Anti-calcitonin gene-related peptide monoclonal antibodies for the treatment of vestibular migraine: A prospective observational cohort study.

BACKGROUND: Vestibular migraine is considered the most common cause of recurrent vertigo for which specific treatments are missing. Monoclonal antibodies against calcitonin gene-related peptide,, are effective in preventing migraine. Since CGRP is also detected in human cochlear and vestibular organs it may also play a role in vestibular physiology. METHODS: This is a prospective observational cohort study, aiming at evaluating the efficacy of erenumab, fremanezumab or galcanezumab for the treatment of fifty vestibular migraine patients. We assessed mean monthly days with headache and dizziness/vestibular symptoms, pain intensity and migraine-related clinical burden occurring for 18 months. RESULTS: Response to treatment was excellent as 45 (90%) patients had at least a 50% reduction in vertigo frequency, 43 (86%) had at least a 50% reduction in headache frequency, and 40 (80%) a MIDAS reduction of at least 50%. Overall, 39 (78%) patients had a concomitant reduction of all three parameters. Mean monthly days with dizziness/vestibular symptoms showed an overall significant decrease from a mean of 10.3 ± 1.9 at baseline to 0.8 ± 0.3 days, difference 9.5 (CI 95% 3.6, 15.4; p < 0.001) after twelve months. CONCLUSION: We show that anti-CGRP mAbs may be effective in the treatment of Vestibular Migraine. Their use should be encouraged early in the disease course to allow for a better symptom control and quality of life improvement.

Tapentadol Immediate Release (IR) versus Morphine Hydrochloride for Postoperative Analgesia of Patients Undergoing Total Abdominal Hysterectomy-A Prospective Cohort Study.

Background and Objectives: This study aimed to examine the efficacy of tapentadol immediate release (IR) and morphine hydrochloride in the treatment of acute postoperative pain after total abdominal hysterectomy, as well as to examine the frequency of opioid-related side effects in observed patients. Materials and Methods: The prospective observational study was conducted over five months, and it included a total number of 100 patients. The two cohorts had different types of postoperative analgesia, and the effects were observed for 24 h postoperatively, by following the pain scores on NRS (Numerical Pain Scale), contentment with analgesia, and opioid-related side effects. Results: Statistical significance was found when assessing pain 24 h after surgery while coughing, where patients in the tapentadol IR group had significantly higher mean pain scores (p < 0.01). The subjective feeling of satisfaction with postoperative analgesia was statistically significant in the tapentadol IR group (p = 0.005). Vertigo appeared significantly more in patients from the morphine group (p = 0.03). Conclusions: Tapentadol IR (immediate release) and morphine hydrochloride are both effective analgesics used in the first 24 h after total transabdominal hysterectomy. Overall satisfaction of patients with analgesia was good. The frequency of side effects was higher in the morphine group, with statistical significance regarding the vertigo.

Emergency medicine updates: Droperidol.

INTRODUCTION: Droperidol is a butyrophenone that has recently been reintroduced after a United States Food and Drug Administration (US FDA) black box warning in 2001. Evidence demonstrates utility in a variety of clinical conditions. OBJECTIVE: This paper provides evidence-based updates concerning the use of droperidol for the emergency clinician. DISCUSSION: Droperidol received a black box warning by the US FDA in 2001 due to concerns for QT prolongation and torsades de pointes; however, reevaluation of the available data suggests droperidol is a safe and efficacious medication. It can be used in the emergency department (ED) setting for many conditions, including acute agitation, headaches, vertigo, nausea, and vomiting. Extensive literature supports that the QT-prolonging effects are transient and that the risk of torsades de pointes is rare with doses utilized in the ED. An electrocardiogram does not need to be routinely obtained before droperidol use but should be considered in patients at high risk for QT prolongation. CONCLUSIONS: Current evidence suggests that droperidol is a safe and effective medication for treating nausea and vomiting, headache, vertigo, and agitation in the ED setting.

Complications and prognosis associated with intra-tympanic steroid injection to treat sudden sensorineural hearing impairment.

PURPOSE: The purpose of this study was to measure the incidence of complications in sudden sensorineural hearing loss (SSNHL) patients treated with intra-tympanic steroid injection (ITSI) and compare hearing recovery rates. MATERIALS AND METHODS: 123 patients with unilateral SSNHL receiving ITSIs were included in this study. Post-ITSI complications were documented including otalgia, dysgeusia, vertigo (duration>1 h), and persistent eardrum perforation. The pain intensity was evaluated with visual analog scale (VAS). Hearing was measured before ITSI and at 1 month after the final ITSI. We compared our patients' hearing threshold between presence and absence of different complications. RESULTS: 47.2% patients experienced post-injection otalgia with the average VAS score 3.2 (range 2-6). Five (4.1%) and six (4.9%) patients exhibited vertigo and persistent eardrum perforations, respectively. The patients were divided into three groups based on the absence of complications and the presence of vertigo and eardrum perforation. The hearing threshold improvements did not differ significantly among the three groups (p = 0.366). Although the difference was not significant (p = 0.664), the proportion of patients experiencing post-ITSI vertigo who were on contemporaneous oral steroids was lower than the proportion of non-vertigo patients on such steroids. CONCLUSION: The incidences of otalgia, vertigo, and persistent eardrum perforation in SSNHL patients treated with ITSI were 47.2%, 4.1% and 4.9%, respectively. We found no association between concurrent oral steroid use and the incidence of post-ITSI eardrum perforation or vertigo. Although statistical significance was lacking, patients who did not take contemporaneous oral steroids may have a higher rate of prolonged post-ITSI vertigo.

Efficacy and safety of cenobamate in patients with uncontrolled focal seizures: A meta-analysis.

OBJECTIVE: To investigate the efficacy and safety of adjunctive cenobamate for treatment of uncontrolled focal seizures. METHODS: We performed a systematic search of Web of Science, MEDLINE (Ovid and PubMed), Cochrane Library, EMBASE and Google Scholar to identify eligible studies. We included randomized placebo-controlled trials (RCTs) for uncontrolled focal seizures. We calculated the risk ratio (RR) of ≥50%, ≥75% and 100% reduction in seizure frequency from baseline, as well as dropout and serious adverse events related to treatment. Quality of included trials was assessed using the Cochrane Collaboration's tool. RESULTS: Two RCTs with a total of 658 patients were included. A significantly larger proportion of patients allocated to cenobamate achieved 50% seizure reduction (RR 2.06, 95% CI 1.70-2.51, p < 0.001) as compared to placebo, subgroup analysis demonstrated that the most effective dose was at 400 mg (RR 2.28, 95% CI 1.57-3.32, p < 0.001). Patients achieving seizure-freedom during the treatment period were 14.9% with cenobamate and 4.5% with placebo (RR 5.32, 95% CI 2.94-9.62, p < 0.001). Dropouts (RR 1.40, 95% CI 1.01-1.94, p = 0.05) and incidence of serious adverse events (RR 1.48, 95% CI 0.93-2.33, p = 0.1) were not significantly higher in patients receiving cenobamate. However, subgroup analyses based on doses suggested that patients exposed to 400 mg cenobamate were more likely to dropout than placebo (RR 2.09, 95% CI 1.17- 3.71, p = 0.012). CONCLUSION: Cenobamate demonstrated favourable efficacy for treatment of uncontrolled focal seizures and showed a dose-related fashion. Cenobamate could be well tolerated, the most common adverse events associated with cenobamate were dizziness, somnolence, fatigue, headache and nausea. Nevertheless, majority of them were mild to moderate in severity.

Epidemiology of cannabidiol related cases reported in the National Poison Data System - 2019-2020.

INTRODUCTION: Cannabidiol (CBD) has become a popular supplement in consumer products in recent years, resulting in part from normalization of the cultivation of low THC cannabis in 2018. However, the actual content of CBD-labeled products is frequently uncertain, as oversight of such products is minimal. To date, there is little pragmatic knowledge regarding exposures to products labeled as containing CBD. METHODS: Cases reported to Poison Control Centers from April 1, 2019 and March 31, 2020, the first year in which CBD was identified uniquely as a substance in the National Poison Data System, were analyzed for demographic, temporal, and clinical trends. RESULTS: Poison Control Centers handled 1581 cases exposures to CBD-containing products between April 1, 2019 and March 31, 2020. There was a significant trend of over 5 additional cases related to this substance per month (linear regression coefficient = 5.2, 95% CI: 1.52-8.98). Patients under age 13 years made up 44.0% of reported exposures. Mild CNS depression (10.3%), tachycardia (5.7%), dizziness/vertigo (5.3%), vomiting (4.9%), nausea (4.5%), and agitation (4.4%) were the most frequently reported symptoms. 13% of cases were coded as having "moderate" or "severe" medical outcomes. There were no fatalities. CONCLUSIONS: Cases reported to Poison Control Centers regarding exposures to CBD-labeled products have been increasing, representing an emerging trend of interest to Poison Control Center professionals, clinicians, and public health officials. Further monitoring of this trend is recommended.

The evaluation of the use of isotretinoin on vestibular system by using vHIT.

AIM: The aim of the present study was to evaluate the effect of isotretinoin (ISO) on peripheral vestibular system using vHIT. MATERIAL AND METHOD: This is a prospective study in which 30 patients administered ISO treatment with the diagnosis of acne vulgaris was evaluated. Following ear nose and throat, examination, audiological and vestibular evaluations were carried out. vHIT tests were conducted before and three months after the use of ISO (0.5-0.75 mg/kg/day). In addition, all participants underwent perceptual vertigo and dizziness tests before and three months after the use of ISO. RESULTS: In vHIT evaluation of all patients, no overt saccade, covert saccade and spontaneous nystagmus finding was observed. Gain and asymmetry were compared before and after the use of ISO: No significant difference was found between lateral semicircular canal, anterior, and posterior semi-circular and symmetry measurements made before ISO use and those made three months after it (p = 1.00; p = 0.99; p = 0.66). Similarly, there was no significant difference in asymmetry values of vertical semicircular canals measured before ISO and three months after it (p = 0.90; p = 0.76). No statistically significant difference was found in vertigo, nausea and dizziness in terms of responses before and 3 months after ISO use (p = 0.063; p = 0.031; p = 0.063). CONCLUSION: Although the studies demonstrating the effect of ISO on cochlea and symptoms occurring during treatment such as nausea, vomiting and vertigo suggest that it may exert effects on peripheral vestibular system, the present study indicates that it has no short terms effects on structures in peripheral vestibular system and vestibuloocular reflex pathways.

Experience with Omalizumab for the treatment of chronic spontaneous urticaria in a tertiary center: real life experience.

PURPOSE: Chronic spontaneous urticaria (CSU) is defined as urticaria and/or angioedema that appears spontaneously due to known or unknown causes and lasts for at least 6 weeks. Omalizumab, an anti-IgE antibody that binds circulating free IgE, has recently emerged as a promising treatment for CSU, a condition which impairs patients' quality of life. We aimed to contribute real life data by reporting our experience with omalizumab in the treatment of intractable CSU. METHODS: Of 140 patients treated with omalizumab in our clinic between September 2013 and January 2018, 86 CSU patients with available current data were retrospectively evaluated in terms of sex, age, urticaria duration, urticaria activity score over 7 days (UAS7) before and after omalizumab, relapses and time to relapse, length of remission after omalizumab cessation, adverse events, and comorbidities. RESULTS: The mean age of the patients was 45.5 ± 14.3 years and 73.3% were women. Mean duration of urticaria before initiation of omalizumab therapy was 54.5 ± 67 months. All patients had used antihistamines before starting omalizumab treatment. The mean number of omalizumab doses was 11.9 ± 9.3. The mean duration of omalizumab treatment was 13.3 ± 10.4 months. Mean UAS7 score was 38.9 ± 4.1 before the start of omalizumab treatment, and 7.9 ± 10.5 after treatment. Treatment was discontinued in 10 patients (11.6%) due to nonresponse or loss of effect. Four patients (4.65%) experienced adverse events. Treatment was discontinued in 1 patient (1.16%) due to side effects. Of the 55 patients whose treatment was discontinued after their symptoms resolved, 31 (56.3%) relapsed after omalizumab cessation. Twenty-four patients (43.6%) did not relapse after omalizumab cessation. CONCLUSIONS: Our results show that omalizumab was an effective treatment for intractable CSU and did not cause any serious adverse effects other than asthenia, vertigo, and injection site reaction in four patients. These findings are relevant because they reflect real-life data.

