Clinical efficacy of comprehensive therapy based on traditional Chinese medicine patterns on patients with pneumoconiosis: a pilot double-blind, randomized, and placebo-controlled study

作     者：Jiansheng Li Hulei Zhao Yang Xie Jieya Li Qingwei Li Xuexin Chen Weiyu Zhang Jiansheng Li;Hulei Zhao;Yang Xie;Jieya Li;Qingwei Li;Xuexin Chen;Weiyu Zhang

作者机构：Collaborative Innovation Center for Chinese Medicine and Respiratory Diseases Co-constructed by Henan Province&Education Ministry of ChinaHenan University of Chinese MedicineZhengzhou 450046China Henan Key Laboratory of Chinese Medicine for Respiratory DiseaseHenan University of Chinese MedicineZhengzhou 450046China Department of Respiratory DiseasesThe First Affiliated Hospital of Henan University of Chinese MedicineZhengzhou 450000China Department of PneumoconiosisHenan Hospital for Occupational DiseasesZhengzhou 450052China Department of Respiratory DiseasesJiaozuo Coal Industry Group Co.Ltd.Central HospitalJiaozuo 454000China Department of PneumoconiosisYima Coal Industry Group Co.Ltd.General HospitalYima 472300China 

出 版 物：《Frontiers of Medicine》 (医学前沿（英文版）)

年 卷 期：2022年第16卷第5期

页      面：736-744页

核心收录：

学科分类：100506[医学-中医内科学] 1005[医学-中医学] 1002[医学-临床医学] 1001[医学-基础医学(可授医学、理学学位)] 10[医学] 

基　　金：This work was supported by the Henan Province Priority and Advantage Discipline Construction Engineering Projects Traditional Chinese Medicine(No.STS-ZYX-2017025) the Special Project of Traditional Chinese Medicine Research in Henan Province(Nos.20-21ZYZD01and2018ZY1003). 

主　　题：pneumoconiosis randomized controlled trials traditional Chinese medicine 

摘      要：Effective therapy options for pneumoconiosis are lacking.Traditional Chinese medicine(TCM)presents a favorable prospect in the treatment of pneumoconiosis.A pilot study on TCM syndrome differentiation can evaluate the clinical efficacy and safety of TCM and lay a foundation for further clinical research.A double-blind,randomized,and placebo-controlled trial was conducted for 24 weeks,in which 96 patients with pneumoconiosis were randomly divided into the control and treatment groups.Symptomatic treatment was conducted for the two groups.The treatment group was treated with TCM syndrome differentiation,and the control group was treated with placebo.The primary outcomes were the six-minute walking distance(6MWD)and the St.George Respiratory Questionnaire(SGRQ)score.The secondary outcomes were the modified British Medical Research Council Dyspnea Scale(mMRC),Chronic Obstructive Pulmonary Disease Assessment Test(CAT),Hospital Anxiety and Depression Scale(HADS),and pulmonary function.Only 83 patients from the 96 patients with pneumoconiosis finished the study.For the primary outcome,compared with the control groups,the treatment group showed a significantly increased 6MWD(407.90 m vs.499.51 m;95%confidence interval(CI)47.25 to 135.97;P0.001)and improved SGRQ total score(44.48 vs.25.67;95%CI 27.87 to 9.74;P0.001).The treatment group also significantly improved compared with the control group on mMRC score(1.4 vs.0.74;95%CI 1.08 to 0.23;P=0.003),CAT score(18.40 vs.14.65;95%CI 7.07 to 0.43;P=0.027),and the total symptom score(7.90 vs.5.14;95%CI 4.40 to 1.12;P0.001).No serious adverse events occurred.This study showed that TCM syndrome differentiation and treatment had a favorable impact on the exercise endurance and quality of life of patients with pneumoconiosis.