Antibiotics for sinusitis account for 1 of every 5 antibiotic prescriptions for adults in the United States. But Amoxicillin, the antibiotic commonly prescribed when a bacterial sinus infection (acute rhinosinusitis) is diagnosed, helps no more than a placebo, according to a new study published Feb 15 in JAMA.
Acute rhinosinusitis is a common disease associated with significant illness, lost time from work, and treatment costs. According to the report’s background section:
"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."
Testing Current Treatment Guidelines
Evidence-based guidelines for this condition recommend reserving antibiotic treatment for patients with moderately severe or severe symptoms. Dr. Jane M. Garbutt 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% 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% concurrently used 1 or more symptomatic treatments (94% for amoxicillin group vs. 90% for control group).
The primary outcome for the study was an improvement in disease-specific quality of life after 3 to 4 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% for amoxicillin group vs. 34% for control group) or at day 10 (78% for amoxicillin group vs. 80% for control group). At day 7, more participants treated with amoxicillin reported symptom improvement (74% for amoxicillin group vs. 56% 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.
The researchers write:
"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 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."
Source: Based on American Medical Association press release, Feb 15, 2012