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The International Journal of... Jun 2024The efficacy of ubrogepant 50 mg versus 100 mg daily for migraine remained controversial. We conducted a systematic review and meta-analysis to compare the efficacy... (Meta-Analysis)
Meta-Analysis
The efficacy of ubrogepant 50 mg versus 100 mg daily for migraine remained controversial. We conducted a systematic review and meta-analysis to compare the efficacy and safety of ubrogepant 50 mg versus 100 mg daily on treatment in migraine patients. We have searched PubMed, EMbase, Web of science, EBSCO, Cochrane library databases and SCOPUS through 21 March 2022 for randomized controlled trials (RCTs) assessing the effect of ubrogepant 50 mg versus 100 mg on treatment efficacy in migraine patients. This meta-analysis was performed using the random-effect model. Three RCTs were included in the meta-analysis. Overall, compared with ubrogepant 100 mg in migraine patients, ubrogepant 50 mg obtained comparable pain freedom at 2 h (OR = 0.86; 95% CI = 0.64-1.15; = 0.310), sustained pain freedom 2-24 h (OR = 0.76; 95% CI = 0.54-1.07; = 0.110), photophobia absence at 2 h (OR = 0.80; 95% CI = 0.63-1.02; = 0.070), phonophobia absence at 2 h (OR = 1.07; 95% CI = 0.82-1.40; = 0.620) and nausea absence at 2 h (OR = 1.02; 95% CI = 0.79-1.32; = 0.880). In terms of safety, adverse events were found to be increased in ubrogepant 100 mg as compared to ubrogepant 50 mg (OR = 0.81; 95% CI = 0.67-0.99; = 0.040), and there was no statistical difference of serious adverse events between two groups (OR = 0.87; 95% CI = 0.40-1.91; = 0.720). Ubrogepant 50 mg and 100 mg may be equally effective to alleviate migraine, but ubrogepant 100 mg led to increase incidence of adverse events.
Topics: Humans; Migraine Disorders; Nausea; Pain; Pyridines; Pyrroles; Treatment Outcome
PubMed: 35999672
DOI: 10.1080/00207454.2022.2090351 -
Journal of the American Academy of... Feb 2023Hyperacusis can be defined as an intolerance of certain everyday sounds, which are perceived as too loud or uncomfortable and which cause significant distress and...
BACKGROUND
Hyperacusis can be defined as an intolerance of certain everyday sounds, which are perceived as too loud or uncomfortable and which cause significant distress and impairment in the individual's day-to-day activities. Misophonia is defined as a high magnitude of emotional and behavioral reaction to certain sounds produced by human beings, such as eating sounds and breathing sounds. Several psychometric instruments have been developed to assess symptoms and the impact of hyperacusis and misophonia; however, to the authors' knowledge, no study has evaluated and compared the methodological quality of the studies on psychometric properties of the existing instruments.
PURPOSE
This article systematically reviews the research studies assessing the psychometric properties of the instruments used for hyperacusis and misophonia and assesses the quality and appropriateness of the methodologies used.
RESEARCH DESIGN
Systematic review.
DATA COLLECTION AND ANALYSIS
A systematic literature search was performed using five electronic literature databases (PubMed, Scopus, PsycINFO, Google Scholar, and Web of Science). Studies were included if they were written in English and reported information about the psychometric properties of instruments measuring hyperacusis or misophonia symptoms or their impact. The quality of the studies and that of the psychometric instruments were evaluated using the consensus-based standards for the selection of health-measurement instruments (COSMIN) tool.
RESULTS
The title and abstracts of 916 articles were screened and 39 articles were selected for full-text evaluation, with 14 articles meeting the inclusion criteria. From these 14 articles, 8 different instruments (5 for hyperacusis and 3 for misophonia) were identified and reviewed comprising: (1) Hyperacusis Questionnaire (HQ), (2) Inventory of Hyperacusis Symptoms, (3) questionnaire on hypersensitivity to sound, (4) Hyperacusis Handicap Questionnaire, (5) short HQ, (6) Amsterdam Misophonia Scale, (7) MisoQuest, and (8) the Misophonia Questionnaire.
CONCLUSION
None of the papers reviewed reported all the information required to meet the COSMIN standards. The studies' methodological quality varied between "very good" and "inadequate" depending on their grade on the COSMIN tool. There is a need for further research on the psychometric properties of the instruments included in this review.
