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Phosphatidylcholine for Steroid-Refractory Chronic Ulcerative Colitis: A Randomized Trial

Wolfgang Stremmel, MD; Robert Ehehalt, MD; Frank Autschbach, MD; and Max Karner, MD
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From University Hospital Heidelberg, Heidelberg, Germany.


Acknowledgment: The authors thank Susanne Schäfer for statistical analysis; Annika Braun, MD, and Alexandra Zahn, MD, for assistance in patient management; and Heather Karner, MA, for proofreading and editing services. They also thank Verena Schmieg and Anja Hanemann for assistance in assessing the follow-up data and Daniela Kautz and Anja Hanemann for assisting in the data management and graph generation.

Grant Support: By the Dietmar-Hopp Foundation (Dr. Stremmel).

Potential Financial Conflicts of Interest: Grants received: W. Stremmel (Dietmar-Hopp Foundation). Patents received: W. Stremmel (for retarded-release phosphatidylcholine as a mucoprotective agent for the large intestine.)

Reproducible Research Statement: The protocol (in German, with an English-language synopsis), data set, and statistical code are available to interested readers by contacting Dr. Stremmel (e-mail, wolfgang.stremmel@med.uni-heidelberg.de).

Requests for Single Reprints: Wolfgang Stremmel, MD, Department of Gastroenterology, University Hospital Heidelberg, Im Neuenheimer Feld 410, D-69120 Heidelberg, Germany; e-mail, wolfgang.stremmel@med.uni-heidelberg.de.

Current Author Addresses: Drs. Stremmel, Ehehalt, and Karner: Department of Gastroenterology, University Hospital Heidelberg, Im Neuenheimer Feld 410, D-69120 Heidelberg, Germany.

Dr. Autschbach: Pathological Institute, University Hospital Heidelberg, Im Neuenheimer Feld 220/221, 69120 Heidelberg, Germany.

Author Contributions: Conception and design: W. Stremmel, M. Karner.

Analysis and interpretation of the data: W. Stremmel, R. Ehehalt, M. Karner.

Drafting of the article: W. Stremmel, M. Karner.

Critical revision of the article for important intellectual content: W. Stremmel, M. Karner.

Final approval of the article: W. Stremmel, R. Ehehalt, F. Autschbach, M. Karner.

Provision of study materials or patients: W. Stremmel, F. Autschbach, M. Karner.

Statistical expertise: W. Stremmel, M. Karner.

Obtaining of funding: W. Stremmel.

Administrative, technical, or logistic support: W. Stremmel, R. Ehehalt, M. Karner.

Collection and assembly of data: W. Stremmel, R. Ehehalt, F. Autschbach, M. Karner.


Ann Intern Med. 2007;147(9):603-610. doi:10.7326/0003-4819-147-9-200711060-00004
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In our study, phosphatidylcholine replaced steroids in 80% of patients who had chronic steroid-refractory ulcerative colitis without clinical deterioration. Fifty percent of the phosphatidylcholine recipients had improvement in the clinical activity index of 50% or more or achieved low clinical activity (clinical activity index score ≤3). Subsequent calculations to adjust for baseline differences and for a potential bias due to dropout patients provided similar results for the primary end point analysis.

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Figures

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Figure 1.
Study flow diagram.

6-MP = 6-mercaptopurine; AZT = azathioprine; CAI = clinical activity index; EAI = endoscopic activity index; ITT = intention to treat; PC = phosphatidylcholine; UC = ulcerative colitis. *Two patients in each group dropped out of the study. They were treated as nonresponders for categorical measurements and were excluded for the analyses of continuous end points.

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Appendix Figure 1.
Changes in steroid doses of phosphatidylcholine recipients (top) and placebo recipients (bottom).
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Figure 2.
Disease activity indexes.

The 25th percentile (lower line of the box), median (horizontal line), 75th percentile (upper line), mean value (solid circle), and extreme value (solid square) are shown. A. The median clinical activity index score decreased by 61%, from 9.0 to 3.5, in the phosphatidylcholine (PC) group (median decrease, 4.5 points [interquartile range {IQR}, 3.0 to 6.0 points]) and by 23%, from 6.5 to 5.0, in the placebo (median decrease, 1.0 point [IQR, 0 to 2.0 points]). B. The median endoscopic activity index score decreased by 57%, from 7.0 to 3.0, in the phosphatidylcholine group (median decrease, 4.0 points [IQR, 3.0 to 5.0 points]) but remained unchanged in the placebo group (median decrease, 0.0 point [IQR, −1.0 to 0 point]). C. The median histologic score decreased by 20%, from 2.5 to 2.0, in the phosphatidylcholine group (median decrease, 0.5 point [IQR, 0 to 1.0 point]), but remained 3.0 in the placebo group (median decrease, 0.0 point [IQR, −0.5 to 1.0 point]). D. The median life quality index increased by 49%, from 112 to 167, in the phosphatidylcholine group (median increase, 36 points [IQR, 26 to 66 points]) and by 8%, from 129 to 139, in the placebo group (median increase, 8 points [IQR, −5 to 26 points]).

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Appendix Figure 2.
Changes in the clinical activity index of phosphatidylcholine recipients (top) and placebo recipients (bottom).
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