Summary of findings for the main comparison. Topical antifungal versus placebo/no treatment for chronic rhinosinusitis.
| Topical antifungal versus placebo/no treatment for chronic rhinosinusitis | ||||||
|
Patient or population: chronic rhinosinusitis Intervention: topical antifungal Comparison: placebo/no treatment | ||||||
| Outcomes | Relative effect (95% CI) | Anticipated absolute effects* (95% CI) | Certainty of the evidence (GRADE) | What happens | ||
| Without topical antifungal | With topical antifungal | Difference | ||||
| Heath‐related quality of life (HRQL) Assessed with: various instruments Follow‐up: range 4 weeks to 6 months № of participants: 312 (5 RCTs) | 4 studies (252 participants) using different disease‐specific quality of life instruments reported no statistically significant difference between the groups receiving topical antifungal and placebo in terms of change from baseline or endpoint values | ⊕⊕⊝⊝ LOW 1 | Topical antifungals may lead to little or no difference in disease‐specific health‐related quality of life, compared to placebo, for patients with chronic rhinosinusitis | |||
| Disease severity score Assessed with: various scales Follow‐up: range 8 weeks to 13 weeks № of participants: 176 (2 RCTs) | 2 studies (all patients with chronic rhinosinusitis with nasal polyps) reported a disease severity score using different symptoms. Ebbens 2006 (116 participants) reported mean change from baseline and found that both the placebo and antifungal group only had small mean changes from baseline, which were not statistically significant between the groups (P = 0.31). Weschta 2004 (60 participants) reported the median disease severity scores at the end of treatment. They found that the median symptom score in the placebo group was significantly lower (fewer symptoms) than the topical antifungal group (P < 0.05).3 | ⊕⊝⊝⊝ VERY LOW 2 | It is uncertain whether topical antifungals improve disease severity scores compared to placebo for people with chronic rhinosinusitis | |||
| Generic HRQL (change from baseline) Assessed with: SF‐36 physical component (higher = better) Scale from: 0 to 100 Follow‐up: mean 13 weeks № of participants: 116 (1 RCT) | — | The mean change from baseline in the SF‐36 physical component score without topical antifungals was 1.4 points | — | MD 0.8 points lower (3.66 lower to 2.06 higher) | ⊕⊕⊝⊝ LOW 7 | There may be little or no difference in generic quality of life (physical component) between topical antifungals and placebo for patients with chronic rhinosinusitis |
| Generic HRQL (change from baseline) Assessed with: SF‐36 mental component (higher = better) Scale from: 0 to 100 Follow‐up: mean 13 weeks № of participants: 116 (1 RCT) | — | The mean change from baseline in SF‐36 mental component score without topical antifungal was 1.9 points | — | MD 2.2 points lower (5.46 lower to 1.06 higher) | ⊕⊕⊝⊝ LOW 7 | There may be little or no difference in generic quality of life (physical component) between the use of topical antifungals and placebo for patients with chronic rhinosinusitis |
| Adverse effects ‐ epistaxis Follow‐up: range 4 weeks to 6 months № of participants: 225 (4 RCTs) | RR 0.97 (95% CI 0.14 to 6.63) | Study population | ⊕⊕⊝⊝ LOW 4 | It is uncertain whether topical antifungals increase the risk of epistaxis compared to placebo for patients with chronic rhinosinusitis | ||
| 1.9% | 1.8% (0.3 to 12.5) | 0.1% fewer (1.6 fewer to 10.6 more) | ||||
| Adverse effects ‐ headache Follow‐up: range 4 weeks to 6 months № of participants: 195 (3 RCTs) | RR 1.26 (95% CI 0.60 to 2.63) | Study population | ⊕⊝⊝⊝ VERY LOW 5 | It is uncertain whether topical antifungals increase the risk of headache compared to placebo for patients with chronic rhinosinusitis | ||
| 11.0% | 13.8% (6.6 to 28.9) | 2.9% more (4.4 fewer to 17.9 more) | ||||
| Adverse effects ‐ local irritation Follow‐up: range 4 weeks to 6 months № of participants: 312 (5 RCTs) | RR 2.29 (95% CI 0.61 to 8.62) | Study population | ⊕⊕⊝⊝ LOW 6 | Topical antifungals may lead to more local irritation events compared to placebo for patients with chronic rhinosinusitis | ||
| 0.7% | 1.5% (0.4 to 5.6) | 0.8% more (0.3 fewer to 5 more) | ||||
| *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; HRQL: health‐related quality of life; MD: mean difference; 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 | ||||||
1Downgraded by two levels due to imprecision: there was some evidence to suggest that the data were skewed in three of the five studies, reducing our confidence in the results. Furthermore, the validity of some instruments was unclear.
2Downgraded by one level due to inconsistency: the results of the two studies appeared to differ from each other. Downgraded by one level due to indirectness: all of the included population had nasal polyps, which may not be representative of all chronic rhinosinusitis patients. Downgraded by two levels due to imprecision: the data from one study had wide confidence intervals and the other study presented only median and interquartile range (IQR) values.
3Ebbens 2006 measured the symptoms of nasal blockage, rhinorrhoea, facial pain, postnasal drip and anosmia. Weschta 2004 measured the symptoms of nasal blockage, facial pain, smell disturbance, nasal discharge and sneezing.
4Downgraded by two levels due to imprecision: only one trial reported any events (two events in treatment group), resulting in very wide confidence intervals. Poor reporting of epistaxis results in the trials.
5Downgraded by one level due to inconsistency: adverse effects were generally poorly reported and definitions were likely to be different between studies as the event rates were very different between studies. Downgraded by two levels due to imprecision. Only one trial reported any events and the confidence intervals were very wide.
6Downgraded by two levels due to imprecision: small numbers of events lead to wide confidence intervals, which include a clinically important increase and a clinically important decrease in adverse effects.
7Downgraded by two levels due to imprecision: results come from one study. A minimally important difference has been identified as three points for the SF‐36 and so the confidence intervals include a potentially clinically important effect.