Phosphatidylcholine for Steroid-Refractory Chronic Ulcerative Colitis

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ARTICLE

Phosphatidylcholine for Steroid-Refractory Chronic Ulcerative Colitis

A Randomized Trial Wolfgang Stremmel, MD; Ehehalt, MD; Autschbach, MD; and Max Karner, MD

6 November 2007 | Volume 147 Issue 9 | Pages 603-610

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.