Fan 2016.

Methods	Parallel‐group randomised controlled trial
Participants	Baseline characteristics Number randomised: participants Number analysed: participants Enteral plus parenteral nutrition Age (years; mean (SD)): 42.31 (14.18) Number of participants (n): 40 Gender (male/female; n): 23/17 Enteral nutrition Age (years, mean (SD)): 40.12 (11.25) Number of participants (n): 40 Gender (male/female; n): 18/22 Parenteral nutrition Age (years, mean (SD)): 41.56 (15.10) Number of participants (n): 40 Gender (male/female; n): 21/19 Inclusion criteria Glasgow Coma Scale score: 6‐8 Nutritional Risk Screening: ≥ 3 Exclusion criteria Use of glucocorticoid and blood products during study Haemodynamic instability Use of immunosuppressive drug in the past 6 months Radiotherapy or chemotherapy in the past 1 year Injured more than 12 hours early before admission Died within 3 weeks Had previous history of metabolic disease such as diabetes mellitus (irritable hyperglycaemia due to injury was exceptional) Baseline imbalances: There was no significant difference among the 3 groups in terms of age, sex, weight, and serum‐albumin at baseline (P > 0.05)
Interventions	Enteral plus parenteral nutrition Dose (total/day): varies Duration of treatment (days): ‐ Route: enteral/IV Intervention: Increase in dosage to maximum of 1000 mL/d was made gradually over 7 days, with pumping speed not exceeding 50 mL/h. Insufficient energy was supplied by PN. All patients were given energy as 105‐126 kJ/kg·d Concomitant medications Enteral nutrition Dose (total/d): varies Duration of treatment (days): ‐ Route: enteral Intervention: nasogastric tube accompanied by subsequent suctioning gastric juice and pumping EN (energy density 6.28 kJ/mL, Nutrison Fibre, NUTRICIA, Holland) within 48 hours after admission. An increase in dosage to the maximum (1500 mL/d) was made gradually over 7 days with pumping speed < 75 mL/h. Only normal sodium, glucose, and saline were given as medicamentous dissolvent in the vein. All patients were given energy as 105 to 126 kJ/kg·d Concomitant medications: nasogastric tube intubation and central venous catheterisation; supplements such as vitamins, microelement, natrium, and kalium were given according to patients’ status; and the headstock was raised to 30 degrees to avoid the counterflow conventionally if necessary Parenteral nutrition Dose (total/d): varies Duration of treatment (days): ‐ Route: IV Intervention: fully parenteral alimentation through central venous catheter within 48 hours after admission. PN was prepared by Intravenous drug dispensing centre with ratio of 2:1 for carbohydrates to lipids, and ratio of 100:1 for calorie nitrogen ratio. All patients were given energy as 105 to 126 kJ/kg·d Concomitant medications: nasogastric tube intubation and central venous catheterisation; supplements such as vitamins, microelement, natrium, and kalium were given according to patients’ status; and the headstock was raised to 30 degrees to avoid the counterflow conventionally if necessary Adherence to regimen: ‐ Duration of trial: January 2009 to May 2012 Duration of follow‐up: ‐
Outcomes	Outcomes sought in review and reported in trial Incidence of clinically important GI bleeding Incidence of VAP Duration of ICU stay Duration of intubation All‐cause mortality in hospital Adverse events of interventions Outcomes sought but not reported in trial All‐cause mortality in ICU Blood transfusions Outcomes reported in trial but not used in review T lymphocyte subsets Plasma levels of IgA, IgM Serum total protein Albumin Prealbumin and haemoglobin Intracranial infection Pyaemia
Notes	Setting: Neurological Intensive Care Unit Source of funding: Natural Science Foundation of Shandong Province (Y2008C35) and Technology Supporting Program of Qingdao (12‐1‐3‐5‐(1)‐nsh) Conflicts of interest: ‐ Ethics approval: This study had been approved by the local institutional review board and the Human Ethics Committee of the Affiliated Hospital of Qingdao University Informed consent: Informed consent had been provided by patients’ guardians Clinical trials registration: ‐ Sample size calculation: ‐ Additional notes: ‐
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	High risk	Quote: "patients were assigned to EN group, PN group and EN+PN groups randomly according to the sequence of their assigned hospital record number" Comment: method of randomisation not adequate
Allocation concealment (selection bias)	Unclear risk	Comment: no information reported
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Comment: no information about blinding reported
Blinding (detection bias) Clinically important upper GI bleeding	Unclear risk	Comment: No definition of criteria was used to diagnose upper GI bleeding as reported
Blinding (detection bias) Nosocomial pneumonia	Unclear risk	Comment: No definition of criteria was used to diagnose nosocomial pneumonia was reported
Blinding of outcome assessment (detection bias) Adverse reactions of interventions	Unclear risk	Comment: no information reported
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Comment: insufficient information to allow judgement; once 120 patients were enrolled, but no information on how many patients fitted eligibility criteria
Selective reporting (reporting bias)	Low risk	Comment: All outcomes listed in the Methods section are also reported in the Results section
Other bias	Low risk	Comment: no other sources of bias suspected