Praxisklinik am Pferdemarkt

Department of Otorhinolaryngology
Senior physician: Dr. G. M. Strasser MD

Pferdemarkt 2a  * 94469 Deggendorf  2002-07-02

Application Monitoring Study on the Efficacy and
Indication Determination for the Rhinobeam Device

The aim of this application monitoring study was to test the effect of the Rhinobeam device on patients with obstructed nasal breathing. The application was investigated on 102 patients in four German ENT practices: 1. group ENT practice of Dr. Strasser and Dr. Dittmar, Deggendorf, 2. group ENT practice of Dr. Nitsche, Dr. Hilbert, and Dr. Denzel, Bergstr. 2 in Nürnberg-Stein, 3. ENT practice of Dr. Schratzenstaller, Fürstenfeldbruck, and 4. ENT practice of Dr. Schwab, Munich-Grünwald. The effect of Rhinobeam was rhinomanometrically assessed in 89 patients and the patients were interviewed. In a further 47 patients, the effect of Rhinobeam was evaluated using a questionnaire. The testing period was from April to July 2002.

I. Rhinomanometric test

63 patients with obstructed nasal passages were tested. Rhinomanometry (blank value measurement) was carried out to objectively assess the nasal airflow before a 9-minute Rhinobeam radiation treatment.

After the Rhinobeam treatment, 44 patients reported experiencing an improvement of nasal respiration. 19 patients reported either no change or that they were not sure. None of the patients complained about a subjectively experienced worsening of nasal breathing.

Objective evidence of an improvement of the nasal flow was provided for 65% of the patients in a second rhinomanometric test carried out immediately after the treatment with Rhinobeam: minimum 15 ml/sec to maximum 99 ml/sec.

II. Questionnaire assessment

A total of 39 patients were treated with the Rhinobeam device three times daily in sessions of 9 min. each over a period of one week without being concomitantly treated with other forms of therapy.

In detail, this group was composed of the following:

Results:

In the patients who were given the device to use at home, application several times daily proved to be correspondingly more effective. The symptom-free period or interval with reduced symptoms after treatment with Rhinobeam was in part relatively short (approx. 20 min. to 60 min.).

Assessment:

The Rhinobeam method obviously has a beneficial effect on symptoms of inflammatory irritation of the nasal mucosa. The following are regarded as possible mechanisms of action:

- Prevention of the release of inflammatory mediators by, for example,
  stabilization of mast cell membranes.

- Vasoconstrictive effect

- Decrease of the permeability of vascular wall cells in the region of the nasal
  mucosa

In the acute phase of the different forms of nasal irritation or mucosal inflammation investigated, application several times daily, if necessary up to a frequency of once per hour, is advisable. In addition, a comparative study should be carried out to test a more powerful version of the Rhinobeam device; here it may be possible to achieve positive effects via indirect or tissue penetrating radiation. Consequently, much more positive effects might be able to achieved by this hitherto side effect-free method. It may then be possible to reduce the currently recommended radiation time of 9 min. to perhaps 5 min; this seems to be important for improving user compliance because in practice only a few patients may be willing to be treated with several 9-min. applications.

 

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