Phytomedicine ELOM-080 in Acute Viral Rhinosinusitis: A Randomized, Placebo-Controlled, Blinded Clinical Trial.

BACKGROUND: ELOM-080 is a phytomedicine approved for the treatment of acute and chronic inflammatory diseases of the respiratory tract, sinusitis, and bronchitis in particular. This prospective, randomized, placebo-controlled, double-blind clinical trial was conducted to assess efficacy and safety of ELOM-080 in the treatment of acute viral rhinosinusitis (AVRS). METHODS: Patients with AVRS received oral treatment (4 × 1 capsule per day) with either ELOM-080 or matching placebo. Primary endpoints were the change in major symptom score (MSS) after 7 and 14 days of treatment assessed by the investigator (MSSINV ). Secondary endpoints were changes in MSS assessed by the patients (MSSPAT ), olfactory function (12-item Sniffin' Sticks), 20-Item Sino-Nasal Outcome Test (SNOT-20 GAV; German adapted version), influence of treatment on viral load, and safety. RESULTS: Four hundred and sixty-three patients were randomized. At day 4, subjective burden of disease (MSS) was significantly ameliorated compared to placebo (p = 0.012). During the first treatment week MSS scores improved about 1 day earlier, and 3 days earlier in the second week. Effect with ELOM-080 on mean MSSINV was statistically significantly superior to placebo at visit 3 (p = 0.016) and visit 4 (p = 0.014). In chemosensory testing identification scores improved comparably in both treatments. The improvement of the SNOT-20 GAV was more pronounced in ELOM-080 patients. Treatment with ELOM-080 indicated a potential for decreasing viral load. Both treatments were well tolerated. CONCLUSION: ELOM-080 improves the burden of AVRS significantly in comparison to placebo, remission of symptoms occurred 3 days earlier. The results confirm the efficacy and safety of ELOM-080 for treatment of AVRS. LEVEL OF EVIDENCE: 1 Laryngoscope, 133:1576-1583, 2023.

Hypoglossal nerve stimulation for obstructive sleep apnea: updated position paper of the German Society of Oto-Rhino-Laryngology, Head and Neck Surgery.

Since the first statement of the German Society of Oto-Rhino-Laryngology, hypoglossal nerve stimulation (HNS) is meanwhile an established treatment option for obstructive sleep apnea (OSA). There are three HNS systems available in Germany which differ in their technical details of the underlying comparable basic principle. For the unilateral HNS with respiratory sensing, several comparative studies, high-volume register analysis and long-term reports exist. The continuous HNS without respiratory sensing does not require a sleep endoscopy for indication. For the bilateral continuous HNS as the single partially implantable device, a feasibility study exists. For indication, the assessment of positive airway pressure failure by sleep medicine is crucial, and the decision for HNS should be made in discussion of other treatment options for at least moderate OSA. The implantation center holds primarily responsibility among the interdisciplinary sleep team and is primary contact for the patient in problems. This depicts why structural processes are required to secure outcome quality and minimize the complications. The aftercare of HNS patients can be provided interdisciplinary and by different medical institutions, whereat, minimal reporting standards to document outcome and usage are recommended.

Diagnosis and treatment of snoring in adults--S1 guideline of the German Society of Otorhinolaryngology, Head and Neck Surgery.

INTRODUCTION: Snoring has received increased attention over the last years. Given its high prevalence and its impact on quality of life, diagnosis and treatment of snoring are of major importance. AIM OF THE GUIDELINE: This guideline aims to promote high-quality care by medical specialists for adults who snore. DIAGNOSTIC MEASURES: Before every intervention, a medical history, clinical examination and sleep test need to be performed. INTERVENTIONS: There is no need to treat snoring unless requested by the snorer. Invasive treatments should be selected with care; for surgical treatment, minimally invasive procedures are preferred. Weight reduction; the avoidance of sleeping pills, alcohol and nicotine; and a regular sleep-wake cycle can be recommended, although convincing evidence is lacking. Since currently, there is not enough evidence to confirm the effectiveness of muscle stimulation or other forms of muscle training, these treatments cannot be recommended. Snoring can be treated successfully with intraoral devices, but it is essential to select suitable subjects. Devices preventing sleep in the supine position can also be helpful in selected cases. The data on the success rates of surgical intervention are often limited to short-term follow-up studies, and not all interventions have been sufficiently evaluated. The techniques used to treat nasal obstruction in snorers are identical to those used for general nasal obstruction. Nasal surgery is only indicated when subjects complain about nasal obstruction. A significant amount of data is available for laser-assisted resection of excessive mucosa; however, resections can be performed with other tools. The efficacy of radiofrequency surgery at the soft palate has been documented in placebo-controlled trials. Soft palate implants can reduce snoring. Tonsillectomy or uvulopalatopharyngoplasty should be selected with care, especially as less invasive alternatives are available.

Lesion formation in radiofrequency surgery of the tongue base.

OBJECTIVES: Temperature controlled radiofrequency volumetric tissue reduction (RFVTR) of the tongue base is a minimally invasive technique for the treatment of obstructive sleep apnea. But despite its widespread use, little is yet known about in vivo effects in humans. Such knowledge would be essential for evidence-based criteria in the selection of energy application. METHODS: In a preparatory in vitro study, porcine tongues were preserved in growing medium. Lesions with different amounts of energy were applied, and maximum diameters were assessed. In the in vivo study, 11 patients were treated with RFVTR at the tongue base by employing different energy levels (800, 600, 400, or 200 J) on two application sites. Magnetic resonance imagery scans were performed 4 to 6, 8 to 10, and 24 hours after surgery. An inversion recovery technique was used to visualize the lesions. RESULTS: RFVTR created lesions at the porcine tongue from 50 J and higher. Maximum lesion sizes were achieved with 400 J. In vivo, all the lesions were clearly visible in the postoperative scans. Lesion size increased with the amount of energy applied. Maximum diameters were created from 600 J and higher. Higher amounts of energy only resulted in a slight increase in lesion length. CONCLUSIONS: The application of 600 J at 85 degrees C leads to optimal lesion sizes. Higher amounts of energy will not lead to a relevant increase in tissue necrosis. With regard to the time needed for application, 600 J appears to be the ideal adjustment for energy delivery in the treatment of the human tongue.