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Purpose: We surveyed the benefit of dietary supplements to treat tinnitus and reported adverse effects., Method: A website was created for people with tinnitus to complete a variety of questions., Results: The 1,788 subjects who responded to questionnaires came from 53 different countries; 413 (23.1%) reported taking supplements. No effect on tinnitus was reported in 70.7%, improvement in 19.0%, and worsening in 10.3%. Adverse effects were reported in 6% (n = 36), including bleeding, diarrhea, headache, and others. Supplements were reported to be helpful for sleep: melatonin (effect size, d = 1.228) and lipoflavonoid (d = 0.5244); emotional reactions: melatonin (d = 0.6138) and lipoflavonoid (d = 0.457); hearing: Ginkgo biloba (d = 0.3758); and concentration Ginkgo biloba (d = 0.3611). The positive, subjective reports should be interpreted cautiously; many might have reported a positive effect because they were committed to treatment and expected a benefit. Users of supplements were more likely to have loudness hyperacusis and to have a louder tinnitus., Conclusions: The use of dietary supplements to treat tinnitus is common, particularly with Ginkgo biloba, lipoflavonoids, magnesium, melatonin, vitamin B12, and zinc. It is likely that some supplements will help with sleep for some patients. However, they are generally not effective, and many produced adverse effects. We concluded that dietary supplements should not be recommended to treat tinnitus but could have a positive outcome on tinnitus reactions in some people.

Background: Several tinnitus sufferers suggest that manganese has been helpful with their tinnitus., Purpose: We tested this in a controlled experiment where participants were committed to taking manganese and Lipoflavonoid Plus(®) to treat their tinnitus., Research Design: Randomized controlled trial., Study Sample: 40 participants were randomized to receive both manganese and Lipoflavonoid Plus(®) for 6 months, or Lipoflavonoid Plus(®) only (as the control)., Data Collection and Analysis: Pre- and postmeasures were obtained with the Tinnitus Handicap Questionnaire, Tinnitus Primary Functions Questionnaire, and tinnitus loudness and annoyance ratings. An audiologist performed the audiogram, the tinnitus loudness match, and minimal masking level., Results: Twelve participants were dropped out of the study because of the side effects or were lost to follow-up. In the manganese group, 1 participant (out of 12) showed a decrease in the questionnaires, and another showed a decrease in the loudness and annoyance ratings. No participants from the control group (total 16) showed a decrease in the questionnaires ratings. Two participants in the control group reported a loudness decrement and one reported an annoyance decrement., Conclusions: We were not able to conclude that either manganese or Lipoflavonoid Plus(®) is an effective treatment for tinnitus., (American Academy of Audiology.)

Purpose: Our objective was to identify activities that influence tinnitus and to determine if conditional probabilities exist among such variables., Method: Two hundred fifty-eight patients were asked the following two questions: "When you have your tinnitus, which of the following makes it worse?" and "Which of the following reduces your tinnitus?", Results: Things that made tinnitus better included noise (31%) and relaxation (15%). Things that made tinnitus worse included being in a quiet place (48%), stress (36%), being in a noisy place (32%), and lack of sleep (27%). Almost 6% of patients suggested coffee/tea and 4% said certain foods made their tinnitus worse. Conditional probabilities indicated that for those whose tinnitus is not worse in quiet, it is usually not reduced by noise. For those whose tinnitus is not worse in noise, it is usually not reduced in quiet., Conclusion: There are dramatic differences among patients. Such differences need to be considered in planning treatments.

Purpose: To create a questionnaire focused on the primary activities impaired by tinnitus and therefore more sensitive to treatments., Method: Questions were developed on (a) emotions, (b) hearing, (c) sleep, and (d) concentration. A 20-item questionnaire was administered to 158 patients. First, confirmatory factor analysis was used to select 3 questions per domain. Second, factor analysis was used to evaluate the appropriateness of the 12-item questionnaire., Results: The analysis indicated that the selected questions successfully represented 4 independent domains. Scores were correlated with the Tinnitus Handicap Questionnaire ( r = .77, p < .01) and loudness ( r = .40, p < .01). The Sleep subscale correlated with the Pittsburgh Sleep Index ( r = .68, p < .01); the Emotion subscale correlated with the Beck Inventory ( r = .66, p < .01) and the Trait Anxiety questionnaire ( r = .67, p < .01). The average scores went from 51% to 38% following treatment., Conclusion: The Tinnitus Primary Function Questionnaire is valid, reliable, and sensitive and can be used to determine the efficacy of clinical trials.

