Evidence map›Paper›PMID 23992649›Full record

Trial reportDrug and alcohol dependence2013

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

Ann M Manzardo, Jianghua He, Albert Poje, Elizabeth C Penick, Jan Campbell, Merlin G Butler

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Drug and alcohol dependence, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 2 pooled it
2.5field-weighted citation impact, top 11% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 2 syntheses or guidelines pooled it, 26 citations in OpenAlex.

  1. Pooled it
  2. Baclofen for alcohol use disorder.The Cochrane database of systematic reviews · 2023
    Pooled it
  3. Trial
  4. Thiamine Deficiency and Neuroinflammation Are Important Contributors to Alcohol Use Disorder.Pathophysiology : the official journal of the International Society for Pathophysiology · 2025
    Review
  5. Review
  6. Article
  7. Review
  8. Review
  9. Article
  10. Review
  11. Article
  12. Article
  13. Article
  14. 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

6 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.
Jianghua He
Albert Poje
Elizabeth C Penick
Jan Campbell
Merlin G Butler
University of Kansas Medical Center · US

Funding

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 RR033179NCRR NIH HHS UL1RR033179
6 · The paper itself

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.

Indexed as

AdultAlcoholismAlgorithmsDiagnostic and Statistical Manual of Mental DisordersDouble-Blind MethodFemaleHumansLongitudinal StudiesMaleMiddle AgedSex CharacteristicsThiamineThiamine DeficiencyTreatment OutcomeYoung AdultbenphothiamineThiamineAlcoholismBenfotiamineFemale alcohol consumptionThiamine

Identifiers

PMID23992649
PMCPMC3818307
OpenAlexW2091380777

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.