Delayed release phosphatidylcholine in chronic-active ulcerative colitis: a randomized, double-blinded, dose finding study.
BACKGROUND
In 2 preceding studies, delayed release phosphatidylcholine (rPC) was found to (a) improve disease activity and (b) withdraw steroids in patients with chronic-active ulcerative colitis.


OBJECTIVE
Objective of the study was to determine the most effective rPC dose with least adverse events.


METHODS
A randomized, dose-controlled, double-blinded study. Four groups of 10 patients each with nonsteroid-treated, chronic-active ulcerative pancolitis with a clinical activity index (CAI) and endoscopic activity index (EAI) >or=7. Patients were treated with oral rPC at doses of 0.5, 1, 3, and 4 g daily over 12 weeks.


RESULTS
The CAI changes from baseline to the end of the study were 2.5 (0.5 g), 7.0 (1 g), 5.5 (3 g), and 6.0 (4 g dose arm). Significant improvement of the CAI was registered between the lowest rPC dose of 0.5 g (control group) and all higher doses of 1.0, 3.0, and 4.0-g rPC (P<or=0.05). Remission (CAI <or=3) was reached in 5/10 and 6/10 patients in the 3 and 4-g dose groups compared with no patients in the 0.5-g arm (P=0.033). In the 1-g dose group only 3/10 patients reached remission (P=0.21). The rates of clinical response (>or=50% CAI improvement) were 70% in all of the effective dose groups (1 to 4 g, P=0.003). This was paralleled by the EAI improvement and by the rates of mucosal healing. Median time to clinical response was 5 (IQR 2 to 8) weeks. Bloating was registered in 40% of the patients irrespective of the treatment dose. Three of the 10 patients in the 4 g dose group reported nausea.


CONCLUSIONS
We found a saturable dose response of rPC in the treatment of chronic-active ulcerative colitis with effective doses >or=1 g per day; doses of 3 and 4 g seem to be superior in achieving remission.
Stremmel
Wolfgang
W
Department of Gastroenterology, University Hospital Heidelberg, Heidelberg, Germany. wolfgang_stremmel@med.uni-heidelberg.de
Braun
Annika
A
Hanemann
Anja
A
Ehehalt
Robert
R
Autschbach
Frank
F
Karner
Max
M
D000328:Adult; D002908:Chronic Disease; D003093:Colitis, Ulcerative / Q000188:drug therapy* / Q000503:physiopathology; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D010713:Phosphatidylcholines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012074:Remission Induction / Q000379:methods; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome
D010713:Phosphatidylcholines