BACKGROUND: Oral phenylephrine is used as a decongestant, yet there is no published systematic review supporting its efficacy and safety.
OBJECTIVE: To assess the efficacy and safety of oral phenylephrine as a nonprescription decongestant.
METHODS: English and non-English language studies through January 2007 in MEDLINE, CCTR, EMBASE, International Pharmaceutical Abstracts, Federal Register, personal files, hand search of references, and a Web of Science cited reference search were included. Randomized, placebo-controlled trials were included that measured the effects of oral phenylephrine on nasal airway resistance (NAR) in patients with nasal congestion. Studies of combination products were excluded. Two investigators independently extracted data on NAR, self-reported decongestant effects, and cardiovascular effects (i.e., heart rate and blood pressure) from each of the included studies. Meta-analyses were performed for NAR and cardiovascular effects. Subjective decongestant effects were summarized
RESULTS: Based on 8 unpublished studies that included 138 patients, phenylephrine 10 mg did not affect NAR more than placebo; the mean maximal difference in relative change from baseline between phenylephrine and placebo was 10.1%, [95% confidence interval, (95% CI) -3.8%, 23.9%]. Eight unpublished studies on phenylephrine 25 mg showed a significant reduction of maximal NAR compared to placebo of 27.6%, [95% CI, 17.5%, 37.7%]. There was significant heterogeneity among the studies included in this analysis, which was partially attributable to different laboratories and methods used. Patient-reported decongestion was not consistently better for any phenylephrine dose compared with placebo, and nasal airway resistance was a more sensitive measurement of efficacy. Phenylephrine showed no consistent effect on heart rate or blood pressure for doses 25 mg.
CONCLUSIONS: There is insufficient evidence that oral phenylephrine is effective for nonprescription use as a decongestant. The FDA should reclassify oral phenylephrine from Category I (safe and effective) to Category III, which requires additional studies to show safety and efficacy.
Key Words: phenylephrine, nasal airway resistance, nasal decongestants, nonprescription, meta-analysis
Reprints: Dr. Hatton, University of Florida College of Pharmacy, PO Box 100316, 1600 SW Archer Road (G225), Gainesville, FL, 32610-0316, 352/265-0408, fax 352/265-1091, email@example.com
Stan Lloyd | EurekAlert!
Win-win strategies for climate and food security
02.10.2017 | International Institute for Applied Systems Analysis (IIASA)
The personality factor: How to foster the sharing of research data
06.09.2017 | ZBW – Leibniz-Informationszentrum Wirtschaft
University of Maryland researchers contribute to historic detection of gravitational waves and light created by event
On August 17, 2017, at 12:41:04 UTC, scientists made the first direct observation of a merger between two neutron stars--the dense, collapsed cores that remain...
Seven new papers describe the first-ever detection of light from a gravitational wave source. The event, caused by two neutron stars colliding and merging together, was dubbed GW170817 because it sent ripples through space-time that reached Earth on 2017 August 17. Around the world, hundreds of excited astronomers mobilized quickly and were able to observe the event using numerous telescopes, providing a wealth of new data.
Previous detections of gravitational waves have all involved the merger of two black holes, a feat that won the 2017 Nobel Prize in Physics earlier this month....
Material defects in end products can quickly result in failures in many areas of industry, and have a massive impact on the safe use of their products. This is why, in the field of quality assurance, intelligent, nondestructive sensor systems play a key role. They allow testing components and parts in a rapid and cost-efficient manner without destroying the actual product or changing its surface. Experts from the Fraunhofer IZFP in Saarbrücken will be presenting two exhibits at the Blechexpo in Stuttgart from 7–10 November 2017 that allow fast, reliable, and automated characterization of materials and detection of defects (Hall 5, Booth 5306).
When quality testing uses time-consuming destructive test methods, it can result in enormous costs due to damaging or destroying the products. And given that...
Using a new cooling technique MPQ scientists succeed at observing collisions in a dense beam of cold and slow dipolar molecules.
How do chemical reactions proceed at extremely low temperatures? The answer requires the investigation of molecular samples that are cold, dense, and slow at...
Scientists from the Max Planck Institute of Quantum Optics, using high precision laser spectroscopy of atomic hydrogen, confirm the surprisingly small value of the proton radius determined from muonic hydrogen.
It was one of the breakthroughs of the year 2010: Laser spectroscopy of muonic hydrogen resulted in a value for the proton charge radius that was significantly...
17.10.2017 | Event News
10.10.2017 | Event News
10.10.2017 | Event News
17.10.2017 | Life Sciences
17.10.2017 | Life Sciences
17.10.2017 | Earth Sciences