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1.
The prevalence of painful diabetic neuropathy in 300 Moroccan diabetics.
Chahbi, Z, Lahmar, B, Hadri, SE, Abainou, L, Kaddouri, S, Qacif, H, Baizri, H, Zyani, M
The Pan African medical journal. 2018;:158
Abstract
Painful diabetic neuropathy is a frequent complication of diabetes. Its diagnosis is clinical. Our goal is to determine the prevalence of painful diabetic neuropathy in this population. We also analyzed the relationship between this neuropathy and certain parameters, concerning the patient and his diabetes. It is a cross sectional study conducted at the department of endocrinology and internal medicine of Avicenne hospital Marrakech-Morocco, among a cohort of 300 diabetic outpatients. We used the DN4 questionnaire (Douleur Neuropathique en 4 questions), for diagnosis. The results showed a prevalence of 15%. In this study: advanced age, female gender, duration of diabetes greater than 10 years, and the lack of medical follow up were found to be statistically significant risk factors for painful diabetic neuropathy, in addition to some diabetes-related comorbidities such as hypertension, dyslipidemia, sedentary life style and diabetic retinopathy. Painful diabetic neuropathy remains undertreated, in fact 74% of our patients did not receive any specific treatment, knowing that the progress in developing effective and well-tolerated therapies has been disappointing.
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2.
Alpha lipoic acid combined with epalrestat: a therapeutic option for patients with diabetic peripheral neuropathy.
Wang, X, Lin, H, Xu, S, Jin, Y, Zhang, R
Drug design, development and therapy. 2018;:2827-2840
Abstract
BACKGROUND Alpha lipoic acid (ALA), a type of antioxidant, is used in combination with epalrestat in the treatment of diabetic peripheral neuropathy (DPN). However, whether combined treatment is superior to epalrestat monotherapy is controversial. METHODS We conducted a systematic search of PubMed, Cochrane Library and Chinese databases to identify all randomized controlled trials (RCTs) up to October 31, 2017. Data were extracted to evaluate methodological quality and analyzed using Review Manager 5.3.0 software. RESULTS Twelve studies were included. Compared to epalrestat monotherapy, ALA 600 mg/d once a day (qd) combined with epalrestat 50 mg three times a day (tid) augmented the total effectiveness rate (14 days - risk ratio [RR]: 1.40, 95% CI: 1.16-1.69, P=0.0005; 28 days - RR: 1.48, 95% CI: 1.27-1.72, P<0.00001); at the same, it could improve the median motor nerve conduction velocity (MNCV) and sensory nerve conduction velocity (SNCV), peroneal MNCV, and SNCV after 14, 21, and 28 days of treatment and could reduce the Toronto Clinical Scoring System (TCSS) (weighted mean difference [WMD]: -1.60, 95% CI: (-2.91, -0.29), P=0.02) and Total Symptom Score (TSS) (WMD: -0.93, 95% CI: -1.27, -0.60, P<0.00001) after 21 days of treatment. The treatment strategy of ALA 300 mg/d qd combined with epalrestat 50 mg tid had the same effects in regard to the total effectiveness rate (RR: 1.37, 95% CI: 1.18-1.59, P<0.0001), median MNCV (WMD: 6.12, 95% CI: 5.04, 7.20, P=0.00001), median SNCV (WMD: 6.70, 95% CI: 5.75, 7.65, P=0.00001), peroneal MNCV (WMD: 6.68, 95% CI: 5.82, 7.55, P=0.00001), and peroneal SNCV (WMD: 4.27, 95% CI: 3.34, 5.20, P=0.00001) after 28 days of treatment. CONCLUSION ALA combined with epalrestat is an effective option for DPN patients. Future large-sample RCTs should be conducted to further confirm this finding.
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3.
The clinical efficacy of epalrestat combined with α-lipoic acid in diabetic peripheral neuropathy: Protocol for a systematic review and meta-analysis.
