Clinical efficacy of acupoint application of Chinese herbal medicine to prevent acute exacerbation of stable chronic obstructive pulmonary disease: A study protocol for a randomized placebo-controlled trial

Abstract Background: Chronic obstructive pulmonary disease (COPD) is a major public health problem that severely affects the quality of life of patients and may even endanger their lives. The key to prevent the progression of COPD is active treatment during the stable phase that prevents and reduces acute exacerbation of COPD. Although modern medicine has achieved significant results in relieving the clinical manifestations of COPD, it is difficult to prevent its progression and acute exacerbation entirely. As one of the classic aspects of acupuncture and moxibustion therapy, acupoint application of Chinese herbal medicine (CHM) can improve the clinical efficacy of Western medicine in treating COPD. To date, however,there is no high-quality clinical trial to assess the effectiveness of CHM acupoint application directly in preventing acute exacerbation of stable COPD.Thus, we designed this randomized placebo-controlled clinical trial to evaluate the long-term efficacy and safety of CHM acupoint application in preventing the acute exacerbation of stable COPD.Methods: The study is a randomized, double-blind, placebo-controlled trial, in which 200 stable COPD patients will be randomly and equally divided into the experimental group or control group. Both groups will undergo standard Western medicine treatment; however, the patients in the experimental group will be also treated with CHM acupoint application, while the control group will be given placebo acupoint application. The duration of the treatment will be 1 month and a follow-up for 11 months. The primary outcome will be the number of acute exacerbation episodes of COPD, and the secondary outcomes will include the lung function, St George's Respiratory Questionnaire, COPD Assessment Test, and 6-Minute Walk Test. A safety assessment will also be performed during the trial.Discussion: The aim of this study is to evaluate the efficacy and safety of CHM acupoint application in preventing acute exacerbation of stable COPD. Our study will provide sound evidence to support the evidence-based medicine of CHM acupoint application as an additional measure in the prevention of acute exacerbation of stable COPD.