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RESULTS: Based on 8 unpublished studies that included 138 patients, phenylephrine 10 mg did not affect NAR more than placebo; the mean maximal difference in relative change from baseline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 Eight unpublished studies on phenylephrine 25 mg showed a significant reduction of maximal NAR compared to placebo of 27.6%, [95% CI, 17.5%, 37.7%].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!
Researchers simplify tiny structures' construction drip by drip
12.11.2018 | Princeton University, Engineering School
Mandibular movement monitoring may help improve oral sleep apnea devices
06.11.2018 | Elsevier
Biochips have been developed at TU Wien (Vienna), on which tissue can be produced and examined. This allows supplying the tissue with different substances in a very controlled way.
Cultivating human cells in the Petri dish is not a big challenge today. Producing artificial tissue, however, permeated by fine blood vessels, is a much more...
Faster and secure data communication: This is the goal of a new joint project involving physicists from the University of Würzburg. The German Federal Ministry of Education and Research funds the project with 14.8 million euro.
In our digital world data security and secure communication are becoming more and more important. Quantum communication is a promising approach to achieve...
On Saturday, 10 November 2018, the research icebreaker Polarstern will leave its homeport of Bremerhaven, bound for Cape Town, South Africa.
When choosing materials to make something, trade-offs need to be made between a host of properties, such as thickness, stiffness and weight. Depending on the application in question, finding just the right balance is the difference between success and failure
Now, a team of Penn Engineers has demonstrated a new material they call "nanocardboard," an ultrathin equivalent of corrugated paper cardboard. A square...
Physicists at ETH Zurich demonstrate how errors that occur during the manipulation of quantum system can be monitored and corrected on the fly
The field of quantum computation has seen tremendous progress in recent years. Bit by bit, quantum devices start to challenge conventional computers, at least...
09.11.2018 | Event News
06.11.2018 | Event News
23.10.2018 | Event News
15.11.2018 | Earth Sciences
15.11.2018 | Physics and Astronomy
15.11.2018 | Physics and Astronomy