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

Zhang 2009.

Methods This was a randomised, controlled, parallel clinical trial
Participants 1. Setting: The trial recruited participants from an outpatient department of dermatology in a Chinese medicine teaching hospital in Jinan, China
2. Age: from 2 to 12 years of age
3. Sex (men/women): did not state
4. Number of participants randomised: 61
5. T/C: 36/25
Interventions I. Treatment group
1. Xiao'er Huashi decoction
1.1 Ingredients and dosage
  • Cangzhu(Rhizoma atractylodis) 6 g

  • Baizhu (Rhizoma atractylodis macrocephalae) 6 g

  • Chenpi (Pericarpium citri reticulatae) 3 g

  • Zexie (Rhizoma alismatis) 6 g

  • Fuling(Poria) 9 g

  • Baixianpi (Cortex dictamni) 6 g

  • Maiya (Fructus hordei germinatus) 15 g

  • Huashi (Talcum) 12 g

  • Gancao(Radix glycyrrhizae) 6 g

  • Laifuzi (Semen raphani) 9 g

  • Binglang (Semen arecae) 9 g

  • Jineijin (Endothelium corneum gigeriae galli) 9 g

  • Shengdihuang (Radix rehmanniae) 6 g

  • Mudanpi (Cortex moutan) 6 g

  • Huangqin (Radix scutellariae) 9 g


1.2 Administration
  • 1 package per day, oral ingestion of the decoction 3 to 4 times daily


1.3 Duration of treatment
  • 4 weeks


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


II. Control group
2. Loratadine granules
2.1 Ingredients and dosage
  • Loratadine 10 mg


2.2 Administration
  • Oral ingestion 10 mg daily for children age 2 to 12 years old with body weight > 30 kg, or 5 mg per night for body weight ≤ 30 kg


2.3 Duration of treatment
  • 4 weeks


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


‐ External use of CHM lotion and CHM cream for both groups
Outcomes 1. EASI score
2. Effectiveness rate
Assessments were conducted at baseline and at the end of the 4‐week treatment period
3. Recurrence rate
Conducted at 4 weeks after the 4‐week treatment period
Notes 1. The trial did not report adverse events
2. The trial did not provide continuous data of EASI score
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 High risk This was not stated
Comment: The appearance and administration of the 2 interventions were different, so it is unlikely that a blinding method was used
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 EASI