Are antibiotics beneficial for patients with sinusitis complaints? A randomized double-blind clinical trial.
BACKGROUND
Sinusitis is the fifth most common reason for patients to visit primary care physicians, yet clinical outcomes relevant to patients are seldom studied.


OBJECTIVE
To determine whether patients with purulent rhinitis, "sinusitis-type symptoms," improved with antibiotics. Second, to examine a clinical prediction rule to provide preliminary validation data.


METHODS
Prospective clinical trial, with double-blinded placebo controlled randomization. The setting was a suburb of Washington, DC, from Oct 1, 2001, to March 31, 2003. All participants were 18 years or older, presenting to a family practice clinic with a complaint of sinusitis and with pus in the nasal cavity, facial pressure, or nasal discharge lasting longer than 7 days. The main outcome measures were resolution of symptoms within a 14-day follow-up period and the time to improvement (days).


RESULTS
After exclusion criteria, 135 patients were randomized to either placebo (n=68) or amoxicillin (n=67) for 10 days. Intention-to-treat analyses showed that 32 (48%) of the amoxicillin group vs 25 (37%) of the placebo group (P=.26) showed complete improvement by the end of the 2-week follow-up period (relative risk=1.3; 95% confidence interval [CI], 0.87-1.94]). Although the rates of improvement were not statistically significantly different at the end of 2 weeks, the amoxicillin group improved significantly earlier, in the course of treatment, a median of 8 vs 12 days, than did the placebo group (P=.039).


CONCLUSIONS
For most patients with sinusitis-type complaints, no improvement was seen with anti-biotics over placebo. For those who did improve, data suggested there is a subgroup of patients who may benefit from antibiotics.
Merenstein
Dan
D
The Johns Hopkins Hospital, 600 North Wolfe St., Carnegie 291, Baltimore, MD 21287-6220, USA. dmerenstein@jhu.edu
Whittaker
Carl
C
Chadwell
Tonya
T
Wegner
Brian
B
D'Amico
Frank
F
D000328:Adult; D000658:Amoxicillin / Q000627:therapeutic use*; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D017060:Patient Satisfaction; D010919:Placebos; D011446:Prospective Studies; D012220:Rhinitis / Q000188:drug therapy; D012852:Sinusitis / Q000188:drug therapy*; D013492:Suppuration; D013997:Time Factors; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D010919:Placebos; D000658:Amoxicillin