Amoxicillin no better than placebo for symptom relief in uncomplicated acute sinusitis

Amoxicillin did not reduce symptoms of sinusitis compared with placebo, according to a recent study.

Researchers in Missouri performed a randomized, placebo-controlled trial between Nov. 1, 2006 and May 2, 2009 to determine whether amoxicillin offered any quality-of-life advantage compared with symptomatic treatments in patients with uncomplicated acute sinusitis. Patients from 10 community practices were randomly assigned to receive a 10-day course of amoxicillin, 1,500 mg/d, or placebo, each delivered in three doses daily. All patients were also given five to seven days' worth of symptomatic treatments for fever, pain, cough and nasal congestion and were instructed to use them as needed.

Improvement in disease-specific quality of life after three to four days of treatment, as determined by the modified Sinonasal Outcome Test-16, was the primary outcome. Secondary outcomes were patients' retrospective rating of change in symptoms and functional status, relapse or recurrent infection, satisfaction with treatment, and adverse effects. Researchers assessed outcomes by telephone on days 3, 7, 10 and 28. The study results were published in the Feb. 15 Journal of the American Medical Association.

Overall, 166 patients were assigned to receive amoxicillin (85 patients) or placebo (81 patients). Most of the patients were women (64%) and white (78%). Rates of use of at least one symptomatic treatment were similar between groups (94% for the amoxicillin group vs. 90% for the placebo group; P=0.34). No significant difference in the primary outcome was seen between groups at days 3 or 10, but the amoxicillin group appeared to do better at day 7 (mean between-group difference in Sinonasal Outcome Test-16 score, 0.19 [95% CI, 0.024 to 0.35]). The groups did not differ in reporting improvement in symptoms at day 3 or day 10, but significantly more patients in the amoxicillin group did report improved symptoms at day 7 (74% vs. 56%; P=0.02). No serious adverse events were reported in either group, and no between-group differences were seen in any other secondary outcomes.

The authors noted that acute sinusitis may not have been present in all of the study patients and that the Sinonasal Outcome Test-16 may not have been able to pinpoint significant between-group differences precisely. However, they concluded that a 10-day course of amoxicillin appears to offer little to no benefit in uncomplicated acute sinusitis. They stressed that their results apply only to those with uncomplicated disease and that patients with serious complications “likely need a different management strategy.”