Clinical trial NCT03169504: Effect of Acupuncture on Patients With Chronic Obstructive Pulmonary Disease
Official title: Effect of Acupuncture on Patients With Chronic Obstructive Pulmonary Disease: a Multi-center, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Pulmonary Disease, Chronic Obstructive
Acupuncture Therapy
Humans
Lead sponsor: Henan University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2017-05-30
Enrollment: 150
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to compare the efficacy of three therapies for chronic obstructive pulmonary disease (COPD) patients: one, conventional drug based on Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2017 and Chinese Medical Association Guidelines; another, acupuncture, an important part of traditional Chinese Medicine; and finally, the combination of conventional drug and acupuncture, and then determine which therapy is the most suitable for patients with COPD.

Detailed description: COPD, characterized by progressive airflow obstruction, airway inflammation, and systemic effects or comorbidities, is a leading cause of morbidity and mortality and is projected to be the third leading cause of death worldwide by 2030. Since breathlessness, exercise limitation and health status impairment broadly exist in COPD patients, effective management should be based on an individualized assessment of disease in order to reduce both current symptoms, which involves relieving symptoms, improving exercise tolerance and health status. At present, although appropriate pharmacologic therapy can relieve COPD symptoms, reduce the frequency and severity of exacerbations, and improve health status and exercise tolerance, its cost and adverse effects can never be ignored.

Acupuncture, an important part of traditional Chinese Medicine, has been used for thousands of years in treating many painful and non-painful conditions. To date, it has become popular and widely practiced in many countries around the world. In the past two decades, acupuncture research has grown markedly, in both the proportion of randomized clinical trials (RCTs) and the impact factor of journals. Evidences from both clinicians and patients suggest that there is some beneficial effect of acupuncture on COPD.

At present, there are many therapies available for patients with COPD, it is difficult for us to identify the most suitable therapy. Thus, this study aims to compare the efficacy of conventional drug, acupuncture and the combination of conventional drug and acupuncture, and then determine which is the most suitable therapy, providing a scientific basis for clinical decision.

This is a multi-center, randomized, controlled trial to compare the efficacy of three therapies for patients with COPD. After a 14-day run-in period, 150 subjects will be randomly assigned to one of the three therapies (conventional drug, acupuncture, and the combination of conventional drug and acupuncture) for 12 weeks treatment. After the treatment period, subjects in three arms will be followed up for 12 weeks. The primary outcomes will include exercise capacity (6MWD) and St. George's Respiratory Questionnaire (SGRQ), and secondary outcomes dyspnea (mMRC), acute exacerbation, lung function, quality of life (COPD assessment test, clinical symptom assessment questionnaire, COPD-PRO and EQ-5D) and health economics.

Eligibility criteria: Inclusion Criteria:

* A diagnosis of COPD with classification of airflow limitation severity from GOLD 1 to GLOD 3 according to GOLD 2017.
* Syndrome differentiation meets criteria of Qi deficiency of the lung ZHEGN, Qi deficiency of the lung and spleen ZHEGN, Qi deficiency of the lung and kidney ZHEGN, or Qi and Yin deficiency of the lung and kidney ZHEGN.
* Age ranges from 40 years to 80 years.

Exclusion Criteria:

* Pregnant and lactating women.
* Patients with severe cardiovascular and cerebrovascular diseases.
* Patients with severe liver and kidney disease.
* Patients with bronchiectasis, active pulmonary tuberculosis, pulmonary embolism or other severe respiratory diseases.
* Patients with tumor after resection, radiotherapy or chemotherapy in the past 5 years.
* Patients with severe neuromuscular disorders.
* Patients with severe arthritis.
* Patients with severe peripheral vascular diseases.
* Patients with severe cognitive and psychiatric disorders.
* Patients who have participated in other clinical studies in the past 4 weeks.
* Patients who have experienced one or more acute exacerbation in the past 4 weeks.
* Patients unwilling to sign informed consent.

Primary outcomes:
measure: 6MWD
timeFrame: Change from baseline 6MWD at week 4, week 8, week 12 of the treatment phase, and week 12 of the follow-up phase.
measure: SGRQ
timeFrame: Change from baseline SGRQ score at week 12 of the treatment phase and week 12 of the follow-up phase.
Secondary outcomes:
measure: mMRC
timeFrame: Change from baseline mMRC score at week 4, week 8, week 12 of the treatment phase, and week 12 of the follow-up phase.
measure: Frequency of acute exacerbation
timeFrame: Change from baseline frequency of acute exacerbation at week 4, week 8, week 12 of the treatment phase, and week 12 of the follow-up phase.
measure: Lung function
timeFrame: Change from baseline lung function at week 12 of the treatment phase and week 12 of the follow-up phase.
measure: CAT
timeFrame: Change from baseline CAT score at week 12 of the treatment phase and week 12 of the follow-up phase.
measure: Clinical symptom assessment questionnaire
timeFrame: Change from baseline clinical symptom assessment questionnaire score at week 12 of the treatment phase and week 12 of the follow-up phase.
measure: COPD-PRO
timeFrame: Change from baseline COPD-PRO score at week 12 of the treatment phase and week 12 of the follow-up phase.
measure: EQ-5D
timeFrame: Change from baseline EQ-5D score at week 12 of the treatment phase and week 12 of the follow-up phase.
measure: Health economics
timeFrame: Up to week 12 of the follow-up phase.
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
state: Henan
Study officials:
affiliation: The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
name: Suyun Li, Professor
role: STUDY_CHAIR
References: