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CNS Drugs May 2020Ubrogepant is a small molecular calcitonin gene-related peptide receptor antagonist that is used for the acute treatment of migraine. (Meta-Analysis)
Meta-Analysis
BACKGROUND
Ubrogepant is a small molecular calcitonin gene-related peptide receptor antagonist that is used for the acute treatment of migraine.
OBJECTIVE
The aim was to conduct a meta-analysis to systematically evaluate the efficacy and safety of ubrogepant for the treatment of episodic migraine compared with placebo in the adult population.
METHODS
We systematically searched PubMed, EMBASE, and the Cochrane Library Central Register of Controlled Trials for relevant randomized clinical trials, from the earliest available date to November 10, 2019, to evaluate the efficacy and safety of short-term ubrogepant use. Inclusion criteria were (1) randomized clinical trial; (2) enrolled adult participants diagnosed with episodic migraine; (3) compared ubrogepant with placebo at doses that were evaluated in phase III clinical trials; (4) enrolled more than 100 patients in each group; and (5) provided any information on primary or secondary outcomes. Trials were excluded if their participants were diagnosed with chronic migraine.
RESULTS
A total of three multicenter, randomized clinical trials with 3326 patients were included. Ubrogepant use was associated with a significantly higher percentage of patients with pain freedom (ubrogepant 20.8%; placebo 12.6%; relative risk [RR] 1.65, 95% confidence interval [CI] 1.38-1.98) and absence of the most bothersome migraine-associated symptoms (ubrogepant 37.3%; placebo 27.6%; RR 1.35, 95% CI 1.20-1.53) at 2 h post-dose compared with placebo. Ubrogepant increased the rate of absence of migraine-associated symptoms at 2 h post-dose compared with placebo (photophobia: RR 1.30 [95% CI 1.18-1.44], I = 49%; phonophobia: RR 1.20 [95% CI 1.11-1.29]; nausea: RR 1.07 [95% CI 1.02-1.13]), and patients were more likely to function normally at 2 h post-dose compared with placebo (RR 1.30 [95% CI 1.16-1.45]). No significant difference was found for treatment-related adverse events within 48 h or 30 days for ubrogepant compared with placebo (48 h: RR 1.07 [95% CI 0.85-1.35]; 30 days: RR 1.03 [95% CI 0.79-1.34]). Subgroup analysis demonstrated that compared to placebo, ubrogepant led to greater rates of freedom from pain at 2 h with 25-mg, 50-mg, and 100-mg doses and absence of the most bothersome symptoms with 50-mg and 100-mg doses.
CONCLUSIONS
The use of ubrogepant as an acute treatment of episodic migraine in adults led to a greater percentage of freedom from pain and absence of the most bothersome symptoms at 2 h post-dose. Short-term use of ubrogepant was not related to an increased risk for adverse events. Further studies are needed to evaluate efficacy and safety for long-term use and in specific subgroups of patients.
Topics: Adult; Calcitonin Gene-Related Peptide Receptor Antagonists; Humans; Migraine Disorders; Pyridines; Pyrroles; Randomized Controlled Trials as Topic
PubMed: 32193827
DOI: 10.1007/s40263-020-00715-7 -
CoDAS 2020this paper aims to identify the most used terminologies to designate the disproportional behavior to sounds in the autism spectrum disorder (ASD) and its relationship...
PURPOSE
this paper aims to identify the most used terminologies to designate the disproportional behavior to sounds in the autism spectrum disorder (ASD) and its relationship with the respective tools for its investigation, as well as its occurrence and outcomes.
RESEARCH STRATEGIES
the databases used were PubMed, PsycINFO, Web of Science, Scielo and Lilacs. The keywords used were "autism", "hyperacusis" and "auditory perception", with the following combinations: "autism AND hyperacusis" and "autism AND auditory perception".
