I error of 1%; and type II error of 20% (80% power). Trial diversity was 59%. The required information size was 9242 participants. The cumulative Z‐curve (blue line) did not cross the trial sequential monitoring boundaries for benefit or harm (red inward sloping lines) and did not enter the trial sequential monitoring area for futility (inner‐wedge with red outward sloping lines). The green dotted lines show the conventional boundaries of the naive alpha of 5% equal to Z‐scores of +1.96 and ‐1.96.
Figuras y tablas -
Figure 6

All‐cause mortality at the end of treatment (median 28 days (range 3 days to 12 weeks) (post hoc analysis). Fourteen trials provided data. The diversity‐adjusted required information size (DARIS) was calculated based on all‐cause mortality of 22% in the control group; risk ratio reduction in the glucocorticosteroid group of 20%; type I error of 1%; and type II error of 20% (80% power). Trial diversity was 59%. The required information size was 9242 participants. The cumulative Z‐curve (blue line) did not cross the trial sequential monitoring boundaries for benefit or harm (red inward sloping lines) and did not enter the trial sequential monitoring area for futility (inner‐wedge with red outward sloping lines). The green dotted lines show the conventional boundaries of the naive alpha of 5% equal to Z‐scores of +1.96 and ‐1.96.

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All‐cause mortality up to 1 year (post hoc analysis). Three trials provided data. The diversity‐adjusted required information size (DARIS) was calculated based on mortality in the control group of 40%; risk ratio reduction of 20% in the glucocorticosteroid group; type I error of 1%; and type II error of 20% (80% power). Trial diversity was 0%. The required information size was 1695 participants. The cumulative Z‐curve (blue line) did not cross the trial sequential monitoring boundaries for benefit or harm (red inward sloping lines). The cumulative Z‐curve crossed the inner‐wedge futility line (red outward sloping lines). The green dotted lines show the conventional boundaries of the naive alpha of 5% equal to Z‐scores of +1.96 and ‐1.96.
Figuras y tablas -
Figure 7

All‐cause mortality up to 1 year (post hoc analysis). Three trials provided data. The diversity‐adjusted required information size (DARIS) was calculated based on mortality in the control group of 40%; risk ratio reduction of 20% in the glucocorticosteroid group; type I error of 1%; and type II error of 20% (80% power). Trial diversity was 0%. The required information size was 1695 participants. The cumulative Z‐curve (blue line) did not cross the trial sequential monitoring boundaries for benefit or harm (red inward sloping lines). The cumulative Z‐curve crossed the inner‐wedge futility line (red outward sloping lines). The green dotted lines show the conventional boundaries of the naive alpha of 5% equal to Z‐scores of +1.96 and ‐1.96.

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Serious adverse events during treatment. There are 15 trials providing data. The diversity‐adjusted required information size (DARIS) was calculated based on an incidence rate of serious adverse events in the control group of 36%; risk ratio reduction of 20% in the glucocorticosteroid group; type I error of 1%; and type II error of 20% (80% power). Trial diversity was 70%. The required information size was 6566 participants. The cumulative Z‐curve (blue line) did not cross the trial sequential monitoring boundaries for benefit or harm (red inward sloping lines), but it entered the trial sequential monitoring area for futility (inner‐wedge futility line red outward sloping lines) indicating that sufficient information was provided. The green dotted lines show the conventional boundaries of the naive alpha of 5% equal to Z‐scores of +1.96 and ‐1.96.
Figuras y tablas -
Figure 8

Serious adverse events during treatment. There are 15 trials providing data. The diversity‐adjusted required information size (DARIS) was calculated based on an incidence rate of serious adverse events in the control group of 36%; risk ratio reduction of 20% in the glucocorticosteroid group; type I error of 1%; and type II error of 20% (80% power). Trial diversity was 70%. The required information size was 6566 participants. The cumulative Z‐curve (blue line) did not cross the trial sequential monitoring boundaries for benefit or harm (red inward sloping lines), but it entered the trial sequential monitoring area for futility (inner‐wedge futility line red outward sloping lines) indicating that sufficient information was provided. The green dotted lines show the conventional boundaries of the naive alpha of 5% equal to Z‐scores of +1.96 and ‐1.96.

