Sugarcane bagasse dietary fiber as an adjuvant therapy for stable chronic obstructive pulmonary disease:a four-center,randomized,double-blind,placebo-controlled study

作     者：Liu Miao Zheng Fengjie Ni Lei Sun Yan Wu Ruohan Zhang Tianyu Zhang Jinchao Zhong Xianggen Li Yuhang 

作者机构：School of Preclinical MedicineBeijing University of Chinese Medicine 

出 版 物：《Journal of Traditional Chinese Medicine》 (中医杂志（英文版）)

年 卷 期：2016年第36卷第4期

页      面：418-426页

核心收录：

学科分类：1007[医学-药学(可授医学、理学学位)] 1005[医学-中医学] 1002[医学-临床医学] 10[医学] 

基　　金：Supported by the National Basic Research Program of China:Study on Mechanism of Lung-Intestine Communication in View of the Theory of COPD Treatment Based on Intestine(No.2009CB522704) 

主　　题：Saccharum Pulmonary disease chronic obstructive Randomized clinical trial Medicine Chinese Traditional 

摘      要：OBJECTIVE:To evaluate the efficacy and safety of sugarcane bagasse dietary fiber as an adjuvant therapy for improving quality of life in patients with stable chronic obstructive pulmonary disease(COPD).METHODS:This was a multicenter,randomized,double-blind,placebo-controlled trial.A total of196 participants were randomized into a trial group(treated with 6 g/day sugarcane bagasse plus conventional treatment,n = 98) and a control group(treated with placebo plus conventional treatment,n = 98).All efficacy analyses were performed according to the intention-to-treat(ITT) principle.A per-protocol analysis set(PPS) was used to analyze the cases that completed the clinical trial with good compliance.The trial period was 30 days,with a 6-month follow-up.Pre-and post-treatmentpulmonary symptom scores(cough,sputum,wheezing,and dyspnea) were recorded for both groups.The St.George s Respiratory Questionnaire(SGRQ) and the modified Medical Research Council(m MRC) dyspnea scale were assessed before treatment and at the end of the 6-month follow-up.RESULTS:The ITT population was 178 and the PPS population was 166.Post-treatment pulmonary clinical symptoms and severity of dyspnea(m MRC and SGRQ evaluation) were significantly improved in both the trial group and the control group(ITT and PPS:P 0.05).However,there was no statistical difference between the two groups in post-treatment pulmonary symptoms and m MRC.There was a greater reduction in the SGRQ subscales of activity,effect and total score in the trial group compared with the control group(ITT and PPS:P 0.01).There was no statistical difference in pre-and post-treatment safety variables in either group.CONCLUSION:Sugarcane bagasse combined with conventional treatment improved quality of life in patients with stable COPD.Sugarcane bagasse appears to be a safe herbal medicine with potential for treating patients with stable COPD when taken orally as an adjuvant therapy.