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.