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Medicine Dec 2021Diabetic peripheral neuropathy (DPN) is one of the most common complications of diabetes mellitus. The main clinical manifestations of DPN include pain, numbness,... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Diabetic peripheral neuropathy (DPN) is one of the most common complications of diabetes mellitus. The main clinical manifestations of DPN include pain, numbness, paraesthesia, and weakness of the lower limbs which often leads to diabetic foot ulceration, eventually resulting in amputation. Based on Traditional Chinese Medicine theory, moxibustion has a great effect on treating and preventing DPN. However, randomized clinical trials done to evaluate the efficacy of this treatment are still lacking. Hence, this study is carried out to evaluate the effectiveness and safety of moxibustion therapy on diabetic peripheral neuropathy.
METHODS
This study will be a pilot, interventional, randomized, 2-armed, parallel, singled-masked, controlled trial. A total of 40 diabetes mellitus patients with peripheral neuropathy will be recruited and assigned randomly into 2 groups (moxibustion group and waiting group) at a 1:1 ratio. This trial consists of an 8-week intervention period and a 4-week follow-up period. During the intervention period, the moxibustion group will take 3 moxibustion sessions per week, whereas no intervention will be done on the waiting group to act as the control group. The outcome will be assessed by an outcome assessor who is unaware of the group assignment. The primary outcome will be pain assessment measured with algometry, Leeds Assessment of Neuropathic Symptoms and Signs pain scale, visual analogue scale, and neuropathy pain scale. The secondary outcome will be an evaluation of functional performance capacity with 6 minutes walking test, evaluation of the Foot and Ankle Ability Measure, and serum HbA1c and albumin levels.
DISCUSSION
We hope that this trial will provide valuable insights on the efficacy of moxibustion in the management of diabetic peripheral neuropathy.
TRIAL REGISTRATION
ClinicalTrials.gov Registry No.: NCT04894461 (URL: https://clinicaltrials.gov/ct2/show/NCT04894461?term=NCT04894461&draw=2&rank=1) Registered on May 20, 2021.
Topics: Acupuncture Therapy; Diabetes Mellitus, Type 2; Diabetic Foot; Diabetic Neuropathies; Humans; Moxibustion; Outcome Assessment, Health Care; Pain; Pain Measurement; Treatment Outcome
PubMed: 34889293
DOI: 10.1097/MD.0000000000028173 -
Cirugia Y Cirujanos 2021Diabetic neuropathy (DN) is one of the most common complications of type 2 diabetes (T2D) and is a leading cause of lower limb amputation. The aim of the present study...
INTRODUCTION
Diabetic neuropathy (DN) is one of the most common complications of type 2 diabetes (T2D) and is a leading cause of lower limb amputation. The aim of the present study was to evaluate the risk factors contributing to DN in Mexican patients through the comparison of T2D patients with and without DN.
MATERIALS AND METHODS
This cross-sectional study consisted of 509 subjects from Mexico who were classified as with DN and without DN. DN was assessed according to Douleur Neuropathique 4 questionnaire. Logistic regression analysis was performed to analyze risk factors contributing to DN.
RESULTS
The prevalence of DN in the studied population was 28.3%. The risk factors associated with DN were T2D duration (odds ratio [OR]: 2.51; 95% confidence interval [CI] 1.36-4.65), glycemic exposure index (OR: 1.82; 95% CI 1.01-3.64), low- and high-density lipoprotein levels (OR: 1.53; 95% CI 1.02-2.31), metformin treatment (OR: 2.08; 95% CI 1.11-3.91), diabetic retinopathy (OR: 1.65; 95% CI 1.07-2.54), and smoking (OR: 1.51; 95% CI 1.00-2.26).
CONCLUSIONS
Therefore, the early identification of risk factors for DN development in Mexican population would allow implementing personalized strategies to improve the overall T2D patients' quality of life and reduce healthcare costs in our country.
