Storck 1968.
Methods | Randomised clinical trial | |
Participants | Country: Sweden Number randomised: 43 Postrandomisation dropouts: not stated Revised sample size: 43 Average age: 59 years Women: 28 (65.1%) Acute interstitial oedematous pancreatitis: not stated Necrotising pancreatitis: not stated Mild pancreatitis: not stated Moderate pancreatitis: not stated Severe pancreatitis: not stated Persistent organ failure: not stated Infected pancreatitis: not stated Inclusion criteria: people with acute pancreatitis | |
Interventions | Group 1: aprotinin (n = 21), first half of the trial ‐ 50,000 to 100,000 units per day and then dose doubled for an average of 12 days Group 2: placebo (n = 22) | |
Outcomes | Mortality Follow‐up: not stated (probably until discharge) |
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Notes | Reasons for postrandomisation dropouts: not stated | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: this information was not available. |
Allocation concealment (selection bias) | Low risk | Quote: "[s]ealed envelopes" |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "double blind" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "double blind" |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: this information was not available. |
Selective reporting (reporting bias) | High risk | Comment: either mortality or adverse events were not reported. |
For profit‐bias | Unclear risk | Comment: this information was not available. |
Other bias | Low risk | Comment: no other risk of bias |