Phosphatidylcholine for steroid-refractory chronic ulcerative colitis: a randomized trial.
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.


METHODS
Randomized, double-blind, placebo-controlled trial conducted from March 2003 to January 2006.


METHODS
University Hospital Heidelberg, a referral center for inflammatory bowel disease.


METHODS
60 patients with chronic steroid-refractory ulcerative colitis and high clinical and endoscopic disease activity indexes (score > or =5).


METHODS
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%.


METHODS
The number of patients achieving complete steroid withdrawal and either a low clinical activity index (< or =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.


CONCLUSIONS
The sample size was small, and the study was of short duration.


CONCLUSIONS
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.
Stremmel
Wolfgang
W
Department of Gastroenterology, University Hospital Heidelberg, Heidelberg, Germany. wolfgang.stremmel@med.uni-heidelberg.de
Ehehalt
Robert
R
Autschbach
Frank
F
Karner
Max
M
D000305:Adrenal Cortex Hormones / Q000008:administration & dosage* / Q000009:adverse effects; D000328:Adult; D003093:Colitis, Ulcerative / Q000188:drug therapy* / Q000378:metabolism / Q000473:pathology; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D016099:Endoscopy, Gastrointestinal; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007413:Intestinal Mucosa / Q000378:metabolism; D008297:Male; D009093:Mucus / Q000378:metabolism; D010713:Phosphatidylcholines / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D011788:Quality of Life; D018401:Sample Size; D016896:Treatment Outcome
D000305:Adrenal Cortex Hormones; D003692:Delayed-Action Preparations; D010713:Phosphatidylcholines