Evidence map›Paper›PMID 23070022›Full record

Trial reportPsychopharmacology2013

A standardized kudzu extract (NPI-031) reduces alcohol consumption in nontreatment-seeking male heavy drinkers.

Scott E Lukas, David Penetar, Zhaohui Su, Thomas Geaghan, Melissa Maywalt, Michael Tracy, John Rodolico, Christopher Palmer, Zhongze Ma, David Y-W Lee

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Psychopharmacology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed
–field-weighted citation impact
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

21 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Trial
  4. Article
  5. Review
  6. Review
  7. Article
  8. Review
  9. Article
  10. Differential Influence ofPharmaceuticals (Basel, Switzerland) · 2021
    Article
  11. Plants with Anti-Addictive Potential.Advances in experimental medicine and biology · 2021
    Article
  12. Article
  13. Article
  14. Applications ofChinese herbal medicines · 2019
    Article
  15. Review
  16. Article
  17. Review
  18. Article
  19. Article
  20. 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

10 authors.

Scott E LukasBehavioral Psychopharmacology Research Laboratory/MIC, Mail Stop 319 McLean Hospital, 115 Mill Street, Belmont, MA 02478, USA. Lukas@mcLean.harvard.edu
David Penetar
Zhaohui Su
Thomas Geaghan
Melissa Maywalt
Michael Tracy
John Rodolico
Christopher Palmer
Zhongze Ma
David Y-W Lee

Funding

Project 4 - Chinese Herbal Medicine to Treat Alcohol &Drug AbuseP01AT002038 · NCCIH · MC LEAN HOSPITAL (BELMONT, MA) · PI LUKAS, SCOTT E · 2004 to 2008
$5.8M
ISOFLAVONE TREATMENT FOR ALCOHOL ABUSER01AA010536 · NIAAA · MC LEAN HOSPITAL (BELMONT, MA) · PI LUKAS, SCOTT E · 1996 to 2011
$5.0M
PHARMACOLOGICAL AND BEHAVIORAL INDICES OF DRUG ABUSEK05DA000343 · NIDA · MC LEAN HOSPITAL (BELMONT, MA) · PI LUKAS, SCOTT E · 1997 to 2008
$1.1M
NCCIH NIH HHS P01 AT002038NCCIH NIH HHS P01-AT002038NIAAA NIH HHS R01 AA010536NIAAA NIH HHS R01-AA10536NIDA NIH HHS K05 DA000343NIDA NIH HHS K05-DA00343
6 · The paper itself

Abstract

objectiveWe previously demonstrated that short-term treatment with a standardized kudzu extract (NPI-031) reduced alcohol drinking by men and women in a natural setting. The present study was conducted in nontreatment-seeking heavy drinkers to assess the safety and efficacy of 4 weeks of kudzu extract in an outpatient setting.

methodThis randomized between-subject, double-blind, placebo-controlled study involved 2 weeks of baseline, 4 weeks of treatment, and 2 weeks of follow-up. Seventeen men (21-33 years) who reported drinking 27.6 ± 6.5 drinks/week with a diagnosis of alcohol abuse/dependence took either kudzu extract (250 mg isoflavones, t.i.d.) or matched placebo on a daily basis. They reported alcohol consumption and desire to use alcohol using a wrist actigraphy device; twice weekly laboratory visits were scheduled to monitor medication adherence and adverse events.

resultsMedication adherence was excellent and there were no adverse events and changes in vital signs, blood chemistry, and renal or liver function. There was no effect on alcohol craving, but kudzu extract significantly reduced the number of drinks consumed each week by 34-57 %, reduced the number of heavy drinking days, and significantly increased the percent of days abstinent and the number of consecutive days of abstinence.

conclusionsA standardized formulation of kudzu extract produced minimal side effects, was well-tolerated, and resulted in a modest reduction in alcohol consumption in young nontreatment-seeking heavy drinkers. Additional studies using treatment-seeking alcohol-dependent persons will be necessary to determine the usefulness of this herbal preparation in reducing alcohol use in other populations.

Indexed as

AdultAlcohol DeterrentsAlcohol DrinkingAlcoholismDouble-Blind MethodDrug-Seeking BehaviorEthanolHumansMaleMedication AdherencePlant ExtractsPuerariaYoung AdultAlcohol DeterrentsEthanolPlant Extracts

Identifiers

PMID23070022
PMCPMC3562758

What OpenQuestion holds

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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.