Skip to main content
. 2018 Jun 4;2018(6):CD008687. doi: 10.1002/14651858.CD008687.pub2

Barandun 1985.

Methods Double‐blind parallel‐group randomised controlled trial
Participants Baseline characteristics
Number randomised: 66 participants
Number analysed: 55 participants
Pirenzepine
  • Age (years; mean (SD)): ‐

  • Number of participants (n): 27

  • Gender (male/female; n): ‐


Cimetidine
  • Age (years; mean (SD)): ‐

  • Number of participants (n): 28

  • Gender (male/female; n): ‐


Inclusion criteria
  • Age > 16 years

  • Patients in surgical ICU


Exclusion criteria
  • Gastroscopy not possible

  • On therapy for ulcus

  • Receiving operation of stomach


Baseline imbalances: baseline imbalances comparable, also in terms of severity of injury/trauma
Interventions Pirenzepine
  • Dose (total/d): 40 mg

  • Duration of treatment (days): ‐

  • Route: IV

  • Intervention: 4 × 10 mg IV

  • Concomitant medications: ‐


Cimetidine
  • Dose (total/d): 800 mg

  • Duration of treatment (days): ‐

  • Route: IV

  • Intervention: 4 × 200 mg IV

  • Concomitant medications: ‐


Adherence to regimen: 11 participants withdrew from the trial. However, no reasons are mentioned in the trial report. Also no mention of which interventional group these 11 participants belonged to
Duration of trial:
Duration of follow‐up: not clearly mentioned, probably until discharge
Outcomes Outcomes sought in review and reported in trial
  • Clinically important upper GI bleeding

  • Adverse events of interventions


Outcomes sought but not reported in trial
  • VAP

  • All‐cause mortality in ICU

  • All‐cause mortality in hospital

  • Duration of ICU stay

  • Duration of intubation

  • Number of participants requiring blood transfusion

  • Number of units of blood transfused


Outcomes reported in trial but not used in review
  • Number of lesions on gastroscopy

Notes Setting: Surgical ICU, Chur, Switzerland
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) Unclear risk Comment: not enough information reported on method of sequence generation
Allocation concealment (selection bias) Unclear risk Comment: not enough information reported on method of allocation concealment
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Comment: This appears to be a double‐dummy placebo‐controlled trial, in which participants from group 1 got a placebo that looks like the intervention in group 2 and vice versa. Thus personnel would have been blinded and likelihood of performance bias is low
Blinding (detection bias) 
 Clinically important upper GI bleeding Unclear risk Comment: not enough information reported on the criteria for diagnosis of upper GI bleeding
Blinding (detection bias) 
 Nosocomial pneumonia Unclear risk Comment: The trial did not address this outcome
Blinding of outcome assessment (detection bias) 
 Adverse reactions of interventions Low risk Comment: This appears to be a double‐dummy placebo‐controlled trial, in which participants from group 1 got a placebo that looks like the intervention in group 2 and vice versa. Thus the likelihood of detection bias seems low
Incomplete outcome data (attrition bias) 
 All outcomes High risk Comment: 11 participants withdrew from the trial, but reasons for withdrawal and the group to which they were randomised are not clearly mentioned in the trial report
Selective reporting (reporting bias) Unclear risk Comment: All intended outcomes were reported but no clear mention of the number of participants in the cimetidine group who had confusion and high K levels
Other bias Low risk Comment: The trial report is unclear on the source of funding. No other sources of bias detected