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Inhaled disodium cromoglycate (DSCG) as maintenance therapy in children with asthma: a systematic review
M J Tasche1, J H Uijen, R M Bernsen
1Department of General Practice, Erasmus University, 3000 DR Rotterdam, The Netherlands.
Insights
Disodium cromoglycate (DSCG) shows insufficient evidence for treating childhood asthma. Despite past inclusion in guidelines, recent analysis of trials suggests limited benefits for wheeze and cough, with potential publication bias affecting results.
Area of Science:
- Pediatric Pulmonology
- Clinical Pharmacology
- Evidence-Based Medicine
Background:
- Disodium cromoglycate (DSCG) was previously recommended in asthma treatment guidelines for children.
- Its current clinical use in pediatric asthma management is infrequent.
- This study re-evaluates the efficacy of DSCG based on published randomized controlled trials.
Purpose of the Study:
- To systematically review and interpret findings from all published randomized, placebo-controlled trials of inhaled DSCG for prophylactic treatment in children with asthma.
- To assess the overall treatment effect and identify potential biases in the existing literature.
Main Methods:
- Conducted a comprehensive search of multiple databases to identify relevant randomized, placebo-controlled trials.
- Included studies focused on children (0-18 years) receiving maintenance inhaled DSCG for asthma and published in English.
- Assessed study quality, computed confidence intervals for treatment effects on cough and wheeze, pooled estimates, tested for homogeneity, and analyzed publication bias using funnel plots.
Main Results:
- Identified 24 randomized, placebo-controlled trials with variable methodological quality.
- Heterogeneity was detected among studies; overall confidence intervals for wheeze (0.11-0.26) and cough (0.13-0.27) were observed.
- Tolerance intervals for both wheeze and cough included zero, indicating uncertainty in demonstrating a significant effect compared to placebo. Funnel plots suggested publication bias, with a lack of small, negative studies.
Conclusions:
- Insufficient evidence supports the beneficial effect of DSCG as maintenance therapy for childhood asthma.
- Apparent publication bias, small overall treatment effects, and tolerance intervals including zero contribute to this conclusion.
- Re-evaluation suggests DSCG's role in pediatric asthma management may be limited based on current evidence.
Background:
Disodium cromoglycate (DSCG) is included in the BTS guidelines on the treatment of asthma for use in children, but is now used only infrequently. We have identified and interpreted the findings of all published randomised, placebo controlled trials of DSCG in the prophylactic treatment of children with asthma.
Methods:
Several databases were searched to identify trials. Studies were included if they investigated subjects with asthma aged 0-18 years old, addressed maintenance treatment with inhaled DSCG, and were published in English. The methodological quality of the studies was assessed independently by three reviewers. The 95% confidence intervals (CI) of differences in the treatment effect for cough and wheeze between placebo and treatment with DSCG were computed. The estimates were pooled and tested for homogeneity and, to assess possible publication bias, a funnel plot was made and tested for symmetry.
Results:
Of the 24 randomised, placebo controlled trials identified, the methodological scores varied widely. The null hypothesis of homogeneity was rejected. Under the assumption of heterogeneity the overall CI for wheeze was 0.11 to 0.26 and for cough was 0.13 to 0.27. The overall tolerance intervals (-0.11 to 0. 48 and -0.04 to 0.43 for wheeze and cough, respectively) both included zero, so it cannot be concluded that future studies will show an effect of DSCG compared with placebo. Older studies were more often in favour of DSCG. The funnel plots suggest publication bias; small studies with negative or equal outcomes are lacking.
Conclusion:
Given the apparent publication bias, the small overall treatment effect, and the tolerance interval including zero, there is insufficient evidence that DSCG has a beneficial effect as maintenance treatment in children with asthma.