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Study flow diagram.

Figuras y tablas -
Figure 1

Study flow diagram.

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

Figuras y tablas -
Figure 2

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

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Figure 3. Risk of bias summary: review authors' judgements about each risk of bias item for each included trial.

Figuras y tablas -
Figure 3

Figure 3. Risk of bias summary: review authors' judgements about each risk of bias item for each included trial.

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Comparison 1: Probiotic versus placebo or no intervention, Outcome 1: All‐cause mortality

Figuras y tablas -
Analysis 1.1

Comparison 1: Probiotic versus placebo or no intervention, Outcome 1: All‐cause mortality

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Comparison 1: Probiotic versus placebo or no intervention, Outcome 2: No recovery (incomplete resolution of clinical symptoms)

Figuras y tablas -
Analysis 1.2

Comparison 1: Probiotic versus placebo or no intervention, Outcome 2: No recovery (incomplete resolution of clinical symptoms)

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Comparison 1: Probiotic versus placebo or no intervention, Outcome 3: Adverse events

Figuras y tablas -
Analysis 1.3

Comparison 1: Probiotic versus placebo or no intervention, Outcome 3: Adverse events

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Comparison 1: Probiotic versus placebo or no intervention, Outcome 4: Quality of life

Figuras y tablas -
Analysis 1.4

Comparison 1: Probiotic versus placebo or no intervention, Outcome 4: Quality of life

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Comparison 1: Probiotic versus placebo or no intervention, Outcome 5: Plasma ammonia concentration (final and change scores) (μmol/L)

Figuras y tablas -
Analysis 1.5

Comparison 1: Probiotic versus placebo or no intervention, Outcome 5: Plasma ammonia concentration (final and change scores) (μmol/L)

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Comparison 2: Probiotic versus lactulose, Outcome 1: All‐cause mortality

Figuras y tablas -
Analysis 2.1

Comparison 2: Probiotic versus lactulose, Outcome 1: All‐cause mortality

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Comparison 2: Probiotic versus lactulose, Outcome 2: No recovery (incomplete resolution of clinical symptoms)

Figuras y tablas -
Analysis 2.2

Comparison 2: Probiotic versus lactulose, Outcome 2: No recovery (incomplete resolution of clinical symptoms)

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Comparison 2: Probiotic versus lactulose, Outcome 3: Adverse events

Figuras y tablas -
Analysis 2.3

Comparison 2: Probiotic versus lactulose, Outcome 3: Adverse events

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Comparison 2: Probiotic versus lactulose, Outcome 4: Health‐related quality of life

Figuras y tablas -
Analysis 2.4

Comparison 2: Probiotic versus lactulose, Outcome 4: Health‐related quality of life

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Comparison 2: Probiotic versus lactulose, Outcome 5: Plasma ammonia concentration (final and change scores) (μmol/L)

Figuras y tablas -
Analysis 2.5

Comparison 2: Probiotic versus lactulose, Outcome 5: Plasma ammonia concentration (final and change scores) (μmol/L)

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Summary of findings 1. Probiotic for people with hepatic encephalopathy

Probiotic versus placebo or no intervention for people with hepatic encephalopathy

Patient or population: people with hepatic encephalopathy
Setting: inpatients
Intervention: probiotic
Comparison: placebo/no intervention

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

No of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Risk with placebo/no intervention

Risk with probiotic

All‐cause mortality

(follow‐up: 2 weeks to 3 months)

Study population

RR 0.58
(0.23 to 1.44)

404
(7 RCTs)

⊕⊕⊝⊝
LOW 1,2

51 per 1000

30 per 1000
(12 to 73)

Moderate

25 per 1000

14 per 1000
(6 to 36)

No‐recovery (incomplete resolution of clinical symptoms)

(follow‐up: 1 month to 3 months)

Study population

RR 0.67
(0.56 to 0.79)

574
(10 RCTs)

⊕⊕⊕⊝
MODERATE 2

790 per 1000

529 per 1000
(442 to 624)

Moderate

877 per 1000

588 per 1000
(491 to 693)

Adverse events ‐ Overt hepatic encephalopathy

(follow‐up: 2 weeks to 3 months)

Study population

RR 0.29
(0.16 to 0.51)

585
(10 RCTs)

⊕⊕⊝⊝
LOW 1,2

168 per 1000

49 per 1000
(27 to 86)

Moderate

169 per 1000

49 per 1000
(27 to 86)

