Hansky 1969.
Methods | Randomised clinical trial | |
Participants | Country: Australia Number randomised: 24 Postrandomisation dropouts: not stated Revised sample size: 24 Average age: not stated Women: 7 (29.2%) Acute interstitial oedematous pancreatitis: not stated Necrotising pancreatitis: not stated Mild pancreatitis: 3 (12.5%) Moderate pancreatitis: 15 (62.5%) Severe pancreatitis: 6 (25%) Persistent organ failure: not stated Infected pancreatitis: not stated Inclusion criteria: people with acute pancreatitis | |
Interventions | Group 1: iniprol (n = 15), single IV dose of 1 million units, followed by 500,000 units IV 4 times daily for 4‐8 days depending upon clinical course Group 2: no intervention (n = 9) | |
Outcomes | Mortality, hospital stay 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) | Unclear risk | Comment: this information was not available. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "[t]he drug was not evaluated in a double‐blind manner". |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "[t]he drug was not evaluated in a double‐blind manner". |
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 | High risk | Quote: "I am grateful to Difrex (Australia) laboratories for supplying . . ." |
Other bias | Low risk | Comment: no other risk of bias |