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How to cite this article Cevette MJ, Barrs DM, Patel A, Conroy KP, Sydlowski S, Nelson BNNGA, Stepanek J, et al. Background: Recent studies in noise-induced and idiopathic sensorineural hearing loss have suggested that magnesium supplementation may lessen both hearing loss and the severity of tinnitus in patients.
Descriptions of tinnitus date back to the time of ancient Egypt, yet science has failed to unravel the mysterious underlying mechanisms that produce these subjective auditory perceptions of sound. Despite these encouraging findings, no controlled study has examined the effect of magnesium supplementation for patients with moderate to severe tinnitus. Between March 6 and December 10, 2008, patients aged 18 years or older who were seen for an audiological evaluation at Mayo Clinic in Scottsdale, Arizona, and who had a Tinnitus Distress Rating (TDR) scale score from 3 through 8 (Figure 1) were eligible for the study. Participants were given a daily magnesium supplement, 532 mg (Mg Plus Protein, 133-mg tablets; Miller Pharmacal Group, Carol Stream, Illinois).
The primary outcome measures were comparisons of TDR scale scores and THI scores as converted to TSS grades at baseline and the end of the study.
The present study indicated that subjects showed significant improvement in their self-rating of tinnitus with a magnesium supplement of 532 mg daily for 3 months. INTRODUCTION: Tinnitus Handicap Inventory (THI) was developed in English to quantify the handicap caused due to tinnitus. OBJECTIVES: India being a multilingual country needs to develop and standardize THI in Indian languages.
MATERIALS AND METHODS: Questions from English version of THI were translated and modified by two professionals who have a degree of MA Kannada. RESULTS: Analysis revealed 14% of the patients fall under the category of Slight, 38% under Mild, 26% under Moderate, 16% under Severe and 6% under Catastrophic group. CONCLUSION: Scores of Cronbach-alpha test shows that Kannada version of THI is a standard and reliable tool for measuring the handicap caused by tinnitus and can successfully classify individuals on a severity basis. Recent interest has surfaced in symptom - specific handicap outcome measures for many audiological and otological diseases4. A symptom specific assessment of many otological disorders will aid in understanding the severity of the symptom and effects of this on routine life. The English version of THI which is shown in Appendix 1 was the only tool available for quantifying the handicap caused by tinnitus. The beta version of THI developed by Newman and Jacobson in 1996 consists of 25 questions under the 3 sub scales of emotional, functional and catastrophic. Individuals who were suffering from tinnitus with or without any otological diseases were selected for the study. Tinnitus questionnaire was administered on the participants using a structured interview by the clinician to have a record of the demographic details and to cognize the type, nature, and the lateralization of the tinnitus, factors that affect tinnitus, presence of hearing loss, and the concern about the tinnitus. Following the administration of the tinnitus questionnaire, the participants were instructed regarding the self - assessing Kannada version of THI, its importance and the system to grade it. Among all the participants, 94% of the participants had a minimum qualification of SSLC and a maximum qualification of a degree and could fill up the Kannada version of THI without the help of the clinician. The results of the THI and the self assessing questionnaire were tabulated and are graphically represented below in Graph 1. After the complete analysis of the obtained data, the percentages of the patients coming under various severities were found out.
The purpose of this study was to develop a handicap inventory in native language (Kannada), to obtain a standard measurement instrument for evaluating tinnitus in patients to apprehend the effects caused due to tinnitus.
From the study, we could observe that the perception of tinnitus handicap differs drastically between subjects as demonstrated by high values of standard deviations, which may be due to effective coping starategies5. Related to the emotional aspects, the Kannada THI allows assessing the relation between tinnitus and manifestation of stress, depression, anxiety & frustration. The result of the current study shows good reliability and internal consistency as indicated by the Cronbach alpha test.
Hence this inventory can serve as an effective tool to successfully classify the individuals into different grades according to the symptoms. Since the main focus of this study was to develop and standardize the THI into Kannada language, and to be administered on all Kannada patients who complain of tinnitus. The main aim of this study was to develop and standardize the Tinnitus Handicap Inventory in Kannada; hence it can be administered on Kannada patients without difficulty. Paper submitted to the ITJ-SGP (Publishing Management System) on December 17, 2012; and accepted on January 17, 2013. Recent interest has surfaced in symptom-specific handicap outcome measures for many audiological and otological diseases. There is no valid and reliable tinnitus handicap inventory for Turkish people in their native language.
We assessed test-retest reliability with a second investigation in 21 randomly chosen patients.
The three groups of patients were divided according to their ages: 19-39 years, 40-59 years, and 60 years and older.
We tested internal validity by multi-item analysis, to assess item convergent and discriminant validity. This study was designed to obtain the THI as a standard measuring instrument for patients and clinicians all over Turkey.
Tinnitus research in an international context requires standardized and validated questionnaires in different languages. All investigated instruments have high internal consistency, high convergence and discriminant validity and good change sensitivity in an unselected large multinational clinical sample and thus appear appropriate to evaluate the effects of tinnitus treatments in a cross-cultural context. BackgroundTinnitus is an auditory sensation in the absence of any external acoustic stimuli. Material and methodsDatabaseThe data analysis was based on data of the Tinnitus Research Initiative Database. Statistical analysisPatient characteristics are summarized as median values and interquartile ranges (first to third quartiles) for continuous variables as well as frequency counts and percentages for categorical data. ResultsPatient characteristicsOut of n=1318 patients, 1149 were from Germany, 38 from Belgium, 98 from Brazil, and 33 from Argentina. ReliabilityWe calculated the internal consistencies of all questionnaires according to the different languages as well as the item-total correlation coefficients. We evaluated the construct validity of the questionnaires by examining their respective correlations and mean values with the subjective ratings on tinnitus severity.
People with tinnitus often characterize their tinnitus as “ringing in the ears” or a “buzzing sound.” The American Tinnitus Association (ATA) describes it as a subjective noise that only the patient can hear. About 50 million people in the United States experience tinnitus to some degree and, in severe cases, seek medical attention.
HR: Why should hearing care professionals who traditionally focus on hearing impairment get involved in tinnitus? Clint Keifer, AuD: As audiologists, we possess an in-depth understanding of the anatomical, physiological, and psychoacoustical aspects of the auditory system. Wendy Switalski, AuD: In conversations I’ve had as an audiologist and as a consultant to audiologists, it is clear that these conditions coexist for so many of our patients.
Clement Sanchez, AuD: Tinnitus can be a problem for those who are hearing impaired and have a hearing loss. Sanchez: Hearing aids can be very effective if they can reduce the symptoms related to the tinnitus. A clinician can play a vital role in helping the patient deal with the sounds of everyday living, instead of avoiding sounds all together. Switalski: Professionals interested in expanding their services have so many resources available. Practices may begin by simply offering tinnitus assessment, patient questionnaires, or surveys. Keifer: Ideally, practices would be “full-service,” but in practical terms, it is difficult for any one practice to offer every possible solution.
Sanchez: Assessing tinnitus can be challenging, so clinicians who decide to add a full-service tinnitus treatment plan have a few details to consider. Aside from my traditional practice, I used to schedule consultation with tinnitus patients 1 day a week and this worked well. HR: I’ve heard that tinnitus patients can consume huge amounts of practice time and many dispensing professionals are not adequately staffed for that. Sanchez: Yes, tinnitus patients will need time to express their fears, frustrations, and the discomfort they are experiencing because the sounds they hear are unclear and can be difficult to describe. I would describe the tinnitus consultation as “a mix of charisma and empathy,” where clinicians can focus on gathering the information that can benefit the treatment. The MADSEN Astera2 features a dedicated tinnitus assessment module designed to help clinicians address increased claims for tinnitus and hearing loss disability.
The new tinnitus test module we have developed as part of fundamental audiometry in MADSEN Astera2 supports the professional through a series of integrated questionnaires. Keifer: Tinnitus treatment protocols should not be rigid, but rather they should adapt to the individual. The treatment may also involve retraining strategies, amplification, masking, sound therapy device application, support group attendance, and so forth. Sanchez: In addition, it will entail an in-depth hearing assessment, such as audiometry with UCL, immittance, otoacoustic emissions (OAE), and auditory brainstem response (ABR).
The full tinnitus psychoacoustic test battery is designed to improve patient counseling and test precision. Visualization of the tinnitus on the audiogram is a great experience for a patient who has looked for help for years and may have felt misunderstood at times. The electronic questionnaires—Tinnitus Functional Index (TFI), Tinnitus Handicap Inventory (THI) and Tinnitus and Hearing Survey (THS)—can be saved in NOAH and are designed to eliminate the need for paper records. The next step is explaining that, for example, a 7 dB tinnitus is quite a small issue that can be managed. Once again, dialogue with other professionals is important and should be considered from the very beginning.
HR: What types of equipment should you consider for your practice when starting up a tinnitus treatment program? Switalski: Having access to the proper audiometer features is important for performing a tinnitus assessment. Otometrics has developed a dedicated tinnitus management tool for audiologists, which is integrated with our clinical audiometer, the MADSEN Astera2. This article provides a review of studies investigating the pharmacological treatment of tinnitus.
Though success rates of 80% tinnitus control are reported with such treatment modalities as biofeedback [3] and tinnitus retraining therapy [4], these modalities of therapy are time consuming for providers and patients alike.
Until recently, the lack of animal models for tinnitus has further limited our ability to define the role of pharmacological agents in preparation for clinical study. As a result, our objectives here are to review the basic and clinical science evidence for the pharmacological treatment of tinnitus, to assess for consensus on symptom definition and outcome reporting, and to chart a course for future efforts. We searched MEDLINE (1966-2005) for English-language studies combining the word tinnitus with the term medical treatment, pharmacologic , or pharmacological.