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Liver‐related mortality up to three months after randomisation. Fifteen trials provided data. The diversity‐adjusted required information size (DARIS) was calculated based on liver‐ related mortality of 30% in the control group; risk ratio reduction in the glucocorticosteroid group of 20%; type I error of 1%; and type II error of 20% (80% power). Trial diversity was 68%. The required information size was 8059 participants. The cumulative Z‐curve (blue line) did not cross the trial sequential monitoring boundaries for benefit or harm (red inward sloping lines) and did not enter the trial sequential monitoring area for futility (inner‐wedge with red outward sloping lines). The green dotted lines show the conventional boundaries of the naive alpha of 5% equal to Z‐scores of +1.96 and ‐1.96.
Figuras y tablas -
Figure 9

Liver‐related mortality up to three months after randomisation. Fifteen trials provided data. The diversity‐adjusted required information size (DARIS) was calculated based on liver‐ related mortality of 30% in the control group; risk ratio reduction in the glucocorticosteroid group of 20%; type I error of 1%; and type II error of 20% (80% power). Trial diversity was 68%. The required information size was 8059 participants. The cumulative Z‐curve (blue line) did not cross the trial sequential monitoring boundaries for benefit or harm (red inward sloping lines) and did not enter the trial sequential monitoring area for futility (inner‐wedge with red outward sloping lines). The green dotted lines show the conventional boundaries of the naive alpha of 5% equal to Z‐scores of +1.96 and ‐1.96.

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Any complications up to three months after randomisation. Fifteen trials provided data. The diversity‐adjusted required information size (DARIS) was calculated based on any complications of 44% in the control group; risk ratio reduction in the glucocorticosteroid group of 20%; type I error of 1%; and type II error of 20% (80% power). Trial diversity was 75%. The required information size was 5887 participants. The cumulative Z‐curve (blue line) did not cross the trial sequential monitoring boundaries for benefit or harm (red inward sloping lines). The cumulative Z‐curve crossed the inner‐wedge futility line (red outward sloping lines). The green dotted lines show the conventional boundaries of the naive alpha of 5% equal to Z‐scores of +1.96 and ‐1.96.
Figuras y tablas -
Figure 10

Any complications up to three months after randomisation. Fifteen trials provided data. The diversity‐adjusted required information size (DARIS) was calculated based on any complications of 44% in the control group; risk ratio reduction in the glucocorticosteroid group of 20%; type I error of 1%; and type II error of 20% (80% power). Trial diversity was 75%. The required information size was 5887 participants. The cumulative Z‐curve (blue line) did not cross the trial sequential monitoring boundaries for benefit or harm (red inward sloping lines). The cumulative Z‐curve crossed the inner‐wedge futility line (red outward sloping lines). The green dotted lines show the conventional boundaries of the naive alpha of 5% equal to Z‐scores of +1.96 and ‐1.96.

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Non‐serious adverse events up to three months after randomisation. Four trials provided data. The diversity‐adjusted required information size (DARIS) was calculated based on non‐serious adverse events of 5% in the control group; risk ratio reduction in the glucocorticosteroid group of 50%; type I error of 1%; and type II error of 20% (80% power). Trial diversity was 0%. The required information size was 2698 participants. The cumulative Z‐curve (blue line) did not cross the trial sequential monitoring boundaries for benefit or harm (red inward sloping lines) and did not enter the trial sequential monitoring area for futility (inner‐wedge with red outward sloping lines). The green dotted lines show the conventional boundaries of the naive alpha of 5% equal to Z‐scores of +1.96 and ‐1.96.
Figuras y tablas -
Figure 11

