Chen 2014.
Methods | Study design: randomised controlled trial Duration of the study, recruitment: 2006 to 2010 Country: China |
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Participants | Participants with colorectal cancer: age, mean ± SD: intervention group: 60.3 ± 17.2, control group: 59.8 ± 18.7 | |
Interventions | Intervention (n = 35): combined Clostridium butyricum and Bifidobacterium capsule: 3 capsules, 3 times a day, administered from 5 days before to 7 days after surgery Control (n = 35): placebo All participants received intravenous chemotherapy (calcium folinate 300 mg, fluorouracil 500 mg) during surgery |
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Outcomes | Proportions of diarrhoea, all‐cause mortality, several other clinical outcomes (first postoperative exhaust time, first defecation time, incidence of abdominal distension, incidence of systematic inflammatory response syndrome (SIRS), time of intraperitoneal catheter drain, incidence of infection of incisional wound, incidence of pulmonary infection, incidence of urinary tract infection, time of fever, incidence of hypoproteinaemia, length of consumption of antibiotics, length of hospital stay, side effects relevant to drug), biochemical indices | |
Notes | Article written in Chinese | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | The random sequence was generated through a random number table |
Allocation concealment (selection bias) | Unclear risk | No relevant information |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Placebo‐controlled trial with similar packaging of capsules |
Blinding of outcome assessment (detection bias) Subjective outcomes | Unclear risk | Insufficient information for judgement |
Blinding of outcome assessment (detection bias) Objective outcomes | Low risk | No information; however it is unlikely that assessment of objective outcomes (mortality) would have been influenced |
Incomplete outcome data (attrition bias) Subjective outcomes | Unclear risk | Five participants in each group were excluded because of metastasis or non‐adherence to treatment strategy. Reasons for dropout were not specified per group |
Incomplete outcome data (attrition bias) Objective outcomes | Unclear risk | Five participants in each group were excluded because of metastasis or non‐adherence to treatment strategy. Reasons for dropout were not specified per group |
Selective reporting (reporting bias) | Unclear risk | No study protocol was available, but all outcomes prespecified in the methods section were reported in the results section |
Other bias | Low risk | No indications of other bias |