Published Online: July 2, 2015
Seasonal allergic rhinitis (AR) is just one of many conditions that can cause nasal congestion, and the impact on sufferers and society is substantial, including lost work productivity and impairments in sleep and quality of life. Of the four main symptoms of AR (itchiness, sneezing, runny nose, and nasal congestion), nasal congestion occurs most often and is considered by people with AR to be more bothersome than the other symptoms. With limitations placed on the over-the-counter sale of pseudoephedrine (a decongestant shown to be effective) since 2006, Phenylephrine HCL (PE) has increasingly entered the marketplace and is widely used by consumers for the treatment of nasal congestion. Based on IMS Health Incorporated state-level data it is possible that the annual cost to American society of using PE for nasal congestion is upwards of half a billion dollars. Yet despite decades of widespread use and a Food and Drug Administration (FDA) indication of 10 mg every 4 hours for the temporary relief of nasal congestion, the most effective dose of PE and duration of action for nasal congestion are unknown. In fact, there have been no large-scale, well-conducted, peer-reviewed clinical studies published supporting the effectiveness of PE for the relief of nasal congestion.
In a recently published article in The Journal of Allergy and Clinical Immunology: In Practice, Meltzer and colleagues reported results from a clinical trial that randomly assigned 539 adults with seasonal AR who were suffering from nasal congestion but were otherwise healthy to receive one of four doses of PE (10 mg, 20 mg, 30 mg, or 40 mg) or placebo tablets that looked similar to the PE tablets. Participants took the study medication for 7 days, approximately every 4 hours, and recorded in a diary, using a 4-point scale, how congested they felt. These assessments included self-evaluation of symptom severity over the preceding 12 hours and at the moment of assessment prior to the next dose.
The results showed that even though PE was well tolerated at doses up to 30 mg, none of the doses (10–40 mg) showed any statistically significant difference in nasal congestion scores compared with placebo. It is likely that similar results would be seen in patients suffering from nasal congestion due to other causes such as nasal membrane swelling from irritants and the common cold.
The study was conducted in response to calls by the FDA upon the pharmaceutical industry to conduct large, well-designed, dose-ranging studies to assess the effectiveness of PE for the relief of nasal congestion. The authors conclude that consumers and healthcare practitioners should be warned about the ineffectiveness of PE to relieve nasal congestion, and the FDA should revise their labeling for PE accordingly.
The Journal of Allergy and Clinical Immunology: In Practice is an official journal of the AAAAI, focusing on practical information for the practicing clinician.