Since tinnitus is a subjective symptom without a known physiologic explanation, randomized placebo-controlled trials are particularly important to validate the effectiveness of any treatment compared to the expected placebo effect.
While several large case series have reported positive results of tinnitus maskers, placebo-controlled trials are required to evaluate the extent of the expected placebo effect. Erlandsson performed a clinical trial in which patients were randomized to receive either a masker or sham device; those receiving the sham device were falsely told that it delivered a beneficial electrical current. Treatment response was based on responses to a questionnaire focusing on both changes in tinnitus level and nonspecific effects on mood, stress, and symptoms other than tinnitus. Neither the treatment nor placebo group reported a significant change in tinnitus intensity. Stephens and Corcoran reported on a controlled study that assigned non-hearing-impaired subjects to either a control group (n=24) with limited counseling or a treatment group (n=5l) with counseling in addition to the use of one of two different tinnitus maskers. Outcomes were assessed with a questionnaire. There were no significant differences among the control and treatment groups, leading the authors to conclude that treatment with maskers has not been found to show a significant advantage compared to counseling alone.
Transcutaneous Electrical Stimulation Of The Ear
Two randomized trials of electrical stimulation were reported in the 1980s with negative results. Dobie and colleagues reported on a randomized, double-blind crossover trial in which 20 patients received an active and disconnected placebo device. Reduction in severity of tinnitus was reported in two of 20 patients with the active device and four of 20 patients with the placebo device. Fifteen of the 20 patients reported no effect with either device. Thedinger and colleagues reported on a single-blind crossover trial of 30 patients who received active or placebo stimulation over two weeks. Only two of the 30 subjects obtained a true positive result. Steenerson and Cronin reported on a large case series of 500 patients with tinnitus who were treated with electrical stimulation twice weekly for a total of six to ten visits. Fifty-three percent of patients reported a significant benefit, defined as an improvement of at least two points on a ten-point scale of tinnitus intensity.
Transmeatal Laser Irradiaton
Tauber and colleagues reported on the use of transmeatal low-level laser therapy for the treatment of chronic tinnitus in 35 patients randomized to receive five single-diode laser treatments at either 635 or 830 nm. The authors reported 13 of 35 patients had reduced tinnitus loudness, while two patients reported absence of tinnitus. However, this was not a placebo-controlled trial, and the authors noted that further study was needed.
Tinnitus Retraining Therapy
While Jastreboff has published the theoretical rationale behind tinnitus-retraining therapy, no controlled trials were identified. Other articles from 1993 to 1998 were identified, but these studies were either focused on tools to evaluate the results of tinnitus retraining or consisted of uncontrolled trials. In a 2003 literature review update, one non-randomized, clinical trial of 108 cases assigned to five categories of tinnitus retraining therapy was identified. However, no randomized studies were identified in the 2003 update. An update in March 2005 reported one randomized controlled trial. This trial compared tinnitus-coping group training to minimal contact interventions or a waiting-list control. The authors reported significant improvements in the tinnitus coping group training over the waiting-list control group
Jastreboff again provides the rationale behind tinnitus-retraining therapy and maintains that it can be an effective method of treatment. Two prospective non-randomized clinical assays were done by Herraiz and colleagues in an attempt to demonstrate the efficacy of tinnitus retraining therapy. The results of these assays concluded that tinnitus retraining is an effective treatment of tinnitus. A prospective quasi-randomized study by Henry and colleagues compared the efficacy of tinnitus retraining therapy and tinnitus masking among 123 subjects. The study concluded that both tinnitus masking and tinnitus retraining are effective therapies, with tinnitus masking demonstrating constant gains and tinnitus retraining demonstrating incremental gains over the 18 month period. None of these studies specifically supports the efficacy of tinnitus retraining therapy. No new randomized, placebo-controlled trials were identified.
Ghossaini and colleagues reported on a randomized, double-blind placebo-controlled study of 37 patients who received either placebo treatment or electromagnetic energy treatment with a Diapulse device for 30 minutes, three times a week for one month. The authors found no significant changes in either group in pretreatment and post-treatment audiometric thresholds, Tinnitus Handicap Inventory scores or tinnitus rating scores, and concluded pulsed electromagnetic energy (27.12 MHz at 600 pulses/second) offered no benefit in the treatment of tinnitus.
Transcranial Magnetic Stimulation
Kleinjung et al. reported on a placebo-controlled cross-over study of low-frequency repetitive transcranial magnetic stimulation in 14 patients with chronic tinnitus. Using a Magstim system, the authors applied transcranial magnetic stimulation to the area of increased metabolic activity in the auditory cortex as identified by fused positron emission tomography and magnetic resonance imaging data. After one week of transcranial magnetic stimulation, 11 of 14 patients experienced a significant reduction in tinnitus (p <0.005), whereas the sham treatment did not result in a significant change. Eight patients also reported reduced tinnitus six months after treatment. The authors noted that the study results are useful to support the association of tinnitus to increased metabolic activity and may assist in identifying new tinnitus treatment possibilities.
