After Leading Decongestant Found Ineffective, Many Doctors Say 'Not Much' Works for Treating Common Cold

When you stroll down the cold and flu aisle in a drugstore it’s easy to get lost in the dizzying array of products promising to clear sinus pressure, dry up sniffles and stop plaguing coughs. Some concoctions even offer it all in one magical pill. However, a government panel has found the evidence behind some of these claims is lackluster — and doctors say that could extend all the way down the aisle.

“There’s just not much that’s very effective for treating the common cold,” said Dr. Lauren Eggert, clinical assistant professor in the Pulmonary Allergy and Critical Care Division at Stanford University. “Most of the things out there — antihistamines, decongestants, cough medicines — none of them have a lot of evidence that they’re super effective at improving cough or common cold symptoms.”

This week the Food and Drug administration determined the country’s leading decongestant is really no better than a sugar pill. In a unanimous vote Tuesday, advisers to the agency said the key drug, phenylephrine, found in Sudafed P.E., Mucinex Sinus Max, Dayquil and other oral medications is simply not effective. The review was prompted by inquiries dating back nearly a decade. And experts warn the ineffectiveness is not limited to just that one drug. More reviews of over-the-counter drugs are expected.

Eggert pointed to the database UpToDate. Physicians use the resource when they want to see the summary of evidence for a group of medications. The conclusions for cold and flu remedies are disconcerting:

• Antihistamines, vitamins and herbal remedies are deemed ineffective.
• Cough syrups, decongestants, expectorants, and zinc may have minimal or uncertain benefits.
• Nasal sprays and analgesics like Tylenol and ibuprofen may be effective.

So, why are there so many cold and flu products on store shelves making big promises with little evidence to back them up?

The FDA’s over-the-counter drug list has not been updated since 1995. And many of the drugs sold today were grandfathered during the ’60s and ’70s when scientific studies were much less rigorous.

“Back in those days, statistics were not very developed,” said Dr. Leslie Hendeles, PharmD, professor emeritus at the University of Florida in Gainesville, who was one of the petitioners who prompted this week’s FDA review. “The whole concept of clinical trials and study design was in its infancy.”

And since then the system for updating the drug list has traditionally taken many years or even decades, requiring multiple rounds of review and public comments.

The passage of the 2020 CARES Act should improve what’s available by streamlining the laborious process that may have allowed unchecked medications on the market. This week’s vote on phenylephrine, which was based on the latest scientific evidence, is the first test case for the law. But the FDA has not yet issued a final decision on whether the product will be removed from store shelves.

“The message here is that there are a lot of products on the market that fall into the same category as phenylephrine,” said Hendeles. “They’re not for diseases where people die or have to go to an emergency room. So they have not gotten the attention — even from the FDA — until now.”

Hendeles believes regulators are likely to ultimately find that many other over-the-counter drugs are futile, too. “I know for sure that the cough suppressants and the expectorants are next in line.”

He points to a compilation of data he presented in a 2018 paper published in the journal Allergy and Asthma Proceedings, where he concluded the marketing claims on products designed for respiratory symptoms are overblown. And the evidence for decongestants, expectorants and cough suppressants does not “justify their use.”

Industry groups like the Consumer Healthcare Products Association maintain that phenylephrine has provided the public with clear health benefits for years. They asked the FDA not to remove it from a list of safe and effective over-the-counter drugs, arguing it provides the public with accessible treatment.

“Simply put, the burdens created from decreased choice and availability of these products would be placed directly onto consumers and an already-strained U.S. healthcare system, which is why CHPA encourages the panel to consider the real-world experience and needs of consumers when making decisions that will have such broad implications,” said Marcia Howard, the association’s vice president of regulatory and scientific affairs, in a statement.

So, what can help your runny nose?

Hendeles recommends steroidal nasal sprays for people suffering from allergies. Look for fluticasone (Flonase) or triamcinolone (Nascort). One squirt in each nostril. Evidence suggests Oxymetazoline Hydrochloride (Afrin or Sinex) is the best nasal spray for people who are sick with a respiratory illness.

What about the rest of the meds lining your medicine cabinet?

“If you’ve used something and you felt like it was helpful, I don’t think there’s a problem with that,” said Eggbert. “There’s little harm for people who are looking for relief. And I do believe in the placebo effect.”

But don’t look for a magical concoction. Single-ingredient products will help lower the possibility for side effects, according to Dr. Shalini Lynch, PharmD, health sciences clinical professor at UCSF’s School of Pharmacy. She says it should be obvious in a day or two if the product is relieving a desired symptom.

Science also supports some natural remedies. Saline nasal rinses may help clear your sinuses and honey can quell your cough. Additionally, it may be worth standing in a steamy shower or filling your humidifier to open your nasal passages. However, Lynch’s best advice is simply to lay low and hydrate.

“The common cold is something that pretty much needs to run its course,” she said. “You want to feel better instantly. But the reality is most cough and cold, viral types of upper respiratory infections, they just take time to go away.”