A randomized placebo-controlled trial of traditional Chinese medicine as an add-on therapy to oral montelukast in the treatment of mild persistent asthma in children.

OBJECTIVES: Traditional Chinese medicine are commonly used for treatment of asthma. However, there are only very limited data about its efficacy in children. Therefore, we aimed to determine the efficacy of augmented Yu Ping Feng San (aYPFS) as an add-on to oral montelukast compared with montelukast alone for treatment of mild persistent asthma in children.

DESIGN: A single centre, placebo-controlled, double-blinded, randomized control trial was carried out. Participants with age 6-18 years who had mild persistent asthma were randomized according to random number list to receive either aYPFS plus montelukast for 24 weeks or placebo plus montelukast for 24 weeks. Primary outcome measure was lung function parameters. Secondary outcome measures were Asthma Control Test™ (ACT™) and Paediatric Allergic Disease Quality of Life Questionnaire (PADQLQ) scores, symptom-free days, short-acting β2-agonist use, use of rescue oral corticosteroids, days of hospitalization for asthma and number of emergency consultation with GPs or AED department.

RESULTS: Twenty-eight participants were randomized to aYPFS group and twenty-nine to placebo group. There was no significant difference in baseline characteristics. There was significant improvement in ACT™ score in aYPFS group (up to 6.9% change from baseline) (p=0.016) but not in the control group. There were no significant differences between groups in other primary and secondary outcome parameters. Dropout because of adverse effects is comparable in both groups.

CONCLUSION: Traditional Chinese medicine aYPFS as an add-on to montelukast improved symptoms of asthma control. Further studies with larger sample size are needed to evaluate its efficacy and safety in childhood asthma.