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Randomized Controlled Trial
. 2024 Mar;30(3):195-202.
doi: 10.1007/s11655-024-3900-8. Epub 2024 Feb 20.

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

Hao-Yue Huang  1   2   3   4 , Yu-Ping Lin  1   2   3   4 , Hua Wei  1   2   3   4 , Yu Fu  5 , Yue-Hong Zhou  6 , Zhao-Hui Fang  7 , Xiao-Tang Qiu  8 , Mei Wang  9 , Qing-Bo Li  10 , Shan-Shan Li  11 , Shi-Dong Wang  12 , Fang Dai  13 , Zhen-Jie Liu  1   2   3   4 , Ling Zhao  1   2   3   4 , Jian-Xuan Wen  1   2   3   4 , Li-Yan Wu  1   2   3   4 , Hui-Yan Zeng  1   2   3   4 , Jin-Ming Zhang  1   2   3   4 , Qi-Yun Lu  1   2   3   4 , Liu He  1   2   3   4 , Wei Song  1   2   3   4 , Lu Sun  1   2   3   4 , Lu-Lu Luo  1   2   3   4 , Jia-Li He  1   2   3   4 , Wen-Wen Xie  1   2   3   4 , Qing-Shun Liang  1   2   3   4 , Yuan Huang  1   2   3   4 , Sheng-Ling Zhu  1   2   3   4 , Jie-Er Long  1   2   3   4 , Zhi-Juan Gao  1   2   3   4 , Ze-Huai Wen  2   4 , Chun-Ji Li  2   4 , Wen-Wei Ouyang  2   4 , Geng Li  2   4 , Ming-Hui Wu  1   2   3   4 , An-Xiang Li  1   2   3   4 , Jin-Zhu Huang  2 , Sanjoy K Paul  14 , Xian-Yu Tang  15   16   17   18 , Guan-Jie Fan  19   20   21   22
Affiliations
Randomized Controlled Trial

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

Hao-Yue Huang et al. Chin J Integr Med. 2024 Mar.

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 TCSSTS 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).

Keywords: Chinese medicine; Tangbi Waixi Decoction; diabetic peripheral neuropathy; herbal medicine foot baths; randomized controlled trial.

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