Prajapati 2017.
| Study characteristics | ||
| Methods | Open‐label randomised controlled trial, single centre | |
| Participants | Country: India Period of recruitment: June 2014 and February 2016 Number randomised: 259 Postrandomisation dropouts: 6 Revised sample size: 253 Average age (years): 54 Males: 83% Decompensated cirrhosis: 100% Acute‐on‐chronic liver failure 0% Alcohol‐related cirrhosis 25% Viral‐related cirrhosis: 13% Autoimmune disease‐related cirrhosis: 0% Other causes of cirrhosis: 50% Inclusion criteria
Exclusion criteria
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| Interventions |
Experimental
Control
All participants received standard medical therapy. Standard medical therapy included antivirals, abstinence from alcohol, nutrition, diuretics, β‐blockers, selective intestinal decontamination, and other supportive measures depending on clinical status and requirement. |
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| Outcomes |
Primary outcome
Secondary outcome
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| Notes | Conflicts of interest: "There are no conflicts of interest." Funding: no information ClinicalTrials.gov number: NCT02642003 |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | The randomisation sequence remained with the statistician. |
| Allocation concealment (selection bias) | Low risk | The sequence remained concealed from the investigators until the intervention was assigned. |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | This was an open‐label study. |
| Blinding of outcome assessment (detection bias) overall mortality | Low risk | No information was given, but for the mortality outcome, low risk of bias. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information was given. |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Twenty participants were lost at follow up (treatment arm: 9, control arm: 11). |
| Selective reporting (reporting bias) | Low risk | The trial reported all‐cause mortality as a primary outcome. |
| Other bias | Low risk | We found no other bias. |