Delayed release phosphatidylcholine in chronic-active ulcerative colitis

• Verfasst von: Stremmel, Wolfgang [VerfasserIn]
• Verfasst von: Gauss, Annika [VerfasserIn]
• Verfasst von: Hanemann, Anja [VerfasserIn]
• Verfasst von: Ehehalt, Robert [VerfasserIn]
• Verfasst von: Autschbach, Frank [VerfasserIn]
• Verfasst von: Karner, Max [VerfasserIn]
• Titel: Delayed release phosphatidylcholine in chronic-active ulcerative colitis
• Titelzusatz: a randomized, double-blinded, dose finding study
• Verf.angabe: Wolfgang Stremmel, MD, Annika Braun, MD, Anja Hanemann, MS, Robert Ehehalt, MD, Frank Autschbach, MD, and Max Karner, MD
• E-Jahr: 2010
• Jahr: May 1, 2010
• Umfang: 7 S.
• Fussnoten: Gesehen am 01.09.2023
• Titel Quelle: Enthalten in: Journal of clinical gastroenterology
• Ort Quelle: Philadelphia, Pa. : Lippincott Williams & Wilkins, 1979
• Jahr Quelle: 2010
• Band/Heft Quelle: 44(2010), 5 vom: Mai/Juni, Seite e101-e107
• ISSN Quelle: 1539-2031
• DOI: doi:10.1097/MCG.0b013e3181c29860
• Datenträger: Online-Ressource
• Sprache: eng
• K10plus-PPN: 1858508355

Abstract

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. - Goal - Objective of the study was to determine the most effective rPC dose with least adverse events. - Study - 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) ≥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≤0.05). Remission (CAI ≤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 (≥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. - Conclusion - We found a saturable dose response of rPC in the treatment of chronic-active ulcerative colitis with effective doses ≥1 g per day; doses of 3 and 4 g seem to be superior in achieving remission.