- Explain to interested patients that this study evaluated an off-label use of the steroid budesonide, as part of a nasal lavage, to treat chronic rhinosinusitis.
- Note that the results showed symptomatic improvement with no adverse effect on adrenal sufficiency, suggesting minimal systemic absorption of the drug.
At the same time, the therapy offered a clinically significant improvement in symptoms in a small open-label study, according to Jay Piccirillo, M.D., and colleagues at Washington University.
The finding begins to clarify the risk of using budesonide as part of a nasal lavage, the researchers said in the March issue of Archives of Otolaryngology -- Head & Neck Surgery.
But they cautioned that the treatment protocol is off-label and still requires a randomized, placebo-controlled trial to assess other risks, such as potential loss of bone mineral density, as well as benefits in chronic rhinosinusitis.
Budesonide, in an aqueous nasal spray, has been shown to be safe and effective for chronic rhinosinusitis and perennial allergic rhinitis.
But used as part of daily nasal lavage, it might be absorbed systemically, causing such unwanted side effects as adrenal suppression.
To test that, the researchers used budesonide respules (sold under the brand name Pulmicort Respules), which are small, plastic, liquid-containing devices that can be used to deliver unit-dose medications in a sterile fashion.
Nine patients with chronic rhinosinusitis were instructed to administer 0.25 milligrams of budesonide, diluted with 5.0 milliliters of isotonic saline daily for 30 days.
Their blood cortisol levels were measured before and after the 30 days using the standard cosyntropin stimulation test. Efficacy of the treatment was assessed using the Sino-Nasal Outcome Test-20 (SNOT-20).
Analysis showed:
- There was little difference in average post-stimulation cortisol levels at baseline and after 30 days -- 33.9 micrograms per deciliter compared with 35.2
- After 30 days, no patient had a post-stimulation cortisol level below the critical level (18 to 20 micrograms per deciliter) that would indicate adrenal insufficiency
- The total SNOT-20 score was 2.4 on average at baseline and 1.4 at the 30-day visit, an improvement that was both statistically and clinically significant (at P=0.02)
The researchers cautioned that the lack of a control group makes it impossible to conclude that the symptomatic improvement resulted from the budesonide therapy. They also acknowledged that they did not document compliance with daily administration.
But, they said, the decrease in SNOT-20 scores was consistent for all patients, "supporting the evidence for the clinical efficacy of this intervention."
Although the use of the medication as part of nasal lavage has not been approved by the FDA, the researchers said, "the off-label use of medications is legal and an accepted part of medical practice."
Dr. Piccirillo and colleagues said their study will help physicians who want to use the method explain potential risks and benefits to patients.
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