Randomized controlled trial of 3 vs 10 days of trimethoprim/sulfamethoxazole for acute maxillary sinusitis.

Objective: To compare 14-day outcomes and relapse and recurrence rates among patients with acute maxillary sinusitis randomized to 3-day (3D) vs 10-day (10D) treatment with trimethoprim/sulfamethoxazole (TMP/SMX).

Setting: University-affiliated Veterans Affairs general medical and acute care clinics.

Patients: Consecutive patients with sinus symptoms and radiographic evidence of maxillary sinusitis (complete opacity, air-fluid level, or > or = 6 mm of mucosal thickening). Patients were excluded for antibiotic use within the past week, TMP/SMX allergy, symptoms for more than 30 days, or previous sinus surgery.

Methods: All subjects (n = 80) received oxymetazoline nasal spray 0.05%, two sprays twice daily for 3 days. Subjects were randomly assigned to TMP/SMX double strength: one tablet twice daily for 10 days or one tablet twice daily for 3 days followed by 7 days of placebo. At 7 and 14 days, patients rated their overall sinus symptoms on a Likert scale. Radiographs were scored at baseline and 14 days by radiologists masked to clinical symptoms and treatment assignment. The primary outcome was number of days to "cure" or "much improvement" in sinus symptoms. Patients who were clinical successes by day 14 were assessed for symptomatic relapse or recurrence at 30 and 60 days, respectively.

Results: Groups were comparable at randomization: male, 100%; black, 53%; median age, 48 years (interquartile range, 41 to 63 years); symptom duration, 10 days (interquartile range, 6 to 17 days); bilateral maxillary disease, 51%; and radiograph score, 4 (interquartile range, 2 to 4). Outcome assessment was completed in 95% of patients at day 14 (n = 76). Medication side effects and use of nonstudy sinus medications were equal between groups. By 14 days, 77% of 3D subjects and 76% of 10D subjects rated their sinus symptoms as cured or much improved (95% confidence interval for difference, -15% to 17%). Median days to cure/much improvement were 5.0 and 4.5 for the 3D and 10D groups, respectively; distributions of time to cure were not different (P = .34). Radiograph scores improved in both groups compared with baseline (2 points; P < .001), but improvement did not differ between groups (P = .31). Eight percent of 3D subjects and 13% of 10D subjects missed work due to sinus symptoms. Of the 52 patients who were clinical successes at 14 days and completed follow-up, three (11%) of 27 3D subjects and one (4%) of 25 10D subjects relapsed symptomatically by day 30; one (4%) of 27 3D subjects and one (4%) of 25 10D subjects suffered symptomatic recurrence between days 30 and 60 (P = .45 for the relapse and recurrence rates combined).

Conclusion: At the 2-week follow-up, clinical symptoms and radiograph scores improved equally following 3 or 10 days of TMP/SMX plus oxymetazoline nasal spray. Symptomatic relapse and recurrence were similar between groups. Three days of antibiotics were as effective as 10 days and, because of the high disease prevalence, hold the potential for substantial cost savings.