BACKGROUND:Granular myringitis is a poorly understood disease which causes considerable discomfort and concern to affected individuals. Some cases may progress to inflammatory obliteration of the deep ear canal. Treatment options are diverse, and no single accepted treatment modality exists. Local application of 5-fluorouracil has recently been trialled in the treatment of chronic otitis media, with promising results. AIM: To investigate the efficacy and safety of topical 5-fluorouracil in cases of granular myringitis. METHODS:Sixty patients with granular myringitis were enrolled in this controlled, double-blinded study. Patients were divided randomly into two equal groups. Patients in the study group (n = 30) received three successive applications of topical 5-fluorouracil 5 per cent cream, with two-week intervals between treatments. Patients in the control group (n = 30) received only local petroleum jelly cream packing at the same intervals. Follow-up appointments were scheduled every two weeks for the first three months; patients were then seen again after two years for evaluation of any persistent disease. Outcome measures were: (1) after three months, symptomatic response to treatment (i.e. quantity of aural discharge as reported by patient) and change in the amount of granulation tissue (as assessed by the physician via endoscopic examination); and (2) persistent disease after two years. RESULTS: There was a highly statistically significant difference in the studied outcomes, comparing the study and control groups. CONCLUSION: Local application of 5-fluorouracil is a new treatment method for granular myringitis. In this study, it proved safe and efficacious, with no serious local reactions or complications.
RCT Entities:
BACKGROUND:Granular myringitis is a poorly understood disease which causes considerable discomfort and concern to affected individuals. Some cases may progress to inflammatory obliteration of the deep ear canal. Treatment options are diverse, and no single accepted treatment modality exists. Local application of 5-fluorouracil has recently been trialled in the treatment of chronic otitis media, with promising results. AIM: To investigate the efficacy and safety of topical 5-fluorouracil in cases of granular myringitis. METHODS: Sixty patients with granular myringitis were enrolled in this controlled, double-blinded study. Patients were divided randomly into two equal groups. Patients in the study group (n = 30) received three successive applications of topical 5-fluorouracil 5 per cent cream, with two-week intervals between treatments. Patients in the control group (n = 30) received only local petroleum jelly cream packing at the same intervals. Follow-up appointments were scheduled every two weeks for the first three months; patients were then seen again after two years for evaluation of any persistent disease. Outcome measures were: (1) after three months, symptomatic response to treatment (i.e. quantity of aural discharge as reported by patient) and change in the amount of granulation tissue (as assessed by the physician via endoscopic examination); and (2) persistent disease after two years. RESULTS: There was a highly statistically significant difference in the studied outcomes, comparing the study and control groups. CONCLUSION: Local application of 5-fluorouracil is a new treatment method for granular myringitis. In this study, it proved safe and efficacious, with no serious local reactions or complications.