Evidence map›Paper›PMID 18473409›Full record

Trial reportWorld journal of gastroenterology2008

N-acetyl-L-cysteine combined with mesalamine in the treatment of ulcerative colitis: randomized, placebo-controlled pilot study.

Luis G Guijarro, Jose Mate, Javier P Gisbert, Jose Luis Perez-Calle, Ignacio Marin-Jimenez, Encarna Arriaza, Tomas Olleros, Mario Delgado, Maria S Castillejo, David Prieto-Merino and 2 more

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in World journal of gastroenterology, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 2 pooled it
0.4field-weighted citation impact, top 30% 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

25 citing papers in PubMed, 2 syntheses or guidelines pooled it, 52 citations in OpenAlex.

  1. Preventing Colitis-Associated Colon Cancer With Antioxidants: A Systematic Review.Cellular and molecular gastroenterology and hepatology · 2021
    Pooled it
  2. Pooled it
  3. Trial
  4. Article
  5. Review
  6. Article
  7. Oxidative stress in gut TImmunometabolism (Cobham, Surrey) · 2024
    Article
  8. Article
  9. Review
  10. Review
  11. Article
  12. Effects of Troponoids on Mitochondrial Function and Cytotoxicity.Antimicrobial agents and chemotherapy · 2022
    Article
  13. Antioxidants (Basel, Switzerland) · 2021
    Review
  14. Article
  15. Review
  16. Article
  17. ROS in gastrointestinal inflammation: Rescue Or Sabotage?British journal of pharmacology · 2017
    Review
  18. Review
  19. Review
  20. Antioxidant Supplements and Gastrointestinal Diseases: A Critical Appraisal.Medical principles and practice : international journal of the Kuwait University, Health Science Centre · 2017
    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

12 authors at 1 institution in 1 country.

Luis G GuijarroUnidad de Toxicologia Molecular Hepatica, Department de Bioquimica & Biologia Molecular, Universidad de Alcala, E-28871, Alcala de Henares, Spain. luis.gonzalez@uah.es
Jose Mate
Javier P Gisbert
Jose Luis Perez-Calle
Ignacio Marin-Jimenez
Encarna Arriaza
Tomas Olleros
Mario Delgado
Maria S Castillejo
David Prieto-Merino
Venancio Gonzalez Lara
Amado-Salvador Pena
Universidad de Alcalá · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimTo evaluate the effectiveness and safety of oral N-acetyl-L-cysteine (NAC) co-administration with mesalamine in ulcerative colitis (UC) patients.

methodsThirty seven patients with mild to moderate UC were randomized to receive a four-wk course of oral mesalamine (2.4 g/d) plus N-acetyl-L-cysteine (0.8 g/d) (group A) or mesalamine plus placebo (group B). Patients were monitored using the Modified Truelove-Witts Severity Index (MTWSI). The primary endpoint was clinical remission (MTWSI < or = 2) at 4 wk. Secondary endpoints were clinical response (defined as a reduction from baseline in the MTWSI of > or = 2 points) and drug safety. The serum TNF-alpha, interleukin-6, interleukin-8 and MCP-1 were evaluated at baseline and at 4 wk of treatment.

resultsAnalysis per-protocol criteria showed clinical remission rates of 63% and 50% after 4 wk treatment with mesalamine plus N-acetyl-L-cysteine (group A) and mesalamine plus placebo (group B) respectively (OR = 1.71; 95% CI: 0.46 to 6.36; P = 0.19; NNT = 7.7). Analysis of variance (ANOVA) of data indicated a significant reduction of MTWSI in group A (P = 0.046) with respect to basal condition without significant changes in the group B (P = 0.735) during treatment. Clinical responses were 66% (group A) vs 44% (group B) after 4 wk of treatment (OR = 2.5; 95% CI: 0.64 to 9.65; P = 0.11; NNT = 4.5). Clinical improvement in group A correlated with a decrease of IL-8 and MCP-1. Rates of adverse events did not differ significantly between both groups.

conclusionIn group A (oral NAC combined with mesalamine) contrarily to group B (mesalamine alone), the clinical improvement correlates with a decrease of chemokines such as MCP-1 and IL-8. NAC addition not produced any side effects.

Indexed as

AcetylcysteineAdultAgedAnti-Inflammatory Agents, Non-SteroidalChemokine CCL2Colitis, UlcerativeDrug Therapy, CombinationFemaleFree Radical ScavengersGlutathioneHumansInterleukin-6Interleukin-8MaleMesalamineMiddle AgedAcetylcysteineAnti-Inflammatory Agents, Non-SteroidalCCL2 protein, humanChemokine CCL2Free Radical ScavengersGlutathioneInterleukin-6Interleukin-8MesalamineTumor Necrosis Factor-alpha

Identifiers

PMID18473409
PMCPMC2710726
OpenAlexW2170014300

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.