The objective of this review was to evaluate the overall efficacy of betahistine for symptoms of vertigo. 30% to 60%: may represent moderate heterogeneity; 50% to 90%: may represent substantial heterogeneity; proportion of patients with improvement according to global judgement of patient subgrouped by diagnosis; proportion of patients with adverse effects. I have had tinnitus for 10 years and last time I asked my ENT if there is a drug I could try, he said there's no cure for tinnitus but I could try betahistine. Betahistine Vertigo is included in this project and if the use of betahistine is ranked as a priority question then a new, updated review will be conducted. Five studies included patients who were designated by the study authors as having clinically defined Mnire's disease or syndrome (Burkin 1967; Mira 2003; Okamoto 1968; Ricci 1987; Salami 1984). " second physician who supplied medication was also unaware". The daily dose should be given in 2 or 3 divided doses throughout the day. Although Mira 2003 collected data using the validated Dizziness Handicap Inventory (DHI), the results were reported only as percentage reductions with no baseline absolute values and missing measures of spread, so no useful data could be extracted. Recruitment completed. There is a concern, however, about potential reporting biases. Inclusion in an NLM database does not imply endorsement of, or agreement with, We included the following outcomes in the 'Summary of findings' table: See Characteristics of included studies; Characteristics of excluded studies; Characteristics of ongoing studies. Usually for adults, administer orally 6 mg to 12 mg three times per day after meals. The studies varied considerably in terms of types of participants, their diagnoses, the dose of betahistine and the length of time the drug was taken for, the study methods and the way any improvement in vertigo symptoms was measured. If you take more than one tablet This review examines whether betahistine is more effective than a placebo (sham medicine) at treating symptoms of vertigo from different causes in patients of any age. Adverse events only reported if "considered to represent adverse reactions to the study drug" without explicit criteria, Some patients asymptomatic throughout entire trial period, Betahistine up to 48 mg per day for 3 months versus placebo. Three studies looked at objective vestibular function tests as an outcome; the numbers of participants were small, techniques of measurement very diverse and reporting details sparse, so analysis of this outcome was inconclusive. It does not work in all cases. Usually for adults, administer orally 6 mg to 12 mg three times per day after meals. Betahistine 16 mg tablets Studies of vestibular modulation by current antihistamines in healthy volunteers are limited, with very few trials specifically evaluating vertigo itself rather than other associated parameters (vertigo sensation intensity, frequency and duration; associated symptoms such as nausea and vomiting, quality of life). As these effects were observed in a crossover design study and details of the timing of drugs and tests were not given, we undertook no further interpretation for this review. We created a funnel plot for this analysis, as more than 10 studies were included (Figure 5). Cause of Tinnitus: Unknown. Mira 2003, Oosterveld 1989 and Legent 1988 were multicentre studies. Ricci 1987 reported in narrative terms the small number of patients in that study. The Mnire's Society for support in planning the review, funding for review author time and support throughout. After an oral 8-day treatment, the only effective dose of betahistine was 30 mg/kg, indicating that a tolerance had developed. WebAlthough betahistine is thought to be specifically effective for Mnire's disease, no evidence for a benefit from the use of betahistine exists, despite its widespread use. Betahistine is a drug treatment, available only in oral form, usually taken in doses from 24 mg to 48 mg daily. It may be a sensation of rotation ('spinning vertigo'), or may be a different sensation of self motion ('nonspinning vertigo'). Betahistine 16 mg 3 times a day for 8 weeks. Duphar H108906NL 1990 included patients with various diagnoses including a majority with BPPV and small numbers with other causes of episodic vertigo. It is a commonly experienced symptom and can cause significant problems with carrying out normal activities. A trial for 6-12 months of taking betahistine may be advised to see if it helps to reduce symptoms. We identified 32 potentially eligible studies and excluded 15 for reasons including having a crossover design with the data from before crossover not extractable, lack of adequate randomisation and ineligible