Vol 4, No 4 (2003): Practical Diabetology
Research paper
Published online: 2003-09-18
The impact of the benfothiamine treatment on the painful diabetic polyneuropathy
Diabetologia Praktyczna 2003;4(4):273-278.
Abstract
INTRODUCTION. The painful diabetic polyneuropathy significantly decreases
the quality of life, causes disability and is resistant to the treatment. All
this brings the frustration to the suffering patients and the therapeutic team.
Most of the clinical trials that tested number of drugs were disappointing because
of the insufficient analgesic result or side effects. The aim of the study was
to assess the efficacy of the treatment with lipophil form of vitamin B1 Benfothiamine
(Benfogamma, Wörwag Pharma) in the painful diabetic polyneuropathy.
MATERIAL AND METHODS. We included 41 patients with type 2 diabetes and painful diabetic polyneuropathy into this study. All the patients scored at least 10 in the 20 point McGill scale. They were administered Benfothiamine 400 mg daily divided into 4 doses for 3 weeks. During the next 9 weeks they were given 150 mg daily in 3 doses. The severity of the pain, the sensation of vibration and touch, and the general well-being of the patients were assessed at the initial visit, after 3 and 12 weeks of treatment.
RESULTS. After 3 weeks of treatment the average threshold for the vibration sensation in the examined group on the right and the left foot improved from 3.47 to 3.74 (P = 0.0637) and from 3.60 to 4.03 (P = 0.0017), respectively. The severity of the pain decreased from 14.32 to 11.88 on the McGill scale (P < 0.0001). After 12 weeks, the further improvement was recorded in respect to the threshold of vibration sensation in the right and the left foot reaching 4.19 (P < 0.0001) and 4.38 (P < 0.0001), respectively. The severity of pain decreased to 8.80 points on the McGill scale (P < 0.0001). The general well-being of the patients improved substantially in 11 subjects, improved moderately in 12, slightly improved in 2, and remained unchanged in 6 diabetic patients. There was no a case of worsening in general well-being condition reported. After 12 weeks the significant improvement in the touch sensation was also observed as compared to the initial visit.
CONCLUSIONS. Benfothiamine has significantly improved the clinical course of the painful diabetic polyneuropathy.
MATERIAL AND METHODS. We included 41 patients with type 2 diabetes and painful diabetic polyneuropathy into this study. All the patients scored at least 10 in the 20 point McGill scale. They were administered Benfothiamine 400 mg daily divided into 4 doses for 3 weeks. During the next 9 weeks they were given 150 mg daily in 3 doses. The severity of the pain, the sensation of vibration and touch, and the general well-being of the patients were assessed at the initial visit, after 3 and 12 weeks of treatment.
RESULTS. After 3 weeks of treatment the average threshold for the vibration sensation in the examined group on the right and the left foot improved from 3.47 to 3.74 (P = 0.0637) and from 3.60 to 4.03 (P = 0.0017), respectively. The severity of the pain decreased from 14.32 to 11.88 on the McGill scale (P < 0.0001). After 12 weeks, the further improvement was recorded in respect to the threshold of vibration sensation in the right and the left foot reaching 4.19 (P < 0.0001) and 4.38 (P < 0.0001), respectively. The severity of pain decreased to 8.80 points on the McGill scale (P < 0.0001). The general well-being of the patients improved substantially in 11 subjects, improved moderately in 12, slightly improved in 2, and remained unchanged in 6 diabetic patients. There was no a case of worsening in general well-being condition reported. After 12 weeks the significant improvement in the touch sensation was also observed as compared to the initial visit.
CONCLUSIONS. Benfothiamine has significantly improved the clinical course of the painful diabetic polyneuropathy.
Keywords: diabetes mellituspolyneuropathybenfotiamine