Non‐serious adverse events up to three months after randomisation. Four trials provided data. The diversity‐adjusted required information size (DARIS) was calculated based on non‐serious adverse events of 5% in the control group; risk ratio reduction in the glucocorticosteroid group of 50%; type I error of 1%; and type II error of 20% (80% power). Trial diversity was 0%. The required information size was 2698 participants. The cumulative Z‐curve (blue line) did not cross the trial sequential monitoring boundaries for benefit or harm (red inward sloping lines) and did not enter the trial sequential monitoring area for futility (inner‐wedge with red outward sloping lines). The green dotted lines show the conventional boundaries of the naive alpha of 5% equal to Z‐scores of +1.96 and ‐1.96.

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Comparison 1 Glucocorticosteroids versus no intervention/placebo, Outcome 1 All‐cause mortality.
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Analysis 1.1

Comparison 1 Glucocorticosteroids versus no intervention/placebo, Outcome 1 All‐cause mortality.

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Comparison 1 Glucocorticosteroids versus no intervention/placebo, Outcome 2 Health‐related quality of life.
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Analysis 1.2

Comparison 1 Glucocorticosteroids versus no intervention/placebo, Outcome 2 Health‐related quality of life.

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Comparison 1 Glucocorticosteroids versus no intervention/placebo, Outcome 3 Number of participants with serious adverse events during treatment.
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Analysis 1.3

Comparison 1 Glucocorticosteroids versus no intervention/placebo, Outcome 3 Number of participants with serious adverse events during treatment.

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Comparison 1 Glucocorticosteroids versus no intervention/placebo, Outcome 4 Liver‐related mortality.
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Analysis 1.4

Comparison 1 Glucocorticosteroids versus no intervention/placebo, Outcome 4 Liver‐related mortality.

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Comparison 1 Glucocorticosteroids versus no intervention/placebo, Outcome 5 Any complication.
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Analysis 1.5

Comparison 1 Glucocorticosteroids versus no intervention/placebo, Outcome 5 Any complication.

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Comparison 1 Glucocorticosteroids versus no intervention/placebo, Outcome 6 Number of participants with non‐serious adverse events up to 3 months' follow‐up after randomisation.
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Analysis 1.6

Comparison 1 Glucocorticosteroids versus no intervention/placebo, Outcome 6 Number of participants with non‐serious adverse events up to 3 months' follow‐up after randomisation.

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Comparison 2 Subgroup analysis: all‐cause mortality up to 3 months after randomisation, Outcome 1 Severity of alcoholic hepatitis.
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Analysis 2.1

Comparison 2 Subgroup analysis: all‐cause mortality up to 3 months after randomisation, Outcome 1 Severity of alcoholic hepatitis.

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Comparison 2 Subgroup analysis: all‐cause mortality up to 3 months after randomisation, Outcome 2 Glucocorticosteroid (prednisolone) dose.
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Analysis 2.2

Comparison 2 Subgroup analysis: all‐cause mortality up to 3 months after randomisation, Outcome 2 Glucocorticosteroid (prednisolone) dose.

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Comparison 2 Subgroup analysis: all‐cause mortality up to 3 months after randomisation, Outcome 3 Alcoholic hepatitis without cirrhosis and with cirrhosis.
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Analysis 2.3

Comparison 2 Subgroup analysis: all‐cause mortality up to 3 months after randomisation, Outcome 3 Alcoholic hepatitis without cirrhosis and with cirrhosis.

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Comparison 2 Subgroup analysis: all‐cause mortality up to 3 months after randomisation, Outcome 4 Hepatorenal syndrome.
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Analysis 2.4

Comparison 2 Subgroup analysis: all‐cause mortality up to 3 months after randomisation, Outcome 4 Hepatorenal syndrome.

