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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

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Chinese Journal of Integrative Medicine 2024年第3期30卷 195-202页

作者： 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 Department of Endocrinology Guangdong Provincial Hospital of Chinese MedicineGuangzhou510120China The Second Clinical College of Guangzhou University of Chinese Medicine Guangzhou510120China Department of Endocrinology The Second Affiliated Hospital of Guangzhou University of Chinese MedicineGuangzhou510120China Guangdong Provincial Academy of Chinese Medical Sciences Guangzhou510120China Department of Endocrinology The First Affiliated Hospital of Henan University of Chinese MedicineZhengzhou450000China Department of Endocrinology Liuyang Hospital of Chinese MedicineChangsha410000China Department of Endocrinology The First Affiliated Hospital of Anhui University of Chinese MedicineHefei230000China Department of Endocrinology Hainan Provincial Hospital of Traditional Chinese MedicineHaikou570100China Department of Endocrinology The Affiliated Hospital of Liaoning University of Traditional Chinese MedicineShenyang110000China Department of Geriatric Luoyang No.1 Hospital of Traditional Chinese MedicineLuoyangHenan Province471000China Department of Endocrinology The Second Affiliated Hospital of Guizhou University of Traditional Chinese MedicineGuiyang550000China Department of Endocrinology Beijing University of Chinese Medicine Affiliated Dongzhimen HospitalBeijing100000China Department of Endocrinology The First Affiliated Hospital of Guizhou University of Traditional Chinese MedicineGuiyang550000China Melbourne EpiCentre The University of Melbourne and Melbourne HealthMelbourne3013Australia

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(P0.05),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.Chi CTR-IOR-16009331)

关键词： Diabetic peripheral neuropathy herbal medicine foot baths Chinese medicine randomized controlled trial Tangbi Waixi Decoction

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diabetic corneal neuropathy as a surrogate marker for Diabetic peripheral neuropathy

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Neural Regeneration Research 2022年第10期17卷 2172-2178页

作者： Wei Zheng So Natalie Shi Qi Wong Hong Chang Tan Molly Tzu Yu Lin Isabelle Xin Yu Lee Jodhbir S.Mehta Yu-Chi Liu Yong Loo Lin School of Medicine National University of SingaporeSingaporeSingapore Singapore Eye Research Institute SingaporeSingapore Department of Endocrinology Singapore General HospitalSingaporeSingapore Department of Cornea and External Eye Disease Singapore National Eye CentreSingaporeSingapore Ophthalmology and Visual Sciences Academic Clinical Program Duke-NUS Medical SchoolSingaporeSingapore

diabetic neuropathy is a prevalent microvascular complication of diabetes mellitus,affecting nerves in all parts of the body including corneal nerves and peripheral nervous system,leading to diabetic corneal neuropathy and Diabetic peripheral neuropathy,respectively.Diabetic peripheral neuropathy is diagnosed in clinical practice using electrophysiological nerve conduction studies,clinical scoring,and skin biopsies.However,these diagnostic methods have limited sensitivity in detecting small-fiber disease,hence they do not accurately reflect the status of diabetic neuropathy.More recently,analysis of alterations in the corneal nerves has emerged as a promising surrogate marker for Diabetic peripheral neuropathy.In this review,we will discuss the relationship between diabetic corneal neuropathy and Diabetic peripheral neuropathy,elaborating on the foundational aspects of each:pathogenesis,clinical presentation,evaluation,and management.We will further discuss the relevance of diabetic corneal neuropathy in detecting the presence of Diabetic peripheral neuropathy,particularly early Diabetic peripheral neuropathy;the correlation between the severity of diabetic corneal neuropathy and that of Diabetic peripheral neuropathy;and the role of diabetic corneal neuropathy in the stratification of complications of Diabetic peripheral neuropathy.

