Evidence map›Paper›PMID 15951544›Full record

Trial reportGut2005

Retarded release phosphatidylcholine benefits patients with chronic active ulcerative colitis.

W Stremmel, U Merle, A Zahn, F Autschbach, U Hinz, R Ehehalt

3 registry-linked trialsOpen access · bronzeAbstract readClinical TrialClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Gut, 2005. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 73 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
73citing papers in PubMed, 1 pooled it
3.9field-weighted citation impact, top 6% 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.

NCT00259545 phase2completednot on this map

Prospektive, Randomisierte Doppelblinde Studie Zur Wirksamkeit Von Intestinal Retardiert Freigesetztem Phosphatidylcholine Bei therapierefraktärer Colitis Ulcerosa Mit Chronisch Aktivem Verlauf Unter Corticosteroiden

TypeinterventionalSponsorHeidelberg UniversityRan2003 to 2006Enrolled60ConditionsUlcerative Colitis, PhosphatidylcholineArmsRetarded Release Phosphatidylcholine (rPC)
NCT00259558 phase2completednot on this map

Prospektive, Randomisierte Doppelblinde Studie Zur Dosisfindung Von Intestinal Redardiert Freigesetztem Phosphatidylcholin Bei Chronisch Aktiver Pancolitis Ulcerosa

TypeinterventionalSponsorHeidelberg UniversityRan2003 to 2006Enrolled60ConditionsUlcerative ColitisArmsretarded release phosphatidylcholine
NCT00259571 phase2 / phase3withdrawnnot on this map

Prospektive, Randomisierte, Doppelblinde, Mesalazin-kontrollierte ("Double-dummy Verfahren) Multizenter-Studie Zur Beurteilung Der Annahme Der äquivalenten Wirkung Von Intestinal Retardiert Freigesetztem Phosphatidylcholin gegenüber Mesalazin (Non-inferiority Study) in Der Remissionserhaltung Der Colitis Ulcerosa.

TypeinterventionalSponsorHeidelberg UniversityEnrolled0ConditionsUlcerative ColitisArmsretarded release phosphatidylcholine
3 · Its place in the literature

Who cites it

73 citing papers in PubMed, 1 synthesis or guideline pooled it, 169 citations in OpenAlex.

  1. Pooled it
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  6. Article
  7. Proinflammatory cytokines modify CaFrontiers in physiology · 2026
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  9. Underneath the Gut-Brain Axis in IBD-Evidence of the Non-Obvious.International journal of molecular sciences · 2024
    Review
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13 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors at 1 institution in 1 country.

W StremmelDepartment of Gastroenterology, University Hospital Heidelberg, Im Neuenheimer Feld 410, 69120 Heidelberg, Germany. wolfgang_stremmel@med.uni-heidelberg.de
U Merle
A Zahn
F Autschbach
U Hinz
R Ehehalt
Heidelberg University · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

aimsWe examined the hypothesis of an anti-inflammatory effect of phosphatidylcholine in ulcerative colitis.

methodsA phase IIA, double blind, randomised, placebo controlled study was performed in 60 patients with chronic active, non steroid dependent, ulcerative colitis, with a clinical activity index (CAI) of > or = 4. Retarded release phosphatidylcholine rich phospholipids and placebo were administered at a dose of 6 g daily over three months. The primary end point was a change in CAI towards clinical remission (CAI < or = 3) or CAI improvement by > or = 50%. Secondary end points included > or = 50% changes in endoscopic activity index (EAI), histology, and quality of life scores.

resultsInduction of clinical remission (CAI < or = 3) as the primary outcome variable was attained by 16 (53%) patients in the phosphatidylcholine treated group compared with three (10%) in the placebo group (p<0.00001). The rate of clinical remission and CAI improvement was 90% in the phosphatidylcholine group and only 10% in the placebo group. A median drop of seven points in the CAI score (70% improvement) was recorded in the phosphatidylcholine group compared with no change in the placebo group. Secondary end point analysis revealed concomitant drops in EAI and histology scores (p = 0.00016 and p = 0.0067 compared with placebo, respectively). Improvement in quality of life was reported by 16 of 29 evaluated patients in the phosphatidylcholine group compared with two of 30 in the placebo group (p = 0.00005).

conclusionRetarded release oral phosphatidylcholine is effective in alleviating inflammatory activity caused by ulcerative colitis.

Indexed as

Administration, OralAdultChronic DiseaseColitis, UlcerativeColonoscopyDelayed-Action PreparationsDouble-Blind MethodFemaleHumansMaleMiddle AgedPhosphatidylcholinesProspective StudiesQuality of LifeSeverity of Illness IndexTreatment OutcomeDelayed-Action PreparationsPhosphatidylcholines

Identifiers

PMID15951544
PMCPMC1774598
OpenAlexW2050817202

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.