Pridmore and colleagues provide the rationale behind transcranial magnetic stimulation and state that there is a good theoretical basis along with early research suggesting that this treatment may have potential. Rossi and colleagues reported on a randomized, double blind, crossover placebo study to evaluate the effects of rTMS on chronic tinnitus. Sixteen subjects participated in the study over a period of five days. Two participants dropped out for transient worsening of tinnitus. Eight out of 14 responded. The study concluded that active repetitive transcranial magnetic stimulation induced an overall significant but transient improvement of subjective tinnitus perception (35% of the basal score). However, this study is small, and further investigation is needed. No additional recent randomized, placebo-controlled trials were identified, and updates failed to identify any significant additional randomized studies or research.
Botulinum Toxin A
Stidham and colleagues explored the use of botulinum toxin A injections for tinnitus treatment under the theory that blocking the autonomic pathways could reduce the perception of tinnitus. In the Stidham et al study, 30 patients were randomized in a double-blind study to receive either three subcutaneous injections of botulinum toxin A around the ear followed by placebo injections four months later, or placebo injections first followed by botulinum toxin A. The authors reported seven patients had reduced tinnitus after the botulinum toxin A injections which was statistically significant when compared to the placebo groups in which only two patients reported reduced tinnitus (p<0.005). The tinnitus handicap inventory scores were also significantly decreased between pretreatment and four months post-botulinum toxin A injections. However, no other significant differences were noted when comparing the two treatments at one and four months after injections. The authors noted larger studies are needed. Also, study limitations, including size and lack of intent to treat analysis, limited interpretation of results.
A review of the literature was conducted based on the MEDLINE database for the period of June 2005 through August 2007. No new randomized, placebo-controlled trials were identified. Thus, the coverage position of this medical policy is unchanged.
Tinnitus Retraining Therapy
An industry-sponsored randomized study compared the efficacy of a customized acoustic stimulus for tinnitus retraining with counseling alone. Fifty (of 88 subjects recruited) were found to meet the inclusion/exclusion criteria. The mean length of time that their tinnitus had been disturbing was 3.6 years (range 0.2 to 23). Patients were allocated into one of four groups: 1) customized acoustic stimulus at high intensity for two hours per day, 2) customized acoustic stimulus at a lower intensity, 3) tinnitus retraining therapy with a broadband stimulator and counseling, or 4) counseling alone. Subjects were instructed to listen to the devices for two hours per day at the time of day when symptoms were most severe and at a level that completely (Group 1) or partially (Group 2) masked the tinnitus; use of the devices averaged 1.8 hours per day (range 0.4 to 6.8). The two customized acoustic stimuli groups were combined in the analysis due to overlap in the self-administered stimulus intensity (absence of statistical difference between the groups). All patients lost to follow-up were included in the data set for analysis with a “last value carried forward.” Mean scores on the Tinnitus Reaction Questionnaire (TRQ) improved over the twelve months of the study for the customized acoustic stimuli. TRQ scores were not significantly improved in the control groups. At the six-month follow-up, 86% of patients in the customized acoustic stimuli groups had met the definition of success based on 40% improvement in TRQ scores. Normalized visual analogue scores for tinnitus severity, general relaxation, and loudness tolerance were improved relative to both baseline and the control group’s scores at twelve months. Perceived benefits were also greater with the customized acoustic stimulus. Another publication from the developers of the device described results for the first 552 patients who had treatment at specialized clinics in Australia. Patients were divided into three levels, based on complicating factors and proposed suitability for the treatment. Tier 1 (237 patients) did not display any nonstandard or complicating factors. Tier 2 (223 patients) exhibited one or more of the following: psychological disturbance, a low level of tinnitus-related disturbance (TRQ score below 17) and/or moderately severe or severe hearing loss in one ear (greater than 50 dB). Tier 3 (92 patients) exhibited one or more of the following: “reactive” tinnitus, continued exposure to high levels of noise during treatment, active pursuit of compensation, multi-tone tinnitus, pulsitile tinnitus, Ménière’s disease, and/or hearing loss of greater than 50 dB in both ears. Of the 552 patients who began therapy, 62 (11%) chose to discontinue treatment for refund and 20 (4%) were lost to follow-up. After an average treatment duration of 37 weeks, the TRQ was reported to be improved (by greater than 40%) in 92% of tier one patients, 60% of tier two patients, and 39% of tier three patients. It was not reported if the reduction in symptoms persisted when treatment stopped. Controlled studies with long-term follow-up are needed to evaluate the durability of treatment and the relative contribution of generalized masking versus desensitization to these results.
A 2008 publication of a randomized placebo-controlled double-blind study with 60 patients reported no efficacy of laser therapy for tinnitus.
