Salminen 1988.
Methods | Study design: 2‐group parallel RCT Duration of the study: not reported; follow‐up until 6 weeks after completion of treatment Country: Finland |
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Participants | Participants with the diagnosis of cervix or uterus carcinoma were included in this study Age: 40 to 75 years Sex: female |
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Interventions | Intervention (n = 11): both dietary counselling and a daily dose of ≥ 2 × 10⁹ live Lactobacillus acidophilus bacteria in the form of a yogurt‐type product 150 mL of the product daily for 5 days before radiotherapy, daily throughout the radiotherapy period including the interval, and then for 10 days after completion of the therapy regimen Control (n = 10): dietary counselling only Sum of internal and external radiation was 8000 cGy for the tumour and 5000 cGy for the pelvic area |
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Outcomes | Frequency and severity of radiotherapy‐induced diarrhoea, intestinal side effects | |
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) | Unclear risk | Method of allocation not described |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No information on blinding: probably not performed |
Blinding of outcome assessment (detection bias) Subjective outcomes | High risk | No information on blinding: probably not performed. High risk of detection bias for 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 | Unclear risk | Two participants were excluded from the control group because of changes in the radiotherapy regimen. One participant from the test group was excluded because she had no pause during radiotherapy. All other participants in the test group tolerated the yogurt treatment well and completed the prescribed treatment regimen Owing to the relatively large numbers of dropouts in this small study, we scored 'unclear' |
Incomplete outcome data (attrition bias) Objective outcomes | Unclear risk | Owing to the relatively large numbers of dropouts in this small study, we scored 'unclear' |
Selective reporting (reporting bias) | Unclear risk | Study was published in 1988, and no study protocol is available. Yet, all outcomes prespecified in the methods section were reported in the results section |
Other bias | Unclear risk | No baseline characteristics are reported in Table 1. As treatment groups are small, baseline differences could have been present by chance |