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

Cao 2009.

Methods This was a randomised, non‐blinded, controlled, parallel clinical trial
Participants 1. Setting: The trial recruited participants from an outpatient department of a university teaching hospital in Nanjing, China
2. Age: from 2 to 16 years of age
3. Sex (men/women): 32/24
4. Number of participants randomised: 56
5. T/C: 32/24
Interventions I. Treatment group
1. Zhuling Jianpi Huashi decoction with individualised modifications
1.1 Ingredients and dosage
  • Fuling (Poria) 6 g

  • Cangzhu (Rhizoma atractylodis) 6 g

  • Baizhu (Rhizoma atractylodis macrocephalae) 6 g

  • Chenpi (Pericarpium citri reticulatae) 3 g

  • Zexie (Rhizoma alismatis) 6 g

  • Baixianpi (Cortex dictamni) 6 g

  • Maiya (Fructus hordei germinatus) 15 g

  • Huashi (Talcum) 6 g

  • Gancao(Radix glycyrrhizae) 4 g


1.2 Administration
  • 1 package per day, drink the decoction twice daily


1.3 Duration of treatment
  • 1 to 4 weeks


1.4 Follow up
  • Did not state


II. Control group
a. oral ingestion
2. Cetirizine hydrochloride drops
2.1 Ingredients and dosage
  • 0.5 ml for 2‐ to 6‐year‐old participants, 1.0 ml for 7‐ to 16‐year‐old participants


2.2 Administration
  • Once daily


2.3 Duration of treatment
  • 1 to 4 weeks


2.4 Follow up
  • Did not state


‐ CHM lotion and cream (external use) were applied in both groups
Outcomes 1. Percentage of reduction of total SASSAD score
2. Effectiveness rate
3. Adverse events
All assessments were conducted at baseline, week 4, and at the end of the 8‐week treatment period, respectively
Notes 1. The trial investigator claimed they included only those who were diagnosed with AD and identified as "spleen deficiency with accumulation of dampness" in Chinese medicine
2. Effectiveness rate = ((pre‐treatment score of SASSAD ‐ post‐treatment score of SASSAD)/pre‐treatment score of SASSAD) * 100%
3. The treatment intervention used was the same as the 1 orally used in Zhang 2005
4. The SASSAD scores were expressed as 'numbers ±' without labels, and we assumed they meant mean ± SD
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "...used SPSS software for randomisation..."
Allocation concealment (selection bias) Unclear risk This was not stated
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Quote: "...no blinding was required"
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Quote: "...no blinding was required"
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Quote: "Those who were not compliant with the treatment were excluded"
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 SASSAD