COPD is a common and deadly disease that is characterized by persistent and progressive airflow limitation. Therefore, exacerbations and comorbidities contribute to overall severity in individual patients. Presently, the classes of medications recommended by GOLD are commonly used in treating COPD. Although more alternative approaches are used in COPD patients, definite effect evidence for TCM treatment is still limited. Hence, based on conventional Western medicine that referred to the GOLD classes of medications, we conducted our study to evaluate the efficacy and safety of TCM treatment by measuring such outcomes, scuh as exacerbations, lung function, symptoms, exercise tolerance and quality of life.
The TCM treatment in this study included Bu-Fei Jian-Pi granules, Bu-Fei Yi-Shen granules and Yi-Qi Zi-Shen granules. These granules are made from highly concentrated, selected Chinese herbs, and are produced in accordance with a traditional Chinese formula. The choice within each granule depends on the patient-specific pattern on which based the TCM theory of lung, spleen and kidney and Chinese medicine pattern theory. Over the 6-month treatment and 12-month follow-up, the TCM granules had beneficial effects on the measured outcomes, with no relevant between-group differences in adverse events.
AECOPD and lung function were the primary outcomes in this study. AECOPD can affect a decrease in lung function and impair the health-related quality of life
. It has been reported that the in patients admitted to intensive care units for AECOPD, their mortality rate was about 11–24%
[21, 22]. Therefore, the reductions in the frequency and duration of exacerbations are a major goal of COPD management and an important indicator for evaluating the treatment
. An accelerated decline in lung function is the main hallmark of COPD. A previous study showed that the rate of decline in FVE1 in COPD patients decreased from 47 ml to 69 ml per year
. According to the results from the well-known UPLIFT Trial and TORCH Trial, the rate of decline in FVE1 in the salmeterol/fluticasone group was 39 ml/yr and the rate of decline in the tiotropium group was 41 ml/yr
[4, 25]. Our results showed that the frequency and the duration of AECOPD in the trial group was 1.02 times and 4.39 days, respectively; however, those in the control group were 1.76 times and 6.37 days respectively. The rate of decline in FVE1 in patients in the trial group increased by approximately 4.16 ml per year, and it decreased approximately 52.54 ml/yr in the control group. The rate of decline in FVE1 in patients in the control group was consistent with that of previous large trials. TCM granules can reduce the frequency and duration of acute exacerbation, and maintain the rate of decline in FEV1. This may be due to the combined effect of conventional Western medicine and Chinese medicines.
Symptoms, exercise tolerance and health status outcomes were also observed in the current study. The characteristic symptoms of COPD are chronic and progressive dyspnea, cough, and sputum production. Although COPD is defined on the basis of airflow limitation, in practice the decision to seek medical help is usually determined by the effect of a symptom on a patient’s daily life. However, in an early or stable state, dyspnea is not obvious and often overlooked by patients and physicians
. Evaluation of the degree in breathing difficulty is important to understand the severity of COPD, the health status of patients and to evaluate clinical intervention effects. Therefore, observations of symptoms and the Dyspnea Scale questionnaire were used in the current study
. The 6MWD is widely used in respiratory disease as a comprehensive evaluation of functional status of the body with moderate or severe disease
. The main objective of the 6MWD is to determine exercise tolerance and oxygen saturation during sub-maximal exercise. The 6MWD is also considered useful in the determination of the point at which patients should be listed for rehabilitation programs. The cut-off point for the 6MWD was approximately 350 m
 and the minimal important difference in COPD patients is 25 m
. Currently, quality of life is an indispensable indicator and assessment tool. Because of the long course of COPD and a progressive decline in lung function, patients’ daily activities are limited and they rely on on family members more, coupled with a financial burden and decreased family status. COPD patients usually have low self-esteem, depression, anxiety, and other adverse effects on psychological emotion and social adaptation ability. There are many types of effective and reliable health related quality of life questionnaires on chronic respiratory diseases
. With better reliability and validity, the WHOQOL-BREF was adopted in the current study to evaluate the quality of life of patients with COPD. Our results showed that the improvement of 6MWD in the trial group was 31.84 m, which, was better than that 14.07 m in the control group. The improvement of quality of life was 13.26% in the trial group and 6.13% in the control group, and symptoms were reduced, with lower dyspnea scale scores in the trial group compared with those in the control group. TCM granules reduced symptoms, and improved exercise tolerance and health status.
In addition, the reasons for the favorable effects of TCM treatment on the clinical parameters in COPD patients were also taken into account. Our results suggest that these favorable effects may be due to the combined effect of conventional Western medicine and Chinese medicines. The clinical effect of the TCM granules lied in reducing the frequency of acute exacerbation, ameliorating symptoms, increasing exercise endurance, and improving quality of life. In view of our previous studies, the mechanism of the TCM granules may be involved in reducing the expression of interleukin (IL)-8, IL-6, IL-10, IL-1β and TNF-α, and regulating the level of inflammatory cytokines. TCM granules may also be involved in regulating the level of cellular immunity, especially the expression of T lymphocyte subsets (CD3+, CD4+, CD8+, CD4+/CD8+) and CD4+CD25+; reducing the expression of matrix metalloproteinase(MMP)-2, MMP-9, improving the expression of tissue inhibitor of metalloproteinases-1, regulating the balance of MMPs, and reducing the expression of JAK/STAT signaling pathways related factors and inflammatory factors.
Based on the the results of our trial, TCM treatment, including Bu-Fei Jian-Pi granules, Bu-Fei Yi-Shen granules, and Yi-Qi Zi-Shen granules, is safe and effective for treating COPD patients. However, there are some limitations for this study. In this study, herbal interventions (the granules) for the three TCM patterns were recognized as whole comprehensive interventions rather than one herbal intervention for each pattern. This study aimed to evaluate comprehensive interventions based on the three common patterns in stable COPD patients. Therefore, the efficacy of each type of herbal intervention on a TCM pattern was not evaluated. In addition, the 6-month treatment duration and 12-month follow-up duration was a little short to observe changes in lung function and to show the fully effect of TCM treatment. Further studies should be performed to evaluate TCM treatment.