"80% of phosphatidylcholine recipients discontinued steroid therapy "

Ann Intern Med. 2007 Nov 6;147(9):603-610.
Phosphatidylcholine for Steroid-Refractory Chronic Ulcerative Colitis:
A Randomized Trial.Stremmel W, Ehehalt R, Autschbach F, Karner M.
University Hospital Heidelberg, Heidelberg, Germany.

BACKGROUND:
Although long-term steroid treatment is discouraged in ulcerative
colitis, alternatives are lacking when therapy with immunosuppressant
drugs fails. An insufficient level of phosphatidylcholine in colonic
mucus is a possible pathogenetic factor for ulcerative colitis.
OBJECTIVE:
To see whether steroid withdrawal is easier with retarded-release
phosphatidylcholine or placebo in adults with chronic steroid-
refractory ulcerative colitis. DESIGN: Randomized, double-blind,
placebo-controlled trial conducted from March 2003 to January 2006.
SETTING:
University Hospital Heidelberg, a referral center for inflammatory
bowel disease.
PATIENTS:
60 patients with chronic steroid-refractory ulcerative colitis and
high clinical and endoscopic disease activity indexes (score >/=5).
INTERVENTION:
Phosphatidylcholine or cellulose placebo was ingested 4 times daily
for 12 weeks for a total dosage of 2 g/d. The follow-up rate was 97%.
MEASUREMENTS:
The number of patients achieving complete steroid withdrawal and
either a low clinical activity index (</=3) or improvement in the
clinical activity index of 50% or more.
RESULTS:
The primary end point was achieved in 15 of 30 (50%)
phosphatidylcholine recipients and in 3 of 30 (10%) placebo recipients
(difference, 40% [95% CI, 19% to 61%]; P = 0.002). Twenty-four
phosphatidylcholine recipients (80%) and 3 (10%) placebo recipients
discontinued steroid therapy without disease exacerbation (difference,
70% [CI, 52% to 88%]; P <0.001). Mild bloating was a common adverse
event. Limitations: The sample size was small, and the study was of
short duration.
CONCLUSION:
Phosphatidylcholine reduced corticosteroid dependence more than
placebo in patients with chronic steroid-refractory ulcerative
colitis. The next step is long-term trials to evaluate the
sustainability of steroid withdrawal in these patients.
ClinicalTrials.gov registration number: NCT00259545.

PMID: 17975182 [PubMed - as supplied by publisher]

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