Abstract: 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.

Key words: Saccharum, Pulmonary disease, chronic obstructive, Randomized clinical trial, Medicine, Chinese Traditional