Summary of findings 2. Systemic antifungal versus placebo/no treatment for chronic rhinosinusitis.
| Systemic antifungal versus placebo/no treatment for chronic rhinosinusitis | ||||||
| Patient or population: chronic rhinosinusitis Intervention: systemic antifungal Comparison: placebo/no treatment | ||||||
| Outcomes | Relative effect (95% CI) | Anticipated absolute effects* (95% CI) | Certainty of the evidence (GRADE) | What happens | ||
| Without systemic antifungal | With systemic antifungal | Difference | ||||
| Heath‐related quality of life (HRQL) Assessed with: Rhinosinusitis Disability Index (RSDI) Follow‐up: 6 weeks № of participants: 53 (1 RCT) | Values for the RSDI results were not provided in the paper but the authors state that "no differences were observed” at any time point measured | ⊕⊕⊝⊝ LOW 1 | Systemic antifungals may lead to little or no difference in disease‐specific health‐related quality of life, compared with placebo, for patients with chronic rhinosinusitis | |||
| Disease severity score Assessed with: overall evaluation of sinusitis measured on a 4‐point scale Follow‐up: 6 weeks № of participants: 53 (1 RCT) | Symptoms of facial pain/pressure, facial congestion and nasal discharge were measured. No values were reported but the authors state that "no differences were observed [between the treatment groups]". | ⊕⊕⊝⊝ LOW 1 | Systemic antifungals may lead to little or no difference in disease severity score, compared with placebo, for patients with chronic rhinosinusitis | |||
| Adverse effects ‐ hepatic toxicity Follow‐up: 6 weeks № of participants: 53 (1 RCT) |
RR 3.35 (95% CI 0.14 to 78.60) | Study population | ⊕⊕⊝⊝ LOW 2 | Systemic antifungal agents may lead to more hepatic toxicity events compared with placebo for patients with chronic rhinosinusitis | ||
| No events were reported | — | — | ||||
| Adverse effects ‐ gastrointestinal disturbances
Follow‐up: 6 weeks
№ of participants: 53 (1 RCT) |
RR 0.37 (95% CI 0.04 to 3.36) | Study population | ⊕⊕⊝⊝ LOW3 | Systemic antifungal agents may lead to more gastrointestinal disturbances compared with placebo for patients with chronic rhinosinusitis | ||
| 10.7% | 4.0% (0.4 to 36.0) | 6.7% fewer (10.3 fewer to 25.3 more) | ||||
| Adverse effects ‐ allergic reactions | No study reported this outcome | |||||
| Generic health‐related quality of life | No study reported this outcome | |||||
| *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; OR: odds ratio; RR: risk ratio; RSDI: Rhinosinusitis Disability Index | ||||||
| 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 | ||||||
1Downgraded by one level due to imprecision: results come from one small study (44 participants). Downgraded by one level due to risk of bias: the paper does not present quantitative results and so is at risk of selective outcome reporting.
2Downgraded by two levels due to imprecision: results come from one small study (44 participants) reporting one event in the systemic antifungal group, leading to very wide confidence intervals.
3Downgraded by two levels due to imprecision: results come from one small study (44 participants) reporting three events in the placebo group and one event in the systemic antifungal group, leading to wide confidence intervals.