PubMed: 35817311
DOI: 10.1055/a-1896-5032 -
International Journal of Environmental... Jun 2022Misophonia is a scarcely known disorder. This systematic review (1) offers a quantitative and qualitative analysis of the literature since 2001, (2) identifies the most... (Review)
Review
Misophonia is a scarcely known disorder. This systematic review (1) offers a quantitative and qualitative analysis of the literature since 2001, (2) identifies the most relevant aspects but also controversies, (3) identifies the theoretical and methodological approaches, and (4) highlights the outstanding advances until May 2022 as well as aspects that remain unknown and deserve future research efforts. Misophonia is characterized by strong physiological, emotional, and behavioral reactions to auditory, visual, and/or kinesthetic stimuli of different nature regardless of their physical characteristics. These misophonic responses include anger, general discomfort, disgust, anxiety, and avoidance and escape behaviors, and decrease the quality of life of the people with the disorder and their relatives. There is no consensus on the diagnostic criteria yet. High comorbidity between misophonia and other psychiatric and auditory disorders is reported. Importantly, the confusion with other disorders contributes to its underdiagnosis. In recent years, assessment systems with good psychometric properties have increased considerably, as have treatment proposals. Although misophonia is not yet included in international classification systems, it is an emerging field of growing scientific and clinical interest.
Topics: Anger; Anxiety Disorders; Emotions; Humans; Hyperacusis; Quality of Life
PubMed: 35682372
DOI: 10.3390/ijerph19116790 -
Otology & Neurotology : Official... Jan 2022To determine outcomes following cochlear implantation (CI) in children with autism spectrum disorder (ASD).
OBJECTIVE
To determine outcomes following cochlear implantation (CI) in children with autism spectrum disorder (ASD).
DATABASES REVIEWED
MEDLINE, Embase, Web of science, Cochrane Library, and Clinicaltrial.gov.
METHODS
The review was performed according to the PRISMA statement. Primary outcomes measures were changes in speech perception and speech production scores. Secondary outcome measures included communication mode, device use, parental recommendation of implant, postoperative hyperacusis, and quality of life measures. Pooled analysis of outcomes was performed if possible.
RESULTS
Twenty-four studies reported on 159 children with ASD. There were improvements in speech perception in 78% of cases and in speech expression in 63% of cases, though the extent of this improvement was variable. Seventy-four percent of children with ASD and CI are nonoral communicators. Intermittent/nonuse rate was 31%. Hearing outcomes are worse compared to children with other disabilities. The vast majority of parents would recommend CI based on their experiences.
CONCLUSION
Outcome in children with ASD and CI are highly variable and significantly poorer compared to non-ASD children. Despite this, most parents report positive experiences and the evidence supports the use of CI in children with ASD.
Topics: Autism Spectrum Disorder; Child; Cochlear Implantation; Cochlear Implants; Humans; Parents; Quality of Life; Speech Perception
PubMed: 34739429
DOI: 10.1097/MAO.0000000000003353 -
Frontiers in Neurology 2021To study the prevalence of hyperacusis in the general population and the special population, and to determine the effect of population differences on hyperacusis. The...
To study the prevalence of hyperacusis in the general population and the special population, and to determine the effect of population differences on hyperacusis. The two authors followed a scoping review methodology and screened nearly 30 years of English literature in Pubmed, Web of Science, OVID, and EBSCO. Then, the extracted results of each study were discussed in groups and subgroups. The authors selected 42 pieces of scientific literature that met the requirements, studying a total of 34,796 subjects, including the general population (28,425 subjects), the special occupation population (2,746 subjects), and the patients with concomitant diseases (5,093 subjects). The prevalence was 0.2-17.2% in the general population, 3.8-67% in the special occupation population, and 4.7-95% in the patients with special diseases. It was found that in the general population, the high prevalence occurs in adolescents and older adults. The prevalence of hyperacusis in women is significantly higher than in men. In people with hearing disorders, the prevalence of hyperacusis is significantly higher than in people with normal hearing. Various diseases (such as Williams syndrome, tinnitus, and autism), as well as various occupations (musicians, music students, teachers, and others), have been found to be high risk factors for hyperacusis. The high prevalence of hyperacusis and the large differences between reported prevalence in different studies deserves our great attention. Additionally, in order to increase the comparability of the studies, a standardized set of criteria are needed to study the prevalence of hyperacusis.
PubMed: 34539554
DOI: 10.3389/fneur.2021.706555 -
Cephalalgia : An International Journal... Nov 2021There are five headache disorders composing the trigeminal autonomic cephalalgias (cluster headache, paroxysmal hemicrania, short-lasting unilateral neuralgiform... (Meta-Analysis)
Meta-Analysis
BACKGROUND AND OBJECTIVE
There are five headache disorders composing the trigeminal autonomic cephalalgias (cluster headache, paroxysmal hemicrania, short-lasting unilateral neuralgiform headache attacks with conjunctival injection and tearing (SUNCT), short-lasting unilateral neuralgiform headache attacks with cranial autonomic symptoms (SUNA), and hemicrania continua). Little is known about these disorders in the pediatric population. The objectives of this study are to report the full age ranges of pediatric trigeminal autonomic cephalalgias and to determine if pediatric-onset trigeminal autonomic cephalalgias display similar signs and symptoms as adult onset.
