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

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

doi:10.1007/s11655-024-3900-8

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

Original Article | Updated：2024-02-22

- 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
- 中国结合医学杂志（英文版） 2024年30卷第3期页码：195-202
- Affiliations：
  
  1.Department of Endocrinology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou (510120), China
  2.The Second Clinical College of Guangzhou University of Chinese Medicine, Guangzhou (510120), China
  3.Department of Endocrinology, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou (510120), China
  4.Guangdong Provincial Academy of Chinese Medical Sciences, Guangzhou (510120), China
  5.Department of Endocrinology, The First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou (450000), China
  6.Department of Endocrinology, Liuyang Hospital of Chinese Medicine, Changsha(410000), China
  7.Department of Endocrinology, The First Affiliated Hospital of Anhui University of Chinese Medicine, Hefei (230000), China
  8.Department of Endocrinology, Hainan Provincial Hospital of Traditional Chinese Medicine, Haikou(570100), China
  9.Department of Endocrinology, The Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shenyang (110000), China
  10.Department of Geriatric, Luoyang No.1 Hospital of Traditional Chinese Medicine, Luoyang, Henan Province (471000), China
  11.Department of Endocrinology, The Second Affiliated Hospital of Guizhou University of Traditional Chinese Medicine, Guiyang (550000), China
  12.Department of Endocrinology, Beijing University of Chinese Medicine Affiliated Dongzhimen Hospital, Beijing (100000), China
  13.Department of Endocrinology, The First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine, Guiyang (550000), China
  14.Melbourne EpiCentre, The University of Melbourne and Melbourne Health, Melbourne (3013), Australia
- Author bio：
  
  Dr. TANG Xian-yu, E-mail: 13922212818@139.com
  Dr. FAN Guan-jie, E-mail: 13925119990@139.com;
- Funds：
  
  the National Science and Technology Support Program(2015BAI04B09)
- DOI：10.1007/s11655-024-3900-8
  中图分类号：
- 纸质出版日期：2024-03，
  
  录用日期：2023-06-07
Scan for full text
Effect and Safety of Herbal Medicine Foot Baths in Patients with Diabetic Peripheral Neuropathy: A Multicenter Double-Blind Randomized Controlled Trial[J]. 中国结合医学杂志（英文版）, 2024,30(3):195-202.

HUANG Hao-yue, LIN Yu-ping, WEI Hua, et al. Effect and Safety of Herbal Medicine Foot Baths in Patients with Diabetic Peripheral Neuropathy: A Multicenter Double-Blind Randomized Controlled Trial[J]. Chinese Journal of Integrative Medicine, 2024,30(3):195-202.
Effect and Safety of Herbal Medicine Foot Baths in Patients with Diabetic Peripheral Neuropathy: A Multicenter Double-Blind Randomized Controlled Trial[J]. 中国结合医学杂志（英文版）, 2024,30(3):195-202. DOI： 10.1007/s11655-024-3900-8.

HUANG Hao-yue, LIN Yu-ping, WEI Hua, et al. Effect and Safety of Herbal Medicine Foot Baths in Patients with Diabetic Peripheral Neuropathy: A Multicenter Double-Blind Randomized Controlled Trial[J]. Chinese Journal of Integrative Medicine, 2024,30(3):195-202. DOI： 10.1007/s11655-024-3900-8.

摘要

Abstract

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 (

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 (

0.05). The number of adverse events did not differ significantly between groups (

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)

关键词

Keywords

diabetic peripheral neuropathyherbal medicine foot bathsChinese medicinerandomized controlled trialTangbi Waixi Decoction

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