SELECTION CRITERIA
individuals diagnosed with ASD of any age group; available abstract; papers in English, Spanish and Brazilian Portuguese; case series, prevalence and incidence studies, cohort and clinical trials.
DATA ANALYSIS
we analyzed studies with individuals diagnosed with ASD of any age group; reference in the title and/or summary of the occurrence of disproportional behavior to sounds, accepting the terms hyper-responsiveness, hypersensitivity and hyperacusis; summary available; papers in English, Spanish and Brazilian Portuguese; series of cases, prevalence and incidence studies, cohort and clinical trials.
RESULTS
Of the 692 studies resulting from the consultation, 13 studies could achieve the established requirements.
CONCLUSION
The term auditory hypersensitivity was the most commonly used to designate disproportional behavior to sounds, followed by hyperacusis. There was no relationship between the terms and the respective research tool, and the questionnaires were the most used to designate the referred behavior, whose reported frequency was from 42.1% to 69.0%. The auditory behavior tests when performed showed the involvement of the auditory, afferent and efferent neural pathways.
Topics: Autism Spectrum Disorder; Humans; Hyperacusis; Reflex, Acoustic; Terminology as Topic
PubMed: 31994595
DOI: 10.1590/2317-1782/20192018287 -
Headache Sep 2019To provide evidence-based recommendations for the acute symptomatic treatment of children and adolescents with migraine.
Practice guideline update summary: Acute treatment of migraine in children and adolescents: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology and the American Headache Society.
OBJECTIVE
To provide evidence-based recommendations for the acute symptomatic treatment of children and adolescents with migraine.
METHODS
We performed a systematic review of the literature and rated risk of bias of included studies according to the American Academy of Neurology classification of evidence criteria. A multidisciplinary panel developed practice recommendations, integrating findings from the systematic review and following an Institute of Medicine-compliant process to ensure transparency and patient engagement. Recommendations were supported by structured rationales, integrating evidence from the systematic review, related evidence, principles of care, and inferences from evidence.
RESULTS
There is evidence to support the efficacy of the use of ibuprofen, acetaminophen (in children and adolescents), and triptans (mainly in adolescents) for the relief of migraine pain, although confidence in the evidence varies between agents. There is high confidence that adolescents receiving oral sumatriptan/naproxen and zolmitriptan nasal spray are more likely to be headache free at 2 hours than those receiving placebo. No acute treatments were effective for migraine-related nausea or vomiting; some triptans were effective for migraine-related phonophobia and photophobia.
RECOMMENDATIONS
Recommendations for the treatment of acute migraine in children and adolescents focus on the importance of early treatment, choosing the route of administration best suited to the characteristics of the individual migraine attack, and providing counselling on lifestyle factors that can exacerbate migraine, including trigger avoidance and medication overuse.
Topics: Adolescent; Analgesics; Child; Evidence-Based Medicine; Female; Humans; Male; Migraine Disorders; Pain Management
PubMed: 31529481
DOI: 10.1111/head.13628 -
JPRAS Open Jun 2019Migraine is a global phenomenon, affecting more than 10% of the world's population. It is characterized by unilateral headache that may be accompanied by vomiting,... (Review)
Review
AIMS
Migraine is a global phenomenon, affecting more than 10% of the world's population. It is characterized by unilateral headache that may be accompanied by vomiting, nausea, photophobia and phonophobia. Some patients with chronic migraine respond to extra-cranial botulinum toxin type A injection, although the benefits observed are temporary. The rationale for surgical trigger site deactivation is to achieve lasting symptomatic improvement or permanent relief from migraine.
METHODS
We performed a PRISMA-compliant systematic review of clinical studies evaluating surgical intervention for migraine by searching Ovid MEDLINE and EMBASE databases from inception to June 2017. Studies were independently screened by two authors. Data were extracted on study characteristics, migraine outcomes, adverse events and recurrence. The quality of evidence was assessed using the GRADE approach. The review protocol was prospectively registered on the PROSPERO database (CRD42017068577).
