Tuesday, February 10, 2009

What is Nasal Ease? Is Nasal Ease Safe and Effective?

I was just asked about the product called Nasal Ease in the U.S. (It goes by the name Nasaleze in other countries.) Due diligence meant that I read through Nasal Ease's website, surfed the Internet, and searched PubMed.

Nasal Ease is an inert cellulose powder. I can not find other details than this. Information seems to be available from 2003. There is very, very little data available.

How does Nasal Ease work? The powder is in a plastic container, which is squeezed and delivers the powder into the nose. The amount of powder is not standardized. There is not data on how the powder is deposited in the nose. This is important because the entire lining of the nose should be coated with this powder to be effective. The powder is supposed to form a barrier against pollen and other allergens from causing allergic rhinitis. There is no other product available to my knowledge with this mechanism of action. A person could get a much relief from using a N95 mask since this also should prevent the allergen from contacting the lining of the nose. It is safer, less invasive, likely to be more effective, and less expensive. Nonetheless, this is a reasonable concept, but nasal mucus is produced constantly and so the powder gets washed off. This is probably the rationale for the their directions to use the powder every 3 hours. There is no data to support this figure. A pessimist could argue that this could represent a method of consuming and so selling more powder. Their information does not list the amount of contents nor even an estimate as to how long the product would last. The box states there are 200 doses. If just 12 doses were used per day, then the bottle should last about 16 days. I did not see any published trials documenting that this is "proven safe and effective for...pregnant and breastfeeding women, and children" and "safe to use with other medications, including other allergy medications." This is stated on the box. Prescription medications are not be allowed to make these statements without data submitted to the FDA. They may be making unsubstantiated claims on the boxes. Since the product has available for several years, I have not seen any efforts by any other company to manufacture a product with a similar mechanism of action or better symptom relief or a longer duration of action. By the way, if Nasal Ease is used, then you should remember that other topical nasal medications would be blocked also.

No long-term studies of intranasal cellulose have been done, so I can't comment on its safety. The five studies I saw were small in number, at single sites, and sometimes by the same investigators. On the website, other references were posters at scientific meetings. This represents effort, but is not as rigorous as having the study data reviewed by unbiased peers and then being published in a scientific journal. Speaking of this, not to offend, but there are higher levels of journals available. If the manufacturers want greater notice in the scientific community, trials with larger number of subjects, multiple sites, different investigators, comparison to an approved medication not just placebo, and longer term followup would be a step in the right direction.

I can not think of a reason to go out of my way to recommend this product to my patients. I agree that thus far there is no safety data which to object to this product. More information is needed. Barring that Nasal Ease would prevent other nasal spray medications from acting, I do not object this drug either.

By publishing this essentially negative review, I realize I am opening myself up again to more negative comments. All I ask is that objective data be produced, not just patient testimonials.

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