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The (Cold) Drugs Don't Work
Does PE stand for Placebo Effect?
I've been blogging semi-regularly for almost 15 years and whenever I feel like I'm "blogged out" with nothing more to say, I inevitably find a topic that I've missed or forgotten to blog. When I read this post and then this paper about the dubious justification for the sale of a common cough and cold ingredient, I was frankly embarrassed that I hadn't already written about it – years ago. Because the ineffectiveness of some cough and cold products is something everyone should be aware of.
We all suffer from coughs and colds. Surprisingly, while there are dozens of brands and formulations of cough and cold remedies on pharmacy shelves, they all use combinations of the same core handful of ingredients. And the evidence supporting some of these products is very, very weak. In the case of phenylephrine, included to treat "congestion", it's widely considered ineffective. Yet the FDA and regulators around the world continue to allow this ingredient to be included in cold products, as if it has medicinal benefits. Considering the evidence, this seems unwarranted.
What is phenylephrine?In 1976, the FDA concluded that three medicines were safe and effective for the treatment of nasal congestion caused by colds, allergies, and sinusitis: phenylpropanolamine, pseudoephedrine, and phenylephrine. Almost 25 years later, phenylpropanolamine was withdrawn from the market after use was associated with strokes. Pseudoephedrine is an effective decongestant that is chemically very similar to methamphetamine, a addictive and controlled drug that subject to abuse. Pseudoephedrine does not share the same stimulant properties as methamphetamine, though it can cause jitteriness, mild tremors, and insomnia. However, because pseudoephedrine can be used to manufacture methamphetamine, the over-the-counter sale of cough and cold products that contain this ingredient are not permitted. Sales were moved "behind the counter" in the US, with the requirement for the customer to produce photo identification and the requirement for the pharmacy to maintain a log of all sales, tracked by customer name and address.
When pseudoephedrine was moved behind the counter, manufacturers of cough and cold products either had to accept a much smaller market for their (effective) product, or…pivot.
It may not be effective. But you cannot make methamphetamine from it.
Some companies reformulated their products to contain phenylephrine instead, the last remaining non-prescription ingredient that the FDA had approved for congestion. Phenylephrine is from a category of drugs called alpha-1 agonists, that stimulate alpha-1 receptors that are present throughout the body, including the nasal passages. It is used as a nasal spray but more commonly as a oral product take to treat nasal congestion. There was a problem with FDA's approval, however. There was little convincing evidence phenylephrine, when taken orally, was effective.
The evidence against phenylephrinePhenylephrine is a poorly-absorbed drug (i.E., it has low bioavailability). Most of the drug is broken down during the absorption process and after passing through the liver. Only an estimated 38% of a dose actually reaches the bloodstream (compared with 90% for pseudoephedrine). In clinical trials, phenylephrine has been compared to other decongestants in a randomized controlled trial of 20 patients (way back in 1971) and found to be no more effective than placebo in reducing airway resistance. Another trial compared single doses of four different decongestants against placebo in 88 patients with congestion. It also found that phenylephrine was no more effective than placebo. In a review of the data that the FDA had considered, that review noted that for the 10mg dose, 4 studies showed efficacy and seven showed no difference from placebo. The authors concluded that a systematic review did not support the FDA's decision. Other trials conducted since that time (like this one in 2009) are supportive of the conclusion that the 10mg dose is ineffective.
The fact that we are relying on trials conducted in the 1970's pretty much tells us what we need to know about phenylephrine. Given how poorly it is absorbed, there is the question of whether simply giving bigger doses will work – and it turns out it may. However, the 10mg dose is what's available in US cough and cold products – and the best evidence shows that this drug is effectively a placebo at that dose. I will point out that the manufacturers of the consumer products that contain this ingredient continue to write their own papers suggesting that there is evidence of efficacy.
The FDA is petitioned…and is finally actingIn 2015, pharmacy professors Randy Hatton and Leslie Hendeles of the University of Florida College of Pharmacy filed a citizen's petition with the FDA, asking it to remove phenylephrine from the monograph of over-the-counter cold remedies, noting the absence of a decongestant effect at the approved dose of 10mg. They noted that since the FDA's Nonprescription Drugs Advisory Committee had called for more research in 2007, four studies had been conducted, and none of those studies demonstrated that phenylephrine was more effective than a placebo. This petition is supported by the American Academy of Allergy, Asthma and Immunology:
The low bioavailability of pharmacologically active oral PE explains the lack of nasal therapeutic efficacy and cardiovascular effects. It is extensively metabolized in the gut mucosa causing insufficient systemic PE levels to produce vasoconstriction of nasal and other blood vessels. Available data do not support whether a dose greater than 40mg of oral PE would be effective or safe. Furthermore, the American Academy of Allergy, Asthma & immunology and the American College of Allergy, Asthma & Immunology in their role as patient advocates have concluded that keeping oral phenylephrine over‐the‐counter does a disservice to patients who might be prone to taking higher doses than recommended due to lack of effect and/or delay their visit to their primary care clinician or a specialist who could help resolve their symptoms.
Ineffective drugs don't deserve stamps of approvalProfessors Hatton and Hendeles reiterated their call for the FDA to take action in 2022, and finally the FDA may act this April:
The committee will discuss the adequacy of efficacy data available for oral phenylephrine as a nasal decongestant and whether oral nasal decongestants phenylephrine hydrochloride and phenylephrine bitartrate should be reclassified as not 'Generally Recognized as Safe and Effective' (GRASE) due to lack of efficacy.
