Clinical Assessment of Acupuncture for the Treatment of Chronic Asthma

Clinical Assessment of Acupuncture for the Treatment of Asthma: A Randomized, Multicenter, Double-blind, Parallel-group Controlled Trial

The purpose of this study is to assess whether acupuncture is effective in the treatment of chronic asthma.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Device: Verum acupuncture; Device: Sham acupuncture

Detailed Description

Asthma is a common chronic disease worldwide with an estimated 300 million affected individuals. In analyses of economic burden of asthma, apart from direct medical costs including hospital admissions and cost of medications, indirect, non-medical costs such as time lost from work account for a considerable part. For all but the most severe patients, the ultimate goal is to prevent symptoms, minimize morbidity from acute episodes, and prevent functional and psychological morbidity to provide a near healthy lifestyle. Although the symptoms can be controlled by drug treatment in most patients, effective low-risk, non-drug approaches such as acupuncture could constitute a significant advance in asthma management. The purpose of this study is to assess whether acupuncture is effective in the treatment of chronic asthma.

There is a 1-week screening period(-1 week) during which participants will be monitored while they use an albuterol inhaler as needed. Study visits will occur at weeks 0(Baseline), weeks 3, weeks 6. Participants will undergo a physical examination, lung function, blood and urine collection. At the Weeks 0 study visit, participants will be randomly assigned to one of the following two groups for 6 weeks of treatment:

• Group 1 will receive verum acupuncture treatment once every two days plus albuterol as needed, prednisone for exacerbation
• Group 2 will receive sham acupuncture treatment once every two days plus albuterol as needed, prednisone for exacerbation

Study visits will occur at Weeks 0, 3, 6. A physical examination, blood collection, and lung function will occur at selected visits. Questionnaires to assess asthma control and quality of life will also be completed. Throughout the study, participants will record asthma symptoms and medication usage in a daily diary.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Gansu
    • Lanzhou, Gansu, China
      • University Hospital of Gansu Traditional Chinese Medicine
  • Henan
    • Kaifeng, Henan, China, 475000
      • Kaifeng Traditional Chinese Medicine hospital
    • Zhengzhou, Henan, China, 450000
      • No.3 hospital of Henan college of Traditional Chinese Medicine
    • Zhengzhou, Henan, China, 450000
      • Zhengzhou Traditional Chinese Medicine hospital
  • Hunan
    • Changsha, Hunan, China, 410000
      • Xiangya Hospital of Central South University
  • Shanghai
    • Shanghai, Shanghai, China
      • Longhua Hospital
    • Shanghai, Shanghai, China, 200030
      • Shanghai First People's Hospital
    • Shanghai, Shanghai, China, 200030
      • Shanghai research institute of acupuncture and meridian，Yueyang Hospital of Integrated Traditional Chinese and Western Medicine
    • Shanghai, Shanghai, China, 201900
      • Shanghai Dachang hospital
    • Shanghai, Shanghai, China
      • Shanghai TCM Integrated hospital
    • Shanghai, Shanghai, China
      • ShuGuang Hospital
  • Zhejiang
    • Wenzhou, Zhejiang, China
      • Wenzhou Hospital of Traditional Chinese Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients diagnosed with mild-to-moderate persistent asthma
• Forced expiratory volume in one second (FEV1) reversibility of greater than or equal to 12% following bronchodilator administration (2 puffs)
• Patients who have given written informed consent

Exclusion Criteria:

• Participation in another clinical trial 1 month prior to study entry
• Use of systemic corticosteroids 2 weeks prior to study entry
• Patients with general infection, lower respiratory infection, pulmonary tuberculosis and fungal infection 1 month prior to study entry
• Hospitalization due to acute exacerbation 3 months prior to study entry
• Patients cannot stop using forbidden drugs which include inhaled corticosteroid, theophylline, long-term β2 agonist, sodium cromoglicate, leukotrienes antagonist and anticholinergic drug
• Patients who are allergic to albuterol and corticosteroid
• Patients with severe primary diseases such as cancer, cardiovascular system, liver, kidney and hematopoietic system diseases
• Wheeze caused by pulmonary tuberculosis, bronchiectasia and cardiac insufficiency
• Patients with hyperthyroidism
• Patients with mental illness, acrasia
• Female patients in pregnancy, lactation period and planning to get pregnant during the trial
• Any significant disorder that in the investigator's opinion, might put the patients at risk or influence the study outcomes
• Acupuncture contraindications: serious allergic or infectious dermatitis and hemorrhagic diseases such as thrombocytopenic purpura and hemophilia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Verum acupuncture; Verum acupuncture treatment once every two days + Albuterol sulfate HFA (Ventolin®™ 100 mcg Inhalation Aerosol) as needed + Prednisone Acetate Tablets(H31020675, 5 mg oral tablet) for exacerbation	Device: Verum acupuncture; 100 patients receive verum acupuncture treatment once every other day,choosing Dazhui(GV14), Fengmen(BL12), Feishu(BL13), needles retention for 30 minutes and no moxibustion or electrical stimulation. Patients receive verum acupuncture once every other day with a total of 20 sessions in 6 weeks. The needle brand is Hwato®™ Sterile Acupuncture Needles for Single Use.
Sham Comparator: Sham acupuncture; Sham acupuncture treatment once every two days + Albuterol sulfate HFA (Ventolin®™ 100 mcg Inhalation Aerosol) as needed + Prednisone Acetate Tablets(H31020675, 5 mg oral tablet) for exacerbation	Device: Sham acupuncture; 100 patients receive sham acupuncture treatment once every other day, choosing Jinsuo(DU08), Ganshu(BL18), Danshu(BL19), needles retention for 30 minutes and no moxibustion or electrical stimulation. Patients receive sham acupuncture once every other day with a total of 20 sessions in 6 weeks. The needle brand is Hwato®™ Sterile Acupuncture Needles for Single Use.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Total score Change from Baseline of Asthma Control Test	Measured during the 6 week treatment period

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of symptom-free days	Measured during the 6 week treatment period
Usage of salbutamol and prednisone	Measured during the 6 week treatment period
Lung function(FEV1, PVC, FEV1/FVC%, FEV1/predicted%)，morning/evening PEF	Measured during the 6 week treatment period
Asthma symptom scores	Measured during the 6 week treatment period
Asthma quality of Life Questionnaire(AQLQ)	Measured during the 6 week treatment period
Total number of exacerbations that require systemic corticosteroid therapy	Measured during the 6 week treatment period
Eosinophil (EOS) count in peripheral blood, T cell classification, serum cytokine levels	Measured during the 6 week treatment period

Collaborators and Investigators

• Sponsor: Shanghai University of Traditional Chinese Medicine
• Collaborators: National Natural Science Foundation of China; Shanghai Municipal Health Bureau
• Investigators: Study Chair: Yong-Qing Yang, Ph.D, Shanghai University of TCM

Publications and helpful links

General Publications

• Yin LM, Wang Y, Fan L, Xu YD, Wang WQ, Liu YY, Feng JT, Hu CP, Wang PY, Zhang TF, Shao SJ, Yang YQ. Efficacy of acupuncture for chronic asthma: study protocol for a randomized controlled trial. Trials. 2015 Sep 23;16:424. doi: 10.1186/s13063-015-0947-z.

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: August 26, 2013
• First Submitted That Met QC Criteria: August 26, 2013
• First Posted (Estimate): August 29, 2013

Study Record Updates

• Last Update Posted (Estimate): April 15, 2016
• Last Update Submitted That Met QC Criteria: April 14, 2016
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Asthma; Acupuncture; Efficacy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: ZYSNXD-CC-ZDYJ039