Question

• In otherwise healthy children with acute sinusitis, are intranasal steroids an effective adjunct to oral antibiotics?

Clinical Bottom Lines

1. Those patients who received intranasal budesonide in conjunction with oral antibiotics exhibited a significant decrease in cough and nasal discharge about one week earlier than those who only received oral antibiotics.¹
   
2. Both groups had a significant decrease in cough and nasal discharge by the end of the three week trial.
   
3. Relapse rates within one month were identical in the two groups.
   

Summary of Key Evidence

1. 151 patients diagnosed with acute sinusitis were initially enrolled.¹ Sinusitis was defined as 2 of 3 major criteria (purulent nasal discharge, pharyngeal drainage, cough) or 1 major and 2 minor criteria (periorbital edema, facial pain, tooth pain, earache, increased wheeze, foul breath, fever). These symptoms needed to be present for at least 7 days.²
   
2. Water's view X-rays were positive (>4 mm membrane thickening) in 79 of 89 patients.
   
3. Patients were excluded if they had a history of allergic rhinitis, asthma, or chronic sinusitis.
   
4. The patients were randomized to Augmentin (40 mg/kg/day) plus budesonide (N=43) or placebo (N=46) nasal sprays for a three week treatment course. Patients and evaluators were blinded to which nasal spray each patient was using. There were no significant differences between the groups.
   
5. The patients or their parents kept a daily symptom log for nasal discharge and cough. They rated their symptoms on a scale of 0-3 (0=no symptom, 3=severe symptom). The patients also were seen by the same physician for weekly follow up.
   
6. 62 patients did not follow through with the daily logs and were dropped from the study. One child was changed to cefaclor due to development of a rash with Augmentin.
   
7. Daily symptom scores were totaled each week and the groups were compared by median weekly symptom score using ANOVA.
   
8. The budesonide group had a significantly greater decrease in both cough and nasal discharge at 2 weeks over the control group.
   
9. Both groups had significant improvement in their symptoms after three weeks treatment. There was no significant difference between the symptom scores of the two groups at the end of the trial.
   
10. Two patients from each group had relapse of sinusitis within one month after completion of the study.

Additional Comments

• 62 patients not accounted for as to which group they originally belonged.
  
• Fever and headaches recorded but not included in results.
  
• Study does not address whether adding intranasal steroids can decrease the length of antibiotics or possibly eliminate the need all together.
  

Citation

1. Barlan IB, et. al. Intranasal budesonide spray as an adjunct to oral antibiotic therapy for acute sinusitis in children. Ann Allergy Asthma Immunol 1997; 78:598-601.
   
2. Shapiro GG, Rachelefsky GS. Introduction and definition of sinusitis. J Allergy Clin Immunol 1992; 90:417-418.

CAT Author: Michael Armstrong, MD, PhD

CAT Appraisers: Eugene Golding, MD

Date appraised: January 27, 2003