Asthma, Asthma Chronic, Asthma (Diagnosis)
Conditions
Brief summary
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.
Interventions
PROCEDUREAcupuncture
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.
PROCEDURESham Acupuncture
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.
OTHERUsual Care
Patients receive routine asthma pharmacological treatment without additional acupuncture intervention.
Sponsors
Shanghai University of Traditional Chinese Medicine
Shanghai Municipal Hospital of Traditional Chinese Medicine
Longhua Hospital
Shanghai Yueyang Integrated Medicine Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Meet the diagnostic criteria for asthma, and be in the chronic persistent phase with mild to moderate disease severity, referring to the grading criteria of the Guidelines for the Prevention and Treatment of Asthma (2024 Edition). * Aged 18 to 70 years, regardless of gender. * Asthma Control Test (ACT) score≤19 points (poorly controlled or very poorly controlled asthma). * Maintain a stable asthma treatment regimen for at least 4 weeks before enrollment. * Clear thinking and consciousness, coherent responses, able to understand the items of various scales and complete the assessment. * Volunteer to participate in this study and sign a written informed consent form.
Exclusion criteria
* Complicated with severe mental illnesses (such as uncontrolled schizophrenia, acute phase of bipolar disorder, etc.) or moderate to severe cognitive impairment (such as dementia), resulting in inability to understand the research process or cooperate with efficacy evaluation. * A history of substance/alcohol dependence within the past 12 months. * Complicated with other physical diseases that may cause depressive symptoms (such as hypothyroidism, chronic pain syndrome, malignant tumors, rheumatoid arthritis, etc.). * Received antidepressant drug treatment within the past 6 months. * Suffering from other respiratory diseases, such as chronic obstructive pulmonary disease (COPD), bronchiectasis, pulmonary fibrosis, etc. * Complicated with other cancers or relatively severe chronic diseases of the heart, liver, kidneys, etc. * Received acupuncture treatment within the past 3 months. * Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Asthma Control Test (ACT) | Change from baseline to week 4 (end of treatment) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital Anxiety and Depression Scale (HADS) | Change from baseline to week 4 (end of treatment) | 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. |
| Asthma-Specific Quality of Life Questionnaire (AQLQ) | Change from baseline to week 4 (end of treatment) | 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. |
Contacts
CONTACTLei-Miao Yin, MD
CONTACTXin Luan, MD
STUDY_DIRECTORLei-Miao Yin, MD
Shanghai Municipal Hospital of Traditional Chinese Medicine
STUDY_CHAIRPing Yin, MD
Longhua Hospital
STUDY_CHAIRXin-Yun Huang, MD
Yueyang Hospital, Shanghai University of Traditional Chinese medicine
Outcome results
None listed