title: 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.
  
  
  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.
authors.affiliation: ANFOMED GmbH, Möhrendorf, Germany. tanja.burkard@anfomed.de
authors.forename: Tanja
authors.initials: T
authors.lastname: Burkard
authors.forename: Annette
authors.initials: A
authors.lastname: Biedermann
authors.forename: Christoph
authors.initials: C
authors.lastname: Herold
authors.forename: Michael
authors.initials: M
authors.lastname: Dietlein
authors.forename: Markus
authors.initials: M
authors.lastname: Rauch
authors.forename: Martin
authors.initials: M
authors.lastname: Diefenbach
mesh_terms: D000328:Adult; D000368:Aged; D000641:Ammonia / Q000378:metabolism; D000704:Analysis of Variance; D002951:Citrates / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005858:Germany; D006501:Hepatic Encephalopathy / Q000175:diagnosis / Q000188:drug therapy* / Q000378:metabolism / Q000523:psychology; D006801:Humans; D058085:Iron Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D009483:Neuropsychological Tests; D010710:Phosphates / Q000009:adverse effects / Q000627:therapeutic use*; D017680:Potassium Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D011594:Psychometrics; D011788:Quality of Life; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002951:Citrates; D058085:Iron Compounds; D010710:Phosphates; D017680:Potassium Compounds; D000641:Ammonia