关键词： corneal nerve quantification corneal nerves diabetic cornea diabetic corneal neuropathy diabetic microvascular complications Diabetic peripheral neuropathy in vivo confocal microscopy neurotrophic keratopathy ocular surface

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The circ_0002538/miR-138-5p/plasmolipin axis regulates Schwann cell migration and myelination in Diabetic peripheral neuropathy

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Neural Regeneration Research 2023年第7期18卷 1591-1600页

作者： Yu-Tian Liu Zhao Xu Wei Liu Sen Ren He-Wei Xiong Tao Jiang Jing Chen Yu Kang Qian-Yun Li Zi-Han Wu Hans-GüNther Machens Xiao-Fan Yang Zhen-Bing Chen Department of Hand Surgery Union HospitalTongji Medical CollegeHuazhong University of Science and TechnologyWuhanHubei ProvinceChina Department of Geriatrics Renmin Hospital of Wuhan UniversityWuhanHubei ProvinceChina Department of Plastic and Hand Surgery Technical University of MunichMunichGermany

Circular RNAs(circRNAs)play a vital role in Diabetic peripheral neuropathy.However,their expression and function in Schwann cells in individuals with Diabetic peripheral neuropathy remain poorly understood.Here,we performed protein profiling and circRNA sequencing of sural nerves in patients with Diabetic peripheral neuropathy and controls.Protein profiling revealed 265 differentially expressed proteins in the Diabetic peripheral neuropathy group.Gene Ontology indicated that differentially expressed proteins were mainly enriched in myelination and mitochondrial oxidative phosphorylation.A real-time polymerase chain reaction assay performed to validate the circRNA sequencing results yielded 11 differentially expressed circRNAs.circ_0002538 was markedly downregulated in patients with Diabetic peripheral neuropathy.Further in vitro experiments showed that overexpression of circ_0002538 promoted the migration of Schwann cells by upregulating plasmolipin(PLLP)expression.Moreover,overexpression of circ_0002538 in the sciatic nerve in a streptozotocin-induced mouse model of Diabetic peripheral neuropathy alleviated demyelination and improved sciatic nerve function.The results of a mechanistic experiment showed that circ_0002538 promotes PLLP expression by sponging miR-138-5p,while a lack of circ_0002538 led to a PLLP deficiency that further suppressed Schwann cell migration.These findings suggest that the circ_0002538/miR-138-5p/PLLP axis can promote the migration of Schwann cells in Diabetic peripheral neuropathy patients,improving myelin sheath structure and nerve function.Thus,this axis is a potential target for therapeutic treatment of Diabetic peripheral neuropathy.

关键词： circ_0002538 circRNA sequencing competing endogenous RNAs demyelination Diabetic peripheral neuropathy miR-138-5 myelination plasmolipin protein profiling Schwann cells

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Non-pharmacological interventions for Diabetic peripheral neuropathy:Are we winning the battle?

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World Journal of Diabetes 2024年第4期15卷 579-585页

作者： Dania Blaibel Cornelius James Fernandez Joseph M Pappachan Department of Endocrinology and Metabolism Lancashire Teaching Hospitals NHS TrustPreston PR29HTUnited Kingdom Department of Endocrinology&Metabolism Pilgrim HospitalUnited Lincolnshire Hospitals NHS TrustBoston PE219QSUnited Kingdom Faculty of Science Manchester Metropolitan UniversityManchester M156BHUnited Kingdom Faculty of Biology Medicine&HealthThe University of ManchesterManchester M139PLUnited Kingdom

Despite the advent of relatively reliable modalities of diagnosing Diabetic peripheral neuropathy(DPN),such as nerve conduction studies,there is still a knowledge gap about the pathophysiology,and thus limited available in-terventions for symptom control and curtailing disease progression.The pharma-cologic aspect of management is mainly centred on pain control,however,there are several important aspects of DPN such as loss of vibration sense,pressure sense,and proprioception which are associated with risks to lower limb health,which pharmacotherapy does not address.Furthermore,published evidence suggests non-pharmacologic interventions such as glycaemic control through dietary modification and exercise need to be combined with other measures such as psychotherapy,to reach a desired,however modest effect.Acupuncture is emerging as an important treatment modality for several chronic medical conditions including neuropathic and other pain syndromes.In their study published in the World Journal of Diabetes on the potential of acupuncture to reduce DPN symptoms and enhance nerve conduction parameters,Hoerder et al have been able to demonstrate that acupuncture improves sensory function and that this effect is likely sustained two months after treatment cessation.Although previous studies also support these findings,larger multi-center randomized control trials including a sham-controlled arm accounting for a placebo effect are required.Overall,given the satisfactory safety profile and the positive results found in these studies,it is likely that acupuncture may become an important aspect of the repertoire of effective DPN management.

