Neither an antibiotic nor a steroid nasal spray is effective against acute bacterial sinusitis, according to a randomized study of 240 adults in the United Kingdom.
These findings add to the growing evidence that antibiotics do not yield useful clinical effects in this patient population, particularly when weighed against their disadvantages, and that topical steroids usually are not beneficial either.
The patients were recruited from 74 primary care practices between 2001 and 2005. The median age was 44 years, and the median duration of symptoms of bacterial sinusitis before the doctor visit was 7 days, Dr. Ian G. Williamson of the University of Southampton (England) and his associates reported.
The subjects were randomly assigned to receive 500 mg of amoxicillin 3 times per day for 7 days or a placebo, in combination with either budesonide or a placebo nasal spray once per day for 10 days. Patients reported the frequency and severity of 11 symptoms in a diary.
The proportion of patients who continued to have symptoms after 10 or more days of treatment was 29% with amoxicillin and 33% with placebo, a difference that was not significant. Similarly, the proportion who continued to have symptoms after 10 days of treatment with budesonide nasal spray was 31%—exactly the same as the proportion who continued to have symptoms with a placebo nasal spray.
There also were no differences between the study groups in time until cure was reported. The investigators said that 40% of the subjects in each group were cured by 1 week (J. Am. Med. Assoc. 2007;298:2487–96).
“Among patients with the typical features of acute bacterial sinusitis, neither an antibiotic nor a topical steroid, alone or in combination, [is] effective in altering the symptom severity, the duration, or the natural history of the condition,” the researchers concluded.
“Our rigorous case definition of sinusitis is likely to mean that less-well-defined cases treated routinely by physicians in primary care will show even less effect from taking antibiotics” and nasal steroids, Dr. Williamson and his associates noted.
Topical steroids may be of some benefit in milder cases of bacterial sinusitis than those that were treated in this study, because drug delivery to the nasal mucosa may be more effective before thick secretions, closure of the ostium, and severe inflammation develop, they added.
The study was “the largest nonpharmaceutically funded double-blind, randomized, placebo-controlled trial assessing the effectiveness of amoxicillin in cases of acute [bacterial] sinusitis … presenting to family physicians, and the only adequately powered trial of budesonide in this patient group,” they said.