Radiofrequency surgery of the soft palate in the treatment of mild obstructive sleep apnea is not effective as a single‐stage procedure: A randomized single‐blinded placebo‐controlled trial

Bäck, Leif; Liukko, Tommi; Rantanen, Irma; Peltola, J.; Partinen, Markku; Ylikoski, Jukka; Mäkitie, Antti

doi:10.1002/lary.20562

Cited by 40 publications

(39 citation statements)

References 13 publications

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“…However, patients in the group without concurrent tonsillectomy (group C) performed significantly poorer regarding AHI as an objective outcome measure than did those who had tonsillectomy, suggesting that patients benefit far less from RAUP than from tonsillectomy. This finding is corroborated by a placebo-controlled trial which showed that radiofrequency surgery of the soft palate was ineffective for treatment of mild-to-moderate OSA [13]. …”

Section: Discussionsupporting

confidence: 64%

Contribution of Hyoid and Tonsillar Procedures to Outcome in Multilevel Surgery for Obstructive Sleep Apnea Syndrome

Tetter¹,

Tschopp²

2016

ORL

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Background/Objective: In multilevel surgery for obstructive sleep apnea (OSA), the contribution of distinct operative steps is still unclear. The aim of the present study is to retrospectively compare different combinations of multilevel surgeries in order to estimate the contribution of hyoid and tonsillar procedures to the outcome. Methods: A total of 45 patients were selected in a retrospectively matched case-control study from a database of patients who underwent surgery for OSA at our institution: group A (n = 15) had hyoid suspension, tonsillectomy, and radiofrequency-assisted uvulopalatoplasty (RAUP); group B (n = 15) had hyoid pharyngoplasty with resection of the hyoid body and preepiglottic fat tissue, tonsillectomy, and RAUP; and group C (n = 15) had hyoid suspension and RAUP but no tonsillectomy, because the tonsils had already been removed. The apnea-hypopnea index (AHI) was defined as the primary outcome measure. Results: The postoperative AHI significantly improved in groups A and B, in which all patients had a tonsillectomy. However, the improvement in the patients of group C, who had no tonsillectomy, was not significant (p = 0.08). Conclusion: The patients having undergone multilevel surgery without tonsillectomy showed significantly poorer postoperative results, suggesting that the effectiveness of hyoid procedures at the level of the hypopharynx may be limited. However, removal of the tonsils is a major predictive factor for postoperative success.

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Section: Discussionsupporting

confidence: 64%

Contribution of Hyoid and Tonsillar Procedures to Outcome in Multilevel Surgery for Obstructive Sleep Apnea Syndrome

Tetter¹,

Tschopp²

2016

ORL

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“…5) The presence of inter-study variability between sham and not sham studies was not ascribable to mean or median age of patients but possibly to other factors. 6) The absence of psychological and psychiatric profile that is relevant for studies were the placebo effect have to be evaluated represents a very important confounding factor [10], [22], [24], [25], [26], [27], [28], [29], [30], [31], [32], [33], [34], [35], [36], [37], [38], [39], [40], [41], [42], [43], [44], [45], [46], [47], [48], [49], [50], [51], [52], [53], [54], [55], [56], [57], [58], [59], [60], [61], [62], [63], [64], [65], [66], [67], [68], [69], [70], [71], [72], [73], [78], [79]. 7) A percentage of 5% of participants lost to the follow-up has been extracted from 30 on the 52 studies examined (ref.).…”

Section: Resultsmentioning

confidence: 99%

Critical review of sham surgery clinical trials: Confounding factors analysis

Ciccozzi

Menga

Ricci

et al. 2016

Annals of Medicine &Amp; Surgery

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ObjectiveSham surgery (placebo surgery) is an intervention that omits the step thought to be therapeutically necessary. In surgical clinical trials, sham surgery serves an analogous purpose to placebo drugs, neutralizing biases such as the placebo effect. A critical review was performed to study the statistical relevance of the clinical trials about sham surgery in the light of potential confounding factors.Materials and methodsFor the critical review 52 articles were included. The possible confounding factors have been studied using a structured interpretative research form designed by the authors. This form includes the following ten confounding factors: I), lack of homogeneity among inclusion/exclusion criteria. II), false double blind. III), lack of post-surgery double blind. IV), power of the study. V), sample characteristics. VI), lost patients to Follow-up. VII), gender distribution. VIII), age equilibrium. IX), lack of psychological patient evaluation. X), lack of psychiatric patient evaluation. In most of the studies, at least one confounding factor was present.ResultsThe analysis of the confounding factors showed that they could influence the reliability of the surgical placebo effects.ConclusionsThe validity of sham surgery should be reconsidered.

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“…However, there are inconsistent findings in daytime sleepiness or other sleep parameters. A more recent, placebo-controlled study has shown that a single step radiofrequency intervention at the soft palate is not effective for the treatment of OSA (table e20) [228].…”

Section: Overview Of the Evidencementioning

confidence: 99%

Non-CPAP therapies in obstructive sleep apnoea

Randerath

Verbraecken²,

Andreas³

et al. 2011

European Respiratory Journal

304

179

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Radiofrequency surgery of the soft palate in the treatment of mild obstructive sleep apnea is not effective as a single‐stage procedure: A randomized single‐blinded placebo‐controlled trial

Abstract: RF surgery of SP is not recommended as a single-stage approach in mild OSAS.

Cited by 40 publications

References 13 publications

Contribution of Hyoid and Tonsillar Procedures to Outcome in Multilevel Surgery for Obstructive Sleep Apnea Syndrome

Contribution of Hyoid and Tonsillar Procedures to Outcome in Multilevel Surgery for Obstructive Sleep Apnea Syndrome

Critical review of sham surgery clinical trials: Confounding factors analysis

Non-CPAP therapies in obstructive sleep apnoea

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