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Comparison 2 Subgroup analysis: all‐cause mortality up to 3 months after randomisation, Outcome 5 Ascites.
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Analysis 2.5

Comparison 2 Subgroup analysis: all‐cause mortality up to 3 months after randomisation, Outcome 5 Ascites.

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Comparison 3 Sensitivity analysis: all‐cause mortality, Outcome 1 Best‐worst scenario all‐cause mortality to 3 months follow‐up.
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Analysis 3.1

Comparison 3 Sensitivity analysis: all‐cause mortality, Outcome 1 Best‐worst scenario all‐cause mortality to 3 months follow‐up.

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Comparison 3 Sensitivity analysis: all‐cause mortality, Outcome 2 Worst‐best scenario all‐cause mortality to 3 months follow‐up.
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Analysis 3.2

Comparison 3 Sensitivity analysis: all‐cause mortality, Outcome 2 Worst‐best scenario all‐cause mortality to 3 months follow‐up.

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Comparison 4 Sensitivity analysis: serious adverse events, Outcome 1 Best‐worse scenario of serious adverse events during treatment.
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Analysis 4.1

Comparison 4 Sensitivity analysis: serious adverse events, Outcome 1 Best‐worse scenario of serious adverse events during treatment.

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Comparison 4 Sensitivity analysis: serious adverse events, Outcome 2 Worst‐best scenario of serious adverse events during treatment.
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Analysis 4.2

Comparison 4 Sensitivity analysis: serious adverse events, Outcome 2 Worst‐best scenario of serious adverse events during treatment.

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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).

Figuras y tablas -
Summary of findings for the main comparison. Glucocorticosteroids for people with alcoholic hepatitis
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Table 1. Number of participants with most often occurring serious adverse events during treatment

Trial

Gastrointestinal haemorrhage

Hepatorenal syndrome (with or without hepatic failure)

Septicaemia

Hepatocellular carcinoma

Prednisolone

Placebo

Prednisolone

Placebo

Prednisolone

Placebo

Prednisolone

Placebo

Helman 1971

3

Porter 1971

4

2

Campra 1973

3

5

4

Blitzer 1977

3

2

2

2 fungal

1

Mendenhall 1977

Not reported

Maddrey 1978

1

1

3

6

Shumaker 1978

3

3

2

Depew 1980

2

1

2

1

Theodossi 1982

11

6

7

6

Bories 1987

3

3

2

Carithers 1989

2

4

1

Mendenhall 1984

2

Ramond 1992

1

2

1

1

De 2014

2

3

3

3

1
Figuras y tablas -
Table 1. Number of participants with most often occurring serious adverse events during treatment
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Table 2. Most often occurring serious adverse events in Thursz trial. Number of events.

Type of adverse event

Prednisolone group

Placebo group

Gastrointestinal haemorrhage plus

variceal bleeding

40

28

Infections

74

43

‐ lung

38

17

‐ sepsis

14

14
Figuras y tablas -
Table 2. Most often occurring serious adverse events in Thursz trial. Number of events.
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Comparison 1. Glucocorticosteroids versus no intervention/placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 All‐cause mortality Show forest plot

15

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

1.1 Up to 3 months after randomisation

15

1861

Risk Ratio (M‐H, Random, 95% CI)

0.90 [0.70, 1.15]

1.2 At the end of treatment

14

1824

Risk Ratio (M‐H, Random, 95% CI)

0.87 [0.66, 1.15]

1.3 At 1 year after randomisation

3

1343

Risk Ratio (M‐H, Random, 95% CI)

1.03 [0.91, 1.17]

2 Health‐related quality of life Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

2.1 Up to three months

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.2 Up to one year

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3 Number of participants with serious adverse events during treatment Show forest plot

15

1861

Risk Ratio (M‐H, Random, 95% CI)

1.05 [0.85, 1.29]

4 Liver‐related mortality Show forest plot

15

1861

Risk Ratio (M‐H, Random, 95% CI)

