We considered heterogeneity statistically significant if the P value was < 0.1. Language was not a barrier to inclusion and we included papers in French, Italian, Japanese and Dutch. Nauta did not consider risk of bias in underlying studies, nor other outcomes than investigator global opinion. Keywords: Mnires disease; betahistine; vestibular disorders. A total of 567 patients had results reported across the 12 published studies, and there were results for an additional 458 patients from the five unpublished studies (1025 patients in total). Betahistine information. Betahistine side effects | Patient Associated symptoms and the quality of life also were significantly improved by This is a generic drug. The proportion of patients reporting side effects of the medication was similar in both groups: 16% in the betahistine groups and 15% in the placebo groups. NACRES: NA.24. There were significant methodological limitations in the conduct and reporting in these studies, particularly in terms of lack of clarity about patient recruitment/diagnostic criteria, choice of outcomes used (and reported) and very small sample sizes. Betahistine: Indications and Precautions This project was supported by the National Institute for Health Research, via Cochrane Infrastructure, Cochrane Programme Grant or Cochrane Incentive funding to Cochrane ENT. The proportion of patients who reported overall reduction in symptoms is given in Analysis 1.1. 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. BETAHISTINE DIHYDROCHLORIDE 16MG TABLETS Web8 mg, 16 mg and 24 mg PART I: HEALTH PROFESSIONAL INFORMATION SUMMARY PRODUCT INFORMATION INDICATIONS AND CLINICAL USE BETAHISTINE (betahistine Ramos Alcocer R, Ledezma Rodrguez JG, Navas Romero A, Cardenas Nuez JL, Rodrguez Montoya V, Deschamps JJ, et al. Dose- and duration-dependent effects of betahistine - PubMed Methods: We identified and evaluated the outcomes of 27 pregnant women who were referred to Terafar (Teratology Information Service, Izmir, Turkey) for a teratological risk assessment. For allocation concealment, two had a low risk rating and 15 were unclear. We scanned the reference lists of identified publications for additional trials and contacted trial authors where necessary. We used standardised data entry forms. Another possible mechanism of action of betahistine is via inhibition of activity within the vestibular nuclei (Timmerman 1994). We contacted the registered companies for any results but these have not been received at the time of writing. Next review due: 24 August 2025, Taking betahistine with other medicines and herbal supplements, you take more than your prescribed dose of betahistine. 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. Duphar H10802786F/M 1989 reported the time since the last attack at study endpoint. Maintenance doses are generally in the range 24 - 48 mg daily. After an oral 8-day treatment, the only effective dose of betahistine was 30 mg/kg, indicating that a tolerance had developed. 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. Why has this not happened yet? tolerability of betahistine in patients with vestibular We were provided with five further unpublished studies for analysis. Betahistine: a retrospective synopsis of safety data Betahistine undergoes extensive first-pass metabolism to the major inactive metabolite 2-pyridyl We can also say that the number of patients who identified such a benefit over and above the placebo effect was small. Betahistine is available in 8mg or 16mg tablets taken 3 times daily. How does betahistine work? It is contraindicated for people with peptic stomach ulcers or tumours of the adrenal gland. This is 1 more than would have had similar symptoms if a sham medicine had been taken instead of betahistine. Five studies were of crossover design, with data before crossover not extractable (Frew 1976; Meyer 1985; Oosterveld 1984; Watanabe 1967; Wilmot 1976). There was one study that included patients with benign paroxysmal positional vertigo and it did not report DixHallpike tests as an outcome measure (Mira 2003). (Handbook 2011)). Future research into the management of vertigo symptoms needs to use more rigorous methodology and include outcomes that matter to patients and their families. Betahistine Acute episodes of Mnire's tend to occur in Sixteen per cent of patients from both the betahistine and the placebo groups withdrew (dropped out) from the studies (RR 0.96, 95% CI 0.65 to 1.42; 481 participants; eight studies). All trials except Ricci 1987 