Wang, X, Lin, H, Xu, S, Jin, Y, Zhang, R
Medicine. 2018;(6):e9828
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Abstract
BACKGROUND Diabetic peripheral neuropathy (DPN) is a common long-term complication of diabetes mellitus, affecting patients in the world. Epalrestat combined with α-lipoic acid (ALA) is the most frequent combine therapy used in the DPN researches. We aim to assess the effectiveness and safety of epalrestat combined with ALA in patients with DPN, compare with epalrestat alone. METHODS We will search Cochrane Library, PubMed, Wanfang Data, China National Knowledge Infrastructure, VIP Chinese Science and Technology Journals Database, and Chinese Biomedical Database from inception until October 31th, 2017. Inclusion the randomized controlled trials and clinical control trials of combine therapy which evaluate clinical efficacy and side effect in people with DPN. Data extraction and risk of bias assessments will be independently conducted by 2 reviewers. The primary outcome measures will be total effective rate, motor nerve conduction velocity (MNCV), sensory nerve conduction velocity (SNCV), Toronto clinical scoring system (TCSS), and total symptom score (TSS). All statistical analyses will be performed using RevMan V.5.3 software. RESULTS This review will evaluate the total effective rate, nerve conduction velocity, TCSS, TSS, and safety of ALA combined with epalrestat for patients with DPN, compare with epalrestat alone. CONCLUSION Our study will provide evidence to assess whether epalrestat combined with ALA is an optional treatment for patients with DPN.
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4.
The FTO variant is associated with chronic complications of diabetes mellitus in Czech population.
Hubacek, JA, Dlouha, D, Klementova, M, Lanska, V, Neskudla, T, Pelikanova, T
Gene. 2018;:220-224
Abstract
BACKGROUND Genome-wide association studies have resulted in the identification of the FTO gene as an important genetic determinant of diabetes mellitus. The aim of this study was to confirm the role of this gene in the development of DM in the Czech-Slavonic population and to analyse whether this gene is associated with common DM complications. METHODS Two groups of patients (814 with T1DM and 848 with T2DM) and a group of healthy controls (2339 individuals) - both of Czech origin - were genotyped for the FTO rs17817449 SNP. ANOVA and logistic regression were used for the statistical evaluations. RESULTS The frequency of the GG genotype was significantly higher in T2DM (25.4% vs. 16.7%, P<0.0005) but not in T1DM patients (19.3% vs. 16.7%, P=0.20) than in controls. The increased risk of development of diabetic nephropathy was observed both for T1DM patients (GG vs. TT homozygotes, P<0.01) and T2DM patients (G carriers vs. TT homozygotes, P<0.05). FTO genotype predicted the development of diabetic neuropathy (GG vs. TT comparison; P<0.01) in the T2DM patients only. No association between FTO genotype and development of retinopathy was detected. All presented values are after adjustment for age, sex, BMI and duration of diabetes. CONCLUSIONS We confirm the association between the FTO rs17817449 SNP and susceptibility to T2DM in the Czech-Slavonic population. The same variant is associated with a spectrum of chronic complications in both types of diabetes.
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A Randomized, Double-Blind Study of the Effects of a Sustained Release Formulation of Sodium Nitrite (SR-nitrite) on Patients with Diabetic Neuropathy.
Soin, A, Bock, G, Giordano, A, Patel, C, Drachman, D
Pain physician. 2018;(2):179-190
Abstract
BACKGROUND Sodium nitrite has been reported to be effective in reducing chronic peripheral pain. OBJECTIVES To evaluate the safety and efficacy of 40 and 80 mg, BID, of an oral sustained release formulation of sodium nitrite (SR-nitrite) in patients suffering from diabetic neuropathy, and to determine whether SR-nitrite would reduce the frequency of headaches reported previously by subjects receiving the same doses of an immediate release formulation. STUDY DESIGN Phase II, single-center, randomized, double-blind, placebo controlled clinical trial. SETTING The Ohio Pain Clinic and Kettering Medical Center. METHODS Twenty-four patients were randomized to 40 mg or 80 mg SR-nitrite or placebo twice daily for 12 weeks. The primary objective was to determine whether headaches would be reduced using SR-nitrite. The primary efficacy endpoint was the mean difference in the change of the Neuropathic Pain Symptom Inventory (NPSI) pain score from baseline to that reported after 12 weeks of treatment. Secondary endpoints included changes from baseline for the Brief Pain Inventory (BPI) Scale, the RAND 36 questionnaire, Short Form McGill Questionnaire, daily patient reported score for neuropathic pain, changes in HbA1c, PulseOx and quantitative sensory testing. RESULTS The number of subjects reporting adverse events and the number of adverse events did not change with dose. There were no reports of treatment-related headaches. Although no significant differences were identified in patient responses to the questionnaires, a trend was observed. In the NPSI assessment, patients in the 40 mg and 80 mg dose group reported a 12.7% and 22.0% reduction in pain, respectively, compared to an 8.4% reduction by patients in the placebo group. A trend was also observed with the BPI total severity score. However, the 40 mg dosing group reported the greatest reduction in pain using the McGill Pain index and via patient logs of daily pain scores, where the mean of pain scores reported by subjects in the 40 mg group dropped by day 41 and generally stayed lower than the mean of scores reported by subjects in either of the other two groups. Patients in the 80 mg SR-nitrite group had an improvement in both Nerve Sensory Conductance and Nerve Sensory Velocity. No changes were observed in HbA1c levels or PulseOx. LIMITATIONS Small sample size. CONCLUSION Sustained release sodium nitrite prevents the prevalent reports of headaches by patients treated with an immediate release formulation of sodium nitrite. In a previous study of patients with peripheral arterial disease (PAD), 40 mg BID treatment led to a statistically significant reduction in reported pain, similar trends were observed at the end of the trial period for most of the pain questionnaires used in the study. The 80 mg BID treatment had the more pronounced affect on bioactivity (quantitative sensory testing), which was similar to the PAD study, where this dose group had the greatest improvement in FMD {AU: spell out FMD}. The ability to alleviate pain with BID treatment of SR-nitrite offers promise for a new non-addictive, non-sedating treatment of chronic pain and warrants further study. KEY WORDS Diabetes, diabetic neuropathy, neuropathic pain, peripheral neuropathy, sodium nitrite.
