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Did not notice the BEMED trial

Posted by rgürkov on 31 May 2017 at 19:16 GMT

Letter to the editor:
One missing piece of information strikes the eye of every reader who has a minimum of knowledge or experience in the field: The prospective double-blind placebo-controlled multicentre-trial on the efficacy of Betahistine in patients with Menière’s disease (1). This trial (BEMED trial) was conducted in 14 universitary medical centres throughout Germany from 2008-2013, according to the rules and regulations fo the German Federal Drug Agency, and the results were published more than a year ago in the British Medical Journal. In this trial, 221 patients were included, and the treatment duration was 9 months, plus a 3 months follow-up period. The results were very clear and unambiguous for the vertigo attacks (=primary endpoint) as well as for all secondary endpoints:

There was no difference between Placebo and Betahistine.

It is basic knowledge ever since in the field that this huge trial is by far the highest quality data worldwide existent on the question of whether Betahistine has any effect. This trial was supported by the German Federal Ministry of Education and Research and, in addition, the data of this trial were given to Abbott in return for financial compensation (1).

This trial therefore should be part of the list of references discussed in the article by Parfenov et al.

R. Gürkov
Department of Otorhinolaryngology Head and Neck Surgery
University of Munich, Germany

References:
1. Adrion C, Fischer CS, Wagner J, et al. 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). BMJ 2016;352:h6816.

Competing interests declared: Consultant for Otonomy Inc (past).
National Coordinating Investigator in a randomized clinical trial of Oto-104 (present).
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