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.