Stuck Boris A, Sauter Alexander, Hörmann Karl, Verse Thomas, Maurer Joachim T
Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Mannheim, Mannheim, Germany.
Sleep. 2005 Jul;28(7):847-50. doi: 10.1093/sleep/28.7.847.
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.
Aim of this study was to assess the efficacy of RF surgery of the soft palate in a randomized, placebo-controlled trial.
Outpatients department at university hospital, department of otorhinolaryngology.
26 patients with primary snoring (AHI < 15, BMI < 35).
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).
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).
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.
近期发表的文献表明,软腭射频(RF)手术可减少打鼾。然而,迄今为止,所有已发表的数据均基于非对照试验。
本研究的目的是在一项随机、安慰剂对照试验中评估软腭射频手术的疗效。
大学医院耳鼻喉科门诊。
26例原发性打鼾患者(呼吸暂停低通气指数<15,体重指数<35)。
患者在局部麻醉下接受软腭温控射频手术治疗。根据随机分组方案,他们接受2次射频手术(总能量:3300焦耳)或安慰剂治疗(插入器械针但不输送能量)。
由同床伴侣使用10厘米视觉模拟量表评估打鼾情况。23例患者完成了研究;12例接受射频手术,11例接受安慰剂治疗。安慰剂组打鼾评分无变化(从8.4±1.6降至8.0±2.3),而射频组有所改善(从8.1±1.3降至5.2±2.4)。两组之间的差异具有统计学意义(p<0.05)。
射频手术明显优于安慰剂,尽管在我们的患者组中打鼾减少程度仅为中度。本研究强调了在打鼾治疗中进行严格对照临床试验的必要性。