Objective: Several reports suggest that zinc, which is involved in several neural transmissions systems throughout the auditory pathway, might help some tinnitus patients. However, previous studies used inadequate experimental designs. Therefore, we tested the effectiveness of zinc to reduce tinnitus., Study Design: Randomized, prospective double-blind placebo-controlled design., Setting: Tertiary referral center., Patients: Tinnitus subjects older than 60 years, who are more likely to have a zinc deficiency., Intervention(s): In Phase 1, 58 subjects were randomized to receive 50 mg of zinc per day for 4 months, and 58 subjects received a placebo. After a 1-month washout period, the 2 groups were crossed over to receive the alternative regime (Phase 2)., Main Outcome Measure: Difference scores between before and after measures of the Tinnitus Handicap Questionnaire. Changes on the difference scores 20 or greater were considered as a statistically significant and, therefore, clinically meaningful improvement for THQ., Results: Five percent (5 of 93 patients) had an improvement of 20 points or greater in THQ scores after zinc treatment, whereas 2% (2 of 94 patients) had an improvement of 20 or greater in THQ scores after placebo. The difference between 2 proportions is 5/93 - 2/94 = 0.03, the estimate of relative improvement is (5/93) / (2/94) = 2.53, with 95% confidence interval from 0.5 to 12.7. From chi-square independent test, there was no significant evidence that patients treated by zinc improved better than those treated by placebo (X2 (1) = 1.4, p > 0.05). The observed power in THQ for zinc is 0.16, and that for placebo is 0.06., Conclusion: Zinc is not an effective treatment for tinnitus in this subgroup of patients.

Chronic tinnitus is a common condition with a high burden of disease. While many different treatments are used in clinical practice, the evidence for the efficacy of these treatments is low and the variance of treatment response between individuals is high. This is most likely due to the great heterogeneity of tinnitus with respect to clinical features as well as underlying pathophysiological mechanisms. There is a clear need to find effective treatment options in tinnitus, however, clinical trials differ substantially with respect to methodological quality and design. Consequently, the conclusions that can be derived from these studies are limited and jeopardize comparison between studies. Here, we discuss our view of the most important aspects of trial design in clinical studies in tinnitus and make suggestions for an international methodological standard in tinnitus trials. We hope that the proposed methodological standard will stimulate scientific discussion and will help to improve the quality of trials in tinnitus., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Tinnitus, the phantom perception of sounds, is a highly prevalent disorder. Although a wide variety of drugs have been investigated off label for the treatment of tinnitus, there is no approved pharmacotherapy. We report an open-label exploratory pilot study to assess the effect of muscle relaxants acting on the central nervous system on tinnitus patients. Cyclobenzaprine at high (30 mg) and low doses (10 mg), orphenadrine (100 mg), tizanidine (24 mg) and eperisone (50 mg) were administered to a maximum of 20 patients per group over a 12-week period. High-dose cyclobenzaprine resulted in a significant reduction in the Tinnitus Handicap Inventory (THI) score between baseline and week 12 in the intention-to-treat sample. On the other hand, other treatments were not effective. These results were confirmed in an explorative analysis where baseline corrected THI and Clinical Global Impression scores at week 12 were compared between groups. The present open trial presents a new promising pharmacotherapy for tinnitus that should be validated in placebo-controlled double-blind trials., (Copyright © 2012 S. Karger AG, Basel.)

Objective: To determine the minimum change of the Tinnitus Handicap Inventory (THI) score that could be considered clinically relevant, the authors compared the absolute change of the THI with the Clinical Global Impression–Improvement (CGI-I) score., Study Design: International studies register with standardized data collection., Setting: Tinnitus Research Initiative (TRI)., Subjects and Methods: Two hundred ten patients of the TRI database were eligible for this study. In the first analysis, the THI score change and CGI-I ratings were compared with equipercentile linking. In a second analysis, the authors categorized the CGI-I into the 4 groups much better or better, minimally better, no change, and worse and calculated the corresponding differences of the THI score and the effect sizes. An effect size separating the minimally better and the no-change groups was chosen, and the referring THI mean score difference was calculated., Results: According to the linking method, a CGI-I value of 3 (minimally better) corresponded to a THI score reduction of 6 to 16, whereas the CGI-I value of 4 (no change) corresponded to the range between improvement by 5 points and worsening by 4 points. For separating the no-change and minimally better groups, an effect size d = 0.5 was determined, resulting in a minimal clinically relevant difference of ΔTHI = 7., Conclusion: Two different methods yielded comparable results in identifying a reduction in the THI score of 6 and 7 points, respectively, as the minimal clinically relevant change. This study provides a first orientation for sample size calculations and for planning the design of future studies.