Short-term efficacy and safety of lasmiditan, a novel 5-HT1F receptor agonist, for the acute treatment of migraine: a systematic review and meta-analysis.

BACKGROUND: Migraine has been recognized as one of common diseases in the world whose current treatment options are not ideal. Lasmiditan, an oral 5-hydroxytryptamine (HT)1F receptor agonist, appears more promising for the acute treatment of migraine because of considerably better effect profiles with no severe adverse events (AEs). This review aimed to systematically evaluate the efficacy and safety of lasmiditan from the results of randomized controlled trials (RCTs). METHODS: PubMed, Cochrane Library, Embase were searched on lasmiditan for the acute treatment of migraine from inception of the databases to Feb 1, 2020. Pain free and pain relief, global impression (very much/much better), and no/mild disability at 2 h in efficacy; total treatment-emergent adverse events (TEAEs), dizziness, nausea, fatigue, paraesthesia and somnolence in safety were extracted from the included studies. A systematic review and meta-analysis was performed using Review Manager Software version 5.3 (RevMan 5.3). RESULTS: Four RCTs with a total of 4960 subjects met our inclusion criteria. The overall effect estimate showed that lasmiditan was significantly superior to placebo in terms of pain free (RR 1.71, 95% CI 1.55-1.87), pain relief (RR 1.40, 95% CI 1.33-1.47), global impression (very much/much better) (RR 1.55, 95% CI 1.44-1.67), and no/mild disability (RR 1.15, 95% CI 1.10-1.20) at 2 h. For the safety, significant number of patients experienced TEAEs with lasmiditan than with placebo (RR 2.77, 95% CI 2.53-3.03), most TEAEs were central nervous system (CNS)-related and included dizziness (RR 5.81, 95% CI 4.72-7.14), nausea (RR 2.58, 95% CI 1.87-3.57), fatigue (RR 5.38, 95% CI 3.78-7.66), paraesthesia (RR 4.48, 95% CI 3.33-6.02), and somnolence (RR 2.82, 95% CI 2.18-3.66). CONCLUSIONS: This meta-analysis suggests that lasmiditan is effective for the acute treatment of migraine with a higher incidence of CNS-related adverse reactions compared with placebo. Long-term, open-label, multi-dose trials are required to verify the current findings.

Safety findings from Phase 3 lasmiditan studies for acute treatment of migraine: Results from SAMURAI and SPARTAN.

BACKGROUND: We assessed the safety profile of lasmiditan, a selective 5-HT1F receptor agonist without vasoconstrictive activity being developed as an acute therapy for migraine. METHODS: SAMURAI and SPARTAN were Phase 3 double-blind studies of patients with migraine, randomized to oral lasmiditan 50 mg (SPARTAN only), 100 mg, 200 mg, or placebo to be taken within 4 hours of onset of migraine pain. Safety data from the studies were integrated. Treatment-emergent adverse events (occurring within 48 hours of first dose) were considered in the analyses. RESULTS: The safety population comprised 1262 patients assigned placebo, and 654, 1265, and 1258 assigned lasmiditan 50 mg, 100 mg, and 200 mg, respectively. There were no deaths; serious adverse events were reported for seven patients (placebo, n = 2 [0.2%]; lasmiditan 50 mg, n = 1 [0.2%]; lasmiditan 100 mg, n = 1 [0.2%]; lasmiditan 200 mg, n = 3 [0.2%]). Patients reporting ≥ 1 treatment-emergent adverse events were: Placebo, n = 174 (13.5%); lasmiditan 50 mg, n = 166 (25.4%); lasmiditan 100 mg, n = 458 (36.2%); and lasmiditan 200 mg, n = 510 (40.6%). Treatment-emergent adverse events were generally mild or moderate in severity. The most common treatment-emergent adverse events with lasmiditan were dizziness, paresthesia, somnolence, fatigue, nausea, muscular weakness and hypoesthesia. There were no ischemic events. CONCLUSIONS: As a centrally-penetrant drug, lasmiditan use was associated with neurologic treatment-emergent adverse events; most were mild or moderate in severity and self-limiting. TRIAL REGISTRATION AT CLINICALTRIALS.GOV: SAMURAI (NCT02439320) and SPARTAN (NCT02605174).