Adverse events ‐ Change of/or withdrawal from treatment

(follow‐up: 1 month to 3 months)

Study population

RR 0.70
(0.46 to 1.07)

551
(9 RCTs)

⊕⊝⊝⊝
VERY LOW 1,2,3

204 per 1000

143 per 1000
(94 to 219)

Moderate

158 per 1000

111 per 1000
(73 to 169)

Quality of life

(follow‐up: 1 month to 3 months)

—

—

—

115
(3 RCTs)

⊕⊕⊝⊝
LOW 1,2

Plasma ammonia concentration (final and change scores) (μmol/L)

(follow‐up: 1 month to 6 months)

—

The mean plasma ammonia concentration (final and change scores) (μmol/L) in the intervention group was 8.29 fewer (13.17 fewer to 3.41 fewer).

—

705
(10 RCTs)

⊕⊕⊝⊝
LOW 2,3

*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; RCT: randomised clinical trial; RR: risk ratio

GRADE Working Group grades of evidence
High quality: We are very confident that the true effect lies close to that of the estimate of the effect.
Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different.
Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect.
Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect.

1Downgraded one level for serious concerns or two levels for very serious concerns of imprecision (based on few events and wide confidence intervals).
2Downgraded one level for serious concerns or two levels for very serious concerns of trials judged as at high risk of bias (most studies at high risk of bias).
3Downgraded one level for serious concerns or two levels for very serious concerns of inconsistency of the outcomes in effects.

Figuras y tablas -
Summary of findings 1. Probiotic for people with hepatic encephalopathy
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Summary of findings 2. Probiotics for people with hepatic encephalopathy

Probiotic versus lactulose for people with hepatic encephalopathy

Patient or population: people with hepatic encephalopathy
Setting: inpatients
Intervention: probiotic
Comparison: lactulose

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

No of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Risk with lactulose

Risk with probiotic

All‐cause mortality

(follow‐up: 1 month to 2 months)

Study population

RR 5.00
(0.25 to 102.00)

200
(2 RCTs)

⊕⊝⊝⊝
VERY LOW 1,2

0 per 1000

0 per 1000
(0 to 0)

No‐recovery (incomplete resolution of clinical symptoms)

(follow‐up: 1 month to 3 months)

Study population

RR 1.01
(0.85 to 1.21)

430
(7 RCTs)

⊕⊝⊝⊝
VERY LOW 2,3,4

521 per 1000

526 per 1000
(443 to 630)

Moderate

500 per 1000

505 per 1000
(425 to 605)

Adverse events ‐ Overt hepatic encephalopathy

(follow‐up: 1 to 3 months)

Study population

RR 1.17
(0.63 to 2.17)

420
(6 RCTs)

⊕⊝⊝⊝
VERY LOW 2,3,4

81 per 1000

95 per 1000
(51 to 177)

Moderate

60 per 1000

70 per 1000
(38 to 129)

Adverse events ‐ Change of/or withdrawal from treatment

(follow‐up: 1 month to 3 months)

Study population

RR 1.27
(0.88 to 1.82)

490
(7 RCTs)

⊕⊝⊝⊝
VERY LOW ,2,3,4

160 per 1000

203 per 1000
(141 to 291)

Moderate

114 per 1000

145 per 1000
(101 to 208)

Quality of life

(follow‐up: 1 month to 3 months)

It is uncertain whether probiotics improve quality of life because the available evidence is of very low quality.

—

69
(1 RCT)

⊕⊝⊝⊝
VERY LOW 1,2

Plasma ammonia concentration (final and change scores) (μmol/L)

(follow‐up: 1 month to 3 months)

—

The mean plasma ammonia concentration (final and change scores) (μmol/L) in the intervention group was 2.93 fewer (9.36 fewer to 3.5 more).

—

325
(6 RCTs)

⊕⊝⊝⊝
VERY LOW 2,3,4

*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; RCT: randomised clinical trial; RR: risk ratio

GRADE Working Group grades of evidence
High quality: We are very confident that the true effect lies close to that of the estimate of the effect.
Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different.
Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect.
Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect.

1Downgraded one for serious concerns or two levels for very serious concerns of imprecision (small samples, very few events, and wide confidence intervals).
2Downgraded one level for serious concerns or two levels for very serious concerns of trials judged as at high risk of bias (majority of studies at high risk of bias).
3Downgraded one level for serious imprecision (95% CI includes null effects).
4Downgraded one level for serious concerns or two levels for very serious concerns of inconsistency in results.