We considered evidence in light of study type, design, clarity, and applicability of findings. Tricyclic antidepressants decrease presynaptic reuptake of norepinephrine and serotonin, whereas selective serotonin reuptake inhibitors (SSRIs) decrease reuptake of serotonin only. The results of clinical studies on antidepressants in the treatment of tinnitus are summarized in Table 1. The results of clinical studies of GABA receptor-binding pharmacological agents are presented in Table 2. No consistent symptom definition was identified in these studies, and all populations were essentially convenience samples from clinics or databases. Studies addressing the use of misoprostol in the treatment of tinnitus are summarized in Table 3. The first study had essentially no symptom definition [23], whereas the most recent two were limited to subjective tinnitus of greater than 6 months' duration with fairly specific inclusion and exclusion criteria. The evidence linking various vitamin B deficiencies and treatments with tinnitus are largely anecdotal [7]. Zinc is an essential nutrient that can influence neurotransmission and is present in highest concentration in the human cochlea [31]. The two placebo-controlled trials of zinc were noticeably thorough with symptom definition, including laterality, constant versus intermittent, quality, pitch, association with disease process, and association with audiometric data. EGB761 is the most common isolate of Ginkgo biloba, one of the most ancient medicinal plants recently reported to increase body circulation and having benefits for vascular insufficiency and cognitive function [7].
To isolate subjects likely to respond to treatment, one study [38] started with an open trial of 80 patients, all of whom received treatment. Overall symptom definition was vague in these studies, and no study presented a systematic method by which to identify significant otological disease as a cause of tinnitus. Antidepressants likely have a role in the management of tinnitus concomitant with major depression or depressed symptoms and can help in ameliorating comorbidities in severe or chronic cases of tinnitus. GABA receptor-binding medications, such as benzodiazepines, appear to be reasonable candidates for tinnitus therapy, given the inhibitory role of GABA in the central nervous system. Of all the nutritional supplements, zinc has had the longest history and has been subjected to the most clinical study. The results of studies on Ginkgo biloba as a whole tend to argue against any benefit for the treatment of tinnitus. Given the likely wide range of potential causes of tinnitus, a thorough definition of the patient population must be established. Once outcome measures are decided, a formal inquiry of statistical power should be reported to determine the required number of subjects in all treatment arms.
Basic science models for tinnitus, though limited, should be used to guide more productive study of pharmacological treatments for tinnitus. The views expressed in this article are those of the authors and do not necessarily reflect the official policy or position of the US Department of the Navy, US Department of Defense, or the US Government.
The aim of our study was to outline the prevalence of hyperlipidemia in patients who had high-frequency hearing loss and tinnitus due to noise exposure. Cochlear hair cells and neural and central auditory pathways are involved in the generation of subjective tinnitus [1].
Decrease in internal diameter of the vascular bed resulting from hyperlipidemia compromises the oxygen transportation capability of the blood to the cochlea, and chronic hypoxia is likely to occur by the reduction in oxygen supply of the inner ear, which in turn would lead to insufficient adjustment of the cochlear metabolism. This may result in the overproduction and accumulation of free radicals, which disturb the microcirculation of the cochlea and play an important role in ischemiainduced cochlear injury [7]. The reasons for the susceptibility to noise-induced hearing loss of patients who have been exposed to a noisy environment have been the subject of various studies. Previous data indicate that the cochlea and the central auditory system age faster and earlier in patients with hyperlipidemia and that the risk of noise-induced hearing loss is much higher [5,11]. The aim of this study was to outline the prevalence of hyperlipidemia in patients who had high-frequency hearing loss and tinnitus due to chronic noise exposure and to evaluate the risk of developing sensory hearing loss in those patients as compared to risk in control subjects.
We conducted this prospective study in 120 consecutive patients with complaints of chronic subjective tinnitus of varying degrees of severity and hearing loss due to noise exposure. The patients were examined otoscopically and were reviewed by an audiometric test battery including puretone audiometer (AC-30, IAC, Copenhagen, Denmark), stapes reflex, and tympanometry (Amplaid 775, Milan, Italy). Antilipid treatment with statin derivatives was planned once-daily oral dosing for up to 1-2 years (minimum, 12.4 months).
We then compared tinnitus scores and hearing levels in patients with no response to antihyperlipidemic therapy and in patients who had a normal blood cholesterol level after the treatment. The duration of tinnitus in patients with noise exposure varied from 2 months to 12 years (mean, 5.5 years). Of 22 patients in the unresponsive group, 6 had high cholesterol and triglyceride, 9 had high triglyceride, and 7 had high cholesterol only before the antilipidemic therapy. Of 20 patients in the responsive group, 7 had high cholesterol or triglyceride, 10 had high triglyceride, and 3 had high cholesterol only before the antilipidemic therapy. The difference between the pitch-match frequencies before and after therapy was not significant.
Epidemiological investigations emphasizing the relationship between hearing loss and the risk factors for coronary artery disease date back to the 1960s [18].
Spencer [19] found that 42.3% of 300 patients with different symptoms of inner-ear pathology had clearly defined hyperlipoproteinemia. The effect of hyperlipidemia on auditory perception has been studied clinically and experimentally.
The exact pathological mechanism for the hyperlipidemia-induced hearing loss remains obscure. In his study of 64 rats, Pillsbury [37] exposed half to loud noise and fed half of each subgroup a fat diet and found elevated auditory brainstem response thresholds in the hyperlipidemic animals.
Studies investigating the restorative possibility of a low-cholesterol diet and antihyperlipidemic therapy on hearing loss and tinnitus are very few.
LDL apheresis has been reported to be much more effective as compared with standard prednisolone, dextran, and pentoxifylline therapy in patients with sudden hearing loss [9].
In our study, changes in tinnitus scores before and after therapy in the responsive group were significant as compared with those in the unresponsive group. Tinnitus and hearing loss are frequently encountered after an acute acoustic and blast trauma or chronic noise exposure. Our objective was to compare quality of life, high-frequency audiometry, and loudness-pitch match in individuals with tinnitus with and without hearing loss.
Tinnitus is defined as a sensation of sound perceived by an individual in the absence of an external sound source, and it affects approximately 15% of the population worldwide [1-3]. This study received approval from the ethics committee of the Universidade Federal de Sao Paulo-Brazil (process no. Nonparametric statistical tests and methods were used in order to compare the results of all procedures between the groups (NL and HI). Reporting on tinnitus assessed using high-frequency audiometry, a number of authors posit a difference in the threshold between individuals with and without tinnitus [11]. Only the younger individuals (up to 28 years of age) in the HI group perceived frequencies of 10 and 12 kHz. Regarding the loudness-pitch match, a statistically significant difference was evident between age groups among NL individuals, with older individuals exhibiting loudness that was 78.40% more intense than younger individuals (Fig.
Greater tinnitus intensity in the HI group denoted a worse hearing threshold, which is in agreement with findings from previous studies [16].
Regarding the THI, a previous study found mild handicap (18-36 points) among the group with normal hearing [7]. Analysis of the WHOQOL questionnaire in the general comparison between groups revealed that the HI individuals scored lower on all the subscales in the NL group (Fig. The pitch of the tinnitus is higher among individuals without hearing loss, whereas the opposite is true with regard to loudness. Further epidemiological evidence indicates that all age groups of Americans fall short of the recommended daily allowance for magnesium by 100 mg daily. These perceptions may be manifestations of damage resulting from noise exposure, ototoxicity, or other abnormal conditions of the auditory system. Additionally, no study to date has examined self-reported tinnitus severity before and after magnesium supplementation. The TDR was adapted from an existing pain scale, with the subject rating him- or herself between 0 (no tinnitus) to 10 (worst possible tinnitus). The Tinnitus Handicap Inventory is a 25-item self-report questionnaire that the patient can complete in about 10 minutes.
A review by the Division of Cardiovascular Diseases indicated that daily magnesium supplementation at the level of 532 mg was benign for heart patients whose kidney function was normal.
After beginning magnesium supplementation, the participants rated themselves daily for 3 months using the TDR. The data collected for each participant included informed consent, sex, date of birth, hearing threshold at 8 frequencies (250, 500, 1,000, 2,000, 3,000, 4,000, 6,000, and 8,000 Hz), weekly diaries of daily TDR ratings of tinnitus, THI questionnaires at baseline and the end of the study, dates of first and last dose of magnesium, number of tablets used, reason for discontinuation, and adverse events. Of these, 2 patients (8%) discontinued the study because of adverse events and subsequently had no follow-up data.
Change in tinnitus rating in 26 patients from baseline to 3 months after treatment with magnesium. In fact, significant improvement in the TDR occurred as early as 1 month into the study, suggesting that benefit of magnesium supplementation occurred early in treatment and was sustained throughout the 3 months of the study. Standing Committee on the Scientific Evaluation of Dietary Reference Intakes, Food and Nutrition Board, Institute of Medicine.
PhD, Department of Otolaryngology, Section of Audiology - Mayo Clinic - Scottsdale - AC - United States. MD, Department of Otolaryngology, Head and Neck Surgery - Mayo Clinic - Scottsdale - United States. AuD, Department of Otolaryngology, Section of Audiology - Mayo Clinic - Scottsdale - United States. AuD, Section of Audiology - Cleveland Clinic Head and Neck Institute - Cleveland - United States.
BS, Department of Otolaryngology, Section of Audiology - Mayo Clinic - Scottsdale - United States.
MD, Division of Preventive, Occupational and Aerospace Medicine - Mayo Clinic - Scottsdale - United States. Translated inventory was given to 50 native Kannada speakers for the familiarity check & the most familiar sentences were included in the study. According to the data obtained from the National Center for Health Statistics, tinnitus is more commonly seen in males than females and increases in prevalence with advancing age.
There are two important aspects of symptom - specific evaluation that is generally done by a valid and reliable inventory5.
A Tinnitus Handicap Inventory (THI) was developed in order to measure the handicap caused by tinnitus.
