BMJ. 2016 Jan 21;352:h6816. doi: 10.1136/bmj.h6816. 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). Adrion C1, Fischer CS2, Wagner J3, Gürkov R4, Mansmann U5, Strupp M6; BEMED study group. Author information 1German Center for Vertigo and Balance Disorders, University Hospital Munich, Campus Grosshadern, Munich, Germany Institute for Medical Informatics, Biometry, and Epidemiology, University of Munich, Campus Grosshadern. 2German Center for Vertigo and Balance Disorders, University Hospital Munich, Campus Grosshadern, Munich, Germany. 3Department of Neurology, University Hospital Munich, 81377 Munich. 4Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Munich. 5Institute for Medical Informatics, Biometry, and Epidemiology, University of Munich, Campus Grosshadern. 6German Center for Vertigo and Balance Disorders, University Hospital Munich, Campus Grosshadern, Munich, Germany Department of Neurology, University Hospital Munich, 81377 Munich [email protected]. Abstract STUDY QUESTION: What is the long term efficacy of betahistine dihydrochloride on the incidence of vertigo attacks in patients with Meniere's disease, compared with placebo? METHODS: The BEMED trial is a multicentre, double blind, randomised, placebo controlled, three arm, parallel group, phase III, dose defining superiority trial conducted in 14 German tertiary referral centres (for neurology or ear, nose, and throat). Adults aged 21-80 years (mean age 56 years) with definite unilateral or bilateral Meniere's disease were recruited from March 2008 to November 2012. Participants received placebo (n=74), low dose betahistine (2×24 mg daily, (n=73)), or high dose betahistine (3×48 mg daily, (n=74)) over nine months. The primary outcome was the number of attacks per 30 days, based on patients' diaries during a three month assessment period at months seven to nine. An internet based randomisation schedule performed a concealed 1:1:1 allocation, stratified by study site. Secondary outcomes included the duration and severity of attacks, change in quality of life scores, and several observer-reported parameters to assess changes in audiological and vestibular function. STUDY ANSWER AND LIMITATIONS: Incidence of attacks related to Meniere's disease did not differ between the three treatment groups (P=0.759). Compared with placebo, attack rate ratios were 1.036 (95% confidence interval 0.942 to 1.140) and 1.012 (0.919 to 1.114) for low dose and high dose betahistine, respectively. The overall monthly attack rate fell significantly by the factor 0.758 (0.705 to 0.816; P<0.001). The population based, mean monthly incidence averaged over the assessment period was 2.722 (1.304 to 6.309), 3.204 (1.345 to 7.929), and 3.258 (1.685 to 7.266) for the placebo, low dose betahistine, and high dose betahistine groups, respectively. Results were consistent for all secondary outcomes. Treatment was well tolerated with no unexpected safety findings. Without a control group of patients who did not receive any intervention to follow the natural course of the disease, the placebo effect could not be accurately assessed and differentiated from spontaneous remission and fluctuation of symptoms. WHAT THIS STUDY ADDS: Current evidence is limited as to whether betahistine prevents vertigo attacks caused by Meniere's disease, compared with placebo. The trial provides information on symptom relief on placebo intervention which is relevant for the design of future studies on potential disease modifying treatments in patients with Meniere's disease. FUNDING, COMPETING INTERESTS, DATA SHARING: Support from the German Federal Ministry of Education and Research (BMBF support code 01KG0708). Potential competing interests have been reported in full at the end of the paper on thebmj.com. Data are available from the corresponding author ([email protected]) or biostatistician ([email protected]).Study registration EudraCT no 2005-000752-32; ISRCTN no ISRCTN44359668.
the problem I see with this study is, their high dose is a lot lower than the study that results in much higher doses of SERC being effective in stopping vertigo attacks.
The biggest compliment that I can pay it, is that in the early days, when I had forgotten to take it, my Meniere’s would remind me. Not with an attack but with a nudge, sort of ‘hang on something is missing’ sort of way. I take it to this day. It does not stop vertigo attacks in my experience. It may well lessen their severity. This trial would infer that the incidence rate is no better than with a placebo. That is the stance of the FDA is it not? And yet here in the UK we are prescribed it as a first line of defence after the low salt advice. The fact that “the placebo effect could not be accurately assessed and differentiated from spontaneous remission and fluctuation of symptoms” is of course the curse that besets us all as we try to unravel our symptoms and the associated causes and effects.
jaypr I am so glad it stops vertigo for you. But I wish they would have given the people on the high doses that the other study did which I think it was 288mg-488mg or something like that and see if they got the same good results. Its frustrating when a study comes out with poor results about a medication but doesn't use the proper dose. It would be like doing a trial on antivirals and giving the subjects 500 mg or 1000 mg a day of Valtrex. OFC the results are going to show poor results