Repeated-measure analysis of variance was used to test (1) the effects of betahistine treatment (controls vs. treated cats), (2) the effects of the betahistine dose (0.2 vs. 2 mg/kg), and (3) the effects of additional selegiline on the lowest betahistine dose (0.2 mg/kg betahistine + 1 mg/kg selegiline). The excluded studies are tabulated in the Characteristics of excluded studies table. For reporting bias, nine were high risk and six low risk. We did not plan or implement any statistical strategies to deal with missing data, except for imputations to estimate missing standard deviations according to the methods recommended in Section 7.7.3 of the Cochrane Handbook for Systematic Reviews of Interventions (Handbook 2011). The quality of evidence reflects the extent to which we are confident that an estimate of effect is correct and we applied this in the interpretation of results. SF36). We judged the quality of evidence overall to be low. The daily dose should be given in 2 or 3 divided doses throughout the day. Cochrane ENT is currently undertaking a formal scoping and prioritisation exercise on the topic of balance disorders. It is therefore important to assess patients presenting with vertigo very carefully to identify the underlying diagnosis. Take the betahistine packet or leaflet inside it, plus any remaining medicine, with you. Two authors independently extracted data to minimise personal bias, and we considered both clinical and statistical heterogeneity before carrying out our analysis. Vertin 16 Tablet How often is dizziness from primary cardiovascular disease true vertigo? WebObjective: To investigate the pregnancy outcomes of women who were exposed to betahistine during their pregnancies. Is betahistine different to antihistamines? People with bronchial Asthma should be closely monitored. Adults: Initial oral treatment is 8 to 16 mg three times daily, taken preferably with meals. The 17 studies in this review had 1025 participants. Unclear which groups they belonged to. Betahistine 16 mg tablets Pooled data showed that the proportion of patients reporting an overall reduction in their vertigo symptoms was higher in the group treated with betahistine than the placebo group: risk ratio (RR) 1.30, 95% confidence interval (CI) 1.05 to 1.60; 606 participants; 11 studies). Most studies commented that the placebo tablet was "identical" or "indistinguishable" from the betahistine preparation, with only two giving no information (Guneri 2012; Ricci 1987). Two studies included patients with BPPV defined by a positive DixHallpike positioning test (Guneri 2012; Mira 2003). Newman-Toker DE, Dy FJ, Stanton VA, Zee DS, Calkins H, Robinson KA. [12] While the onset of its effects vary between formulations, bilastine generally takes effect within 3060 minutes. For intervention effect measures with continuous data we planned to calculate the difference in means (mean difference, MD) between the groups, provided that different studies used the same scale of measurement. Mira 2003 also used the Dizziness Handicap Inventory and some other scales whose validation references could not be obtained (Dizziness Assessment Rating Scale, GISFaV). Low quality evidence suggests that patients suffering from vertigo from different causes may have some benefit from betahistine in terms of reduction in vertigo symptoms. BETAHISTINE DIHYDROCHLORIDE 16MG TABLETS The daily dose With regard to subgroup analysis, we extracted data on underlying diagnosis if applicable, along with treatment protocol (dose and duration of drug). Betahistine 24 mg twice a day versus placebo for 30 days, Randomised in groups of 4 before study started using tables, "neither patient nor investigator knew which treatment was being given". 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. Evidence that is largely of low quality suggests that in patients suffering from vertigo from different neurootological causes there may be a positive effect of betahistine in terms of reduction in vertigo symptoms. tolerability of betahistine in patients with vestibular My consultant, having confirmed the diagnosis, and noting that I was not fully controlled tripled my dose from 16mg to 48 mg three times daily, and told me if I remained attack free for 6 months I should then wean myself off. When your symptoms are under control, your doctor may reduce your dose to 8mg, taken 3 times a day. But, since 2016, at last, a very high quality RCT with 220 patients has been published: BEMED trial: Adrion et al, 2016 BMJ. Federal government websites often end in .gov or .mil. You may report side effects to your national health agency. 