0.89 [0.69, 1.14]

4.1 Up to 3 months' follow‐up after randomisation

15

1861

Risk Ratio (M‐H, Random, 95% CI)

0.89 [0.69, 1.14]

5 Any complication Show forest plot

15

1861

Risk Ratio (M‐H, Random, 95% CI)

1.04 [0.86, 1.27]

5.1 Number of participants with complications up to 3 months' follow‐up after randomisation

15

1861

Risk Ratio (M‐H, Random, 95% CI)

1.04 [0.86, 1.27]

6 Number of participants with non‐serious adverse events up to 3 months' follow‐up after randomisation Show forest plot

4

160

Risk Ratio (M‐H, Fixed, 95% CI)

1.99 [0.72, 5.48]
Figuras y tablas -
Comparison 1. Glucocorticosteroids versus no intervention/placebo
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Comparison 2. Subgroup analysis: all‐cause mortality up to 3 months after randomisation

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Severity of alcoholic hepatitis Show forest plot

15

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

1.1 Mild alcoholic hepatitis

4

182

Risk Ratio (M‐H, Random, 95% CI)

1.02 [0.58, 1.80]

1.2 Severe alcoholic hepatitis

14

1679

Risk Ratio (M‐H, Random, 95% CI)

0.92 [0.73, 1.16]

2 Glucocorticosteroid (prednisolone) dose Show forest plot

15

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

2.1 Less than or equal to 40 mg

10

1547

Risk Ratio (M‐H, Random, 95% CI)

0.75 [0.50, 1.14]

2.2 More than 40 mg

5

314

Risk Ratio (M‐H, Random, 95% CI)

1.02 [0.79, 1.30]

3 Alcoholic hepatitis without cirrhosis and with cirrhosis Show forest plot

15

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

3.1 Alcoholic hepatitis

3

123

Risk Ratio (M‐H, Random, 95% CI)

0.79 [0.18, 3.48]

3.2 Alcoholic hepatitis with cirrhosis

12

1738

Risk Ratio (M‐H, Random, 95% CI)

0.92 [0.74, 1.16]

4 Hepatorenal syndrome Show forest plot

10

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

4.1 With hepatorenal syndrome

8

1382

Risk Ratio (M‐H, Random, 95% CI)

1.00 [0.85, 1.17]

4.2 Without hepatorenal syndrome

2

129

Risk Ratio (M‐H, Random, 95% CI)

0.56 [0.05, 6.49]

5 Ascites Show forest plot

13

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

5.1 With ascites

13

729

Risk Ratio (M‐H, Random, 95% CI)

0.82 [0.60, 1.12]
Figuras y tablas -
Comparison 2. Subgroup analysis: all‐cause mortality up to 3 months after randomisation
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Comparison 3. Sensitivity analysis: all‐cause mortality

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Best‐worst scenario all‐cause mortality to 3 months follow‐up Show forest plot

15

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

1.1 Up to 3 months

15

1861

Risk Ratio (M‐H, Random, 95% CI)

0.82 [0.64, 1.05]

2 Worst‐best scenario all‐cause mortality to 3 months follow‐up Show forest plot

15

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

2.1 Up to 3 months

15

1861

Risk Ratio (M‐H, Fixed, 95% CI)

1.21 [1.06, 1.37]
Figuras y tablas -
Comparison 3. Sensitivity analysis: all‐cause mortality
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Comparison 4. Sensitivity analysis: serious adverse events

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Best‐worse scenario of serious adverse events during treatment Show forest plot

15

1861

Risk Ratio (M‐H, Random, 95% CI)

1.00 [0.83, 1.21]

2 Worst‐best scenario of serious adverse events during treatment Show forest plot

15

1861

Risk Ratio (M‐H, Fixed, 95% CI)

1.18 [1.05, 1.31]
Figuras y tablas -
Comparison 4. Sensitivity analysis: serious adverse events
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