- Benfotiamine in diabetic polyneuropathy (BENDIP): results of a randomised, double blind, placebo-controlled clinical study (2008)
Efficacy and safety of benfotiamine in treatment of diabetic polyneuropathy.
Double blind, placebo-controlled, phase-III-study. 181 patients were screened. 165 patients with symmetrical, distal diabetic polyneuropathy were randomised to one of three treatment groups entering the wash-out phase and 133/124 patients were analysed in the ITT/PP analysis: Benfotiamine 600 mg per day (n=47/43), benfotiamine 300 mg per day (n=45/42) or placebo (n=41/39).
After 6 weeks of treatment, the primary outcome parameter NSS (Neuropathy Symptom Score) differed significantly between the treatment groups (p=0.033) in the PP (per protocol) population. In the ITT (intention to treat) population, the improvement of NSS was slightly above significance (p=0.055). The TSS (Total Symptom Score) showed no significant differences after 6 weeks of treatment. The improvement was more pronounced at the higher benfotiamine dose and increased with treatment duration. In the TSS, best results were obtained for the symptom "pain". Treatment was well tolerated in all groups.
Benfotiamine may extend the treatment option for patients with diabetic polyneuropathy based on causal influence on impaired glucose metabolism. Further studies should confirm the positive experiences.
temporary analgesic co-medication was allowed, e.g. paracetamol up to a daily dose of 5 × 500 mg.
- The Effects of Long-Term Oral Benfotiamine Supplementation on Peripheral Nerve Function and Inflammatory Markers in Patients With Type 1 Diabetes
A 24-month, double-blind, randomized, placebo-controlled trial (2012)
http://care.diabetesjournals.org/conten ... 5.full.pdf
OBJECTIVE To study the effects of long-term oral benfotiamine supplementation on peripheral nerve function and soluble inflammatory markers in patients with type 1 diabetes.
RESEARCH DESIGN AND METHODS The study randomly assigned 67 patients with type 1 diabetes to receive 24-month benfotiamine (300 mg/day) or placebo supplementation.
Peripheral nerve function and levels of soluble inflammatory variables were assessed at baseline and at 24 months.
RESULTS Fifty-nine patients completed the study. Marked increases in whole-blood concentrations of thiamine and thiamine diphosphate were found in the benfotiamine group (both P , 0.001 vs. placebo). However, no significant differences in changes in peripheral nerve function or soluble inflammatory biomarkers were observed between the groups.
CONCLUSION Our findings suggest that high-dose benfotiamine (300 mg/day) supplementation over 24 months has no significant effects upon peripheral nerve function or soluble markers of inflammation in patients with type 1 diabetes.
Symptomatic polyneuropathy was not an inclusion criterion in the current study (symptom scoring was not meaningful because most patients were asymptomatic). However, because the former studies did not report neurophysiologic function, we cannot exclude that the reported effect was related to symptom reduction and not improved nerve function per se.
take control of your own health.
pursue optimal self care, with or without a diagnosis.
https://www.lifeextension.com/Magazine/ ... ne/Page-01
I have been taking their ComfortMAX™ nerve product for the past few weeks, and have been taking the active ingredient in powder form, palmitoylethanolamide or PEA as it is often referred to, for over 1 month, and while I have no way of knowing for sure if palmitoylethanolamide is the reason I am feeling better, I have been feeling better since I started taking palmitoylethanolamide with regard to my nerve pain. BUT, I had been doing a little bit better anyway over the past few months anyway, and in fairness I have probably added about a dozen new supplements to my already long list over the past 4-6 months.
In any case, regardless of the exact reason, I am happy to be doing so much better!
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