Methodological aspects of clinical trials in tinnitus: A proposal for an international standard

Department of Psychiatry and Psychotherapy, University of Regensburg, Germany.
Journal of psychosomatic research (Impact Factor: 2.74). 08/2012; 73(2):112-21. DOI: 10.1016/j.jpsychores.2012.05.002
Source: PubMed


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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Available from: Eman Khedr, May 07, 2014
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    • "are but a few questionnaires used to measure various parameters of therapy outcomes (Phillips & McFerran, 2010). Landgrebe et al. (2012; pp.116) described an outcome measurement as " the single most important factor in conducting a clinical trial in tinnitus. " Clinicians use knowledge about how well treatment works when deciding how best to treat their patients. "
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    ABSTRACT: In Europe alone, over 70 million people experience tinnitus; for seven million people, it creates a debilitating condition. Despite its enormous socioeconomic relevance, progress in successfully treating the condition is somewhat limited. The European Union has approved funding to create a pan-European tinnitus research collaboration network (2014–2018). The goal of one working group is to establish an international standard for outcome measurements in clinical trials of tinnitus. Importantly, this would enhance tinnitus research by informing sample-size calculations, enabling meta-analyses, and facilitating the identification of tinnitus subtypes, ultimately leading to improved treatments. The first meeting followed a workshop on " Agreed Standards for Measurement: An International Perspective " with invited talks on clinimetrics and existing international initiatives to define core sets for outcome measurements in hearing loss (International classification of functioning , disability, and health core sets for hearing loss) and eczema (Harmonizing outcome measures for eczema). Both initiatives have taken an approach that clearly distinguishes the specification of what to measure from that of how to measure it. Meeting delegates agreed on taking a step-wise roadmap for which the first output would be a consensus on what outcome domains are essential for all trials. The working group seeks to embrace inclusivity and brings together clinicians, tinnitus researchers, experts on clinical research methodology, statisticians, and representatives of the health industry. People who experience tinnitus are another important participant group. This meeting report is a call to those stakeholders across the globe to actively participate in the initiative.
    Full-text · Article · Dec 2014 · Trends in Amplification
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    • "Recently there has been a growing interest in how the separate psychoacoustic characteristics of the tinnitus signal (e.g., loudness, pitch, noise vs. pure tone) are encoded and how their changes affect neuronal processing in the tinnitus aversive network (van der Loo et al., 2009; Vanneste et al., 2010; Adamchic et al., 2012a). Traditionally therapeutic interventions have been evaluated either in their effects on tinnitus distress or on tinnitus loudness (Aazh et al., 2008; De Ridder and Vanneste, 2011; Landgrebe et al., 2012; Tass et al., 2012). However, recent results suggest existence of an interdependence between perceptual characteristics of tinnitus and the related handicap. "
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    ABSTRACT: Neuroimaging studies have identified networks of brain areas and oscillations associated with tinnitus perception. However, how these regions relate to perceptual characteristics of tinnitus, and how oscillations in various frequency bands are associated with communications within the tinnitus network is still incompletely understood. Recent evidence suggests that apart from changes of the tinnitus severity the changes of tinnitus dominant pitch also have modulating effect on the neuronal activity in a number of brain areas within the tinnitus network. Therefore, in a re-analysis of an existing dataset, we sought to determine how the oscillations in the tinnitus network in the various frequency bands interact. We also investigate how changes of tinnitus loudness, annoyance and pitch affect cross-frequency interaction both within and between nodes of the tinnitus network. Results of this study provide evidence that in tinnitus patients, aside from the previously described changes of oscillatory activity, there are also changes of cross-frequency coupling (CFC); phase-amplitude CFC was increased in tinnitus patients within the auditory cortex and the dorsolateral prefrontal regions between the phase of delta-theta and the amplitude of gamma oscillations (Modulation Index [MI] 0.17 in tinnitus patients vs. 0.08 in tinnitus free controls). Moreover, theta phase in the anterior cingulate region modulated gamma in the auditory (MI 0.1) and dorsolateral prefrontal regions (MI 0.19). Reduction of tinnitus severity after acoustic coordinated reset therapy led to a partial normalization of abnormal CFC. Also treatment induced changes in tinnitus pitch significantly modulated changes in CFC. Thus, tinnitus perception is associated with a more pronounced CFC within and between nodes of the tinnitus network. Cross-frequency coupling can coordinate tinnitus-relevant activity in the tinnitus network providing a mechanism for effective communication between nodes of this network.
    Full-text · Article · Sep 2014 · Frontiers in Neuroscience
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    • "Perhaps this finding indicates that despite the combined and conventional fittings provide the same reduction in the discomfort resulting from tinnitus, it could be that the combined use is more effective in reducing the magnitude of tinnitus , in respect of the loudness. We believe that further studies are required to prove this hypothesis, as in general the tinnitus loudness varies between 5 and 10 dB and does not correlate with the degree of discomfort (Landgrebe et al., 2012). In our study, the mean was 10.2 dB (combined fitting) and 9 dB (amplification alone) before using the hearing aids, turning to 7.2 dB (p < .01) "
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    ABSTRACT: Hearing aids with an integrated sound generator have been used to enhance the treatment of tinnitus. The main aim of this study was to verify whether the combined use of amplification and sound generator is more effective than conventional amplification alone in reducing tinnitus annoyance by means of the use of a new hearing aid with an integrated sound generator. A total of 49 patients underwent a blind randomized clinical trial. Tinnitus annoyance was measured by Tinnitus Handicap Inventory and numerical scales, and psychoacoustic measures of tinnitus were also performed. The sound generator was set at the lowest intensity capable of providing relief from tinnitus. Results showed that 62.5% of the patients presented a reduction in tinnitus annoyance in the combined fitting group and in the group with amplification alone, 78% showed a reduction. This difference between the groups was not statistically significant.
    Full-text · Article · May 2014 · Trends in hearing
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