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. 2023 Jun 6;2023(6):CD013532. doi: 10.1002/14651858.CD013532.pub2

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
  • Patients with alcoholic hepatitis with a modified Maddrey’s discriminant function of 32 or more

  • Aged 18 to 75 years

  • With an average alcohol intake of more than 100 g/day during the 3 months before enrolment


Exclusion criteria
  • The presence of hepatocellular carcinoma or portal vein thrombosis

  • Refusal to participate in the study

  • Prior treatment with steroids

  • Any significant comorbidities including hepatorenal syndrome

  • Grade 3 or 4 hepatic encephalopathy

  • Upper gastrointestinal bleeding within the preceding 10 days

  • Uncontrolled bacterial infection

  • Human immunodeficiency virus infection

  • Hepatitis B virus infection

  • Hepatitis C virus seropositivity

  • Autoimmune hepatitis

  • Haemochromatosis

  • Wilson’s disease

  • Alpha‐1‐antitrypsin deficiency

  • Pregnancy

  • Any previous known hypersensitivity to G‐CSF

Interventions Experimental
  • G‐CSF (Biocon, Bangalore, India) was given at a dosage of 5 μg/kg subcutaneously every 12 hours for 5 consecutive days, and standard medical therapy plus G‐CSF (group A; n = 23)


Control
  • Standard medical therapy alone (group B; n = 23)


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
  • Survival at 90 days after recruitment and commencement of treatment


Secondary outcomes
  • Mobilisation of CD34 + cells in peripheral blood

  • A surrogate marker for haematopoietic stem cell mobilisation

  • Improvement in clinical scores (MELD, mDF, and CTP)

  • Safety of G‐CSF in alcoholic hepatitis patients

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.