Evidence map›Paper›PMID 18549459›Full record

Trial reportAlimentary pharmacology & therapeutics2008

Clinical trial: comparison of ibuprofen-phosphatidylcholine and ibuprofen on the gastrointestinal safety and analgesic efficacy in osteoarthritic patients.

F L Lanza, U K Marathi, B S Anand, L M Lichtenberger

Open access · bronzeAbstract readClinical Trial, Phase IIComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Alimentary pharmacology & therapeutics, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed
4.0field-weighted citation impact, top 7% 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

24 citing papers in PubMed, 66 citations in OpenAlex.

  1. From pain relief to mucosal grief: A comprehensive review of NSAID enteropathy.Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology · 2026
    Review
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  5. Design and evaluation of a novel nanodrug delivery system for reducing the side effects of clomiphene citrate on endometrium.Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences · 2020
    Article
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  8. Review
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  13. Convergence of nanotechnology and cancer prevention: are we there yet?Cancer prevention research (Philadelphia, Pa.) · 2014
    Review
  14. Role of phospholipids in protection of the GI mucosa.Digestive diseases and sciences · 2013
    Article
  15. Review
  16. Review
  17. Article
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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

4 authors at 4 institutions in 1 country.

F L LanzaHouston Institute of Clinical Research, Houston, TX, USA.
U K Marathi
B S Anand
L M Lichtenberger
Baylor College of Medicine · USHouston Institute for Clinical Research · USPLx Pharma (United States) · USThe University of Texas Health Science Center at Houston · US

Funding

Tissue Analysis & Molecular Imaging CoreP30DK056338 · NIDDK · BAYLOR COLLEGE OF MEDICINE · PI Geoffrey A Preidis · 2001 to 2026
$28.3M
GI safety and therapeutics of oil-based PC-NSAIDsR42DK063882 · NIDDK · PLX PHARMA, INC. · PI LICHTENBERGER, LENARD M · 2004 to 2010
$2.3M
Clinical Studies with Phospholipid-Associated NSAIDsR03DK059403 · NIDDK · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI LICHTENBERGER, LENARD M · 2001 to 2004
$142k
NIDDK NIH HHS P30 DK056338NIDDK NIH HHS P30DK 056338NIDDK NIH HHS R03 DK059403NIDDK NIH HHS R03 DK59403NIDDK NIH HHS R42 DK063882
6 · The paper itself

Abstract

backgroundChronic use of NSAIDs is associated with gastrointestinal (GI) toxicity that increases with age.

aimTo evaluate the GI safety and therapeutic efficacy of ibuprofen chemically associated with phosphatidylcholine (PC) in osteoarthritic (OA) patients.

methodsA randomized, double-blind trial of 125 patients was performed. A dose of 2400 mg/day of ibuprofen or an equivalent dose of ibuprofen-PC was administered for 6 weeks. GI safety was assessed by endoscopy. Efficacy was assessed by scores of analgesia and anti-inflammatory activity. Bioavailability of ibuprofen was pharmacokinetically assessed.

resultsIbuprofen-PC and ibuprofen provided similar bioavailability/therapeutic efficacy. In the evaluable subjects, a trend for improved GI safety in the ibuprofen-PC group compared with ibuprofen that did not reach statistical significance was observed. However, in patients aged >55 years, a statistically significant advantage for ibuprofen-PC treatment vs. ibuprofen in the prevention of NSAID-induced gut injury was observed with increases in both mean Lanza scores and the risk of developing >2 erosions or an ulcer. Ibuprofen-PC was well tolerated with no major adverse events observed.

conclusionIbuprofen-PC is an effective osteoarthritic agent with an improved GI safety profile compared with ibuprofen in older OA patients, who are most susceptible to NSAID-induced gastroduodenal injury.

Indexed as

AdolescentAdultAgedAged, 80 and overAnalgesics, Non-NarcoticAnti-Inflammatory Agents, Non-SteroidalDouble-Blind MethodDrug Therapy, CombinationFemaleGastrointestinal HemorrhageHumansIbuprofenMaleMiddle AgedOsteoarthritisPhosphatidylcholinesAnalgesics, Non-NarcoticAnti-Inflammatory Agents, Non-SteroidalIbuprofenPhosphatidylcholines

Identifiers

PMID18549459
PMCPMC3353548
OpenAlexW2160616339

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.