Characterization of Dizziness After Lasmiditan Usage: Findings From the SAMURAI and SPARTAN Acute Migraine Treatment Randomized Trials.

TRIAL DESIGN: SAMURAI and SPARTAN were double-blind, placebo-controlled Phase 3 studies conducted in the United States, as well as the United Kingdom and Germany (SPARTAN only). Individuals with migraine were randomized to receive oral lasmiditan 50 mg (SPARTAN only), 100 mg, 200 mg, or placebo within 4 hours of onset of a migraine attack. The aim of this analysis was to characterize dizziness reported with lasmiditan treatment. METHODS: Data from SAMURAI and SPARTAN were pooled for the current post hoc analyses. Onset time and duration of dizziness were analyzed using descriptive statistics. Subgroup analyses based on presence/absence of dizziness were performed for the endpoints of interference with daily activity, patient global impression of change (PGIC), pain at 2 hours, and most bothersome symptom (MBS) at 2 hours based on adverse events occurring within 2 hours of taking study drug. RESULTS: Dizziness incidence was as follows: Placebo (N = 1262), 2.9% (0.1% severe); lasmiditan 50 mg (N = 654), 8.6% (0.3% severe); lasmiditan 100 mg (N = 1265), 14.9% (0.7% severe); and lasmiditan 200 mg (N = 1258), 16.8% (1.4% severe). Among participants who received lasmiditan as their first dose, risk factors for dizziness were higher lasmiditan dosage, being non-Hispanic/Latino, mild or moderate severity of migraine attack, and lower body mass index. The median time to onset of dizziness was generally 30-40 minutes, and the median duration was 1.5-2 hours. The presence of dizziness did not appear to have a negative influence on lasmiditan's effect on daily activity, PGIC, freedom from pain, or MBS. Overall, 21 participants experienced vertigo: Lasmiditan 50 mg, n = 2 (0.3%); 100 mg, n = 11 (0.9%); 200 mg, n = 7 (0.6%); and placebo, n = 1 (<0.1%). CONCLUSION: The incidence of dizziness with lasmiditan increased with dose. Dizziness was generally mild or moderate in severity and of quick onset and short duration. The presence of dizziness did not influence drug efficacy.

Eslicarbazepine acetate as monotherapy in clinical practice: Outcomes from Euro-Esli.

OBJECTIVES: To assess the effectiveness and safety/tolerability of eslicarbazepine acetate (ESL) monotherapy in clinical practice in Europe. MATERIALS AND METHODS: Euro-Esli was a pooled analysis of 14 European clinical practice studies. Responder rate (≥50% seizure frequency reduction) and seizure freedom rate (seizure freedom at least since prior visit) were assessed after 3, 6 and 12 months of ESL treatment and at last visit. Adverse events (AEs) and AEs leading to ESL discontinuation were assessed throughout follow-up. A subanalysis was conducted to assess outcomes for patients treated initially with ESL monotherapy and for patients treated at the last visit with ESL monotherapy. RESULTS: ESL was used as monotherapy in 88/2045 (4.3%) patients initially and in 229/1340 (17.1%) patients at the last visit. At 12 months, responder and seizure freedom rates were 94.1% and 88.2%, respectively, in patients treated initially with ESL monotherapy, and 93.2% and 77.4%, respectively, in patients treated at the last visit with ESL monotherapy. Corresponding values for patients treated initially with ESL adjunctive therapy were 74.8% and 39.0%, respectively; and for patients treated at the last visit with ESL adjunctive therapy, corresponding values were 70.4% and 25.9%, respectively. Safety and tolerability were generally comparable in patients treated with ESL as monotherapy or adjunctive therapy. The most commonly reported AEs (≥5% of patients in any group) were dizziness, somnolence, instability/ataxia, and fatigue. CONCLUSIONS: These clinical practice data support the use of ESL as monotherapy, as well as adjunctive therapy, for focal-onset seizures, complementing evidence from clinical trials.