关键词： Diabetic peripheral neuropathy Diabetes mellitus Pharmacotherapy Acupuncture Neuropathic pain Nonpharmacological intervention

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Efficacy and safety of Buyang Huanwu decoction(补阳还五汤)for Diabetic peripheral neuropathy:a systematic review and Meta-analysis

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中医杂志:英文版 2023年第5期43卷 841-850页

作者： ZHANG Meizhen HAO Xiaohui TANG Yiting CHEN Yupeng HE Puyu ZHAO Liming PANG Bing NI Qing Department of Endocrinology Guang’anmen Hospital of China Academy of Chinese Medical SciencesBeijing 100053China Graduate School of Beijing University of Chinese Medicine Beijing 100029China

OBJECTIVE:To evaluate the efficacy and safety of Buyang Huanwu decoction(BYHWD)in treating Diabetic peripheral neuropathy(DPN).METHODS:Eight electronic databases,including China National Knowledge Infrastructure Database,Wanfang Database,China Science and Technology Journal Database,Chinese Biomedical Literature Database,Cochrane Library,Embase,Web of Science,and PubM ed,were searched for randomized controlled trials(RCTs)of BYHWD to treat DPN.We identified all RCTs related to BYHWD and those on the treatment of DPN with the combination of mecobalamin.RevMan software was used for the statistical analysis.RESULTS:Twenty-one RCTs with a total of 1945 patients were included.The methodological quality of the literature included was low.Meta-analysis showed that the efficacy of the treatment group was significantly better than that of the control group in the treatment of DPN with BYHWD[risk ratio(RR)=0.33,95%CI(0.27,0.40),Z=11.25,P<0.00001].The median nerve of median motor nerve conduction velocity(MNCV)[mean difference(MD)=4.16,95%CI(1.35,6.98)]and median sensory NCV(SNCV)[(MD=3.28,95%CI(2.35,4.22)]were improved in the treatment group.The MNCV in the common peroneal nerve[(MD=1.63,95%CI(0.39,2.87)]and SNCV[(MD=4.56,95%CI(3.16,5.97)]were significantly higher than those in the control group(P<0.01).Plasma viscosity[(MD=-0.15,95%CI(-0.20,-0.09),Z=5.17,P<0.01)],whole blood high shear[(MD=-0.83,95%CI(-1.56,-0.11),Z=2.26,P=0.02)]and whole blood low shear[(MD=-1.61,95%CI(-2.28,-0.94),Z=4.68,P<0.01)]decreased significantly after treatment.There was no significant difference in fasting blood glucose[(MD=-0.42,95%CI(-0.89,0.05),Z=1.76,P=0.08)]between the treatment and control groups;postprandial blood glucose[(MD=-0.62,95%CI(-1.19,0.05),Z=2.12,P=0.03)]decreased significantly.No significant difference was found in the blood lipid levels between the treatment and control groups,including triglycerides[(MD=-0.21,95%CI(-0.52,0.10),Z=1.34,P=0.18)]and cholesterol[(MD=-0.13,95%CI(-0.27,0.00),Z=1.92,P=0.06)].Of the 21 RCTs,only five

关键词： Diabetic peripheral neuropathy safety treatment outcome nerve conduction studies hemorheology randomized controlled trial Meta-analysis Buyang Huanwu decoction

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Long-term efficacy and safety of Huangqi(Radix Astragali Mongolici)-based Traditional Chinese Medicine in Diabetic peripheral neuropathy:a Meta-analysis of randomized controlled trials

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Journal of Traditional Chinese Medicine 2024年第2期44卷 229-242页

作者： PING Jing HAO Hongzheng WU Zhenqi ZOU Meijuan LI Zuojing CHENG Gang School of Life Sciences and Biopharmaceutics Shenyang Pharmaceutical UniversityShenyang 110000China Department of Endocrinology Affiliated Hospital of Liaoning University of Traditional Chinese MedicineShenyang 110000China Department of Research Administration Affiliated Hospital of Liaoning University of Traditional Chinese MedicineShenyang 110000China School of Pharmacy Shenyang Pharmaceutical UniversityShenyang 110000China

