Balloon Eustachian Tuboplasty-A Feasible Double-Blinded Sham Surgery Randomized Clinical Trial Protocol to Study Efficacy.

INTRODUCTION: Balloon Eustachian tuboplasty (BET) is used to treat obstructive Eustachian tube dysfunction (OETD) and recurrent otitis media with effusion (OME). However, there are no indisputable evidence of its efficacy. Here, we present a multicenter, double-blinded, randomized, placebo-controlled trial (MDRCT) design to evaluate the efficacy of BET, and the results of a pilot trial with 3- and 12-months' follow-up. MATERIAL AND METHODS: This was a prospective MDRCT. For a pilot study, OETD (n = 10) and OME (n = 5) patients were recruited and followed. Detailed inclusion and exclusion criteria were used. Participants were randomized at beginning of the operation to active or sham surgery. All procedures were performed under local anesthesia. Controls were performed in double-blinded manner (both patient and physician), at 3 and 12 months after the procedure. RESULTS: Altogether, 20 ears were treated and followed for 12 months, including 14 active BETs and 6 sham surgeries. Both the active and sham surgery were performed under local anesthesia without problems or deviations from the protocol. There were no differences in the preoperative symptoms (ETDQ-7) or objective measures (tympanometry, Valsalva and Toynbee maneuvers, tubomanometry, Eustachian tube score) between active and sham surgery arms. During follow-up, we noticed largely similar reduction in subjective symptoms and improvement in Eustachian tube score both in active and sham surgery arms. CONCLUSIONS: The pilot study demonstrates that our MDRCT protocol is feasible, and that blinded RCTs are dearly needed to objectively measure the efficacy of BET. LEVEL OF EVIDENCE: 2 Laryngoscope, 134:1874-1881, 2024.

Severe acute otitis media and mastoiditis caused by group A beta-hemolytic streptococcus.

OBJECTIVE: To describe the characteristics, diagnostics, treatment, and outcome of severe acute otitis media (AOM) and acute mastoiditis (AM) caused by group A beta-hemolytic streptococcus (GAS). STUDY DESIGN: A retrospective cohort study. METHODS: The yearly incidence of inpatient care-needing GAS AOM/AM patients in our hospital catchment area between 2002 and 2018 was investigated. A detailed analysis was performed for cases treated during the last GAS epidemic in 2017-2018. Anamnesis, signs and symptoms, pure-tone audiometry results, treatment, complications, and outcome were collected from medical charts. Patients responded to an otology-specific health-related quality of life survey (EOS-16) 1.5 to 3 years after their treatment. RESULTS: The number of GAS infections peaks at approximately 7-year intervals. During 2017 and 2018, altogether 37 patients (29 adults and 8 children) were hospitalized due to GAS AOM/AM. AM was diagnosed in 14 (38%) patients. The disease progression was typically very rapid. At presentation, all patients had severe ear pain, 68% tympanic membrane perforation and discharge, 43% fever, and 43% vertigo. In pure-tone audiometry, there was usually a marked mixed hearing loss at presentation. There was a significant recovery in both air and bone conduction thresholds; the pure tone average improvement from presentation was 32.3 ± 14.8 dB. Rapid strep tests (RST) proved to be more sensitive than bacterial culture in identifying GAS as a cause of AOM/AM. CONCLUSION: GAS AOM/AM has a rapid onset. Hearing loss usually includes a sensorineural component, which is usually reversible with adequate treatment. RST seems to be useful in detecting GAS from middle ear discharge. LEVEL OF EVIDENCE: 4.

Development of otology specific outcome measure: Ear Outcome Survey-16 (EOS-16).

PURPOSE: An important outcome measure of patient care is the impact on the patient's health-related quality of life (HRQoL). Current ear-specific HRQoL instruments are designed for one diagnosis and emphasize different subdivisions such as symptoms, hearing problems, psychosocial impact, and the need for care. The optimal length of the recall period has not been studied. For these reasons, a new survey is needed that would cover most chronic ear diseases. METHODS: A preliminary 24-item survey (EOS-24) was created. Untreated adult patients (included n = 186) with one of seven different chronic otologic conditions from all university hospitals in Finland were recruited to respond to EOS-24 and the 15D general HRQoL instrument. The recruiting otologists evaluated the severity of the disease and the disability caused by it. A control group was recruited. Based on the patients' responses in different diagnosis groups, the items were reduced according to pre-defined criteria. The resulting survey was validated using a thorough statistical analysis. RESULTS: The relevance and necessity of the original 24 items were thoroughly investigated, leading to the exclusion of 8 items and the modification of 1. The remaining 16 items were well-balanced between subdivisions and were useful in all seven diagnosis groups, thus constituting the final instrument, EOS-16. The most suitable recall period was three months. CONCLUSIONS: EOS-16 has been created according to the HRQoL survey guidelines with a versatile nationwide patient population. The survey has been validated and can be used for a wide range of chronic ear diseases as a HRQoL instrument.

Renal xanthine oxidoreductase activity during development of hypertension in spontaneously hypertensive rats.

BACKGROUND: Hyperuricaemia and reactive oxygen species have recently been associated with essential hypertension. Xanthine oxidoreductase (XOR) produces urate and, in its oxidase isoform, reactive oxygen species also. Our previous studies indicated that hypertension-prone rat strains have greater renal XOR activity than their normotensive counterparts, and that dietary sodium modifies renal XOR activity. OBJECTIVE: To clarify whether renal XOR induction precedes or follows the development of hypertension. METHODS: Five-week-old spontaneously hypertensive rats (SHRs) and Wistar-Kyoto (WKY) rats were kept for 3-8 weeks on low sodium (0.3% salt w/w) or high sodium (6.0% salt w/w) intakes, with or without allopurinol, an inhibitor of XOR, to study the possible pathogenetic role of XOR in hypertension. Systolic blood pressure (SBP), renal XOR activity and mRNA expression were measured. RESULTS: Regardless of sodium intake, renal XOR activity increased twofold during growth in SHRs, but not in WKY rats. SBP increased from 122 +/- 4 to 241 +/- 13 mmHg in SHRs kept on the high-sodium diet and to 204 +/- 11 mmHg in those on the low-sodium diet. At the end of the experiment, renal XOR activity correlated with SBP in SHRs. Allopurinol prevented hypertension-induced left ventricular and renal hypertrophy in SHRs, but had negligible effect on blood pressure. CONCLUSION: Renal XOR induction in SHRs does not precede the development of hypertension, but progress concomitantly with an increase in SBP. The results indicate a role for locally synthesized XOR in the development of hypertension-associated end-organ damage, but no major role in the development of hypertension.