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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.

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.

journal_name

Eur J Gastroenterol Hepatol

journal_title

European journal of gastroenterology & hepatology

authors

Burkard T,Biedermann A,Herold C,Dietlein M,Rauch M,Diefenbach M

doi

10.1097/MEG.0b013e32835afaa5

subject

Has Abstract

pub_date

2013-03-01 00:00:00

pages

352-8

issue

eissn

0954-691X

issn

1473-5687

journal_volume

pub_type

杂志文章,多中心研究,随机对照试验

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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.