Cheng 2010.
Methods | This was a randomised, double‐blind, placebo‐controlled, parallel clinical trial | |
Participants | 1. Setting: The trial recruited participants from the department of Integration of Traditional Chinese and Western Medicine, in a university hospital in Taiwan 2. Age: from 8 to 23 years of age 3. Sex (men/women): 37/34 4. Number of participants randomised: 71 5. T/C: 47/24 |
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Interventions |
I. Treatment group 1. Xiao‐Feng‐San (XFS) 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
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Outcomes | 1. Improvement of clinical lesion score from baseline (the sum of erythema score and surface damage score measured by clinician‐rated score) 2. Improvement of itching relief score from baseline (measured by participant‐rated score) 3. Improvement of sleep score from baseline (measured by participant‐rated score) 4. Adverse events 5. Full blood count, serum bilirubin, aspartate aminotransferase, alkaline phosphatase, albumin, urea and electrolytes, creatinine, calcium, phosphate, glucose, creatine phosphokinase and immunologic markers (IgE, eosinophil count, eosinophil cationic protein, IL‐5, IL‐13) All assessments were conducted at baseline and weeks 4, 8, and 12 of the trial |
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Notes | 1. Outcomes 1 to 3 were expressed as least‐squares means ± SE at end points 2. There was a total of 15 withdrawals/dropouts. 69 participants (T/C: 46/23) were included in the ITT analysis 3. The final number of participants completing the entire trial was 56 (T/C: 35/21) 4. Ingredients of the treatment intervention were also used by Luo 2010 5. The trial was supported by the Department of Health, Committee on Chinese Medicine and Pharmacy, Taiwan |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Eligible patients were randomized at a ratio of 2:1 to receive XFS or placebo for an 8‐week treatment period" |
Allocation concealment (selection bias) | Low risk | Quote: "The computer generated randomisation list was drawn up by an independent statistician and placed in an envelope until the study was completed" |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "Both participants and evaluating physicians were unaware [of] the interventions used" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Both participants and evaluating physicians were unaware [of] the interventions used" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Incomplete outcome data and ITT analysis were addressed |
Selective reporting (reporting bias) | Unclear risk | There was insufficient information |
Other potential sources of bias (use of published validated scoring system ) | Unclear risk | Quote: "...using a standardised scoring system" Comment: We found no evidence that the scoring system had been validated |