Transcranial Magnetic Stimulation (rTMS)
One randomized, double-blind, sham-controlled cross-over trial (16 patients) used low-frequency (1Hz) rTMS over the auditory association cortex (left temporoparietal region) for five days, with two weeks follow-up after (and between) each condition. Two patients dropped out due to worsening of tinnitus (one from each condition); sham treatment resulted in a less than 10% improvement in visual analogue scale (VAS) over the 3-week assessment. The average improvement in VAS for active rTMS (about 35%) was maintained for one week following treatment. Of the 14 patients who completed the study, eight (57%) were classified as responders (25% or greater improvement in VAS); no baseline factors were found to be associated with a positive response. Another small randomized sham controlled study (eight subjects) found a temporary (30 minutes or less) duration-dependent reduction in tinnitus (in about 50% of subjects) following a single 5-, 15- or 30-minute session of rTMS over temporoparietal areas associated with excessive tinnitus-related activity (guided by positron emission tomography with and without intravenous lidocaine). The authors reported that the response to treatment was negatively correlated (r=-0.62) with disease duration.
Kleinjung et al. reported results from a prospective observational study of rTMS for ten days over the primary auditory cortex (identified by magnetic resonance imaging) in 45 patients. Forty percent of patients were classified as responders (five points or more on a tinnitus questionnaire) and 60% as non responders; improvement in symptoms was maintained for 90 days. Post hoc analysis found that a positive response was associated with absence of a hearing impairment and disease duration of less than three years. Recent experimental studies, which are testing different locations and schedules along with beginning to identify the patient population that might benefit from this treatment, indicate that rTMS for tinnitus is investigational.
Transmeatal Laser Irradiation
A 2008 publication of a randomized placebo-controlled double-blind study with 60 patients reported no efficacy of laser therapy for tinnitus.
A search of peer-reviewed literature through August 2009 identified no new clinical trial publications or any additional information that would change the coverage position of this medical policy.
A search of peer reviewed literature was conducted through June 2011. Review of literature addressed below resulted in no change to the coverage position of this medical policy.
Transcranial magnetic stimulation or repetitive transcranial magnetic stimulation (rTMS)
A small (n=19) randomized double-blinded sham-controlled parallel trial from Brazil that had six-month follow-up after rTMS was identified. As earlier studies had showed improved outcomes in the absence of hearing impairment, only subjects with normal pure tone audiometry were included in this trial. Five sessions of rTMS (17 minutes per session) were performed on five consecutive business days. Placebo stimulation was performed with a sham coil system which mimics the sound of active stimulation, without producing a magnetic field. Tinnitus severity on the THI showed a decrease from baseline (29.8) to 1-month (19.4) and 6-month (22.8) follow-up. There was no change in the THI following sham stimulation (28.9 at baseline, 28.9 at 1 month, and 29.6 at 6 months).
In 2010, Anders et al. published results of a double-blinded randomized sham-controlled trial with 42 patients who had chronic, treatment resistant tinnitus and completed two weeks of rTMS treatment over the left primary auditory cortex. An additional ten patients withdrew from the study before the end of treatment due to adverse effects such as headache, worsening of tinnitus or perceived lack of efficacy. Tinnitus severity was measured at baseline, the end of treatment (week 2) and during follow-up at 6, 14, and 26 weeks. The baseline THI was 37.1 for the active treatment and 26.5 for the sham treatment. At the end of the stimulation phase, both active and sham groups showed a significant reduction in the symptoms of tinnitus as measured by the THI and Tinnitus Questionnaire. In the active rTMS group, tinnitus severity with the THI was rated as 31.8 at two weeks, increasing to around 33 through the twenty-six weeks of follow-up. In the sham group, the THI was 23.1 at week two, rising to 27.7 by twenty-six weeks. A similar pattern was observed with the Tinnitus Questionnaire. Interpretation of this study is limited due to the differences in baseline scores and improvement in the sham group immediately following treatment. In addition, the clinical significance of a four-point change in the THI and three-point change in the tinnitus questionnaire is unclear.
Tinnitus Coping Therapy
A 2007 Cochrane review that identified six randomized trials in which 285 patients with tinnitus received cognitive behavioral therapy or a control condition (another treatment or wait list), was updated in 2010 with two additional trials and a total of 468 participants. As was previously found, there was no significant difference in subjective tinnitus loudness between cognitive behavioral therapy and either no treatment or another intervention, but an improvement in quality of life. The updated analysis found evidence that depression scores improved when comparing cognitive behavioral therapy to no treatment, but there was no evidence of benefit in depression scores when compared to other treatments (yoga, education, and minimal contact-education).
A 2010 Cochrane review evaluated evidence for masking in the management of tinnitus in adults. Included in the review were six randomized controlled trials (553 participants) that used noise-generating devices or hearing aids as the sole management tool or in combination with other strategies, including counseling. Heterogeneity in outcome measures precluded meta-analysis of the data. The risk of bias was medium in three studies and high in three studies. The authors concluded that due to the lack of quality research and the common use of combined approaches (hearing therapy plus counseling), the limited data failed to show evidence of the efficacy of masking therapy in tinnitus management.
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