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| Name | Class |
|---|---|
| Shanghai Municipal Hospital of Traditional Chinese Medicine | OTHER |
| Longhua Hospital | OTHER |
| Shanghai Yueyang Integrated Medicine Hospital | OTHER |
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Asthma is a common chronic respiratory disease with a low clinical control rate, highlighting the need for novel therapeutic strategies. Recurrent asthma attacks emotional symptoms, such as anxiety and depression, etc. On the contrary, symptoms such as anxiety and depression worsen asthma control. Acupuncture is commonly applied as an effective traditional Chinese medical therapy for asthma. Acupoints GV14, BL13 and BL12 are adopted for the intervention of asthma. GV20 and GV29 are selected to improve emotional symptoms including depression. Nevertheless, standardized therapeutic regimens of acupuncture for asthma and its concomitant emotional symptoms are still lacking. 180 patients with mild to moderate asthma will be recruited in this multicenter randomized controlled trial, randomly assigned to the true acupuncture group, sham acupuncture group and usual care group. The primary outcome is the score of the Asthma Control Test (ACT). Secondary outcomes include the Hospital Anxiety and Depression Scale (HADS), Asthma Quality of Life Questionnaire (AQLQ), pulmonary function, and fractional exhaled nitric oxide (FeNO). The superiority of combined acupuncture therapy in improving asthma control, relieving negative emotions, and enhancing quality of life is to be verified in this study, with high quality evidence for acupuncture treatment of asthma thereby to be provided.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| True Acupuncture Group | Experimental | Acupuncture Group: On routine standard asthma treatment, participants receive acupuncture. Disposable sterile needles (Wuxi Jiajian Medical Instrument Co., Ltd.) are used: 0.25 mm×25 mm for Baihui (GV20), Yintang (GV29); 0.30 mm×40 mm for Dazhui (GV14), bilateral Fengmen (BL12) and Feishu (BL13).Qualified acupuncturists perform treatment following GB/T 12346-2021. Patients sit with routine skin disinfection. Baihui: 15-30° oblique insertion, 0.5 cun. Yintang: downward oblique puncture 0.3-0.5 cun with skin pinched. Dazhui: perpendicular 0.5-1 cun. Fengmen and Feishu: perpendicular toward spine, 0.5-0.8 cun. Even reinforcing-reducing manipulation is applied. Each session lasts 30 minutes, 3 times weekly for 10 sessions. Eye masks are used; operators are separated from outcome assessors. |
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| Sham Acupuncture Group | Sham Comparator | Sham Acupuncture Group: On the basis of routine standard asthma treatment, participants receive Streitberger placebo needle intervention. The Streitberger placebo needle (Asiamed GmbH, Germany) is a non-penetrating sham acupuncture device with identical appearance to real needles but a blunt tip. Upon gentle skin contact, the shaft retracts into the handle, secured by an external patch to simulate needle insertion visually. The same acupoints are used as in the acupuncture group: GV14, BL13, BL12, GV20 and GV29.Participants sit with routine skin disinfection. The placebo needle base pad is fixed on acupoints. Vertical pressure on the handle retracts the shaft without skin penetration. Each session lasts 30 minutes, 3 times weekly for 10 consecutive sessions. Needles are removed directly without hemostasis. Eye masks are used during treatment; operators are separated from outcome assessors. |
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| Usual Care Group | Active Comparator | Participants receive only standard pharmacological treatment for asthma in accordance with clinical guidelines, without any acupuncture or related interventions. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Procedure | Patients are seated with routine disinfection of acupoints. Dazhui (GV14) is perpendicularly needled 0.5-1 cun; Feishu (BL13) and Fengmen (BL12) are perpendicularly needled toward the spine for 0.5-0.8 cun; Baihui (GV20) is needled subcutaneously at 15-30° to the scalp for 0.5 cun; Yintang (GV29) is obliquely needled downward for 0.3-0.5 cun after pinching local skin . Even reinforcing-reducing manipulation is adopted. Each treatment lasts 30 minutes, three times weekly (no treatment on Sundays) for 10 consecutive sessions. Eye masks are used, with separation of operators and outcome assessors. |
| Measure | Description | Time Frame |
|---|---|---|
| Asthma Control Test (ACT) | The Asthma Control Test (ACT) is a validated 5-item self-reported questionnaire assessing overall asthma control, with total scores ranging from 5 to 25. Higher scores indicate better asthma control. | Change from baseline to week 4 (end of treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital Anxiety and Depression Scale (HADS) | A validated self-rating scale containing anxiety (HADS-A) and depression (HADS-D) subscales, each with 7 items. Lower scores indicate less anxiety and depressive symptoms. | Change from baseline to week 4 (end of treatment) |
| Asthma-Specific Quality of Life Questionnaire (AQLQ) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lei-Miao Yin, MD | Contact | +86 21 56639828 | collegeylm@shutcm.edu.cn | |
| Xin Luan, MD | Contact | +86 17701614380 | lx931163088@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Lei-Miao Yin, MD | Shanghai Municipal Hospital of Traditional Chinese Medicine | Study Director |
| Ping Yin, MD | Longhua Hospital | Study Chair |
| Xin-Yun Huang, MD |
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Individual participant data will not be shared due to participant privacy protection and limited research resources
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D004194 | Disease |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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Masking is applied to participants and outcome assessors. Participants in the true acupuncture and sham acupuncture groups are blinded to group allocation, while participants in the usual-care group are unblinded. Outcome assessors remain blinded throughout the trial. Acupuncturists and clinical care providers are unblinded due to the nature of acupuncture intervention.
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| Sham Acupuncture | Procedure | Patients are seated with routine disinfection of acupoints. Streitberger non-penetrating placebo needles are applied to the same acupoints as true acupuncture (Dazhui GV14, Feishu BL13, Fengmen BL12, Baihui GV20, Yintang GV29) with identical position, duration and frequency. Each sham session lasts 30 minutes, three times weekly (no treatment on Sundays) for 10 consecutive sessions. Eye masks are used, with separation of operators and outcome assessors. |
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| Usual Care | Other | Patients receive routine asthma pharmacological treatment without additional acupuncture intervention. |
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A validated self-reported questionnaire evaluating asthma-related quality of life, covering symptoms, activity limitation, emotional function and environmental stimuli. Higher scores represent better quality of life. |
| Change from baseline to week 4 (end of treatment) |
| Yueyang Hospital, Shanghai University of Traditional Chinese medicine |
| Study Chair |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |