Well-done randomized trials offer the highest-quality scientific evaluation of any medical intervention. Unfortunately, randomized trials of surgical interventions are extremely difficult to perform, for numerous reasons. In sleep surgery, there have been a number of randomized trials showing that surgical treatment of obstructive sleep apnea can offer important benefits that matter to patients. These include a placebo-controlled randomized trial comparing the combination of palate and tongue radiofrequency against placebo and against CPAP, showing meaningful improvements in sleep apnea and increases in sleep-related quality of life that were similar to CPAP.
Last year, the prestigious medical journal The Journal of the American Medical Association published the results of an Australian randomized trial of the combination of palate surgery and tongue radiofrequency. This study was the Sleep Apnea Multilevel Surgery (SAMS) Trial, and it was a major effort led by physicians from Australia (and one from the US), many of whom I am proud to call good friends. Compared to conservative medical management (advice on sleep positioning, weight loss, and similar guidance), surgery showed a substantial and greater improvement in sleep apnea (apnea-hypopnea index) as well as daytime sleepiness (Epworth Sleepiness Scale score, ESS). Among 51 study participants who underwent surgery, the average apnea-hypopnea index decreased from 47.9 to 20.8, and the ESS improved from 12.4 to 5.3. Both of these are significant statistically but also clinically (matter to patients). No changes overall were seen in the medical management group. While some may criticize the fact that many participants in the surgery group still had some sleep apnea, it is important that this study included study participants with a body mass index up to 38 kg/m2, which is generally considered relatively high. The result is that they included many obstructive sleep apnea patients who would be very difficult to treat with almost any surgical intervention.
It is interesting that tongue radiofrequency is often dismissed as a treatment for obstructive sleep apnea, even though there is substantial evidence that they can provide substantial benefits in selected patients. This is especially true for tongue radiofrequency, where there are at least 30 published studies supporting its role. These studies show that tongue radiofrequency provides greater benefits in those who are not obese (body mass index below 30 kg/m2). I use this information as one factor in deciding what treatment options might make sense for each patient. I have treated hundreds of patients with tongue radiofrequency, and it is one procedure that can be more-difficult to obtain insurance authorization. The publication of the SAMS Trial will hopefully make tongue radiofrequency available to even more patients, as I can now cite it as yet another study supporting tongue radiofrequency as an important treatment of obstructive sleep apnea.