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Is there any evidence on the clinical and cost effectiveness of injection snoreplasty (sotradecol or sodium tetradecyl sulphate)?
A 2009 Health Technology Assessment (HTA) examined surgical procedures and non-surgical devices for the management of non-apnoeic snoring: a systematic review of clinical effects and associated treatment costs (1). This discusses injection snoreplasty and reports that only one pre-post study was found that assessed injection snoreplasty. In the study by Brietzke and colleagues the aim was to assess the effects of injection snoreplasty in their pre–post study. There is no evidence on the effects of injection snoreplasty other than in the 2-week post-treatment period.
“The treatment protocol consisted of a first injection to the soft palate midline of 2.0 ml of 1% sodium tetradecyl sulphate (10 mg/ml). For repeat procedures 3% Sotradecol (Bioniche Pharma; 30 mg/ml) was generally used and the site of injection modified to include the lateral areas of the soft palate as well as those not adequately stiffened by the previous procedure. Treatment sessions were performed 6–8 weeks apart, with a mean of 1.8 sessions per patient (range 1–4). Patients were followed up for 10 days post each procedure.”
At follow up Brietzke et al reports:
“At follow-up 25 of the 27 patients (92%) reported a significant decrease in snoring. Based on the results from 13 patients there was an increase in voluntary awake palatal flutter snoring from 74.1 Hz at baseline to 105.4 Hz at follow-up, resulting in an average increase of 31.3 Hz. The significance of comparison of the means was not reported. Postoperative pain scores for days 1–5 showed that pain levels were generally low, with a score of 3 on day 1 that steadily decreased to a score of 1 on day 5.”
A summary of the results for subjectively assessed snoring and ESS outcomes, objectively assessed snoring measurements and PSG parameter outcomes for studies assessing palatal stiffening techniques can be found in the full paper and are displayed in Tables 40–42 respectively.
In the summary of results the authors of the HTA assessment report on injection snoreplasty:
“Patient- and partner-reported snoring severity
In the one study that assessed injection snoreplasty, 92% of patients or their partners reported that snoring was no longer a problem at follow-up.
Objective measures of snoring sound
There was an increase in voluntary awake palatal flutter snoring of 31.3 Hz at post-treatment follow up. No significance test for a comparison of the pre- and post-treatment means was reported.
Adverse events Postoperative pain
Postoperative pain scores were all categorised as mild.”
In the conclusion the authors note on injection snoreplasty
“Given the limited very poor-quality evidence available on the effects of injection snoreplasty it is not possible to draw any conclusions regarding the safety and efficacy of this treatment without consideration of substantive further evidence on the use of this technology.”
ATTRACT found no evidence on the cost effectiveness of injection snoreplasty
1. http://www.hta.ac.uk/fullmono/mon1303.pdf