A form of light treatment called rhinophototherapy is being studied in the United States and may one day provide patients with allergic rhinitis and other diseases of the upper airway, such as nasal polyposis, with an alternative to standard therapies.
Explore This IssueMarch 2007
The technology is being developed at Allux Medical in Menlo Park, Calif., to treat hyper-reactive airway mucosa. According to company president and CEO Erica Rogers, the first application of rhinophototherapy may be for allergic rhinitis, although the technology has not yet been approved by the Food and Drug Administration and no therapeutic devices are currently available in the United States.
The experts interviewed for this article agreed that although the technology is intriguing, further research is needed to establish long-term efficacy and safety.
How It Works
The therapy uses a combination of UV-B (5%), UV-A (25%), and visible light (70%), which practitioners shine directly into the intranasal cavity.
We believe it works through a mechanism similar to that of light therapy used for patients with dermatological diseases such as atopic dermatitis and eczema, said James Hadley, MD, Associate Professor of Otolaryngology at the University of Rochester Medical Center. Light therapy induces apoptosis of the inflammatory cells in the organ-whether the skin or nasal mucosa-that cause disease symptoms, he said.
This is an exciting concept that may have potential, commented Bradley F. Marple, MD, Professor and Vice Chairman of Otolaryngology at the University of Texas-Southwestern Medical Center. Most other treatments, with exception of immunotherapy, are directed toward blockage of inflammatory mediators, whereas rhinophototherapy downregulates the cells that generate the allergic response, he said.
Although relatively simple to use, administering the therapy requires physicians to have a background in rhinology and allergic disease management, said Dr. Hadley. Whether they are ENTs, allergists, or family physicians who are trained in this, they need to know the inner workings of nasal anatomy.
The technology has been studied most extensively in Eastern Europe, where a recent study (J Allergy Clin Immunol 2005;115(3):541-7) indicated strong efficacy in allergic rhinitis patients. The study’s lead author, Andrea I. Koreck, MD, PhD, who at the time was with the Department of Dermatology and Allergology at the University of Szeged in Hungary, is now a researcher at Allux Medical.
Dr. Koreck and her colleagues conducted a randomized, double-blind study during the ragweed season in 49 patients with hay fever who received either rhinophototherapy using a combination of UV-B (5%),UV-A (25%), and visible light (70%), referred to as mUV/VIS, or low-intensity visible light as a control.
Investigators illuminated each intranasal cavity three times a week for three weeks.
Researchers found that rhinophototherapy resulted in a significant improvement of clinical symptoms for sneezing (p < 0.016), rhinorrhea (p < 0.007), nasal itching (p < 0.014), and total nasal score (p < 0.004) compared to baseline. None of the scores improved significantly in the control group.
The treatment also reduced the number of inflammatory cells and the level of mediators that cause allergic rhinitis and other diseases of the airway such as nasal polyps. For example, in nasal lavage, rhinophototherapy significantly reduced the number of eosinophils and the levels of eosinophilic cationic protein and interleukin-5. In vitro irradiation of T cells and eosinophils with mUV/VIS light dose-dependently induced apoptosis.
The therapy was also well tolerated. All patients in the mUV/VIS group experienced dryness of the nasal mucosa; however, all but one described this side effect as mild. Six patients in the control group reported dryness of the nasal mucosa. This side effect, can easily be managed by using Vitamin A oil, said one of the study coauthors, Lajos Kemeny, MD, PhD, who is also a cofounder of Rhinolight in Szeged, Hungary, which produces the rhinophototherapy device for distribution in Europe.
Although not reported in the study, patients can theoretically experience irritation of the nasal membranes similar to sunburn, said Dr. Hadley. To avoid this problem, further research needs to determine the timing and delivery of the therapy and how it is going to affect the cells produced inside the nose, he said.
Until the Hungarian data can be reproduced in other studies, the evidence to date does not support inclusion of phototherapy to treat symptoms of allergic rhinitis into the standards of care, said Ms. Rogers in a March 2006 interview with ENToday.
