2. Dexamethasone compared to budesonide for croup.
| Dexamethasone compared to budesonide for croup | ||||||
| Patient or population: children with croup Intervention: dexamethasone Comparison: budesonide | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Certainty of the evidence (GRADE) | Comments** | |
| Budesonide | Dexamethasone | |||||
| Change in croup score. Assessed with different scores in different studies. Lower scores mean fewer symptoms. (follow‐up: 6 hours) | The mean change in croup score was ‐2.93 to ‐2.00. | The mean change in croup score was 0.46 standard deviations more (0.79 more to 0.13 more). | ‐ | 326 (4 RCTs) | ⊕⊕⊝⊝ LOWa, b | A standard deviation of 0.46 represents a moderate difference between groups. |
| Change in croup score. Assessed with different scores in different studies. Lower scores mean fewer symptoms. (follow‐up: 12 hours) | The mean change in croup score was ‐3.07 to ‐2.33. | The mean change in croup score was 0.75 standard deviations more (1.19 more to 0.30 more). | ‐ | 84 (2 RCTs) | ⊕⊕⊝⊝ LOWc, d | A standard deviation of 0.75 represents a large difference between groups. |
| Return visits or (re)admissions or both | Study population | RR 0.69 (0.40 to 1.22) | 374 (5 RCTs) | ⊕⊕⊕⊝ MODERATEe | ||
| 122 per 1000 | 84 per 1000 (49 to 149) | |||||
| Adverse events | 4/6 (67%) studies reported collecting adverse events data, and 3/4 (75%) studies reported no serious adverse events (Duman 2005; Johnson 1998; Vad Pedersen 1998). Klassen 1998 reported 1 case of oral thrush in the budesonide group (1/65, 1.5%), and 1 case of hives and 1 case of violent behaviour in the dexamethasone group (2/69, 2.9%). | |||||
| *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).
**We used Cohen's interpretation of effect sizes to determine the magnitude of the difference between groups (0.2 represents a small effect, 0.5 represents a medium effect, 0.8 represents a large effect). CI: confidence interval; 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. | ||||||
aWe downgraded by one level for risk of bias. The contributing studies were at high (n = 2) and unclear (n = 2) risk of bias. Allocation concealment was unclear in two studies; blinding was unclear in two studies; and one study was unblinded. There was a baseline imbalance in croup score in one study. bWe downgraded by one level for inconsistency. There was substantial heterogeneity (I² = 51%), and variation in point estimates. cWe downgraded by one level for risk of bias. The contributing studies were at high risk of bias. Allocation concealment was unclear in both studies; blinding was unclear in one study, and the other study was unblinded. There was a baseline imbalance in croup score in one study. dWe downgraded by one level for imprecision. The sample size was small (did not meet the optimal information size). eWe downgraded by one level for imprecision. The sample size was small (did not meet the optimal information size). The effect estimate included a null effect as well as considerable benefit for dexamethasone compared to budesonide.