Antibiotic, steroid ineffective against sinusitis

No treatment seems to be the best approach to acute maxillary sinusitis. A head-to-head comparison found placebos just as effective as a commonly prescribed antibiotic and topical steroids used alone or in combination.

Sinus infections are among the most common clinical problems, and antibiotics are prescribed in as many as 98% of cases. Many patients demand a prescription. In fact, in the new study, researchers’ recruitment efforts were significantly hampered by patient refusals to risk assignment to a placebo group.

In their double-blind trial, researchers from the University of Southampton in England asked local family physicians to recruit a total of 240 patients with purulent rhinorrhea, localized pain, and other symptoms of sinusitis. The patients were randomly assigned to receive one of four regimens: an antibiotic and steroid, an antibiotic and placebo, steroid and placebo, or two placebos. Those treated with antibiotics took a seven-day course of amoxicillin 50 mg three times a day. Those on the steroid regimen used budesonide 200 µg in each nostril once a day for 10 days.

All the participants kept diaries, rating 11 symptoms on a scale of 0 (normal) to 6 (“as bad as it could be.”) Symptoms included nasal blockage, discharge, unpleasant taste or smell, pain, headache, level of restricted activities, and overall “level of wellness.” Among those taking the antibiotic, 29% experienced symptoms that persisted 10 days or more, compared with 33.6% of placebo patients, a difference that did not reach statistical significance. The researchers speculated that antibiotics do not typically penetrate well into localized cavities.

Among those taking the steroid, the proportion whose symptoms persisted were identical to that of those taking a placebo: 31.4%. Budesonide did offer some relief to patients whose symptoms were mild at the outset, but it proved detrimental to those who started at lower levels of wellness or whose activities were limited.

“Most cases resolve with symptomatic treatment and analgesics, which should remain the mainstay of treatment,” the research team concludes (JAMA. 2007;298:2487-2496).

In an accompanying editorial, Morten Lindbaek, MD, of the department of general practice at the University of Oslo, recommends clinicians wait a week before prescribing antibiotics, pointing out that they cannot be completely avoided. Patients whose sinusitis is accompanied by fever, malaise, and “a deteriorated general condition” need them, although these patients are rare in general practice, he observes.

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