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Methodological aspects of clinical trials in tinnitus: a proposal for an international standard
Authors:Michael Landgrebe  Andréia Azevedo  David Baguley  Carol Bauer  Anthony Cacace  Claudia Coelho  John Dornhoffer  Ricardo Figueiredo  Herta Flor  Goeran Hajak  Paul van de Heyning  Wolfgang Hiller  Eman Khedr  Tobias Kleinjung  Michael Koller  Jose Miguel Lainez  Alain Londero  William H Martin  Mark Mennemeier  Jay Piccirillo  Dirk De Ridder  Rainer Rupprecht  Grant Searchfield  Sven Vanneste  Florian Zeman  Berthold Langguth
Institution:Department of Psychiatry and Psychotherapy, University of Regensburg, Germany. michael.landgrebe@klinik.uni-regensburg.de
Abstract:Chronic tinnitus is a common condition with a high burden of disease. While many different treatments are used in clinical practice, the evidence for the efficacy of these treatments is low and the variance of treatment response between individuals is high. This is most likely due to the great heterogeneity of tinnitus with respect to clinical features as well as underlying pathophysiological mechanisms. There is a clear need to find effective treatment options in tinnitus, however, clinical trials differ substantially with respect to methodological quality and design. Consequently, the conclusions that can be derived from these studies are limited and jeopardize comparison between studies. Here, we discuss our view of the most important aspects of trial design in clinical studies in tinnitus and make suggestions for an international methodological standard in tinnitus trials. We hope that the proposed methodological standard will stimulate scientific discussion and will help to improve the quality of trials in tinnitus.
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