Treatment with the antibiotic amoxicillin for patients with acute uncomplicated rhinosinusitis (inflammation of the nasal cavity and sinuses) did not result in a significant difference in symptoms compared to patients who received placebo, according to a study in the Feb. 15, 2012 issue of JAMA. Antibiotics are commonly used to treat this condition even though there is limited evidence supporting their effectiveness.
Acute rhinosinusitis is a common disease associated with significant illness, lost time from work, and treatment costs. Considering the public health threat posed by increasing antibiotic resistance, strong evidence of symptom relief is needed to justify prescribing of antibiotics for this usually self-limiting disease. Placebo-controlled clinical trials to evaluate antibiotic treatment have had conflicting results, likely due to differences in diagnostic criteria and outcome assessment, according to background information in the article. Evidence-based guidelines for this condition recommend reserving antibiotic treatment for patients with moderately severe or severe symptoms. Antibiotics for sinusitis account for 1 in 5 antibiotic prescriptions for adults in the United States.
Jane M. Garbutt, MBChB, and colleagues from the Washington University School of Medicine, St. Louis, conducted a study to examine the effect of amoxicillin treatment over symptomatic treatments on disease-specific quality of life in adults with clinically diagnosed acute bacterial rhinosinusitis. The trial included 166 adults (36 percent male) who were randomized to receive a 10-day course of either amoxicillin (1,500 mg/d; n = 85) or placebo (n = 81) administered in 3 doses per day. Some of the most common symptoms reported by participants at the beginning of the study included facial pain or pressure, postnasal discharge, and cough and runny nose. All patients received a 5- to 7-day supply of symptomatic treatments for pain, fever, cough, and nasal congestion to use as needed; 92 percent concurrently used 1 or more symptomatic treatments (94 percent for amoxicillin group vs. 90 percent for control group).
The primary outcome for the study was the improvement in disease-specific quality of life after three to four days of treatment as assessed with the Sinonasal Outcome Test-16 (minimally important difference of 0.5 units on a 0-3 scale). Secondary outcomes included the patient's assessment of change in sinus symptoms and functional status, recurrence or relapse, and satisfaction with and adverse effects of treatment. The outcomes were assessed by a telephone interview at days 3, 7, 10, and 28.
The researchers found that the average change in test scores was similar in both groups at day 3 (amoxicillin group, 0.59; control group, 0.54) and at day 10 (average difference between groups, 0.01), but differed at day 7, favoring amoxicillin (average difference between groups of 0.19). There were no statistically significant differences in reported symptom improvement at day 3 (37 percent for amoxicillin group vs. 34 percent for control group) or at day 10 (78 percent for amoxicillin group vs. 80 percent for control group). At day 7, more participants treated with amoxicillin reported symptom improvement (74 percent for amoxicillin group vs. 56 percent for control group).
The authors found there was also no difference by study group in terms of days missed from work or inability to perform usual activities; rates of relapse and recurrence by 28 days; additional health care use; and satisfaction with treatment. No serious adverse events occurred. The study groups did not differ in reporting adverse effects from the study medication.
There is now a considerable body of evidence from clinical trials conducted in the primary care setting that antibiotics provide little if any benefit for patients with clinically diagnosed acute rhinosinusitis. Yet, antibiotic treatment for upper respiratory tract infections is often both expected by patients and prescribed by physicians, the researchers write. The National Institute for Health and Clinical Excellence guidelines in the United Kingdom, and more recent guidelines in the United States, suggest watchful waiting as an alternative approach to the management of patients for whom reassessment is possible; this approach delays and may preclude antibiotic treatment while providing symptomatic treatments and an explanation of the natural history of the disease.
This study was funded by a grant from the National Institute of Allergy and Infectious Diseases.
Reference: JAMA. 2012;307:685-692.