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

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 B ₁ , B ₂ , B ₆ , and B ₁₂ ), ‘new formulation’ [i.e. identical to the ‘old formulation’ with additional folic acid (vitamin B ₉ )], 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.