OBJECTIVE:To assess the long-term effectiveness of Huangqi(Radix Astragali Mongolici,HQ)-based Traditional Chinese Medicine(TCM)in the treatment of Diabetic peripheral neuropathy(DPN).METHODS:Nine databases were searched to retrieve available randomized controlled trials that compared HQbased TCM and Western Medicines in the treatment of DPN.The methodological quality of the included studies was assessed using the Cochrane bias risk tool,and RevMan 5.4 was used for data analysis.The effect estimates of interest were risk ratio(RR),mean difference(MD)or standardized mean difference(SMD)with 95%confidence interval(CI).RESULTS:The results from 48 available studies assessing 3759 patients demonstrated that cases administered HQ-based TCM[RR=1.30,95%CI(1.21,1.40),P<0.00001]or HQ-based TCM combined with Western Medicines[RR=1.25,95%CI(1.19,1.31),P<0.00001]exhibited higher total efficacy rates than individuals who received Western Medicine alone.The results showed that the HQ-based TCM group had decreased Toronto Clinical Scoring System scores[MD=-1.50,95%CI(-1.83,-1.17),P<0.00001],and reduced serum interleukin 6[SMD=-0.57,95%CI(-0.87,-0.27),P=0.0002]and tumor necrosis factors-αlevels[SMD=-0.60,95%CI(-0.95,-0.25),P=0.0009].In addition,both HQ-based TCM and HQbased TCM combined with Western Medicine increased nerve conduction velocity and decreased glycaemia compared with Western Medicine alone.In terms of blood lipids,oxidative stress and adverse drug reactions,there were no significant differences between the HQ-based TCM groups and the Western Medicine control group.CONCLUSION:The current Meta-analysis revealed that HQ-based TCM yields higher efficacy and safety than Western Medicine alone for the treatment of DPN,although further well-designed RCTs are required to validate these findings.

关键词： Huangqi(Radix Astragali Mongolici) medicine Chinese traditional Diabetic peripheral neuropathy Meta-analysis

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Transplantation of engineered exosomes derived from bone marrow mesenchymal stromal cells ameliorate Diabetic peripheral neuropathy under electrical stimulation

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Bioactive Materials 2021年第8期6卷 2231-2249页

作者： Anamika Singh Alok Raghav Parvaiz Ahmad Shiekh Ashok Kumar Biomaterial and Tissue Engineering Group Department of Biological Sciences and BioengineeringIndian Institute of Technology KanpurKanpur208016UPIndia Centre for Nanosciences Indian Institute of Technology KanpurKanpur208016UPIndia Centre for Environmental Sciences and Engineering Indian Institute of Technology KanpurKanpur208016UPIndia

Diabetic peripheral neuropathy(DPN)is a long-term complication associated with nerve dysfunction and uncontrolled hyperglycemia.In spite of new drug discoveries,development of effective therapy is much needed to cure DPN.Here,we have developed a combinatorial approach to provide biochemical and electrical cues,considered to be important for nerve regeneration.Exosomes derived from bone marrow mesenchymal stromal cells(BMSCs)were fused with polypyrrole nanoparticles(PpyNps)containing liposomes to deliver both the cues in a single delivery vehicle.We developed DPN rat model and injected intramuscularly the fused exosomal system to understand its long-term therapeutic effect.We found that the fused system along with electrical stimulation normalized the nerve conduction velocity(57.60±0.45 m/s)and compound muscle action potential(16.96±0.73 mV)similar to healthy control(58.53±1.10 m/s;18.19±1.45 mV).Gastrocnemius muscle morphology,muscle mass,and integrity were recovered after treatment.Interestingly,we also observed paracrine effect of delivered exosomes in controlling hyperglycemia and loss in body weight and also showed attenuation of damage to the tissues such as the pancreas,kidney,and liver.This work provides a promising effective treatment and also contribute cutting edge therapeutic approach for the treatment of DPN.

关键词： Exosomes Bone marrow mesenchymal stromal cells Polypyrrole Diabetes mellitus Diabetic peripheral neuropathy

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Strategies and Research Progress of Chinese Medicine in Prevention and Treatment of Diabetic peripheral neuropathy

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Chinese Journal of Integrative Medicine 2018年第10期24卷 794-800页

作者： YANG Dan LIANG Xiao-chun Department of Traditional Chinese Medicine Peking Union Medical College Hospital Peking Union Medical CollegeTranslational Medicine Center Chinese Academy of Medical Sciences

Diabetic peripheral neuropathy （DPN） seriously affects the quality of life in patients with type 2 diabetes mellitus. This paper reviews the role of Chinese medicine in the main treatment goal of DPN, including protecting pancreatic β-cells, in the use of antioxidation therapy to delay disease progression, and in the endpoint of neural repair and regeneration. We propose that protecting the body from injury caused by high glucose and oxidative stress, and promoting repair and regeneration of nerves should be the research direction for the prevention and treatment of DPN.

