Evidence map›Paper›PMID 24373555›Full record

Trial reportNutrition journal2013

Tocotrienols for normalisation of hepatic echogenic response in nonalcoholic fatty liver: a randomised placebo-controlled clinical trial.

Enrico Magosso, Mukhtar Alam Ansari, Yogheswaran Gopalan, Ibrahim Lutfi Shuaib, Jia-Woei Wong, Nurzalina Abdul Karim Khan, Mohamed Rizal Abu Bakar, Bee-Hong Ng, Kah-Hay Yuen

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Nutrition journal, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 35 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 9 pooled it
2.6field-weighted citation impact, top 10% 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

35 citing papers in PubMed, 9 syntheses or guidelines pooled it, 78 citations in OpenAlex.

  1. Pooled it
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  3. Vitamin E for people with non-alcoholic fatty liver disease.The Cochrane database of systematic reviews · 2024
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  8. ESPEN guideline on clinical nutrition in liver disease.Clinical nutrition (Edinburgh, Scotland) · 2019
    Guideline
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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

9 authors at 2 institutions in 1 country.

Enrico Magosso
Mukhtar Alam Ansari
Yogheswaran Gopalan
Ibrahim Lutfi Shuaib
Jia-Woei Wong
Nurzalina Abdul Karim Khan
Mohamed Rizal Abu Bakar
Bee-Hong Ng
Kah-Hay YuenSchool of Pharmaceutical Sciences, Universiti Sains Malaysia, Penang, Malaysia. khyuen@usm.my.
Universiti Sains Malaysia · MYUniversiti Teknologi MARA · MY

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNonalcoholic fatty liver disease (NAFLD) is one of the commonest liver disorders. Obesity, insulin resistance, lipid peroxidation and oxidative stress have been identified amongst the possible hits leading to the onset and progression of this disease. Nutritional evaluation of NAFLD patients showed a lower-than-recommended intake of vitamin E. Vitamin E is a family of 8 isoforms, 4 tocopherols and 4 tocotrienols. Alpha-tocopherol has been widely investigated in liver diseases, whereas no previous clinical trial has investigated tocotrienols for NAFLD. Aim of the study was to determine the effects of mixed tocotrienols, in normalising the hepatic echogenic response in hypercholesterolaemic patients with ultrasound-proven NAFLD.

methodsEighty-seven untreated hypercholesterolaemic adults with ultrasound-proven NAFLD were enrolled and randomised into control group (n = 44) and tocotrienols group (n = 43). The treatment, either mixed tocotrienols 200 mg twice daily or placebo, had a 1-year duration.Normalisation of hepatic echogenic response, being the trial primary aim, was used in sample size calculations. The data were assessed according to intention to treat principle as primary outcome. Per protocol analysis was also carried out as secondary outcome measurement.

resultsThirty and 34 participants concluded the study in the tocotrienols and placebo group respectively. Alpha-tocopherol levels were within the normal range for all subjects. As primary outcome, the normalisation of hepatic echogenic response was significantly higher for the tocotrienols treated group compared to the placebo group in the intention to treat analysis (P = 0.039; 95% CI = 0.896-6.488). As secondary objective, the per protocol assessment also showed significant rate of remission (P = 0.014; 95% CI = 1.117-9.456). Worsening of NAFLD grade was recorded in two patients in the placebo group, but none in the group treated with tocotrienols. No adverse events were reported for both groups.

conclusionThis is the first clinical trial that showed the hepatoprotective effects of mixed palm tocotrienols in hypercholesterolemic adults with NAFLD.

Indexed as

AdultAgedAlanine Transaminasealpha-TocopherolApolipoproteins BAspartate AminotransferasesCholesterolC-Reactive ProteinDose-Response Relationship, DrugDouble-Blind MethodFatty LiverFemalegamma-GlutamyltransferaseHumansLiverMaleAlanine Transaminasealpha-TocopherolApolipoproteins BAspartate AminotransferasesCholesterolC-Reactive Proteingamma-GlutamyltransferaseTocotrienolsTriglycerides

Identifiers

PMID24373555
PMCPMC3877967
OpenAlexW2124456564

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.