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. 2013 Sep 10;2013(9):CD008642. doi: 10.1002/14651858.CD008642.pub2

Cheng 2010.

Methods This was a randomised, double‐blind, placebo‐controlled, parallel clinical trial
Participants 1. Setting: The trial recruited participants from the department of Integration of Traditional Chinese and Western Medicine, in a university hospital in Taiwan
2. Age: from 8 to 23 years of age
3. Sex (men/women): 37/34
4. Number of participants randomised: 71
5. T/C: 47/24
Interventions I. Treatment group
1. Xiao‐Feng‐San (XFS)
1.1 Ingredients and dosage
  • Fangfeng(Radix saposhnikovia) 2.5 mg

  • Jingjie(Herba schizonepetae) 2.5 mg  

  • Danggui (Radix angelicae sinensis) 2.5 mg

  • Shengdihuang (Radix rehmanniae) 2.5 mg

  • Kushen(Radix sophorae flavescentis) 2.5 mg

  • Cangzhu(Rhizoma atractylodis) 2.5 mg

  • Chantui(Periostracum cicdae) 2.5 mg

  • Yamazi(Linum usitatissimum) 2.5 mg

  • Zhimu(Rhizoma anemarrhenae) 2.5 mg

  • Shigao(Gypsum fibrosum) 2.5 mg

  • Chuanmutong (Caulis clematidis armandii) 1.25 mg

  • Gancao(Radix glycyrrhizae) 1.25 mg

  • Niubangzi(Fructus arctii) 2.5 mg


1.2 Administration
  • 3 times daily orally, 1 sachet of granules for 3 to 7 year‐olds, 2 sachets for 8 to 12 year‐olds, and 3 sachets for those aged 13 and over. There were 3 grams of XFS concentrated particles in each sachet


1.3 Duration of treatment
  • 8 weeks


1.4 Follow up
  • 4 weeks after the 8‐week treatment period


II. Control group
2. Placebo
2.1 Ingredients and dosage
  • Placebo was made of caramel, lactose, and starch ‐ at a ratio of 2:1:1 ‐ and put into identical‐appearing 3 g packs. The placebo mixture has no known benefit in atopic dermatitis but has a similar appearance and taste to the active treatment


2.2 Administration
  • Same as at 1.2


2.3 Duration of treatment
  • 8 weeks


2.4 Follow up
  • 4 weeks after the 8‐week treatment period

Outcomes 1. Improvement of clinical lesion score from baseline (the sum of erythema score and surface damage score measured by clinician‐rated score)
2. Improvement of itching relief score from baseline (measured by participant‐rated score)
3. Improvement of sleep score from baseline (measured by participant‐rated score)
4. Adverse events
5. Full blood count, serum bilirubin, aspartate aminotransferase, alkaline phosphatase, albumin, urea and electrolytes, creatinine, calcium, phosphate, glucose, creatine phosphokinase and immunologic markers (IgE, eosinophil count, eosinophil cationic protein, IL‐5, IL‐13)
All assessments were conducted at baseline and weeks 4, 8, and 12 of the trial
Notes 1. Outcomes 1 to 3 were expressed as least‐squares means ± SE at end points
2. There was a total of 15 withdrawals/dropouts. 69 participants (T/C: 46/23) were included in the ITT analysis
3. The final number of participants completing the entire trial was 56 (T/C: 35/21)
4. Ingredients of the treatment intervention were also used by Luo 2010
5. The trial was supported by the Department of Health, Committee on Chinese Medicine and Pharmacy, Taiwan
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Eligible patients were randomized at a ratio of 2:1 to receive XFS or placebo for an 8‐week treatment period"
Allocation concealment (selection bias) Low risk Quote: "The computer generated randomisation list was drawn up by an independent statistician and placed in an envelope until the study was completed"
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Quote: "Both participants and evaluating physicians were unaware [of] the interventions used"
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Quote: "Both participants and evaluating physicians were unaware [of] the interventions used"
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Incomplete outcome data and ITT analysis were addressed
Selective reporting (reporting bias) Unclear risk There was insufficient information
Other potential sources of bias (use of published validated scoring system ) Unclear risk Quote: "...using a standardised scoring system"
Comment: We found no evidence that the scoring system had been validated