首页|Effect and Safety of Herbal Medicine Foot Baths in Patients with Diabetic Peripheral Neuropathy:A Multicenter Double-Blind Randomized Controlled Trial

Effect and Safety of Herbal Medicine Foot Baths in Patients with Diabetic Peripheral Neuropathy:A Multicenter Double-Blind Randomized Controlled Trial

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Objective:To evaluate the effect and safety of foot baths with Tangbi Waixi Decoction(TW)in treating patients with diabetic peripheral neuropathy(DPN).Methods:It is a multicenter double-blinded randomized controlled trial.Participants with DPN were recruited between November 18,2016 and May 30,2018 from 8 hospitals in China.All patients received basic treatments for glycemic management.Patients received foot baths with TW herbal granules either 66.9 g(intervention group)or 6.69 g(control group)for 30 min once a day for 2 weeks and followed by a 2-week rest,as a therapeutic course.If the Toronto Clinical Scoring System total score(TCSS-TS)≥6 points,the patients received a total of 3 therapeutic courses(for 12 weeks)and were followed up for 12 weeks.The primary outcome was change in TCSS-TS score at 12 and 24 weeks.Secondary outcomes included changes in bilateral motor nerve conduction velocity(MNCV)and sensory nerve conduction velocity(SNCV)of the median and common peroneal nerve.Safety was also assessed.Results:Totally 632 patients were enrolled,and 317 and 315 were randomized to the intervention and control groups,respectively.After the 12-week intervention,patients in both groups showed significant declines in TCSS-TS scores,and significant increases in MNCV and SNCV of the median and common peroneal nerves compared with pre-treatment(P＜0.05).The reduction of TCSS-TS score at 12 weeks and the increase of SNCV of median nerve at 24 weeks in the control group were greater than those in the intervention group(P＜0.05).The number of adverse events did not differ significantly between groups(P＞0.05),and no serious adverse event was related with treatment.Conclusion:Treatment of TW foot baths was safe and significantly benefitted patients with DPN.A low dose of TW appeared to be more effective than a high dose.(Registry No.ChiCTR-IOR-16009331)

diabetic peripheral neuropathyherbal medicine foot bathsChinese medicinerandomized controlled trialTangbi Waixi Decoction

HUANG Hao-yue、LIN Yu-ping、WEI Hua、FU Yu、ZHOU Yue-hong、FANG Zhao-hui、QIU Xiao-tang、WANG Mei、LI Qing-bo、LI Shan-shan、WANG Shi-dong、DAI Fang、LIU Zhen-jie、ZHAO Ling、WEN Jian-xuan、WU Li-yan、ZENG Hui-yan、ZHANG Jin-ming、LU Qi-yun、HE Liu、SONG Wei、SUN Lu、LUO Lu-lu、HE Jia-li、XIE Wen-wen、LIANG Qing-shun、HUANG Yuan、ZHU Sheng-ling、LONG Jie-er、GAO Zhi-juan、WEN Ze-huai、LI Chun-ji、OUYANG Wen-wei、LI Geng、WU Ming-hui、LI An-xiang、HUANG Jin-zhu、Sanjoy K Paul、TANG Xian-yu、FAN Guan-jie

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Department of Endocrinology,Guangdong Provincial Hospital of Chinese Medicine,Guangzhou(510120),China

The Second Clinical College of Guangzhou University of Chinese Medicine,Guangzhou(510120),China

Department of Endocrinology,The Second Affiliated Hospital of Guangzhou University of Chinese Medicine,Guangzhou(510120),China

Guangdong Provincial Academy of Chinese Medical Sciences,Guangzhou(510120),China

Department of Endocrinology,The First Affiliated Hospital of Henan University of Chinese Medicine,Zhengzhou(450000),China

Department of Endocrinology,Liuyang Hospital of Chinese Medicine,Changsha(410000),China

Department of Endocrinology,The First Affiliated Hospital of Anhui University of Chinese Medicine,Hefei(230000),China

Department of Endocrinology,Hainan Provincial Hospital of Traditional Chinese Medicine,Haikou(570100),China

Department of Endocrinology,The Affiliated Hospital of Liaoning University of Traditional Chinese Medicine,Shenyang(110000),China

Department of Geriatric,Luoyang No.1 Hospital of Traditional Chinese Medicine,Luoyang,Henan Province(471000),China

Department of Endocrinology,The Second Affiliated Hospital of Guizhou University of Traditional Chinese Medicine,Guiyang(550000),China

Department of Endocrinology,Beijing University of Chinese Medicine Affiliated Dongzhimen Hospital,Beijing(100000),China

Department of Endocrinology,The First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine,Guiyang(550000),China

Melbourne EpiCentre,The University of Melbourne and Melbourne Health,Melbourne(3013),Australia

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National Science and Technology Support Program

2015BAI04B09

2024

10.1007/s11655-024-3900-8

中国结合医学杂志(英文版)
中国中西医结合学会 中国中医研究院

中国结合医学杂志(英文版)

CSTPCD
影响因子：1.056
ISSN：1672-0415
年,卷(期)：2024.30(3)
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