Anticholinergic and sedative medications and the risk of vertigo or dizziness in the German primary care setting-A matched case-control study from the CONTENT registry.

PURPOSE: To date, there is little information on the utilization of anticholinergic and sedative (AS) medications to vertigo or dizziness (VoD) patients in the German primary care setting. The objective of this study was to evaluate AS medication use and its association with VoD within the German primary care setting. METHODS: Cases with VoD from the CONTENT (CONTinuous morbidity registration Epidemiologic NeTwork) database were 1:1 matched to controls on age, sex, and comorbidities by propensity score matching. AS medication was defined using the fourth level of Anatomical Therapeutic Chemical Classification (ATC) Codes. A prescription of AS medication any time within the study period formed the primary exposure. Multivariable conditional logistic regression examined the association between AS use and VoD. RESULTS: Of a total of N = 151 446 patients, 6971 (4.6%) cases and 6971 corresponding controls were analyzed (mean age (sd): 59.9 years (20.9), 64.2% female). Dizziness and giddiness (ICD-10 Code R42) were diagnosed most prominently (87.2%). AS medication was prescribed on 1072 of 10 552 (10.2%) consultation days with VoD diagnoses. After adjusting for covariates, AS use was significantly and independently associated with VoD, adjusted odds ratio (1.37; 95% CI: 1.18-1.58), compared with no AS use. CONCLUSION: Primary care practitioners should consider AS medication as a risk factor for VoD and avoid prescribing AS medications after a VoD diagnosis. Caution should also be taken when prescribing AS medications to older adults (≥65 years). Systematical calculations of AS medication burden for patients could help acknowledge this issue and raise awareness for prescription habits in primary care.

Comparative effectiveness of antiepileptic drugs in patients with mesial temporal lobe epilepsy with hippocampal sclerosis.

OBJECTIVE: Mesial temporal lobe epilepsy with hippocampal sclerosis (MTLE-HS) is a common epilepsy syndrome that is often poorly controlled by antiepileptic drug (AED) treatment. Comparative AED effectiveness studies in this condition are lacking. We report retention, efficacy, and tolerability in a cohort of patients with MTLE-HS. METHODS: Clinical data were collected from a European database of patients with epilepsy. We estimated retention, 12-month seizure freedom, and adverse drug reaction (ADR) rates for the 10 most commonly used AEDs in patients with MTLE-HS. RESULTS: Seven hundred sixty-seven patients with a total of 3,249 AED trials were included. The highest 12-month retention rates were observed with carbamazepine (85.9%), valproate (85%), and clobazam (79%). Twelve-month seizure freedom rates varied from 1.2% for gabapentin and vigabatrin to 11% for carbamazepine. Response rates were highest for AEDs that were prescribed as initial treatment and lowest for AEDs that were used in a third or higher instance. ADRs were reported in 47.6% of patients, with the highest rates observed with oxcarbazepine (35.7%), topiramate (30.9%), and pregabalin (27.4%), and the lowest rates with clobazam (6.5%), gabapentin (8.9%), and lamotrigine (16.6%). The most commonly reported ADRs were lethargy and drowsiness, dizziness, vertigo and ataxia, and blurred vision and diplopia. SIGNIFICANCE: Our results did not demonstrate any clear advantage of newer versus older AEDs. Our results provide useful insights into AED retention, efficacy, and ADR rates in patients with MTLE-HS.

Differences in VigiBase® reporting of aminoglycoside and capreomycin-suspected ototoxicity during tuberculosis treatment.

