Summary of findings 4. Probiotics compared with placebo for treatment of diarrhoea due to radiotherapy (with or without chemotherapy) in participants with cancer.
| Probiotics compared with placebo for treatment of diarrhoea due to radiotherapy (with or without chemotherapy) in participants with cancer | ||||||
| Patient or population: participants with cancer treated with radiotherapy (with or without chemotherapy) Setting: secondary care Intervention: probiotics Comparison: placebo | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with placebo | Risk with probiotics | |||||
| Reduction in severity of diarrhoea | "The average diarrhoea grade (rated by the investigators using standard scores ranging from 0 for no diarrhoea to 3 for severe diarrhoea) was 0.7 for the Antibiophilus group and 1.0 for the placebo group at the end of the study (no significant difference between the two groups)" | ‐ | 205 (1 RCT) |
⊕⊕⊕⊝ MODERATEa,b | ||
| Quality of life ‐ not measured | ‐ | ‐ | ‐ | ‐ | ‐ | |
| Time to rescue medication (in hours) | Mean time to rescue medication (in hours) was 0 | MD 13 higher (0.86 lower to 26.86 higher) | ‐ | 205 (1 RCT) | ⊕⊕⊕⊝ MODERATEa,b | |
| Requiring rescue medication for diarrhoea | Study population | RR 0.74 (0.53 to 1.03) | 205 (1 RCT) | ⊕⊕⊕⊝ MODERATEa,b | ||
| 476 per 1000 | 352 per 1000 (252 to 490) | |||||
| Adverse events | "Serious adverse events were not observed. In the Antibiophilus group, three participants reported mild to moderate gastrointestinal problems; in the placebo group two participants reported moderate to severe gastrointestinal events, and one patient observed a mild labial oedema. All documented events were of a transient nature; in three patients, symptomatic treatment of adverse events was prescribed" | ‐ | 205 (1 RCT) | ⊕⊕⊕⊝ MODERATEa | ||
| Mortality | Although not mentioned explicitly, no studies reported any deaths | ‐ | 205 (1 RCT) | ⊕⊕⊕⊝ MODERATEa | ||
| *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; MD: mean difference; OIS: optimal information size; 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. | ||||||
aOne study in 205 participants; OIS not reached.
bCI includes both benefit and harm.