Topics: Cross-Sectional Studies; Diabetes Mellitus, Type 2; Diabetic Neuropathies; Humans; Mexico; Quality of Life; Risk Factors
PubMed: 33784285
DOI: 10.24875/CIRU.20000243 -
Experimental and Clinical Endocrinology... Feb 2023
Topics: Humans; Diabetic Neuropathies; Diabetes Mellitus
PubMed: 36720239
DOI: 10.1055/a-1946-3813 -
JAMA Neurology Jun 2021Many patients with diabetic peripheral neuropathy experience chronic pain and inadequate relief despite best available medical treatments. (Randomized Controlled Trial)
Randomized Controlled Trial
IMPORTANCE
Many patients with diabetic peripheral neuropathy experience chronic pain and inadequate relief despite best available medical treatments.
OBJECTIVE
To determine whether 10-kHz spinal cord stimulation (SCS) improves outcomes for patients with refractory painful diabetic neuropathy (PDN).
DESIGN, SETTING, AND PARTICIPANTS
The prospective, multicenter, open-label SENZA-PDN randomized clinical trial compared conventional medical management (CMM) with 10-kHz SCS plus CMM. Participants with PDN for 1 year or more refractory to gabapentinoids and at least 1 other analgesic class, lower limb pain intensity of 5 cm or more on a 10-cm visual analogue scale (VAS), body mass index (calculated as weight in kilograms divided by height in meters squared) of 45 or less, hemoglobin A1c (HbA1c) of 10% or less, daily morphine equivalents of 120 mg or less, and medically appropriate for the procedure were recruited from clinic patient populations and digital advertising. Participants were enrolled from multiple sites across the US, including academic centers and community pain clinics, between August 2017 and August 2019 with 6-month follow-up and optional crossover at 6 months. Screening 430 patients resulted in 214 who were excluded or declined participation and 216 who were randomized. At 6-month follow-up, 187 patients were evaluated.
INTERVENTIONS
Implanted medical device delivering 10-kHz SCS.
MAIN OUTCOMES AND MEASURES
The prespecified primary end point was percentage of participants with 50% pain relief or more on VAS without worsening of baseline neurological deficits at 3 months. Secondary end points were tested hierarchically, as prespecified in the analysis plan. Measures included pain VAS, neurological examination, health-related quality of life (EuroQol Five-Dimension questionnaire), and HbA1c over 6 months.
RESULTS
Of 216 randomized patients, 136 (63.0%) were male, and the mean (SD) age was 60.8 (10.7) years. Additionally, the median (interquartile range) duration of diabetes and peripheral neuropathy were 10.9 (6.3-16.4) years and 5.6 (3.0-10.1) years, respectively. The primary end point assessed in the intention-to-treat population was met by 5 of 94 patients in the CMM group (5%) and 75 of 95 patients in the 10-kHz SCS plus CMM group (79%; difference, 73.6%; 95% CI, 64.2-83.0; P < .001). Infections requiring device explant occurred in 2 patients in the 10-kHz SCS plus CMM group (2%). For the CMM group, the mean pain VAS score was 7.0 cm (95% CI, 6.7-7.3) at baseline and 6.9 cm (95% CI, 6.5-7.3) at 6 months. For the 10-kHz SCS plus CMM group, the mean pain VAS score was 7.6 cm (95% CI, 7.3-7.9) at baseline and 1.7 cm (95% CI, 1.3-2.1) at 6 months. Investigators observed neurological examination improvements for 3 of 92 patients in the CMM group (3%) and 52 of 84 in the 10-kHz SCS plus CMM group (62%) at 6 months (difference, 58.6%; 95% CI, 47.6-69.6; P < .001).
CONCLUSIONS AND RELEVANCE
Substantial pain relief and improved health-related quality of life sustained over 6 months demonstrates 10-kHz SCS can safely and effectively treat patients with refractory PDN.
TRIAL REGISTRATION
ClincalTrials.gov Identifier: NCT03228420.