made reference to adverse effects. Betahistine Redon C, Lopez C, Bernard-Demanze L, Dumitrescu M, Magnan J, Lacour M, et al. Dosage. The daily dose should be given in 2 or 3 divided doses throughout the day. This type of dizziness is thought to originate in the inner ear labyrinth or its neural connections. Legent 1988 reported nonvestibular complaint effects in 91% of both the placebo and the betahistine groups, but it was unclear how many patients were in each group. If you take betahistine every day it is unlikely to stop all attacks but it may reduce the number and/or severity of attacks. Of those studies where headache was recorded as an unwanted effect in either group, the pooled risk ratio was 0.88 (95% CI 0.15 to 5.19; 515 participants; four studies) (Analysis 1.5). The unpublished studies used totals of 36 mg (Duphar 77054 1983), or 48 mg (Duphar H10800580M 1984; Duphar H10802786F/M 1989; Duphar H10803592F 1997; Duphar H108906NL 1990). LM and KH selected studies, extracted data and assessed risk of bias. Betahistine is a pharmaceutical histamine regulator thats been used to treat vertigo for about 40 years. Her evidENT team at UCL is supported by her NIHR Research Professorship award with the remit to develop a UK infrastructure and programme of clinical research in ENT, Hearing and Balance. 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. WebBetahistine products target certain histamine receptors (like those for allergies). Nauta found a beneficial effect of betahistine over placebo for both Mnire's disease and vestibular vertigo, calculating a pooled odds ratio (OR) of 2.58 (95% CI 1.67 to 3.99), with subanalyses conducted for patients with Mnire's disease (OR 3.37, 95% CI 2.14 to 5.29) and for vestibular vertigo (OR 2.23, 95% CI 1.20 to 4.14). If a protocol could not be obtained, then we compared the outcomes listed in the methods section with those reported in the results. 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. Insurance does not cover betahistine. For the outcome proportion of patients with an improvement in symptoms, a variety of (nonvalidated) scales with different numbers of ordinal points were reported in the studies. The excluded studies are tabulated in the Characteristics of excluded studies table. Thirdly, it is possible that the numbers of participants in the higherdose group were inadequate to detect a small effect. Comparison 1: Betahistine versus placebo, Outcome 3: Proportion of patients with adverse effects. Salami 1984 reported that in the betahistine group, in 13 patients with abnormal tests at baseline 10 patients (77%) had normalisation after six weeks of treatment. Medication No other responses had been received by the time of submission. There are many other evidencebased treatments for particular conditions that cause vertigo, which should be offered where appropriate. These are not all of the side effects that may occur. Ikuti petunjuk yang ada di kemasan atau sesuai anjuran dokter; Betahistine bisa dikonsumsi baik sebelum maupun sesudah makan The high rate of unwanted symptoms in the placebo group was notable. Mira 2003 reported that randomised patients were all accounted for and there was a low rate of attrition so we rated it low risk. PRODUCT MONOGRAPH - pdf.hres.ca Where we found studies with more than two groups (e.g. Psychological disorders and primary cardiological disorders can also cause a sensation of vertigo (NewmanToker 2008; Wiltink 2009). It may be a sensation of rotation ('spinning vertigo'), or may be a different sensation of self motion ('nonspinning vertigo'). 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? Neuhauser HK, Brevern M, Radtke A, Lezius F, Feldmann M, Ziese T, et al. 16 mg tablets: half or one tablet three times a day. Are there any long-term side effects? Betahistine is an analogue of histamine, and is a weak histamine H1 receptor agonist and potent histamine H3 receptor antagonist. Kiran Hussain has no interests to declare. Name. Author roles were predefined in the review process. Duphar 77054 1983 reported the intention to collect vestibulometric tests as outcomes, but these were not done at the "discretion of the investigator". This review was published in 2016 and has a last search date of 21 September 2015. WebBetahistine dihydrochloride doses of 80 to 1600 mcg/kg/min administered as a continuous infusion to dogs with Heidenhain pouches produced a slight increase in the rate of acid secretion corresponding to 8.8% to 17.6% of the maximum response to histamine.