Figuras y tablas -
Summary of findings 2. Probiotics for people with hepatic encephalopathy
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Table 1. Types of probiotics used across studies

Study

Probiotics used

Bajaj 2008

Streptococcus thermophilus, Lactobacillus bulgaricus, Lactobacillus acidophilus, Lactobacillus casei, Bifidobacteria

Bajaj 2014a

Lactobacillus GG AT strain 53103

Dhiman 2013a

VSL#3 (containing Bifidobacterium breve, Bifidobacterium longum, Bifidobacterium infantis, Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus paracasei, Lactobacillus bulgaricus, Streptococcus thermophilus)

Liu 2004

Pediacoccus pentosaceus, Leuconostoc mesenteroides, Lactobacillus paracasei, Lactobacillus plantarum

Loguercio 1987

Enterococcus lactic acid bacteria strain SF68

Loguercio 1995

Enterococcus faecium strain SF68

Lunia 2014

VSL#3 (containing Streptococcus thermophilus, Bifidobacterium breve, Bifidobacterium longum, Bifidobacterium infantis, Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus paracasei, Lactobacillus bulgaricus)

Malaguarnera 2010

Bifidobacterium (subtype not available)

Mittal 2009

VSL#3 (containing Streptococcus thermophilus, Bifidobacterium breve, Bifidobacterium longum, Bifidobacterium infantis, Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus paracasei, Lactobacillus bulgaricus)

Mouli 2014

VSL#3 (4 strains of Lactobacillus (L acidophilus DSM 24735, L plantarum DSM 24730, L paracasei DSM 24733, L delbrueckii subsp. bulgaricus DSM 24734), 3 strains of Bifidobacterium (B longum DSM 24736, B breve DSM 24732, B infantis DSM 24737), and 1 strain of Streptococcus (S thermophilus DSM 24731))

Nair 2008

Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium longum, Saccharomyces boulardii

Pereg 2011

Lactobacillus acidophilus, Lactobacillus bulgaricus, Bifidobacterium bifidum, Streptococcus thermophilus (Bio Plus, Supherb, Israel)

Qiao 2010

Bifid triple viable (not further specified)

Saji 2011

Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium longum, Saccharomyces boulardii

Sharma 2008

Enterococcus faecalis, Clostridium butyricum, Bacillus mesentricus, lactic acid Bacillus

Sharma 2014

Velgut ERIS Pharmaceuticals, Ahmadabad, India (Lactobacillus acidophilus, Lactobacillus rhamnosus, Lactobacillus plantarum, Lactobacillus casei, Bifidobacterium longum, Bifidobacterium infantis, Bifidobacterium breve, Saccharomyces boulardii, Streptococcus thermophilus)

Shavakhi 2014

Balance (Protexin Co., Somerset, UK) Lactobacillus strains (L casei, L rhamnosus, L acidophilus, L bulgaricus), Bifidobacterium strains (B breve, B longum), and Streptococcus thermophilus

Vlachogiannakos 2014

Lactobacillus plantarum 299v

Zhao 2013

Unclear

Zhitai 2013

Live Bacillus cereus capsules

Ziada 2013

Lactobacillus acidophilus

Figuras y tablas -
Table 1. Types of probiotics used across studies
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Table 2. Heterogeneity subgroup analysis

Probiotic versus placebo or no intervention

No‐recovery

Studies

Participants

Effect estimate

Risk ratio [95% CI]

Difference P

Type of probiotic

10

574

—

0.69

Lactobacillus

4

195

0.67 [0.45, 1.00]

—

Mixed

5

309

0.65 [0.50, 0.83]

—

Unclear

1

70

0.76 [0.58, 0.98]

—

Grade of hepatic encephalopathy

10

574

—

0.06

Minimal

8

473

0.63 [0.52, 0.76]

—

Overt

2

101

0.98 [0.64, 1.48]

—

Duration of therapy

10

574

—

0.43

<= 1 month

4

228

0.75 [0.58, 0.96]

—

1 > 2 months

3

117

0.65 [0.38, 1.10]

—

2 + months

3

229

0.58 [0.43, 0.78]

—

Co‐interventions

10

574

—

0.17

No treatment

8

473

0.63 [0.52, 0.76]

—

Bioactive fermentable fibre

1

40

1.00 [0.54, 1.86]

