Evidence map›Paper›PMID 27184636›Full record

Trial reportSaudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association

An open-label randomized control study to compare the efficacy of vitamin e versus ursodeoxycholic acid in nondiabetic and noncirrhotic Indian NAFLD patients.

Pathik Parikh, Meghraj Ingle, Jatin Patel, Prasad Bhate, Vikas Pandey, Prabha Sawant

Open access · diamondAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 1 pooled it
3.3field-weighted citation impact, top 8% 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

19 citing papers in PubMed, 1 synthesis or guideline pooled it, 34 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Relationship between three commonly used non-invasive fibrosis biomarkers and improvement in fibrosis stage in patients with non-alcoholic steatohepatitis.Liver international : official journal of the International Association for the Study of the Liver · 2019
    Trial
  5. Trial
  6. Trial
  7. Article
  8. Review
  9. Review
  10. Review
  11. Article
  12. Review
  13. Article
  14. An Update on Efficacy and Safety of Emerging Hepatic Antifibrotic Agents.Journal of clinical and translational hepatology · 2021
    Review
  15. Review
  16. Article
  17. Review
  18. Review
  19. Is vitamin e or ursodeoxycholic acid a valid treatment option for nonalcoholic fatty liver disease in 2016?Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors at 1 institution in 1 country.

Pathik ParikhDepartment of Gastroenterology, Lokmanya Tilak Municipal Medical College, Mumbai, Maharashtra, India.
Meghraj IngleDepartment of Gastroenterology, Lokmanya Tilak Municipal Medical College, Mumbai, Maharashtra, India.
Jatin PatelDepartment of Gastroenterology, Lokmanya Tilak Municipal Medical College, Mumbai, Maharashtra, India.
Prasad BhateDepartment of Gastroenterology, Lokmanya Tilak Municipal Medical College, Mumbai, Maharashtra, India.
Vikas PandeyDepartment of Gastroenterology, Lokmanya Tilak Municipal Medical College, Mumbai, Maharashtra, India.
Prabha SawantDepartment of Gastroenterology, Lokmanya Tilak Municipal Medical College, Mumbai, Maharashtra, India.
Lokmanya Tilak Municipal General Hospital and Lokmanya Tilak Municipal Medical College · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND/

aimThe study was carried out to compare the efficacy of Vitamin E versus Ursodeoxycholic acid (UDCA) in nondiabetic nonalcoholic fatty liver disease (NAFLD) patients. PATIENTS AND

methodsWe randomized 250 non cirrhotic and non diabetic NAFLD patients diagnosed on ultrasound, with raised alanine aminotransferase (ALT) level. (>40 IU/L), to receive Vitamin E 400 mg twice a day (Group A) or UDCA 300 mg twice a day (Group B) for 52 weeks. Lifestyle modification to achieve at least 5% weight reduction and subsequent weight control and regular exercise was advised to both groups. The primary study endpoint was normalization of ALT. Secondary endpoints were the proportion of patients with reduction in ALT, relative reduction in the NAFLD Fibrosis score (NFS), symptomatic improvement and tolerability.

resultsOne hundred and fifty patients received UDCA as compared to 100 patients receiving Vitamin E. The treatment groups were comparable at entry with regard to age (44.1 vs 42.4 years), gender (67% vs 63% female), risk factors for nonalcoholic steatohepatitis, hypochondriac pain, serum liver biochemistries, and NAFLD Fibrosis score. The primary endpoint was achieved in 21 (14%) and 19 (19%) of patients in Group A and Group B, respectively (P = 0.2). The proportion of patients with reduction in ALT (56% vs 63%, P = 0.2), symptomatic improvement (78% vs 67%, P= 0.058), reduction in the NFS (44% vs 47%, P= 0.69), and tolerability (98% vs 95%, P= 0.2) were similar between Group A and Group B, respectively.

conclusionUDCA is an effective and safe alternative to Vitamin E in nondiabetic-noncirrhotic Indian NAFLD patients.

Indexed as

AdultAlanine TransaminaseAntioxidantsCholagogues and CholereticsFemaleHumansIndiaMaleMiddle AgedNon-alcoholic Fatty Liver DiseaseProspective StudiesTreatment OutcomeUrsodeoxycholic AcidVitamin EAlanine TransaminaseAntioxidantsCholagogues and CholereticsUrsodeoxycholic AcidVitamin E

Identifiers

PMID27184636
PMCPMC4898087
OpenAlexW2380501139

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-SA
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.