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

Sun 2009.

Methods This was a randomised, double‐blind, placebo‐controlled, parallel clinical trial
Participants 1. Setting: The trial recruited participants from an outpatient department of dermatology in a Chinese medicine teaching hospital in Guangzhou, China
2. Age: from 3 to 20 years of age
3. Sex (men/women): 12/13
4. Number of participants randomised: 25
5. T/C: 14/11
Interventions I. Treatment group
1. Jianpi Shenshi granules
1.1 Ingredients and dosage
  • Dangshen (Radix codonopsis)

  • Zexie (Rhizoma alismatis)

  • Fuling (Poria)

  • Yiyiren (Semen coicis)

  • Baizhu (Rhizoma atractylodis macrocephalae)

  • Dazao (Fructus jujubae)

  • Shanyao (Rhizoma dioscoreae)

  • Chenpi (Pericarpium citri reticulatae)

  • Baibiandou (Semen lablab album)

  • Jiegen (Radix platycodi)

  • Did not provide dosage of the ingredients


1.2 Administration
  • 6 grams for 3 to 11 year‐olds, 12 grams for 12 to 20 year‐olds, dissolved the granules with boiling water, oral ingestion 3 times daily


1.3 Duration of treatment
  • 4 weeks


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


II. Control group
2. Placebo
2.1 Ingredients and dosage
  • Did not provide ingredients and dosage


2.2 Administration
  • 5 grams for 3 to 11 year‐olds, 15 grams for 12 to 20 year‐olds, dissolved the granules with boiling water, oral ingestion 3 times daily


2.3 Duration of treatment
  • 4 weeks


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


‐ Both groups applied non‐medicinal moisturising cream topically and oral ingestion of cyproheptadine tablets for cases with severe itchiness
Outcomes 1. SCORAD score
2. Severity of itching score (measured by participant‐rated score, scale unknown)
3. Sleeping disturbance rate
4. Skin lesion area
5. Severity of skin lesion
6. Effectiveness rate
7. Adverse events
All assessments were conducted at baseline and at the end of the 4‐week treatment period
8. Recurrence rate
Conducted at 24 weeks after the 4‐week treatment period
Notes 1. The trial investigator claimed that they included only those who were diagnosed with AD and identified as "spleen deficiency" in Chinese medicine
2. The trial was funded by Department of Science and Technology, Guangdong Provience, China
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk This was not stated
Allocation concealment (selection bias) Unclear risk This was not stated
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Quote: "...double‐blind controlled trial"
Comment: No details of blinding were provided, and the paper was published by only 1 author without acknowledgment
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk This was not stated
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk This was not stated
Comment: The numbers of participants randomised and analysed were equivalent. It seems that there were no withdrawals/dropouts in this study
Selective reporting (reporting bias) Unclear risk There was insufficient information
Other potential sources of bias (use of published validated scoring system ) Low risk The trial used SCORAD