Benfotiamine in Treatment of Alcoholic Polyneuropathy: An 8-Week Randomized Controlled Study (Bap I Study)

Abstract

A three-armed, randomized, multicentre, placebo-controlled double-blind study was used to examine the efficacy of benfotiamine vs a combination containing benfotiamine and vitamins B6 and B12 in out-patients with severe symptoms of alcoholic polyneuropathy (Benfotiamine in treatment of Alcoholic Polyneuropathy, BAP I). The study period was 8 weeks and 84 patients fulfilled all the prerequisite criteria and completed the study as planned. Benfotiamine led to significant improvement of alcoholic polyneuropathy. Vibration perception (measured at the tip of the great toe) significantly improved in the course of the study, as did motor function. and the overall score reflecting the entire range of symptoms of alcoholic polyneuropathy. A tendency toward improvement was evident for pain and co-ordination; no therapy-specific adverse effects were seen.

Alcoholic Polyneuropathy: Clinical Assessment of Treatment Outcomes Following Therapy with Nucleotides and Vitamin B12

“…Safety assessments took into account vital signs at each assessment and occurrence, severity, and duration of any adverse effects, including changes in laboratory tests. These assessments were adopted based on previous clinical studies of alcoholic polyneuropathy (Peters et al 2006;Woelk et al, 1998).…”

Botulinum toxin type A combined with neurodynamic mobilization for lower limb spasticity: a case report

“…32 Therefore, BoNT-A may be a useful option for painful localized contractures that do not respond to standard treatment. 32 Several studies investigating the effects of benfotiamine (a lipid-soluble derivative of vitamin B1 with high bioavailability) on polyneuropathy have shown significant improvements in vibration perception threshold, 33 nerve conduction velocity, 34 neuropathy score, and pain. 35 These studies highlight the improvements in sensory and motor function in patients with polyneuropathy when treated with mono-or polyvitamin formulations.…”

Benfotiamine, thiamine monophosphate chloride and thiamine pyrophosphate chloride, as sources of vitamin B1 added for nutritional purposes to food supplements - Scientific Opinion of the Panel on Food Additives and Nutrient Sources added to Food (ANS)

“…The petitioner indicates that out of eleven trials with clinical endpoints, seven (Winkler et al, 1999;Woelk et al, 1998;Haupt et al, 1998;Barkai et al, 1998;Simeonov et al, 1997;Stracke et al, 1996;Ledermann and Wiedley, 1989) explicitly reported no side effects at all or no differences in side effect incidence between active and placebo groups.…”

“…Most of the controlled trials (Winkler et al, 1999;Woelk et al, 1998;Haupt et al, 1998;Simeonov et al, 1997;Stracke et al, 1996;Ledermann and Wiedley, 1989) also monitored a variety of biochemical parameters, including aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyltransferase (gamma-GT), total and HDL cholesterol, triglycerides, creatine, alkaline phosphatase (ALP), white and red blood cell counts, hemoglobin, sodium, haematocrit, potassium, urea, uric acid, serum protein, and erythrocyte sedimentation rate, urine albumin, sugar and protein, as well as parameters most directly related to diabetic disease state. These trials have consistently shown that there were no statistically significant differences in these parameters between the exposed and control groups.…”