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The Journal of Headache and Pain Sep 2023Intranasal agents may be ideal for the treatment of migraine patients. Many new acute intranasal-specific therapies have been developed, but few of them have been... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Intranasal agents may be ideal for the treatment of migraine patients. Many new acute intranasal-specific therapies have been developed, but few of them have been directly compared. The aim of this network meta-analysis (NMA) was to compare the efficacy and safety of various intranasal agents for the treatment of acute migraine in adult patients.
METHODS
The Cochrane Register of Controlled Trials, Embase, and PubMed were searched from inception to 15 August 2023. Randomized controlled trials (RCTs) using intranasal agents (no restrictions on dose, formulation, dosing regimen or timing of the first dose) to treat adult patients with acute migraine were included. The primary efficacy endpoint was pain freedom at 2 h, and the primary safety endpoint was adverse events (AEs). The analysis process followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines.
RESULTS
Nineteen studies (21 RCTs, 9738 participants) were included. Compared to the placebo, 5 mg of zolmitriptan using a conventional liquid nasal spray device was the most effective for pain freedom at 2 h [odds ratio (OR): 4.67, 95% confidence interval (CI): 3.43 to 6.43] and 24 h (OR: 5.49, 95% CI: 3.58 to 8.42) among all the interventions. Butorphanol nasal spray 1 mg was the most effective (OR: 8.62, 95% CI: 1.11 to 66.92) for pain freedom at 1 h, but with low-quality evidence. DFN-02 presented the highest freedom from nausea (OR: 4.95, 95% CI: 1.29 to 19.01) and phonophobia (OR: 5.36, 95% CI: 1.67 to 17.22) at 2 h, albeit with lower odds of achieving complete pain freedom. ROX-828 showed the highest improvement in freedom from photophobia at 2 h (OR: 4.03, 95% CI: 1.66 to 9.81). Dihydroergotamine nasal spray was significantly associated with the highest risk of AEs (OR: 9.65, 95% CI: 4.39 to 21.22) and was not recommended for routine use. Zavegepant nasal spray demonstrated the lowest risk of AEs (OR: 2.04, 95% CI: 1.37 to 3.03). The results of sensitivity analyses for the primary endpoints (pain freedom at 2 h and AEs) were generally consistent with those of the base case model.
CONCLUSIONS
Compared with other new intranasal-specific therapies in treating migraine attacks, zolmitriptan nasal spray 5 mg was the most effective agent for pain freedom at 2 h. Zavegepant nasal spray 10 mg had the fewest adverse side effects.
Topics: Adult; Humans; Nasal Sprays; Network Meta-Analysis; Migraine Disorders; Oxazolidinones
PubMed: 37723470
DOI: 10.1186/s10194-023-01662-6 -
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 -
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 -
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 -
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 -
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 -
International Journal of Pediatric... Jan 2014To systematically review the literature describing the relationship between autism spectrum disorder (ASD) and peripheral hearing loss including literature... (Review)
Review
OBJECTIVE
To systematically review the literature describing the relationship between autism spectrum disorder (ASD) and peripheral hearing loss including literature recommendations for audiological assessment and auditory habilitation in cases where peripheral hearing loss and ASD coexist.
DATA SOURCES
Published studies indexed in MEDLINE (1948-2011).
REVIEW METHODS
The search strategy identified 595 potential studies. After a review of the titles, 115 abstracts were reviewed and 39 articles were retrieved and assessed independently by at least two authors for possible inclusion. 22 articles pertained to children with ASD and peripheral hearing loss, hearing assessment in children with ASD, audiological habilitation for children with ASD or hyper-responsiveness in children with ASD. 17 further studies were garnered from the reference section of the 22 papers.