India being a multilingual country with a multicultural background, there is no such inventory available in any of the Indian languages other than in Tamil. For the present study, the English version of THI was translated to Kannada using the standard Translation-back-translation method (Bardley, 1994) by two professors who have a degree of MA in Kannada. Participants were interviewed briefly regarding tinnitus and those who complained tinnitus for more than 3 months were included for the further procedures, so that, they can quantify accurately the physical, emotional and catastrophic impacts of tinnitus on their daily acvtivities. Thereafter based on the subject's grading for all the questions, the total scores were calculated.
Rest percentages of participants were from a lower socio-economic status and could fill up the questionnaire only with the help of the clinician due to their inability to read and understand Kannada. Cronbach alpha test was administered to check for the internal consistency and reliability of the Kannada version of the THI and also an Item-Total Correlation was also carried out.
Thus, according to the Cronbach alpha score, the Kannada version of THI has got a good internal consistency and reliability to administer on the tinnitus patients in the Kannada population.
With the administration of Kannada THI it was found that, all the subjects could quantify the severity of tinnitus from slight degree to catastrophic degree, and thus fulfilled the aim of the study. Tinnitus assessment not only involves to match the tinnitus, ascertain the intensity of the tinnitus and to find out the intensity of wide band noise that can mask the tinnitus, but also involve administration of various inventories like THI to rate and assess the severity of tinnitus in order to help the clinician to counsel the patient as well as to know the level at which the management options should begin8.
With respect to the functional aspect, the Kannada THI allows to identify the relationship between tinnitus and activities involving concentration, hearing acuity, attention & reading. This inventory could easily be understood to all the laymen and 94% of patients could fill the inventory without any help from the clinician. Following all the analysis and standardization, the Kannada version of THI came out successfully for the evaluation of tinnitus and found to be reliable. The Kannada version will help the patients with tinnitus to comprehend the severity and intensity of their problem and also considered as a reliable instrument for the verification of the impairment in the quality of life due to tinnitus. Department of Speech Language Pathology - All India Institute of Speech & Hearing - Mysore - India. Each of two individuals independently translated and retranslated the English version of the THI, and it was adapted by an expert team. That is, clinicians plan to quantify their patients' symptoms, administer their treatment, and get objective results about the patient's satisfaction.
Therefore, most clinicians use their own questionnaires, which lack reliability or validity (or both). This study sought to analyze the validity and reliability of the Turkish version of the THI. Internal consistency reliability of the Turkish version of the THI was assessed using Cronbach's alpha. This was assessed by categorizing the patients into three groups according to their age and according to tinnitus duration. We investigated the differences in the mean values for scale and subscales, though the F test results did not provide significant results. The 25-item inventory can be used in neurootology clinics to evaluate the tinnitus symptom and its impact on knowledge and attitudes toward tinnitus.
After minor alterations in translation and retranslation, scaling assumptions were met satisfactorily for the three multi-item subscales, and the first Turkish-language scale for evaluating tinnitus was developed. The aim of the present set of analyses was the reassessment of basic psychometric properties according to classical test theory of self-report instruments that are being used within the multicentre Tinnitus Research Initiative (TRI) database project. However, some paradoxical correlations between individual items of the TBF-12, constructed as a shortform of the THI, and the corresponding THI-items were seen. Tables 6 and 7 summarize the THI, TBF12, TQ, Mini-TQ, and TQ-12 scores according to the categories of patient-perceived severity (not a problem, a small problem, a moderate problem, a big problem, a very big problem) at baseline and final visit. In some cases of objective tinnitus, physicians can identify the symptom with the use of a stethoscope placed on the neck or directly in the ear canal. There is currently no known cure for tinnitus; however, there are advanced devices and treatments today that can help alleviate tinnitus symptoms. Drs Sanchez, Switalski, and Keifer share their thoughts on the benefits of tinnitus assessment, and provide advice to audiologists and hearing care professionals who are interested in adding tinnitus assessment to their practice. As hearing care professionals, we are skilled in diagnostic, counseling, and rehabilitative approaches to managing auditory disorders.
And for some of them, treating the tinnitus is necessary to address the concerns that led them to seek hearing care in the first place.
They may have difficulty sleeping, be unable to concentrate, and experience irritability and high stress levels. A hearing aid can amplify soft sounds, which can have a “masking” effect and helps to decrease the contrast between the environmental sounds and the tinnitus.
This is an important step to address the patient’s fears and provide supportive tools when the tinnitus is too intense. Today, tinnitus management tools also include sound enrichment devices, sound generation pillows, as well as sound generators like MP3 and relaxing music.
Are there different levels at which practices can participate, or should every hearing care practice seek to have a full-service tinnitus treatment plan? They can also provide informational counseling and supplement their fittings with hearing instruments that include features and options for tinnitus relief. My recommendation would be to offer as many options as possible within the means of the practice and the practitioner.
Collaboration with other professionals like ENTs, psychologists, and general practitioners is helpful. Prior to the consultation, patients can fill out questionnaires in the waiting room to avoid external influences during the test.
While proper diagnostic testing and quantification measures should be performed for hearing and tinnitus aspects, the treatment options will vary greatly based on the individual and should focus on addressing identifiable needs. Tinnitus can be viewed as a spectrum disorder where trying a combination of approaches may be necessary. Highlighted in magnifying glass on lower left is the electronic questionnaires for the TFI, THI, and Tinnitus and Hearing Survey (THS), which saves in NOAH and eliminates the need for paper records.
Clinicians should ensure they are working with a subjective tinnitus and characterization via the existing questionnaires, like the Tinnitus Handicap Inventory (THI), Tinnitus Functional Index (TFI), and Tinnitus Handicap Questionnaire (THQ). Testing efficiency and immediate availability of measurement results allow more time for consultation.
Test results will provide the professional with information concerning the effect of an external sound on the tinnitus. A high-resolution audiometer in frequency (1 Hz) and intensity (1 dB) is required to perform a characterization of the tinnitus.
Today’s clinicians and audiologists can now more effectively evaluate the tinnitus and its impact on the lives of their patients.
Tinnitus continues to be a significant and costly health problem without a uniformly accepted treatment.
It is reported to occur in up to 30% of individuals in those nations, with 10-15% of individuals experiencing symptoms significant enough to require medical attention [1].
Currently, no drug exists with an indication for tinnitus, though several are used "off-label," and side effects can be an issue that limits compliance.


We excluded studies not focused on tinnitus, nonpharmacological articles, and studies addressing a particular neurootological disease.
Heller [1] reviewed classification systems of tinnitus, although none are universally used.
Although the anticholinergic, antihistaminic, and adrenergic activities of tricyclic antidepressants are postulated to play a role in the mitigation of tinnitus [9], no basic science studies have demonstrated a plausible biological mechanism. In a small study, trimipramine failed to demonstrate any subjective or audiometric benefit over placebo [9].
Decreased GABA activity is postulated as a potential causative factor for tinnitus that results from abnormal activation of central nervous system auditory pathways.
Alprazolam, a drug that potentiates GABA activity at GABA-A receptors, was found to decrease both subjective loudness and intensity matching of tinnitus in a double-blind, placebo-controlled, prospective study [18]. Subjective outcomes measures ranged from yes or no responses on tinnitus improvement, to visual analog scales, to the 25- question THI. In guinea pigs, a model of prostaglandin activity suggested that prostaglandins may act as neuromodulators of cochlear afferent transmission [22].
The first demonstrated a subjective report of 33% response to active treatment as compared to 0% with placebo treatment and showed that responders to medication had statistically significantly decreased subjective rating-scale scores of tinnitus after 16 days of treatment, as compared to the scores of nonresponders [23]. Subjective outcome measures were limited to yes or no improvement replies and visual analog scales, without any tools to measure impact of tinnitus on functioning.
In a double-blind, placebo-controlled, prospective trial of 48 patients treated with nicotinamide (vitamin B3), results were no better than those from placebo [29]. The reported incidence of zinc deficiency in patients with tinnitus is inconsistent, with some reporting a positive correlation [31-35] and others finding no relationship [36,37].
All studies used an analog subjective tinnitus rating scale-either from 0 to 7 or from 0 to 10-as the main outcome measure, with one trial [35] using loudness matching as an additional outcome measure. Improvement in blood circulation to the organ of Corti has been suggested as a mechanism for ameliorating tinnitus [38]. One trial demonstrated a statistically significant decrease in tinnitus loudness matching as compared with results from placebo [40]. Only those who reported some improvement (n = 21) were invited into a randomized, placebo-controlled, crossover study.
Similarly, despite their widespread use and in the absence of compelling clinical evidence, none of the commonly advocated nutritional supplements are any more effective than is placebo in tinnitus control.
In particular, several animal studies suggested that changes in the GABA-A-receptor binding in the brainstem and inferior colliculus may be responsible for tinnitus, though the relationships are complex.
The zinc studies have similar characteristics, although a trend toward helping elderly patients with zinc deficiency was identified [36].
Given the lack of adequate basic science models, disparity in symptom definitions and outcome measures, and overall lack of power of past studies, it is also not possible to exclude most (if not all) of the reviewed treatments from future analysis.
Such models as conditioned lick suppression in the presence of sound [46] still rely on salicylate toxicity that may not accurately mimic the wide range of potential causes of tinnitus. Studies should include a table that offers information on age, gender, subjective versus objective tinnitus, laterality, constant versus intermittent, location (central versus cochlear), duration, hearing function, any known tinnitus causing disease, psychiatric illness, systemic illness, current medications for tinnitus, past medications for tinnitus, and baseline measures of the impact of tinnitus on quality of life. However, every effort should be made to use subjective measures that have clinical significance, with an a priori decision on the defined level of improvement that constitutes a relevant outcome.
Studies should be prospective, randomized, doubleblind, placebo-controlled, crossover investigations with adequate washout time between placebo and active treatment.
