Singh 2014.
| Study characteristics | ||
| Methods | Open‐label randomised pilot study | |
| Participants | Country: India Period of recruitment: from July 2010 to June 2012 Number randomised: 46 Postrandomisation dropouts: 0 Revised sample size: 46 Average age: 43 Males: 100% Decompensated cirrhosis: not reported Acute‐on‐chronic liver failure: 100% Alcohol‐related cirrhosis: 100% Viral‐related cirrhosis: 0% Autoimmune disease‐related cirrhosis: 0% Other causes of cirrhosis: 0% Inclusion criteria
Exclusion criteria
|
|
| Interventions |
Experimental
Control
All participants received standard medical therapy. Standard medical therapy: diuretics, sodium restriction, and albumin for the treatment of ascites, or fresh frozen plasma for coagulopathy, antibiotics for any focus of infection, and also primary treatment with pentoxifylline at a dose of 400 mg three times a day and normal hospital nutrition (1800 to 2000 kcal per day). |
|
| Outcomes |
Primary outcome
Secondary outcomes
|
|
| Notes | Conflicts of interest: none Funding: none Trial registration: not reported |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | After admission, the participants were randomised into 2 groups. A randomisation code was generated. Randomisation was performed using sequentially numbered envelopes. |
| Allocation concealment (selection bias) | Low risk | Randomisation was performed using sequentially numbered envelopes. |
| 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 | Low risk | All included participants were analysed. |
| 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. |