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

Yang 2007.

Methods This was a randomised, controlled, parallel clinical trial
Participants 1. Setting: The trial recruited participants from an outpatient department of dermatology of a Chinese medicine teaching hospital in Shenzhen, China
2. Age: from 5 to 25 years of age
3. Sex (men/women): 35/29
4. Number of participants randomised: 64
5. T/C: 32/32
Interventions I. Treatment group
a. Oral ingestion
1. Jianpi Zhiyang granules
1.1 Ingredients and dosage
  • Huangqi (Radix astragali)

  • Baizhu (Rhizoma atractylodis macrocephalae)

  • Danggui (Radix angelicae sinensis)

  • Sheshouwu (Radix polygoni)

  • Shengdihuang (Radix rehmanniae)

  • Baishao (Radix paeoniae alba)

  • Chuangxiong (Rhizoma chuanxiong)

  • Fangfeng(Radix saposhnikovia)

  • Jingjie(Herba schizonepetae)

  • Baijili (Fructus tribuli terrestris)

  • Gouteng (Ramulus uncariae cum uncis)

  • Gancao(Radix glycyrrhizae)

  • Did not provide dosage of the ingredients


1.2 Administration
  • 10 grams 3 times daily, half dosage for children < 6 years of age


1.3 Duration of treatment
  • 4 weeks


1.4 Follow up
  • Did not state


b. Topical application
1. Pibao Xiaoyan Xuanshi ointment
1.1 Ingredients and dosage
  • Shengyaodi (Hydrargyrum oxydatum crudum bottom)

  • Shenghualiu (Sublimed Sulfur)

  • Shechuangzi (Fructus cnidii)

  • Zhangnao (Camphora)

  • Bingpian (Borneolum syntheticum), etc

  • Did not provide dosage of the ingredients


1.2 Administration
  • Twice daily topically


1.3 Duration of treatment
  • 4 weeks


1.4 Follow up
  • Did not state


II. Control group
a. Oral ingestion
2. Loratadine tablet
2.1 Ingredients and dosage
  • Loratadine 10 mg/tablet


2.2 Administration
  • 10 mg oral ingestion daily for adults and children 2 to 12 years old with body weight > 30 kg, 5 mg daily for body weight < 30 kg


2.3 Duration of treatment
  • 4 weeks


2.4 Follow up
  • Did not state


b. Topical application
2. Hydrocortisone butyrate cream
2.1 Ingredients and dosage
  • 1% hydrocortisone butyrate


2.2 Administration
  • Twice daily topically


2.3 Duration of treatment
  • 4 weeks


2.4 Follow up
  • Did not state

Outcomes 1. SCORAD score
2. Severity of itching score (measured by participant‐rated VAS, scale 0 to 10)
3. Effectiveness rate
4. Adverse events
5. Serum IgE level and eosinophil count
All assessments were conducted at baseline and at the end of the 4‐week treatment period
Notes 1. The oral ingestion treatment intervention was the same as that used in Jin 2007
2. The trial was funded by Shenzhen Science and Technology Planning Project, 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 High risk This was not stated
Comment: The appearance and administration of the 4 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 insuficient information
Other potential sources of bias (use of published validated scoring system ) Low risk The trial used SCORAD