Low-Cholesterol Diet and Antilipid Therapy in Managing Tinnitus and Hearing Loss in Patients with Noise-Induced Hearing Loss and Hyperlipidemia.
We investigated the role of a low-cholesterol diet and antihyperlipidemic therapy to alleviate the severity of tinnitus and possibly promote hearing gain after therapy in patients with acoustic trauma. Analysis of the epidemiological data indicates that exposure to noise is widespread and is one of the most common causes of tinnitus, which leads to various somatic and psychological disorders and interferes with the quality of life [2]. Auditory perception in such cochleas is very sensitive to reduction of the oxygenation in the inner ear [6]. Platelet aggregation and blood viscosity due to high lipid levels will intensify inner-ear damage owing to slowing of microcirculation and will contribute to the development of both progressive and sudden hearing loss [8,9]. Gratton and Wright [10] demonstrated the accumulation of lipid in the stria vascularis and outer hair cells in chinchillas after experimentally induced hypercholesterolemia, which might intensify the detrimental effect of ototoxic drugs or noise. We instituted a low-cholesterol diet and antihyperlipidemic therapy to investigate whether any benefit accrued in terms of hearing gain and tinnitus relief. The project was approved by the local medical research ethical committee, and we obtained informed consent from each patient. Audiometric tests included air- and boneconduction thresholds for pure tones of 125-8,000 Hz, tests of speech reception and speech discrimination, contralateral and ipsilateral reflex measurements, and tympanometry. Measurement of loudness of the tinnitus was based on subjective assessment by the patients.
Daily dosage ranged from 10 to 40 mg for simvastatin (Zocor) and from 10 to 80 mg for atorvastatin calcium (Lipitor). Average ages of patients in the unresponsive and the responsive groups were 39 and 42 years, respectively. Wilcoxon and Mann-Whitney U tests were used to compare the pretreatment data with the posttreatment results and to compare the results of responders and nonresponders. None of these patients demonstrated any drop to normal ranges in cholesterol or triglyceride values after the treatment. When those patients were asked to qualify the severity of their tinnitus, seven rated their tinnitus as the same (35%), two rated it as increased (10%), seven rated it as decreased (35%), and four had no tinnitus (20%). The correlation between serum lipids and auditory dysfunction has been investigated before, and it has been reported that sensorineural hearing loss is more prominent in those with high levels of cholesterol, triglyceride, and lowLDL and in patients with low HDL concentration [18-23].
Increased blood viscosity and atherosclerosis of the cochlear vessels reduce the blood perfusion of the cochlea and promote hearing impairment [6,8,19,20,23,24].
When patients were required to qualify the severity of their tinnitus, 35% of the patients in the responsive group rated their tinnitus as decreased, and 20% of patients reported no tinnitus. Even though other factors making the patients susceptible to noise-induced hearing loss should be considered, on the basis of present results it can be concluded that the incidence of hyperlipidemia is high among patients with noise-induced hearing loss and that significant improvement in lowered intensity of tinnitus and in average hearing thresholds at higher frequencies can be achieved after lowering patients' serum lipid level [43]. Impact of Tinnitus on Quality of Life, Loudness and Pitch Match, and High-Frequency Audiometry. A study carried out on a random sample (45% men and 55% women) in a large Brazilian city found that 25% of the interviewees complained of tinnitus [4]. WHOQOL [9,10] questionnaire: Investigation of quality of life, addressing mental health, motor skills, and cognitive and social aspects.
We used the Mann-Whitney test for the analysis of the questionnaires, high-frequency audiometry, and loudness-pitch match. Although we did not include any individuals without tinnitus in the present study, the NL group demonstrated a frequency difference of 18 kHz, as those up to 28 years of age perceived this frequency, whereas older individuals did not (Fig.
Mean high-frequency audiometry values comparing individuals with and without hearing loss according to age group.
Mean loudness values of tinnitus comparing individuals with and without hearing loss according to age group.
Mean pitch values of tinnitus comparing individuals with and without hearing loss according to age group. A statistically significant difference was evident between NL and HI groups with regard to loudness (see Fig.
Mean handicap values on Tinnitus Handicap Inventory comparing individuals with and without hearing loss according to age group. Comparison of mean World Health Organization Quality of Life (Abbreviated) values comparing individuals with and without hearing loss according to questionnaire subscales. Individuals with tinnitus and hearing impairment have higher high-frequency thresholds, with complete hearing loss at some frequencies, as compared to those without hearing loss. The handicap caused by tinnitus is moderate among individuals with hearing impairment and in older individuals with normal hearing, whereas this handicap is mild among younger individuals with normal hearing. Purpose: The purpose of this study was to examine any potential benefit in lessening the severity of tinnitus in patients taking supplemental magnesium. However, many individuals have idiopathic tinnitus for which no specific cause can be determined. For example, the putative magnesium mechanism within the auditory system involves a metabolic cellular cascade of events. The purpose of this study was to examine any potential lessening of the severity of tinnitus in patients receiving magnesium supplementation. The Tinnitus Handicap Inventory (THI) and Tinnitus Severity Scale (TSS) (Table 1), developed by McCombe et al. A review by the Mayo Pharmacy indicated that there were no major drug interactions with magnesium at the levels of the current protocol. Differences in TDR scores before and after supplementation were compared to determine any effect of supplementation on a participant's self-rated tinnitus. The adverse event data included the date of onset and whether the adverse event led to premature discontinuation of the intervention. The THI was measured at the time of discontinuation if a patient discontinued the study before 3 months. Tinnitus questionnaire was then administered, followed by the Kannada version of THI on 140 patients and total scores were obtained.
The diagnosis and rational management of tinnitus is one of the legacies of the past millennium, which the medical profession has carried unsolved to this century2. Initially, the self-assessment tool assesses the severity of symptoms and provides objective data about the severity of the symptomand later, the evaluation allows investigators to accurately assess and compare the pre-treatment and post-treatment periods. THI is a method of quantifying the impact that tinnitus has on an individual's daily living conditions.
The translated form of the inventory was given to 50 native Kannada speakers who were exposed to Kannada language or had first language as Kannada, who were able to read and write Kannada, for the content validation. Individuals with any significant neurological history, history of psychiatric or psychological counseling with regard to their tinnitus were excluded from the study.
Under the functional subscale, 30% of responses were for YES and 50% of responses were for NO and 20% of responses were for SOMETIMES. 38% of patients fall under the category of mild, 26% of patients fall under the category of Moderate, and 16% fall under the category of severe and 6% fall under the category of catastrophic group which is represented in Graph 2. Also a comparative study was carried out between the English version of THI and the Kannada version of THI.
The quality and intensity of tinnitus can affect daily routine of an individual which have an effect on the individual's psychological functioning7.
The catastrophic aspect of Kannada THI allows identification of negative sensations produced by the tinnitus in the patient's lives such as intolerance, loss of control of the sensation. The English version of THI is currently used by most of the audiologists and otorhinolaryngologist to find out the severity of the problem in different patient population and found to be difficult to administer on native speakers of Karnataka. The recruited subjects for this research presented changes in their Quality of Life (QL) as regards to the functional, emotional and catastrophic aspects due to tinnitus. The functional neuroanatomy of tinnitus: evidence for limbic system links and neural plasticity. Validity of the Italian adaptation of the Tinnitus Handicap Inventory; focus on quality of life and psychological distress in tinnitus-sufferers. Brazilian Portuguese Language version of the "Tinnitus Handicap Inventory": validity and reproducibility.
The Tinnitus Handicap-Support Questionnaire [1,7], the Tinnitus Effect Questionnaire [8], and the Tinnitus Severity Questionnaire [9] are measurement tools in the English literature, but they have no (or low) internal consistency reliability and low test-retest reliability. One translator was aware of the purpose of the study and the concepts involved in the instrument: to obtain a better idiomatic and conceptual-rather than literal-equivalence between the two versions of the inventory and to render the intended measurement more reliable. We made an inspection of the percentage of subjects responding "yes," "sometimes," or "no" to individual questions. Total scale scores, Pearson's correlation coefficients (r), and ICCs for three subscales are shown in Table 7. Patients with tinnitus generally live with their problem for long periods of time; thus, they want to know their symptom's quality or intensity. On the basis of our study results, we found the first Turkish version of the THI to be a measure that is acceptable, reliable, and valid for evaluating tinnitus in patients. The Hearing Handicap Inventory for Adults: Psychometric adequacy and audiometric correlates.
Functional status and well-being of patients with chronic conditions: Results from the Medical Outcomes Study. Brazilian- Portuguese validation of the University of Washington Quality of Life Questionnaire for patients with head and neck cancer.
In JM Aran, R Dauman (eds), Tinnitus 91: Proceedings of the Fourth International Tinnitus Seminar. This rather large range can be explained with the highly variable definitions used in clinical trials as well as with the different duration and nature of this condition [2].Many people experience a a€?ringing in their earsa€? from time to time but, in the majority of cases, this phantom perception disappears spontaneously after a short time. To assess convergent validity, Pearsona€™s correlation was computed to measure the association between the total scores of all tinnitus-related questionnaires. With this clinical foundation, few other health professionals are as well suited to help those with tinnitus.
For example, the US Center for Health Statistics estimates that tinnitus was reported by 25% of those who are hearing impaired and have hearing loss. The hearing care professional needs to consider these issues if they want to succeed in managing the hearing loss on top of the tinnitus. However, it’s important to check the effect of the external sound on the tinnitus before introducing the benefits of wearing a hearing aid to the patient. Additionally, training from hearing instrument manufacturers and collaborating with colleagues can be valuable. Then be sure to include information that the patient may benefit from—like additional options or resources not offered at your practice. It is important to consider that treating patients with tinnitus requires the ability to listen and a high degree of patience. When testing patients with tinnitus, clinicians should consider scheduling a dedicated time just for consultation because it will take longer than usual and the patient is expecting a solution.
