Treatment with benfotiamine in patients with diabetic sensorimotor polyneuropathy: A double-blind, randomized, placebo-controlled, parallel group pilot study over 12 months

Stirban, Ovidiu Alin; Zeller-Stefan, Helga; Schumacher, Jochen; Gaus, Wilhelm; Ziegler, Dan; Schuerholz, Thomas; Pop‐Busui, Rodica

doi:10.1016/j.jdiacomp.2020.107757

Cited by 7 publications

(3 citation statements)

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“…In 2017, Cvijanović et al, conducted an observational study to evaluate the effect of several agents (including benfotiamine) on the neurophysiological state of patients with symptomatic diabetic neuropathy had confirmed that benfotiamine could improve the neurophysiological parameters of peripheral neurons (38). In 2020, Stirban (40) with a longer study period. They administered benfotiamine 600mg/day for three months, followed by 300mg/day until the study ended versus placebo.…”

Section: Vitamin B1 and Diabetic Neuropathymentioning

confidence: 99%

Role of Neurotropic B Vitamins in the Treatment of Diabetic Neuropathy: Narrative Review

Essa¹,

Aladul²

2022

Iraqi J. Pharm.

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Diabetic neuropathy (DN) is the presence of signs and symptoms that are suggestive of neuropathy in diabetic patients, after excluding other possible causes of nerve damage. Diabetic neuropathy and its complications affect the quality of life, sleep patterns, and daily activities of the patient. Up to date no FDA-approved reversing treatment was found. Studies showed that neurotropic B vitamins (vitamin B1, B6 and B12) had an important role in nerve regeneration and included in prescriptions of DN. However, these vitamins were not included in the guidelines of DN management. The aim of this review is to explore the role of neurotropic B vitamins in the treatment of DN including the mechanism of action and the evidence supporting their use. Review of the literature revealed many clinical trials examining the effect of these vitamins (alone or combined) for DN. These vitamins and/or their derivatives had well-illustrated disease-modifying mechanisms on DN. However, larger randomized clinical trials for longer periods are needed to approve their use in DN and to be included in national and international guidelines. This was hindered by the fact that vitamins are non-patentable and therefore fewer funds would be allocated for large randomized clinical trials.

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Section: Vitamin B1 and Diabetic Neuropathymentioning

confidence: 99%

Role of Neurotropic B Vitamins in the Treatment of Diabetic Neuropathy: Narrative Review

Essa¹,

Aladul²

2022

Iraqi J. Pharm.

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“…[ 237 ] In addition, Benfotiamine has been shown to be effective as an antioxidant and has been studied more in relationship to microvascular complications in diabetes. [ 238 ] However, the outcomes of using vitamins as exogenous antioxidants for the treatment of MI in clinic have been inconsistent over the past few decades. [ 239 ] Clinical trials on small clinical cohorts reported the treatment efficacy of combined treatment with antioxidant vitamins A, C, and E and beta‐carotene in patients with recent acute MI.…”

Section: Introduction Of Ihdmentioning

confidence: 99%

Reactive Oxygen Species Scavenging Nanomedicine for the Treatment of Ischemic Heart Disease

Zhang

Dalan

et al. 2022

Advanced Materials

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Ischemic heart disease (IHD) is the leading cause of disability and mortality worldwide. Reactive oxygen species (ROS) have been shown to play key roles in the progression of diabetes, hypertension, and hypercholesterolemia, which are independent risk factors that lead to atherosclerosis and the development of IHD. Engineered biomaterial‐based nanomedicines are under extensive investigation and exploration, serving as smart and multifunctional nanocarriers for synergistic therapeutic effect. Capitalizing on cell/molecule‐targeting drug delivery, nanomedicines present enhanced specificity and safety with favorable pharmacokinetics and pharmacodynamics. Herein, the roles of ROS in both IHD and its risk factors are discussed, highlighting cardiovascular medications that have antioxidant properties, and summarizing the advantages, properties, and recent achievements of nanomedicines that have ROS scavenging capacity for the treatment of diabetes, hypertension, hypercholesterolemia, atherosclerosis, ischemia/reperfusion, and myocardial infarction. Finally, the current challenges of nanomedicines for ROS‐scavenging treatment of IHD and possible future directions are discussed from a clinical perspective.

