A prospective, randomised, placebo-controlled trial of postoperative oral steroid in allergic fungal sinusitis |
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Authors: | V Rupa Mary Jacob Mary Somini Mathews Mandalam S Seshadri |
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Institution: | (1) Department of ENT, Christian Medical College and Hospital, Vellore, 632004, India;(2) Department of Pathology, Christian Medical College and Hospital, Vellore, India;(3) Department of Microbiology, Christian Medical College and Hospital, Vellore, India;(4) Department of Endocrinology, Christian Medical College and Hospital, Vellore, India |
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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. After 12 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 postoperative oral steroid therapy
for at least 12 weeks is recommended in all patients who undergo excisive surgery for AFS. |
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