Evidence map›Paper›PMID 21787433›Full record

Trial reportBMC clinical pharmacology2011

The effects of polyunsaturated fatty acids in alcohol dependence treatment--a double-blind, placebo-controlled pilot study.

Marina N Fogaça, Ruth F Santos-Galduróz, Jaqueline K Eserian, José Carlos F Galduróz

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC clinical pharmacology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01211769 (Alcohol Dependence), which is not on this map. Cited by 8 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 2 pooled it
0.4field-weighted citation impact, top 33% 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.

NCT01211769 phase3completednot on this map

Alcohol Dependence: Study of the Possible Reduction of Compulsion by Association of Naltrexone With Poly-unsaturated Fatty Acids (PUFAs)

TypeinterventionalSponsorFederal University of São PauloRan2006 to 2008Enrolled80ConditionsAlcohol DependenceArmsNaltrexone, PUFAs, Placebo, Naltrexone + Placebo
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Pooled it
  3. Review
  4. Article
  5. Mineral oil: safety and use as placebo in REDUCE-IT and other clinical studies.European heart journal supplements : journal of the European Society of Cardiology · 2020
    Article
  6. Article
  7. Article
  8. Article
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

4 authors at 2 institutions in 1 country.

Marina N FogaçaPsychobiology Department, Federal University of São Paulo, Edifício de Ciências Biomédicas, Rua Botucatu 862 - 1° Andar, São Paulo, Brasil.
Ruth F Santos-Galduróz
Jaqueline K Eserian
José Carlos F Galduróz
Universidade Federal de São Paulo · BRUniversidade Paulista · BR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe lipid fraction of cell membranes consists of polyunsaturated fatty acids (PUFAS), and chronic alcohol use alters it, modifying its permeability, what might contribute for the dysfunctional metabolism observed in the central nervous system of alcohol dependent patients. Therefore, the supplementation of PUFAS can be an important adjuvant in alcoholism treatment.

methodsThis was a placebo controlled, double blind, randomized study where, 80 alcohol dependent patients, according to DSM-IV, were allocated in four groups with 20 patient each: 'PUFAS', 'Naltrexone', 'Naltrexone + PUFAS' and 'Placebo'. Those substances were administered for 90 days and scales were applied to assess patients craving (OCDS) and alcohol dependence severity (SADD) at baseline and after 90 days. PUFAS serum levels were assessed before and after treatment by high performance liquid chromatography assay.

resultsForty-three patients completed the trial. There was a significant improvement over time on drinking days, SADD and OCDS scores in all groups (p < 0.001). The drinking days comparison between groups did not show statistical significant difference. The same effect was observed for compulsion (OCDS) and severity of dependence scale (SADD). The serum levels of PUFAS increased in all the supplemented groups after treatment, although not significantly.

conclusionsThe oral supplementation of 2 g PUFAS for 3 months did not significantly differ from placebo in reducing the amount of alcohol ingestion, or OCDS and SADD scores in a group of alcohol dependent patient.

trial registrationNCT01211769.

Indexed as

AdultAlcoholismDiagnostic and Statistical Manual of Mental DisordersDouble-Blind MethodFatty Acids, UnsaturatedFollow-Up StudiesHumansMaleMiddle AgedNaltrexoneNarcotic AntagonistsPilot ProjectsPlacebosFatty Acids, UnsaturatedNaltrexoneNarcotic AntagonistsPlacebos

Identifiers

PMID21787433
PMCPMC3162484
OpenAlexW2158771846

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.