Effectiveness of Acupuncture for Asthma

Study Overview
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Brief Summary
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What is the trend of changes in asthmatic patients' daily peak expiratory flow (PEF) variability, pulmonary function, and quality of life (QOL) with acupuncture treatment on specific acupoints (CV22 and bilateral LU5, ST40, BL13, EXB1) compared with minimal acupuncture treatment (sham control group) on non-acupoints, and no acupuncture treatment (waiting list control group)?

Official Title
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Effectiveness of Acupuncture for Asthma: A Randomized, Sham-acupuncture and Waiting-list Controlled Trial

Conditions
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Asthma

Intervention / Treatment
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* Device: Disposable stainless steel acupuncture (0.2mmx4mm)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged 19-70 years at least 12% improvement in forced expiratory volume in one second (FEV1)after the administration of short acting beta2 agonist. at least one typical asthmatic symptom using more than one routine anti-asthmatic medicine Exclusion Criteria: acupuncture for asthma within 12 months of the study emergency department visit within one month of the study hospitalization for asthma within three months of the study severe upper respiratory tract infections within six weeks of the study systemic infections, cancers, autoimmune disorders, cardiac failures, myofacial infarcts,angina pectoris, renal failures or hepato-biliary diseases smoke more than ten cigarettes per day

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active acupuncture<br> | Device: Disposable stainless steel acupuncture (0.2mmx4mm)<br>* For active acupuncture group, needles were inserted into nine acupoints (CV22 and bilateral LU5, ST40, BL13, EXB1)with De-qi three times a week for 4 weeks. For sham acupuncture group, Nine non-acupoints corresponded with each active acupoint were treated with minimal penetration into skin three times a week for 4 weeks.<br>|
| Sham Comparator: Sham acupuncture<br> | Device: Disposable stainless steel acupuncture (0.2mmx4mm)<br>* For active acupuncture group, needles were inserted into nine acupoints (CV22 and bilateral LU5, ST40, BL13, EXB1)with De-qi three times a week for 4 weeks. For sham acupuncture group, Nine non-acupoints corresponded with each active acupoint were treated with minimal penetration into skin three times a week for 4 weeks.<br>|
| No Intervention: Waiting list control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of weekly average of peak expiratory flow (PEF)values in the morning at home |  | From 1 week of run-in period to the 4th week of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forced expiratory volume in 1 second (FEV1) Baseline Dyspnea Index (BDI) Transition Dyspnea Index (TDI) Quality of Life Questionnaire for Adult Korean Asthmatics (QLQAKA) |  | Baseline and 2 weeks, 4 weeks, 6 weeks after Baseline (BDI for baseline only, TDI for 2, 4, and 6 weeks after baseline) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, Acupuncture, Pulmonary function, Quality of life