Effect of traditional Chinese medicine on outcomes in patients with mild/moderate chronic obstructive pulmonary disease: study protocol for a randomized placebo-controlled trial

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Abstract

Background

Chronic obstructive pulmonary disease (COPD) has become a major public health problem worldwide because of its high and increasing prevalence, morbidity, and mortality. Little attention has been paid to earlier stages of COPD or before it has developed. Reportedly, TCM may have some advantages in relieving symptoms and reducing the incidence of COPD exacerbations. We postulate that patients with COPD will benefit from therapy with TCM treatment according to syndrome differentiation.

Methods and design

A prospective, multi-center, double-blinded and randomized controlled method will be used to test the therapeutic effects of TCM treatment according to syndrome differentiation. A total of 504 patients will be enrolled into this study with 252 in each treatment group. Patients will receive medication according to their assigned group. TCM for COPD will be administered twice daily over 52 weeks, and all patients will follow the treatment program for 52 weeks. The FEV ₁ and exacerbations will be used as the primary outcome measures. The quality of life and the Modified Medical Research Council (MMRC) Dyspnea Scale, and the 6-min walk test (6MWD) will be used as the secondary outcome measures.

Discussion

We postulate that patients with COPD will benefit from therapy with TCM treatment according to syndrome differentiation.

Trial registration

This study is registered at ClinicalTrials.gov, NCT01486186

Related collections

Most cited references 12

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The CONSORT (Consolidated Standards of Reporting Trials) statement is used worldwide to improve the reporting of randomized, controlled trials. Schulz and colleagues describe the latest version, CONSORT 2010, which updates the reporting guideline based on new methodological evidence and accumulating experience.

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Previous studies of lung function in relation to smoking cessation have not adequately quantified the long-term benefit of smoking cessation, nor established the predictive value of characteristics such as airway hyperresponsiveness. In a prospective randomized clinical trial at 10 North American medical centers, we studied 3, 926 smokers with mild-to-moderate airway obstruction (3,818 with analyzable results; mean age at entry, 48.5 yr; 36% women) randomized to one of two smoking cessation groups or to a nonintervention group. We measured lung function annually for 5 yr. Participants who stopped smoking experienced an improvement in FEV(1) in the year after quitting (an average of 47 ml or 2%). The subsequent rate of decline in FEV(1) among sustained quitters was half the rate among continuing smokers, 31 +/- 48 versus 62 +/- 55 ml (mean +/- SD), comparable to that of never-smokers. Predictors of change in lung function included responsiveness to beta-agonist, baseline FEV(1), methacholine reactivity, age, sex, race, and baseline smoking rate. Respiratory symptoms were not predictive of changes in lung function. Smokers with airflow obstruction benefit from quitting despite previous heavy smoking, advanced age, poor baseline lung function, or airway hyperresponsiveness.

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To evaluate the short-form 36-item questionnaire (SF-36) as an instrument for measuring health-related quality of life (HRQL) in patients with symptomatic COPD. Observational data at a single point in time. Outpatient pulmonary clinic. Fifty male patients with COPD and no significant comorbidity. HRQL was assessed with the SF-36, which consists of 36 questions that cover nine health domains. Clinical ratings of dyspnea were measured by the multidimensional baseline dyspnea index (BDI). Pulmonary function tests included forced vital capacity (FVC), forced expiratory volume in 1 s (FEV1), and maximal inspiratory mouth pressure (PImax). The mean (+/- SD) age of the patients was 72 +/- 8 years. The BDI focal score was 5.6 +/- 2.3, FEV1 was 1.32 +/- 0.60 L (48 +/- 22% pred), and PImax was 62 +/- 23 cm H2O. The BDI focal score was significantly correlated with seven of nine components of the SF-36 (range of r, 0.42 to 0.91; p < 0.05). The FEV1 percent of predicted and PImax were significantly correlated with five of nine health components (range of r, 0.30 to 0.65 and 0.31 to 0.61, respectively). Using linear regression model analysis with the different SF-36 components as the dependent variable and BDI, FVC, FEV1, and PImax as independent variables, the BDI score was the only significant predictor of social and physical functioning, role-physical, vitality, pain, health perceptions, and health transition (p < 0.05). The SF-36 is a valid instrument to measure HRQL in patients with COPD. The severity of dyspnea but not respiratory function was a significant predictor of various components of HRQL.

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Author and article information

Journal

Journal ID (nlm-ta): Trials

Journal ID (iso-abbrev): Trials

Title: Trials

Publisher: BioMed Central

ISSN (Electronic): 1745-6215

Publication date Collection: 2012

Publication date (Electronic): 16 July 2012

Volume: 13

Page: 109

Affiliations

[1 ]Department of Respiratory Diseases, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Zhengzhou, Henan Province, 450000, People’s Republic of China

[2 ]Institute of Geriatrics, Henan University of Traditional Chinese Medicine, Zhengzhou, Henan Province, 450008, People’s Republic of China

Article

Publisher ID: 1745-6215-13-109

DOI: 10.1186/1745-6215-13-109

PMC ID: 3475096

PubMed ID: 22799753

SO-VID: aa7e0534-6352-4fc3-8a42-d2fccf686d11

License:

This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

History

Date received : 8 January 2012

Date accepted : 16 July 2012

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