For this, I would recommend using an analog visual scale of relief to set the objective from the very beginning. When the patient becomes more comfortable describing their situation, the clinician should then begin to drive the conversation. Then the follow-up treatment can be done online, where the answers provided previously can help clinicians evaluate the impact of this strategy. This may include education, information, or recommendations for further medical evaluation or treatment by other professionals.
Psychoacoustical tests are also important and can include pitch and loudness matching and minimum masking level (MML). If there is a positive impact, like an attenuation of the perception, a strategy like the TRT (Tinnitus Retraining Therapy) can be considered. A wide variety of studies exploring prescription, supplement, and vitamin therapies are assessed for efficacy of treatment and for establishing consistencies in symptom definition, assessment, and outcome measures.
Of the 342,903 US veterans receiving disability pensions in 2004, 84% received payment for a tinnitus disability. In addition, its presence in isolation or in the setting of specific disease entities, such as hearing loss, Meniere's disease, or trauma, is inconsistent. As a result, despite their efficacy, widespread use for such a common problem is unlikely and economically unfeasible. Since then, Dobie [6] reviewed well-controlled, randomized clinical trials for all treatments of tinnitus. In comparison, multiple nutritional supplements are sold individually or in combination with claims of tinnitus relief. Of the 59 results remaining, primary focus was given to summarizing developments since previous reviews [5-7].
Therefore, we reviewed studies in our effort for their inclusion of the symptom location, character, loudness, pitch, impact on daily life, association with hearing loss or other neurootological disease, and verification with such measures as audiometry, pitch matching, loudness matching, and masking level. A trial of nortriptyline demonstrated statistically significant subjective and objective improvements within both treatment and placebo groups but essentially no differences between groups [10]. The inferior colliculus projects auditory information via the ventral medial geniculate body of the thalamus in the classic auditory pathway. No statistical comparison was made between treatment and placebo groups, only within those groups.
The Lioresal trial used loudness matching, pitch matching, and maskability as audiometric outcomes.
Audiometric outcomes in the most recent trials included tinnitus frequency and intensity matching.
More recently, the anticoagulant sodium enoxaparin was compared to combination therapy of corticosteroids, vasoactive agents, multivitamins, and anticoagulants, with a reported abatement of tinnitus symptoms [27].
A statistically significant increased incidence of vitamin B 12 deficiency was identified in patients with chronic tinnitus and noise-induced hearing loss (NIHL) as compared with NIHL and normal subjects, with reported improved symptoms after replacement therapy [30].
No substantial basic science evidence demonstrates the role of zinc in the pathogenesis or treatment of tinnitus. The first reported no significant difference between Zn2+ , 22 mg three times daily, and placebo [37].
No discussion of statistical power was mentioned in any study, and enrollment ranged from 40 to 96 subjects. The statistical significance was recorded as p Ginkgo biloba treatment before being randomly assigned to oral therapy versus placebo. Even with this selection, no significant improvement on subjective scores of tinnitus was found as compared to results from placebo. The THI was used as a quality-of-life outcome in the most recent study [42], and a similar questionnaire was used in the largest study [41]. Despite this lack of conclusive evidence, much can be gathered from the available research on the pharmacological management of tinnitus. Other antidepressants, such as SSRIs, likely are similarly effective, although a placebocontrolled, prospective study of SSRI medications is needed. The available clinical studies using benzodiazepines are of short duration and have limited patient numbers. Thus, though zinc deficiency can be a cause of tinnitus, zinc replacement in tinnitus sufferers with normal zinc levels is of little benefit. Clinical investigations, including a large number of subjects as well as meta-analysis, failed to show any benefit over placebo. Given that a placebo can result in a 30-40% response rate for tinnitus, similar findings with treatment should be presented with caution [10,48]. Antidepressant treatment of tinnitus patients: Report of a randomized clinical trial and clinical prediction of benefit. GABAAbenzodiazepine- chloride receptor-targeted therapy for tinnitus control: Preliminary report.
Effectiveness of Ginkgo biloba in treating tinnitus: Double blind, placebo controlled trial.
Ginkgo biloba does not benefit patients with tinnitus: A randomized placebo-controlled double-blind trial and meta-analysis of randomized trials.
Enhancing intrinsic cochlear stress defenses to reduce noise-induced hearing loss [candidate's thesis]. Fortytwo hyperlipidemic patients with subjective tinnitus and hearing loss due to noise exposure were enrolled for the study. It has been reported that high-plasma cholesterol and triglyceride levels are one of the major risk factors for the development of occupational hearing loss [3-5]. It seems that noise and other metabolic disturbances have a synergistic effect on the development of tinnitus and hearing loss [5].
A diagnosis of acoustic trauma was verified by an ear, nose, and throat physician according to a clinical history of chronic noise exposure in patients who sought medical help for complaints of tinnitus and high-frequency hearing loss. Patients who had chronic otitis media or middle-ear effusion, those with an abnormal ear drum (perforation, retraction, etc.) or auditory canal, and those who had abnormal tympanometry (other than type A) were excluded. In the study, from 120 patients we chose 42 male patients (35%) with elevated cholesterol or triglyceride or both (age range, 19-60 years; mean age, 45 years). The patients were separated into two groups: the "unresponsive" group, made up of 22 patients who had no response to either of the therapies and still had hyperlipidemia, and the "responsive" group, consisting of 20 patients who had lower cholesterol or triglyceride levels.
The results of the blood lipid profiles were withheld from the individual to prevent a placebo effect with the tinnitus therapy. The significance of the difference in patient's comments on their tinnitus after the treatment ("same," "decreased," "increased," and "disappeared") was analyzed using McNemar and chi-square tests.
However, the incidence of hyperlipidemia among a selected group of patients with neurosensory hearing loss varies. They selected a group of subjects aged between 20 and 50 years and compared auditory thresholds at high frequencies and serum lipid levels.
Noise and metabolic disturbances have a synergistic effect on the development of tinnitus and hearing loss. Effects of experimental cochlear thrombosis on oxygenation: Auditory function of the inner ear. Direct effects of intraperilymphatic reactive oxygen species generation on cochlear function. Clinical utility of LDL-apheresis in the treatment of sudden hearing loss: A prospective, randomized study.
The relation of hearing in the elderly to the presence of cardiovascular disease and cardiovascular risk factors.
Appearance of free radicals in the guinea pig inner ear after noise-induced acoustic trauma. Progressive sensorineural hearing loss, subjective tinnitus and vertigo caused by elevated blood lipids. A comparison of auditory brainstem evoked potentials in hyperlipidemic and normolipidemic subjects. Exploration of the early auditory effects of hyperlipoproteinemia and diabetes mellitus using otoacoustic emissions. Hypertension, hyperlipoproteinemia, chronic noise exposure: Is there a synergism in cochlear pathology? Effects of noise exposure and hypercholesterolemia on auditory function in the New Zealand white rabbit. Hearing improvement after therapy for hyperlipidemia in patients with chronic-phase sudden deafness. A prospective case-controlled study of 197 men, 50-60 years old, selected at random from a population at risk from hyperlipidemia to examine the relationship between hyperlipidemia and sensorineural hearing loss.
All participants underwent loudness-pitch match and highfrequency audiometry and responded to the Tinnitus Handicap Inventory (THI) and World Health Organization Quality of Life (WHOQOL) questionnaires. Comparing the HI and NL groups showed statistically significant differences up to 16,000 Hz, with the NL group requiring less intensity to perceive the frequencies than those in the HI group (see Fig. We found statistically significant differences between those with and without hearing loss on the physical and psychological subscales, which corroborates a previous study that compared individuals with noiseinduced hearing loss to those with normal hearing [18].
Among individuals with normal hearing, age affects the thresholds of highfrequency audiometry.
Individuals with hearing loss have a poorer quality of life than individuals without hearing loss, especially in the physical and psychological domains. Adaptacao para lingua portuguesa do questionario Tinnitus Handicap Inventory: Validade e reprodutibilidade. Desenvolvimento da versao em Portugues do instrumento de avaliacao de qualidade de vida da OMS (WHOQOL-100). Aplicacao da versao em Portugues do instrumento abreviado de avaliacao de qualidade de vida WHOQOL-bref. Acufenometria: O resgate de um instrumento de avaliacao do zumbido e sua correlacao com perdas sensorias. Emissoes otoacusticas e audiometria de altas frequencias: Eestudo em pacientes com zumbido sem perda auditiva [tese].
Alteracoes auditivas relacionadas ao zumbido nos disturbios otologicos e da articulacao temporo-mandibular.
Research Design: The study was a single-arm, open-label, before-and-after study of oral magnesium (532 mg per day) in 26 patients for 3 months. Although often presenting in conjunction with hearing loss, the magnitude of hearing loss does not necessarily correspond with the severity of tinnitus.
Specifically, magnesium deficiency leads to increased permeability of the calcium channel in the hair cells with a consequent over-influx of calcium, an increased release of glutamate via exocytosis, and overstimulation of N-methyl-D-aspartate receptors on the auditory nerve fibers. In addition, all participants completed another THI after 3 months of magnesium supplementation. The mean hearing thresholds and mean TDR scores before and after treatment were assessed using a paired t test.
For the subjects lost to follow-up, we assumed for the purposes of this analysis that there was no benefit from treatment. Effect of various serotoninergically induced manipulations on audiogenic seizures in magnesium-deficient mice. Influence of dietary magnesium on the amplitude of wave V of the auditory brainstem response. Guidelines for the grading of tinnitus severity: the results of a working group commissioned by the British Association of Otolaryngologists, Head and Neck Surgeons, 1999. The THI was developed by the British Association of Otolaryngologist, Head and Neck surgeons, which consists of 50 questions6. The speakers were given a five-point rating scale to grade the items from very familiar to non-familiar. A score of 4 was given for YES and a score of 0 was given for NO and a score of 2 was given for SOMETIMES.