METHODS
Search criteria in Medline Ovid, Embase, PsycINFO, and Cochrane Library were created by a librarian. The remainder of the steps were independently performed by two neurologists using PRISMA guidelines. Inclusion criteria for titles and abstracts were articles discussing cases of trigeminal autonomic cephalalgias with age of onset 18 or younger, as well as any epidemiological report on trigeminal autonomic cephalalgias (as age of onset data was often found in the results section but not in the title or abstract). Data extracted included age of onset, sex, and International Classification of Headache Disorders criteria for trigeminal autonomic cephalalgias (including pain location, duration, frequency, autonomic features, restlessness) and some migraine criteria (photophobia, phonophobia, and nausea). Studies that did not meet full criteria for trigeminal autonomic cephalalgias were examined separately as "atypical trigeminal autonomic cephalalgias"; secondary headaches were excluded from this category.
RESULTS
In all, 1788 studies were searched, 86 met inclusion criteria, and most (56) examined cluster headache. In cluster headache, onset occurred at every pediatric age (range 1-18 years) with a full range of associated features. Autonomic and restlessness features were less common in pediatric patients, while migrainous features (nausea, photophobia, and phonophobia) were found at similar rates. The sex ratio of pediatric-onset cluster headache (1.8, 79 male and 43 female) may be lower than that of adult-onset cluster headache. Data for other trigeminal autonomic cephalalgias, while more limited, displayed most of the full range of official criteria. The data for atypical trigeminal autonomic cephalalgias were also limited, but the most common deviations from the official criteria were abnormal frequencies and locations of attacks.
CONCLUSIONS
Trigeminal autonomic cephalalgias can start early in life and have similar features to adult-onset trigeminal autonomic cephalalgias. Specifically, pediatric-onset cluster headache patients display the full range of each criterion for cluster headache (except maximum frequency of six instead of eight attacks per day). However, cranial autonomic features and restlessness occur at a lower rate in pediatrics. Additional information is needed for the other trigeminal autonomic cephalalgias. As for expanding the ICHD-3 criteria for pediatric-onset trigeminal autonomic cephalalgias, we have only preliminary data from atypical cases, which suggests that the frequency and location of attacks sometimes extend beyond the official criteria. This study was registered as a systematic review in PROSPERO (registration number CRD42020165256).
Topics: Adolescent; Adult; Child; Child, Preschool; Female; Headache; Headache Disorders; Humans; Infant; Male; Paroxysmal Hemicrania; SUNCT Syndrome; Trigeminal Autonomic Cephalalgias
PubMed: 34407646
DOI: 10.1177/03331024211027560 -
The Canadian Journal of Neurological... Sep 2022Migraine is a common primary headache disorder diagnosed in the emergency department (ED). This systematic review sought to compare the efficacy of sodium valproate (SV)... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Migraine is a common primary headache disorder diagnosed in the emergency department (ED). This systematic review sought to compare the efficacy of sodium valproate (SV) to dopamine antagonists (DA) in relieving pain due to acute migraine.
METHODS
Two research librarians helped create a search strategy including Embase, Ovid Medline, and the Cochrane Database of Clinical Trials from inception to June 1, 2020, updated May 19, 2021. Two investigators identified randomized control trials (RCTs) including adult patients with acute migraine presenting to the ED or acute clinical setting comparing SV to a DA with the aim of relieving pain. Primary outcome was headache relief at 1 hour from treatment. Secondary outcomes included pain relief at 24 hours, relief of associated symptoms (e.g. nausea, photo-/phonophobia, etc.), and need for rescue analgesia. Meta-analysis was performed and presented as odds ratios.
RESULTS
Four RCTs with 470 patients were identified from an initial pool of 454 titles. Two studies compared SV to a DA alone and two compared SV to a DA plus one other agent (sumatriptan or dihydroergotamine). Three studies were included for meta-analysis. Pain relief had a pooled odds ratio of 1.14 at 1 hour and 0.42 at 24 hours. Three articles reporting the need for rescue analgesia had pooled odds ratio of 2.76.
CONCLUSIONS
Sodium valproate is not more effective than DA at reducing migraine headache pain at 1 hour and less effective at 24 hours. Dopamine antagonists should be used over SV for the management of patients with acute migraine.
