Double-blind, randomized placebo-controlled clinical trial of benfotiamine for severe alcohol dependence

Abstract

Alcohol dependence is associated with severe nutritional and vitamin deficiency. Vitamin B1 (thiamine) deficiency erodes neurological pathways that may influence the ability to drink in moderation. The present study examines tolerability of supplementation using the high-potency thiamine analog, benfotiamine (BF), and BF's effects on alcohol consumption in severely affected, self-identified, alcohol dependent subjects. A randomized, double-blind, placebo-controlled trial was conducted on 120 non-treatment seeking, actively drinking, alcohol dependent men and women volunteers (mean age=47 years) from the Kansas City area who met DSM-IV-TR criteria for current alcohol dependence. Subjects were randomized to receive 600 mg benfotiamine or placebo (PL) once daily by mouth for 24 weeks with 6 follow-up assessments scheduled at 4 week intervals. Side effects and daily alcohol consumption were recorded. Seventy (58%) subjects completed 24 weeks of study (N=21 women; N=49 men) with overall completion rates of 55% (N=33) for PL and 63% (N=37) for BF groups. No significant adverse events were noted and alcohol consumption decreased significantly for both treatment groups. Alcohol consumption decreased from baseline levels for 9 of 10 BF treated women after 1 month of treatment compared with 2 of 11 on PL. Reductions in total alcohol consumption over 6 months were significantly greater for BF treated women (BF: N=10, -611 ± 380 standard drinks; PL: N=11, -159 ± 562 standard drinks, p-value=0.02). BF supplementation of actively drinking alcohol dependent men and women was well-tolerated and may discourage alcohol consumption among women. The results do support expanded studies of BF treatment in alcoholism.

Keywords: Alcoholism; Benfotiamine; Female alcohol consumption; Thiamine.

Figure 1. Average Daily Alcohol Consumption Based upon Timeline Followback Assessment

Mean daily alcohol consumption recorded as standard drinks (SD) equivalent to 0.6 fluid ounces (18ml) or 14 grams of alcohol calculated in 4 week blocks for completed male and female subjects.

Figure 2

Change in Mean Daily Alcohol Consumption in Completed Females

Figure 3. Change in Total Alcohol Consumption among Female Completers

Box plots represent the distribution of the calculated change (observed – expected) in total alcohol consumption within each treatment group. The “expected” total alcohol consumption assumes that the mean daily alcohol consumption is sustained for 6 months while the “observed” alcohol consumption reflects the sum of the mean daily consumption over the 6 month study time interval. The extended bars for each box show the minimum and maximum values of the respective sample distributions