Sleep · 2005
Radiofrequency surgery of the soft palate in the treatment of snoring. A placebo-controlled trial.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Stuck Boris A, Sauter Alexander, Hörmann Karl, Verse Thomas, Maurer Joachim T
Аннотация
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.
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.