Zhu 2014.
Methods | Randomised clinical trial | |
Participants | Country: China Number randomised: 39 Postrandomisation dropouts: not stated Revised sample size: 39 Average age: 43 years Women: 18 (46.2%) Acute interstitial oedematous pancreatitis: not stated Necrotising pancreatitis: not stated Mild pancreatitis: 0 (0%) Moderate pancreatitis: 0 (0%) Severe pancreatitis: 39 (100%) Persistent organ failure: not stated Infected pancreatitis: not stated Inclusion criteria
Exclusion criteria
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Interventions | Group 1: probiotics (n = 20), 2 tablets twice daily for 14 days (Japanese preparation) Group 2: placebo (n = 19) | |
Outcomes | Serious adverse events, adverse events, requirement for endoscopic or radiological drainage, infected pancreatic necrosis Follow‐up: not stated (probably 2 weeks) |
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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 | 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 |
ERCP: endoscopic retrograde cholangiopancreatography; ICU: intensive care unit; IU: international unit; IV: intravenous; KIU: kallikrein inhibitor units; MRC: Medical Research Council (1 MRC = 1 IU); PR: per rectum; SC: subcutaneous.