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.

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.

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.

CONCLUSIONS

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.