PURPOSE: To evaluate the association between the use of streptomycin, amikacin, kanamycin and capreomycin in tuberculosis (TB) treatment and the pharmacovigilance reporting of ototoxicity (deafness or hearing loss, tinnitus and vertigo). Second, to analyze patient demographic and geographic factors that influence the reporting of ototoxicity in TB treatment. METHODS: A case/non-case disproportionality analysis of the VigiBase® individual case safety reports (ICSRs) of patients treated for TB using multidrug regimens that contain either of streptomycin, amikacin, kanamycin or capreomycin. Cases were reports of ototoxicity; non-cases were other adverse drug reactions (ADRs). The unit of analysis was the drug-ADR pair. We calculated reporting odds ratios (RORs) and their 95% confidence intervals (CI). The referent drug was streptomycin. RESULTS: By June 2014, there were 3361 drug-ADR pairs in VigiBase® (1693 ICSRs) where the parenteral administration of the four drugs for TB treatment was suspected of causing the reported ADRs. Deafness, tinnitus and vertigo were reported in 576 drug-ADR pairs (cases), the rest being other ADRs (non-cases). Reporting of deafness was most disproportionately associated with amikacin use (ROR 9.3; 95%CI 3.8-23.0), followed by kanamycin use (ROR 4.3; 95%CI 1.3-14.2). Reporting of vertigo was inversely associated with capreomycin use (ROR 0.1; 95%CI 0.01-0.4). Geographic region affected the reporting of ototoxicity while age and sex did not. CONCLUSION: Spontaneous reporting of deafness cases within VigiBase® was most disproportionately associated with amikacin use, followed by kanamycin. There were regional variations in the global reporting of ototoxicity. These findings should be verified through a follow up study. Copyright © 2016 John Wiley & Sons, Ltd.

Tinnitus: Evaluation of Intratympanic Injection of Combined Lidocaine and Corticosteroids.

BACKGROUND: Tinnitus is an annoying problem and until now there is no consensus on its treatment. AIMS: In this prospective study, we evaluated the effectiveness of intratympanic lidocaine and dexamethasone (ITLD) injections for the management of subjective idiopathic tinnitus (SIT). METHODS: Forty patients with SIT attended the Department of Otorhinolaryngology, Tanta University Hospital, Egypt, between May 2013 and May 2014. The patients were categorized into two groups: group A included 20 patients treated with ITLD injection, and group B included 20 patients treated with intratympanic saline injection as a control. Intratympanic injections were performed four times within 4 weeks in a double-blind manner. At the end of the treatment program, we analyzed the improvement and worsening rates of tinnitus using the following parameters: tinnitus questionnaires, Tinnitus Handicap Index (THI), and loudness matching test. RESULTS: The effectiveness rates of the ITLD group reported in the tinnitus questionnaires, the THI and the loudness matching test were 74.3% in all tests, compared to 26.7, 40.0 and 26.7%, respectively, in the saline group. There was a statistically significant difference between the groups within 2 months after injection. To analyze the therapeutic effect of ITLD on tinnitus of 6 months duration, the improvement rates reported in the tinnitus questionnaires, the THI and the loudness matching test were 78.5% in all tests in the ITLD group, compared to 40.0, 40.0 and 30.0%, respectively, in the saline group. CONCLUSION: There were statistically significant differences between both groups. ITLD seems to be effective for idiopathic tinnitus.

Chemical labyrinthectomy for the worse ear of adult Nigerians with bilateral Meniere's disease: preliminary report of treatment outcomes.

