Barandun 1985.
Methods | Double‐blind parallel‐group randomised controlled trial | |
Participants |
Baseline characteristics Number randomised: 66 participants Number analysed: 55 participants Pirenzepine
Cimetidine
Inclusion criteria
Exclusion criteria
Baseline imbalances: baseline imbalances comparable, also in terms of severity of injury/trauma |
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Interventions |
Pirenzepine
Cimetidine
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 |
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Outcomes |
Outcomes sought in review and reported in trial
Outcomes sought but not reported in trial
Outcomes reported in trial but not used in review
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Notes |
Setting: Surgical ICU, Chur, Switzerland Source of funding: ‐ Conflicts of interest: ‐ Ethics approval: ‐ Informed consent: ‐ Clinical trials registration: ‐ Sample size calculation: ‐ |
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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 |