GM-CSF mouthrinses in the treatment of severe oral mucositis - A pilot study

Objective. The aim of this open trial was to test the efficacy of granulocy te-macrophage colony-stimulating factor (GM-CSF) mouthrinses as a potential treatment in reducing the duration of severe oral mucositis in patients un dergoing bone marrow transplantation for hematologic malignancies. Study design. The study group was composed of 10 consecutive patients suffe ring from severe oral mucositis during bone marrow transplantation procedur es. The control group was similar to the study group in age and gender and comprised 29 historical patients with similar clinical characteristics. Fre shly prepared GM-CSF mouthwash (0.5 mu g/mL) was administered to the study population for 1 minute 3 times per day after oral hygiene procedures, star ting from the first day of mucositis until clinical improvement of oral les ions. The study and control populations were compared with respect to durat ion of severe oral mucositis (1-9 days, 10-19 days, greater than or equal t o 20 days). Results. There was no statistically (chi(2) exact test) significant differe nce in mean mucositis score between the study group (11.9 +/- 6.1) and the control group (16.6 +/- 8.9). However, the duration of severe mucositis app eared to be reduced; 60% of the GMCSF mouthrinse patients had severe mucosi tis for less than 9 days, whereas only 28% of the controls had severe mucos itis for less than 9 days, in addition, 10% of the CM-CSF mouthrinse patien ts experienced severe mucositis lasting 20 or more days, whereas 34% of the controls experienced severe mucositis for 20 or more days. Conclusions. These findings suggest that GM-CSF may reduce the duration of severe mucositis, but controlled, double-blind clinical trials are now requ ired.