Topics: Aged; Diabetic Neuropathies; Female; Follow-Up Studies; Humans; Male; Middle Aged; Pain Management; Pain Measurement; Prospective Studies; Spinal Cord Stimulation; Treatment Outcome
PubMed: 33818600
DOI: 10.1001/jamaneurol.2021.0538 -
Nutrients Oct 2020To investigate the efficacy of Superoxide Dismutase, Alpha Lipoic Acid, Acetyl L-Carnitine, and Vitamin B12 (B12) in one tablet in Diabetic Neuropathy (DN). (Randomized Controlled Trial)
Randomized Controlled Trial
AIM
To investigate the efficacy of Superoxide Dismutase, Alpha Lipoic Acid, Acetyl L-Carnitine, and Vitamin B12 (B12) in one tablet in Diabetic Neuropathy (DN).
PATIENTS-METHODS
In this prospective, double-blind, placebo-controlled study, 85 patients with Diabetes Mellitus Type 2 (DMT2) were randomly assigned, either to receive the combination of four elements (active group, = 43), or placebo ( = 42) for 12 months. We used the Michigan Neuropathy Screening Instrument Questionnaire and Examination (MNSIQ and MNSIE), measured the vibration perception threshold (BIO), and Cardiovascular Autonomic Reflex Tests (CARTs). Nerve function was assessed by DPN Check [sural nerve conduction velocity (SNCV) and amplitude (SNAP)]. Pain (PS) and quality of life (QL) questionnaires were administered.
RESULTS
At follow-up, BIO, MNSIQ, QL, PAIN, and SNCV, SNAP, and B12 levels had significantly improved inactive group ( <0.001, <0.001, <0.001, <0.001, = 0.027, = 0.031, and <0.001 respectively), whereas the inplacebo group MCR (mean circular resultant) and PAIN deteriorated ( <0.001, <0.001). The changes in MNSIQ, QL, SNCV, BIO, and PAIN differed significantly between groups ( <0.001, <0.001, = 0.031, <0.001, and <0.001 respectively).
CONCLUSIONS
The combination of the four elements in one tablet for 12 months in patients with DMT2 improved all indices of peripheral neuropathy, including SNAP and SNCV, pain, and Quality of Life perception, except CARTs and MNSIE.
Topics: Aged; Carnitine; Diabetes Mellitus, Type 2; Diabetic Neuropathies; Double-Blind Method; Drug Combinations; Female; Humans; Male; Middle Aged; Neural Conduction; Pain Measurement; Prospective Studies; Quality of Life; Reflex; Superoxide Dismutase; Thioctic Acid; Treatment Outcome; Vitamin B 12
PubMed: 33114210
DOI: 10.3390/nu12113254 -
BMC Endocrine Disorders Feb 2021Advanced glycation end-products (AGEs) are heterogeneous molecules produced by the non-enzymatic glycation of proteins, lipids, or nucleic acids during hyperglycaemia.... (Review)
Review
Advanced glycation end-products (AGEs) are heterogeneous molecules produced by the non-enzymatic glycation of proteins, lipids, or nucleic acids during hyperglycaemia. Accumulation of AGEs in the peripheral nerves has recently been proposed as an additional risk factor for the development of diabetic neuropathy (DN). The gold standard for measurement of tissue-bound AGEs is tissue biopsy. However, their assessment with the newer, fast and simple method of skin autofluorescence (sAF) has recently gained special interest by virtue of its non-invasive, highly reproducible nature and its acceptable correlation with the reference method of skin biopsy. Accumulation of tissue AGEs evaluated by sAF has been shown to independently correlate with DN. Importantly, increasing evidence underscores their potential value as early biomarkers of the latter. Further important associations include diabetic nephropathy, diabetic retinopathy and cardiovascular autonomic neuropathy. However, the value of the implementation of screening with skin AGEs for DN remains unclear. The aim of the present review is to critically summarise current evidence on the association between skin AGEs and diabetic microvascular complications, with a particular emphasis on diabetic neuropathy, and to note the most important limitations of existing knowledge. Longer follow-up studies are also highly anticipated to clarify its role and provide data on patient selection and cost-effectiveness.