Topics: Adult; Dopamine Antagonists; Emergency Service, Hospital; Humans; Migraine Disorders; Pain; Valproic Acid
PubMed: 34382533
DOI: 10.1017/cjn.2021.195 -
Headache Feb 2021To review the acute migraine clinical trial literature and provide a summary of the endpoints and outcomes used in such trials.
BACKGROUND/OBJECTIVE
To review the acute migraine clinical trial literature and provide a summary of the endpoints and outcomes used in such trials.
METHOD
A systematic literature review, following a prespecified (but unregistered) protocol developed to adhere to recommendations of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses, was conducted to understand endpoints and outcomes used in acute migraine clinical trials. Predefined terms were searched in PubMed to locate clinical trials assessing acute migraine treatments. Final database search was conducted on October 28, 2019. Identified publications were reviewed against established inclusion and exclusion criteria to determine eligibility. Data related to general trial design characteristics, sample characteristics, and outcomes and endpoints reported in each publication were extracted from eligible publications. Descriptive summaries of design features, sample characteristics, and the endpoints and outcomes employed across publications were constructed. Outcomes are presented within four broad categories: (a) pain-related outcomes (pain relief, pain freedom, etc.), (b) associated symptoms (nausea, photophobia, etc.), (c) disability/impairment/impact, (d) patient-reported outcome measures (PROMs, general health and migraine/headache-specific). Endpoint types were categorized within three broad categories: (a) change from baseline, (b) fixed timepoint, and (c) responder definitions (e.g., 50% reduction). This review focuses on a subset of recent (1998 or later) randomized and blinded publications evaluating drugs or medical devices.
RESULTS
Of 1567 publications found through the initial search and reference section reviews, 705 met criteria and were included for data extraction. Inter-rater agreement kappas for the descriptive variables extracted had an average kappa estimate of 0.86. The more recent, randomized and blinded pharmaceutical and medical device article subset includes 451 publications (451/705, 63.9%). The outcomes and endpoints varied substantially across trials, ranging from pain relief or freedom, freedom from or relief of migraine-associated symptoms, use of acute or rescue medication, and various other PROMs, including measures of satisfaction and quality of life. Within the recent randomized and blinded article subset, most articles examined ≥1 pain-related outcome (430/451, 95.3%). Of the publications that examined pain, outcomes most often used were pain relief (310/430, 72.1%), pain freedom (279/430, 64.9%), and headache recurrence (202/43,051, 47.0%) or rescue medication use (278/430, 64.9%). Associated symptoms such as nausea, photophobia, and phonophobia were more frequently measured (299/451, 66.3%) compared to most bothersome associated symptom (16/451, 3.5%), as it is a new addition to regulatory guidance. Over one-third of eligible publications examined disability/impairment (186/451, 41.2%) or ≥1 PROM (159/451, 35.3%). The definition of the endpoints used (e.g., change from baseline, fixed timepoint comparisons, categorization of "responders" to treatment based on wide variety of "responder definitions") also differed substantially across publications.
CONCLUSION
Acute migraine clinical trials exhibit a large amount of variability in outcomes and endpoints used, in addition to the variability in how outcomes and endpoints were used from trial-to-trial. There were some common elements across trials that align with guidance from the International Headache Society, the Food and Drug Administration and other regulatory agencies (e.g., assessing pain and associated symptoms, 2-hour post-treatment). Other aspects of acute migraine clinical trial design did not follow guidance. For example, multi-item PROMs intended to measure constructs (e.g., scales) are rarely used, the use of pain-related outcomes is inconsistent, some associated symptom assessments are idiosyncratic, and the timing of the assessment of primary endpoints is variable. The development of a core set of outcomes and endpoints for acute migraine clinical trials that are patient-centered and statistically robust could improve the conduct of individual trials, facilitate cross-trial comparisons, and better support informed treatment decisions by healthcare professionals and patients.
Topics: Acute Disease; Clinical Trials as Topic; Humans; Migraine Disorders; Outcome Assessment, Health Care
PubMed: 33611818
DOI: 10.1111/head.14067 -
Ear and Hearing 2021Hyperacusis, defined as decreased tolerance to sound at levels that would not trouble most individuals, is frequently observed in individuals with autism spectrum... (Meta-Analysis)
Meta-Analysis
OBJECTIVES
Hyperacusis, defined as decreased tolerance to sound at levels that would not trouble most individuals, is frequently observed in individuals with autism spectrum disorder (ASD). Despite the functional impairment attributable to hyperacusis, little is known about its prevalence or natural history in the ASD population. The objective of this study was to conduct a systematic review and meta-analysis estimating the current and lifetime prevalence of hyperacusis in children, adolescents, and adults with ASD. By precisely estimating the burden of hyperacusis in the ASD population, the present study aims to enhance recognition of this particular symptom of ASD and highlight the need for additional research into the causes, prevention, and treatment of hyperacusis in persons on the spectrum.
