AllerVarx, a new dietary supplement, claims to relieve nasal allergy symptoms, but the only “evidence” is a single disreputable clinical trial with no control group. There is no reason to try this unproven remedy when there are so many effective remedies offered by mainstream medicine.
Allergic rhinitis can be treated effectively, but not with dietary supplements
A newspaper ad alerted me to a new dietary supplement, AllerVarx, a remedy for seasonal allergy symptoms. It describes AllerVarx as an all-natural, clinically proven blend of three ingredients: Perilla, Quercetin, and Vitamin D3. It promises instant relief, a 70% reduction in allergy symptoms, and no side effects.
The ad gave me déjà vu. I’ve seen the same kind of ad over and over, but usually for things like memory loss, urinary symptoms, diabetes, arthritis, weight loss, etc. This surprised me because it was the first I’d seen for seasonal allergies. One of the theories about why people turn to alternative medicine is that it fills an unmet need, treating conditions that mainstream medicine does not deal with satisfactorily. But mainstream medicine has a whole armamentarium of treatments for seasonal allergies that have been tested and proven effective. Is there any reason to prefer an alternative remedy?
The ad distorts the truth about conventional treatments
The ad claims that conventional treatments are problematic. It distorts the truth, saying the leading over-the-counter brands are “not an option.” Why?
- Antihistamines make you drowsy. [This is a bit misleading. The newer antihistamines are much less likely to cause drowsiness, and most people tolerate them well.]
- Decongestants have a “horrifying” effect on blood pressure, sending it “skyrocketing” and they can’t be taken every day or with most medications. [This is demonstrably wrong: the truth is that they only raise the systolic blood pressure by an average of 1.2 mm and most patients with high blood pressure can take decongestants.]
It fails to mention that there are other effective treatments, both prescription and over-the-counter. And nowhere does it compare the effectiveness of Allervarx to any other treatment.
According to a review article in American Family Physician, the first-line treatment for allergic rhinitis is a corticosteroid nasal spray. If this doesn’t control symptoms, second-line therapies are indicated: antihistamines, decongestants, cromolyn, leukotriene receptor antagonists, and nonpharmacological therapies such as nasal irrigation. Immunotherapy is also available for severe cases.
Their claims for the ingredients
Perilla “immediately blocks the release of histamines.”
Quercetin “makes sure that your histamines stay blocked: and delivers fast action!”
Vitamin D3 “acts as a natural anti-inflammatory and supports normal function of immune systems, improving that ‘blocked up’ feeling.”
Checking their claims on the Natural Medicines Comprehensive Database
The Natural Medicines Comprehensive Database is an independent source of information about natural medicines: it rates them for safety and effectiveness, includes all kinds of information, and provides references. I refer to it frequently and consider it the most reliable source of information about dietary supplements. Here’s what it has to say about the ingredients in AllerVarx:
Perilla: There is insufficient reliable evidence to rate its effectiveness; there is only preliminary evidence of a possible effect in allergic rhinitis. It gives Perilla a safety rating of “Possibly safe” and recommends against using it during pregnancy and lactation because of insufficient reliable evidence.
Quercetin: Rated as possibly effective for prostatitis. No rating of effectiveness for allergic rhinitis, but does mention that there is preliminary evidence that it might work similarly to cromolyn, inhibiting antigen-stimulated histamine release from mast cells of patients with allergic rhinitis. Rated as “possibly safe;” avoid using in pregnancy and lactation.
Vitamin D3: Does not rate effectiveness for allergic rhinitis because there is no evidence for that. Mentions that administering it during the first year of life could potentially increase the risk of allergic rhinitis later in life.
They refer to a clinical trial that showed the product reduced allergy symptoms by 70%. There is actually no clinical trial of AllerVarx; they are referring to a trial of the supplement Lertal, which appears to be the same product sold under a different brand name in Europe. It is the only study in humans. It was an open-label observational study with only 23 subjects. It compared patient-reported symptoms at baseline and one month, grading them by number of episodes per day:
- 1= 1-5 episodes a day
- 2= 6-10 episodes
- 3 = 11 or more episodes
They found a 70% reduction in sneezing, rhinorrhea, nasal obstruction, ocular itching, lacrimation and congestion of the conjunctiva. And they found a 73% reduction of use of anti-allergic drugs.