The European Experience
Rhinophototherapy was approved for medical treatment in Hungary in 2003 and is indicated there for patients with seasonal and perennial allergic rhinitis. Patients who tend to benefit the most from the therapy are those with allergic rhinitis who are resistent to pharmacotherapy, and in cases when medicine treatment cannot be applied or there is a contraindication of drugs, said Dr. Kemeny, who is also Professor in the Department of Dermatology and Allergology at the University of Szeged.
In Europe, Rhinolight treatment is recommended on two successive weeks, and depending on the severity of the symptoms, four to six treatments are required (two to three treatments per week).
The first treatment is two minutes long, and all treatments can be a maximum of three minutes long. No more than four treatments per week are recommended. The treatment can be repeated in case of an allergic reaction or at the onset of a new pollen season. Due to the lack of proper clinical data and experience, the treatment can be applied only with individual evaluation of risks in patients younger than age 14.
Rhinophototherapy is being used in more than 150 centers throughout 11 European countries, added Dr. Kemeny. More than 30,000 patients have been treated in the last three years.
Patients for whom this treatment is contraindicated include those with nose abnormalities, acute respiratory infections, history of repeated and/or severe epistaxis, nasal tumors, photosensitivity, photoallergy, or use of concomitant therapies such as antibiotics that are photosensitizing, according to Dr. Koreck, who spoke to ENToday in March 2006.
The experts interviewed for this article agreed that more research is needed. Even though the technology sounds promising, practitioners need long-term efficacy and safety data, said Pramod S. Kelkar, MD, an allergist-immunologist at Allergy and Asthma Care in Maple Grove, Minn. Physicians also need to know how the rhinophototherapy compares with other treatments, he said.
Such data are currently limited. However, in a pilot study (Clin Immunol 2005;115(suppl.1):S50), Dr. Kemeny and his colleagues compared the clinical efficacy of rhinophototherapy with a nonsedating antihistamine, fexofenadine hydrochloride, in 18 ragweed-allergic patients in Szeged, Hungary, during ragweed season.
Eleven patients received intranasal irradiation with increasing doses of mUV/VIS light for two weeks and seven patients received 120 mg fexofenadine HCl once daily for the same period of time.
Rhinophototherapy resulted in a significantly better reduction of individual symptom scores for rhinorrhea and nasal obstruction and of total nasal score compared with fexofenadine HCl, reported the researchers. However, no significant differences between the two treatments were observed in reducing symptom scores for sneezing, nasal itching, palate itching, and eye symptoms. This suggests that intranasal phototherapy may be an alternative for patients not controlled by antihistamines, wrote Dr. Kemeny and his coauthors.
In addition to comparing efficacy, studies of rhinophototherapy also need to consider how acceptable the technology is to patients compared with other allergic rhinitis treatments, said Dr. Hadley.
Patient acceptance of rhinophototherapy may be favorable because people may be more likely to undergo 15 to 20 minutes of rhinophototherapy for a couple of weeks, versus nasal medications that have side effects, or shots, which can be painful, said Dr. Hadley.
Some patients may want a more natural therapy, and may favor rhinophototherapy for this reason, noted Dr. Kelkar. Only allergy shots provide a natural way to build the immunity to reduce allergic rhinitis symptoms and are effective in the long-term, he said. A study comparing the two treatments would be beneficial, he added.
Currently, Dr. Kemeny and his colleagues at Rhinolight are developing protocols and upgrades for new rhinophototherapy indications, including chronic rhinosinusitis and nasal polyposis. We are managing clinical trials for these purposes in Switzerland, Germany, Japan, Croatia, Poland and in Hungary, he said.
In the United States, additional human clinical trials are under way, wrote Ms. Rogers in an e-mail about research at Allux. The company is also exploring other confidential ENT applications with similar technology.
If researchers can provide good data that rhinophototherapy is safe in the long term and has good short-term and long-term outcomes, while being cost-effective, it may be an option, concluded Dr. Kelkar.
©2007 The Triological Society