benphothiamine and Alcoholism studies

benfotiamine : A thioester that is a synthetic analogue of thiamine obtained by acylative cleavage of the thiazole ring and O-phospohorylation.

Alcoholism: A primary, chronic disease with genetic, psychosocial, and environmental factors influencing its development and manifestations. The disease is often progressive and fatal. It is characterized by impaired control over drinking, preoccupation with the drug alcohol, use of alcohol despite adverse consequences, and distortions in thinking, most notably denial. Each of these symptoms may be continuous or periodic. (Morse & Flavin for the Joint Commission of the National Council on Alcoholism and Drug Dependence and the American Society of Addiction Medicine to Study the Definition and Criteria for the Diagnosis of Alcoholism: in JAMA 1992;268:1012-4)

Research Excerpts

Excerpt	Relevance	Reference
" Baclofen has been shown to promote abstinence, to reduce craving, and to reduce anxiety in alcohol-dependent individuals, and it promises to be a useful agent, although clinical data are limited at present."	5.24	Randomized open-label trial of baclofen for relapse prevention in alcohol dependence. ( Arora, S; Elwadhi, D; Gupta, M; Rastogi, R; Verma, P, 2017)
"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."	5.20	Change in psychiatric symptomatology after benfotiamine treatment in males is related to lifetime alcoholism severity. ( Butler, MG; Manzardo, AM; Pendleton, T; Penick, EC; Poje, A, 2015)
"Alcohol dependence is associated with severe nutritional and vitamin deficiency."	2.78	Double-blind, randomized placebo-controlled clinical trial of benfotiamine for severe alcohol dependence. ( Butler, MG; Campbell, J; He, J; Manzardo, AM; Penick, EC; Poje, A, 2013)

Research

Studies (5)

Authors

Clinical Trials (1)

Trial Overview

Trial Outcomes

Alcoholism Severity Scale

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	1 (20.00)	18.2507
2000's	1 (20.00)	29.6817
2010's	3 (60.00)	24.3611
2020's	0 (0.00)	2.80

Authors	Studies
Manzardo, AM	2
He, J	1
Poje, A	2
Penick, EC	2
Campbell, J	1
Butler, MG	2
Pendleton, T	1
Gupta, M	1
Verma, P	1
Rastogi, R	1
Arora, S	1
Elwadhi, D	1
Kretschmar, C	1
Kaumeier, S	1
Haase, W	1
Ayazpoor, U	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
The Effectiveness of Benfotiamine in Reducing Abusive Drinking Among Family History Positive and Negative Alcoholics[NCT00680121]	Phase 4	120 participants (Actual)	Interventional	2008-07-31	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

The alcoholism severity scale measures the severity of a person's dependence to alcohol. The scale ranges from a score of 0 (least severe) to 33 (most severe). The higher the score the worse the dependence. (NCT00680121)
Timeframe: 6 Months

Barrett Impulsivity Scale: Total Impulsiveness

Intervention	scores on a scale (Mean)
Control Group	14.0
Benfotiamine	10.7

Scale measures impulsiveness. It includes 30 items that are scored to yield six first-order factors (attention, motor, self-control, cognitive complexity, perseverance, and cognitive instability impulsiveness) and three second-order factors (attentional, motor, and non-planning impulsiveness). Items are scored on a 4 point scale with 1 point equaling rarely/never up to 4 points equaling almost always/always. Total impulsivity score ranges from 30 (least impulsive) to 120 (most impulsive). The higher the score the higher the level of impulsiveness. (NCT00680121)
Timeframe: 6 Months

Change in Average Daily Alcohol Consumption

Intervention	scores on a scale (Mean)
Control Group	65.0
Benfotiamine	65.4

measured as standard drinks of alcohol per day (SD/day) (NCT00680121)
Timeframe: Change from Baseline to 6 Months

Symptom Checklist-90 (SCL-90): Global Severity Index

Intervention	alcoholic drinks per day (Mean)
Control Group	-3.4
Benfotiamine	-3.0

The SCL-90 is a brief multidimensional self-report inventory that screens for nine symptoms of psychopathology and provides three global distress indicators. It provides an overview of symptom severity and intensity. The outcome measures psychiatric symptoms using a 30-item scale reported as t-scores relative to a normative population. (NCT00680121)
Timeframe: 6 Months

Article	Year
Double-blind, randomized placebo-controlled clinical trial of benfotiamine for severe alcohol dependence. Drug and alcohol dependence, 2013, Dec-01, Volume: 133, Issue:2 Topics: Adult; Alcoholism; Algorithms; Diagnostic and Statistical Manual of Mental Disorders; Double-Blind M	2013
Change in psychiatric symptomatology after benfotiamine treatment in males is related to lifetime alcoholism severity. Drug and alcohol dependence, 2015, Jul-01, Volume: 152 Topics: Adult; Alcoholism; Depression; Double-Blind Method; Humans; Male; Middle Aged; Psychiatric Status Ra	2015
Randomized open-label trial of baclofen for relapse prevention in alcohol dependence. The American journal of drug and alcohol abuse, 2017, Volume: 43, Issue:3 Topics: Adult; Alcohol Abstinence; Alcohol Drinking; Alcoholism; Anxiety; Baclofen; Craving; GABA-B Receptor	2017
[Medicamentous therapy of alcoholic polyneuropathy. Randomized double-blind study comparing 2 vitamin B preparations and a nucleotide preparation]. Fortschritte der Medizin, 1996, Nov-20, Volume: 114, Issue:32 Topics: Adult; Alcoholism; Cytidine; Double-Blind Method; Drug Administration Schedule; Drug Therapy, Combin	1996

benphothiamine and Alcoholism