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. 2015 Mar 23;2015(3):CD010605. doi: 10.1002/14651858.CD010605.pub2

Huang 2008.

Methods Study design: prospective randomised trial with parallel‐group design
Country of origin: China
Pre‐sample size estimation: not stated
Intention‐to‐treat: yes
Participants Number of participants randomly assigned: 32
Group I (n = 18)

  • Mean age (years ± SD): 49 ± 11

  • Gender ratio (male/female): 10/8


Group II (n = 14)

  • Mean age (years ± SD): 47 ± 15

  • Gender ratio (male/female): 7/7


Inclusion criteria

  • Patients with severe acute pancreatitis defined according to Bangkok 2002 criteria

  • Admitted within 48 hours of symptoms onset

  • Age < 75 years

  • Not having surgery within the past 2 weeks


Exclusion criteria

  • Recurrent acute pancreatitis after admission

  • Low compliance

  • Cancer at any site

  • Severe cardiovascular, lung and/or renal dysfunction

  • Immunosuppressant treatment

  • Exacerbation of chronic pancreatitis

  • Pregnant or breastfeeding women


Causes of acute pancreatitis: not stated
Participant attrition/loss to follow‐up/deviations from protocol: none stated
Interventions Group I: polymeric EN formulation
Group II: polymeric EN formulation supplemented with glutamine (0.1 g/kg body weight/d) and arginine (0.2 g/kg body weight/d)
Administration of EN in both groups started within 72 hours from admission and lasted for at least 14 days. Route and rate of administration were not stated
Outcomes Outcomes

  • Mortality

  • SIRS

  • Organ failure

  • Adverse events

  • Infected pancreatic necrosis

  • Length of hospital stay
Notes Additional information was requested 7 February 2014, but no reply has been received
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Method of randomisation was described as 'simple randomisation method', but no other information was provided
Allocation concealment (selection bias) Unclear risk Not enough information was provided to assess this outcome
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Trial did not provide information for assessment of this domain, but it is not likely to have been blinded
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Trial did not provide information for assessment of this domain, but it is not likely to have been blinded
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Seems that no losses to follow‐up and no withdrawals occurred
Selective reporting (reporting bias) Low risk All outcomes were reported
Other bias Low risk Trial seems to be free of other potential sources of bias