Benfotiamine in diabetic polyneuropathy (BENDIP): results of a randomised, double blind, placebo-controlled clinical study.
Level 2 - randomized trial
Individual randomized controlled trial
PubMed 18473286 · doi:10.1055/s-2008-1065351
What was done
A double-blind, placebo-controlled, phase-III randomized trial evaluated the efficacy and safety of benfotiamine in 165 patients with symmetrical, distal diabetic polyneuropathy. Following a wash-out phase, patients were allocated to benfotiamine 600 mg daily, benfotiamine 300 mg daily, or placebo for 6 weeks. A total of 133 patients were analyzed in the intention-to-treat (ITT) group (benfotiamine 600 mg: n=47; benfotiamine 300 mg: n=45; placebo: n=41) and 124 in the per-protocol (PP) group (benfotiamine 600 mg: n=43; benfotiamine 300 mg: n=42; placebo: n=39). The primary outcome was change in Neuropathy Symptom Score (NSS); Total Symptom Score (TSS) was also evaluated.
What was found
After 6 weeks of treatment, the primary outcome NSS differed significantly across groups in the per-protocol analysis (p=0.033), but did not reach statistical significance in the ITT population (p=0.055). Overall TSS showed no significant difference between groups after 6 weeks, though the best response within TSS was reported for the symptom "pain". Symptom improvement was more pronounced at 600 mg per day than at 300 mg per day and increased over time. Treatment was well tolerated across all groups.
Why it matters
This study provides evidence that high-dose benfotiamine may reduce symptomatic burden in diabetic polyneuropathy, supporting its potential role as a treatment option targeting impaired glucose metabolism.
Limits
The primary outcome failed to reach statistical significance in the intention-to-treat analysis (p=0.055), and the secondary TSS measure was not statistically significant. The treatment duration was brief (6 weeks), group sizes were relatively small, and the abstract provides no numerical baseline/endpoint symptom values or objective nerve conduction measurements.
Cited by
- partial Benfotiamine, typically taken with alpha-lipoic acid, treats burning feet and peripheral neuropathy.