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Randomized Controlled Trial
. 2015 Jul 1:152:257-63.
doi: 10.1016/j.drugalcdep.2015.03.032. Epub 2015 Apr 8.

Change in psychiatric symptomatology after benfotiamine treatment in males is related to lifetime alcoholism severity

Ann M Manzardo  1 , Tiffany Pendleton  2 , Albert Poje  2 , Elizabeth C Penick  2 , Merlin G Butler  2
Affiliations
Randomized Controlled Trial

Change in psychiatric symptomatology after benfotiamine treatment in males is related to lifetime alcoholism severity

Ann M Manzardo et al. Drug Alcohol Depend. .

Abstract

Background: Severe alcoholism can be associated with significant nutritional and vitamin deficiency, especially vitamin B1 (thiamine) which is associated with neurological deficits impacting mood and cognition. Alcohol consumption was reduced among female but not male alcoholics after supplementation with the high potency thiamine analog benfotiamine (BF). We examined the relationship between lifetime alcoholism severity, psychiatric symptoms and response to BF among the alcohol dependent men from this cohort.

Methods: Eighty-five adult men (mean age=48±8 years) meeting DSM-IV-TR criteria for a current alcohol use disorder who were abstinent <30days participated in a randomized, double-blind, placebo-controlled trial of 600mg BF vs placebo (PL) for 6 months. Psychometric testing included a derived Lifetime Alcoholism Severity Score (AS), Symptom Checklist 90R (SCL-90R), and the Barratt Impulsivity Scale (BIS) at baseline and at 6 months.

Results: Baseline SCL-90-R scale scores for men with high alcoholism severity (AS≥24; N=46 HAS) were significantly greater than for men with low alcoholism severity (AS<24; N=39 LAS), but BIS scores did not differ. MANOVA modeling at follow-up (N=50 completed subjects) identified a significant treatment effect (F=2.5, df=10, p<0.03) and treatment×alcoholism severity level interaction (F=2.5, dfnum=10, dfden=30, p<0.03) indicating reduced SCL-90-R scores among BF treated, HAS males. Above normal plasma thiamine levels at follow-up predicted reduced depression scores in a BF-treated subset (F=3.2, p<0.09, N=26).

Conclusion: BF appears to reduce psychiatric distress and may facilitate recovery in severely affected males with a lifetime alcohol use disorder and should be considered for adjuvant therapy in alcohol rehabilitation.

Trial registration: #NCT00680121 High Dose Vitamin B1 to Reduce Abusive Alcohol Use.

Keywords: Alcoholism; Benfotiamine (BF); Thiamine deficiency; Vitamin B1.

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Conflict of interest statement

Conflict of Interest

No conflict declared

Figures

Figure 1
Figure 1
Symptom Checklist-90-R (SCL-90-R) normative scores for males at baseline by alcoholism severity level relative to non-psychiatric controls. SCL-90-R normative scores relative to non-psychiatric controls for high (AS ≥ 24) and low (AS < 24) alcoholism severity level. Normative SCL-90-R scores are derived from mean raw scores of 99% non-psychiatric Caucasian male controls. Data are presented as area T scores with a mean=50th centile and a standard deviation=10. Mean values compared using ANOVA.* p<0.05.
Figure 2
Figure 2
Barratt Impulsiveness Raw Scores for males at baseline by alcoholism severity level. Barratt Impulsiveness Scale scores for high (AS ≥ 24) and low (AS < 24) alcoholism severity groups. Mean values compared using ANOVA.
Figure 3
Figure 3
Sample medians are indicated by black squares and means are indicated by the horizontal lines. Vertical lines show the maximum and minimum values. Sample medians are indicated by black squares and means are indicated by the horizontal lines. Vertical lines show the maximum and minimum values.
Figure 4
Figure 4
Change in baseline scl-90-r symptoms for benfotiamine vs placebo treatment for low severity males with alcoholism. Sample medians are indicated by black squares and means are indicated by the horizontal lines. Vertical lines show the maximum and minimum values.
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