Evidence map›Paper›PMID 20104219›Full record

Trial reportThe American journal of gastroenterology2010

Cognitive function does not worsen during long-term low-dose peginterferon therapy in patients with chronic hepatitis C.

Robert J Fontana, Linas A Bieliauskas, Carla Back-Madruga, Karen L Lindsay, Heather J Litman, Anna Sf Lok, Ziad Kronfol, HALT-C Trial Group

Open access · greenAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The American journal of gastroenterology, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
1.1field-weighted citation impact, top 23% 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

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 15 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. 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 at 4 institutions in 1 country.

Robert J FontanaDivision of Gastroenterology, Department of Internal Medicine, University of Michigan, 3912 Taubman Center, Ann Arbor, MI 48109-0362, USA. rfontana@med.umich.edu
Linas A Bieliauskas
Carla Back-Madruga
Karen L Lindsay
Heather J Litman
Anna Sf Lok
Ziad Kronfol
HALT-C Trial Group
University of Michigan–Ann Arbor · USUniversity of Southern California · USNew England Research Institutes · USOnline Technologies (United States) · US

Funding

ZOPOLRESTAT IN NORMOTENSIVE, TYPE 1 DIA WITH INCIPIENT NEPHROPATHYM01RR000043 · NCRR · UNIVERSITY OF SOUTHERN CALIFORNIA · PI ZAIA, JOHN A · 1985 to 2010
$76.4M
MICHIGAN INSTITUTE FOR CLINICAL AND HEALTH RESEARCH (MICHR) (UL1): (BPCA)UL1RR024986 · NCRR · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI SHANLEY, THOMAS P. · 2007 to 2011
$51.2M
ZINC GLUCONATE GLYCINE LOZENGES &VITAMIN C EFFECTS ON COMMON COLDM01RR000042 · NCRR · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI ORAL, ELIF ARIOGLU · 1985 to 2007
$40.8M
HEPATITIS C CLINICAL TRIAL-DATA COORDINATING CENTER-267092328N01DK092328 · NIDDK · NEW ENGLAND RESEARCH INSTITUTES, INC. · 1999 to 2004
$1.5M
HEPATITIS C CLINICAL TRIAL-CLINICAL CENTERSN01DK092325 · NIDDK · UNIVERSITY OF SOUTHERN CALIFORNIA · PI LINDSAY, KAREN L · 1999 to 2000
$697k
HEPATITIS C CLINICAL TRIAL-CLINICAL CENTERSN01DK092323 · NIDDK · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI LOK, ANNA SF · 1999 to 2000
$233k
NCRR NIH HHS 1 UL1 RR024986NCRR NIH HHS M01 RR000042NCRR NIH HHS M01 RR000043NCRR NIH HHS M01RR-00042NCRR NIH HHS M01RR-00043NCRR NIH HHS UL1 RR024986NIDDK NIH HHS N01 DK092323NIDDK NIH HHS N01 DK092325NIDDK NIH HHS N01 DK092328NIDDK NIH HHS N01-DK-9-2323NIDDK NIH HHS N01-DK-9-2325NIDDK NIH HHS N01-DK-9-2328
6 · The paper itself

Abstract

objectivesNeuropsychiatric toxicity is a common dose-limiting side effect of interferon therapy. The primary aim of this study was to determine whether patients receiving long-term low-dose peginterferon therapy had a higher incidence of cognitive side effects compared with untreated patients enrolled in the Hepatitis C Antiviral Long-Term treatment against Cirrhosis (HALT-C) Trial.

methodsA total of 129 patients with chronic hepatitis C and advanced fibrosis completed a battery of 10 neuropsychological tests and the Beck Depression Inventory at pretreatment baseline and at months 12, 24, 36, and 48 while receiving long-term peginterferonalpha2a (90 microg/week) or no therapy during the randomized phase of the HALT-C Trial. Cognitive impairment was defined as a global deficit score (GDS) > or = 1.0.

resultsThe mean age was 51.2 years, 67% were male, and 42% had cirrhosis. After accounting for baseline GDS scores, the mean GDS scores did not significantly change over time (P=0.46) nor with treatment group (P=0.49). Cognitive function was also not influenced by medication adherence in the 66 patients receiving maintenance peginterferon (P=0.14) after controlling for baseline GDS scores and time. Beck Depression scores did not significantly increase over time (P=0.60), nor did they vary by treatment group (P=0.74). Although 32% of patients experienced objective worsening of their liver disease during follow-up, the frequency and severity of cognitive impairment did not differ in those with and without disease progression (P=0.71).

conclusionsMeasures of cognitive function were neither influenced by low-dose peginterferon treatment nor with objective evidence of liver disease progression in patients with advanced chronic hepatitis C prospectively followed up for 3.5 years.

Indexed as

Analysis of VarianceAntiviral AgentsCognitionDisease ProgressionFemaleHepatitis C, ChronicHumansInterferon-alphaInterferon alpha-2Liver CirrhosisMaleMiddle AgedNeuropsychological TestsPolyethylene GlycolsProportional Hazards ModelsRecombinant ProteinsAntiviral AgentsInterferon-alphaInterferon alpha-2peginterferon alfa-2aPolyethylene GlycolsRecombinant Proteins

Identifiers

PMID20104219
PMCPMC3772520
OpenAlexW2063153695

What OpenQuestion 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 OpenQuestion graph.