title: Erythrocytapheresis versus phlebotomy in the maintenance treatment of HFE hemochromatosis patients: results from a randomized crossover trial.
abstract: BACKGROUND
  Phlebotomy is standard maintenance treatment of patients with hereditary hemochromatosis (HH). Erythrocytapheresis, which selectively removes red blood cells, provides a new, potentially more effective treatment option. Our aim was to evaluate the effectiveness of erythrocytapheresis over phlebotomy for maintenance therapy in patients with HH.
  
  
  METHODS
  We conducted a two-treatment-arms, randomized, crossover clinical trial, involving 46 patients, treated for 1 year with either erythrocytapheresis or phlebotomy to keep the ferritin level at not more than 50 µg/L. After 1 year, patients were switched to the other treatment modality. Primary endpoint was the number of treatment procedures per treatment year. Secondary endpoints were intertreatment intervals, several aspects of health-related quality of life, costs, and patient discomfort as well as preference for one of both treatments.
  
  
  RESULTS
  The mean number of required treatment procedures per treatment year was significantly higher using phlebotomy versus erythrocytapheresis (3.3 vs. 1.9; mean difference, 1.4; 95% confidence interval, 1.1-1.7). The median intertreatment time was 2.3 times longer for erythrocytapheresis. There was no significant difference in overall health assessed by SF-36 and EQ-5D, respectively, between both treatments arms. The number of self-reported swollen joints was significantly higher during phlebotomy treatment. The mean treatment costs of one treatment year were 235€ for phlebotomy versus 511€ for erythrocytapheresis. Eighty percent of patients preferred erythrocytapheresis as treatment method.
  
  
  CONCLUSIONS
  Erythrocytapheresis significantly reduced the number of treatment procedures per treatment year, although the mean treatment costs per year are higher in our health care system. It is the preferred treatment for the majority of patients.
authors.affiliation: Department of Transfusion Medicine, Sanquin Blood Supply, Amsterdam, the Netherlands.|Department of Internal Medicine, Division of Gastroenterology, Maastricht University Medical Centre, Maastricht, the Netherlands.
authors.forename: Eva
authors.initials: E
authors.lastname: Rombout-Sestrienkova
authors.affiliation: Department of Methodology and Statistic, School for Public Health and Primary Care (CAPHRI), Maastricht University.
authors.forename: Bjorn
authors.initials: B
authors.lastname: Winkens
authors.affiliation: Department of Clinical Epidemiology and Medical Technology Assessment.
authors.forename: Brigitte A B
authors.initials: BA
authors.lastname: Essers
authors.affiliation: Department of Clinical Epidemiology and Medical Technology Assessment.
authors.forename: Fred H M
authors.initials: FH
authors.lastname: Nieman
authors.affiliation: Department of Research, Sanquin Blood Supply.
authors.forename: Paulus A H
authors.initials: PA
authors.lastname: Noord
authors.affiliation: Department of Internal Medicine, Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands.
authors.forename: Mirian C H
authors.initials: MC
authors.lastname: Janssen
authors.affiliation: Department of Internal Medicine, Zuyderland Medical Center, Heerlen/Brunssum/Sittard, the Netherlands.
authors.forename: Cees Th B M
authors.initials: CT
authors.lastname: van Deursen
authors.affiliation: Department of Internal Medicine, Division of Rheumatology.
authors.forename: Annelies
authors.initials: A
authors.lastname: Boonen
authors.affiliation: Department of Transfusion Medicine, Sanquin Blood Supply, Amsterdam, the Netherlands.
authors.forename: Ellen P J M
authors.initials: EP
authors.lastname: Reuser-Kaasenbrood
authors.affiliation: Department of Transfusion Medicine, Sanquin Blood Supply, Amsterdam, the Netherlands.
authors.forename: Judith
authors.initials: J
authors.lastname: Heeremans
authors.affiliation: Department of Transfusion Medicine, Sanquin Blood Supply, Amsterdam, the Netherlands.
authors.forename: Marian
authors.initials: M
authors.lastname: van Kraaij
authors.affiliation: Department of Internal Medicine, Division of Gastroenterology, Maastricht University Medical Centre, Maastricht, the Netherlands.
authors.forename: Ad
authors.initials: A
authors.lastname: Masclee
authors.affiliation: Department of Internal Medicine, Division of Gastroenterology, Maastricht University Medical Centre, Maastricht, the Netherlands.
authors.forename: Ger H
authors.initials: GH
authors.lastname: Koek
mesh_terms: D000328:Adult; D000368:Aged; D001781:Blood Component Removal / Q000379:methods*; D018592:Cross-Over Studies; D017707:Erythrocyte Transfusion / Q000379:methods*; D005260:Female; D006432:Hemochromatosis / Q000628:therapy*; D006801:Humans; D016014:Linear Models; D008297:Male; D008875:Middle Aged; D018962:Phlebotomy; D011788:Quality of Life; D016896:Treatment Outcome