participants. We used the standard methodological procedures expected by Cochrane. The high rate of unwanted symptoms in the placebo group was notable. Six studies reported adverse effects in sufficient detail to analyse how many individuals reported upper gastrointestinal effects (Conraux 1988; Duphar 77054 1983; Duphar H10803592F 1997; Duphar H108906NL 1990; Mira 2003; Otto 2008). The proportion of patients who reported overall reduction in symptoms is given in Analysis 1.1. The paper reported a statistically significant difference in change in sway on Romberg and Unterberger tests, with a greater reduction in the betahistine group than in the placebo group. WebA long-term high-dose treatment with betahistine (at least 48 mg three times daily), has shown a significant effect on the frequency of the attacks 15. Is betahistine different to antihistamines? Language was not a barrier to inclusion and we included papers in French, Italian, Japanese and Dutch. [6] The findings of this review do not negate the need for a proper clinical assessment of patients with the symptom of vertigo with the goal of making a diagnosis. The 17 studies in this review had 1025 participants. Four studies made direct or indirect reference to compliance checks either by checking tablet containers or by labelling some patients as noncompliant (Canty 1981; Fischer 1985; Okamoto 1968; Oosterveld 1989). We rated the quality of the evidence for this outcome as low (see Table 1). Betahistine As betahistine mesilate: 6-12 mg tid. Canty 1981 reported assessing caloric tests at baseline and after treatment, stating that the test was abnormal in nine patients before treatment with "some improvement" in two of these. Methods: We treated BPPV patients with Betahistine (12 mg/time, 3 times/day) for 4 weeks and observed the clinical efficacy and the expression of CTRP family members in BPPV patients. Chronic vertigo is a challenging problem. the contents by NLM or the National Institutes of Health. Okamoto K, Hazeyama F, Taira T, Yoshida A, Onoda T. Therapeutic results of betahistine on Meniere's disease. Guneri 2012 and Mira 2003 used DixHallpike positioning testing to assess resolution of BPPV. Betahistine hydrochloride is a medication commonly prescribed for tinnitus, or ringing in the ears, dizziness and vertigo. Future studies should be conducted and reported according to the CONSORT statement. Duphar H10802786F/M 1989 did not describe adverse effects directly but measured "tolerance" on a fourpoint ordinal scale. This might be expected, given the fact that the studies were heterogeneous in terms of both participant diagnoses and also the diagnostic criteria used to identify subgroupings. It is also known as One study, at high risk of bias, included 72 people with benign paroxysmal positional vertigo (BPPV) and compared betahistine with placebo; all patients also had particle repositioning manoeuvres. Then, we constructed a vertigo mice model of vestibular dysfunction with gentamicin (150 mg/Kg) and a BPPV model of Slc26a4 loop/loop mutant mice. It has been used in some countries for many years as a treatment for Mnire's disease or syndrome, where it has been thought to be especially effective for the symptoms of vestibular vertigo. Betahistine 11 dropouts in betahistine group and 15 in placebo group; reasons unclear. WebChild: As 15 mg tab: 5-12 years Initially, 15 mg to be taken 2 hours before travel, then 7.5 mg 8 hourly during the journey if necessary; >12 years Same as adult dose. Four registered clinical trials were identified through the search. Betahistine 16 mg 3 times a day for 3 months versus placebo, Groups "similar at baseline" clinically but data not given. Betahistine Why might betahistine have an effect on such a heterogeneous group of patients with vertigo from so many different and contrasting conditions? BETAHISTIN TABLET merupakan obat generik dengan kandungan Betahistine Mesylate 6 mg per tablet. Betahistine Mira E, Guidetti G, Ghilardi L, Fattori B, Malannino N, Maiolino L, et al. Start at a low dose.maybe 4mg 3Xday and every couple weeks titrate up until at least 16mg 3Xday. Adrion C, Fischer C S, Wagner J, Gurkov R, Mansmann U, Strupp M. Efficacy and safety of betahistine treatment in patients with Meniere's disease: primary results of a long term, multicentre, double blind, randomised, placebo controlled, dose defining trial (BEMED trial), Clinical and demographic features of vertigo: findings from the REVERT registry. Sometimes improvement could be observed only after a couple of weeks of treatment. We assessed heterogeneity by inspection of the point estimates and confidence intervals on the forest plots. The purpose of this review is to evaluate the evidence from high-quality clinical