Topics: Diabetic Angiopathies; Diabetic Neuropathies; Glycation End Products, Advanced; Humans; Optical Imaging; Skin
PubMed: 33622304
DOI: 10.1186/s12902-021-00697-7 -
PloS One 2019Therapeutic footwear becomes the first treatment line in the prevention of diabetic foot ulcer and future complications of diabetes. Previous studies and the... (Randomized Controlled Trial)
Randomized Controlled Trial
Clinical efficacy of therapeutic footwear with a rigid rocker sole in the prevention of recurrence in patients with diabetes mellitus and diabetic polineuropathy: A randomized clinical trial.
BACKGROUND
Therapeutic footwear becomes the first treatment line in the prevention of diabetic foot ulcer and future complications of diabetes. Previous studies and the International Working Group on the Diabetic Foot have described therapeutic footwear as a protective factor to reduce the risk of re-ulceration. In this study, we aimed to analyze the efficacy of a rigid rocker sole to reduce the recurrence rate of plantar ulcers in patients with diabetic foot.
METHODS
Between June 2016 and December 2017, we conducted a randomized controlled trial in a specialized diabetic foot unit.
PARTICIPANTS AND INTERVENTION
Fifty-one patients with diabetic neuropathy who had a recently healed plantar ulcer were randomized consecutively into the following two groups: therapeutic footwear with semi-rigid sole (control) or therapeutic footwear with a rigid rocker sole (experimental). All patients included in the study were followed up for 6 months (one visit each 30 ± 2 days) or until the development of a recurrence event.
MAIN OUTCOME AND MEASURE
Primary outcome measure was recurrence of ulcers in the plantar aspect of the foot.
FINDINGS
A total of 51 patients were randomized to the control and experimental groups. The median follow-up time was 26 [IQR-4.4-26.1] weeks for both groups. On an intention-to-treat basis, 16 (64%) and 6 (23%) patients in the control and experimental groups had ulcer recurrence, respectively. Among the group with >60% adherence to therapeutic footwear, multivariate analysis showed that the rigid rocker sole improved ulcer recurrence-free survival time in diabetes patients with polyneuropathy and DFU history (P = 0.019; 95% confidence interval, 0.086-0.807; hazard ratio, 0.263).
CONCLUSIONS
We recommend the use of therapeutic footwear with a rigid rocker sole in patients with diabetes with polyneuropathy and history of diabetic foot ulcer to reduce the risk of plantar ulcer recurrence.
TRIAL REGISTRATION
ClinicalTrials.gov NCT02995863.
Topics: Adolescent; Adult; Aged; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetic Foot; Diabetic Neuropathies; Female; Foot; Foot Ulcer; Humans; Male; Middle Aged; Recurrence; Shoes; Treatment Outcome
PubMed: 31295292
DOI: 10.1371/journal.pone.0219537 -
Diabetes Research and Clinical Practice Dec 2023Diabetic peripheral neuropathy (DPN) is found in around one third of people with diabetes, but remains inadequately diagnosed and treated. Its management includes three... (Review)
Review
Diabetic peripheral neuropathy (DPN) is found in around one third of people with diabetes, but remains inadequately diagnosed and treated. Its management includes three cornerstones: 1) causal treatment with lifestyle modification, intensive diabetes therapy aimed at near-normoglycemia, and multifactorial cardiovascular risk intervention, 2) pathogenesis-oriented pharmacotherapy, and 3) symptomatic pain relief. Since symptomatic analgesic monotherapy only relieves the pain without targeting the underlying neuropathy and both has limited efficacy and is associated with adverse events, there is an unmet need for additional approaches derived from the pathogenetic concepts of DPN. Preclinical studies have suggested that diabetic neuropathy can be prevented or improved through the use of various agents that interfere with the pathophysiology of the underlying condition. Some of these encouraging findings could be translated successfully into the clinical setting. Efficacy and excellent safety were demonstrated in several meta-analyses (α-lipoic acid) and randomized clinical trials (benfotiamine, actovegin, epalrestat) in the treatment of symptomatic DPN. The NATHAN 1 trial demonstrated an improvement of neuropathic signs (deficits, impairments) after four years in asymptomatic DPN. These compounds are currently authorized for treatment of DPN in several countries. Long-term pivotal clinical trials should further establish their value as mono- and combination therapies in DPN.
