Macdougall 1977.
Methods | Open‐label randomised controlled trial | |
Participants |
Baseline characteristics Number randomised: 75 participants Number analysed: 75 participants Antacids
No prophylaxis
Inclusion criteria
Exclusion criteria: ‐ Baseline imbalances: ‐ |
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Interventions |
Antacids
No prophylaxis
Adherence to regimen: The first 25 participants received either antacids or no prophylaxis. The trial was discontinued when H2 receptor antagonists became available. Of the 50 remaining participants, 10 received metiamide and 16 received cimetidine (after case reports of agranulocytosis by metiamide). The remaining 24 got no prophylaxis Duration of trial: January 1975 to July 1976 Duration of follow‐up: ‐ |
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Outcomes |
Outcomes sought in review and reported in trial
Outcomes sought in review but not reported in trial
Outcomes reported in trial but not used in review
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Notes |
Setting: Liver Unit, King's College Hospital and Medical School, Denmark Hill, London SES Source of funding: ‐ Conflicts of interest: ‐ Ethics approval: ‐ Clinical trials registration: ‐ Sample size calculation: ‐ Additional notes: Only data for the comparison of antacid with no prophylaxis were extracted for the review, as it was felt that the second part of the trial, which compared H2 receptor antagonist vs no prophylaxis, was not a properly randomised trial |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: not clearly mentioned in the study report |
Allocation concealment (selection bias) | Unclear risk | Comment: not clearly mentioned in the study report |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: This was not a placebo‐controlled trial, and the trial was stopped and H2 receptors administered instead of antacids |
Blinding (detection bias) Clinically important upper GI bleeding | Low risk | Comment: unclear on blinding of outcome assessors, but the definition for diagnosis of GI bleeding is mentioned in the study report |
Blinding (detection bias) Nosocomial pneumonia | Unclear risk | Comment: Study did not address this outcome |
Blinding of outcome assessment (detection bias) Adverse reactions of interventions | Low risk | Comment: unclear on blinding of outcome assessors, but outcomes of interest were objective in nature |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: All randomised participants were part of the final analysis |
Selective reporting (reporting bias) | High risk | Comment: Data are not reported separately for participants who received cimetidine and metiamide. Mortality data are clubbed for both groups of controls (those compared with antacids and H2 receptor antagonists) |
Other bias | High risk | Comment: unclear on source of funding and baseline characteristics of participants |