trials to work out the effect of betahistine on people's tinnitus. All studies with analysable data lasted three months or less. WebThese results demonstrate that gastrodin has a consistent improvement effect on vestibular functions compared with betahistine but less effect on GI functions and gut microbiota, suggesting that gastrodin may be more suitable for vestibular disease patients with Vertigo, tinnitus &/or hearing loss associated w/ Meniere's syndrome. Will it Generic quality of life (we assessed diseasespecific quality of life scales as part of the primary outcome). This means that there may be limited applicability to primary care settings where these resources are absent. betahistine Medication The Dizziness Handicap Inventory (DHI) is a mixture of quality of life and symptom severity scores, which is considered under symptomspecific measures. We were provided with five further unpublished studies for analysis. These scales were not described as validated. Betahistine This review and analysis were set up to answer the question, "is betahistine of overall benefit to patients with symptoms of vertigo?". For higher doses (48 mg or more) the pooled RR was 1.16 (95% CI 0.92 to 1.48; 314 participants; five studies), also with high statistical heterogeneity (I2 = 54%). How long does it take to work? Though the pharmacologically approved dosage is only 48 mg/day, many, if not most, patients especially those with Mnires disease need much higher doses for any clinically observable benefit with this dose. In this small study of 10 patients therapy was for a mean of 10.4 months in the betahistine group and 7.0 months in the placebo group. Two studies were identified as progressing but with data not yet published. Why is Cochrane being biased by publication bias (or inclusion bias)? Duphar H10800580M 1984 included patients labelled as having "central signs" with shortlived episodes of vertigo, this list including changes in handwriting, spontaneous or induced/gaze evoked nystagmus, nystagmus on cervical or vertebrobasilar privation test and unilateral or bilateral hypo or hyperexcitability of vestibular function (Duphar H10803592F 1997). In view of this, and the chronic and episodic nature of the condition of interest (vertigo), we used data from crossover trials only if data from before the crossover could be obtained. Depending on the number points in these scales (and how the data were reported), we either dichotomised these or analysed them as continuous outcomes. Guneri 2012 used published validated scales (Dizziness Handicap Inventory (Jacobson 1990), Vestibular Disorders Activities of Daily Living Scale (Cohen 2000), Vertigo Symptom Scale (Yardley 1998), and European Evaluation of Vertigo Scale (Megnigbeto 2001). Duration of treatment available for analysis in this review was a fixed interval of two weeks (Burkin 1967; Guneri 2012; Okamoto 1968), one month (Duphar H10803592F 1997), five weeks (Oosterveld 1989), six weeks (Salami 1984), two months (Canty 1981; Duphar H108906NL 1990), and three months (Conraux 1988; Fischer 1985; Legent 1988; Mira 2003, Duphar 77054 1983; Duphar H10800580M 1984; Duphar H10802786F/M 1989). It is rapidly and completely absorbed. Recruitment of adequate numbers has clearly been problematic for researchers and this should be considered in future trial designs, such as by using a multicentred trial design. The recommended dosage for adults is 2448 mg administered across several doses during the day. High-Dose Betahistine Improves Cognitive Function in Study duration was three months or less in all cases except Ricci 1987, where duration of therapy was variable (using a protocol of 10 times mean duration of interval between attacks for each patient to determine treatment length). Where there was a sufficient number of trials (more than 10) in any metaanalysis, we assessed publication bias according to the recommendations on testing for funnel plot asymmetry as described in Section 10.4 of the Cochrane Handbook for Systematic Reviews of Interventions (Egger 1997; Handbook 2011). Adrian James for supplying data on papers including correspondence from study authors. For Duphar H10803592F 1997, information on all the lost participants was incomplete and we judged it high risk. It is important to remember that the absence of an effect in the higherdose group in this subgroup analysis does not necessarily indicate that there genuinely is no effect. Legent 1988 reported mean duration of attacks per patient in hours. But, since 2016, at last, a very high quality RCT with 220 patients has been published: BEMED trial: Adrion et al, 2016 BMJ. The Brny Society and international collaborating organisations have recently published consensus clinical criteria for