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. Dizziness is a term that is commonly used by patients to describe various sensations of lightheadedness, imbalance, illusory feelings of movement or disorientation. Where possible, take the tablets with something to eat. Betahistine can cross the bloodbrain barrier: the cell bodies of histaminecontaining neurons project throughout the brain, including the ventromedial hypothalamic nucleus, the thalamus and the cerebral cortex, and betahistine has measurable effects on regional cerebral blood flow (Barak 2008). The usual dose after this is Betahistine is a drug that may work by improving blood flow to the inner ear. For our review we chose to use the patient's perspective for improvement rather than the investigator's perspective. It was also the most common drug prescribed across every diagnostic group (Mnire's, benign paroxysmal positional vertigo, peripheral vestibular vertigo and 'other' vertigo) (Agus 2013). Do patients suffering from vertigo from different causes benefit from the drug betahistine? BETAHISTINE 16 MG TABLETS | Drugs.com Disesuaikan menurut respons individu; Dosis pemeliharaan: 1-2 tablet diminum 3 kali sehari; Cara Menggunakan. Betahistine hydrochloride 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. Daily dose should not exceed 48 mg. Webtitle; country; indication for betahistine HCl use; dose; strength; dosage form; ROA; frequency and duration of therapy; any combination therapy utilized; if applicable, formulation of compounded products; study design; and any discussion surrounding the use of betahistine HCl compared to alternative therapies. Betahistine is a licensed drug for Menieres disease-like symptom complexes, which contains the active ingredient betahistine dihydrochloride (maximum daily dose 48 mg) or betahistine dimesylate (maximum daily dose 36 mg). Della Pepa 2006 and Nauta 2014 both found favourable effects of betahistine, as we did. Maintenance doses are generally in the range 24 - 48 mg daily. WebOn this page about Betahistine (AS) you will find information relating to side effects, age restrictions, food interactions, whether the medicine is available at a government subsidised price on the pharmaceutical benefits scheme (PBS) as well as other useful information. Importantly, vertigo increases the risk of falls, which in particular is becoming a major public health problem in the elderly. In some cases symptoms may be mild or there may be a single shortlived episode. See Characteristics of excluded studies for details of the 15 studies that we excluded. We excluded six studies as there was no evidence of randomisation (Bertrand 1972; Hommes 1972; Purohit 1988; Singarelli 1979; Verspeelt 1996), or randomisation was inadequate (Elia 1966). Three studies reported that compliance was explicitly checked by direct questioning and container checks (Duphar H10803592F 1997; Duphar H108906NL 1990; Otto 2008). Dose Betahistine Improves Cognitive Function in Betahistine (intraperitoneal or oral administration; 0.1-30 mg/kg; single dose) with acute administration has increased tele-methylhistamine (t-MeHA) levels with an ED of 0.4 mg/kg, indicating the inverse agonism. AS provided advice as needed throughout. We concluded betahistine might reduce the number of attacks, vertigo intensity and lead to a symptomatic improvement according to global judgement in patients with Meniere s disease, but the certainty of evidence is low. Raw data for outcomes missing, e.g. Compliance checks were not reported in most studies (Burkin 1967; Conraux 1988; Duphar 77054 1983; Duphar H10800580M 1984; Duphar H10802786F/M 1989; Guneri 2012; Legent 1988; Mira 2003; Ricci 1987; Salami 1984). These data strongly suggest that therapeutic effects of betahistine result from an enhancement of histamine neuron activity induced by inverse agonism at H(3) autoreceptors. 