RESULTS
The search strategy identified 789 articles; of them, 18 studies (4 RCTs and 14 case series) were eligible for analysis. Surgical interventions were heterogeneous and variably involved peripheral nerve decompression by myectomy or foraminotomy, nerve excision, artery resection and/or nasal surgery. All studies reported significant reductions in migraine intensity, frequency, duration and composite headache scores following surgery. Study heterogeneity precluded formal meta-analysis. Where reported, adverse event rates varied markedly between studies. The quality of included studies was consistently low or very low.
CONCLUSION
There is insufficient evidence to support the effectiveness of any specific surgical intervention for chronic migraine, especially with regard to permanent relief; however, all included studies report improvements in key outcomes following migraine surgery. A definitive, well-powered RCT with objective surgical and patient-reported outcome measures and robust adverse event reporting is required.
PubMed: 32158867
DOI: 10.1016/j.jpra.2019.01.002 -
The Cochrane Database of Systematic... Dec 2018Tinnitus affects 10% to 15% of the adult population, with about 20% of these experiencing symptoms that negatively affect quality of life. In England alone there are an... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Tinnitus affects 10% to 15% of the adult population, with about 20% of these experiencing symptoms that negatively affect quality of life. In England alone there are an estimated ¾ million general practice consultations every year where the primary complaint is tinnitus, equating to a major burden on healthcare services. Clinical management strategies include education and advice, relaxation therapy, tinnitus retraining therapy (TRT), cognitive behavioural therapy (CBT), sound enrichment using ear-level sound generators or hearing aids, and drug therapies to manage co-morbid symptoms such as insomnia, anxiety or depression. Hearing aids, sound generators and combination devices (amplification and sound generation within one device) are a component of many tinnitus management programmes and together with information and advice are a first line of management in audiology departments for someone who has tinnitus.
OBJECTIVES
To assess the effects of sound therapy (using amplification devices and/or sound generators) for tinnitus in adults.
SEARCH METHODS
The Cochrane ENT Information Specialist searched the Cochrane ENT Register; Central Register of Controlled Trials (CENTRAL, via the Cochrane Register of Studies); Ovid MEDLINE; Ovid Embase; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 23 July 2018.
SELECTION CRITERIA
Randomised controlled trials (RCTs) recruiting adults with acute or chronic subjective idiopathic tinnitus. We included studies where the intervention involved hearing aids, sound generators or combination hearing aids and compared them to waiting list control, placebo or education/information only with no device. We also included studies comparing hearing aids to sound generators, combination hearing aids to hearing aids, and combination hearing aids to sound generators.
DATA COLLECTION AND ANALYSIS
We used the standard methodological procedures expected by Cochrane. Our primary outcomes were tinnitus symptom severity as measured as a global score on multi-item tinnitus questionnaire and significant adverse effects as indicated by an increase in self-reported tinnitus loudness. Our secondary outcomes were depressive symptoms, symptoms of generalised anxiety, health-related quality of life and adverse effects associated with wearing the device such as pain, discomfort, tenderness or skin irritation, or ear infections. We used GRADE to assess the quality of evidence for each outcome; this is indicated in italics.
