Evidence map›Paper›PMID 25908323›Full record

Trial reportDrug and alcohol dependence2015

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

Ann M Manzardo, Tiffany Pendleton, Albert Poje, Elizabeth C Penick, Merlin G Butler

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Drug and alcohol dependence, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00680121 (The Effectiveness of Benfotiamine in Reducing Abusive Drinking Among Family History Positive and Negative Alcoholics), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
0.7field-weighted citation impact, top 29% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00680121 phase4completednot on this map

The Effectiveness of Benfotiamine in Reducing Abusive Drinking Among Family History Positive and Negative Alcoholics

TypeinterventionalSponsorUniversity of KansasRan2008 to 2013Enrolled120ConditionsAlcoholismArmsBenfotiamine, Placebo
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 11 citations in OpenAlex.

  1. Baclofen for alcohol use disorder.The Cochrane database of systematic reviews · 2023
    Pooled it
  2. Article
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 1 institution in 1 country.

Ann M ManzardoDepartment of Psychiatry & Behavioral Sciences, University of Kansas Medical Center, United States. Electronic address: amanzardo@kumc.edu.
Tiffany PendletonDepartment of Psychiatry & Behavioral Sciences, University of Kansas Medical Center, United States.
Albert PojeDepartment of Psychiatry & Behavioral Sciences, University of Kansas Medical Center, United States.
Elizabeth C PenickDepartment of Psychiatry & Behavioral Sciences, University of Kansas Medical Center, United States.
Merlin G ButlerDepartment of Psychiatry & Behavioral Sciences, University of Kansas Medical Center, United States.
University of Kansas Medical Center · US

Funding

Research Design and Analysis Core (RDAC)P30HD002528 · NICHD · UNIVERSITY OF KANSAS LAWRENCE · PI FOWLER, STEPHEN CLETIUS · 1985 to 2015
$22.1M
Heartland Institute for Clinical and Translational ResearchUL1TR000001 · NCATS · UNIVERSITY OF KANSAS MEDICAL CENTER · PI BAROHN, RICHARD J. · 2012 to 2015
$13.0M
WRITING AND WT LOSS MAINTENANCEM01RR023940 · NCRR · UNIVERSITY OF KANSAS MEDICAL CENTER · PI BURNS, JEFFREY MURRAY · 2007 to 2009
$6.6M
HEARTLAND INSTITUTE FOR CLINICAL AND TRANSLATIONAL RESEARCHUL1RR033179 · NCRR · UNIVERSITY OF KANSAS MEDICAL CENTER · PI BAROHN, RICHARD J. · 2011 to 2011
$3.2M
NCATS NIH HHS UL1 TR000001NCATS NIH HHS UL1TR000001NCRR NIH HHS M01 RR023940NCRR NIH HHS MO1RR023940NCRR NIH HHS UL1 RR033179NICHD NIH HHS HD02528NICHD NIH HHS P30 HD002528
6 · The paper itself

Abstract

backgroundSevere 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.

methodsEighty-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.

resultsBaseline 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).

conclusionBF 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.

Indexed as

AdultAlcoholismDepressionDouble-Blind MethodHumansMaleMiddle AgedPsychiatric Status Rating ScalesThiamineYoung AdultbenphothiamineThiamineAlcoholismBenfotiamine (BF)Thiamine deficiencyVitamin B1

Identifiers

PMID25908323
PMCPMC4550087
OpenAlexW2000443797

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.