This was a useless study, the kind of junk science that is designed to practically guarantee a positive result. There was no control group. The number of patients was small. Open label means the subjects knew they were taking AllerVarx, and presumably were led to expect it would reduce their symptoms. Subjective symptoms were reported using an awkward measure: “episodes per day” divided into 4 groups by frequency. No objective parameters were measured.
Checking their claims on PubMed
The company website lists 18 references, but they are all basic science and animal studies. The one whose title sounds possibly relevant is an incomplete reference that lists only the authors and title but gives no information about where the study can be found. One reference is a market report about allergy drug sales, and one is a patent! There has been only the one human study.
Pubmed lists a single systematic review of herbal medicines for allergic rhinitis that does not even mention perilla or quercetin.
- Perilla inhibits histamine release in vitro and in mouse models.
- A study of the effect of perilla and rosmarinic acid on allergic inflammatory reactions in mice and in tissue culture.
An online review of AllerVarx pointed out:
Neither AllerVarx’s website nor the study itself referenced clinical evidence regarding “stabilized mast cells,” a reduction in histamines and inflammation, or a reduction in the expression of interleukins (IL-6 and TNF-alpha), as claimed on the supplement’s site.
They also don’t provide evidence that their patented bi-layer “fast slow” technology necessarily allows controlled ingredient release, or that this technology delivered measurably better results in their clinical study.
That same review says the company, Innovus Pharmaceuticals, has an F rating with the Better Business Bureau. And apparently they don’t manufacture AllerVarx, but are selling the European product Lertal under an in-license, merely changing the brand name. It was launched as Allervarx in May of 2017.
As I said, I have seen this kind of ad many times before. It is a half-page newspaper ad thinly disguised as a news report. It uses the buzz word “natural.” It makes unsupported claims. It refers to a clinical study but fails to provide references. It offers a money-back guarantee. It says supplies are limited, so call now! They have established a special hotline to deal with the demand. A special introductory discount is available. An accompanying photo of a doctor in a white coat with a stethoscope around his neck is intended to inspire confidence. Long on hype but short on substance.
These deceptive marketing techniques are red flags that suggest to me that the seller is only out to make a buck and the information is not to be trusted.
At the bottom, in small print, there is the required FDA disclaimer that this product that they are selling to treat allergic rhinitis is not intended to treat any disease! The company website claims the product will “provide relief during the allergy season.” In my opinion, this goes beyond the “structure and function” claims allowed for dietary supplements and constitutes an illegal claim that it is effective in treating a disease. A 30-day supply sells for $49.99. There is a 30-day refund policy, but it doesn’t refund S&H, and they subtract a $10 restocking fee. And customers would have to make a quick decision to apply for a refund within the time limit.
Why would anyone choose this product?
An article on WebMD lists 30 supplements that are used to treat allergic rhinitis. Perilla is listed; quercetin is not. Perilla and 18 more of the listed items are rated as “insufficient evidence.” Seven are listed as “possibly effective” and four are listed as “possibly ineffective.”
With all the conventional treatments that have been proven effective and all those other dietary supplements (that have not been proven effective) to choose from, why would anyone choose AllerVarx? Cost is not a reason: it is more expensive than many of the proven treatments. The fact that it doesn’t require a prescription is not a reason: many of the effective conventional remedies are available over-the-counter. The lack of side effects might be a reason, but absence of side effects is no advantage if there is also an absence of effects.
I don’t think there is any valid reason to choose AllerVarx, but if a patient wanted to ignore reason in favor of hope and the attraction of “trying something new,” I couldn’t object. There is no evidence that it is unsafe. If a patient tries it and thinks it helps, OK. (But experience tells us there’s a good possibility the perceived relief won’t last and the patient will soon be trying another unproven remedy.) If it doesn’t help, they will only have their allergy symptoms a bit longer and will be out a few bucks.
This article was originally published in the Science-Based Medicine Blog.