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Alcohol and Alcoholism Advance Access published online on August 21, 2006
Alcohol and Alcoholism, doi:10.1093/alcalc/agl058
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© The Author 2006. Published by Oxford University Press on behalf of the Medical Council on Alcohol. All rights reserved
Received April 25, 2006
Revised July 4, 2006
Accepted July 4, 2006

Article

TREATMENT OF ALCOHOLIC POLYNEUROPATHY WITH VITAMIN B COMPLEX: A RANDOMISED CONTROLLED TRIAL

T. J. PETERS 1 *, J. KOTOWICZ 2, W. NYKA 3, W. KOZUBSKI 4, V. KUZNETSOV 5, F. VANDERBIST 6, S. DE NIET 6, D. MARCEREUIL 6, and M. COFFINER 6

1 Department of Clinical Biochemistry, Kings College, London, UK
2 Department of Neurology, Klinika Neurologiczna z Poradnia, Wojskowy Instytut Medyczny, Warszawa, Poland
3 Department of Neurology for Adults, Medical University of Gdansk, Gdansk, Poland
4 Department of Neurology, University of Medical Sciences, Poznan, Poland
5 Psychiatric Department, Kiev Medical Academy of Postgraduate Education, Kiev, Ukraine
6 Laboratoires SMB, R&D Department, Bruxelles, Belgium

* To whom correspondence should be addressed.
T. J. PETERS, E-mail: timothy{at}peters24.freeserve.co.uk


  Abstract

Aims: To evaluate the therapeutic efficacy and safety of BEFACT® Forte ‘new formulation’ and BEFACT® Forte ‘old formulation’ in the treatment of sensory symptoms of alcoholic polyneuropathy. Methods: A multi-centre, randomised, double-blind, placebo-controlled study was conducted on 325 patients with sensory symptoms and signs of alcoholic polyneuropathy. Patients were randomised to the ‘old formulation’ (i.e. vitamins B1, B2, B6, and B12), ‘new formulation’ [i.e. identical to the ‘old formulation’ with additional folic acid (vitamin B9)], or placebo in a 1:1:1 ratio. One tablet of the study medication (‘new formulation’ or ‘old formulation’) or placebo was taken orally, three times a day, over a 12-week treatment period. Results: Therapeutic efficacy was assessed in 253 patients by measuring vibration perception threshold (biothesiometry), intensity of pain, sensory function, co-ordination, and reflex responses. Patients treated with the ‘new formulation’ or ‘old formulation’ showed significant improvement in the primary efficacy endpoint (vibration perception threshold at the big toe) and secondary efficacy endpoints in comparison to placebo. The active treatment groups were comparable to placebo in terms of safety. Conclusions: A specific vitamin B complex (with and without folic acid) significantly improved symptoms of alcoholic polyneuropathy over a 12-week treatment period.


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