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. Four studies did not give complete data for the group allocation of the lost participants (Conraux 1988; Fischer 1985; Legent 1988; Oosterveld 1989). Swallow the tablet whole with a drink of water. When your symptoms are under control, your doctor may reduce your dose to 8mg, taken 3 times a day. Conclusion: Our findings suggest that betahistine (48 mg/day) therapy is effective in treating vertigo in routine clinical settings. When your symptoms are under control, your doctor may reduce your dose to 8mg, taken 3 times a day. Proportion of participants withdrawing (dropping out) from the study due to all causes. Sixteen studies including 953 people compared betahistine with placebo; the studies were at high to unclear risk of bias. 16 mg tablets: half or one tablet three times a day. The daily dose should be given in 2 or 3 divided doses throughout the day. All studies with analysable data lasted three months or less. Two studies were identified as progressing but with data not yet published. Betahistine Do not take two doses within approximately two hours of each other. It may be a sensation of rotation ('spinning vertigo'), or may be a different sensation of self motion ('nonspinning vertigo'). Get someone else to drive you or call for an ambulance. Mira 2003 reported that randomised patients were all accounted for and there was a low rate of attrition so we rated it low risk. Serc Dosage We pooled the data, giving a risk ratio of 0.96 (95% CI 0.65 to 1.42; 481 participants; eight studies; I2 = 0%). Firstly, it is possible that the effect in the lowdose group is a false positive finding. Betahistine is available in 8mg or 16mg tablets taken 3 times daily. uncompensated vestibular disease), we planned to undertake subgroup analysis. patient and investigator satisfaction, Betahistine 16 mg twice a day for 3 months versus placebo, Pharmaceutical company funded, interest declared, "according to the random list", "Randomisation in groups of 4". Some people find that taking Betahistine improves vertigo, but also other Menieres symptoms. These are not all of the side effects that may occur. Concurrent use of other medication for nonneurotological conditions was acceptable if used equally in each group. Proportion of patients with adverse effects. Dosage can be adjusted to suit individual patient needs. #1MeSH descriptor: [Dizziness] explode all trees, #1 TS=(vertig* or bppv or meniere* or vestibular or (endolymphatic and hydrops) or (labyrinth and hydrops) or (labyrinth and syndrome) or (cochlea and hydrops)), 1.2.1 Betahistine dose less than 48 mg per day, 1.2.2 Betahistine dose 48 mg or over per day, Betahistine 4 mg 4 times a day versus placebo over 2 weeks before crossover, Random sequence generation (selection bias), Blinding of participants and personnel (performance bias), Doubleblind; "neither patient nor investigator knew which group" but no further details, Blinding of outcome assessment (detection bias), Betahistine 32 mg for 8 weeks versus placebo, Some participants in both groups had no symptoms throughout the trial duration, "Doubleblind", but no further information, Participants lost to followup: 0 in first treatment phase (before crossover), Outcome measures unclear. All studies where gender was reported had mixed male and female participants. The https:// ensures that you are connecting to the This is because these treatments may be contraindicated in some patients and others may fail to respond or have ongoing symptoms. Webmum daily dose 48 mg) or betahistine dimesylate (max - imum daily dose 36 mg). Similarly, six studies used a fourpoint ordinal scale (Canty 1981; Duphar 77054 1983; Duphar H10803592F 1997; Fischer 1985; Otto 2008; Salami 1984), and six studies used a fivepoint ordinal scale (Conraux 1988; Duphar H10802786F/M 1989; Duphar H10800580M 1984; Duphar H10803592F 1997; Legent 1988; Oosterveld 1989). WebDosage . Analysis was "as treated". We assessed the variation in treatment effects by means of the Cochrane test for heterogeneity and quantified it using the I2 statistic. One registered clinical trial was a drug company trial of betahistine for postvestibular neurotomy patients with Mnire's disease, which was closed in 2006 ({"type":"clinical-trial","attrs":{"text":"NCT00160238","term_id":"NCT00160238"}}NCT00160238). All studies with analysable data lasted three months or less. 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). Betahistine 16 mg 3 times a day for 8 weeks. Pathy J, Menon G, Reynolds A, Van Strik R. Betahistine hydrochloride (Serc) in cerebrovascular disease a placebo-controlled study. A double-blind placebo-controlled study. 