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Topical 5-fluorouracil for granular myringitis: a double-blinded study

  • A M Atef (a1), M M Hamouda (a1), A H A Mohamed (a1) and A F A Fattah (a1)



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.


To investigate the efficacy and safety of topical 5-fluorouracil in cases of granular myringitis.


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.


There was a highly statistically significant difference in the studied outcomes, comparing the study and control groups.


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.


Corresponding author

Address for correspondence: Dr A Atef, 7 Mahmoud Afifi Street, Almaza, Cairo, Egypt11341. Fax: 0020224193790 E-mail:


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1Schuknecht, HF. Pathology of the Ear. Cambridge, Massachusetts: Harvard University Press, 1974;218
2Levinson, RM. The management of granular myringitis and retraction pockets. In Surgery of the Ear & Temporal Bone. New York: Raven Press, 1993;139–44
3Blevins, NH, Karmody, CS. Chronic myringitis, prevalence, presentation and natural history. Otol Neurotol 2001;22:310
4Wolf, M, Primov-Fever, A, Barshack, I, Polack-Charcon, S, Kronenberg, L. Granular myringitis incidence and clinical characteristics. Otol Neurotol 2006;27:1094–7
5Khalifa, MC, El-Fouly, S, Basssiouny, A, Kamel, M. Granular myringitis. J Laryngol Otol 1982;96:1099–101
6Makino, K, Amatsu, M, Kinishi, M, Mohri, M. The clinical features and pathogenesis of myringitis granulose. Arch Otolaryngol 1988;245:224–9
7Stoney, P, Kwok, P, Hawke, M. Granular myringitis: a review. J Otolaryngol 1992;21:129–35
8El-Seifi, A, Fouad, B. Granular myringitis. Am J Otol 2000;21:462–7
9Smith, MF. The topical use of 5-fluorouracil in the ear in the management of cholesteatoma and excessive mucous secretion. Laryngoscope 1985;95:1202–3
10Miller, E. The metabolism and pharmacology of 5-fluorouracil. J Surg Oncol 1971;3:309–15
11Heidelberger, C, Ghobar, A, Baker, RK. Studies of fluorinated pyrimidines X. In vivo studies on tumor resistance. Cancer Res 1960;20:897902
12Goette, DK. Topical chemotherapy with 5-fluorouracil. J Am Acad Dermatol 1981;4:633–49
13Perrett, CM, McGregor, JM, Warwick, J, Karran, P, Leigh, IM, Proby, CM et al. Treatment of post- transplant premalignant skin disease: a randomized intrapatient comparative study of 5-fluorouracil cream and topical photodynamic therapy. Br J Dermatol 2007;156:320–8
14Smith, HG, Healy, GB, Vaughan, CW, Strong, MS. Topical chemotherapy of recurrent respiratory papillomatosis. A preliminary report. Ann Otol Rhinol Laryngol 1980;89:472–8
15Takahashi, H, Funabiki, K, Hasebe, S, Fukuda-Yamamoto, T, Kaieda, S, Iwanaga, T et al. Clinical efficacy of 5-fluorouracil (5-FU) topical cream for treatment of cholesteatoma. Auris Nasus Larynx 2005;32:353–7
16Jung, HH, Cho, SD, Yoo, CK, Lim, HH, Chea, SW. Vinegar treatment in the management of granular myringitis. J Laryngol Otol 2002;116:176–80
17Iwanaga, T, Tanaka, F, Tsukasaki, N, Terakado, N, Kaieda, S, Takasaki, A et al. Does topical application of 5-fluorouracil ointment influence inner ear function? Otolaryngol Head Neck Surg 2006;134:961–5
18Yamamoto-Fukada, T, Terakado, M, Hishikawa, Y, Koji, T, Takahashi, H. Topical application of 5-fluorouracil on attic cholesteatoma results in downregulation of keratinocyte growth factor and reduction of proliferative activity. Eur Arch Otolaryngol 2008;265:1173–8


Topical 5-fluorouracil for granular myringitis: a double-blinded study

  • A M Atef (a1), M M Hamouda (a1), A H A Mohamed (a1) and A F A Fattah (a1)


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