title: 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.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Paediatrics, Kwong Wah Hospital, Hong Kong Special Administrative Region.
authors.forename: Pak-Hong
authors.initials: PH
authors.lastname: Chan
authors.affiliation: Department of Paediatrics, Kwong Wah Hospital, Hong Kong Special Administrative Region.
authors.forename: Ching-Yee
authors.initials: CY
authors.lastname: To
authors.affiliation: Department of Paediatrics, Kwong Wah Hospital, Hong Kong Special Administrative Region.
authors.forename: Eric Yat-Tung
authors.initials: EY
authors.lastname: Chan
authors.affiliation: Chinese Medicine Clinical Research and Service Centre, Kwong Wah Hospital, Hong Kong Special Administrative Region.
authors.forename: Handong
authors.initials: H
authors.lastname: Li
authors.affiliation: Chinese Medicine Clinical Research and Service Centre, Kwong Wah Hospital, Hong Kong Special Administrative Region.
authors.forename: Xiuxia
authors.initials: X
authors.lastname: Zhang
authors.affiliation: Department of Paediatrics, Kwong Wah Hospital, Hong Kong Special Administrative Region.
authors.forename: Pok-Yu
authors.initials: PY
authors.lastname: Chow
authors.affiliation: Chinese Medicine Clinical Research and Service Centre, Kwong Wah Hospital, Hong Kong Special Administrative Region.
authors.forename: Po-Ling
authors.initials: PL
authors.lastname: Liu
authors.affiliation: Department of Paediatrics, Kwong Wah Hospital, Hong Kong Special Administrative Region.
authors.forename: Shuk-Yu
authors.initials: SY
authors.lastname: Leung
authors.affiliation: Department of Paediatrics, Kwong Wah Hospital, Hong Kong Special Administrative Region.
authors.forename: Chung-Hong
authors.initials: CH
authors.lastname: Chan
authors.affiliation: Chinese Medicine Clinical Research and Service Centre, Kwong Wah Hospital, Hong Kong Special Administrative Region.
authors.forename: Ka-Yan
authors.initials: KY
authors.lastname: Chan
authors.affiliation: Department of Paediatrics, Kwong Wah Hospital, Hong Kong Special Administrative Region.
authors.forename: Johnny Yick-Chun
authors.initials: JY
authors.lastname: Chan
authors.affiliation: Department of Paediatrics, Kwong Wah Hospital, Hong Kong Special Administrative Region.
authors.forename: Jonathan Pak-Heng
authors.initials: JP
authors.lastname: Ng
authors.affiliation: Department of Paediatrics, Kwong Wah Hospital, Hong Kong Special Administrative Region. Electronic address: dkkng@ha.org.hk.
authors.forename: Daniel Kwok-Keung
authors.initials: DK
authors.lastname: Ng
mesh_terms: D000085:Acetates / Q000627:therapeutic use*; D000293:Adolescent; D001249:Asthma / Q000188:drug therapy*; D002648:Child; D003521:Cyclopropanes; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008516:Medicine, Chinese Traditional / Q000379:methods; D011788:Quality of Life; D011804:Quinolines / Q000627:therapeutic use*; D013440:Sulfides
chemical_list: D000085:Acetates; D003521:Cyclopropanes; D004365:Drugs, Chinese Herbal; D011804:Quinolines; D013440:Sulfides; C506362:yu ping feng san; C093875:montelukast
keywords: Asthma; Clinical trials; Complementary medicine and alternative medicine; Leukotriene antagonists; Traditional chinese medicine