Behandelcentrum Neuropathische Pijn

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Benfotiamine (B1)

Benfotiamine is een synthetische variant van vitamine B1, en wordt beter in het lichaam opgenomen. dit middel lost namelijk goed op in vet (lipofiel). Duitse onderzoekers keken naar het effect van twee verschillende doseringen, 300 mg en 600 mg versus placebo in totaal. In de zogenaamde per protocol analyse bleek dat de twee groepen die benfotiamine kregen een betere neuropathische symptoomscore hadden, dan de placebo groep. Vooral de pijn reageerde het beste: 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.^[1]

In een eerdere studie met 40 patienten werd ook hetzelfde anti-pijn effect gevonden.^[2] Deze studie vergeleek 400 mg versus placebo gedurende 3 weken

Benfothiamine heeft in uiteenlopende diermodellen ook positieve effecten, die een toepassing bij mensen ondersteunen.^[3]^[4] Ook is er sprake van een synergie tussen analgetica en deze lipofiele vorm van vitamine B1.^[5] Thiamine zelf had eerder ook al duidelijk effecten laten zien. ^[6]

Studie naar effecten thiamine

In de VS was een studie opgezet naar de effecten van vitamine B1 op de neuropathie bij diabetes. De rationale van die studie is:

It is estimated that more then 5 million people in the United States suffer from Diabetes Mellitus, and of these up to 80% suffer from painful diabetic peripheral neuropathy. Multiple medications have been tried for the treatment of painful diabetic neuropathy. These medications are directed at symptomatic relief and do not address the underlying cause of painful peripheral neuropathy. Thiamine is a water-soluble vitamin that participates in carbohydrate metabolism. Deficiency of thiamine causes beriberi, characterized by painful peripheral neuropathy and cardiomyopathy.

Basic research has suggested that thiamine deficiency may also be involved in the etiology of diabetic neuropathy by preventing the glycation of nerve fibers as well as apoptosis of endothelial cells. A study in the developing world found that oral thiamine and pyridoxine were helpful in improving the pain experienced in diabetic peripheral neuropathy as well as improving signs of neuropathy seen on neurological examination.

A screening study of patients with type II diabetes found that 76% of patients tested had a low serum thiamine level.Our study will examine the effect of oral thiamine supplementation on the symptom of pain in painful diabetic peripheral neuropathy. In addition we will follow serum thiamine levels to see if clinical change correlates with changes in serum thiamine levels.

Helaas is die studie nooit echt goed van start gegaan en zullen we de resultaten niet leren kennen.

Prof.dr. Jan M. Keppel Hesselink november 2009

Referenties

[1]: Stracke H, Gaus W, Achenbach U, Federlin K, Bretzel RG. | Benfotiamine in diabetic polyneuropathy (BENDIP): results of a randomised, double blind, placebo-controlled clinical study. | Exp Clin Endocrinol Diabetes. | 2008 Nov;116(10):600-5. Epub 2008 May 13.

[2]: 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 Feb;43(2):71-7.

[3]: Balakumar P, Sharma R, Singh M. | Benfotiamine attenuates nicotine and uric acid-induced vascular endothelial dysfunction in the rat. | Pharmacol Res. | 2008 Nov-Dec;58(5-6):356-63. Epub 2008 Oct 2.

[4]: Beltramo E, Berrone E, Tarallo S, Porta M. | Effects of thiamine and benfotiamine on intracellular glucose metabolism and relevance in the prevention of diabetic complications. | Acta Diabetol. | 2008 Sep;45(3):131-41. Epub 2008 Jun 26.

[5]: Mixcoatl-Zecuatl T, Quinonez-Bastidas GN, Caram-Salas NL, Ambriz-Tututi M, Araiza-Saldana CI, Rocha-Gonzalez HI, Medina-Santillan R, Reyes-Garcia G, Granados-Soto V. | Synergistic antiallodynic interaction between gabapentin or carbamazepine and either benfotiamine or cyanocobalamin in neuropathic rats. | Methods Find Exp Clin Pharmacol. | 2008 Jul-Aug;30(6):431-41.

[6]: Abbas ZG, Swai AB. | Evaluation of the efficacy of thiamine and pyridoxine in the treatment of symptomatic diabetic peripheral neuropathy. | East Afr Med J. | 1997 Dec;74(12):803-8.