Seasonal Affective Disorder (SAD)
Currently, no phototherapy device has final market approval from the U.S. Food and Drug Administration (FDA) for the treatment of SAD or other depressive disorders. While light boxes or light visors cannot be marketed directly for the treatment for SAD or promoted for other health benefits, these devices are commercially available.
A randomly controlled study by Koreck et al. investigated the potential role of phototherapy in the management of allergic rhinitis. Phototherapy using both ultraviolet and visible light has been shown to have a significant immunosuppressive effect, and has been used widely for the treatment of a number of inflammatory skin diseases, including atopic dermatitis. The main mechanisms by which phototherapy induces immunosuppression include the induction of apoptosis (cell death) of infiltrating T cells, induction of immunomodulatory cytokines such as interleukin-10, and reduction in the function and absolute number of Langerhans cells. Other studies have also shown that phototherapy with UVA, UVB, and visible light is capable of significantly inhibiting the wheal reaction to an allergen skin test, even at doses below that which produced erythema.
In view of the positive results seen with phototherapy for allergic skin disorders, this study was designed to evaluate whether phototherapy with a combination of UVA, UVB, and visible light is effective for the treatment of allergic rhinitis. This randomized, double-blind study involved 49 patients with hay fever during the ragweed season. Patients were exposed to phototherapy by illuminating the intranasal cavity three times weekly for three weeks with either the study UVA, UVB light or a low-dose visible light control.
The results showed that in the patients exposed to the study light, rhinophototherapy was tolerated well and actually resulted in a significant improvement in clinical symptoms of sneezing, rhinorrhea, nasal itching, and total nasal score, with no significant benefit seen in the control group. Effects on nasal congestion were less notable. Nasal lavage studies revealed a significant reduction in nasal eosinophils and levels of eosinophilic cationic protein and interleukin-5. In vitro studies showed that irradiation of T cells and eosinophils with mixed ultraviolet and visible light reduced eosinophil and T-cell survival in a dose-dependent fashion.
The authors concluded that phototherapy is an effective treatment modality for allergic rhinitis, and may offer a new treatment of immune-mediated mucosal diseases.
Although this is a well constructed study that demonstrates the efficacy of phototherapy in the treatment of allergic rhinitis the sample size is very small and the results of the study are very short term. The study did not address risks to the sinuses from the use of ultraviolet light.
Another small trial was conducted by Neuman et al. in 1997. This study also concluded that allergic rhinitis if uncomplicated by polyps or chronic sinusitis could be effectively treated by narrow-band red light illumination of the nasal mucosa. This was also a very small trial without long term results.
- Rhinophototherapy does not have final regulatory approval from the Food and Drug Administration.
- Rhinophototherapy is not supported by evidence in the peer-reviewed medical literature that:
- Permits conclusions on the effect of rhinophototherapy on long term health outcomes.
- Demonstrates an improvement in net health outcome through use of rhinophototherapy.
- Demonstrates that rhinophototherapy is as beneficial as established alternatives.
- Rhinophototherapy is not supported by a coverage position of the Centers for Medicare and Medicaid Services (CMS) or other authoritative guidelines.
A literature search of Medline database was performed through January 2009. No articles or studies were identified that would change the coverage position of this medical policy.
A search of peer- reviewed literature through April 2011 identified no new clinical trial publications or any additional information that would change the coverage position of this medical policy.
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