Evidence map›Paper›PMID 24583757›Full record

Trial reportJournal of clinical gastroenterology2015

Double-blind randomized placebo-controlled clinical trial of omega 3 fatty acids for the treatment of diabetic patients with nonalcoholic steatohepatitis.

Srinivasan Dasarathy, Jaividhya Dasarathy, Amer Khiyami, Lisa Yerian, Carol Hawkins, Ruth Sargent, Arthur J McCullough

Open access · greenAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of clinical gastroenterology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 69 papers, 15 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
69citing papers in PubMed, 15 pooled it
12.2field-weighted citation impact, top 1% 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

69 citing papers in PubMed, 15 syntheses or guidelines pooled it, 165 citations in OpenAlex.

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9 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 4 institutions in 1 country.

Srinivasan DasarathyDepartments of *Gastroenterology †Pathobiology ∥Pathology, Cleveland Clinic Departments of ¶Gastroenterology ‡Family Medicine §Pathology, MetroHealth Medical Center, Cleveland, OH.
Jaividhya Dasarathy
Amer Khiyami
Lisa Yerian
Carol Hawkins
Ruth Sargent
Arthur J McCullough
University Gastroenterology · USCleveland Clinic · USDay Family Medicine · USMetroHealth · US

Funding

NASH PROJECTU01DK061732 · CLEVELAND CLINIC LERNER COM-CWRU · 2002 to 2025
$2.0M
NCATS NIH HHS UL1 TR000439NCATS NIH HHS UL1TR000439NIDDK NIH HHS DK83414NIDDK NIH HHS R01 DK083414NIDDK NIH HHS U01 DK061732PHS HHS U01061732
6 · The paper itself

Abstract

backgroundNonalcoholic steatohepatitis (NASH) is common and severe in patients with diabetes mellitus. Although, there are no effective treatments for NASH in diabetic patients, preliminary reports suggest that polyunsaturated fatty acids (PUFA) may be beneficial in these patients.

aimA prospective, randomized, double-blind placebo-controlled study (NCT 00323414) was performed in NASH patients with diabetes. Clinicaltrials.gov (NCT 00323414). SUBJECTS AND

methodsA total of 37 patients (50.6 ± 9.8 y) with well-controlled diabetes (HbA1C<8.5%) were randomized to receive either PUFA containing eicosapentaenoic acid (2160 mg) and docosahexaenoic acid (1440 mg) daily or an isocaloric, identical placebo containing corn oil for 48 weeks under CONSORT guidelines. Clinical, demographics, biochemical laboratory tests, body composition using DEXA, and liver biopsy were performed at randomization and at the end of treatment. Liver biopsy was scored by the NASH CRN criteria. An intention-to-treat analysis was performed.

resultsAt inclusion, sex, age, body weight, biochemical tests, glucose control, and liver histology were similar in the 2 treatment groups. There was no change in liver enzymes, body weight, or body composition during the study in either group. At the end of the treatment, hepatic steatosis and the activity score improved (P<0.05) and lobular inflammation worsened (P<0.001) with placebo but was unchanged with PUFA. At the end of the treatment, insulin resistance (serum glucose and HOMA) worsened with PUFA but not placebo.

conclusionsPUFA provided no benefit over placebo in NASH patients with diabetes. The effects of PUFA on histology and insulin resistance were inferior to placebo. These data provide no support for PUFA supplements in NASH.

Indexed as

Administration, OralAdultBiomarkersBiopsyCapsulesDiabetes MellitusDocosahexaenoic AcidsDouble-Blind MethodDrug Therapy, CombinationEicosapentaenoic AcidFeasibility StudiesFemaleHumansInsulin ResistanceIntention to Treat AnalysisMaleBiomarkersCapsulesDocosahexaenoic AcidsEicosapentaenoic Acid

Identifiers

PMID24583757
PMCPMC4147029
OpenAlexW2080725795

What Socratic 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 Socratic graph.