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: firstname.lastname@example.org
Received May 29, 2012
Accepted October 2, 2012