Jin 2007.
Methods | This was a randomised, controlled, parallel clinical trial | |
Participants | 1. Setting: The trial recruited participants from an outpatient department of dermatology in a Chinese medicine hospital in Shenzhen, China 2. Age: from 10 to 52 years of age 3. Sex (men/women): 40/22 4. Number of participants randomised: 62 5. T/C: 32/30 |
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Interventions |
I. Treatment group 1. Jianpi Zhiyang granules 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
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Outcomes | 1. SCORAD score 2. Severity of itching score (measured by patient‐rated VAS, scale 0 to 10) 3. 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 trial did not report adverse events 2. The treatment intervention was the same as that orally ingested in the Yang 2007 study |
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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 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 | Unclear risk | Quote: "Those who did not completed the trial 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 SCORAD |