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European Journal of Gastroenterology & Hepatology:
doi: 10.1097/MEG.0b013e32835afaa5
Original Articles: Complicated Liver Disorders

Treatment with a potassium–iron–phosphate–citrate 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

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Abstract

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.

© 2013 Lippincott Williams & Wilkins, Inc.

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