The objective of this study was to assess the effectiveness of variable titration, low-dose intratympanic gentamycin (ITG) into the worse affected ear of patients with bilateral Meniere's disease (MD). It is a prospective analytic case series conducted in a tertiary care referral hospital in a developing economy and a tertiary care otologic private ENT clinic. Patients with MD who failed or are intolerant to medical treatment were recruited based on the criteria of definite MD and bilateral ear involvement. 0.75 cc of low-dose (40 mg/ml) buffered gentamycin was injected into the worse affected ear and patients followed up every 2 months, and the regime repeated only if subjective vertigo persists. The patient's age, sex, duration of MD symptom, ear first affected, ear selected for ITG, pure tone threshold at each visit, duration of caloric response (in seconds) for the injected ear, status of tinnitus in both ipsilateral (injected) and contralateral ears, total number of injections before last follow-up, and time since last follow-up are entered into the study protocol and analyzed. Nine patients with a mean age of 45 years and mean duration of symptoms of 59 months were treated. The mean total number of injections was 2.8 with a mean follow-up period of 34 months. Three cases showed drop in pure tone average threshold (2.5-7.5 dB) while an increase in threshold was noted in six cases (2.5-5 dB). All cases demonstrated decrease in duration of response to iced water caloric stimulation in ipsilateral ear, and 4/9 of contralateral ear. The variable titration method using low-dose intratympanic gentamycin directed at worse ear of adult Nigerians with bilateral Meniere's disease appears to be highly effective. More studies are needed.

[The causes of falls and injuries after falls in women over the age of 50 living alone in Krakow]. / Przyczyny upadków i urazów po upadkach u kobiet powyzej 50 roku zycia zyjacych samodzielnie w Krakowie.

INTRODUCTION: Falls are one of the most devastating health problems of elderly people. The identification of causes of falls helps to establish proper prevention strategies. MATERIAL AND METHOD: The study was based on a group of community-dwelling, independent women aged over 50 years. The frequency of falls was calculated on the basis of a retrospective analysis of 1326 cases. 100 women were chosen for a telephone questionnaire to identify causes and consequences of falls. The average age was 63.9 (SD 8.6) and the average BMI was 27.6 (SD 5.4). RESULTS: Approximately 31% of 1326 women reported at least one fall a year. In the year preceding the questionnaire 62% of the participants reported one fall, 26%--two falls, 8%--three falls and 5%--four and more falls. In the surveyed group of 100 women 72% of falls occurred outdoors, which is 2.5 times more often than at home (28%). 68% of falls occurred between 12 pm and 6 pm. Summer is the season of the highest occurrence of falls (37%). In winter, the frequency of outdoor falls increases, whereas during summer the frequency of falls happening in and outdoors does not differ. The most frequent cause of falls, both in and outdoors, was slipping. Other important risk factors include: hypnotic drugs, walking impairments, balance deficit, vertigo, analgesics. Most of the falls had various intrinsic and extrinsic causes. KEY POINTS: We found that 30% of women aged over 50 years falls at least once a year. Both at home and outside falls resulted from slipping. For almost 80% of falls as a consequence of an injury. The majority of falls had intrinsic and extrinsic origins.

Treatment Modalities for Trigeminal Neuralgia and the Need for Vigilance in Monitoring Adverse Drug Events: A Case Report.

INTRODUCTION: Trigeminal neuralgia is a rare condition characterised by paroxysms of intense pain in the distribution of the trigeminal nerve. This condition significantly diminishes the patient's quality of life, and the side effects from chronic use of medications for symptomatic relief further exacerbate their distress. CASE DESCRIPTION: The case report discusses a patient diagnosed with Trigeminal Neuralgia who commenced carbamazepine treatment. The report tracks the disease's progression, medication adjustments, and the eventual emergence of vertigo due to long-term carbamazepine use. CONCLUSION: The article covers fundamental information about trigeminal neuralgia and its management and also offers a comprehensive review of the basics of vertigo. It delves into carbamazepine's mechanism of action and its associated side effects. The paper also looks at prospective therapy changes that could improve patients' quality of life.

A rare adverse effect of metronidazole: nervous system symptoms.

Metronidazole, as a 5-nitroimidazole compound, is effective on anaerobic bacteria and protozoon diseases. Mostly, metronidazole is a tolerable drug but rarely presents serious adverse effects on the nervous system. In case of these adverse effects, treatment must be stopped.In this report, a 3-year-old child hospitalized because of diarrhea is presented. During the metronidazole treatment, loss of sight, vertigo, ataxia, and headache occurred as the adverse effects. By this report, we want to express the rare adverse effects of drugs in the differential diagnoses of nervous system diseases.