Methodological aspects of clinical trials in tinnitus: a proposal for an international standard.
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.
Department of Psychiatry and Psychotherapy, University of Regensburg, Germany. michael.landgrebe@klinik.uni-regensburg.de
Michael
M
Landgrebe
Andréia
A
Azevedo
David
D
Baguley
Carol
C
Bauer
Anthony
A
Cacace
Claudia
C
Coelho
John
J
Dornhoffer
Ricardo
R
Figueiredo
Herta
H
Flor
Goeran
G
Hajak
Paul
P
van de Heyning
Wolfgang
W
Hiller
Eman
E
Khedr
Tobias
T
Kleinjung
Michael
M
Koller
Jose Miguel
JM
Lainez
Alain
A
Londero
William H
WH
Martin
Mark
M
Mennemeier
Jay
J
Piccirillo
Dirk
D
De Ridder
Rainer
R
Rupprecht
Grant
G
Searchfield
Sven
S
Vanneste
Florian
F
Zeman
Berthold
B
Langguth
D002986:Clinical Trials as Topic / Q000592:standards*; D019317:Evidence-Based Medicine; D006801:Humans; D012107:Research Design / Q000592:standards*; D014012:Tinnitus / Q000628:therapy*