Objective This pivotal phase III study, SIAXI, investigated the efficacy and safety of incobotulinumtoxinA for the treatment of chronic sialorrhea due to Parkinson disease (PD), atypical parkinsonism, stroke, or traumatic brain injury (TBI). Methods Adult patients with PD (70.7%), atypical parkinsonism (8.7%), stroke (19.0%), or TBI (2.7%) were randomized (2:2:1) to double-blind treatment with placebo (n = 36), or total doses of incobotulinumtoxinA 75 U (n = 74) or 100 U (n = 74), in a single treatment cycle. The coprimary endpoints were change in unstimulated salivary flow rate from baseline to week 4, and patients9 Global Impression of Change Scale score at week 4. Adverse events were recorded throughout. Results A total of 184 patients were randomized. Both incobotulinumtoxinA dose groups showed reductions in mean unstimulated salivary flow rate at week 4, with a significant difference vs placebo in the incobotulinumtoxinA 100 U group (p = 0.004). Patients9 Global Impression of Change Scale scores also improved at week 4, with a significant difference vs placebo in the incobotulinumtoxinA 100 U group (p = 0.002). A lasting effect was observed at week 16 post injection. The most frequent treatment-related adverse events in the incobotulinumtoxinA 75 U and 100 U groups were dry mouth (5.4% and 2.7% of patients) and dysphagia (2.7% and 0.0% of patients). Conclusions IncobotulinumtoxinA 100 U is an effective and well-tolerated treatment of chronic sialorrhea in adults. ClinicalTrials.gov identifier NCT02091739. Classification of evidence This study provides Class I evidence that incobotulinumtoxinA reduces salivary flow rates in patients with chronic sialorrhea due to PD, atypical parkinsonism, stroke, or TBI.
11 December 2000 in European Archives of Oto-Rhino-Laryngology
Only a few case reports have been published about hearing impairment following lumbar puncture, and not all were thoroughly documented by audiograms. We present nine cases of hearing loss following myelography, lumbar puncture, and spinal anesthesia. We speculate that this rare complication arises only in persons with a wholly or partially patent cochlear aqueduct, and occurs via the release of perilymphatic fluid in the cerebrospinal space. Hearing loss was seen in eight of the nine patients in the lower frequencies, and in six of the nine patients on both sides. Recovery to normal hearing was noticed in six of the nine patients. Transient hearing loss may occur more often than it is generally assumed, and the symptom can remain unnoticed. Since not all of these hearing losses proved to be fully reversible, we suggest informing patients about this complication for medicolegal reasons.
KHKopf- Und Hals-Chirurgie Deutsche Gesellschaft Für Hals-Nasen-Ohren-Heilkunde
Kopf- Und Hals-Chirurgie Deutsche Gesellschaft Für Hals-Nasen-Ohren-Heilkunde
Die neue revidierte Leitlinie „Hörsturz” (gültig bis 2012) definiert die einseitige, plötzliche Innenhörstörung nicht als Notfall hinsichtlich Diagnostik und Therapie. Die erforderliche Minimaldiagnostik sollte eine Hals-Nasen-Ohren-ärztliche Untersuchung mit Ohrmikroskopie, Tonaudiogramm und Stimmgabelprüfungen, sowie Tympanogramm und Vestibularisprüfung umfassen. Die Klassifikation nach dem vorherrschenden Frequenzverlust wird zur klinischen Differenzierung möglicher pathogenetischer Mechanismen, die im übrigen noch weitgehend unklar sind, nützlich gehalten. Aus Erfahrung heraus haben sich Glukokortikoide und rheologische Therapien als meistversprechend auch vor dem Hintergrund jüngster Studien herausgestellt. Die intratympanale Gabe von Glukokortikoiden kann angesichts der Datenlage als Reservetherapie in Erwägung gezogen werden. The Revised Version of the German Guidelines “Sudden Idiopathic Sensorineural Hearing Loss” The new revised version (exspires 2012) for sudden, unilateral, sensorineural hearing loss stresses the urgence but not the emergency of diagnostics and therapy in this inner ear disfunction with still increasing incidence. Minimum diagnostics should comprise ENT examination with earmicroscopy, pure tone and tuning fork hearing tests, tympano- and vestibulometry. Classification by frequency loss seems of interest in regard to different underlying pathology, which is still obscure. Therefore from experience glucocorticoids and rheological therapy are recommended in the light of some favoring recent studies. The intratympanic applikation of glucokorticoids is considered as spare therapy. 1 Konsensusbericht im Auftrag des Präsidiums der Deutschen Gesellschaft für Hals-Nasen-Ohren-Heilkunde, Kopf- und Hals-Chirurgie