Evidence map›Paper›PMID 18224442›Full record

Trial reportDigestive diseases and sciences2008

Primary prevention of adverse gastroduodenal effects from short-term use of non-steroidal anti-inflammatory drugs by omeprazole 20 mg in healthy subjects: a randomized, double-blind, placebo-controlled study.

Jay C Desai, Shefali M Sanyal, Tyralee Goo, Ariel A Benson, Carol A Bodian, Kenneth M Miller, Lawrence B Cohen, James Aisenberg

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Digestive diseases and sciences, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00778193 (A Randomized, Blinded, Placebo-Controlled Study of the Effect of Naproxen, Aspirin, Celecoxib, or Clopidogrel on Gastroduodenal Healing), which is not on this map. Cited by 9 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 2 pooled it
0.8field-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.

NCT00778193 phase4completednot on this map

A Randomized, Blinded, Placebo-Controlled Study of the Effect of Naproxen, Aspirin, Celecoxib, or Clopidogrel on Gastroduodenal Healing

TypeinterventionalSponsorResearch Associates of New York, LLPRan2007 to 2008Enrolled125ConditionsGastroduodenal UlcerArmsNaproxen, Aspirin, Celecoxib, Clopidogrel, Placebo
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 2 syntheses or guidelines pooled it, 23 citations in OpenAlex.

  1. [Clinical Guidelines for Drug-induced Peptic Ulcer, 2020 Revised Edition].The Korean journal of gastroenterology = Taehan Sohwagi Hakhoe chi · 2020
    Guideline
  2. Prevention of chronic NSAID induced upper gastrointestinal toxicity.The Cochrane database of systematic reviews · 2000
    Pooled it
  3. Trial
  4. Trial
  5. Review
  6. Article
  7. Review
  8. Article
  9. 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 1 institution in 1 country.

Jay C DesaiDepartment of Medicine (Gastroenterology), The Mount Sinai School of Medicine, New York, NY 10075-0903, USA.
Shefali M Sanyal
Tyralee Goo
Ariel A Benson
Carol A Bodian
Kenneth M Miller
Lawrence B Cohen
James Aisenberg
Icahn School of Medicine at Mount Sinai · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The effectiveness of low-dose omeprazole as primary prevention of gastrointestinal adverse events due to episodic use of non-selective NSAIDs was evaluated. Healthy adults aged 50-75 who did not take chronic NSAIDs were randomized to a 6.5-day treatment of naproxen 500 mg twice daily plus omeprazole 20 mg daily or naproxen 500 mg twice daily plus placebo. Seventy subjects were enrolled (mean age 58.6 years, proportion >60 = 41.4%). Subjects receiving naproxen plus omeprazole developed fewer gastroduodenal ulcers compared to subjects receiving naproxen plus placebo (11.8% vs. 46.9%, P = 0.002). Likewise, naproxen plus omeprazole was associated with a decreased risk of ulceration and/or >5 erosions (38.2% vs. 81.3%, P < or = 0.001), and a smaller change in dyspepsia score. Considering their relatively low cost, ready availability, and favorable safety profile, low-dose PPI co-prescription in healthy adults requiring short-term therapy with non-selective NSAIDs may be reasonable.

Indexed as

AgedAnti-Inflammatory Agents, Non-SteroidalDouble-Blind MethodDuodenal UlcerDuodenoscopyDyspepsiaFemaleGastroscopyHelicobacter pyloriHumansMaleMiddle AgedNaproxenOmeprazolePilot ProjectsProton Pump InhibitorsAnti-Inflammatory Agents, Non-SteroidalNaproxenOmeprazoleProton Pump Inhibitors

Identifiers

PMID18224442
OpenAlexW2140790966

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.