title: Efficacy of a Chinese herbal medicine for the treatment of atopic dermatitis: a randomised controlled study.
abstract: BACKGROUND
  More randomised control trials are required to assess the efficacy of traditional Chinese medicine. This multi-centre, randomised, assessor-blind, controlled study assessed the efficacy of the Chinese herbal formula Pei Tu Qing Xin Tang (PTQXT) for treating patients with atopic dermatitis (AD).
  
  
  METHODS
  Patients aged 5-25 years with moderate-to-severe AD were randomised to receive a 12-week treatment involving either oral administration of PTQXT; oral administration of PTQXT combined with an external application of Chinese herbs; or oral administration of antihistamine and a placebo of PTQXT pills added to topical 1% mometasone furoate. The primary end-point measure was the change in the Scoring Atopic Dermatitis Index (SCORAD) at the end of the observation period, and secondary end-points included quality of life (QOL). The outcomes were evaluated at baseline, then every 4 weeks from week 4 to week 12 and every 8 weeks from week 12 to week 36.
  
  
  RESULTS
  Two hundred and seventy-five patients were recruited. During the 12-week treatment period, up to the primary end-point, the mean SCORAD decreased gradually in all three groups. At week 28 and week 36, there was a significantly greater decrease in the mean SCORAD for the Chinese herbal medicine-treated groups than for the control group (at week 28, P=0.002 and P=0.036, respectively; at week 36, P<0.001 and P=0.002, respectively). At week 36, the difference in QOL scores showed a significantly greater improvement in both Chinese herbal medicine-treated groups than in the control group (P<0.001 and P<0.001, respectively).
  
  
  CONCLUSIONS
  PTQXT is effective in decreasing the severity of the disease and improving the QOL in patients with moderate-to-severe AD.
  
  
  BACKGROUND
  Chinese Clinical Trial Registry: ChiCTR-TRC-08000156.
authors.affiliation: Department of Dermatology, 2nd Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.
authors.forename: Junfeng
authors.initials: J
authors.lastname: Liu
authors.affiliation: Department of Dermatology, 2nd Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.
authors.forename: Xiumei
authors.initials: X
authors.lastname: Mo
authors.affiliation: Department of Clinical Epidemiology, 2nd Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China; Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Canada.
authors.forename: Darong
authors.initials: D
authors.lastname: Wu
authors.affiliation: Department of Clinical Epidemiology, 2nd Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.
authors.forename: Aihua
authors.initials: A
authors.lastname: Ou
authors.affiliation: Department of Dermatology, 2nd Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.
authors.forename: Suqin
authors.initials: S
authors.lastname: Xue
authors.affiliation: Department of Dermatology, 2nd Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.
authors.forename: Chi
authors.initials: C
authors.lastname: Liu
authors.affiliation: Department of Dermatology, 2nd Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.
authors.forename: Hongyi
authors.initials: H
authors.lastname: Li
authors.affiliation: Department of Clinical Epidemiology, 2nd Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.
authors.forename: Zehuai
authors.initials: Z
authors.lastname: Wen
authors.affiliation: Department of Dermatology, 2nd Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China. Electronic address: 4910702@163.com.
authors.forename: Dacan
authors.initials: D
authors.lastname: Chen
mesh_terms: D000284:Administration, Oral; D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D002648:Child; D003876:Dermatitis, Atopic / Q000188:drug therapy*; D004365:Drugs, Chinese Herbal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D055118:Medication Adherence; D010919:Placebos; D011788:Quality of Life; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D004365:Drugs, Chinese Herbal; D010919:Placebos
keywords: Atopic dermatitis; Efficacy; Pei Tu Qing Xin Tang; Randomised controlled trial; Traditional Chinese medicine