Why the approval has persisted so long is puzzling from an evidence perspective, but perhaps it was sensible to the FDA. Phenylephrine is safe at the 10mg dose, and withdrawing the drug might raise more questions about why this drug was permitted in cough and cold products, for decades, without clear evidence of effectiveness. Until that time, remember that the only available non-prescription oral decongestant that has been shown to actually be effective is pseudoephedrine. Ask your pharmacist is pseudoephedrine is right for you.
The Best Ways To Manage Your Seasonal Allergies While Pregnant
© November27/Shutterstock Pregnant woman sneezing into tissue The sneezing, sinus congestion, runny nose, and itchy eyes that come along with seasonal allergies aren't pleasant for anyone. For some people, however, there are a number of things that may take their allergy symptoms to new heights. This can range from using the wrong kind of air filter in your home, letting clothes dry outdoors, not using hot-enough water in your washing machine, or even walking into a friend's house filled with houseplants.
But environmental triggers may not be the only influencing factor when it comes to worsening allergies. Rather, one-third of expecting women claim that their seasonal allergies tend to kick it up a notch throughout pregnancy, according to experts at the Allergy & Asthma Network. While this leaves two-thirds of women reporting either no changes to their allergies or even improvement in their allergy symptoms, those who are negatively affected will likely have questions about the safest and most effective ways to manage their allergies while pregnant.
Seasonal Allergies Or Pregnancy Rhinitis?
© Dragana Gordic/Shutterstock Pregnant woman sneezing in doctor's office Most often, worsening allergies during pregnancy are more likely to occur in women with pre-existing seasonal allergies. However, it is not impossible for first-time allergies to emerge during pregnancy either, notes the Allergy & Asthma Network.
That said, certain allergy-like symptoms experienced during pregnancy — such as nasal congestion — may not be related to allergies at all. Sometimes referred to as pregnancy rhinitis, the condition occurs as a result of hormonal changes that prompt the swelling of mucous membranes as a patient enters their second trimester. What sets allergies apart from pregnancy rhinitis, however, is that allergies will be accompanied by sneezing and itching, while pregnancy rhinitis will not.
Once you've ruled out pregnancy rhinitis, talk to your physician about what kinds of allergy-relief treatment methods would be best based on your specific health needs. Generally speaking, however, there are some daily tactics one can implement to help keep allergy symptoms at bay during pregnancy.
Daily Tips And Recommended Medications
© JPC-PROD/Shutterstock Pregnant woman consulting with pharmacist The best way to manage seasonal allergies while pregnant is to try and avoid allergens as much as possible, as this method carries the least risk. If you find your allergies are triggered by pollen and other outdoor allergens, minimize the chances of exposure by keeping doors and windows closed. For indoor allergens such as dust mites or pet dander, try having your pet sleep in an alternate bedroom, and use protective encasings to keep your mattress and pillows free of contaminants.
When it comes to medication treatment options, your doctor may suggest oral antihistamines or saline nasal sprays for more mild cases of seasonal allergies (via UT Southwestern Medical Center). The majority of research regarding the safety profile of these drugs has been on first-generation oral antihistamines such as Dimetapp, Chlor-Trimeton, and Benadryl (via HealthDay). Therefore, these may be among your physician's top recommendations, as no danger to the fetus has been identified in relation to these medications. Conversely, Sudafed is not advised for use during the first trimester of pregnancy, as it can pose minor risk of abdominal wall birth defects.
While it's best to avoid starting any new allergy medications during pregnancy, those who were already receiving immunotherapy treatments should continue taking these medications as prescribed. While there is a slight risk of pregnancy complications with these treatments, the risk may be higher if a patient discontinues use and develops an ear or sinus infection that requires antibiotic or oral steroid treatments, per UT Southwestern Medical Center.
Read this next: Seasonal Allergies Explained: Causes, Symptoms, And Treatments
Boy Among First To Try New Peanut Allergy Drug
26 March 2023
Image source, Sandwell and West Birmingham NHS Trust
Image caption,Hugo will have to take the drug daily for two to three years
A schoolboy has become one of the first people to try a new drug for peanut allergies, a hospital trust said.
Hugo Codona, 10, from Lichfield, was given a dose of Palforzia at Sandwell Hospital, in West Bromwich.
The treatment is designed to increase tolerance of peanut protein and reduce the risk of severe reactions like anaphylaxis.
It was first approved the NHS last year following research trials.
Peanut allergies currently affect more than six million people in the UK, Europe and America.
The allergy affects approximately 2% (one in 50) of children in the UK and is one of the most common causes of food-related deaths.
Children who are given the treatment can receive the drug in escalating doses to desensitise them to peanut proteins, enabling tolerance to be carefully built over time.
The drug comes in capsules with a measured amount of peanut powder inside and can be mixed with food such as yoghurt to build up a tolerance, Sandwell and West Birmingham NHS Trust said.
Hugo said: "I felt nervous at first, but this is going to help me in the future and give me confidence in dealing with my peanut allergy."
"It will be worth it as it means we can go on family holidays, to restaurants and the cinema without the worry and fear," his mum Lucy added.
'Reduce the risk'
The youngster will have to take the drug daily for two to three years and afterwards a small amount of peanut will need to be eaten every day for the rest of his life.
Aneta Ivanova, paediatric allergy nurse consultant at Sandwell and West Birmingham NHS Trust, which runs Sandwell Hospital, said: "It is not a cure for a peanut allergy, however it does reduce the risk of having a severe allergic reaction like anaphylaxis."
A global trial of the drug had previously indicated that nearly 60% of patients who had completed the programme could tolerate 1000mg of peanut protein by the end of the trial.
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