Effectiveness of Acupuncture for Asthma

Overview

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)?

Full Title of Study: “Effectiveness of Acupuncture for Asthma: A Randomized, Sham-acupuncture and Waiting-list Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: April 2009

Interventions

  • Device: Disposable stainless steel acupuncture (0.2mmx4mm)
    • 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.

Arms, Groups and Cohorts

  • Experimental: Active acupuncture
  • Sham Comparator: Sham acupuncture
  • No Intervention: Waiting list control

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Korea Institute of Oriental Medicine
  • Provider of Information About this Clinical Study
    • Sun-Mi Choi, Korea Institute of Oriental Medicine

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