The overall Cronbach alpha score of both the THI versions and the individual scores for all the three subscales in both the versions were compared. From the current study, it is clear that the Kannada version of THI is readily available, easy to understand and is a reliable tool for measuring the handicap occurring due to tinnitus. We assessed the internal consistency and reliability of the Turkish version by Cronbach's alpha. Additionally, these evaluations quantify the effects of tinnitus on functional, emotional, and social life.
The original Tinnitus Handicap Inventory (THI), developed by a working group commissioned by the British Association of Otolaryngologists, Head and Neck Surgeons, consists of 50 questions [10]. The other translator was unaware of the translation objective, and this was useful in eliciting unexpected meanings from the original tool. We assessed internal consistency coefficients (ICCs) for all three subscales: emotional, catastrophic, and functional. Item 21 had the greatest contribution-the emotional subscale-because of its highest item-total correlation score.
This preliminary version of the THI is able to detect the quality of the tinnitus symptom and its impact on patients' daily lives and psychosocial functioning, in addition to registering satisfaction with treatment.
Tinnitus symptoms are referred to as a chronic condition when lasting more than six months. To analyze relations between the TBF12 and the corresponding questions of the THI, we used cross tabulations as well as Spearmana€™s rank correlation coefficient for each question.Known group differences (discriminant validity) involve the assessment of a tinnitus questionnairesa€™ ability to distinguish between different levels of tinnitus severity. Good tinnitus resources are needed in every community to bring new exposure and business to your office. The Tinnitus Clinic at Oregon Health and Science University found that 90% of their patients who have tinnitus also have some degree of hearing loss. If the patient can accept a sound generating strategy, many hearing instrument manufacturers deliver interesting solutions today—with or without an amplifier for the hearing loss. This review reveals no compelling evidence suggesting the efficacy of any pharmacological agent in the treatment of tinnitus. In that year, it was the third most prevalent disability among veterans, after hearing loss and generalized musculoskeletal disability.
Therefore, therapy tends to be individualized and can range from placebo to surgery, with a multitude of options found between. Thus, the potential for a safe and effective oral pharmacological intervention has the hope of offering widely accessible and acceptable treatment for tinnitus patients. Most recently, Seidman and Babu [7] reviewed the role of alternative nutritional and medicinal treatment.
Though these claims may be based on some science, their marketing and manufacturing is minimally regulated, with side effects and drug interactions poorly characterized.
We supplemented sources by personal files and cross-referenced articles of the primary search.
We also gave attention to the presence of specific, defined outcome measures, including changes in audiometric tests or quality-of-life measures, such as the tinnitus handicap inventory (THI) [8].


However, a follow-up study from the same trial (and apparently the same data set) demonstrated a statistically significant decrease in tinnitusrelated disability via the multidimensional pain inventory (MPI) tinnitus interference questionnaire and in tinnitus loudness via audiometric matching at the frequency of tinnitus as compared with placebo [11]. Audiometric analysis was more consistent and typically involved pure-tone thresholds, speech discrimination, uncomfortable loudness levels, and tinnitus frequency and intensity matching. However, projections also occur via the dorsal and medial thalamic nuclei via the nonclassic pathway that subsequently projects to the amygdala and association cortices.
The study lacked details of patient selection, crossover of treatment and placebo groups, and a discussion of the potential impact of drowsiness, caused by the sedating action of alprazolam, on loss of blinding. The gabapentin and clonazepam trial used SPECT imaging with 99Tc-HMPAO to identify increased perfusion in the medial temporal lobe system as evidence of treatment success.
Statistical power was alluded to in all trials, though not formally discussed, and was the subject of a critique on the study of prostaglandins in tinnitus [26].
However, the study did not include any statistical analysis comparing groups, offered no placebo, had a total of 20 subjects in each group, and was not blinded. However, a more recent study reported a statistically significant improvement in subjective rating of tinnitus both within the Zn2+ 50-mg daily treatment group and in comparison with placebo [35].
Finally, only 22 of 60 patients completed all phases of evaluation, although all subjects were analyzed on an intention-totreat basis. Studies with larger power, longer follow-up, and consideration for potential dependency are needed. In particular, the studies on misoprostol failed to show subjective improvements, and the clinical significance of decreased tinnitus loudness matching is doubtful. An experiment using a behavioral avoidance task during sound was able to reduce false-positive avoidance (presumably caused by tinnitus) with the use of N-methyl- D -aspartate receptor-blocking agents that may play a role as local therapeutics [47].
Specific selection, inclusion, and exclusion criteria should be presented, and convenience samples should be avoided. Outcomes that are likely to be clinically significant are those associated with a meaningful improvement in a patient's life.
Statistical comparison of baseline characteristics of treatment groups should address any significant differences.
As more than 70% of patients with noise-induced hearing loss also suffer from tinnitus, efforts to reduce the impact of environmental noise on hearing should continue, including the use of pharmacological agents. All patients who were required to complete the questionnaire and who were subjected to clinical examination were military personnel. A pure-tone signal was presented continuously at 50-Hz intervals at between 10- and 20-dB levels.
We placed all these patients on a low-cholesterol diet or antihyperlipidemic therapy (Table 2). When patients were asked to qualify the severity of their tinnitus, 10 rated their tinnitus as the same (47%), 9 rated it as increased (42%), 2 rated it as decreased (9%), and 1 patient had no tinnitus (2%).
Lowry and Isaacson [12] reported 20% hyperlipoproteinemia among 100 patients with bilateral hearing loss.
Lipidosis of the inner ear has been postulated by Nguyen and Brownell [33] as an alternate mechanism. Insufficient perfusion of the cochlea due to increased blood viscosity and microthrombosis related to hyperlipidemia has been claimed to cause susceptibility to noiseinduced hearing loss [35]. We found in our study that the incidence of hyperlipidemia among patients with noiseinduced tinnitus and hearing loss was 35%. Characteristics of tinnitus and etiology of associated hearing loss: A study of 123 patients. On high-frequency audiometry, older individuals required 77.15% more intensity than did young individuals. The degree of discomfort, intolerance, or incapacity caused to the individual is often not related to the loudness (sensation of intensity) of the tinnitus.
When the pitch of the tinnitus was considered higher then the conventional range, high-frequency stimuli were presented. The maximum score on the questionnaire is 100 points, with higher scores denoting a greater degree of handicap that the individuals attribute to tinnitus in their lives. This demonstrates that the older individuals had a greater sensation of intensity than younger individuals. In previous studies, the frequency found among individuals with normal hearing was 6,000 Hz [13,14]. The HI group required double the loudness of the NL group, which is explained by the increase in tonal threshold in this group. The authors of the study cited found no significant handicap in the group with hearing loss, whereas in our study, we found moderate handicap (38-56 points) among the HI patients in both age groups, demonstrating that the coexistence of hearing impairment and tinnitus has a greater impact on the life of affected individuals (see Fig. Tinnitus severity was evaluated and recorded daily by the patient using the Tinnitus Distress Rating (TDR) scale of 0 (no tinnitus) to 10 (worst possible tinnitus). Recent studies of both noise-induced hearing loss and idiopathic sensorineural hearing loss have suggested that magnesium supplementation may lessen the severity of tinnitus in patients. The THI scores were converted to the grades of the TSS for the purpose of categorizing the numeric values of the THI into a reliable 5-item grading scheme.
These participants were included because if noncompleters doing poorly enough to drop out were not analyzed, then selection bias would be likely. Later, a modified beta version with 25 questions was developed by Newman et al.5 which is in the form of a self-assessment report that a person suffering from the condition can fill in. In such circumstance administering these inventories becomes difficult and sometimes impossible too. Later, all the 50 filled inventories were assessed to find out if all the words and the meaning of the questions were understood by the Kannada speakers. Once the subject finished rating the questions, they were grouped under 5 categories based on the severity that is Slight, Mild, Moderate, Severe and Catastrophic. Because the items having high item-total correlation were considered more representative of the scale's content, all itemtotal statistics were reported and are shown in Table 4.
Some people are able to ignore this phantom sound and do not feel severely impaired, while others suffer considerably from these symptoms. In this analysis, scores of each questionnaire were compared to tinnitus-related severity (not a problem, a small problem, a moderate problem, a big problem, a very big problem) rated by patients themselves. To assess if patientsa€™ heterogeneity in age and tinnitus duration has influence on tinnitus severity and thus is potentially confounding the results, we analyzed the correlations between both variables and all questionnaires. For example, a clinician may have to wait for the patient to fall asleep using a sound generator pillow. Analysis of prior investigations provides insight to appropriate methods for future work, which are outlined. Auditory disabilities taken together resulted in more than $1 billion of payment by the US Department of Veterans Affairs in fiscal year 2004 alone [2]. Finally, consensus on accepted outcomes for treatment is lacking, owing to the subjective nature of tinnitus.
This form of therapy can be self-administered and selfmonitored, reducing the impact on medical resources for treatment. Although not establishing consensus, these studies identified some agents with promise, but the lack of uniform symptom definitions, outcome measures, and statistical power of the studies reviewed renders interpreting these conclusions challenging.
Thus, the pharmacological treatment of tinnitus remains a realm of pseudoscience and supplements. We reviewed studies for basic and clinical science evidence for the pathophysiology and treatment of tinnitus, symptom definition, outcome measure, statistical power, and potential for future research. Both studies highlighted the effectiveness of nortriptyline treatment of the depression associated with the tinnitus. This nonclassic pathway receives somatosensory input, which may be abnormally redirected to auditory regions of the central nervous system and perceived as tinnitus [14]. Baclofen (Lioresal), a GABA analog with binding to the GABA-B receptor, was found to be no more effective than placebo in a double-blind, placebo-controlled, prospective trial [19]. Statistical power was specifically mentioned in the Lioresal trial, as 90 patients were calculated as the minimum number necessary to afford a power of 80% to detect a clinically significant difference between treatment groups.
