3 days of trimethoprim-sulfamethoxazole was as effective as 10 days in improving symptoms in acute maxillary sinusitis
ACP J Club. 1995 Nov-Dec;123:68. doi:10.7326/ACPJC-1995-123-3-068
Williams JW Jr, Holleman DR Jr, Samsa GP, Simel DL. Randomized controlled trial of 3 vs 10 days of trimethoprim/sulfamethoxazole for acute maxillary sinusitis. JAMA. 1995 Apr 5;273:1015-21.
To compare the effectiveness of 3-day trimethoprim-sulfamethoxazole (TMP-SMX) treatment with that of 10-day TMP-SMX treatment in improving symptoms and relapse and recurrence rates in patients with acute maxillary sinusitis.
Randomized, double-blind, controlled trial with 60-day follow-up.
University-affiliated Veterans Affairs general medical and acute care clinics.
80 consecutive men (median age 47 y) with sinus symptoms and radiographic evidence of maxillary sinusitis defined as complete opacity, air-fluid level, or ≥ 6 mm of mucosal thickening. Exclusion criteria were symptoms for > 1 month, immunocompromising states, previous sinus surgery, antibiotic use within the previous week, or TMP-SMX allergy.
All patients received oxymetazoline nasal spray, 0.05%, 2 sprays twice daily for 3 days. 40 patients were assigned to receive TMP-SMX, 160/800-mg tablet twice daily for 10 days, and 40 patients were assigned to receive TMP-SMX, 160/800-mg tablet twice daily for 3 days, then placebo twice daily for 7 days.
Main outcome measures
Patient-rated overall sinus symptoms on a Likert scale; radiograph scores; and number of days to cure or much improvement in sinus symptoms. Clinical successes at day 14 were assessed for symptomatic relapse at 30 days or recurrence at 60 days.
By day 14, 77% of patients assigned to 3-day TMP-SMX rated their sinus symptoms as cured or much improved compared with 76% of patients assigned to 10-day TMP-SMX (Table). Median days to cure or much improvement were 5.0 and 4.5 for the 3-day and 10-day groups, respectively (P = 0.34). Radiograph scores improved in both groups but did not differ between groups (P = 0.31). The 30-day relapse rate (11% in the 3-day group and 4% in the 10-day group) and the 60-day recurrence rate (4% in both groups) did not differ between treatment groups (for both relapses and recurrences P = 0.45) (Table). This study had an 80% power to detect a 2.5-day or longer time to clinical success in the 3-day TMP-SMX treatment group.
In patients with acute maxillary sinusitis, 3-day treatment with trimethoprim-sulfamethoxazole was as effective as 10-day treatment at 14 days. Relapse rates at 30 days and recurrence rates at 60 days were similar between groups.
Sources of funding: In part, Veterans Affairs Health Services Research and Development, and Burroughs Wellcome Co.
For article reprint: Dr. J.W. Williams, Ambulatory Care Service (11C), Audie L. Murphy Memorial Veterans Hospital, 7400 Merton Minton Boulevard, San Antonio, TX 78284, USA. FAX 210-567-4423.
Table. 3 days of trimethoprim-sulfamethoxazole (TMP-SMX) vs 10 days of TMP-SMX in acute maxillary sinusitis*
|Outcome at 14 d||3 d of TMP-SMX||10 d of TMP-SMX||RBI (95% CI)||NNT|
|Cured or much improved||77%||76%||1.6% (-22 to 33)||Not significant|
|Outcome of 30 d||RRI (CI)||NNH|
|Relapse or recurrence||15%||8%||85% (-57 to 720)||Not significant|
*Abbreviations defined in Glossary; RBI, RRI, NNT, NNH, and CI calculated from data in article.
The study by Williams and colleagues is the first to examine the important question of length of antibiotic therapy for uncomplicated acute sinusitis. The results suggest that 3 days of therapy may be as effective as traditional 7- to 14-day courses. This is contrary to some recommendations that advise that even longer courses of therapy for acute sinusitis are necessary to prevent complications (1).
The study, although important, is weakened by the participation of a small number of patients and by the use of radiographic criteria to diagnose sinusitis. The small number of patients makes it impossible to tell whether modest but clinically significant differences in the rates of relapse or serious complications would be found in a larger trial. Mucosal thickening on radiograph was used to diagnose sinusitis in almost half of the patients, but this thickening may be seen in nonbacterial illnesses (2). Patients without bacterial sinusitis (e.g., with viral illnesses) would not be expected to respond differently to a different duration of antibiotic therapy. If a substantial number of these patients participated in the trial, it might mask a difference in response among those with bacterial sinusitis. A trial using sinus aspiration and culture to diagnose sinusitis is needed to address this issue.
In a reliable patient with acute sinusitis who is otherwise healthy, it is now reasonable to initially prescribe a 3-day course of antibiotics plus a topical nasal decongestant treatment. I hope that a larger trial will address this important issue.
Laura Willett, MD
Robert Wood Johnson Medical SchoolNew Brunswick, New Jersey, USA