关键词： Diabetic peripheral neuropathy pancreatic β-cell anti-oxidative stress neural repair and regeneration Chinese medicine

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Cell metabolism pathways involved in the pathophysiological changes of Diabetic peripheral neuropathy

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Neural Regeneration Research 2024年第3期19卷 598-605页

作者： Yaowei Lv Xiangyun Yao Xiao Li Yuanming Ouyang Cunyi Fan Yun Qian Department of Orthopedics Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of MedicineShanghaiChina Shanghai Engineering Research Center for Orthopaedic Material Innovation and Tissue Regeneration ShanghaiChina Youth Science and Technology Innovation Studio of Shanghai Jiao Tong University School of Medicine ShanghaiChina College of Fisheries and Life Science Shanghai Ocean UniversityShanghaiChina

Diabetic peripheral neuropathy is a common complication of diabetes mellitus.Elucidating the pathophysiological metabolic mechanism impels the generation of ideal therapies.However,existing limited treatments for Diabetic peripheral neuropathy expose the urgent need for cell metabolism research.Given the lack of comprehensive understanding of energy metabolism changes and related signaling pathways in Diabetic peripheral neuropathy,it is essential to explore energy changes and metabolic changes in Diabetic peripheral neuropathy to develop suitable treatment methods.This review summarizes the pathophysiological mechanism of Diabetic peripheral neuropathy from the perspective of cellular metabolism and the specific interventions for different metabolic pathways to develop effective treatment methods.Various metabolic mechanisms(e.g.,polyol,hexosamine,protein kinase C pathway)are associated with Diabetic peripheral neuropathy,and researchers are looking for more effective treatments through these pathways.

关键词： cell metabolism Diabetic peripheral neuropathy peripheral nerve injury protein kinase C pathway reactive oxygen species.

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Jinmaitong(筋脉通)Alleviates the Diabetic peripheral neuropathy by Inducing Autophagy

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Chinese Journal of Integrative Medicine 2016年第3期22卷 185-192页

作者：屈岭张宏顾蓓戴威吴群励孙连庆赵丽石玥梁晓春 Department of Traditional Chinese Medicine Peking Union Medical College HospitalPeking Union Medical CollegeChinese Academy of Medical Sciences Cell Center Institute of Basic Medical SciencePeking Union Medical CollegeChinese Academy of Medical Sciences Department of Electron Microscope Institute of Basic Medical SciencePeking Union Medical CollegeChinese Academy of Medical Sciences

Objective： To observe the deregulation of autophagy in Diabetic peripheral neuropathy （DPN） and investigate whether Jinmaitong （筋脉通, JMT） alleviates DPN by inducing autophagy. Methods： DPN models were established by streptozotocin-induced diabetic rats and Schwann cells （SCs） cultured in high glucose medium. The pathological morphology was observed by the improved Bielschowsky＇s nerve fiber axonal staining and the Luxol fast blue-neutral red myelin staining. The ultrastructure was observed by the transmission electron microscopy. Beclinl level was detected by immunohistochemistry and Western blot. The proliferation of cultured SCs was detected by methylthiazolyldiphenyl-tetrazolium bromide. Results： diabetic peripheral nerve tissues demonstrated pathological morphology and reduced autophagic structure, accompanied with down-regulation of Beclinl. JMT apparently alleviated the pathological morphology change and increased the autophagy [in vivo, Beclinl integral optical density （IOD） value of the control group 86.6 ± 17.7, DM 43.9± 8.8, JMT 73.3 ± 17.8, P〈0.01 or P〈0.05, in vitro Beclinl IOD value of the glucose group 0.47 ± 0.25 vs the control group 0.88 ± 0.29, P〈0.05]. Consequently, inhibition of autophagy by 3-methyladenine resulted in a time- and concentration- dependent decrease of the proliferation of SCs （P〈0.05, P〈0.01）. Conclusions： Down-regulation of autophagy in SCs might contribute to the pathogenesis of DPN. JMT alleviates diabetic peripheral nerve injury at least in part by inducing autophagy.

关键词： Diabetic peripheral neuropathy Schwann cells autophagy Beclinl Jinmaitong Chinese medicine

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