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Benfotiamine in the treatment of
diabetic polyneuropathy--a three-week randomized, controlled pilot study
(BEDIP study).
Haupt E, Ledermann H, Kopcke
W.
Saale-Klinik, Bad Kissingen, Lindenfels, Germany.
BfA.Saaleklinik@t-online.de
OBJECTIVE: The aim of the study was
to evaluate the efficacy of benfotiamine administered over three weeks
(allithiamine; a lipid-soluble vitamin B1 prodrug with high
bioavailability) to patients with diabetic polyneuropathy in a
randomized, placebo-controlled, double-blind, two-center pilot study.
MATERIAL AND METHODS: Forty inpatients (23 male, 18 female, age range 18
- 70 years) with a history of type 1 or 2 diabetes and polyneuropathy of
not longer than two years, were included in the study. Twenty Patients
received two 50 mg benfotiamine tablets four times daily and 20 patients
received placebo over the three-week study period. Two clinical units
were involved with 10 patients receiving placebo and 10 patients
benfotiamine in each. The neuropathy score according to Katzenwadel et
al. [1987] was used to evaluate symptoms of polyneuropathy, vibration
perception threshold and both the physician's and the patient's own
assessment were documented. RESULTS: A statistically significant (p =
0.0287) improvement in the neuropathy score was observed in the group
given active drug when compared to the placebo-treated controls. There
was no statistically significant change observed in the tuning fork
test. The most pronounced effect on complaints was a decrease in pain (p
= 0.0414). More patients in the benfotiamine-treated group than in the
placebo group considered their clinical condition to have improved (p =
0.052). No side effects attributable to benfotiamine were observed. The
differences between the groups cannot be attributed to a change in
metabolic parameters since there were no significant alterations in the
HbA1 levels and blood sugar profiles. The body mass index of the two
groups did not differ. CONCLUSION: This pilot investigation (BEDIP
Study) has confirmed the results of two earlier randomized controlled
trials and has provided further evidence for the beneficial effects of
benfotiamine in patients with diabetic neuropathy.
PMID: 15726875
[PubMed - in process]
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