DESIGN
We searched PubMed and ProQuest to identify peer-reviewed articles published in English after January 1993. We additionally performed targeted searches of Google Scholar and the gray literature, including studies published through May 2020. Eligible studies included at least 20 individuals with diagnosed ASD of any age and reported data from which the proportion of ASD individuals with current and/or lifetime hyperacusis could be derived. To account for multiple prevalence estimates derived from the same samples, we utilized three-level Bayesian random-effects meta-analyses to estimate the current and lifetime prevalence of hyperacusis. Bayesian meta-regression was used to assess potential moderators of current hyperacusis prevalence. To reduce heterogeneity due to varying definitions of hyperacusis, we performed a sensitivity analysis on the subset of studies that ascertained hyperacusis status using the Autism Diagnostic Interview-Revised (ADI-R), a structured parent interview.
RESULTS
A total of 7783 nonduplicate articles were screened, of which 67 were included in the review and synthesis. Hyperacusis status was ascertained in multiple ways across studies, with 60 articles employing interviews or questionnaires and seven using behavioral observations or objective measures. The mean (range) age of samples in the included studies was 7.88 years (1.00 to 34.89 years). The meta-analysis of interview/questionnaire measures (k(3) = 103, nASD = 13,093) estimated the current and lifetime prevalence of hyperacusis in ASD to be 41.42% (95% CrI, 37.23 to 45.84%) and 60.58% (50.37 to 69.76%), respectively. A sensitivity analysis restricted to prevalence estimates derived from the ADI-R (k(3) = 25, nASD = 5028) produced similar values. The estimate of current hyperacusis prevalence using objective/observational measures (k(3) = 8, nASD = 488) was 27.30% (14.92 to 46.31%). Heterogeneity in the full sample of interview/questionnaire measures was substantial but not significantly explained by any tested moderator. However, prevalence increased sharply with increasing age in studies using the ADI-R (BF10 = 93.10, R2Het = 0.692).
CONCLUSIONS
In this meta-analysis, we found a high prevalence of current and lifetime hyperacusis in individuals with ASD, with a majority of individuals on the autism spectrum experiencing hyperacusis at some point in their lives. The high prevalence of hyperacusis in individuals with ASD across the lifespan highlights the need for further research on sound tolerance in this population and the development of services and/or interventions to reduce the burden of this common symptom.
Topics: Adolescent; Adult; Autism Spectrum Disorder; Bayes Theorem; Child; Humans; Hyperacusis; Parents; Prevalence
PubMed: 33577214
DOI: 10.1097/AUD.0000000000001005 -
Advances in Therapy Dec 2020Use of triptans for acute treatment of migraine is associated with insufficient efficacy and/or tolerability in approximately 30-40% of people. We conducted a systematic...
INTRODUCTION
Use of triptans for acute treatment of migraine is associated with insufficient efficacy and/or tolerability in approximately 30-40% of people. We conducted a systematic literature review (SLR) to synthesize definitions, terminology, subsequent treatment outcomes, and characteristics associated with this subpopulation.
METHODS
A comprehensive SLR was conducted to identify studies, published from Jan 1995 to May 2019, which focused on insufficient efficacy and/or tolerability to triptans.
RESULTS
Thirty-five publications were identified, of which 22 described randomized controlled trials and open-label studies, and 13 described observational studies. Across studies, multiple objectives and a high amount of variability in methodologies and outcomes were noted. The most commonly applied measures of efficacy were headache pain freedom and pain relief at 2 h. Ten studies assessed efficacy of switching or optimizing treatment in patients with historical insufficient efficacy or tolerability to previous triptan treatment and demonstrated varying levels of success. Factors associated with increased risk of triptan insufficient efficacy included severe baseline headache severity, photophobia, phonophobia, nausea, and depression.
CONCLUSIONS
Irrespective of the methodology or definition used to identify people with insufficient efficacy and/or tolerability to triptans, study results support the assertion that a high unmet need remains for effective acute treatment of migraine.
Topics: Administration, Oral; Adult; Female; Humans; Male; Middle Aged; Migraine Disorders; Nausea; Pain Management; Randomized Controlled Trials as Topic; Serotonin Receptor Agonists; Severity of Illness Index; Treatment Outcome; Tryptamines
PubMed: 32990921
DOI: 10.1007/s12325-020-01494-9