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 |
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Interventions |
I. Treatment group 1. Jianpi Shenshi granules 1.1 Ingredients and dosage
1.2 Administration
1.3 Duration of treatment
1.4 Follow up
II. Control group 2. Placebo 2.1 Ingredients and dosage
2.2 Administration
2.3 Duration of treatment
2.4 Follow up
‐ Both groups applied non‐medicinal moisturising cream topically and oral ingestion of cyproheptadine tablets for cases with severe itchiness |
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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 |
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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 |
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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 | 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 |