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. 2018 Jun 4;2018(6):CD008687. doi: 10.1002/14651858.CD008687.pub2

Fang 2014.

Methods Parallel‐group randomised controlled trial
Participants Baseline characteristics
Number randomised: 120
Number analysed: 120
Early onset drug treatment
  • Age (years; mean (SD)): 47.62 (5.33)

  • Number of participants (n): 40

  • Gender (male/female; n): 27/13


Late onset drug treatment
  • Age (years; mean (SD)): 46.57 (5.71)

  • Number of participants (n): 40

  • Gender (male/female; n): 26/14


Enteral nutrition
  • Age (years; mean (SD)): 47.08 (5.26)

  • Number of participants (n): 40

  • Gender (male/female; n): 28/12


Inclusion criteria:
  • Open craniocerebral injury

  • Brain contusion

  • Skull fracture

  • Subarachnoid haemorrhage

  • Diffuse axonal injury

  • Glasgow Coma Scale score 3 to 8


Exclusion criteria
  • Peptic ulcer disease before admission

  • Gastrointestinal ulcer before admission

  • Coagulopathy or other severe comorbidity


Baseline imbalances: no baseline difference in sex, age, BMI, and causes of brain injury
Interventions Early‐onset drug treatment
  • Dose (total/d):

  • Duration of treatment (days):

  • Route: IV or PO

  • Intervention: omeprazole (80 mg/d) or lansoprazole (60 mg/d), plus sucralfate (4 g/d), starting 12 to 24 hours after admission

  • Concomitant medications


Late‐onset drug treatment
  • Dose (total/d):

  • Duration of treatment (days):

  • Route: IV or PO

  • Intervention: omeprazole (80 mg/d) or lansoprazole (60 mg/d), plus sucralfate (4 g/d), starting 48 to 72 hours after admission

  • Concomitant medications


Enteral nutrition
  • Dose (total/d):

  • Duration of treatment (days):

  • Route: IV or NG tube

  • Intervention: IV nutrition (within 24 hours of admission) and early enteral nutrition (12 to 24 hours after admission), no drug treatment

  • Concomitant medications: ‐


Adherence to regimen:
Duration of follow‐up:
Duration of trial: May 2011 to May 2013
Outcomes Outcomes sought in review and reported in trial
  • Clinically important GI bleeding


Outcomes sought in review and not reported in trial
  • Ventilator‐associated pneumonia

  • Duration of ICU stay

  • All‐cause mortality

  • Duration of intubation

  • Participants requiring blood transfusion

  • Units blood transfused

  • Adverse events of interventions


Outcomes reported in trial, but not used in review
  • Gastric pH after treatment

  • Peptic ulcer healing time

Notes Setting: Department of Nursing, First People’s Hospital of Yunnan Province, Kunming, Yunnan Province, China
Source of funding:
Conflicts of interest:
Ethics approval:
Informed consent:
Clinical trials registration:
Sample size calculation:
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Comment: randomisation by random number tables
Allocation concealment (selection bias) Unclear risk Comment: no information reported
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Comment: no information reported
Blinding (detection bias) 
 Clinically important upper GI bleeding Unclear risk Comment: no definition of criteria used to diagnose upper GI bleeding as reported
Blinding (detection bias) 
 Nosocomial pneumonia Unclear risk Comment: Study did not address this outcome
Blinding of outcome assessment (detection bias) 
 Adverse reactions of interventions Unclear risk Comment: no information reported
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Comment: All participants were observed and analysed after intervention
Selective reporting (reporting bias) Low risk Comment: All observed results were reported, including stress ulcer bleeding rate in group A; the correlation between gastric pH and ulcer healing time in group A; incidence of stress ulcer bleeding rate by different gastric pH and different blood sugar level in group C; clinical therapeutic effects
Other bias Low risk Comment: no other sources of bias suspected