This is the first report of the double blind randomized clinical trial, in which we investigated the influence of Filgrastim(r) on the quality of life and treatment costs of chronic sinusitis patients who did not respond to regular treatments.
The quality of life of 56 patients was assessed 5 times during the 24-week trial with the EuroQol, the SF-36 and the McGill Pain questionnaire. We further controlled for "responsiveness", based on clinical impression.
Direct medical and indirect non-medical costs per patient during the trial were analyzed, based on data from clinical record forms and the hospital information system. We further compared the direct medical costs to the costs of regular treatment.
The quality of life scores were all below population norm scores. Quality of life scores of the Filgrastim(r) group suggested a better quality of life than the placebo group, although none of the differences were statistically significant. There were indications that controlling for responsiveness increased the power of the design.
The difference in costs between the trial groups were driven by the Filgrastim(r) costs (Euro 4899). When Filgrastim(r) costs were neglected, no difference in costs remained. Except for Filgrastim(r), total direct costs summed up to Euro 2712 and the indirect costs to Euro 582. Total direct costs of a 24-week regular treatment were three times lower than the costs of the trial treatment.
While significantly increasing treatment costs, Filgrastim(r) administration does not lead to a better quality of life of chronic sinusitis patients, although there were