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Retinopathy, Neuropathy, and Subsequent Cardiovascular Events in Patients with Type 2 Diabetes and Acute Coronary Syndrome in the ELIXA: The Importance of Disease Duration.
Seferovic, JP, Bentley-Lewis, R, Claggett, B, Diaz, R, Gerstein, HC, Køber, LV, Lawson, FC, Lewis, EF, Maggioni, AP, McMurray, JJV, et al
Journal of diabetes research. 2018;:1631263
Abstract
INTRODUCTION We investigated the association of diabetic retinopathy and neuropathy with increased risk of recurrent cardiovascular (CV) events in 6068 patients with type 2 diabetes mellitus (T2DM) and recent acute coronary syndrome (ACS) enrolled in the Evaluation of Lixisenatide in Acute Coronary Syndrome (ELIXA). METHODS History of retinopathy and neuropathy as well as duration of T2DM were self-reported at screening. Proportional hazards regression models were used to assess relationships between retinopathy, neuropathy, and recurrent CV events. RESULTS At screening, retinopathy and neuropathy were reported in 10.7% and 17.5% of patients, respectively, while 5.7% reported both. When adjusted for randomized treatment only, both retinopathy and neuropathy were associated with a primary composite outcome (CV death, nonfatal MI, stroke, or hospitalization for unstable angina) (retinopathy: HR 1.44, 95% CI 1.19-1.75; neuropathy: HR 1.33, 95% CI 1.12-1.57), CV composite (CV death, nonfatal MI, stroke, hospitalization for heart failure (HF)) (retinopathy: HR 1.57, 95% CI 1.31-1.88; neuropathy: HR 1.38, 95% CI 1.19-1.62), myocardial infarction (retinopathy: HR 1.38, 95% CI 1.08-1.76; neuropathy: HR 1.26, 95% CI 1.02-1.54), HF hospitalization (retinopathy: HR 2.03, 95% CI 1.48-2.78; neuropathy: HR 1.71, 95% CI 1.30-2.27), and all-cause mortality (retinopathy: HR 1.65, 95% CI 1.28-2.12; neuropathy: HR 1.43, 95% CI 1.14-1.78). When included in the same model, and adjusted for T2DM duration, there were no independent associations of either with CV outcomes, while T2DM duration remained strongly associated with all outcomes. Addition of demographic characteristics and CV risk factors did not further alter these relationships. CONCLUSIONS In patients with T2DM and recent ACS, a history of retinopathy and/or neuropathy and longer T2DM duration could be considered clinical markers for high risk of recurrent CV events. This trial is registered with the ELIXA (Evaluation of Lixisenatide in Acute Coronary Syndrome), ClinicalTrials.gov registration number NCT01147250.
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The impact of diabetes on corneal nerve morphology and ocular surface integrity.
Markoulli, M, Flanagan, J, Tummanapalli, SS, Wu, J, Willcox, M
The ocular surface. 2018;(1):45-57
Abstract
Diabetes mellitus is a chronic disease that results from inadequate insulin production or ineffective insulin utilization. It is one of the most common systemic diseases worldwide with increasing prevalence. Diabetes mellitus is associated with premature mortality, macrovascular complications such as cardiovascular disease, and microvascular complications, including nephropathy leading to kidney failure, potentially blinding diabetic retinopathy, and diabetic neuropathy. While the retinal complications of diabetes are well recognized by eye care professionals, the effects on the ocular surface are poorly understood. Recent studies have reported on the association between peripheral neuropathy and corneal neuropathy, showing the latter to be of predictive value for the systemic disease. Corneal neuropathy can lead to loss of corneal sensation and can ultimately result in neurotrophic ulcers and significant visual morbidity. The epithelial fragility and poor wound healing that result from reduced epithelial adhesion to the underlying basement membrane in diabetes, together with corneal neuropathy, are thought to increase the susceptibility to persistent corneal erosions and infection, as well as to increase the risk of post-surgical complications. The aim of this article is to review the impact of diabetes on corneal nerve morphology and ocular surface integrity. Changes in the tear film and ocular surface microbiome are highlighted in discussion of the mechanisms that underpin ocular surface changes that increase the susceptibility to corneal erosion and infection.
