A prospective, randomised, placebo-controlled trial of postoperative oral steroid in allergic fungal sinusitis

Abstract

The aim of this study is to determine the effectiveness of postoperative oral steroid in controlling disease in patients with allergic fungal sinusitis (AFS). The study design includes prospective, randomised, double blind,placebo-controlled trial using oral prednisolone.Twenty-four patients diagnosed with AFS underwent sinus surgery (endoscopic sinus surgery with or without open surgery) to completely excise disease. Patients were randomised to receive either oral steroid (n = 12) or placebo(n = 12) soon after surgery. All patients were also administered itraconazole and steroid nasal spray in the postoperative period. Subjective evaluation of symptom relief and objective evaluation by rigid nasal endoscopy at 6 and 12 weeks following surgery was performed. After12 weeks, the code was broken and the two groups of patients were identified to note their response to treatment.At 6 weeks, complete relief of preoperative symptoms was obtained in eight patients who had received oral steroid and none who had received placebo (p = 0.001). Partial relief of preoperative symptoms was obtained in four who had received oral steroid and eight who had received placebo.Nasal endoscopy revealed that 8 of 12 patients who had received oral steroid and 1 patient who had received placebo were disease free (p = 0.009). At 12 weeks, complete symptom relief was obtained by all patients who received oral steroid but only one who received placebo(p = 0.0001). Nasal endoscopy at 12 weeks revealed that all 12 patients who had received oral steroid and only 1 patient (the same patient) who had received placebo were disease free (p = 0.0001). In conclusion, postoperative oral steroid in a tapering dose produces significant subjective and objective improvement of patients with AFS. It is also effective in preventing early recurrence. Inclusion of post operative oral steroid therapy for at least 12 weeks is recommended in all patients who undergo excisive surgery for AFS.

International Consensus Statement on Allergy and Rhinology: Rhinosinusitis

“…One group (n = 12) was treated with oral itraconazole (200 mg/day for 12 weeks) and the other group (n = 12) had oral itraconazole plus oral corticosteroids (50 mg prednisone × 6 weeks and then tapered off over 6 additional weeks. Rupa et al 1106 found that although partial relief of initial sinus symptoms was reported in all 12 patients randomized to 12 weeks of oral itraconazole alone, the nasal endoscopic evaluation revealed that only 1 of the 12 patients had no evidence of disease. This finding contrasted with 8 of the 12 patients having no evidence of disease if oral corticosteroids were added to the oral itraconazole.…”

“…Although uncommon, oral corticosteroids are associated with side effects such as Cushing's disease, blood sugar dyscrasias, gastrointestinal tract ulcer, and avascular necrosis. 1106 Topical corticosteroid use is also related with mild adverse effects, such as nasal dryness, bleeding, burning sense, and throat irritation. 1153 In conclusion, topical corticosteroid can be used as preoperative treatment for better surgical field.…”

Reactividad cruzada en sinusitis alérgica fúngica. Reporte de caso

“…Está comprobado que el uso de esteroides sistémicos disminuye la tasa de recurrencia. 8 Se desarrolló interés creciente por el manejo de estos pacientes con antifúngico sistémico como itraconazol, con base en el beneficio que reportaba para pacientes con ABPA; 9 sin embargo, su eficacia en RAF no ha sido establecida y actualmente no se recomienda su uso. 10 Por otro lado, la inmunoterapia se ha convertido de forma reciente en una herramienta terapéutica valiosa en estos pacientes, segura y efectiva, con la capacidad de disminuir las dosis de esteroide tópico sistémico y las tasas de re-intervención.…”

Extensive Allergic Fungal Rhinosinusitis: Ophthalmic and Skull Base Complications

“…Such mucosal changes, if unchecked, can lead to similar pre-operative circumstances requiring surgical intervention. Post-operative oral steroid therapy is well proven to improve symptoms and prevent early recurrences [18] and augments topical corticosteroids. The role of topical antifungals, however, needs to be evaluated to prevent recurrences.…”