Summary of findings 2. Probiotics compared with placebo for prevention of diarrhoea in participants with cancer treated with chemotherapy.
| Probiotics compared with placebo for prevention of diarrhoea in participants with cancer treated with chemotherapy | ||||||
| Patient or population: participants with cancer treated with 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 | |||||
| Any diarrhoea | Study population | RR 0.59 (0.36 to 0.96) | 106 (2 RCTs) | ⊕⊕⊝⊝ LOWa | In another cross‐over study, 6 of 22 suffered from diarrhoea during the probiotic period compared with 10 of 22 during the placebo period (no paired analysis presented) | |
| 491 per 1000 | 289 per 1000 (177 to 471) | |||||
| Quality of life ‐ not measured | ‐ | ‐ | ‐ | ‐ | ‐ | |
| Diarrhoea grade 2 or higher | Study population | RR 0.67 (0.22 to 2.05) | 46 (1 RCT) | ⊕⊕⊝⊝ LOWb,c | In another cross‐over study, 3 of 22 suffered from grade 2 diarrhoea or higher during the probiotic period compared with 7 of 22 during the placebo period (no paired analysis presented) | |
| 261 per 1000 | 175 per 1000 (57 to 535) | |||||
| Diarrhoea grade 3 or higher | Study population | RR 0.11 (0.01 to 1.95) | 46 (1 RCT) | ⊕⊕⊝⊝ LOWb,c | In another cross‐over study, 1 of 22 suffered from grade 3 diarrhoea or higher during the probiotic period compared with 4 of 22 during the placebo period (no paired analysis presented) | |
| 174 per 1000 | 19 per 1000 (2 to 339) | |||||
| Diarrhoea grade 4 | Study population | RR 0.33 (0.01 to 7.78) | 46 (1 RCT) | ⊕⊕⊝⊝ LOWb,c | ||
| 43 per 1000 | 14 per 1000 (0 to 338) | |||||
| Time to rescue medication ‐ not measured | ‐ | ‐ | ‐ | ‐ | ‐ | |
| Requiring rescue medication for diarrhoea | Results not quantified. "Participants on probiotic arm used less loperamide and diphenoxylate/atropine compared to participants on placebo arm" | ‐ | 46 (1 RCT) | ⊕⊕⊝⊝ LOWc | ||
| Adverse events | Results not quantified. No differences between groups reported | ‐ | 106 (2 RCTs) | ⊕⊕⊝⊝ LOWc | ||
| Mortality | Although not mentioned explicitly, no studies reported any deaths | ‐ | 128 (3 RCTs) | ⊕⊕⊝⊝ LOWc | ||
| *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; 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. | ||||||
aOIS not reached. CI includes irrelevant benefit.
bWide CI that includes both benefit and harm.
cOIS not reached.