title: Efficacy and tolerability of a Chinese herbal medicine concoction for treatment of atopic dermatitis: a randomized, double-blind, placebo-controlled study.
abstract: BACKGROUND
  There has been considerable interest in traditional Chinese herbal medicine (TCHM) as a treatment for atopic dermatitis (AD). A twice-daily concoction of an ancestral formula containing five herbs has been found to be beneficial in an open study.
  
  
  OBJECTIVE
  To assess the efficacy and tolerability of the concoction in children with AD.
  
  
  METHODS
  Following a 2-week run-in period, children with long-standing moderate-to-severe AD were randomized to receive a 12-week treatment with twice-daily dosing of three capsules of either TCHM or placebo. The SCORing of Atopic Dermatitis (SCORAD) score, Children's Dermatology Life Quality Index (CDLQI), allergic rhinitis score, and requirement for topical corticosteroid and oral antihistamine were assessed before and at weeks 4, 8, 12 and 16 after treatment. Adverse events, tolerability, haematological and biochemical parameters were monitored during the study.
  
  
  RESULTS
  Eighty-five children with AD were recruited. Over 12 weeks, the mean SCORAD score fell from 58.3 to 49.7 in the TCHM group (n = 42; P = 0.003) and from 56.9 to 46.9 in the placebo group (n = 43; P = 0.001). However, there was no significant difference in the scores at the corresponding time points between the two groups. The CDLQI in TCHM-treated patients was significantly improved compared with patients receiving placebo at the end of the 3-month treatment and 4 weeks after stopping therapy (P = 0.008 and 0.059, respectively). The total amount of topical corticosteroid used was also significantly reduced by one-third in the TCHM group (P = 0.024). No serious adverse effects were observed between the groups.
  
  
  CONCLUSIONS
  The TCHM concoction is efficacious in improving quality of life and reducing topical corticosteroid use in children with moderate-to-severe AD. The formulation was palatable and well tolerated.
authors.affiliation: Department of Paediatrics, Chinese University of Hong Kong, Shatin, Hong Kong SAR, China. ehon@cuhk.edu.hk
authors.forename: K L E
authors.initials: KL
authors.lastname: Hon
authors.forename: T F
authors.initials: TF
authors.lastname: Leung
authors.forename: P C
authors.initials: PC
authors.lastname: Ng
authors.forename: M C A
authors.initials: MC
authors.lastname: Lam
authors.forename: W Y C
authors.initials: WY
authors.lastname: Kam
authors.forename: K Y
authors.initials: KY
authors.lastname: Wong
authors.forename: K C K
authors.initials: KC
authors.lastname: Lee
authors.forename: Y T
authors.initials: YT
authors.lastname: Sung
authors.forename: K F
authors.initials: KF
authors.lastname: Cheng
authors.forename: T F
authors.initials: TF
authors.lastname: Fok
authors.forename: K P
authors.initials: KP
authors.lastname: Fung
authors.forename: P C
authors.initials: PC
authors.lastname: Leung
mesh_terms: D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D003876:Dermatitis, Atopic / Q000188:drug therapy*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D004365:Drugs, Chinese Herbal / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage; D006801:Humans; D008297:Male; D010349:Patient Compliance; D008517:Phytotherapy / Q000009:adverse effects / Q000379:methods*; D011788:Quality of Life; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D004365:Drugs, Chinese Herbal; D005938:Glucocorticoids