Evidence map›Paper›PMID 17356040›Full record

Trial reportGut2007

Randomised, double blind, placebo controlled trial of intravenous antioxidant (n-acetylcysteine, selenium, vitamin C) therapy in severe acute pancreatitis.

Ajith K Siriwardena, James M Mason, Srinivasan Balachandra, Anil Bagul, Simon Galloway, Laura Formela, Jonathan G Hardman, Saurabh Jamdar

Open access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Gut, 2007. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 63 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
63citing papers in PubMed, 11 pooled it
7.9field-weighted citation impact, top 2% 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

63 citing papers in PubMed, 11 syntheses or guidelines pooled it, 171 citations in OpenAlex.

  1. Pooled it
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  4. Pharmacological interventions for acute pancreatitis.The Cochrane database of systematic reviews · 2017
    Pooled it
  5. Pooled it
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  8. N-acetylcysteine for sepsis and systemic inflammatory response in adults.The Cochrane database of systematic reviews · 2012
    Pooled it
  9. Pooled it
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  11. Antioxidant supplements for preventing gastrointestinal cancers.The Cochrane database of systematic reviews · 2008
    Pooled it
  12. Trial
  13. Safety and efficacy of vitamin-based antioxidant therapy in patients with severe acute pancreatitis: a randomized controlled trial.Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association
    Trial
  14. Review
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  20. Article

3 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 4 institutions in 1 country.

Ajith K SiriwardenaHepatobiliary Unit, Department of Surgery, Manchester Royal Infirmary, Manchester M13 9WL, UK. ajith.siriwardena@cmmc.nhs.uk
James M Mason
Srinivasan Balachandra
Anil Bagul
Simon Galloway
Laura Formela
Jonathan G Hardman
Saurabh Jamdar
Manchester Royal Infirmary · GBDurham University · GBSalford Royal Hospital · GBWythenshawe Hospital · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBased on equivocal clinical data, intravenous antioxidant therapy has been used for the treatment of severe acute pancreatitis. To date there is no randomised comparison of this therapy in severe acute pancreatitis.

methodsWe conducted a randomised, double blind, placebo controlled trial of intravenous antioxidant (n-acetylcysteine, selenium, vitamin C) therapy in patients with predicted severe acute pancreatitis. Forty-three patients were enrolled from three hospitals in the Manchester (UK) area over the period June 2001 to November 2004. Randomisation stratified for APACHE-II score and hospital site, and delivered groups that were similar at baseline.

resultsRelative serum levels of antioxidants rose while markers of oxidative stress fell in the active treatment group during the course of the trial. However, at 7 days, there was no statistically significant difference in the primary end point, organ dysfunction (antioxidant vs placebo: 32% vs 17%, p = 0.33) or any secondary end point of organ dysfunction or patient outcome.

conclusionsThis study provides no evidence to justify continued use of n-acetylcysteine, selenium, vitamin C based antioxidant therapy in severe acute pancreatitis. In the context of any future trial design, careful consideration must be given to the risks raised by the greater trend towards adverse outcome in patients in the treatment arm of this study.

Indexed as

AcetylcysteineAcute DiseaseAdultAgedAntioxidantsAPACHEAscorbic AcidDouble-Blind MethodDrug Administration ScheduleDrug Therapy, CombinationFemaleHumansInfusions, IntravenousMaleMiddle AgedOxidative StressAcetylcysteineAntioxidantsAscorbic AcidSelenium

Identifiers

PMID17356040
PMCPMC2000286
OpenAlexW2138579645

What OpenQuestion holds

Textmetadata
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.