There is no significant difference between an over-the-counter decongestant and a prescription medication that costs almost four times as much in relieving hay fever symptoms, report researchers from the University of Chicago in the February issue of Archives of Otolaryngology - Head & Neck Surgery.
The study, conducted during the 2003 ragweed allergy season in Chicago, found that daily doses of 240 mg of pseudoephedrine hydrochloride (Sudafed. 24 Hour) were just as effective as 10 mg daily of montelukast sodium (Singulair.) at relieving symptoms such as nasal congestion, runny nose, sneezing and itching, and at improving quality of life for those with hay fever -- without any additional side effects.
"This came as a genuine surprise," said Fuad Baroody, M.D., associate professor of surgery at the University of Chicago and director of the study. "Our hypothesis was that montelukast would have additional benefits and pseudoephedrine would interfere with sleep, but when we compared them head-to-head we found that for treatment of allergic rhinitis, these drugs at these doses were virtually identical."
In fact, pseudoephedrine had small advantages in specific categories. It was slightly more effective, for example, in reducing congestion, which it was specifically designed to do.
Despite similar results, the drugs work in completely different ways. Pseudoephedrine, designed to treat nasal congestion, constricts vessels within the nasal mucosa, thus leading to a more patent airway and less nasal congestion. It does not have known anti-inflammatory effects.
On the other hand, Montelukast, originally designed to treat asthma, antagonizes leukotrienes, substances released during the allergic response. These substances have potent inflammatory effects and are known to cause nasal congestion and contribute to chronic inflammation, which is one of the hallmarks of allergic rhinitis.
Because of these properties, montelukast was approved by the FDA to treat allergic rhinitis, and "indeed," notes Baroody, "this study is one of few that shows that montelukast causes a significant improvement in nasal airflow, an objective measure of nasal congestion, an effect shared by pseudoephedrine in this study."
Another difference between the agents is the cost. At www.drugstore.com, timed-release 240 mg capsules of pseudoephedrine cost about 80 cents a day, compared to $3.20 a day for montelukast. Since allergic rhinitis - the nasal congestion, runny nose, sneezing and itching associated with seasonal allergies such as hay fever -- affects about 40 million people in the United States, the difference can add up.
This study compared these two treatments in 58 adults with ragweed allergy during the hay fever season, from mid-August until late September, of 2003. Participants recorded their allergy symptoms, quality of life without medication, and peak nasal inspiratory flow (PNIF - a measure of air flow through the nose) for two days before beginning the drug trial.
During the study, 30 patients took montelukast and 28 took pseudoephedrine each morning for 14 days. For these two weeks, they recorded allergy symptoms and PNIF twice a day. At the end of the study they filled out another questionnaire about quality of life and side effects.
"There were two surprises," Baroody said. "We expected pseudoephedrine to be effective against congestion, but we underestimated its impact on sneezing, runny nose and itching."
The second was the lack of sleep problems among those taking pseudoephedrine. Although nervousness, anxiety, insomnia, dry mouth and palpitations have all been associated with pseudoephedrine in previous studies, neither medication caused any significant side effects in this investigation.
"Both medications were well tolerated," note the authors, "and pseudoephedrine did not lead to any of its well-known stimulant adverse effects, likely owing to its once-daily administration in the morning and lower blood levels in the later hours of the day closer to bedtime."
Additional authors include Samantha Mucha, Marcy de Tineo, and Robert Naclerio of the University of Chicago. This study was supported in part by a medical school grant from Merck & Co. Inc., the makers of Singulair. Merck also contributed editorial suggestions during the preparation of this article. Drs. Naclerio and Baroody belong to the Speakers Bureaus of Merck & Co. Inc. and Dr. Baroody has received honoraria from Merck.