Evidence map›Paper›PMID 36899430›Full record

ArticleTrials2023

Efficacy of silymarin in patients with non-alcoholic fatty liver disease - the Siliver trial: a study protocol for a randomized controlled clinical trial.

Camila Ribeiro de Avelar, Beatriz Vieira Coelho Nunes, Betina da Silva Sassaki, Mariana Dos Santos Vasconcelos, Lucivalda Pereira Magalhães de Oliveira, André Castro Lyra, Allain Amador Bueno, Rosângela Passos de Jesus

Registry-linked trialFull text readClinical Trial Protocol
In one paragraph

Article in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03749070 (Efficacy of Silymarin in Patients With Non-alcoholic Fatty Liver Disease - The SILIVER Trial), which is not on this map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
–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.

NCT03749070 naunknown statusnot on this map

Efficacy of Silymarin in Patients With Non-alcoholic Fatty Liver Disease - The SILIVER Trial: Randomized Clinical Trial

TypeinterventionalSponsorCamila Ribeiro de AvelarRan2019 to 2022Enrolled132ConditionsNon-Alcoholic Fatty Liver DiseaseArmsSilymarin
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Review
  6. Review
  7. Review
  8. Article
  9. Review
  10. Preventive and Therapeutic Effects ofACS pharmacology & translational science · 2023
    Article
  11. Current Therapeutical Approaches Targeting Lipid Metabolism in NAFLD.International journal of molecular sciences · 2023
    Review
  12. Iranian journal of parasitology
    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

8 authors.

Camila Ribeiro de AvelarDepartment of Nutrition Sciences, Federal University of Bahia, Bahia, 32 Araújo Pinho Street, Canela, Salvador, Bahia, 40.110-150, Brazil. contato@camilaavelar.com.br.ORCID http://orcid.org/0000-0002-6388-3723
Beatriz Vieira Coelho NunesDepartment of Nutrition Sciences, Federal University of Bahia, Bahia, 32 Araújo Pinho Street, Canela, Salvador, Bahia, 40.110-150, Brazil.
Betina da Silva SassakiDepartment of Nutrition Sciences, Federal University of Bahia, Bahia, 32 Araújo Pinho Street, Canela, Salvador, Bahia, 40.110-150, Brazil.
Mariana Dos Santos VasconcelosDepartment of Nutrition Sciences, Federal University of Bahia, Bahia, 32 Araújo Pinho Street, Canela, Salvador, Bahia, 40.110-150, Brazil.
Lucivalda Pereira Magalhães de OliveiraDepartment of Nutrition Sciences, Federal University of Bahia, Bahia, 32 Araújo Pinho Street, Canela, Salvador, Bahia, 40.110-150, Brazil.
André Castro LyraGastrohepatology Service, Professor Edgard Santos University Hospital, Federal University of Bahia, Salvador, Bahia, Brazil.
Allain Amador BuenoCollege of Health, Life and Environmental Sciences, University of Worcester, Worcester, WR2 6AJ, UK.
Rosângela Passos de JesusDepartment of Nutrition Sciences, Federal University of Bahia, Bahia, 32 Araújo Pinho Street, Canela, Salvador, Bahia, 40.110-150, Brazil.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNon-alcoholic fatty liver disease (NAFLD) is one of the most prevalent liver diseases globally. Pharmacological treatments for NAFLD are still limited. Silymarin, a compound extracted from Silybum marianum, is an herbal supplement traditionally used in folk medicine for liver disorders. It has been proposed that silymarin may possess hepatoprotective and anti-inflammatory properties. The present trial aims to assess the efficacy of silymarin supplementation in the adjuvant treatment of NAFLD in adult patients.

methodThis is a randomized double-blind placebo-controlled clinical trial recruiting adult NAFLD patients in therapy on an outpatient basis. Participants are randomized to an intervention (I) or control (C) group. Both groups receive identical capsules and are followed for 12 weeks. I receives 700mg of silymarin + 8mg vitamin E + 50mg phosphatidylcholine daily, while C receives 700mg maltodextrin + 8mg vitamin E + 50mg phosphatidylcholine daily. Patients undergo a computerized tomography (CT) scan and blood tests at the beginning and end of the study. Monthly face-to-face consultations and weekly telephone contact are carried out for all participants. The primary outcome assessed will be change in NAFLD stage, if any, assessed by the difference in attenuation coefficient between liver and spleen, obtained by upper abdomen CT. DISCUSSION: The results of this study may provide a valuable opinion on whether silymarin can be used as adjuvant therapy for the management or treatment of NAFLD. The data presented on the efficacy and safety of silymarin may provide more foundation for further trials and for a possible use in clinical practice.

trial registrationThis study has been approved by the Research Ethics Committee of the Professor Edgard Santos University Hospital Complex, Salvador BA, Brazil, under protocol 2.635.954. The study is carried out according to guidelines and regulatory standards for research involving humans, as set out in Brazilian legislation. Trial registration - ClinicalTrials.gov : NCT03749070. November 21, 2018.

Indexed as

Non-alcoholic Fatty Liver DiseaseSilymarinAdultDietary SupplementsDouble-Blind MethodHumansRandomized Controlled Trials as TopicVitamin ESilymarinVitamin EClinical trialNon-alcoholic fatty liver diseaserandomized controlled trialSilymarin

Identifiers

PMID36899430
PMCPMC10000352

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.