Valderrama 1992.
Methods | Randomised clinical trial | |
Participants | Country: Spain Number randomised: 105 Postrandomisation dropouts: 5 (4.8%) Revised sample size: 100 Average age: 57 years Women: 53 (53%) 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: gabexate mesilate (n = 51), 12 mg/kg/day continuous IV for 4‐12 days based on disappearance of abdominal pain or requirement for surgery Group 2: placebo (n = 49) | |
Outcomes | Mortality, serious adverse events, adverse events, sepsis Follow‐up: not stated (probably until discharge) |
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Notes | Reasons for postrandomisation dropouts: protocol violations | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "computer generated" |
Allocation concealment (selection bias) | Low risk | Quote: "consecutively numbered boxes containing FOY or placebo" |
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 | High risk | Comment: there were postrandomisation dropouts. |
Selective reporting (reporting bias) | Low risk | Comment: mortality and adverse events were reported. |
For profit‐bias | High risk | Quote: "[t]he authors thank Laboratorio Dr Esteve SA for supplies of gabexate mesylate (FOY)". |
Other bias | Low risk | Comment: no other risk of bias |