Artikel
Radiofrequency surgery of the soft palate in the treatment of snoring: a placebo controlled trial
Suche in Medline nach
Autoren
-
Boris A. Stuck
- Dept. of Otorhinolaryngology, Head and Neck Surgery, University Hospital Mannheim
-
Alexander Sauter
- Dept. of Otorhinolaryngology, Head and Neck Surgery, University Hospital Mannheim
-
Karl Hörmann
- Dept. of Otorhinolaryngology, Head and Neck Surgery, University Hospital Mannheim
-
Thomas Verse
- Dept. of Otorhinolaryngology, Head and Neck Surgery, University Hospital Mannheim
-
Joachim T. Maurer
- Dept. of Otorhinolaryngology, Head and Neck Surgery, University Hospital Mannheim
| Veröffentlicht: | 22. September 2005 |
|---|
Gliederung
Text
Introduction: Although radiofrequency (RF) surgery of the soft palate in the treatment of snoring has received increasing attention over the last years and numerous trials support the idea of clinical efficacy along with minimal postoperative morbidity, significant placebo-effects have to be kept in mind when treating patients for snoring. Aim of the study was to evaluate the effects of RF-surgery of the soft palate in a randomized, placebo-controlled clinical trial
Methods: 26 patients with primary snoring (AHI<15, BMI<35) were included in this prospective study. According to a randomization protocol they received either 2 sessions of temperature-controlled RF-surgery or ‘placebo’ (insertion of the device needle without the delivery of RF-energy) under local anesthesia. Altogether, 3300 Joule were delivered at 7 application sites in the RF-group. The principle investigator was not informed about the results of the randomization process (‚observer blind’). Therapeutic effects were evaluated with a 10 cm visual analoge scale for the bed partner.
Results: 23 patients completed the study according to the protocol; 12 recieving RF-surgery and 11 receiving placebo. Against our expectations, snoring scores did not improve in the placebo group (8.41.6 to 8.02.3). With respect to the visual analoge scales, snoring did improve in the RF-group from 8.11.3 preoperatively to 5.22.4 after treatment. The difference between the two groups was statistically significant (p<0.05).
Discussion: This is the first time that the efficacy of a surgical procedure for the treatment of snoring has been documented with the help of a placebo-controlled trial. Although RF-surgery was significantly better than placebo, the postoperative snoring scores of the RF-group were all but satisfying and the majority of the patients asked for further treatment possibilities. With regard to the high costs associated with the procedure for single use devices and the previously documented relapse of snoring over time RF-surgery of the soft palate can not generally be recommended as a treatment for snoring.
