Urbancsek 2001.
| Methods | Study design: randomised, double‐blind, parallel‐group design Duration of the study: August 1996 to end of June 1998 Country: Hungary |
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| Participants | People with cancer in the age range 19 to 75 years developing diarrhoea within 4 weeks after receiving radiotherapy (median cumulative radiation dose 50 Gy per patient) in the abdominal region, patients with clinical evidence of severe diarrhoea‐induced dehydration, and patients with bloody diarrhoea were not eligible Mean age, years (range): 59 (28 to 81) versus 60 (33 to 86) Sex, % (male/female): 25/75 versus 26/76 |
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| Interventions | Intervention (n = 102): Lactobacillus rhamnosus (Antibiophilus, each sachet containing 1.5 g of Lactobacillus rhamnosus equivalent to 1.5 × 10⁹ CFU) 3 times a day Control (n = 103): identical‐appearing sachets of placebo, each containing 700 mg corn starch, 797 mg microcrystalline cellulose, 1.37 mg iron oxide, 1.13 mg dispersed orange (colouring agent), and 1 mg caramel aroma, 3 times a day |
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| Outcomes | Time to and frequency of rescue medication per participant. Documentation of any possible adverse reactions was provided on a volunteer basis. Secondary efficacy endpoints included average number of daily bowel movements, diarrhoea grading, and faeces consistency ratings | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Randomised study, yet method of randomisation not described |
| Allocation concealment (selection bias) | Low risk | Pre‐packaged (blinded) study medication differing solely in patient numbers on the medication package was provided to investigators by the sponsor |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Study was described to be 'double‐blind': neither the patient nor the treating physician knew if the patient was receiving study drug or placebo |
| Blinding of outcome assessment (detection bias) Subjective outcomes | Low risk | Participants were blinded to treatment allocation: low risk for assessment of subjective outcomes |
| 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 | Low risk | Intention‐to‐treat analysis was performed |
| Incomplete outcome data (attrition bias) Objective outcomes | Low risk | Intention‐to‐treat analysis was performed |
| Selective reporting (reporting bias) | Unclear risk | No study protocol is available, but all outcomes prespecified in the methods section were reported in the results section |
| Other bias | Low risk | No indications of other bias |
5‐FU: 5‐fluorouracil 5‐HT₃: 5‐hydroxytryptamine receptor CFU: colony‐forming units CTC: Common Toxicity Criteria CTCAE: Common Terminology Criteria for Adverse Events ECOG: Eastern Cooperative Oncology Group EORTC‐QLQ‐C30: questionnaire developed to assess the quality of life of patients with cancer FIGO: International Federation of Gynaecology and Obstetrics NCI: National Cancer Institute RCT: randomised controlled trial RT: radiotherapy SAE: serious adverse event SD: standard deviation SIRS: systemic inflammatory response syndrome WHO: World Health Organization