Kedarisetty 2015.

Study characteristics
Methods	Randomised clinical trial, monocentric
Participants	Country: India Period of recruitment: May 2011 to June 2012 Number randomised: 55 Postrandomisation dropouts: 3 Revised sample size: 55 Average age (years): 45 Males: 53% Decompensated cirrhosis: 100% Acute‐on‐chronic liver failure: 0% Alcohol‐related cirrhosis: 64% Viral‐related cirrhosis: 6% Autoimmune disease‐related cirrhosis: excluded Other causes of cirrhosis: 25% Inclusion criteria Patients with decompensated liver cirrhosis Exclusion criteria Aged younger than 18 years or older than 65 years With evidence of alcoholic hepatitis or active alcohol abuse with last intake 1 month With suspected autoimmune hepatitis (antinuclear antibody/anti‐smooth muscle antibody‐positive in titers 1:80 or IgG 1.5 times upper limit of normal, or both) Hepatocellular carcinoma Any focus of sepsis as proven by culture positivity or presence of spontaneous bacterial peritonitis Multi‐organ dysfunction Grade 3 or 4 hepatic encephalopathies (as per West Haven criteria) Human immunodeficiency virus seropositivity Pregnancy Uncontrolled hypertension Coronary artery disease Planned for liver transplantation Refusal to participate in the study
Interventions	Experimental G‐CSF at a dose of 5 μg/kg subcutaneously at days 1, 2, 3, 4, 5 and then every third day until day 28 (total 12 doses), along with DPO 40 mg/wk subcutaneously for 4 weeks (total 4 doses) Control Placebos in the same manner All participants received standard medical therapy. Standard medical therapy included albumin, diuretics, nutritional rehabilitation, b‐blockers and treatment based on aetiology, such as antivirals for hepatitis B.
Outcomes	Primary outcome Overall survival at 12 months Secondary outcomes Survival at 6 months Reduction in liver disease severity scores Reduction in need for large‐volume paracentesis Development of new‐onset complications, such as acute kidney injury, sepsis, and variceal bleed Change in alpha‐foetoprotein levels at 1 month Haemodynamic improvement at 1 month Histological evidence of hepatic regeneration Safety of treatment
Notes	Conflicts of interest: the authors disclosed no conflicts. Funding: Dr. Reddys’ Laboratories, Hyderabad, India, provided the generic drugs G‐CSF, DPO, and placebos; they provided no financial assistance of any kind. Clinicaltrials.gov number: NCT01384565
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	The block randomisation was done with a block size of 10. An independent statistician, using a computer‐generated random number table, performed sequence generation.
Allocation concealment (selection bias)	Low risk	Allocation concealment was done using a sequentially numbered, opaque, sealed envelope.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Both the study investigators and the participants were blinded to the study treatment through identical vials coded as A and B in the 2 groups, respectively.
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	Three participants were lost at follow up in 1 group, but none were lost in the other group.
Selective reporting (reporting bias)	Low risk	The trial reported all‐cause mortality as the primary outcome.
Other bias	Low risk	We found no other bias.