Liu Miao, Zheng Fengjie, Ni Lei, Sun Yan, Wu Ruohan, Zhang Tianyu, Zhang Jinchao, Zhong Xianggen, Li Yuhang
J Tradit Chin Med. 2016 Aug;36(4):418-26. doi: 10.1016/s0254-6272(16)30057-7.
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).
This was a multicenter, randomized, double-blind, placebo-controlled trial. A total of 196 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-treatment pulmonary 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 (mMRC) dyspnea scale were assessed before treatment and at the end of the 6-month follow- up.
The ITT population was 178 and the PPS population was 166. Post-treatment pulmonary clinical symptoms and severity of dyspnea (mMRC 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 mMRC. 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.
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.
评估甘蔗渣膳食纤维作为辅助治疗手段改善稳定期慢性阻塞性肺疾病（COPD）患者生活质量的疗效和安全性。
这是一项多中心、随机、双盲、安慰剂对照试验。总共196名参与者被随机分为试验组（每日服用6克甘蔗渣加常规治疗，n = 98）和对照组（服用安慰剂加常规治疗，n = 98）。所有疗效分析均按照意向性分析（ITT）原则进行。采用符合方案分析集（PPS）对依从性良好并完成临床试验的病例进行分析。试验期为30天，随访6个月。记录两组治疗前后的肺部症状评分（咳嗽、咳痰、喘息和呼吸困难）。在治疗前和6个月随访结束时评估圣乔治呼吸问卷（SGRQ）和改良的医学研究委员会（mMRC）呼吸困难量表。
ITT人群为178例，PPS人群为166例。试验组和对照组治疗后的肺部临床症状和呼吸困难严重程度（mMRC和SGRQ评估）均有显著改善（ITT和PPS：P < 0.05）。然而，两组治疗后的肺部症状和mMRC之间无统计学差异。试验组的SGRQ活动、影响和总分分量表较对照组有更大程度的降低（ITT和PPS：P < 0.01）。两组治疗前后的安全性变量无统计学差异。
甘蔗渣联合常规治疗可改善稳定期COPD患者的生活质量。甘蔗渣作为辅助治疗口服时似乎是一种安全的草药，有治疗稳定期COPD患者的潜力。
