In a review of the literature published in The Cochrane Library, two Israeli authors conclude that the use of topical corticosteroid nasal sprays-either alone or in combination with antibiotic therapy-shows an advantage over placebo in the treatment of the symptoms of acute rhinosinusitis. But should these results change the way otolaryngologists treat a condition that is one of the most common reasons for office visits?
The researchers, Anca Zalmanovici, MD, and John Yaphe, MD, family physicians at Rabin Medical Center in Petach Tikva, Israel, reviewed four major studies. The studies, which were double-blind and placebo-controlled, included some 2000 participants in 16 countries.
In the studies reviewed, diagnosis was determined by X-ray or nasal endoscopy, and defined as having symptom duration of less than eight weeks. The intranasal corticosteroids prescribed were fluticasone propionate (Flonase), mometasone furoate (Nasonex), and budesonide (Rhinocort).
Of those treated with steroids, 73% showed relief or marked improvement of their symptoms during the study period (15 and 21 days), whereas 66.4% of those using placebo showed such improvement. These differences may seem modest but are statistically significant. For every 100 patients treated with intranasal corticosteroids, seven additional patients had complete or marked symptom relief, the researchers point out.
In addition, higher doses of nasal steroids worked better than lower ones. Subjects receiving daily doses of 400 micrograms experienced a greater rate of relief from symptoms than those receiving 200 micrograms per day.
There were no serious side effects reported in the steroid treatment. However, a significant deterrent to prescribing the sprays is cost. Without insurance coverage, the sprays can cost about $100 per month. And the introduction of generic versions has not lowered that price significantly. A physician may consider such a sum rather steep for the hastened relief of an acute condition that resolves with no treatment at all in more than 80% of cases.
However, each year some 37 million Americans suffer the symptoms of acute rhinosinusitis, and many demand relief-from specialists, as well as primary care physicians-of a condition that disrupts job productivity, education, and quality of life.
What’s an Otolaryngologist to Do?
Although some otolaryngologists rarely see acute rhinosinusitis in its early stages, and encounter mostly exacerbated cases after preliminary treatment has failed, other specialists, including Berrylin J. Ferguson, MD, of the University of Pittsburgh School of Medicine, often get calls from patients within days of their showing symptoms. Like most physicians, she will not consider prescribing antibiotics within seven days of onset. Rather, she starts these patients on time-tested remedies for colds, including plenty of fluids and vitamin C, with, perhaps, an over-the-counter topical decongestant. (Not all traditional home therapies are advisable. Bradley Marple, MD, Professor of Otolaryngology at University of Texas Southwestern Medical School, cautioned that patients who seek relief via steam inhalation risk burning themselves.)
When severe symptoms persist for more than a week, a closer look may be warranted. Dr. Marple believes that nothing can replace a careful history and exam. At this point many doctors will start patients on an antibiotic regimen, but Dr. Marple pointed out that of an estimated one billion upper respiratory infections each year, only 0.5% to 2% involve bacterial infection.
A specimen culture would make a definitive case for or against antibiotic treatment, but in actuality, this is not done in most cases. Antibiotic therapy is incidental to the improvement of most cases of sinusitis, since the majority of cases are viral, said Dr. Ferguson.
Martin Citardi, MD, of the Cleveland Clinic, said that an accurate diagnosis, including assessment of symptom severity and duration, should lead to treatment that is customized for each patient. Before prescribing either antibiotics or topical corticosteroids, comorbidities, such as lung disease, must be considered. The physician should probe for a history of multiple upper respiratory infections. Dr. Ferguson, whose area of expertise is in allergy management and sinonasal disorders, emphasized that the practitioner should take allergies into account. It is also crucial to determine which other drugs the patient is taking, especially Coumadin.
While taking a conservative view of antibiotic use, Dr. Citardi also warned against excessive caution when a bacterial cause may be likely. The much-publicized growth of drug-resistant bacteria seems to have plateaued, he said.
When to Consider Steroids
Whether or not antibiotics are employed, this is the point where the physician may consider topical corticosteroid therapy. Stilianos Kountakis, MD, Professor of Otolaryngology at the Medical College of Georgia, believes they are a good shotgun treatment, because of their safety. The medications are not absorbed in significant amounts, and there is no problem of immunosuppression, said Dr. Kountakis. He would not, however, prescribe oral corticosteroids for acute bacterial rhinosinusitis unless the patient is a few days into an effective antibiotic regimen to avoid immunosuppression.
Dr. Citardi pointed out that the sprays are beneficial on several levels. First, of course, they are anti-inflammatory, reducing the edema that causes the discomfort of rhinosinusitis. These complex drugs also may affect ciliary function. Even the preservatives in most steroidal nasal sprays may be useful as antibacterial agents.
If topical corticosteroids are to be prescribed, the clinician may wonder: which one? In the reviewed studies and in interviews with experts, there was no preference shown. Although the drugs differ from each other pharmacologically, their benefits are almost identical. Even though some insurers may insist that generic fluticasone propionate be prescribed, there is no real therapeutic-or economic-difference between it and the proprietary drugs.
In the rare cases in which morbidity progresses to the chronic stage, or if nasal polyps develop, topical corticosteroids should be tried, but this is not an FDA-approved treatment for these conditions. Fungal complication is another area beyond the scope of the studies. Dr. Marple said that these conditions may differ fundamentally from acute rhinosinusitis.
Although corticosteroid sprays are undoubtedly helpful in the treatment of many cases of acute rhinosinusitis, one should not prescribe these drugs cavalierly. Although absorption is minuscule, and they are generally very well tolerated, there is the cost issue. And there is always the possibility of unexpected consequences with large-scale use, said Dr. Citardi.
Experts Assess the Review
So how do the experts assess the review? Dr. Citardi found its conclusions intriguing, and said that they confirm his anecdotal experience, in which patients reported that the topical nasal steroid sprays have seemed to reduce symptoms of the common cold. But, in the end, the reported advantage remains relatively small.
Dr. Ferguson also found that the study validated her experience, but she looks forward to reviews that will include newer and better studies being conducted now. She also pointed out a fundamental problem in assessment: The studies in the review defined acute as a condition lasting under 8 weeks, whereas the standard definition for American otolaryngologists is under 4 weeks.
Dr. Kountakis also pointed to newer studies in the field, and said that he finds the topical corticosteroids useful in practice, but the literature can’t make a compelling argument that [the sprays] are greatly beneficial in acute rhinosinusitis. As such, the review is not a tremendous breakthrough.
Dr. Marple found that the review confirmed his own observations. He likes the efficacy of the steroid sprays and their applicability in a wide range of cases. And the review underscored the treatment’s safety, which, he said, is their strong suit. As for the cost issue, they’re expensive-but so are antibiotics, which appear less likely to offer the patient relief.
©2008 The Triological Society