Quality of life of patients with refractory chronic rhinosinusitis: effects of filgrastim treatment.
In this double-blind placebo-controlled randomized clinical trial, we investigated the influence of filgrastim administration on the quality of life (QOL) of refractory chronic sinusitis patients who did not respond to regular treatments. QOL was considered to be an important outcome measurement because apart from classic sinusitis parameters, it measures the overall burden of the symptomatology of chronic sinusitis patients caused by general malaise, tiredness, and social impediments. The QOL of 56 patients was assessed five times during the 24-week trial with the EuroQol, the Short Form (SF)-36, and the McGill pain questionnaire (MPQ). The QOL scores were all well below population norm scores and scores in a group of patients with chronic sinusitis who had sinus surgery. QOL scores of the filgrastim group suggested a better QOL than the placebo group, although none of the differences were statistically significant. There were indications that it might be possible to determine a subpopulation in which the results are better. Although the QOL measurements were not able to show a significant treatment effect of filgrastim in this group of patients with refractory chronic sinusitis, these measurements are important in studying chronic sinusitis because they enable the comparison of the burden of illness of patients with chronic sinusitis with other patient groups.
van Agthoven
M
M
Institute for Medical Technology Assessment, Erasmus Medical Centre, Rotterdam, The Netherlands. vanagthoven@bmg.eur.nl
Fokkens
W J
WJ
van de Merwe
J P
JP
Marijke van Bolhuis
E
E
Uyl-de Groot
C A
CA
Busschbach
J J
JJ
D000328:Adult; D004311:Double-Blind Method; D005260:Female; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D011994:Recombinant Proteins; D012220:Rhinitis / Q000188:drug therapy*; D012852:Sinusitis / Q000188:drug therapy*; D011795:Surveys and Questionnaires
D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; D000069585:Filgrastim