Xue 2011.
Methods | This was a randomised, controlled, parallel clinical trial | |
Participants | 1. Setting: The trial recruited participants from a Chinese medicine hospital in Jiangmen, China 2. Age: from 2 to 12 years of age 3. Sex (men/women): 37/26 4. Number of participants randomised: 63 5. T/C: 33/30 |
|
Interventions |
I. Treatment group 1. Shengxue Runfu decoction with individualised modifications 1.1 Ingredients and dosage
1.2 Administration
1.3 Duration of treatment
1.4 Follow up
II. Control group 2. Loratadine tablet 2.1 Ingredients and dosage
2.2 Administration
2.3 Duration of treatment
2.4 Follow up
‐ Topical application of CHM ointment and emollients for both groups |
|
Outcomes | 1. SCORAD score 2. Severity of itching score (measured by participant‐rated score, scale 0 to 10) 3. Skin lesion area score 4. Severity of skin lesion score 5. Effectiveness rate 6. Chinese medicine clinical syndrome score All assessments were conducted at baseline, week 4, and at the end of the 8‐week treatment period |
|
Notes | 1. The trial investigators claimed that they included only those who were diagnosed with AD and identified as "blood deficiency with wind‐dryness" in Chinese medicine 2. Did not report adverse event 3. The trial was funded by Guangdong Bureau of Chinese Medicine, 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 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 | High risk | Quote: "...only those who took the herbal decoction for 20 days or more at week 4 of the trial were included for statistic analysis" Comment: ITT was not used for those who took herbal decoction for less than 20 days |
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 |