—

Lactulose

1

61

0.96 [0.55, 1.69]

—

Plasma ammonia concentration

Studies

Participants

Effect estimate

Mean difference [95% CI]

Difference P

Type of probiotic

10

580

—

0.35

Bifidobacterium

1

125

‐9.35 [‐16.09, ‐2.61]

—

Lactobacillus

3

121

‐11.90 [‐24.41, 0.60]

—

Mixed

4

190

‐1.80 [‐9.65, 6.06]

—

Unclear

2

144

‐17.02 [‐44.07, 10.02]

—

Grade of hepatic encephalopathy

10

580

—

0.85

Minimal

9

455

‐8.50 [‐14.38, ‐2.62]

—

Overt

1

125

‐9.35 [‐16.09, ‐2.61]

—

Duration of therapy

10

580

—

0.58

<=1 month

4

232

‐5.93 [‐12.25, 0.39]

—

1 > 2 months

4

211

‐5.11 [‐14.56, 4.34]

—

2 + months

2

137

‐18.53 [‐42.32, 5.26]

—

Co‐interventions used

10

580

—

0.11

No treatment

7

354

‐10.42 [‐18.68, ‐2.17]

—

Bioactive fermentable fibre

1

40

‐2.90 [‐5.51, ‐0.29]

—

Lactulose

2

186

‐7.88 [‐14.29, ‐1.47]

—

Probiotic versus lactulose

Plasma ammonia concentration

Studies

Participants

Effect estimate

Mean difference [95% CI]

Difference P

Type of probiotic

6

325

—

0.13

Enterococcus SF68

2

56

‐12.83 [‐24.51, ‐1.15]

—

Mixed

2

139

1.34 [‐1.72, 4.40]

—

Lactobacillus

1

50

‐3.17 [‐17.17, 10.83]

—

Unclear

1

80

1.31 [‐5.70, 8.32]

—

Grade of hepatic encephalopathy

6

325

—

0.02

Minimal

4

269

1.16 [‐1.59, 3.91]

—

Overt

2

56

‐12.83 [‐24.51, ‐1.15]

—

CI: confidence interval
Figuras y tablas -
Table 2. Heterogeneity subgroup analysis
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Comparison 1. Probiotic versus placebo or no intervention

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1.1 All‐cause mortality Show forest plot

7

404

Risk Ratio (M‐H, Random, 95% CI)

0.58 [0.23, 1.44]

1.1.1 2 weeks

1

46

Risk Ratio (M‐H, Random, 95% CI)

Not estimable

1.1.2 1 month

1

80

Risk Ratio (M‐H, Random, 95% CI)

0.33 [0.01, 7.95]

1.1.3 2 months

3

117

Risk Ratio (M‐H, Random, 95% CI)

0.72 [0.11, 4.66]

1.1.4 3 months

2

161

Risk Ratio (M‐H, Random, 95% CI)

0.57 [0.19, 1.74]

1.2 No recovery (incomplete resolution of clinical symptoms) Show forest plot

10

574

Risk Ratio (M‐H, Random, 95% CI)

0.67 [0.56, 0.79]

1.2.1 1 month

4

228

Risk Ratio (M‐H, Random, 95% CI)

0.75 [0.58, 0.96]

1.2.2 2 months

3

117

Risk Ratio (M‐H, Random, 95% CI)

0.65 [0.38, 1.10]

1.2.3 3 months

3

229

Risk Ratio (M‐H, Random, 95% CI)

0.58 [0.43, 0.78]

1.3 Adverse events Show forest plot

11

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

1.3.1 Overt hepatic encephalopathy

10

585

Risk Ratio (M‐H, Random, 95% CI)

0.29 [0.16, 0.51]

1.3.2 Infection

1

37

Risk Ratio (M‐H, Random, 95% CI)

Not estimable

1.3.3 Hospitalisation

3

163

Risk Ratio (M‐H, Random, 95% CI)

0.67 [0.11, 4.00]

1.3.4 Intolerance leading to discontinuation

1

37

Risk Ratio (M‐H, Random, 95% CI)

Not estimable

1.3.5 Change of/or withdrawal from treatment

9

551

Risk Ratio (M‐H, Random, 95% CI)

0.70 [0.46, 1.07]

1.4 Quality of life Show forest plot

3

Mean Difference (IV, Random, 95% CI)

Subtotals only

1.4.1 SF‐36 Physical

1

20

Mean Difference (IV, Random, 95% CI)

