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Benfotiamine in the treatment of diabetic polyneuropathy--a three-week randomized, controlled pilot study (BEDIP study).
Int J Clin Pharmacol Ther. 2005 Feb; 43(2):71-7.IJ

Abstract

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.

Authors+Show Affiliations

Saale-Klinik, Bad Kissingen, Lindenfels, Germany. BfA.Saaleklinik@t-online.deNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

15726875

Citation

Haupt, E, et al. "Benfotiamine in the Treatment of Diabetic Polyneuropathy--a Three-week Randomized, Controlled Pilot Study (BEDIP Study)." International Journal of Clinical Pharmacology and Therapeutics, vol. 43, no. 2, 2005, pp. 71-7.
Haupt E, Ledermann H, Köpcke W. Benfotiamine in the treatment of diabetic polyneuropathy--a three-week randomized, controlled pilot study (BEDIP study). Int J Clin Pharmacol Ther. 2005;43(2):71-7.
Haupt, E., Ledermann, H., & Köpcke, W. (2005). Benfotiamine in the treatment of diabetic polyneuropathy--a three-week randomized, controlled pilot study (BEDIP study). International Journal of Clinical Pharmacology and Therapeutics, 43(2), 71-7.
Haupt E, Ledermann H, Köpcke W. Benfotiamine in the Treatment of Diabetic Polyneuropathy--a Three-week Randomized, Controlled Pilot Study (BEDIP Study). Int J Clin Pharmacol Ther. 2005;43(2):71-7. PubMed PMID: 15726875.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Benfotiamine in the treatment of diabetic polyneuropathy--a three-week randomized, controlled pilot study (BEDIP study). AU - Haupt,E, AU - Ledermann,H, AU - Köpcke,W, PY - 2005/2/25/pubmed PY - 2005/4/27/medline PY - 2005/2/25/entrez SP - 71 EP - 7 JF - International journal of clinical pharmacology and therapeutics JO - Int J Clin Pharmacol Ther VL - 43 IS - 2 N2 - 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. SN - 0946-1965 UR - https://www.unboundmedicine.com/medline/citation/15726875/Benfotiamine_in_the_treatment_of_diabetic_polyneuropathy__a_three_week_randomized_controlled_pilot_study__BEDIP_study__ L2 - https://medlineplus.gov/diabeticnerveproblems.html DB - PRIME DP - Unbound Medicine ER -