MAIN RESULTS
This review included eight studies (with a total of 590 participants). Seven studies investigated the effects of hearing aids, four combination hearing aids and three sound generators. Seven studies were parallel-group RCTs and one had a cross-over design. In general, risk of bias was unclear due to lack of detail about sequence generation and allocation concealment. There was also little or no use of blinding.No data for our outcomes were available for any of our three main comparisons (comparing hearing aids, sound generators and combination devices with a waiting list control group, placebo or education/information only). Data for our additional comparisons (comparing these devices with each other) were also few, with limited potential for data pooling.Hearing aid only versus sound generator device onlyOne study compared patients fitted with sound generators versus those fitted with hearing aids and found no difference between them in their effects on our primary outcome, tinnitus symptom severity measured with the Tinnitus Handicap Inventory (THI) at 3, 6 or 12 months (low-quality evidence). The use of both types of device was associated with a clinically significant reduction in tinnitus symptom severity.Combination hearing aid versus hearing aid onlyThree studies compared combination hearing aids with hearing aids and measured tinnitus symptom severity using the THI or Tinnitus Functional Index. When we pooled the data we found no difference between them (standardised mean difference -0.15, 95% confidence interval -0.52 to 0.22; three studies; 114 participants) (low-quality evidence). The use of both types of device was again associated with a clinically significant reduction in tinnitus symptom severity.Adverse effects were not assessed in any of the included studies.None of the studies measured the secondary outcomes of depressive symptoms or depression, anxiety symptoms or generalised anxiety, or health-related quality of life as measured by a validated instrument, nor the newly developed core outcomes tinnitus intrusiveness, ability to ignore, concentration, quality of sleep and sense of control.
AUTHORS' CONCLUSIONS
There is no evidence to support the superiority of sound therapy for tinnitus over waiting list control, placebo or education/information with no device. There is insufficient evidence to support the superiority or inferiority of any of the sound therapy options (hearing aid, sound generator or combination hearing aid) over each other. The quality of evidence for the reported outcomes, assessed using GRADE, was low. Using a combination device, hearing aid or sound generator might result in little or no difference in tinnitus symptom severity.Future research into the effectiveness of sound therapy in patients with tinnitus should use rigorous methodology. Randomisation and blinding should be of the highest quality, given the subjective nature of tinnitus and the strong likelihood of a placebo response. The CONSORT statement should be used in the design and reporting of future studies. We also recommend the use of validated, patient-centred outcome measures for research in the field of tinnitus.
Topics: Acoustic Stimulation; Adult; Hearing Aids; Humans; Randomized Controlled Trials as Topic; Sound; Tinnitus
PubMed: 30589445
DOI: 10.1002/14651858.CD013094.pub2 -
International Journal of Environmental... Sep 2018Professional musicians (PMs) are at high risk of developing hearing loss (HL) and other audiological symptoms such as tinnitus, hyperacusis, and diplacusis. The aim of...
Professional musicians (PMs) are at high risk of developing hearing loss (HL) and other audiological symptoms such as tinnitus, hyperacusis, and diplacusis. The aim of this systematic review is to (A) assess the risk of developing HL and audiological symptoms in PMs and (B) evaluate if different music genres (Pop/Rock Music-PR; Classical Music-CL) expose PMs to different levels of risk of developing such conditions. Forty-one articles including 4618 PMs were included in the study. HL was found in 38.6% PMs; prevalence was significantly higher among PR (63.5%) than CL (32.8%) PMs; HL mainly affected the high frequencies in the 3000-6000 Hz range and was symmetric in 68% PR PMs and in 44.5% CL PMs. Tinnitus was the most common audiological symptom, followed by hyperacusis and diplacusis. Tinnitus was almost equally distributed between PR and CL PMs; diplacusis was more common in CL than in PR PMs, while prevalence of hyperacusis was higher among PR PMs. Our review showed that PR musicians have a higher risk of developing HL compared to CL PMs; exposure to sounds of high frequency and intensity and absence of ear protection may justify these results. Difference in HL symmetry could be explained by the type of instruments used and consequent single-sided exposure.
