The quality of evidence is downgraded by study limitations (lack of/unclear allocation concealment and lack of blinding) and by imprecise results (few patients and outcome events and wide confidence intervals).
A Cochrane review [Abstract] 1 included 21 RCTs with a total of 1420 subjects to assess the beneficial and harmful effects probiotics, compared to placebo or no intervention, or with any other treatment for patients with acute or chronic hepatic encephalopathy. Duration of administration ranged from 10 days to 180 days.
No effect was found on all-cause mortality when probiotics were compared with placebo or no treatment (7 trials; 404 participants; RR 0.58, 95% CI 0.23 to 1.44). No-recovery (as measured by incomplete resolution of symptoms) was lower for participants treated with probiotic (10 trials; 574 participants; RR 0.67, 95% CI 0.56 to 0.79). Adverse events were lower for participants treated with probiotic than with no intervention when considering the development of overt hepatic encephalopathy (10 trials; 585 participants; RR 0.29, 95% CI 0.16 to 0.51), but effects on hospitalisation and change of/or withdrawal from treatment were uncertain (hospitalisation: 3 trials, 163 participants; RR 0.67, 95% CI 0.11 to 4.00; change of/or withdrawal from treatment: 9 trials, 551 participants; RR 0.70, 95% CI 0.46 to 1.07).
Probiotics may slightly improve quality of life compared with no intervention (3 trials; 115 participants). Plasma ammonia concentration was lower for participants treated with probiotic (10 trials; 705 participants; MD -8.29 μmol/L, 95% CI -13.17 to -3.41). There were no reports of septicaemia attributable to probiotic in any trial.When probiotics were compared with lactulose, the effects on all-cause mortality were uncertain (2 trials; 200 participants; RR 5.00, 95% CI 0.25 to 102.00); lack of recovery (7 trials; 430 participants; RR 1.01, 95% CI 0.85 to 1.21); adverse events considering the development of overt hepatic encephalopathy (6 trials; 420 participants; RR 1.17, 95% CI 0.63 to 2.17); hospitalisation (1 trial; 80 participants; RR 0.33, 95% CI 0.04 to 3.07); intolerance leading to discontinuation (3 trials; 220 participants; RR 0.35, 95% CI 0.08 to 1.43); change of/or withdrawal from treatment (7 trials; 490 participants; RR 1.27, 95% CI 0.88 to 1.82); quality of life (results not meta-analysed; 1 trial; 69 participants); and plasma ammonia concentration overall (6 trials; 325 participants; MD -2.93 μmol/L, 95% CI -9.36 to 3.50). There were no reports of septicaemia attributable to probiotic in any trial.
| Outcome | Number of participants (studies) | Assumed risk (control) | Corresponding risk (probiotic) | Relative effect (95% CI) | Quality of evidence (GRADE) |
|---|---|---|---|---|---|
| All-cause mortality | 404 (7) | 51 per 1000 | 30 per 1000 (12 to 73) | RR 0.58 (0.23 to 1.44) | low |
| No recovery | 574 (10) | 790 per 1000 | 529 per 1000(442 to 624) | RR 0.67 (0.56 to 0.79) | moderate |
| Adverse events (follow-up 1 to 3 months) | 585 (10) | 168 per 1000 | 49 per 1000 (27 to 86) | RR 0.29 (0.16 to 0.51) | low |
Date of latest search: 2017-02-23
Primary/Secondary Keywords