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 |
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Interventions |
I. Treatment group a. Oral ingestion 1. Jianpi Zhiyang granules 1.1 Ingredients and dosage
1.2 Administration
1.3 Duration of treatment
1.4 Follow up
b. Topical application 1. Pibao Xiaoyan Xuanshi ointment 1.1 Ingredients and dosage
1.2 Administration
1.3 Duration of treatment
1.4 Follow up
II. Control group a. Oral ingestion 2. Loratadine tablet 2.1 Ingredients and dosage
2.2 Administration
2.3 Duration of treatment
2.4 Follow up
b. Topical application 2. Hydrocortisone butyrate cream 2.1 Ingredients and dosage
2.2 Administration
2.3 Duration of treatment
2.4 Follow up
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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 |
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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 |
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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 |