Mnire's disease (LopezEscamez 2015), taking forward the previously widely used American criteria (AAOHNS 1995). We assessed studies for clinical, statistical and methodological heterogeneity. It is estimated from sales information that >130 million patients have been exposed to the drug since its registration in 1968. For sequence generation six studies had a low risk rating and 11 were unclear. This is a generic drug. Experiments were conducted on betahistine-treated cats receiving daily doses of 2, 5, 10, or 50 mg/kg during 1 week, 3 weeks, 2 months, or 3 months. NACRES: NA.24. The rate of upper gastrointestinal symptoms and headache was similar in the betahistine and placebo groups. Proportion of participants withdrawing (dropping out) from the study due to all causes. Some people find that taking Betahistine improves vertigo, but also other Menieres symptoms. It is a drug for Meniere's and I don't have this disease. Salami 1984 reported total duration of attacks. Oosterveld 1989 reported adverse effects in detail but this was a crossover study and the figures provided pooled both crossover periods so we did not include the data in this analysis. The oldest participants in the studies were in the eighth decade (Guneri 2012; Otto 2008). WebDosage . Risk of bias is presented graphically in Figure 2 and Figure 3. Salami A, Delle PM, Tinelli E, Jankowska B. In controlled clinical trials, betahistine administered orally was found to be more effective than placebo or other drugs in improving the symptoms related to Mnires disease, such as vertigo sensation. If 100 patients with vertigo are treated with betahistine, 60 will improve. Dizziness is a term that is commonly used by patients to describe various sensations of lightheadedness, imbalance, illusory feelings of movement or disorientation. There could be a number of possible explanations for this observation. Duphar H10803592F 1997 reported the total number of attacks through the 30day study period. The participants in each group may be related in some way, therefore this needs to be taken into account in the analysis, otherwise there is a unit of analysis error, which would produce an artificially small P value and a risk of false positive results. Two different review authors independently dichotomised these into 'improved' or 'not improved' whenever possible. Participants lost to followup: 10. Vertigo is a symptom in which individuals experience a false sensation of movement. Do not take a double dose to make up for the forgotten dose. We also found two registered clinical trials that had been terminated early due to poor recruitment ({"type":"clinical-trial","attrs":{"text":"NCT00160238","term_id":"NCT00160238"}}NCT00160238; {"type":"clinical-trial","attrs":{"text":"NCT00474409","term_id":"NCT00474409"}}NCT00474409). Where possible, take the tablets with something to eat. Dosage can be adjusted to suit individual patient needs. Summary of Product Characteristics (SmPC) - (emc) - medicines Coding envelopes all returned unopened. Currently patients are generally treated in general practice with betahistine (off-label use), while stronger evidence exists for the effectiveness of vestibular rehabilitation. Kruschinski C, Kersting M, Breull A, Kochen MM, Koschack J, Hummers-Pradier E. Frequency of dizziness-related diagnoses and prescriptions in a general practice database, Zeitschrift fur Evidenz Fortbildung und Qualitat im Gesundheitswesen. Betahistine hydrochloride. Three studies also reported vestibular function tests (caloric, stabilometry, nystagmography) (Canty 1981; Mira 2003; Salami 1984). Insurance does not cover betahistine. Taking too much betahistine can make you feel sick or sleepy, or give you stomach ache. It is therefore important to assess patients presenting with vertigo very carefully to identify the underlying diagnosis. Betahistine for Mnire's disease or syndrome - PMC We resolved disagreements by discussion or with the input of the third author (AS). There are four possible ratings: high, moderate, low and very low. Redon C, Lopez C, Bernard-Demanze L, Dumitrescu M, Magnan J, Lacour M, et al. These symptoms are usually not serious and subside in between doses. WebDiuretics and/or betahistine should also be offered for maintenance therapy to reduce symptoms or prevent Menires disease attacks. Betahistine Webmum daily dose 48 mg) or betahistine dimesylate (max - imum daily dose 36 mg). Proportion of patients with reduction in vertigo symptoms (considering together the intensity, frequency and duration those symptoms). WebBetahistine products target certain histamine receptors (like those for allergies). All studies except Guneri 2012 and Ricci 1987 made some comment on tolerability or safety. WebBetahistine add-on