The other two studies were prospective, double-blind, placebo-controlled trials by the same authors in different patient populations with similar results. A recent novel study compared subcutaneous periauricular injections of botulinum toxin A with placebo in a double-blind, prospective, crossover, randomized, controlled trial and reported significant differences between groups along with a significant decrease in THI scores between pretreatment and 4-month post-botulinum toxin A therapy [28]. The remaining trials showed no benefit as compared to placebo, and each had unique features that merit review.
This was a large trial involving age, gender, and duration-of-symptoms matching analysis that revealed no differences in subjective rating scales of loudness, annoyance, and quality-of-life impact. Discussion of statistical power along with recruitment of adequate subjects was obtained in two studies [41,42], both reporting no effect of treatment. These models have advanced our understanding of tinnitus as a central phenomenon and can be used to refine the exploration for effective pharmacotherapy. Benzodiazepines may prove to be counterproductive in the long run if suppression of neural plasticity is indeed something that will prevent reconditioning of nonclassic auditory pathways, as theorized in tinnitus retraining therapy [4].
However, these studies were also underpowered and did not address quality-of-life outcomes that may be evident with treatment. However, more standardized definition of zinc deficiency along with higher-powered studies are needed to address this potential treatment. At best we can say that no benefit has accrued for the given dose and extract used in these studies. Riboflavin (B12) deficiency was demonstrated in sufferers with noise-induced hearing loss and tinnitus as compared to those without tinnitus. Very likely, different treatments for tinnitus will emerge for different groups of patients on the basis of comorbid illness and tinnitus duration, severity, or location. Small improvements may be meaningless to those with mild tinnitus but very important to those whose tinnitus is disabling. We excluded on the basis of their response to the questionnaire or clinical examination subjects who had a history of familial hearing loss, head trauma, collagen disease, neurological or hormonal disturbance, addiction to alcohol, or ototoxic drug therapy. The main criteria for response to the antihyperlipidemic therapy was defined as a return to normal cholesterol or triglyceride levels after therapy or at least a 40% drop from either of the initial blood cholesterol or triglyceride levels if the values were slightly above the normal limits. The latter authors showed that the lateral wall of outer hair cells from guinea pig cochlea incorporates water-soluble cholesterol. Axelsson and Lindgren [34] matched 78 men at age 50 years with high serum cholesterol levels to 75 randomly selected 50-year-old men and found significant correlation between noise exposure and high cholesterol level. On the THI questionnaire, individuals in the NL group exhibited mild handicap, whereas those in the HI group exhibited moderate handicap.
In 15-20% of cases, tinnitus affects quality of life, with repercussions involving sleep habits, concentration, emotional stability, and social activities [6]. The sample was made up of 52 individuals divided into two groups (28 with normal hearing [NL group] and 24 with moderate to severe neurosensory hearing loss [HI group]. Loudness was obtained immediately after the obtainment of the pitch using a caparison method, beginning with an intensity of 10 dB above the average of 500, 1,000, and 2,000 Hz, varying in intervals of 5 dB on the basis of patients' sensation. Our study corroborates this, as older individuals had higher high-frequency thresholds, especially in the HI group. This may be explained by both the characteristic increase in tonal threshold that accompanies hearing loss and the descending hearing impairment among the individuals selected for the study. In our study, mean tinnitus pitch for the HI group was 6,000 Hz, which is similar to results in a study carried out on individuals with acoustic trauma, whose pitch ranged from 6,000 to 8,000 Hz [15]. Furthermore, we observed a statistically significant difference between groups regarding pitch, for which higher frequencies (10,000 Hz) were achieved among the HI group. The Tinnitus Handicap Inventory (THI) was administered before and at the end of the study, and scores were converted to the grades of the 5-item Tinnitus Severity Scale (TSS). This relationship suggests these processes may be linked by underlying imbalances at the level of the hair cell. Magnesium improved hearing recovery and lessened tinnitus in patients with idiopathic sudden hearing loss (Gordin et al., 2002).
Therefore, subjects with no follow-up were treated as though they had no improvement and were included in the analysis. The self report has been developed subsequent to previous studies that have thrown up reliable data that can be used to classify tinnitus into different grades according to the degree to which the tinnitus has affected a subject. As this inventory quantified the alterations of the daily life of an individual due to tinnitus and due to the non capability of multilingual Speech & Hearing professionals to translate accurately the English version of THI to the regional languages and to avoid communication interpretation, there is a need to develop and standardize the Tinnitus Handicap Inventory in Indian languages. The questions which were rated as 1 or 2 were selected for the inventory and any questions with ratings over 3 were re-framed according to the familiarity of the speakers.
All the participants underwent assessment by an otorhinolaryngologist and complete audiological evaluation prior to the administration of the inventory. We assessed construct validity by analyzing the patients according to their age and to tinnitus duration. These findings indicate that the Turkish version of the THI has good stability in the test-retest trial to assess the clinical change. Collection of data for the TRI database was approved by the local ethics committee of the University of Regensburg, Germany.The data set of 1 May 2011 contained a total of n=1636 patients, of which n=1318 were eligible for our analyses. To test if higher scores of each questionnaire are linearly related to a higher level of patient-self-reported severity, we conducted the Spearman's rank correlation coefficient.SensitivityTo assess change sensitivity, we used the PGI-C to identify whether patients changed over time. TBF12 at last visit was r=0.43, which was not significant because of the small sample size. Accessible, efficient, and effective treatment for this potentially disabling symptom remains elusive. All these issues lay the foundation for a heterogeneous body of literature on the topic that is largely devoid of compelling evidence for any particular treatment protocol.
Additionally, such therapy may also benefit by reducing the causes of tinnitus and not just providing symptomatic relief. Further complicating matters is that largescale, well-controlled clinical trials of pharmacological agents are expensive and time consuming if conducted properly. Compared to placebo, amitriptyline demonstrated a statistically significant decrease in a subjective measure of tinnitus intensity in a single-blind prospective trial [12].
Subjective outcomes ranged from a simple yes or no response to the question, "Has your tinnitus improved?" [10] to longer multipart questionnaires, such as the Iowa Tinnitus Handicap Questionnaire [11]. Salicylate toxicity, a known cause of reversible tinnitus in humans, also results in GAD upregulation and increased GABA receptor affinity in the inferior colliculus of rats [15].
The study did demonstrate a statistically significant improvement on the THI within the treatment group, but this was not considered clinically significant, and treatment was associated with significant side effects leading to withdrawal from the study by 26% of participants. The studies found a statistically significant decrease in loudness matching and a statistically insignificant decrease in subjective rating of tinnitus in patients with hypertension or diabetes mellitus (or both) [24] or the absence of systemic or other known otological disease [25]. The study identified having limited power, with a total of 26 subjects completing injections and follow-up, and the differences in groups incorporated those improved, those worsened, and those unchanged, without specifically addressing the statistical difference in improvement alone. Two additional, nonplacebo- controlled studies investigated the incidence of zinc deficiency in patients with tinnitus along with the potential for improvement with zinc replacement. However, this study was done completely by mail or phone, and no physical or audiometric evaluation was performed on patients. Another GABA-active drug, baclofen, showed promise in a limited animal study, although the single clinical study with significant design limitations demonstrated no better efficacy than that of placebo.
Effective definition of the study population will enable important post hoc analyses to reveal these potential treatments. Visual analog scales are useful but should record variables of annoyance and awareness in addition to simply loudness. The difference between tinnitus scores in the unresponsive and responsive groups and the change in tinnitus scores before and after therapy in the responsive group were significant. None of the patients had cerebrovascular disease, hypertension, electrolyte imbalance, cranial nerve deficit, or clinical signs of peripheral neuropathy. Then, the pitch-match frequency threshold of the tinnitus was measured as the tinnitus loudness match of the pure-tone stimulus presented with a 1-dB increase of tinnitus frequency. Morizono and Paparella [30], using cholesterolfed rabbits, showed increased auditory dysfunction with time at all frequencies.
This uptake of cholesterol is accompanied by an increased stiffness of the cells, which may impair the cells' electromotile response.
Enhancement of cochlear action potentials and auditory brainstem responses has been demonstrated after limited intake of cholesterol. However, patients were at the chronic phase, more than 1 month from the onset of the hearing loss.
On the WHOQOL questionnaires, the HI group demonstrated greater impairment on the physical and psychological domains than did the NL group. The aim of our study was to compare quality of life, high-frequency audiometry, and loudness-pitch match in individuals with tinnitus with and without hearing loss, according to age group.
These groups were subdivided according to age: one subgroup up to 28 years and the other older than 28 years. Statistically significant differences were found between age groups at frequencies of 10, 12, 14, and 16 kHz (see Fig.
