Placebo As Good As Common Treatments For Sinus Infections

Editor's Choice
Main Category: Ear, Nose and Throat
Also Included In: Primary Care / General Practice;  Pharmacy / Pharmacist;  Clinical Trials / Drug Trials
Article Date: 05 Dec 2007 - 10:00 PDT

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A placebo is likely to be just as effective as common acute sinusitis treatments involving a topical steroid and an antibiotic, according to an article published in the Journal of the American Medical Association (JAMA), 5th December issue.

Sinus infection (acute sinusitis) is often diagnosed and treated without clinical information, even though it is a common clinical problem which has symptoms similar to those found in other illnesses, the authors explain.

92% of patients in the UK and 85-98% of those in the USA are prescribed antibiotics, even though a bacterial cause is uncertain. The writers say "Because there are no satisfactory studies of microbiological etiology from typical primary care patient practices, wide-scale overtreatment is likely occurring."

The widespread use of antibiotics may be having an impact on raised antibiotic resistance rates in the community. While topical steroids are commonly used to treat acute sinusitis, research on their effectiveness has been limited.

Ian G. Williamson, M.D., of the University of Southampton, England, and team carried out a double-blind randomized placebo-controlled trial to find out how effective amoxicillin (an antibiotic) and budesonide (a topical steroid) were for the treatment of acute maxillary sinusitis (rhinosinusitis - inflammation of the nasal cavity and sinuses).

240 adult patients were included in the trial. They all had non-recurrent sinusitis and were being treated at 58 GP (General Practitioner) practices, during the period Nov 2001 - Nov 2005.

They were randomly selected into one of four groups:

1. antibiotic and nasal steroid (500 mg of amoxicillin 3 times per day for 7 days and 200 μg of budesonide in each nostril once per day for 10 days)
2. placebo antibiotic and nasal steroid
3. antibiotic and placebo nasal steroid
4. placebo antibiotic and placebo nasal steroid

The researchers found that:

-- 29% of those receiving amoxicillin had symptoms lasting more than ten days
-- 36% of patients not receiving amoxicillin had symptoms lasting for more than ten days
-- 31.4% of those receiving topical budesonide had symptoms lasting for more than ten days
-- 31.4% of those not receiving budesonide had symptoms lasting for more than ten days

Further analysis found that nasal steroids were much more effective for those whose symptoms were less severe at baseline.

The researchers wrote "Our main conclusions are that among patients with the typical features of acute bacterial sinusitis, neither an antibiotic nor a topical steroid alone or in combination are effective in altering the symptom severity, the duration, or the natural history of the condition. Topical steroids are likely to be effective in those with such features but who have less severe symptoms at presentation to the physician," the authors write.

Editorial

Morten Lindbaek, M.D., University of Oslo, Norway, in an Accompanying Editorial wrote:

"The study by Williamson et al has implications for clinicians who treat patients with acute sinusitis-like symptoms. This study reinforces the lack of benefit from antibiotics shown in a number of other studies that recruited patients based on clinical symptoms and findings. Most patients with acute purulent sinusitis recover without antibiotic treatment, as was also observed in a study that used sinus computed tomography scans as the diagnostic standard. But some patients with sinusitis are more ill than others with fever, malaise, and deteriorated general condition. These patients still are in need of antibiotics, although they are relatively uncommon in general practice. So far there is no reliable way to distinguish viral sinusitis from bacterial sinusitis in the general practice setting, and a point of care test that could single out patients who could benefit from antibiotic treatment is not available."

"Antibiotics and Topical Nasal Steroid for Treatment of Acute Maxillary Sinusitis - A Randomized Controlled Trial"
Ian G. Williamson, MD; Kate Rumsby, BA; Sarah Benge, PhD; Michael Moore, FRCGP; Peter W. Smith, PhD; Martine Cross, BA; Paul Little, MD
JAMA. 2007;298(21):2487-2496.
Click here to see the abstract online

Editorial
"Acute Sinusitis-To Treat or Not to Treat?"
Morten Lindbaek, MD
JAMA. 2007;298(21):2543-2544.
Clic here to see the Editorial

Written by - Christian Nordqvist
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