Topics: Hearing Disorders; Hearing Loss, Noise-Induced; Humans; Hyperacusis; Music; Occupational Diseases; Prevalence; Risk Factors; Sound; Tinnitus
PubMed: 30261653
DOI: 10.3390/ijerph15102120 -
Cephalalgia : An International Journal... Jun 2018Objective To systematically review the association between migraine and rosacea. Background Migraine is a complex disorder with episodes of headache, nausea, photo- and... (Meta-Analysis)
Meta-Analysis
Objective To systematically review the association between migraine and rosacea. Background Migraine is a complex disorder with episodes of headache, nausea, photo- and phonophobia. Rosacea is an inflammatory skin condition with flushing, erythema, telangiectasia, papules, and pustules. Both are chronic disorders with exacerbations of symptoms almost exclusively in areas innervated by the trigeminal nerve. Previous studies found an association between these disorders. We review these findings, provide a meta-analysis, and discuss possible pathophysiological commonalities. Methods A search through PubMed and EMBASE was undertaken for studies investigating the association between all forms of migraine and rosacea published until November 2016, and meta-analysis of eligible studies. Results Nine studies on eight populations were identified. Studies differed in methodology and diagnostic process, but all investigated co-occurrence of migraine and rosacea. Four studies were eligible for meta-analysis, resulting in a pooled odds ratio of 1.96 (95% confidence interval 1.41-2.72) for migraine in a rosacea population compared to a non-rosacea population. Conclusion Our meta-analysis confirmed an association in occurrence of migraine and rosacea. Future studies should specifically investigate possible shared pathophysiological mechanisms between the two disorders.
Topics: Humans; Migraine Disorders; Rosacea
PubMed: 28920449
DOI: 10.1177/0333102417731777 -
Cephalalgia : An International Journal... Sep 2017Introduction Migraine headache is a neurological disorder whose attacks are associated with nausea, vomiting, photophobia and phonophobia. Treatments for migraine aim to... (Comparative Study)
Comparative Study Meta-Analysis Review
Introduction Migraine headache is a neurological disorder whose attacks are associated with nausea, vomiting, photophobia and phonophobia. Treatments for migraine aim to either prevent attacks before they have started or relieve attacks (abort) after onset of symptoms and range from complementary therapies to pharmacological interventions. A number of treatment-related adverse events such as somnolence, fatigue, and chest discomfort have previously been reported in association with triptans. The comparative tolerability of available agents for the abortive treatment of migraine attacks has not yet been systematically reviewed and quantified. Methods We performed a systematic literature review and Bayesian network meta-analysis for comparative tolerability of treatments for migraine. The literature search targeted all randomized controlled trials evaluating oral abortive treatments for acute migraine over a range of available doses in adults. The primary outcomes of interest were any adverse event, treatment-related adverse events, and serious adverse events. Secondary outcomes were fatigue, dizziness, chest discomfort, somnolence, nausea, and vomiting. Results Our search yielded 141 trials covering 15 distinct treatments. Of the triptans, sumatriptan, eletriptan, rizatriptan, zolmitriptan, and the combination treatment of sumatriptan and naproxen were associated with a statistically significant increase in odds of any adverse event or a treatment-related adverse event occurring compared with placebo. Of the non-triptans, only acetaminophen was associated with a statistically significant increase in odds of an adverse event occurring when compared with placebo. Overall, triptans were not associated with increased odds of serious adverse events occurring and the same was the case for non-triptans. For the secondary outcomes, with the exception of vomiting, all triptans except for almotriptan and frovatriptan were significantly associated with increased risk for all outcomes. Almotriptan was significantly associated with an increased risk of vomiting, whereas all other triptans yielded non-significant lower odds compared with placebo. Generally, the non-triptans were not associated with decreased tolerability for the secondary outcomes. Discussion In summary, triptans were associated with higher odds of any adverse event or a treatment-related adverse event occurring when compared to placebo and non-triptans. Non-significant results for non-triptans indicate that these treatments are comparable with one another and placebo regarding tolerability outcomes.
Topics: Acute Disease; Anti-Inflammatory Agents, Non-Steroidal; Clinical Trials as Topic; Drug Therapy, Combination; Humans; Migraine Disorders; Naproxen; Sumatriptan; Treatment Outcome; Tryptamines
PubMed: 27521843
DOI: 10.1177/0333102416660552 -
BMJ Open Jun 2016To systematically review studies of the epidemiology of tinnitus and hyperacusis in children and young people, in order to determine the methodological differences... (Review)
Review
OBJECTIVES
To systematically review studies of the epidemiology of tinnitus and hyperacusis in children and young people, in order to determine the methodological differences implicated in the variability of prevalence estimates and the influence of population characteristics on childhood tinnitus and hyperacusis.