11 dropouts in betahistine group and 15 in placebo group; reasons unclear. There were no studies that reported using a generic healthrelated quality of life instrument (e.g. 3Nonvalidated outcome measures were used to measure improvement. Lempert T, Olesen J, Furman J, Waterston J, Seemungal B, Carey J, et al. Usually for adults, administer orally 6 mg to 12 mg three times per day after meals. Vertigo is a subjective experience. This review examines whether betahistine is more effective than a placebo at treating symptoms of vertigo from different causes. Betahistine 16 mg 3 times a day for 3 months versus placebo, Groups "similar at baseline" clinically but data not given. Mnire's disease is a progressive disease of the inner ear characterized by vertigo, tinnitus, and hearing loss. These may include nausea, upset stomach, vomiting, diarrhea and stomach cramping. In a study of medical practice in a variety of settings across 13 countries worldwide betahistine was the most common drug prescribed, being issued in twothirds of cases of vertigo. Betahistine or Cinnarizine for treatment of Meniere Crossover trials may have a carryover effect. Subgroups still showed high statistical heterogeneity (Mnire's: I2 = 41%; other vertigo: I2 = 68%). Why is Cochrane being biased by publication bias (or inclusion bias)? Adults: Initial oral treatment is 8 to 16 mg three times daily, taken preferably with meals. Nonetheless, betahistine is often prescribed for tinnitus. Submitted comment and authors' response incorporated. WebThe tablets should be swallowed preferably with a drink of water, and are best taken with or after a meal. For sequence generation six studies had a low risk rating and 11 were unclear. It is also known as betahistine dihydrochloride and has a number of different proprietary names, including Serc, Betaserc and Hiserk. We conducted available case analysis. Mira E, Guidetti G, Ghilardi L, Fattori B, Malannino N, Maiolino L, et al. We used the GRADE approach to rate the overall quality of evidence. 2HCl. Betahistine undergoes extensive first-pass metabolism to the major inactive metabolite 2-pyridyl Other indications have also been studied, such as the treatment BETAHISTINE VIATRIS is used to treat a disorder of your inner ear. We considered heterogeneity statistically significant if the P value was < 0.1. Adverse effects are Monthly vertigo attack frequency significantly decreased during the 2-month treatment period (p < 0.001) and continued to decrease during the 2-month follow-up, Dose No published studies excluded those who had previously been on betahistine, but two unpublished studies did (Duphar H10803592F 1997; Duphar H108906NL 1990). The studies included in this review were conducted in clinical populations that appear to be similar to those who might receive betahistine in clinical practice, in that the participants all had vertigo with broad diagnostic inclusion criteria. Betahistine is a strong H3 antagonist and a weak H1 agonist26with three sites of action. Unsurprisingly, perhaps, given its lack of specificity, the experience of dizziness is common. 8-mg tab 1-2 tab tid; 16-mg tab -1 tab tid; 24-mg tab 1 tab bid. Maintenance doses are generally in the range 24 - 48 mg daily. The oldest participants in the studies were in the eighth decade (Guneri 2012; Otto 2008). [6] Adrian James for supplying data on papers including correspondence from study authors. Betahistine hydrochloride. FOIA We planned to conduct a sensitivity analysis by comparing the effect of the inclusion and exclusion of studies based on eligibility criteria or data analysis methods where required. Then, we constructed a vertigo mice model of vestibular dysfunction with gentamicin (150 mg/Kg) and a BPPV model of Slc26a4loop/loop mutant mice. Twelve studies yielded analysable data. Randomised controlled trials. We included all categories of neurotological diagnosis (including, for example, central neurological conditions and vestibular schwannoma). Betahistine comes as 8mg or 16mg tablets. Guneri 2012 reported that there was no statistically significant difference ("P value > 0.05") in the mean scores between groups at one week. Data reportedly in analysis (Prof M Strupp, personal communication). The majority of studies were singlecentre and appeared to take place in specialist centres. We identified an additional 10 records from handsearching, contacting manufacturers and experts, and from the reference lists of relevant studies. 