Among the HI group, pitch was 6,000 Hz, which is a frequency encountered within the conventional range. A number of authors believe that the THI questionnaire may be used as a measure for quantifying the impact of tinnitus on daily living [7,8]. The purpose of this phase 2 study was to investigate whether the treatment was effective at all, and, as such, a placebo control was not performed. The possible influence of magnesium and its antagonist, calcium, has been discussed in the literature as a contributing factor in the mitigation of noise-induced hearing loss, ototoxicity, and the hyperexcitability of the auditory system (Cevette et al., 2003). THI consists of 25 questions under the 3 sub-scales of emotional, functional and catastrophic. Internal validity was tested by multi-item analysis, to assess item convergence and discriminant validity. The THI, beta version, is the most standardized tinnitus handicap- measuring tool in the literature (Table 1). One of them was a medical doctor, and the other was a chiropractor; however, both were unaware of the content and original wording of the THI. Three days after the first investigation, the inventory was answered again by randomly selected patients. Because of the small sample sizes in some PGI-C categories, the data were pooled into the categories a€?improveda€™ (PGI-C values 1a€“3), a€?unchangeda€™ (PGI-C value 4), and a€?worseneda€™ (PGI-C values 5a€“7) to yield a sufficient number of cases in each category. Much of the available clinical data, therefore, comes from small studies with significant design flaws. However, comparisons were made before and after treatment within groups but not between groups. GABA inhibition at the level of the inferior colliculus in rats is also associated with development of audiogenic seizures [16]. A prospective study reported 90% improvement in those completing treatment with combined gabapentin and clonazepam in a select group of patients with severe, disabling tinnitus verified by decreased perfusion on SPECT imaging of the amygdala-hippocampus region [20]. The first study reported a significantly increased incidence of zinc deficiency in tinnitus as compared with healthy controls and a significant decrease on a subjective rating scale with Zn2+ 34-68 mg daily over 2 weeks [32]. The most recent randomized, controlled trial showed no significant improvement with Ginkgo biloba by itself and also no benefit when considered in a meta-analysis along with other trials in the literature [42].
The doses used in the studies were substantially lower than those demonstrating benefit in the animal model. Currently, no clinical study has used gabapentin alone, though this seems a logical choice for chronic therapy, given its limited side-effect profile and lack of addiction potential. It seems that the order of destruction and the high-frequency nature of the auditory dysfunction are correlated not only with the frequency and severity of the noise exposure but with the presence of the secondary pathology, as the formation of vasoactive lipid peroxidation products after intense noise is similar to the condition seen in metabolic damage to the organ of Corti [7,14-17]. In a survey of 44 patients with cochlear-type hearing loss, Booth [26] found hyperlipidemia in 28% of the men and 10% of the women. These authors observed hearing improvement of more than 10 dB in 9 of the 12 patients after antihyperlipidemic therapy. In a study involving a group with hearing conditions and temporomandibular disorders, the pitch most often encountered was high [9].
All data were collected at Mayo Clinic in Scottsdale, Arizona, between March 6 and December 10, 2008. Permanent and temporary changes in auditory function have been linked to nutritional deficiencies of magnesium. Based on the results of the present study, the authors have initiated a Phase 3 study using a placebo and double-blinding to control for factors unrelated to the magnesium supplementation. The THI beta version is one of the best and most standardized tinnitus measuring tools and has got a good reliability, validity and a good internal consistency to administer on tinnitus patients.
An expert team composed of one of the investigators and a bilingually experienced translator reviewed the preliminary version of the THI. We calculated Pearson correlation coefficients for total item score and score for three subscales and ICCs. Its primary use is the stratification of patients with tinnitus according to the impact of tinnitus symptoms in daily life [11]. To assess the magnitude of the difference in scores between patients who improved, unchanged, or worsened, we calculated standardized response means (SRMs) by dividing the mean score changes by the standard deviation (SD) of the change [31]. A retrospective look at SSRI use in patients with tinnitus reported a statistically significant improvement on a tinnitus severity index over time in 23 of 30 patients [13].
No discussion of statistical power was mentioned in any study, and studies involved between 19 and 92 subjects. In an analysis of inferior colliculus hyperexcitability, various GABAergic agents were found to have very different effects on modulating evoked potentials, suggesting agonist-receptor variability with potential clinical implications for treatment.
However, improvement was defined on subjective analog scales from 0 to 7, no control or placebo was used, and the 30% of patients who dropped out of the study for various reasons were not included in analysis.
The second study found no strong relationship of zinc deficiency and tinnitus and failed to demonstrate significant improvement with Zn2+ 220 mg daily for 2 months, although a trend toward improved symptoms in elderly patients with hearing loss was noticed [36]. Many have been shown to reduce noise-induced hearing loss in animal models, and the effects are both peripherally and centrally mediated [45]. Again, widely recognized categorical scales and scored questionnaires that measure quality-of-life impact are recommended. In this manner, preventive measures may provide restorative support to the injured cochlea. We required all patients to rate their tinnitus from 1 to 10, with 10 being loudest (Table 1). On high-frequency audiometry, individuals with tinnitus and HI exhibited higher thresholds, with complete hearing loss at some frequencies. It demonstrates adequate reliability-validity and has good internal consistency, reliability, and convergent and construct validity. Construct validity was assessed by separating the patients into three groups according to their age and to tinnitus duration. It is also useful to calculate the efficient of multiple determination (R2) by using multiple linear regression to understand the importance of an item. So far, data from eight study centers from five different countries have contributed data to this project.The data base, which is maintained at the Tinnitus Center in Regensburg, is open for clinical studies on tinnitus that contain a standardized data set.
Moreover, the THI has been often used as a primary outcome measurement for testing the efficacy of therapeutic interventions, even if the questionnaire has not been primarily developed for this purpose.The TBF-12, developed by Greimel et al.
However, no control group was included, nor was mention made of when patients began SSRI use relative to their initial tinnitus severity index score. In those with normal hearing, zinc deficiency may play a role in the development of tinnitus, and zinc supplementation may be helpful in those cases [33,37]. Statistical analysis should compare effects within all treatment arms as well as between arms. Each level was defined by short explanations to simplify the patients' grading of their tinnitus.
The WHOQOL and THI questionnaires revealed that individuals with HI experienced a poorer quality of life than did those with normal hearing.
There was no significant change in hearing thresholds from 250 Hz through 8,000 Hz for either ear during the duration of the study (Table 2). The Turkish version of the THI is a highly consistent and reliable measure that can be used in evaluating symptoms in tinnitus patients. Internal validity was tested by multi-item analysis to assess item convergence and discriminant validity.
In this approach, one of the items is taken to be a dependent variable whereas others are taken to be independent variables. The data set includes three patient self-report forms for assessing tinnitus symptoms, i.e. Finally, single-photon emission computed tomography (SPECT) imaging has suggested a loss of GABA inhibition in the amygdalahippocampus formation in humans with tinnitus [17].
Though they may not prove useful in treating tinnitus, antioxidants may help to reduce the noise-induced injuries that precipitate tinnitus. Data Collection and Analysis: The main outcome measures were mean TDR scale scores and THI scores as converted to TSS grades. There was a significant decrease in the severity of tinnitus for subjects on the basis of their THI responses (P=.03). We asked them whether they had any difficulties in understanding the questions or had any comments regarding the content or layout of the inventory.
However, a few questions are formulated in a slightly different manner, and the responses are a€?never a”€ sometimes a”€ oftena€?.
Side effects of active and placebo treatment should be carefully documented and analyzed for possible effects on subjects discontinuing the trial. Those patients whose THI scores translated to "slight" or greater grade on the TSS before the intervention showed a significant decrease in the severity of their tinnitus (P=.008) (Table 3).
According to the answers obtained from the interview and face validity test, we performed minor alterations, and our Turkish version of the THI was finalized.
When an item was deleted, Cronbach's alpha for that item did not change, except for items 2, 15, and 19.
Psychometric properties of the assessments instruments have been documented in various reports [6a€“15]. Therefore, it can be concluded that all items indicated high internal consistency (Cronbach's alpha scale, 0.886). However, data about change sensitivity are only available for the THI [16], the TQ [17] and the TBF-12 [15]. To further complicate matters, the TBF-12 has recently been renamed as THI-12 [15].The TQ is a self-report measure of tinnitus-related distress as perceived by patients [8]. Figure 3 graphically represents the change in TDR in 26 patients from baseline to 3 months after treatment with magnesium. This questionnaire has been translated into and validated in different languages, into German [26], Dutch, French [10], and Chinese [27]. Thus, for example, even if the TBF-12 is considered a short version of the THI [15], cross-validation data between TBF-12 and THI are not available.
In the current study, the sum score was calculated according to the validation of the TQ in the German language, which was based on 40 out of all 52 items [28]; items nos.
Conclusion: The results suggest that magnesium may have a beneficial effect on perception of tinnitus-related handicap when scored with the THI. After supplementation, by intention-to-treat analysis, 14 of 26 patients (54%) continued to have more than slight impairment; by analysis of patients who completed the study, only 7 of 19 patients (37%) had more than slight impairment. Moreover, replication of psychometric criteria in follow-up studies is considered important since the validity and the usefulness of self-report instruments are empirical issues that depend on a growing body of evidence [18].Furthermore, in case of multicentre projects and questionnaires in different languages, it has to be established that such instruments work properly in every language (FDA guidance 2009). Only then analyses of multicentre projects are reliable allowing unbiased conclusions with regard to the value of therapeutic options of tinnitus symptoms.The aim of the present set of analyses is therefore the reassessment of basic psychometric properties according to classical test theory [19, 20] of self-report instruments used within the multicentre TRI database project. The TQ, the most widely used questionnaire in German-speaking areas, has also been applied as a primary outcome measurement in various clinical trials [5].
Because the 52 questions of the TQ are a rather high number to be filled in by patients during every visit, two shorter versions, the TQ 12 and the Mini-TQ, have been developed.
The TQ 12, developed by Hiller and Goebel [29] according to an optimal combination of high item-total correlations, reliability, and sensitivity in assessing changes, consists of 12 items that correspond to items nos. The two short versions are not an extra part of the TRI Case Report Form but can be easily extracted and calculated.Both the Tinnitus Severity Scale and the Patient Global Impressiona€“Change (PGI-C) consist of only one question to measure the subjective perception of patients about their tinnitus severity at the time and the change of tinnitus complaints over time. The Tinnitus Severity Scale asks patients how much of a problem tinnitus symptoms are at the time and provides the following response options: not a problem, a small problem, a moderate problem, a big problem, or a very big problem. Since patients from some of the centers have not filled in every questionnaire and some patients have had only baseline data, the number of complete questionnaires for each language and each visit are shown in Table 2.



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