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“…However, participants had almost normal nerve function prior to treatment which did not leave any room for a meaningful degree of improvement 15. In a recent pilot randomised controlled trial (RCT) which was terminated prematurely due to technical reasons, administration of benfotiamine over 6 months (600 mg/day for 3 months, followed by 300 mg/day until the study end) resulted in a reduction of neuropathic symptoms assessed by the Michigan Neuropathy Screening Instrument (MNSI) questionnaire, while changes in neuropathic deficits (MNSI physical examination), quality of life and pain did not reach statistical significance 4 16. In people with diabetes as well as in tobacco smoking individuals, benfotiamine was shown to improve endothelial function 17 18.…”

Section: Introductionmentioning

confidence: 99%

BOND study: a randomised double-blind, placebo-controlled trial over 12 months to assess the effects of benfotiamine on morphometric, neurophysiological and clinical measures in patients with type 2 diabetes with symptomatic polyneuropathy

et al. 2022

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IntroductionDiabetic sensorimotor polyneuropathy (DSPN) affects approximately 30% of people with diabetes, while around half of cases are symptomatic. Currently, there are only few pathogenetically oriented pharmacotherapies for DSPN, one of which is benfotiamine, a prodrug of thiamine with a high bioavailability and favourable safety profile. While benfotiamine has shown positive effects in preclinical and short-term clinical studies, no long-term clinical trials are available to demonstrate disease-modifying effects on DSPN using a comprehensive set of disease-related endpoints.Methods and analysisThe benfotiamine on morphometric, neurophysiological and clinical measures in patients with type 2 diabetes trial is a randomised double-blind, placebo-controlled parallel group monocentric phase II clinical trial to assess the effects of treatment with benfotiamine compared with placebo in participants with type 2 diabetes and mild to moderate symptomatic DSPN. Sixty participants will be 1:1 randomised to treatment with benfotiamine 300 mg or placebo two times a day over 12 months. The primary endpoint will be the change in corneal nerve fibre length assessed by corneal confocal microscopy (CCM) after 12 months of benfotiamine treatment compared with placebo. Secondary endpoints will include other CCM measures, skin biopsy and function indices, variables from somatic and autonomic nerve function tests, clinical examination and questionnaires, general health, health-related quality of life, cost, safety and blood tests.Ethics and disseminationThe trial was approved by the competent authority and the local independent ethics committee. Trial results will be published in peer-reviewed journals, conference abstracts, and via online and print media.Trial registration numberDRKS00014832.

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Treatment with benfotiamine in patients with diabetic sensorimotor polyneuropathy: A double-blind, randomized, placebo-controlled, parallel group pilot study over 12 months

Cited by 7 publications

References 2 publications

Role of Neurotropic B Vitamins in the Treatment of Diabetic Neuropathy: Narrative Review

Role of Neurotropic B Vitamins in the Treatment of Diabetic Neuropathy: Narrative Review

Reactive Oxygen Species Scavenging Nanomedicine for the Treatment of Ischemic Heart Disease

BOND study: a randomised double-blind, placebo-controlled trial over 12 months to assess the effects of benfotiamine on morphometric, neurophysiological and clinical measures in patients with type 2 diabetes with symptomatic polyneuropathy

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Treatment with benfotiamine in patients with diabetic sensorimotor polyneuropathy: A double-blind, randomized, placebo-controlled, parallel group pilot study over 12 months

Cited by 7 publications

References 2 publications

Role of Neurotropic B Vitamins in the Treatment of Diabetic Neuropathy: Narrative Review

Role of Neurotropic B Vitamins in the Treatment of Diabetic Neuropathy: Narrative Review

Reactive Oxygen Species Scavenging Nanomedicine for the Treatment of Ischemic Heart Disease

BOND study: a randomised double-blind, placebo-controlled trial over 12 months to assess the effects of benfotiamine on morphometric, neurophysiological and clinical measures in patients with type 2 diabetes with symptomatic polyneuropathy

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Treatment with benfotiamine in patients with diabetic sensorimotor polyneuropathy: A double-blind, randomized, placebo-controlled, parallel group pilot study over 12 months