Evaluation of the efficacy of Yiqi Jiedu decoction on diabetic peripheral neuropathy and related brain function changes: A randomized controlled trial protocol

IF 1.7 4区医学 Q3 INTEGRATIVE & COMPLEMENTARY MEDICINE

European Journal of Integrative Medicine Pub Date : 2025-08-26 DOI:10.1016/j.eujim.2025.102543

Chaofan Sun , Guoxing Ling , Chunquan Sun , Xingzhong Feng

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引用次数: 0

Abstract

Introduction

Diabetic peripheral neuropathy (DPN) is a common complication of type 2 diabetes, characterized by high disability and mortality rates. Pain, the primary symptom of DPN, leads to increased central nervous system responsiveness and decreased pain thresholds, resulting in conditions like hyperalgesia, anxiety, and depression—collectively referred to as "central sensitization." Changes in brain structure and function are closely linked to this phenomenon but remain unclear. While functional magnetic resonance imaging (fMRI) technology can monitor brain function changes, there is limited research on the effects of interventions on these functions in patients with DPN. Yiqi Jiedu (YQJD) Decoction has been used in China to treat DPN for many years, with some studies indicating it may improve symptoms and quality of life, but there is a lack of high-quality clinical evidence, and its central mechanism of action remains unclear.

Methods

This ongoing randomized, double-blind, placebo-controlled trial aims to enroll about 88 patients aged 45–75 with DPN, diagnosed with qi deficiency and blood stasis syndrome. Participants will be randomly assigned in a 1:1 ratio to either receive YQJD Granules or the placebo, with follow-up assessments at weeks 4 and 8. The primary outcomes include the Toronto Clinical Scoring System (TCSS), Michigan Diabetic Neuropathy Score (MDNS), Traditional Chinese Medicine (TCM) syndrome score, nerve conduction velocity, and fMRI changes. Secondary outcomes will assess psychological characteristics in patients and changes in serum cytokines and glucose-lipid metabolism indicators.

Discussion

This study aims to evaluate the efficacy and safety of YQJD Decoction in the treatment of DPN using fMRI technology. It will analyze changes in brain regions before and after treatment, explore the cerebral effects of YQJD, and elucidate the relationship between central sensitization and brain effect patterns in the pathogenesis of DPN. The findings of this study will provide clinical evidence and mechanistic insights for the integration of TCM and Western medicine in the treatment of DPN. It is expected to reveal the central mechanisms involved in the intervention of neuropathic pain through Chinese herbal medicine.

Trial registration

Chinese clinical trial registry, ChiCTR2400084649. Registered on 22 May 2024, https://www.chictr.org.cn/.

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益气解毒汤对糖尿病周围神经病变及相关脑功能改变的疗效评价：随机对照试验方案

糖尿病周围神经病变（DPN）是2型糖尿病的常见并发症，其特点是高致残率和死亡率。疼痛是DPN的主要症状，导致中枢神经系统反应性增加和疼痛阈值降低，导致痛觉过敏、焦虑和抑郁等症状，统称为“中枢敏感化”。大脑结构和功能的变化与这一现象密切相关，但目前尚不清楚。虽然功能磁共振成像（fMRI）技术可以监测脑功能的变化，但关于干预措施对DPN患者这些功能的影响的研究有限。益气解毒汤在中国治疗DPN已有多年历史，一些研究表明益气解毒汤可以改善DPN的症状和生活质量，但缺乏高质量的临床证据，其主要作用机制尚不清楚。这项正在进行的随机、双盲、安慰剂对照试验旨在招募约88名年龄在45-75岁之间、诊断为气虚血瘀证的DPN患者。参与者将以1:1的比例随机分配接受YQJD颗粒或安慰剂，并在第4周和第8周进行随访评估。主要结局包括多伦多临床评分系统（TCSS）、密歇根糖尿病神经病变评分（MDNS）、中医证候评分、神经传导速度和功能磁共振成像（fMRI）变化。次要结局将评估患者的心理特征和血清细胞因子和糖脂代谢指标的变化。本研究旨在应用功能磁共振成像技术评价益芩汤治疗DPN的疗效和安全性。研究将分析治疗前后脑区变化，探讨青芪汤的脑效应，阐明中枢致敏与DPN发病机制中脑效应模式的关系。本研究结果将为中西医结合治疗DPN提供临床依据和机制见解。以期揭示中药干预神经性疼痛的中枢机制。中国临床试验注册中心，ChiCTR2400084649。2024年5月22日注册，网址：https://www.chictr.org.cn/。

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来源期刊

European Journal of Integrative Medicine INTEGRATIVE & COMPLEMENTARY MEDICINE-

CiteScore

4.70

自引率

4.00%

发文量

102

审稿时长

33 days

期刊介绍： The European Journal of Integrative Medicine (EuJIM) considers manuscripts from a wide range of complementary and integrative health care disciplines, with a particular focus on whole systems approaches, public health, self management and traditional medical systems. The journal strives to connect conventional medicine and evidence based complementary medicine. We encourage submissions reporting research with relevance for integrative clinical practice and interprofessional education. EuJIM aims to be of interest to both conventional and integrative audiences, including healthcare practitioners, researchers, health care organisations, educationalists, and all those who seek objective and critical information on integrative medicine. To achieve this aim EuJIM provides an innovative international and interdisciplinary platform linking researchers and clinicians. The journal focuses primarily on original research articles including systematic reviews, randomized controlled trials, other clinical studies, qualitative, observational and epidemiological studies. In addition we welcome short reviews, opinion articles and contributions relating to health services and policy, health economics and psychology.