Cao 2009.
Methods | This was a randomised, non‐blinded, controlled, parallel clinical trial | |
Participants | 1. Setting: The trial recruited participants from an outpatient department of a university teaching hospital in Nanjing, China 2. Age: from 2 to 16 years of age 3. Sex (men/women): 32/24 4. Number of participants randomised: 56 5. T/C: 32/24 |
|
Interventions |
I. Treatment group 1. Zhuling Jianpi Huashi decoction with individualised modifications 1.1 Ingredients and dosage
1.2 Administration
1.3 Duration of treatment
1.4 Follow up
II. Control group a. oral ingestion 2. Cetirizine hydrochloride drops 2.1 Ingredients and dosage
2.2 Administration
2.3 Duration of treatment
2.4 Follow up
‐ CHM lotion and cream (external use) were applied in both groups |
|
Outcomes | 1. Percentage of reduction of total SASSAD score 2. Effectiveness rate 3. Adverse events All assessments were conducted at baseline, week 4, and at the end of the 8‐week treatment period, respectively |
|
Notes | 1. The trial investigator claimed they included only those who were diagnosed with AD and identified as "spleen deficiency with accumulation of dampness" in Chinese medicine 2. Effectiveness rate = ((pre‐treatment score of SASSAD ‐ post‐treatment score of SASSAD)/pre‐treatment score of SASSAD) * 100% 3. The treatment intervention used was the same as the 1 orally used in Zhang 2005 4. The SASSAD scores were expressed as 'numbers ±' without labels, and we assumed they meant mean ± SD |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "...used SPSS software for randomisation..." |
Allocation concealment (selection bias) | Unclear risk | This was not stated |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "...no blinding was required" |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "...no blinding was required" |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Quote: "Those who were not compliant with the treatment were excluded" 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 SASSAD |