Topics: Humans; Combined Modality Therapy; Diabetes Mellitus; Diabetic Neuropathies; Pain; Thioctic Acid
PubMed: 38245327
DOI: 10.1016/j.diabres.2023.110764 -
Diabetes Research and Clinical Practice Dec 2023The diabetic neuropathies represent the commonest long-term complications of diabetes, and may be the presenting feature of Type 2 diabetes. In clinical practice, distal... (Review)
Review
The diabetic neuropathies represent the commonest long-term complications of diabetes, and may be the presenting feature of Type 2 diabetes. In clinical practice, distal symmetrical polyneuropathy (DSPN) and the autonomic neuropathies are the most frequently seen forms of diabetic neuropathy. The 2017 American Diabetes Association classification system for the neuropathies of diabetes are in general use. Treatment challenges remain and the need for revised recommendations and further discussion of management of severely painful DSPN that does not fully respond to conventional medical management is clear, especially in light of the recent opioid crisis in the USA.
Topics: Humans; Autonomic Nervous System; Diabetes Mellitus, Type 2; Diabetic Neuropathies; Pain; Polyneuropathies
PubMed: 38245328
DOI: 10.1016/j.diabres.2023.110758 -
Diabetes & Metabolism Journal Jul 2021Diabetic peripheral neuropathy (DPN) is one of the most serious complications of type 2 diabetes mellitus (T2DM). DPN increases the risk of ulcers, foot infections, and...
BACKGROUND
Diabetic peripheral neuropathy (DPN) is one of the most serious complications of type 2 diabetes mellitus (T2DM). DPN increases the risk of ulcers, foot infections, and noninvasive amputations, ultimately leading to long-term disability.
METHODS
Seven hundred patients with T2DM were investigated from 2013 to 2017 in the Sanlin community by obtaining basic data from the electronic medical record system (EMRS). From September 2018 to July 2019, 681 patients (19 missing) were investigated using a questionnaire, physical examination, biochemical index test, and follow-up Toronto clinical scoring system (TCSS) test. Patients with a TCSS score ≥6 points were diagnosed with DPN. After removing missing values, 612 patients were divided into groups in a 3:1 ratio for external validation. Using different Lasso analyses (misclassification error, mean squared error, -2log-likelihood, and area under curve) and a logistic regression analysis of the training set, models A, B, C, and D were established. The receiver operating characteristic (ROC) curve, calibration plot, dynamic component analysis (DCA) measurements, net classification improvement (NRI) and integrated discrimination improvement (IDI) were used to validate discrimination and clinical practicality of the model.
RESULTS
Through data analysis, model A (containing four factors), model B (containing five factors), model C (containing seven factors), and model D (containing seven factors) were built. After calibration, ROC curve, DCA, NRI and IDI, models C and D exhibited better accuracy and greater predictive power.
CONCLUSION
Four prediction models were established to assist with the early screening of DPN in patients with T2DM. The influencing factors in model C and D are more important factors for patients with T2DM diagnosed with DPN.
Topics: Diabetes Mellitus, Type 2; Diabetic Neuropathies; Humans; ROC Curve; Risk Factors
PubMed: 34352988
DOI: 10.4093/dmj.2020.0100