A new study involving more than 150 patients ages 18 to 70 suggests that the antibiotic amoxicillin may be no better than a placebo in improving symptoms for those with sinusitis -- a common inflammation of the nasal passages and sinuses.
Findings from the trial -- published in the Journal of the American Medical Association -- show that when adults with a standard case of sinusitis were treated with either a 10-day course of amoxicillin or a placebo, by the third day both groups fared about the same in terms of recovery.
"The major implication might be a paradigm shift in how these patients are cared for," Jane Garbutt, MD, a research associate professor of medicine and pediatrics at Washington University School of Medicine in St. Louis, tells WebMD. "So most people didn't derive any clinical benefit from the antibiotic, so most people likely don't need any antibiotic treatment."
Garbutt and her colleagues used CDC guidelines for the evaluation and treatment of adults with sinusitis, which suggested that doctors only prescribe antibiotic treatment for the condition when patients have moderately severe or severe symptoms.
All the patients in the new study met the clinical guidelines for having sinusitis -- they had sinus-related symptoms, for at least seven but less than 28 days, that included facial pain, nasal congestion, and cough.
"Nobody disputes that some of these patients have a bacterial infection and would benefit from an antibiotic," she says. "The problem is we don't know who they are."
Garbutt writes that 1 in 5 of all adult antibiotic prescriptions in the U.S. is for the treatment of sinusitis, "and we're suggesting that might not be the best plan," she says, adding that 80% of patients with sinusitis get better on their own within 10 days.
Better for Public Health
Study results may have implications for the country's overall public health.
"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 [sudden-onset sinusitis]," the researchers write. "Yet, antibiotic treatment for upper respiratory tract infections is often both expected by patients and prescribed by physicians."
Prescribing antibiotics to treat conditions that don't require them contributes to a public health threat of increasing antibiotic resistance.
"I think the data are something like 90% of people that go to a doctor's office and receive this diagnosis will be given an antibiotic prescription," Garbutt says, "so I think that we should try and significantly reduce that percentage."
"We measured lots of different outcomes and we didn't find any benefit in any of them. So days missed from work, days not able to do usual activities, side effects of treatment, satisfaction with treatment -- we didn't see any difference in a whole plethora of things," she says.
The authors recruited adults with sinusitis from 10 offices of primary care physicians in St. Louis, Mo.
Participants were 166 adults ages 18 to 70 who met specific national diagnostic criteria for sinusitis. Per the recommendations of the CDC expert panel guidelines on sinusitis, only patients with moderate, severe, or very severe symptoms were included.
Of the 166 patients, 85 were randomly assigned to receive a 10-day course of amoxicillin and 81 received a placebo. Both groups were also given a five- to-seven day supply of medications to provide symptom relief, such as acetaminophen for pain or fever and pseudoephedrine for nasal congestion.
Researchers assessed patients with a standardized measure of sinus-related symptoms called the Sinonasal Outcome Test-16, or SNOT-16. With the SNOT-16, patients rated how much each of 16 sinus-related symptoms bothered them within the past few days. To track their symptoms, patients also used a six-point scale to assess symptom change.
Watch and Wait
Garbutt and her colleagues point to guidelines in the U.K. and some more recent guidelines in the U.S. that suggest "watchful waiting" instead of treatment with antibiotics when possible in patients with less severe sinusitis.
"If it's just usual, uncomplicated [sudden-onset] sinusitis that forms the majority of the patients, we would suggest that the doctor have a conversation with the patient, explain that they think it's more likely to be viral than bacterial and that they're going to be well within 10 days, and that they should use a painkiller, and that they really don't think there's any clinical benefit to them of taking the antibiotic," Garbutt says.
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