Bu-Fei Yi-Shen granule combined with acupoint sticking therapy in patients with stable chronic obstructive pulmonary disease: A randomized, double-blind, double-dummy, active-controlled, 4-center study

This manuscript is to evaluate the efficacy and safety of traditional Chinese medicine Bu-Fei Yi-Shen granule combined with acupoint sticking therapy in patients with stable COPD. The interventions reduced the frequency and duration of acute exacerbation, ameliorating symptoms, improving quality of...

Full description

Saved in:
Bibliographic Details
Published in:Journal of ethnopharmacology 2012-06, Vol.141 (2), p.584-591
Main Authors: Li, Jian-Sheng, Li, Su-Yun, Yu, Xue-Qing, Xie, Yang, Wang, Ming-Hang, Li, Ze-Geng, Zhang, Nian-Zhi, Shao, Su-Ju, Zhang, Yi-Jie, Zhu, Lin, Guo, Lian-Xiang, Bai, Yun-Ping, Wang, Yan-Fang
Format: Article
Language:English
Subjects:
Acupoint sticking therapy
Acupuncture Points
Acupuncture Therapy - adverse effects
Administration, Oral
Aged
Bronchodilator Agents - administration & dosage
Bu-Fei Yi-Shen granule
China
Chronic obstructive pulmonary disease
Clinical trials
Combined Modality Therapy
Delayed-Action Preparations
Double-Blind Method
Drugs, Chinese Herbal - adverse effects
Drugs, Chinese Herbal - therapeutic use
Dyspnea - etiology
Dyspnea - physiopathology
Dyspnea - prevention & control
Exercise Test
Exercise Tolerance - drug effects
Female
Forced Expiratory Volume - drug effects
Humans
Lung - drug effects
Lung - physiopathology
Male
Medicine, Chinese Traditional
Middle Aged
Plants, Medicinal
Pulmonary Disease, Chronic Obstructive - complications
Pulmonary Disease, Chronic Obstructive - diagnosis
Pulmonary Disease, Chronic Obstructive - physiopathology
Pulmonary Disease, Chronic Obstructive - therapy
Quality of Life
Respiratory System Agents - adverse effects
Respiratory System Agents - therapeutic use
Surveys and Questionnaires
Theophylline - administration & dosage
Time Factors
Traditional Chinese medicine
Treatment Outcome
Vital Capacity - drug effects
Walking
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:This manuscript is to evaluate the efficacy and safety of traditional Chinese medicine Bu-Fei Yi-Shen granule combined with acupoint sticking therapy in patients with stable COPD. The interventions reduced the frequency and duration of acute exacerbation, ameliorating symptoms, improving quality of life and other outcomes (ChiCTR-TRC-11001409). Bu-Fei Yi-Shen granule combined with acupoint sticking therapy has been used in the patients with stable chronic obstructive pulmonary disease (COPD) as major traditional interventions for the treatment of the disease. The objective of this study was to evaluate the efficacy and safety of traditional Chinese herbal medicine, the Bu-Fei Yi-Shen granule combined with acupoint sticking therapy in patients with stable COPD. A 4-center, double-blinded, double-dummy and randomized controlled method was conducted. 244 patients who were divided into the trial group (n=122, treated with Bu-Fei Yi-Shen granule combined with Shu-Fei Tie acupoint sticking therapy and oral placebo sustained-release theophylline) and the control group (n=122, treated with oral sustained-release theophylline and placebo Bu-Fei Yi-Shen granule combined with placebo Shu-Fei Tie acupoint sticking therapy). The frequency and duration of acute exacerbation, lung function, clinical symptoms, six-minute walking distance, dyspnea grade and quality of life were observed during the 4-month treatment period, and for a further 6 months follow-up. Two hundred and twenty one patients fully completed the study, intent-to-treat (ITT) population was 234 and per-protocol (PP) population was 221. After treatment for 4 months and follow-up for 6 months, there were differences between the experimental and control group in frequency of acute exacerbation (ITT: P=0.007, P=0.013; PP: P=0.045, P=0.046); duration of acute exacerbation (ITT: P=0.030, P=0.005; PP: P=0.048, P=0.006); scores of symptoms (ITT: P=0.000, P=0.000; PP: P=0.000, P=0.000); six-minute walking distance (ITT: P=0.002, P=0.001; PP: P=0.002, P=0.001); dyspnea grade (ITT: P=0.014, P=0.009; PP: P=0.018, P=0.012); physiological aspects (ITT: P=0.003, P=0.000; PP: P=0.001, P=0.000); psychological aspects (ITT: P=0.007, P=0.001; PP: P=0.001, P=0.000) and environment aspects (ITT: P=0.003, P=0.000; PP: P=0.001, P=0.000) of the WHOQOL-BREF questionnaire. There were no differences between the experimental and control group in FVC, FEV1 and FEV1% and adverse events. Bu-Fei Yi-Shen granule combined with acupoint st
ISSN:0378-8741
1872-7573
DOI:10.1016/j.jep.2011.08.060