0.00 [‐5.47, 5.47]

1.4.2 SF‐36 Mental

1

20

Mean Difference (IV, Random, 95% CI)

‐4.00 [‐9.82, 1.82]

1.4.3 Change in Total SIP Score

2

95

Mean Difference (IV, Random, 95% CI)

‐3.66 [‐7.75, 0.44]

1.4.4 Change in SIP Psychological Score

2

95

Mean Difference (IV, Random, 95% CI)

‐3.54 [‐4.95, ‐2.12]

1.4.5 Change in SIP Physical Score

2

95

Mean Difference (IV, Random, 95% CI)

‐2.94 [‐4.44, ‐1.44]

1.5 Plasma ammonia concentration (final and change scores) (μmol/L) Show forest plot

10

705

Mean Difference (IV, Random, 95% CI)

‐8.29 [‐13.17, ‐3.41]

1.5.1 1 month

5

357

Mean Difference (IV, Random, 95% CI)

‐5.55 [‐10.67, ‐0.42]

1.5.2 2 months

4

211

Mean Difference (IV, Random, 95% CI)

‐5.11 [‐14.56, 4.34]

1.5.3 3 months

1

73

Mean Difference (IV, Random, 95% CI)

‐6.79 [‐10.39, ‐3.19]

1.5.4 6 months

1

64

Mean Difference (IV, Random, 95% CI)

‐31.08 [‐40.50, ‐21.66]
Figuras y tablas -
Comparison 1. Probiotic versus placebo or no intervention
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Comparison 2. Probiotic versus lactulose

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

2.1 All‐cause mortality Show forest plot

2

200

Risk Ratio (M‐H, Random, 95% CI)

5.00 [0.25, 102.00]

2.1.1 1 month

1

80

Risk Ratio (M‐H, Random, 95% CI)

Not estimable

2.1.2 2 months

1

120

Risk Ratio (M‐H, Random, 95% CI)

5.00 [0.25, 102.00]

2.2 No recovery (incomplete resolution of clinical symptoms) Show forest plot

7

430

Risk Ratio (M‐H, Random, 95% CI)

1.01 [0.85, 1.21]

2.2.1 1 month or less

5

255

Risk Ratio (M‐H, Random, 95% CI)

0.94 [0.75, 1.20]

2.2.2 2 months

1

95

Risk Ratio (M‐H, Random, 95% CI)

0.98 [0.65, 1.47]

2.2.3 3 months

1

80

Risk Ratio (M‐H, Random, 95% CI)

1.24 [0.85, 1.80]

2.3 Adverse events Show forest plot

7

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

2.3.1 Overt hepatic encephalopathy

6

420

Risk Ratio (M‐H, Random, 95% CI)

1.17 [0.63, 2.17]

2.3.2 Infection

0

0

Risk Ratio (M‐H, Random, 95% CI)

Not estimable

2.3.3 Hospitalisation

1

80

Risk Ratio (M‐H, Random, 95% CI)

0.33 [0.04, 3.07]

2.3.4 Intolerance leading to discontinuation

3

220

Risk Ratio (M‐H, Random, 95% CI)

0.35 [0.08, 1.43]

2.3.5 Change of/or withdrawal from treatment

7

490

Risk Ratio (M‐H, Random, 95% CI)

1.27 [0.88, 1.82]

2.4 Health‐related quality of life Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Subtotals only

2.4.1 Change in Total SIP Score

1

69

Mean Difference (IV, Random, 95% CI)

0.65 [‐1.13, 2.43]

2.4.2 Change in SIP Psychological Score

1

69

Mean Difference (IV, Random, 95% CI)

0.48 [‐1.04, 2.00]

2.4.3 Change in SIP Physical Score

1

69

Mean Difference (IV, Random, 95% CI)

0.38 [‐0.61, 1.37]

2.5 Plasma ammonia concentration (final and change scores) (μmol/L) Show forest plot

6

325

Mean Difference (IV, Random, 95% CI)

‐2.93 [‐9.36, 3.50]

2.5.1 1 month or less

5

248

Mean Difference (IV, Random, 95% CI)

‐4.30 [‐13.17, 4.56]

2.5.2 3 months

1

77

Mean Difference (IV, Random, 95% CI)

1.16 [‐1.96, 4.28]
Figuras y tablas -
Comparison 2. Probiotic versus lactulose
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