RESULTS
Controversy exists in the literature regarding prevalence of hearing impairment among individuals with ASD. In cases where ASD and hearing impairment co-exist, diagnosis of one condition often leads to a delay in diagnosing the other. Audiological assessment can be difficult in children with ASD and test-retest reliability of behavioural thresholds can be poor. In cases where hearing impairment exists and hearing aids or cochlear implantation are recommended, devices are often fit with special considerations for the child with ASD. Hyper-responsiveness to auditory stimuli may be displayed by individuals with ASD. Evidence or the suspicion of hyper-responsiveness may be taken into consideration when fitting amplification and planning behavioural intervention.
CONCLUSIONS
Prevalence rates of hearing impairment among individuals with ASD continue to be debated. At present there is no conclusive evidence that children with ASD are at increased risk of peripheral hearing loss. A complete audiological assessment is recommended in all cases where ASD is suspected so as not to delay the diagnosis of hearing impairment in the event that hearing loss and ASD co-exist. Objective assessment measures should be used to confirm behavioural testing in order to ensure reliability of audiological test results. Fitting of hearing aids or cochlear implantation are not contraindicated when hearing loss is present in children with ASD; however, success with these devices can be variable.
Topics: Autistic Disorder; Cochlear Implantation; Hearing Aids; Hearing Loss; Hearing Tests; Humans; Prevalence
PubMed: 24300947
DOI: 10.1016/j.ijporl.2013.10.063 -
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 -
Journal of Psychosomatic Research May 2023Tinnitus is a multifactorial symptom, which shows similarities with the involved mechanisms in chronic pain. The aim of this systematic review is to provide an overview... (Review)
Review
OBJECTIVE
Tinnitus is a multifactorial symptom, which shows similarities with the involved mechanisms in chronic pain. The aim of this systematic review is to provide an overview of studies comparing patients with only tinnitus to patients with pain (headache, temporomandibular joint (TMJ) pain or neck pain) with or without tinnitus, regarding tinnitus-related, pain-related, psychosocial and cognitive factors.
METHODS
This systematic review was written following the PRISMA guidelines. To identify relevant articles, PubMed, Web of Science and Embase databases were searched. The risk of bias was rated using the Newcastle Ottawa scale for case-control studies.
RESULTS
Ten articles were included in the qualitative analysis. The risk of bias ranged from low to moderate. Low to moderate evidence shows that patients with tinnitus experience higher mean symptom intensity, but lower psychosocial and cognitive distress, compared to patients with pain. Inconsistent results were found for tinnitus-related factors. Low to moderate evidence points to a higher severity of hyperacusis and psychosocial distress in patients with both pain and tinnitus, compared to patients with tinnitus only, as well as for positive associations between tinnitus-related factors and the presence or intensity of pain.
CONCLUSION
This systematic review shows that psychosocial dysfunctions are more clearly present in patients with pain only, compared to patients with tinnitus only and the co-occurrence of tinnitus and pain increases psychosocial distress as well as hyperacusis severity. Some positive associations were identified between tinnitus-related and pain-related factors.
Topics: Humans; Tinnitus; Hyperacusis; Headache; Neck Pain; Cognition
PubMed: 36863293
DOI: 10.1016/j.jpsychores.2023.111201 -
The Cochrane Database of Systematic... Nov 2022Tinnitus is a symptom defined as the perception of sound in the absence of an external source. In England alone there are an estimated ¾ million general practice... (Review)
Review
BACKGROUND
Tinnitus is a symptom defined as the perception of sound in the absence of an external source. 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. OBJECTIVES: To assess the effects of Ginkgo biloba for tinnitus in adults and children.
SEARCH METHODS
The Cochrane ENT Information Specialist searched the Cochrane ENT Register; CENTRAL (2022, Issue 6); 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 7 June 2022.
SELECTION CRITERIA
Randomised controlled trials (RCTs) recruiting adults and children with acute or chronic subjective tinnitus. We included studies where the intervention involved Ginkgo biloba and this was compared to placebo, no intervention, or education and information. Concurrent use of other medication or other treatment was acceptable if used equally in each group. Where an additional intervention was used equally in both groups, we analysed this as a separate comparison. The review included all courses of Ginkgo biloba, regardless of dose regimens or formulations, and for any duration of treatment.
