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This study used a multicentre parallel three-armed randomised sham-controlled clinical trial methodology in order to objectively and normatively assess the efficacy of acupuncture on Quchi the Sea of Blood the Foot Sanli and the Sanyinjiao in the treatment of moderate-to-severe atopic dermatitis so as to obtain high-level evidence-based medical evidence.
This study adopts a multi-centre, parallel, three-armed, randomized, sham-controlled clinical trial method, and will be conducted at Yueyang Hospital of Integrative Medicine affiliated with Shanghai University of Traditional Chinese Medicine, Huashan Hospital affiliated with Fudan University, and Seventh People's Hospital affiliated with Shanghai University of Traditional Chinese Medicine. Eligible patients with moderate-to-severe AD will be divided into three groups using stratified block randomisation in the ratio of 2:2:1: the acupuncture group, the sham-acupuncture group and the waitlisted control group. The total observation period is 9 weeks, including a 1-week introduction period, a 4-week treatment period and a 4-week follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| acupuncture group | Experimental |
| |
| sham acupuncture group | Sham Comparator |
| |
| Alternate control group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acupuncture | Device | Subjects in the acupuncture group received traditional acupuncture. The needles were inserted to induce a sense of 'getting qi' and left in place for 30 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| SCORing atopic dermatitis（SCORAD） | SCORAD range of 0 ~ 103 points.The condition is classified as mild, moderate or severe according to the score, with the higher the score, the more severe the condition. | This indicator will be measured at baseline day 1 (V2), day 27 ± 1 (V9), and day 56 ± 3 (V10). |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Oriented Eczema Measure (POEM) | Patients themselves assessed the frequency and severity of 7 symptoms occurring in the past 1 week, with each entry on a 5-point scale corresponding to a score of 0, 1, 2, 3, and 4. Scores ranged from 0 ~ 28, with higher scores indicating greater severity. | This indicator will be measured at baseline day 1 (V2), day 27 ± 1 (V9), and day 56 ± 3 (V10). |
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Inclusion Criteria:
Meet the diagnostic criteria for moderate to severe atopic dermatitis;
Exclusion Criteria:
Patients who are in the acute onset of the disease and have erosions exudates and secondary infections;
Patients who have participated in other clinical studies in the past 3 months or are participating in other clinical studies; ③ Patients with severe haematological diseases (e.g. platelet count <50×109 /L) and other serious diseases that may affect operation and efficacy;
Current systematic use of glucocorticosteroids discontinued for less than 7 days; immunosuppressants (cyclosporine methotrexate tretinoin etc.) discontinued for less than 1 month; dulprevirizumab discontinued for less than 1 month JAK inhibitors discontinued for less than 2 weeks;
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| sham acupuncture | Device | Sterile disposable retractable needles and a fake placebo acupuncture device are used for sham acupuncture. The acupuncturist attached the base of the sham acupuncture device to the acupoints, and then inserted sterile disposable blunt-tipped retractable needles into the tubes; when the blunt tips touched the skin, the needles retracted into the handles, and there was no sensation of getting qi. |
|
| Dermatology Life Quality Index（DLQI） | The questionnaire contains 10 questions. Scores range from 0 to 30, with higher scores indicating a greater impact on quality of life. | This indicator will be measured at baseline day 1 (V2), day 27 ± 1 (V9), and day 56 ± 3 (V10). |
| Peak Pruritus Numerical Rating Scale（PP-NRS） | The PP-NRS is a patient self-report, with a score of 0 for no itching and 10 for the worst itching imaginable, with the patient scoring the worst itching experienced in the last 24 h. The PP-NRS is a patient self-report, with a score of 0 for no itching and 10 for the worst itching imaginable. | This indicator will be measured at baseline day 1 (V2), day 27 ± 1 (V9), and day 56 ± 3 (V10). |
| Skin Peripheral sympathetic nerve activity (SKNA) | Measured with neuECG, SKNA in µV | This indicator will be measured at baseline day 1 (V2), day 27 ± 1 (V9). |
| Serum total IgE | This indicator will be measured at baseline day 1 (V2), day 27 ± 1 (V9). |
| Peripheral blood serum cytokines（IL-4,IL-13,IL-31,IL-33,INF-α） | This indicator will be measured at baseline day 1 (V2), day 27 ± 1 (V9). |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |