Ultramicronized Palmitoylethanolamide and Luteolin Supplement Combined with Olfactory Training to Treat Post-COVID-19 Olfactory Impairment: A Multi-Center Double-Blinded Randomized Placebo- Controlled Clinical Trial.

BACKGROUND: Olfactory training is the only evidence-based treatment for post-viral olfactory dysfunction. Smell disorders after SARS-CoV-2 infection have been attributed to neuroinflammatory events within the olfactory bulb and the central nervous system. Therefore, targeting neuroinflammation is one potential strategy for promoting recovery from post-COVID-19 chronic olfactory dysfunction. Palmitoylethanolamide and luteolin (PEA-LUT) are candidate antiinflammatory/ neuroprotective agents. OBJECTIVE: To investigate recovery of olfactory function in patients treated with PEA-LUT oral supplements plus olfactory training versus olfactory training plus placebo. METHODS: Multicenter double-blinded randomized placebo-controlled clinical trial was held. Eligible subjects had prior COVID-19 and persistent olfactory impairment >6 months after follow-up SARS-CoV-2 negative testing, without prior history of olfactory dysfunction or other sinonasal disorders. Participants were randomized to daily oral supplementation with ultramicronized PEA-LUT 770 mg plus olfactory training (intervention group) or olfactory training with placebo (control). Sniffin' Sticks assessments were used to test the patients at baseline and 90 days. RESULTS: A total of 185 patients, including intervention (130) and control (55) were enrolled. The intervention group showed significantly greater improvement in olfactory threshold, discrimination, and identification scores compared to controls (p=0.0001). Overall, 92% of patients in the intervention group improved versus 42% of controls. Magnitude of recovery was significantly greater in the intervention group versus control (12.8 + 8.2 versus mean 3.2 + 3), with >10-fold higher prevalence of anosmia in control versus intervention groups at the 90-day endpoint. CONCLUSION: Among individuals with olfactory dysfunction post-COVID-19, combining PEA-LUT with olfactory training resulted in greater recovery of smell than olfactory training alone.

CoQ10 and Vitamin A Supplementation Support Voice Rehabilitation. A Double-Blind, Randomized, Controlled, Three-Period Cross-Over Pilot Study.

Objectives: To evaluate the effectiveness of an adjuvant therapy (CoQ10 in its water-soluble form and vitamin A) in supporting voice rehabilitation in a large group of patients with muscle tension dysphonia (MTD). Study Design: Twelve-week, double-blind, randomized, controlled, three-period cross-over pilot study. The primary endpoint was the change in the Dysphonia Severity Index (DSI) over the 12-week study period. Secondary endpoints were the changes in the subcomponents of DSI, including MPT, F0-high, I-low, and jitter. Exploratory endpoints were the changes in the Shimmer and in Voice Handicap Index (VHI). Methods: Patients were randomly assigned in a 1:1 ratio to two counter-balanced arms. Group A (ADJ-PLA) patients were administered QTer 300 mg and Vit A acetate 500.000 Ul/g 1 mg twice daily for a 4-week intervention period, followed by a 4-week period of wash-out, and then were submitted to a last 4-week period of placebo. Patients in Group B (PLB-ADJ) were given the treatment period in reverse order. Both groups received a 45-min voice therapy in a group format once a day for 4 weeks during the first and the second active periods. The therapy was held during the wash-out period. Results: The analysis of main time effect indicated a trend toward recovery of vocal function regardless of group assignment. A significant time by group effect was found on DSI [F = 3.4 (2.5, 80.5), p = 0.03], F0-high [F = 4.5 (2.6, 82.9), p = 0.008] and Shimmer [F = 3.6 (1.5, 46.9), p = 0.048], under CoQ10 and Vit A treatment, with a small effect size. There was no significant time by group effect on the other study measures, namely MPT, I-low, VHI. Conclusions: A trend toward recovery of vocal function was observed in all the patients, likely due to voice rehabilitation. The improvement of DSI was greater under CoQ10 and Vitamin treatment, indicating a more pronounced improvement of vocal quality under adjuvant therapy. The study protocol was reviewed and approved by the Ethics Committee of Policlinico Umberto I Hospital, Rome, Italy Rif. 3069/13.02.2014.

The role of speech rate for Italian-speaking cochlear implant users: insights for everyday speech perception.