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Combined treatment of traditional Chinese medicine and western medicine in the treatment of diabetic peripheral neuropathy.
Xu, JY, Gao, HY
Journal of biological regulators and homeostatic agents. 2018;(4):945-949
Abstract
Diabetic peripheral neuropathy (DPN), a common complication of diabetes, has a high morbidity, and currently there is no effective therapy. To investigate the clinical effect of traditional Chinese medicine in combination with Western medicine, 88 patients with early DPN who were admitted to Binzhou City Center Hospital, Shandong, China, between November 2015 and November 2016, were selected as the research subjects and were randomly divided into a control group and an observation. Patients in the control group were treated by conventional Western medicine, while patients in the observation group were treated by traditional Chinese medicine in addition to conventional Western medicine. The clinical effect was compared between the two groups. The results demonstrated that the overall effective rate of the observation group was much higher than that of the control group, and the difference was statistically significant (P less than 0.05). The vibration perception threshold (VPT) of nervus peroneus communis, nervus suralis and posterior tibial nerve of the two groups significantly declined after treatment (P less than 0.05), however, the decreae in the observation group was more obvious (P less than 0.05). The improvement of glycosylated hemoglobin (HbAlc) and blood glucose of the observation group was superior to that of the control group, and the difference had statistical significance (P less than 0.05). In conclusion, traditional Chinese medicine in combination with Western medicine has a remarkable effect in the treatment of DPN and can effectively relieve vital signs and clinical symptoms of patients and significantly improve nerve conduction velocity. The therapy is worth clinical application and promotion.
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9.
[Alpha-lipoic acid in the treatment of diabetic polyneuropathy].
Chukanova, EI, Chukanova, AS
Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova. 2018;(1):103-109
Abstract
The issues of classification, pathogenesis, pathomorphology and treatment of diabetic polyneuropathy (DPN) are addressed. Pathogenetic mechanisms of the action of alpha-lipoic acid in treatment of DPN are justified. The authors present the results of randomized placebo-controlled trials of alpha-lipoic acid that revealed the high clinical efficacy and absence of side-effects even during the long-term treatment.
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10.
Effect of lifestyle interventions on diabetic peripheral neuropathy in patients with type 2 diabetes, result of a randomized clinical trial.
Ghavami, H, Radfar, M, Soheily, S, Shamsi, SA, Khalkhali, HR
Agri : Agri (Algoloji) Dernegi'nin Yayin organidir = The journal of the Turkish Society of Algology. 2018;(4):165-170
Abstract
OBJECTIVES Diabetic peripheral neuropathy (DPN) is the most common and troublesome complication of diabetes leading to great morbidity and resulting in a huge economic burden for diabetes care. Over half of people with diabetes develop neuropathy. Also, DPN is a major cause of reduced quality of life due to pain, sensory loss, gait instability, fall-related injury, and foot ulceration and amputation. The aim of this study was evaluating the effects of lifestyle interventions on diabetic neuropathy severity in diabetes type 2 outpatients. METHODS This clinical trial conducted on 74 patients with DPN that divided with random allocation into intervention or control group. The lifestyle interventions applied in the intervention group beginning four educational sessions on lifestyle that emphasize strategies for lowering blood sugar, increasing physical activity, promoting weight loss, prudent diet, and foot caring. Each session was lasted for1.5 hour. Then patients followed for 12 weeks. During this period, they received counseling on mentioned lifestyle interventions. DPN severity in both groups measured using modified Toronto Clinical Neuropathy Score (mTCNS) at the beginning of study and at the end of counseling for 12 weeks. RESULTS Comparing differences of mean of DNP severity before and after lifestyle intervention between two groups of study, there was a significant difference (p<0.001). DNP severity in control group had not any change or it increased in some participants, but DNP decreased in intervention group, after applying lifestyle intervention. CONCLUSION Lifestyle interventions can contribute to reducing DPN severity, and consequently decreasing neuropathic pain.