Lin 2016.

Methods	Parallel‐group randomised controlled trial
Participants	Baseline characteristics Number randomised: 120 participants Number analysed: 120 participants Lansoprazole Age (years; mean (SD)): 66.7 (16.8) Number of participants at baseline (n): 60 Gender (male/female; n): 38/22 Other medications Age (years; mean (SD)): 64.8 (18.6) Number of participants at baseline (n): 60 Gender (male/female; n): 37/23 Inclusion criteria Receiving mechanical ventilation for > 48 hours Underwent nasogastric tube intubation Prepared to be weaned from the ventilator Difficult to wean patients (not weaned off the mechanical ventilator 48 to 72 hours after resolution of their underlying disease process) Exclusion criteria Pregnancy Age < 18 years Allergic to lansoprazole Having active UGI bleeding Receiving PPIs or H2RAs within 1 week Baseline imbalances: no difference in gender, age, and mean number of comorbidities between the 2 groups. Use of ulcerogenic medications was similar between the 2 groups. There was no significant difference between the 2 groups in GCS scores, initial APACHE II score in the medical or surgical ICUs, ventilator‐dependent days before starting to be weaned, rapid shallow index (a weaning parameter), and baseline albumin and haemoglobin levels before weaning
Interventions	Lansoprazole Dose (total/d): 30 mg Duration of treatment (days): 14 Route: NG tube Intervention: lansoprazole OD 30 mg once daily (takepron OD 30 mg/tab, TAKEDA Pharmaceutical Company, Ltd., Osaka, Japan) via NG tube Concomitant medications: bolus feeding from the NG tube, NSAID, aspirin, steroids, anticoagulant in some patients Other medications Dose (total/d): ‐ Duration of treatment (days): 14 Route: NG tube Intervention: no PPIs or other medications for treating peptic ulcers Concomitant medications: bolus feeding from the NG tube, NSAID, aspirin, steroids, anticoagulant in some patients Adherence to treatment: ‐ Duration of trial: June 2009 ‐ February 2012 Duration of follow‐up: 30 days
Outcomes	Outcomes sought in review and reported in trial Gastrointestinal bleeding defined as follows: (1) a 'coffee ground' substance from the NG aspirate ≥ 60 mL; (2) fresh blood from the NG tube; or (3) passage of tarry stool. UGI bleeding definition: UGI bleeding with haemoglobin level decrease ≥ 2 g/dL or in need of a blood transfusion of > 2 units Ventilator‐associated pneumonia defined as clinical pulmonary infection score > 6, with scoring system composed of body temperature, white blood cell count, purulent secretions, diffuse or localised pulmonary infiltrate in XR, progression of infiltrate, and culture of secretions Mortality Outcomes sought in review but not reported in trial Duration of ICU stay Duration of intubation Blood transfusion Adverse events of interventions Outcomes reported in trial but not used in review Successful weaning rate
Notes	Setting: Respiratory Care Center, Division of Gastroenterology and Hepatology, Far Eastern Memorial Hospital, New Taipei City, Taiwan Sponsorship source: Quote: "This study was supported by a grant from Far Eastern Memorial Hospital (FEMH) (FEMH‐2008‐C‐043)" Conflicts of interest: ‐ Ethics approval: Quote: "The protocol was approved by the Research Ethics Review Committee of the Far Eastern Memorial Hospital" Informed consent: Quote: "After obtaining written consent from their families..." Clinical trials registration: ClinicalTrials.gov ID: NCT00708149, Sample size calculation: ‐
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	High risk	Quote: "They were randomly allocated into two groups using blocked randomisation"
Allocation concealment (selection bias)	Unclear risk	Comment: no details reported.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Quote: "non‐double‐blind" Comment: Performance bias is a possibility, even if outcomes are objective
Blinding (detection bias) Clinically important upper GI bleeding	Low risk	Comment: outcome measured objectively as defined in the trial report
Blinding (detection bias) Nosocomial pneumonia	Low risk	Comment: outcome measured objectively as defined in the trial report
Blinding of outcome assessment (detection bias) Adverse reactions of interventions	Unclear risk	Quote: "randomised, non‐double‐blind" Comment: no blinding in place, lack of blinding unlikely to influence outcome measures and outcomes
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: no incomplete reporting suspected; all participants randomised at baseline are also included in analyses
Selective reporting (reporting bias)	Low risk	Quote: "(ClinicalTrials.gov ID: NCT00708149). Outcome measures. The primary end point of our study was apparent UGI bleeding 2,20 within 2 weeks of enrolment, which was defined as follows: (1) a 'coffee ground' substance from the NG aspirate 60 mL; (2) fresh blood from the NG tube; or (3) passage of tarry stool. Secondary end points included clinically significant UGI bleeding 2,20 (definition: UGI bleeding with haemoglobin level decrease !2 gm/dL or in need of a blood transfusion of > 2 units), successful weaning rate, ventilator‐associated pneumonia (definition: clinical pulmonary infection score 21 > 6, a scoring system composed of body temperature, white blood cell count, purulent secretions, diffuse or localized pulmonary infiltrate in CXR, progression of infiltrate, and culture of secretions), and a 30‐day survival rate" Comment: All outcomes reported in the Methods section are also reported in the Results
Other bias	Low risk	Comment: no other sources of bias suspected