treatment in posterior benign paroxysmal positional vertigo resulted in improvements in both visual analog scale score and dizziness handicap inventory. Maintenance doses are generally in the range 24 - 48 mg daily. If either author identified a paper as potentially suitable, we reviewed the full text of the article. WebThis study describes the pharmacokinetics of betahistine in ADHD subjects at doses higher than 50 mg. Dosis awal Betahistine: 1-2 tablet, diminum 4 kali sehari atau 3 tablet diminum 2 kali sehari. Betahistine Where we found studies with more than two groups (e.g. National Library of Medicine Secondly, it is possible that the difference between the two subgroups is accounted for by other methodological differences between the studies, such as participant diagnoses. Duphar H10802786F/M 1989 reported the time since the last attack at study endpoint. These are not all of the side effects that may occur. We assessed the variation in treatment effects by means of the Cochrane test for heterogeneity and quantified it using the I2 statistic. Betahistine 'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study. Guneri 2012 reported that there was no statistically significant difference ("P value > 0.05") in the mean scores between groups at one week. You can buy betahistine dihydrochloride at the discounted price of $4,828.15 by using the WebMDRx coupon. Della Pepa 2006 and Nauta 2014 both found favourable effects of betahistine, as we did. Ramos Alcocer R, Ledezma Rodrguez JG, Navas Romero A, Cardenas Nuez JL, Rodrguez Montoya V, Deschamps JJ, et al. After removal of duplicates we were left with 445 records. Also using first arm of crossover only. At the time of the publication of this review, core outcome measures for dizziness had not been identified. See Characteristics of excluded studies for details of the 15 studies that we excluded. Using the GRADE system, we judged the quality of evidence overall to be low for two outcomes (proportion of patients with improvement and proportion with adverse events). Where the study design used independent groups, we treated the study as an independent comparison. Conraux 1988 reported raw data and measures of spread were missing for important variables that were apparently collected, such as frequency of attacks; we thus rated it high risk. Salami 1984 reported zero attrition (personal communication reported in James 2001) and so we rated this low risk. We planned to analyse all participants according to the group randomised in the studies. Betahistine comes as 8mg or 16mg tablets. The usual starting dose is 16mg, taken 3 times a day. Leave 6 to 8 hours between doses. When your symptoms are under control, your doctor may reduce your dose to 8mg, taken 3 times a day. Swallow the tablet whole with a drink of water. It's a good idea to take your betahistine tablets after a meal. A Scottish study estimated that 21% of the population had experienced vertigo and 16% of these found the symptoms moderately or severely disruptive (Hannaford 2005). Most outcomes not given as raw data or measures of spread missing, Betahistine 12 mg 3 times a day versus placebo for 12 weeks, Envelopes provided to participants stating allocation; returned sealed envelope collection not reported; opacity not stated, "Double blind", but no further information, 50 randomised, 33 analysed; betahistine participants dropped out due to increased symptoms or high anxiety levels making assessment difficult; analysis is "as treated", No exclusion of participants who had previously taken betahistine, 12 weeks betahistine 16 mg 3 times a day versus placebo, Randomisation list drawn up before the start of the study outside treatment centre. Her institution has received a grant from GSK for a study on the microbiology of acute tympanostomy tube otorrhoea. You may report side effects to the FDA at 1-800-332-1088. The coordinator of these two trials confirmed progress by personal communication (BEMED; BETAVEST). If you have any further questions on the use of this product, ask your doctor or pharmacist. We planned to include crossover trials if the results from before the crossover were extractable, to avoid the potential for carryover effects. Call your doctor for medical advice about side effects. Data from a single doubleblind, placebocontrolled clinical study suggest significant effects of betahistine on some cognitive function tests (Pathy 1977). 3Nonvalidated outcome measures were used to measure improvement. Vertigo has many causes including vestibular disorders such as Mnire's disease, vestibular neuritis, benign paroxysmal positional vertigo and migraine, each of which can be diagnosed by standardised criteria.
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