***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: The Tinnitus Research Consortium ( TRC ) issued a Request for Proposals in 2003 to develop a new tinnitus outcome measure that would : ( 1 ) be highly sensitive to treatment effects ( vali date d for " responsiveness " ) ; ( 2 ) address all major dimensions of tinnitus impact ; and ( 3 ) be vali date d for scaling the negative impact of tinnitus . A grant was received by M. Meikle to conduct the study . In that observational study , all of the TRC objectives were met , with the final 25-item Tinnitus Functional Index ( TFI ) containing eight subscales . The study was published in 2012 , and since then the TFI has received increasing international use and is being translated into at least 14 language s. The present study utilized data from a r and omized controlled trial ( RCT ) that involved testing the efficacy of  " telephone tinnitus education " as intervention for bothersome tinnitus . These data were used to confirm results from the original TFI study . Overall , the TFI performed well in the RCT with Cohen 's d being 1.23 . There were large differences between the eight different subscales , ranging from a mean 13.2-point reduction ( for the Auditory subscale ) to a mean 26.7-point reduction ( for the Relaxation subscale ) . Comparison of TFI performance was made with the Tinnitus H and icap Inventory . All of the results confirmed sensitivity of the TFI along with its subscales . This article is part of a Special Issue entitled OBJECTIVE Using a r and omized group design , the efficacy of an outpatient cognitive-behavioral Tinnitus Coping Training ( TCT )  was compared to two minimal-contact ( MC ) interventions . METHODS TCT was conducted in a group format with 11 sessions ( total n=43 ) . One MC [ MC-E ( education ) , n=16 ] consisted of two group sessions in which education on tinnitus was presented and self-help strategies were introduced . The second MC [ MC-R ( relaxation ) , n=16 ] comprised four sessions . Besides education , music-supported relaxation was suggested as self-help strategy and audiotapes with relaxing music were provided . Furthermore , a waiting-list control group was installed ( WC , n=20 ) . Data were assessed at baseline ( pretherapy ) and at posttherapy period . Only  TCT  was additionally evaluated at a 6-month and a 12-month follow-up . Several outcome variables ( e.g. , awareness of tinnitus ) were recorded in a tinnitus diary . Tinnitus coping and disability due to tinnitus were assessed by question naires . Subjective ratings of improvement were also requested from the patients . Furthermore , inventories of psychopathology were given to the patients . RESULTS Findings reveal highly significant improvements in  TCT  in comparison to the control group ( WC ) . MC interventions do not differ significantly from each other , but are superior to WC in a few domains of outcome . Outcome in TCT is somewhat superior to combined MC interventions in two domains of data , but not regarding disability reduction . Effect sizes , nevertheless , indicate distinct differences in degree of improvement , with TCT achieving the best results . CONCLUSIONS A sequential scheme for the treatment of chronic tinnitus  is discussed on the basis of cost-effectiveness considerations Many tinnitus sufferers believe that their tinnitus has an organic basis and thus seek medical rather than psychological treatments . Tinnitus has been found to be associated with negative appraisal , dysfunctional attention shift , and heightened psychophysiological arousal , so cognitive-behavioral interventions and biofeedback are commonly suggested as treatments . This study developed and investigated the efficacy of a biofeedback-based cognitive-behavioral treatment for tinnitus . In total , 130 tinnitus patients were r and omly assigned to an intervention or a wait-list control group . Treatment consisted of 12 sessions of a biofeedback-based behavioral intervention over a 3-month period . Patients in the wait-list group participated in the treatment after the intervention group had completed the treatment . Results showed clear improvements regarding tinnitus annoyance , diary ratings of loudness , and feelings of controllability . Furthermore , changes in coping cognitions as well as changes in depressive symptoms were found . Improvements were maintained over a 6-month follow-up period in which medium-to-large effect sizes were observed . The treatment developed and investigated in this study is well accepted and leads to clear and stable improvements . Through demonstration of psychophysiological interrelationships , the treatment enables patients to change their somatic illness perceptions to a more psychosomatic point of view For the first time , the therapeutic effects on  subacute and chronic tinnitus  of an inpatient multimodal treatment concept based on principles of Ericksonian hypnosis ( EH ) were examined by st and ardized criteria of the Tinnitus Question naire ( TQ ) and Health Survey ( SF-36 ) within a controlled prospect i ve , longitudinal study . A total of 393 patients were treated within an inpatient closed-group 28-day- setting based on a re source -oriented , hypnotherapeutic concept . The severity of tinnitus was assessed by TQ at times of admission , discharge and also at a 6- and 12-month follow-up . Health-related quality of life was evaluated before and after therapy using the SF-36 . After therapy , a decrease in TQ score was seen in 90.5 % of the patients with subacute tinnitus and in 88,3 % of those with chronic tinnitus . Assessment of the TQ score at the end of therapy revealed highly significant improvements of 15.9/14.1 points in mean . Effect sizes in the treatment groups ( 0.94/0.80 ) were superior to those in the waiting-list controls ( 0.14/0.23 ) . The TQ score remained stable in the follow-up controls . Significant improvement in health-related quality of life has been observed within the treatment groups depending on initial level of tinnitus serverity I – IV according to TQ . Using a multimodal treatment concept with emphasis on re source -activating approaches of EH the annoyance of tinnitus can be significantly reduced while health-related quality of life is enhanced within a comparatively short treatment period of 28 days Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more Since very little is understood about the exact aetiology of tinnitus , this has made treatment of the condition difficult . Even though approximately 10 - 15 % of the general population suffer from tinnitus , only 2 % consider it serious enough to warrant any treatment . The main problem arising from tinnitus is the disturbance it causes not only in day to day life but also in sleep , leading to fatigue and general discomfort . The present study focused on the effect of Melatonin in conjunction with Sulodexide as a treatment method for tinnitus . Overall , 102 patients suffering from tinnitus were evaluated in a prospect i ve r and omised controlled study conducted in a tertiary care ENT department . After r and omisation , 34 patients were treated with Melatonin and Sulodexide , another 34 were treated with Melatonin alone , while the remaining 34 ( control group ) were managed without treatment in order to evaluate spontaneous variations in the quality of tinnitus . Patients were assessed prospect ively with the Tinnitus H and icap Inventory and Acufenometry , both pre- and post-treatment . Among the patients studied , better results with both Tinnitus H and icap Inventory and Acufenometry were found in the group who received Melatonin and Sulodexide compared to those receiving Melatonin alone . No improvement was observed in the control group . In conclusion , Melatonin in combination with Sulodexide is , in our opinion , a viable treatment option for patients suffering from central or sensorineural tinnitus Objectives Question naires are essential for measuring tinnitus severity and intervention-related change but there is no st and ard instrument used routinely in research setting s. Most tinnitus question naires are optimised for measuring severity but not change . However , the Tinnitus Functional Index ( TFI ) cl aims to be optimised for both . It has not however been fully vali date d for research purpose s. Here we evaluate the relevant psychometric properties of the TFI , specifically the question naire factor structure , reproducibility , validity and responsiveness guided by quality criteria for the measurement properties of health-related question naires . Methods The study involved a retrospective analysis of data collected for 294 members of the general public who participated in a r and omised controlled trial of a novel tinnitus device ( Clinical Trials.gov Identifier : NCT01541969 ) . Participants completed up to eight commonly used assessment question naires including the TFI , Tinnitus H and icap Inventory ( THI ) , Tinnitus H and icap Question naire ( THQ ) , a Visual Analogue Scale of loudness ( VAS-Loudness ) , Percentage Annoyance question , the Beck 's Depression Inventory ( BDI ) , Beck 's Anxiety Inventory ( BAI ) , and the World Health Organisation Quality of Life-Bref ( WHOQOL-BREF ) . A series of analyses assessed the study objectives . Forty four participants completed the TFI at a second visit ( within 7–21 days and before receiving any intervention ) providing data for reproducibility assessment s. Results The 8-factor structure was not fully confirmed for this general ( non- clinical ) population . Whilst it was acceptable st and alone subscale , the ‘ auditory ’ factor showed poor loading with the higher order factor ‘ functional impact of tinnitus ’ . Reproducibility assessment s for the overall TFI indicate high internal consistency ( α = 0.80 ) and extremely high reliability ( ICC : 0.91 ) , whilst agreement was borderline acceptable ( 93 % ) . Construct validity was demonstrated by high correlations between scores on the TFI and THI ( r = 0.82 ) and THQ ( r = 0.82 ) , moderate correlations with VAS-L ( r = 0.46 ) , PR-A ( r = 0.58 ) , BDI ( r = 0.57 ) , BAI ( r = 0.39 ) and WHOQOL ( r = −0.48 ) . Floor effects were observed for more than 50 % of the items . A smallest detectable change score of 22.4 is proposed for the TFI global score . Conclusion Even though the proposed 8-factor structure was not fully confirmed for this population , the TFI appears to cover multiple symptom domains , and to measure the construct of tinnitus with an excellent reliability in distinguishing between patients . While the TFI may discriminate those whose tinnitus is not a problem , floor effects in many items means it is less appropriate as a measure of change in this subgroup . Further investigation is needed to determine whether these effects are relevant in other population The main component of tinnitus retraining therapy ( TRT ) is structured counseling . We conducted a r and omized clinical trial to test the hypothesis that group educational counseling based on TRT principles would effectively treat veterans who have clinical ly significant tinnitus . Veterans with clinical ly significant tinnitus were r and omized into one of three groups : educational counseling , traditional support , and no treatment . Subjects in the first two groups attended four 1.5 h group sessions each week . All subjects completed outcome question naires at baseline and at 1 , 6 , and 12 mo . A total of 269 subjects participated : 94 in the educational counseling group , 84 in the traditional support group , and 91 in the no-treatment group .  Statistical analyses showed that educational counseling provided significantly more benefit than either traditional support or no treatment , as measured by the Tinnitus Severity Index . Results suggest that group educational counseling can significantly benefit many  tinnitus patients and could be integral to a " progressive intervention " approach to tinnitus clinical management Objective The aim of this study was to investigate if cognitive behavior therapy ( CBT ) provided via the Internet results in significant decreases of distress in individuals with tinnitus . Methods Participants were recruited through Web pages and newspaper articles and thereafter r and omly allocated to a CBT self-help manual in six modules or to a waiting-list control group ( WLC ) . All treatment and contact with participants were conducted via the Internet with Web pages and E-mail correspondence . Participants were 117 individuals with tinnitus of duration of more than 6 months . In the first r and omized controlled phase of the study , 26 completed all stages of treatment ( 51 % dropout ) , and 64 of the WLC group completed measures . At 1-year follow-up , all participants had been offered the program and 96 provided outcome measures ( 18 % dropout rate from baseline ) . Tinnitus-related problems were assessed before and after treatment and at the 1-year follow-up . Daily diary ratings were included for 1 week before and 1 week following the treatment period . Results Tinnitus-related distress , depression , and diary ratings of annoyance decreased significantly . Immediately following the r and omized controlled phase ( with a WLC ) , significantly more participants in the treatment group showed an improvement of at least 50 % on the Tinnitus Reaction Question naire . At the uncontrolled follow-up , 27 ( 31 % ) of all participants had achieved a clinical ly significant improvement . Conclusions CBT via the Internet can help individuals decrease annoyance associated with tinnitus . High dropout rates or delay in completing treatment can be a characteristic of treatment studies using the Internet but should be contrasted with the cost effectiveness and accessibility of the Internet Background Tinnitus , the perception of sound in absence of an external acoustic source , impairs the quality of life in 2 % of the population . Since in most cases causal treatment is not possible , the majority of therapeutic attempts aim at developing and strengthening individual coping and habituation strategies . Therapeut 
    Output:
    
RESULTS The evidence strongly favored a statistically significant decrease in the impact of tinnitus over time , though there was significant heterogeneity and clinical significance can not be interpreted .
Outcome data regarding secondary measures did not demonstrate any clinical ly significant change .
Participants allocated to the no-intervention or waiting-list control arm of clinical trials for a tinnitus intervention show a small but significant improvement in self-reported measures of tinnitus with time ; the clinical significance of this finding is unknown .
There is , however , considerable variation across individuals .