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. Given that the BEMED trial has clearly shown the absence of any therapeutic effect of Betahistine, the obvious question arises: Is Cochrane getting money from the Betahistine industry? LM entered data into RevMan 5, and carried out and interpreted the analysis. It is estimated from sales information that >130 million patients have been exposed to the drug since its registration in 1968. 'Effects of betahistine on central vestibular compensation in acute unilateral vestibular failure: a doubleblind, placebocontrolled trial', Ongoing (Prof Strupp, personal communication). However, the symptom of vertigo has many possible causes. Betahistine information. Betahistine side effects | Patient The dose may be adjusted according to the age of patient and severity of symptoms. Louisa Murdin has no interests to declare. Daily dose should not exceed 48 mg. This aim of this project is to establish priority questions (including populations, interventions, comparators and outcomes) for new or updated systematic reviews on balance disorders. 32 missing/excluded; unclear from which groups some of them originate, 26 with vertigo as part of "vertebrobasilar ischaemia" (see below, clinical diagnosis), Betahistine 12 mg 3 times a day versus placebo for 4 weeks, Study was designed to compare betahistine and placebo with a third comparator group (fixed proprietary combination of dimenhydrinate and cinnarizine). Pharmacokinetics and Dose Proportionality Leave 6 to 8 hours between doses. "Physician doing Epley manoeuvre did not know who would be allocated." Betahistine Cinnarizine: A Contemporary Review - PMC - National Center for Reassessment of the effect of betahistine for Mnire's disease is now warranted. betaserc dosage. Of the 17 studies included, five were unpublished trials, but the manufacturers could provide us with data. Keywords: Betahistine; Dizziness; Epley maneuver; Quality of life; Vertigo. The BEMED study referred to was not complete when the review was published. We resolved differences of opinion by discussion in the first instance, with input from the third author (AS) if necessary. Diagnostic criteria for Meniere's disease, The effect of Serc (betahistine hydrochloride) on the circulation of the inner ear in experimental animals, Vestibular rehabilitation for unilateral peripheral vestibular dysfunction, The European Evaluation of Vertigo (EEV) scale: a clinical validation study, Revue de Laryngologie - Otologie - Rhinologie, Epidemiology of balance symptoms and disorders in the community: a systematic review, Meta-analysis of clinical studies with betahistine in Meniere's disease and vestibular vertigo, Outcome of symptoms of dizziness in a general practice community sample. If sufficient data were available for different conditions (e.g. After removal of duplicates we were left with 445 records. WebBetahistine is a structural analogue of histamine that is prescribed for the treatment of vestibular disorders such as Mnire's disease and the symptomatic treatment of vertigo. Duphar H10802786F/M 1989 described coding envelopes all being returned unopened, but opacity was not stated so we rated this as unclear. Betaserc Dosage National Institute for Health Research, UK, {"type":"clinical-trial","attrs":{"text":"NCT00160238","term_id":"NCT00160238"}}, {"type":"clinical-trial","attrs":{"text":"NCT00474409","term_id":"NCT00474409"}}, 1.1 Proportion of patients with improvement according to global judgement of patient: subgrouped by diagnosis, 1.2 Proportion of patients with improvement according to global judgement of patient: subgrouped by drug dose, 1.3 Proportion of patients with adverse effects, 1.4 Proportion of patients with upper gastrointestinal adverse effects, Betahistine treatment for Meniere's syndrome, Betahistine in peripheral vertigo: a double-blind, placebo-controlled, cross-over study of Serc versus placebo, Chronic vertigo sensations. Betahistine 16 mg tablets - Summary of Product Since 2016, I am waiting for the Cochrane review to be updated to include this extremely important RCT. It is a drug for Meniere's and I don't have this disease. Two authors selected studies for inclusion, extracted data and judged risk of bias independently, with recourse to the third author for resolution of disagreement or uncertainty. Some