Evidence map›Paper›PMID 27842532›Full record

Trial reportBMC psychiatry2016

Silybin supplementation during HCV therapy with pegylated interferon-α plus ribavirin reduces depression and anxiety and increases work ability.

Giulia Malaguarnera, Gaetano Bertino, Giuseppe Chisari, Massimo Motta, Michele Vecchio, Marco Vacante, Filippo Caraci, Carmela Greco, Filippo Drago, Giuseppe Nunnari and 1 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC psychiatry, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01957319 (Silybin Supplementation During HCV Therapy With Pegylated Interferon-α2b Plus Ribavirin Reduces Depression and Increases Work Ability), which is not on this map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
5.1field-weighted citation impact, top 5% 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.

NCT01957319 phase3completednot on this map

Silybin Supplementation During HCV Therapy With Pegylated Interferon-α2b Plus Ribavirin Reduces Depression and Increases Work Ability

TypeinterventionalSponsorUniversity of CataniaRan2010 to 2013Enrolled72ConditionsWork Ability, DepressionArmsSilybin 94 mg + vitamin E 90 mg + phospholipids 194 mg, sugar pill
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 1 synthesis or guideline pooled it, 25 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Review
  5. Review
  6. Review
  7. Review
  8. Review
  9. Review
  10. Article
  11. Article
  12. Antiviral Activities of Silymarin and Derivatives.Molecules (Basel, Switzerland) · 2019
    Review
  13. Anorectal mucosal melanoma.Oncotarget · 2018
    Review
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

11 authors at 2 institutions in 1 country.

Giulia MalaguarneraResearch Center "The Great Senescence", University of Catania, Catania, Italy. giulia.malaguarnera@live.it.ORCID http://orcid.org/0000-0003-3655-4307
Gaetano BertinoDepartment of Experimental and Clinical Medicine, University of Catania, Catania, Italy.
Giuseppe ChisariDepartment of Biomedical and Biotechnological Sciences, University of Catania, Catania, Italy.
Massimo MottaResearch Center "The Great Senescence", University of Catania, Catania, Italy.
Michele VecchioU.O.C Physical Medicine and Rehabilitation, A.O.U. Policlinico Vittorio Emanuele, Catania, Italy.
Marco VacanteResearch Center "The Great Senescence", University of Catania, Catania, Italy.
Filippo CaraciDepartment of Drug Sciences, University of Catania, Catania, Italy.
Carmela GrecoResearch Center "The Great Senescence", University of Catania, Catania, Italy.
Filippo DragoDepartment of Biomedical and Biotechnological Sciences, University of Catania, Catania, Italy.
Giuseppe NunnariDepartment of Experimental and Clinical Medicine, University of Catania, Catania, Italy.
Michele MalaguarneraResearch Center "The Great Senescence", University of Catania, Catania, Italy.
University of Catania · ITAzienda Ospedaliero-Universitaria Policlinico - Vittorio Emanuele · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHepatitis C virus infection and interferon treatment are often associated with anxiety, depressive symptoms and poor health-related quality of life. To evaluate the Silybin-vitamin E-phospholipids complex effect on work ability and whether health related factors (anxiety and depression) were associated with work ability in subjects with chronic hepatitis C treated with Pegylated-Interferon-α2b (Peg-IFN) and Ribavirin (RBV).

methodsThirty-one patients (Group A) with chronic hepatitis and other 31 subjects in Group B were recruited in a randomized, prospective, placebo controlled, double blind clinical trial. Group A received 1.5 mg/kg per week of Peg-IFN plus RBV and placebo, while Group B received the same dosage of Peg-IFN plus RBV plus association of Silybin 94 mg + vitamin E 30 mg + phospholipids 194 mg in pills for 12 months. All subjects underwent to laboratory exams and questionnaires to evaluate depression (Beck Depression Inventory - BDI), anxiety (State-trait anxiety inventory - STAI) and work ability (Work ability Index - WAI).

resultsThe comparison between group A and group B showed significant differences after 6 months in ALT (P < 0.001), and viremia (P < 0.05), after 12 months in ALT (P < 0.001), and AST (P < 0.001), at follow up in AST (P < 0.05), and ALT (P < 0.001). Significant difference were observed after 1 month in WAI (p < 0.001) and BDI (P < 0.05), after 6 months in WAI (P < 0.05) and STAI (P < 0.05), after 12 months and at follow up in WAI, STAI and BDI (p < 0.01).

conclusionsThe supplementation with Silybin-vitamin E -phospholipids complex increased work ability and reduced depression and anxiety in patients treated with Peg-IFN and RBV.

trial registrationNCT01957319 , First received: September 25, 2013. Last updated: September 30, 2013 (retrospectively registered).

Indexed as

AnxietyDepressionHepatitis C, ChronicAdultAntioxidantsAntiviral AgentsDouble-Blind MethodDrug Therapy, CombinationFemaleHumansInterferon-alphaMaleMiddle AgedPsychiatric Status Rating ScalesRibavirinSilybinAntioxidantsAntiviral AgentsInterferon-alphaRibavirinSilybinSilymarinAnxietyDepressionHepatitis CInterferonSilybinWork ability index

Identifiers

PMID27842532
PMCPMC5109776
OpenAlexW2555602186

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.