DATA SOURCES
Articles were retrieved from PubMed, EMBASE and Scopus databases and from the relevant reference lists using the methods described in the study protocol, which has previously been published. Reporting Items for Systematic Review (PRISMA) guidelines were followed.
ELIGIBILITY CRITERIA
Studies addressing childhood prevalence, for example, children and young people aged 5-19 years.
DATA SELECTION
2 reviewers independently assessed the studies for eligibility, extracted data and assessed study consistency. Owing to the heterogeneity in the methodologies among the reported studies, only narrative synthesis of the results was carried out.
RESULTS
Having identified 1032 publications, 131 articles were selected and 25 articles met the inclusion criteria and had sufficient methodological consistency to be included. Prevalence estimates of tinnitus range from 4.7% to 46% in the general paediatric population and among children with normal hearing, and from 23.5% to 62.2% of population of children with hearing loss. Reported prevalence ranged from 6% to 41.9% when children with hearing loss and normal hearing were both included. The prevalence of hyperacusis varied from 3.2% to 17.1%.
CONCLUSIONS
Data on prevalence vary considerably according to the study design, study population and the research question posed. The age range of children studied was varied and a marked degree of variation between definitions (tinnitus, hyperacusis) and measures (severity, perception, annoyance) was observed. The lack of consistency among studies indicates the necessity of examining the epidemiology of tinnitus and hyperacusis in children and adolescents with a set of standardised criteria.
TRIAL REGISTRATION NUMBER
CRD42014013456.
Topics: Adaptation, Psychological; Adolescent; Child; Comorbidity; Female; Humans; Hyperacusis; Male; Prevalence; Referral and Consultation; Research Design; Tinnitus
PubMed: 27259524
DOI: 10.1136/bmjopen-2015-010596 -
Cephalalgia : An International Journal... Sep 2015The objective of this review is to describe auditory hallucinations (paracusias) associated with migraine attacks to yield insights into their clinical significance and... (Review)
Review
OBJECTIVE
The objective of this review is to describe auditory hallucinations (paracusias) associated with migraine attacks to yield insights into their clinical significance and pathogenesis.
BACKGROUND
Isolated observations have documented rare associations of migraine with auditory hallucinations. Unlike visual, somatosensory, language, motor, and brainstem symptoms, paracusias with acute headache attacks are not a recognized aura symptom by the International Headache Society, and no systematic review has addressed this association.
METHODS
We retrospectively studied patients experiencing paracusias associated with migraine at our center and in the literature.
RESULTS
We encountered 12 patients (our center = 5, literature = 7), 58% were female, and 75% had typical migraine aura. Hallucinations most commonly featured voices (58%), 75% experienced them during headache, and the duration was most often <1 hour (67%). No patients described visual aura evolving to paracusias. Most patients (50%) had either a current or previous psychiatric disorder, most commonly depression (67%). The course of headache and paracusias were universally congruent, including improvement with headache prophylaxis (58%).
CONCLUSION
Paracusias uncommonly co-occur with migraine and usually feature human voices. Their timing and high prevalence in patients with depression may suggest that paracusias are not necessarily a form of migraine aura, though could be a migraine trait symptom. Alternative mechanisms include perfusion changes in primary auditory cortex, serotonin-related ictal perceptual changes, or a release phenomenon in the setting of phonophobia with avoidance of a noisy environment.
Topics: Adolescent; Adult; Female; Hallucinations; Humans; Male; Middle Aged; Migraine Disorders; Migraine with Aura; Retrospective Studies; Young Adult
PubMed: 25480808
DOI: 10.1177/0333102414563088