STUDY OBJECTIVES: Recent publications have demonstrated a reduction in snoring with radiofrequency (RF) surgery of the soft palate. Yet so far, all published data has been based on non-controlled trials. DESIGN: Aim of this study was to assess the efficacy of RF surgery of the soft palate in a randomized, placebo-controlled trial. SETTING:Outpatients department at university hospital, department of otorhinolaryngology. PATIENTS: 26 patients with primary snoring (AHI < 15, BMI < 35). INTERVENTIONS: Patients were treated with temperature-controlled RF surgery of the soft palate under local anesthesia. In accord with a randomization protocol they received 2 sessions of RF surgery (total amount of energy: 3.300 Joule) or placebo (insertion of device needle without energy delivery). MEASUREMENTS AND RESULTS:Snoring was evaluated by the bed partner with 10 cm visual analogue scales. 23 patients completed the study; 12 receivedRF-surgery and 11 received placebo. Snoring scores did not change in the placebo group (8.4 +/- 1.6 to 8.0 +/- 2.3) while improving in the RF-group (8.1 +/- 1.3 to 5.2 +/- 2.4). The difference between the groups was statistically significant (p < 0.05). CONCLUSION:RF-surgery was significantly better than placebo, although the reduction in snoring was only moderate in our group of patients. This study underlines the necessity for well-controlled clinical trials in the treatment of snoring.
RCT Entities:
STUDY OBJECTIVES: Recent publications have demonstrated a reduction in snoring with radiofrequency (RF) surgery of the soft palate. Yet so far, all published data has been based on non-controlled trials. DESIGN: Aim of this study was to assess the efficacy of RF surgery of the soft palate in a randomized, placebo-controlled trial. SETTING: Outpatients department at university hospital, department of otorhinolaryngology. PATIENTS: 26 patients with primary snoring (AHI < 15, BMI < 35). INTERVENTIONS:Patients were treated with temperature-controlled RF surgery of the soft palate under local anesthesia. In accord with a randomization protocol they received 2 sessions of RF surgery (total amount of energy: 3.300 Joule) or placebo (insertion of device needle without energy delivery). MEASUREMENTS AND RESULTS: Snoring was evaluated by the bed partner with 10 cm visual analogue scales. 23 patients completed the study; 12 received RF-surgery and 11 received placebo. Snoring scores did not change in the placebo group (8.4 +/- 1.6 to 8.0 +/- 2.3) while improving in the RF-group (8.1 +/- 1.3 to 5.2 +/- 2.4). The difference between the groups was statistically significant (p < 0.05). CONCLUSION: RF-surgery was significantly better than placebo, although the reduction in snoring was only moderate in our group of patients. This study underlines the necessity for well-controlled clinical trials in the treatment of snoring.
Authors: Boris A Stuck; Jürgen Abrams; Richard de la Chaux; Alfred Dreher; Clemens Heiser; Winfried Hohenhorst; Thomas Kühnel; Joachim T Maurer; Wolfgang Pirsig; Armin Steffen; Thomas Verse Journal: Sleep Breath Date: 2010-07-18 Impact factor: 2.816
Authors: Boris A Stuck; Alfred Dreher; Clemens Heiser; Michael Herzog; Thomas Kühnel; Joachim T Maurer; Hans Pistner; Helmut Sitter; Armin Steffen; Thomas Verse Journal: Sleep Breath Date: 2014-04-13 Impact factor: 2.816
Authors: B A Stuck; J Abrams; R de la Chaux; A Dreher; C Heiser; W Hohenhorst; T Kühnel; J T Maurer; W Pirsig; A Steffen; T Verse Journal: HNO Date: 2010-03 Impact factor: 1.284
Authors: Karl A Franklin; Heidi Anttila; Susanna Axelsson; Thorarinn Gislason; Paula Maasilta; Kurt I Myhre; Nina Rehnqvist Journal: Sleep Date: 2009-01 Impact factor: 5.849