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Treatment with a potassiumironphosphatecitrate complex improves PSE scores and quality of life in patients with minimal hepatic encephalopathy: a multicenter, randomized, placebo-controlled, double-blind clinical trial

Burkard, Tanjaa; Biedermann, Annetteb; Herold, Christophc; Dietlein, Michaeld; Rauch, Markuse; Diefenbach, Martinf

European Journal of Gastroenterology & Hepatology: March 2013 - Volume 25 - Issue 3 - p 352–358
doi: 10.1097/MEG.0b013e32835afaa5
Original Articles: Complicated Liver Disorders

Objective: Minimal hepatic encephalopathy (MHE) is one of the possible complications of liver cirrhosis. In this study, a potassium–iron–phosphate–citrate complex was analyzed for its efficacy and safety in the treatment of MHE, as this complex is supposed to bind to the major pathogenic factor of MHE: intestinal ammonia.

Materials and methods: In this placebo-controlled, double-blind clinical trial, 51 patients with MHE were randomized into two groups at a ratio of 1 : 1 and treated for 4 weeks either with a potassium–iron–phosphate–citrate complex or a placebo. The efficacy of treatment was assessed according to changes in the portosystemic encephalopathy (PSE) score. Further assessments included alterations in quality of life and safety evaluations.

Results: Significantly more patients showed improvements in the PSE syndrome test from pathological to nonpathological PSE scores in the potassium–iron–phosphate–citrate-treated group (72.0%) than in the placebo group (26.9%; P=0.0014). Furthermore, quality of life improved at a higher grade in the verum group (by 0.7±0.6 U) compared with the placebo group (by 0.2±0.6 U; P=0.0036). Adverse events occurring in 28.0% of potassium–iron–phosphate–citrate-treated patients were generally mild or moderate and affected mainly the gastrointestinal tract.

Conclusion: Treatment with potassium–iron–phosphate–citrate significantly improved PSE scores and quality of life in patients with MHE. The potassium–iron–phosphate–citrate complex is a well-tolerated treatment option in MHE.

aANFOMED GmbH, Möhrendorf

bGeneral Medical Practice, Blankenhain

cJoint Practice of Specialists in Internal Medicine, Nürnberg

dJoint Practice of Specialists in Internal Medicine, Augsburg

eJoint Practice of Specialists in General Medicine, Ornbau

fDreluso Pharmazeutika Dr. Elten & Sohn, Hessisch Oldendorf, Germany

Correspondence to Tanja Burkard, MSc, MD, ANFOMED GmbH, Röttenbacher Str. 17, 91096 Möhrendorf, Germany Tel: +49 9133 7762 0; fax: +49 9133 7762 62; e-mail: tanja.burkard@anfomed.de

Received May 29, 2012

Accepted October 2, 2012

© 2013 Lippincott Williams & Wilkins, Inc.