DATA COLLECTION AND ANALYSIS
We used standard Cochrane methods. Our primary outcomes were tinnitus symptom severity measured as a global score on a multi-item tinnitus questionnaire and serious adverse effects (bleeding, seizures). Our secondary outcomes were tinnitus loudness (change in subjective perception), tinnitus intrusiveness, generalised depression, generalised anxiety, health-related quality of life and other adverse effects (gastrointestinal upset, headache, allergic reaction). We used GRADE to assess the certainty of the evidence for each outcome.
MAIN RESULTS
This review included 12 studies (with a total of 1915 participants). Eleven studies compared the effects of Ginkgo biloba with placebo and one study compared the effects of Ginkgo biloba with hearing aids to hearing aids alone. All included studies were parallel-group RCTs. In general, risk of bias was high or unclear due to selection bias and poor reporting of allocation concealment and blinding of participants, personnel and outcome assessments. Due to heterogeneity in the outcomes measured and measurement methods used, only limited data pooling was possible. Ginkgo biloba versus placebo When we pooled data from two studies for the primary outcome tinnitus symptom severity, we found that Ginkgo biloba may have little to no effect (Tinnitus Handicap Inventory scores) at three to six months compared to placebo, but the evidence is very uncertain (mean difference (MD) -1.35 (scale 0 to 100), 95% confidence interval (CI) -8.26 to 5.55; 2 studies; 85 participants) (very low-certainty). Ginkgo biloba may result in little to no difference in the risk of bleeding or seizures, with no serious adverse effects reported in either group (4 studies; 1154 participants; low-certainty). For the secondary outcomes, one study found that there may be little to no difference between the effects of Ginkgo biloba and placebo on tinnitus loudness measured with audiometric loudness matching at 12 weeks, but the evidence is very uncertain (MD -4.00 (scale -10 to 140 dB), 95% CI -13.33 to 5.33; 1 study; 73 participants) (very low-certainty). One study found that there may be little to no difference between the effects of Ginkgo biloba and placebo on health-related quality of life measured with the Glasgow Health Status Inventory at three months (MD -0.58 (scale 0 to 100), 95% CI -4.67 to 3.51; 1 study; 60 participants) (low-certainty). Ginkgo biloba may not increase the frequency of other adverse effects (gastrointestinal upset, headache, allergic reaction) at three months compared to placebo (risk ratio 0.91, 95% CI 0.52 to 1.60; 4 studies; 1175 participants) (low-certainty). None of the studies reported the other secondary outcomes of tinnitus intrusiveness or changes in depressive symptoms or depression, anxiety symptoms or generalised anxiety. Gingko biloba with concurrent intervention versus concurrent intervention only One study compared Ginkgo biloba with hearing aids to hearing aids only. It assessed the mean difference in the change in Tinnitus Handicap Inventory scores and tinnitus loudness using a 10-point visual analogue scale (VAS) at three months. The study did not report adverse effects, tinnitus intrusiveness, changes in depressive symptoms or depression, anxiety symptoms or generalised anxiety, or health-related quality of life. This was a single, very small study (22 participants) and for all outcomes the certainty of the evidence was very low. We were unable to draw meaningful conclusions from the numerical results.
AUTHORS' CONCLUSIONS
There is uncertainty about the benefits and harms of Ginkgo biloba for the treatment of tinnitus when compared to placebo. We were unable to draw meaningful conclusions regarding the benefits and harms of Ginkgo biloba when used with concurrent intervention (hearing aids). The certainty of the evidence for the reported outcomes, assessed using GRADE, ranged from low to very low. Future research into the effectiveness of Ginkgo biloba 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: Adult; Child; Humans; Ginkgo biloba; Headache; Hypersensitivity; Seizures; Tinnitus; Randomized Controlled Trials as Topic
PubMed: 36383762
DOI: 10.1002/14651858.CD013514.pub2