Question

• In an otherwise healthy child with clinically diagnosed sinusitis, do antibiotics relieve symptoms more quickly compared to supportive care?

Clinical Bottom Lines

1. There was no difference in sinus symptoms in patients with sinusitis who received Amoxicillin, Augmentin, or placebo.  All patients improved over time.
2. There was no significant difference in side effects between the treatment and placebo groups.
3. In an otherwise healthy patient with persistent (>10 days), mild symptoms (fever <39, no facial swelling/pain) and good follow up, it may be reasonable to withhold antibiotics and treat supportively.

Summary of Key Evidence

1. 188 patients were enrolled.  Patients were 1-18 years old drawn from 3 suburban St. Louis pediatric practices.  All patients had 10-28 days of persistent upper respiratory symptoms and a clinical diagnosis of sinusitis.¹
2. Patients excluded if they had “fulminant sinusitis” (fever>39, facial swelling/pain), were allergic to the study drug, had concurrent illness requiring antibiotic, had complication of sinus disease, chronic (>28 days) sinus disease, had received antibiotics in the preceding 2 weeks, or had cystic fibrosis.
3. Primary outcome measure was change insymptom score measured by S5 questionnaire (validated pediatric sinus severity scale).
4. Secondary outcomes included: adverse effects, recurrence or relapse, functional status, lost time from school/day care, satisfaction with treatment, compliance.
5. Patients received either Amoxicillin (40mg/kg/D), Augmentin (45 mg/kg/D) or placebo for 14 days.
6. Phone interviews conducted at days 3, 7, 10, 14, 21, 28, 60.
7. All patients improved over time with no differences in any outcomes at any time.
8. Patients treated with Amoxicillin had a higher incidence of abdominal pain compared to the other groups.  Otherwise no differences in adverse effects.
9

Additional Comments

• This study used low-dose amoxicillin which may undertreat resistant organisms.
• In contrast to this study, recent AAP guidelines suggest treatment of all children with sinusitis with antibiotics.
²

Citation

1. Garbutt JM, et al. A randomized, placebo-controlled trial of antimicrobial treatment for children with clinically diagnosed acute sinusitis. Pediatrics 2001;107(4): 619-25.
2. AAP Subcommittee on Management of Sinusitis. Clinical practice guideline: management of sinusitis.  Pediatrics  2001;108(3): 798-808.

CAT Author: Jason Kahn, MD

CAT Appraisers: John G. Frohna, MD

Date appraised: September 24, 2001