Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
Effect of Acupuncture on Patients With Chronic Obstructive Pulmonary Disease: a Multi-center, Randomized, Controlled Trial
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.
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.
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