Major sinus medicine component questioned

To the sick, to the allergic, to the tissue-clutching, stuffy-nosed sufferer, there's a certain aisle in the drugstore that offers unbridled hope, where shelves overflow with cold and sinus medicines advertising relief. It seems that all a bleary-eyed person needs to do is pluck one from a cornucopia and breathe easy.

Now, science has a more definitive solution to our drugstore dilemma: Keep on walking.

A study published in the Journal of Allergy and Clinical Immunology: In Practice, examined phenylephrine, the decongestant that appears in many over-the-counter cold medicines found on store shelves, including Tylenol Sinus, Sudafed PE and Advil Sinus Congestion & Pain.

Phenylephrine worked no better than a placebo at reducing nasal congestion in people suffering from seasonal allergies - even at doses four times higher than is typical in cold or sinus medicines.

"It's a rip-off," said Leslie Hendeles, a professor of pharmacy and pediatrics at the University of Florida, who receives no funding from drug companies and wrote an accompanying editorial. "Right now, people with a stuffy nose deserve to get relief from an effective medicine."

The study, funded by the pharmaceutical company Merck (which last year sold an allergy medicine that contains a rival decongestant to Bayer), is the latest piece of evidence to cast doubt on the effectiveness of phenylephrine.

One study showed that the majority of the drug is broken down in the gut and the liver, flushed out of a person's system before it makes it into the bloodstream.

A 2009 study that will sound especially sinister to anyone who suffers from allergies put 39 patients with a grass allergy into a sealed room called the "Vienna Challenge Chamber." Then, the scientists piped in grass pollen. The people were given phenylephrine, a sugar pill or another decongestant called pseudoephedrine. Phenylephrine did no better than the placebo, while pseudoephedrine-which must be obtained by going to the pharmacist's counter - beat them both.

Not everyone agrees that the evidence shows phenylephrine doesn't work. In 2007, a Food and Drug Administration advisory committee deemed that evidence was "suggestive" that it worked.

"Phenylephrine 10 mg is safe when used according to the label and has been proven effective for nasal decongestion in multiple clinical trials," said Barbara Kochanowski, the vice president of regulatory and scientific affairs at the Consumer Healthcare Products Association, a trade association that represents over-the-counter drugmakers.

Evidence of phenylephrine's effectiveness comes from a review that combined and analyzed the results of seven individual studies. It found that the drug had a small, but real, effect on nasal airway resistance, a technical measure of constricted airflow, in 113 people. One to three hours after taking the drug, people experienced at least a20 percent reduction in nasal airway resistance.

The new study examined the drug in more than 500 people with seasonal allergies, at escalating doses. That meant it would have increased the amount of the drug that bypassed the gut and liver and made it into the bloodstream. Even then, phenylephrine worked only as well as a placebo. The study used a measure of how patients felt - a nasal congestion symptom score - instead of measuring airway flow.

There is a lot at stake: Upper respiratory ailments accounted for $1.1 billion in annual drug sales in 2014, according to data from the Nielsen Company.

Hendeles is drafting his second citizen's petition to the Food and Drug Administration to have phenylephrine reviewed. He argues that companies simply do not want to cut into sales by putting drugs behind a pharmacy counter, which is required by law for pseudoephedrine, because it can be used to make methamphetamine. The Combat Methamphetamine Epidemic Act of 2006 made it harder to obtain.

Rather than have products vanish from store shelves, Hendeles said, companies began reformulating medications that previously contained pseudoephedrine with phenylephrine.

It can be a confusing situation for consumers, with seemingly identical drugs having different active ingredients. For example, Sudafed has pseudoephedrine in it, but the active ingredient in Sudafed PE is phenylephrine. Advil Cold & Sinus has pseudoephedrine, but Advil Allergy & Congestion Relief contains phenylephrine.

While pseudoephedrine has more evidence to support its use than phenylephrine, Wanda Filer, president of the American Academy of Family Physicians, said she tends to recommend that patients skip all decongestants. None of the drugs work very well, and they can come with side effects such as jitteriness, dry mouth and elevated blood pressure. Instead, she recommends taking a hot shower or filling a sink with hot water, draping a towel over your head and breathing in the steam.

"Frequently, I find an awful lot of people may get an hour of relief; over the long term, they seem to feel worse," Filer said.