This study investigated the effect of speech rate for Italian-speaking cochlear implant (CI) users with the aim of gaining insight into everyday listening situations where speaker's rate may vary considerably together with speech level in fluctuating background noise. The test material was prepared by processing the Italian STARR test with temporal compression of sentence material. Twelve adult CI users were divided into two subgroups based on their STARR performance: good and poor performers. The effect of varying speech rate was remarkable for both subgroups. Good performers showed significant performance deterioration for the faster speech rate, whereas outcomes for poor performers improved significantly for the slower speech rate. Background noise is inevitable during daily life and CI users face a variety of speakers, so must cope with changes in both speech level and rate. Traditional tests with a single talker speaking very clearly while using a moderate to low speech rate may overestimate everyday speech perception for CI users. The use of tests that mimic everyday perception is of great importance and should become a routine part of audiometric measures for hearing impaired people.

Recovery from Repeated Sudden Hearing Loss in a Patient with Takayasu's Arteritis Treated with Hyperbaric Oxygen Therapy: The First Report in the Literature.

Hearing loss has been rarely reported in Takayasu's arteritis, may present as Sudden Sensorineural Hearing Loss, and usually responds well to corticosteroid therapy. Hyperbaric Oxygen Therapy is commonly used as a supplementary treatment to corticosteroids for Sudden Sensorineural Hearing Loss. We present the case of a 36-year-old woman with Takayasu's arteritis who had two episodes of sudden hearing loss involving one ear at a time with an 11-month delay between each episode. During the first episode, the patient was treated with high-dose intramuscular corticosteroids with a temporary improvement of auditory threshold that deteriorated 14 days after cessation of therapy. In the second episode, Hyperbaric Oxygen Therapy was associated with corticosteroids, with improvements in both ears, including the one that was unresponsive in the long term to previous pharmacologic therapy. In this case, Hyperbaric Oxygen Therapy could have acted synergically with corticosteroids playing a role in hearing restoration.

Kawasaki disease: an evolving paradigm.

Kawasaki disease (KD) is a self-limited childhood systemic vasculitis that exhibits a specific predilection for the coronary arteries. KD predominantly affects young children between the ages of 6months and 4years. Incidence rates in Asians are up to 20 times higher than Caucasians. The aetiology of KD is not known. One reasonable open hypothesis is that KD is caused by an infectious agent that produces an autoimmune disease only in genetically predisposed individuals. The typical presentation of KD is a young child who has exhibited a high swinging fever for five or more days that persists despite antibiotic and/or antipyretic treatment. The lips are dry and cracked. There is a characteristic strawberry tongue, and a diffuse erythema of oropharyngeal mucosal surfaces. Lymphadenopathy is usually unilateral and confined to the anterior cervical triangle. Coronary aneurysms generally appear during the convalescence phase (beginning during the second week). The absence of any laboratory tests for KD means that the diagnosis is made by the presence of a constellation of clinical features. The aim of echocardiography is to assess the presence of coronary artery dilatation or aneurysm formation. Effective therapies exist for most patients with acute KD, but the exact mechanisms of action are not clear. Treatment with aspirin and intravenous immunoglobulins (IVIG) are first-line therapies. However, options are plentiful for the children who fail this treatment, but these treatments are not as beneficial. Some centres attempt to salvage resistant patients using intravenous pulsed doses of methylprednisolone. Other centres use infliximab or combinations of these approaches.

EMLA(®) cream as local anesthetic for radiofrequency turbinate tissue reduction.

Radiofrequency volumetric tissue reduction is a minimally invasive technique in the treatment of turbinate hypertrophy and is generally performed under local anesthesia. However, perioperative discomfort and pain are common side effects and studies concerning the technique of choice to anesthetize the nasal mucosa in this procedure are lacking. The aim of this prospective controlled trial is to assess the effectiveness of EMLA(®) cream as a topical anesthetic for radiofrequency volumetric tissue reduction of inferior turbinates comparing its effect with that obtained using a traditional anesthetic technique. 200 consecutive patients undergoing volumetric tissue reduction with topical anesthesia were enrolled. Patients were divided into two groups: Group A included 100 patients treated by placing cotton pledgets soaked with lidocaine 10% in the inferior meatus followed by the injection of 2% lidocaine into the head of the inferior turbinate; Group B included 100 patients treated with EMLA(®) cream. Patients were evaluated before and after surgery using rhinomanometry for obstructive symptoms. Four VAS about pain, troublesome swallowing, choking sensation and intraoperative anxiety were submitted to each patient immediately after surgery and after 2 months to assess various aspects of perioperative discomfort. A significant increase of nasal airflow was observed without differences between the two groups. Subjective evaluation regarding perioperative discomfort showed significant differences between Groups A and B immediately after surgery although it was less pronounced 2 months later. The results of this study suggest that EMLA(®) cream is an efficient tool in obtaining an adequate anesthetic effect in this procedure.