studies suggest that betahistine is generally well tolerated[2] but there is some evidence of side effects generally gastrointestinal upset[1]. betahistine The usual starting dose is 16mg, taken 3 times a day. WebBetahistine products target certain histamine receptors (like those for allergies). Studies took place in the USA (Burkin 1967), the UK (Canty 1981), France (Conraux 1988; Legent 1988), the Netherlands (Fischer 1985; Oosterveld 1989), Italy (Mira 2003; Ricci 1987; Salami 1984), Turkey (Guneri 2012), Japan (Okamoto 1968), and Germany (Otto 2008). PubChem Substance ID: 329748927. PRODUCT MONOGRAPH - pdf.hres.ca The Dizziness Handicap Inventory (DHI) is a mixture of quality of life and symptom severity scores, which is considered under symptomspecific measures. We used standardised data entry forms. One patient in Duphar H108906NL 1990 had respiratory distress on betahistine and one patient in Duphar H10803592F 1997 had an asthma attack on betahistine. Betahistine Helped My Severe Tinnitus Betahistine dihydrochloride in the treatment of peripheral vestibular vertigo, European Archives of Oto-Rhino-Laryngology. Similarly, in this study, we found that combination therapy with cinnarizine (75 mg) and betahistine (24 mg) has superior efficacy and tolerability compared with those of respective monotherapies. 8 mg tablets: one or two. Four studies showed some differences between active and placebo groups at baseline, not accounted for in the analysis techniques (Fischer 1985; Legent 1988; Otto 2008; Ricci 1987). The pooled data should be interpreted with caution as the tests of statistical heterogeneity gave high results. two or more active treatments being tested against placebo), we established which of the comparisons were relevant to the systematic review and relevant to each of the metaanalyses that we implemented. You could also ask a pharmacist for advice on other ways to help you remember to take your medicine. There are many other evidencebased treatments for particular conditions that cause vertigo, which should be offered where appropriate. official website and that any information you provide is encrypted Betahistine betahistine 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. Watanabe K, Fukami J, Yoshimoto H, Ueda M, Suzuki J. If the data were compatible and of sufficient quality we planned to combine them to give summary measures of effect. Likewise, Duphar H10803592F 1997 stated "neither patient nor investigator knew which treatment was being given" and we allocated low risk. Seven studies collected parallel data on the investigator global impression of treatment (Fischer 1985; Duphar H108906NL 1990; Duphar 77054 1983; Duphar H10802786F/M 1989; Duphar H10800580M 1984; Duphar H10803592F 1997; Mira 2003). 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. There are evidencebased treatments for common conditions that cause symptoms of vertigo (e.g. When all studies are taken together, the proportion of patients reporting a reduction of their vertigo symptoms was significantly higher in the betahistine group than in the placebo group. 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. Click to view Betaserc detailed prescribing information. If you take more than one tablet Protocol first published: Issue 8, 2013Review first published: Issue 6, 2016. We assessed studies for clinical, statistical and methodological heterogeneity. Dosage. Acute episodes of Mnire's tend to occur in In longer studies, results may be recorded at more than one time interval. How and when to take betahistine - NHS We used abstract review to eliminate any trials that were clearly ineligible. 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. betahistine We also contacted manufacturers and researchers in the field. High-Dose Betahistine Improves Cognitive Function in The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the Systematic Reviews Programme, NIHR, NHS or the Department of Health. Betahistine Three studies used a crossover design, from which data were extractable prior to crossover (Burkin 1967; Canty 1981; Oosterveld 1989). Coding envelopes all returned unopened. 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. Two studies did not report age and gender data for participants (Conraux 1988; Legent 1988). 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.
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