Purpose: To determine (a) changes in the Tinnitus Handicap Questionnaire (THQ) for patients using cochlear implants, (b) differences between patients who receive total or partial relief, and (c) identifiable characteristics of those who report tinnitus after implantation., Method: Pre- and postoperatively, 244 adults were administered the THQ when they reported tinnitus., Results: Of the 153 patients who had tinnitus preoperatively, 94 (61%) patients reported total suppression and 59 (39%) reported a partial reduction. In 91 patients who did not have tinnitus before implantation, 11 (12%) reported tinnitus postimplantation. The THQ score decreased from 41% preimplant to 30% postimplant. The largest reductions involved social handicap and hearing. Patients with a more severe hearing loss might be more likely to experience an exacerbation of their tinnitus. We were not able to clearly identify differences between patients who received total or partial relief and the characteristics of patients who reported tinnitus after implantation. Those who acquired tinnitus had the shortest duration hearing loss (5.6 years) and were the oldest (63 years). The average THQ score of patients getting tinnitus was 29%., Conclusions: Most tinnitus patients benefit from receiving a cochlear implant.

We studied the relationship between tinnitus pitch and the audiogram in 195 patients. Patients with tone-like tinnitus reported a higher pitch (mean = 5385 Hz) compared to those with a noise-like quality (mean = 3266 Hz). Those with a flat audiogram were more likely to report: a noise-like tinnitus, a unilateral tinnitus, and have a pitch < 2000 Hz. The average duration of bilateral tinnitus (12 years) was longer than that of unilateral tinnitus (5 years). Older subjects reported a less severe tinnitus handicap questionnaire score. Patients with a notched audiogram often reported a pitch or=8000 Hz. We failed to find a relationship between the pitch and the edge of a high frequency hearing loss. Some individuals did exhibit a pitch at the low frequency edge of a hearing loss, but we could find no similar characteristics among these subjects. It is possible that a relationship between pitch and audiogram is present only in certain subgroups.

Purpose: We believe it is important to uncover tinnitus subgroups to identify subsets of patients most likely to benefit from different treatments. We review strategies for subgrouping based on etiology, subjective reports, the audiogram, psychoacoustics, imaging, and cluster analysis., Method: Preliminary results of a 2-step cluster analysis based on 246 participants from whom we had 26 categorical and 25 continuous variables were determined., Results: A 4-cluster solution suggested the following subgroups: (a) constant distressing tinnitus, (b) varying tinnitus that is worse in noise, (c) tinnitus patients who are copers and whose tinnitus is not influenced by touch (somatic modulation), and (d) tinnitus patients who are copers but whose tinnitus is worse in quiet environments., Conclusions: Subgroups of tinnitus patients can be identified by using statistical approaches. The subgroups we identify here represent a preliminary attempt at identifying such patients. One next step would be to explore clinical trials of tinnitus treatments based on subgroup analyses or on using subgroups in the selection criteria.

We review a few issues related to clinical trials for treating patients with tinnitus, including the study population, design, choice of measurement variables, and some new approaches to data analysis. We emphasize the importance of being aware of different subgroups of tinnitus patients, and that patients who have had tinnitus for less than 6 months could be more amenable to treatment than patients who have had their tinnitus for a longer period. We distinguish the tinnitus itself, from the reactions to the tinnitus. When the treatment is intended to reduce the tinnitus, we recommend measuring the magnitude of the tinnitus. We provide arguments and data to support the use of the Tinnitus Handicap Questionnaire as a measure of the reaction to the tinnitus. We suggest that the current quality of life measures are not valid for measuring lifestyle effects of alleviating tinnitus. Because tinnitus likely has different subgroups, and because tinnitus affects people differently, we believe data analysis should emphasize individuals, not groups. A clinically meaningful effect should represent a valid and reliable statistical change for an individual.

Conclusion: There are many possible control conditions to consider in designing research on tinnitus treatments. Some of the counseling procedures involve more than simply 'talking' or providing information, and it is important to make this distinction. Several good handicap scales are available, but we believe that 100-point interval scales have some superior attributes. Both primary and secondary measures of benefit should be used. Open trials have some merit, but should only be used cautiously. Several recent guidelines have been suggested for improving the design and reporting of clinical trials., Objectives: This paper reviews some basic considerations in the design of research to evaluate tinnitus treatments, particularly counseling and sound therapies., Methods: We have reviewed some of the basic issues, referenced some relevant work, and provided some data supporting some of our assertions., Results: We provide some recommendations for consideration for the design of clinical trials.

We comment on three areas related to tinnitus. The standard of care should include counseling that is collaborative and that addresses the overall emotional well-being of the patient. Utilizing management and coping strategies is desirable. Our new tinnitus activities treatment is an example of such a protocol. We believe that the notions of fearfulness and acceptance have the potential to be integrated into tinnitus treatment. Some patients reject, control or accept their tinnitus. We believe in some instances there may be a common genetic cause of tinnitus and depression. A potential candidate is the serotonin transporter gene SLC6A4., (Copyright (c) 2006 S. Karger AG, Basel.)