Summary of findings 3. Probiotics compared with other active treatment for prevention of diarrhoea in participants with cancer treated with radiotherapy (with or without chemotherapy).
| Probiotics compared with other active treatment for prevention of diarrhoea in participants with cancer treated with radiotherapy (with or without chemotherapy) | ||||||
| Patient or population: participants with cancer treated with radiotherapy (with or without chemotherapy) Setting: secondary care Intervention: probiotics Comparison: other active treatment | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with other active treatment | Risk with probiotics | |||||
| Any diarrhoea | Study population | RR 0.30 (0.11 to 0.81) | 21 (1 RCT) | ⊕⊝⊝⊝ VERY LOWa,b,c | ||
| 900 per 1000 | 270 per 1000 (99 to 729) | |||||
| Quality of life ‐ not measured | ‐ | ‐ | ‐ | ‐ | ‐ | |
| Severity of diarrhoea: grade 3 or higher | Study population | OR 0.38 (0.16 to 0.89) | 148 (1 RCT) | ⊕⊕⊝⊝ LOWb,c | Based on an analysis that addressed the factorial design of this study | |
| 373 per 1000 | 184 per 1000 (87 to 346) | |||||
| Time to rescue medication ‐ not measured | ‐ | ‐ | ‐ | ‐ | ‐ | |
| Requiring rescue medication for diarrhoea | Study population | RR 0.44 (0.22 to 0.86) | 63 (2 RCTs) | ⊕⊝⊝⊝ VERY LOWa,b,c | ||
| 567 per 1000 | 249 per 1000 (125 to 487) | |||||
| Adverse events | No differences between groups in all studies | ‐ | 211 (3 RCTs) |
⊕⊝⊝⊝ VERY LOWa,b,c | ||
| Mortality | Although not mentioned explicitly, no studies reported any deaths | ‐ | 211 (3 RCTs) |
⊕⊕⊝⊝ LOWc,d | ||
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; OIS: optimal information size; OR: odds ratio; RCT: randomised controlled trial; RR: risk ratio. | ||||||
| GRADE Working Group grades of evidence. High certainty: We are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: We are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: Our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low certainty: We have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect. | ||||||
aHigh risk of detection bias.
bHigh risk of performance bias.
cVery small study/studies. OIS not reached.
dHigh risk of bias in all studies. Not downgraded for mortality.