TangBi Formula for Painful Diabetic Distal Symmetric Polyneuropathy: A Multicenter, Randomized, Double-Blind, Placebo-Controlled and Parallel-Group Trial

IF 3 2区医学 Q2 ENDOCRINOLOGY & METABOLISM

Journal of Diabetes Pub Date : 2025-01-05 DOI:10.1111/1753-0407.70045

Xuefei Zhao, Xuedong An, Yashan Cui, Liu Dong, Zhaohui Fang, Zhonghua Zheng, Xinhe Zuo, Huailin Gao, Tianshu Gao, Qing Ni, Fengmei Lian, Xiaolin Tong

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引用次数: 0

Abstract

Objective

To determine whether the use of herbal medicines combined with conventional treatment is more effective than conventional medication alone in improving clinical symptoms in patients with diabetic distal symmetric polyneuropathy (DSPN).

Methods

This multicenter, placebo-controlled, double-blind, randomized controlled clinical trial recruited patients from 6 clinical centers in mainland China. A total of 188 patients were randomly assigned in a 1:1 ratio to the treatment group (Tangbi Formula plus methylcobalamin) and the control group (placebo plus methylcobalamin). Subjects were reassessed after the 24-week intervention. The primary outcomes were differences in changes in clinical signs and symptoms and changes in the Michigan Diabetic Neuropathy Score (MDNS) between the two groups before and after treatment. Secondary outcomes were changes in nerve conduction velocity (NCV) and single clinical signs and symptoms as measured by the visual-analogue scale (VAS) and Toronto clinical scoring system (TCSS).

Results

Compared with the placebo group, after 24 weeks of treatment, the MDNS score of TangBi Formula group was significantly reduced (p < 0.001). There were no significant changes in NCV results in either group before or after treatment. Compared with baseline, the difference in the change value of VAS score between the two groups after treatment was statistically significant (p = 0.031). A statistically significant difference in the change value of TCSS after treatment compared to baseline was found between the two groups (p = 0.033 at 12 weeks and p = 0.030 at 24 weeks). No severe adverse events due to study participation or study intervention were reported.

Conclusions and Relevance

This trial demonstrated that combining Tangbi Formula with basal therapy can be safer and more effective in improving the symptoms of DSPN patients.

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糖痹方治疗疼痛性糖尿病远端对称性多神经病变：一项多中心、随机、双盲、安慰剂对照、平行组试验。

目的：探讨中药联合常规治疗在改善糖尿病远端对称性多神经病变（DSPN）患者临床症状方面是否比单独使用常规药物更有效。方法：该多中心、安慰剂对照、双盲、随机对照临床试验从中国大陆6个临床中心招募患者。188例患者按1:1的比例随机分为治疗组（糖痹方加甲钴胺）和对照组（安慰剂加甲钴胺）。干预24周后对受试者进行重新评估。主要结局是两组患者治疗前后临床体征和症状的变化以及密歇根糖尿病神经病变评分（MDNS）的变化。次要结果是神经传导速度（NCV）的变化，以及用视觉模拟量表（VAS）和多伦多临床评分系统（TCSS）测量的单一临床体征和症状的变化。结果：与安慰剂组比较，治疗24周后，糖痹方组MDNS评分明显降低(p)。结论及相关性：本试验表明，糖痹方联合基础治疗对改善DSPN患者的症状更安全、更有效。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Diabetes ENDOCRINOLOGY & METABOLISM-

CiteScore

6.50

自引率

2.20%

发文量

审稿时长

>12 weeks

期刊介绍： Journal of Diabetes (JDB) devotes itself to diabetes research, therapeutics, and education. It aims to involve researchers and practitioners in a dialogue between East and West via all aspects of epidemiology, etiology, pathogenesis, management, complications and prevention of diabetes, including the molecular, biochemical, and physiological aspects of diabetes. The Editorial team is international with a unique mix of Asian and Western participation. The Editors welcome submissions in form of original research articles, images, novel case reports and correspondence, and will solicit reviews, point-counterpoint, commentaries, editorials, news highlights, and educational content.