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. 2019 Jan 8;2019(1):CD008248. doi: 10.1002/14651858.CD008248.pub2

Neurophysiological model‐based treatments for tinnitus

John S Phillips 1,✉, Don McFerran 2
PMCID: PMC6353153

Abstract

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:

To assess the effectiveness of neurophysiological‐model based treatments (NMT) for the treatment of subjective idiopathic tinnitus.

Background

This is one of a number of tinnitus reviews produced by the Cochrane Ear, Nose & Throat Disorders Group, which use a standard Background. The following paragraphs ('Description of the condition') are based on earlier work in the following reviews and reproduced with permission: Baldo 2006; Bennett 2007; Hilton 2004; Hobson 2007; Phillips 2008.

Description of the condition

Tinnitus can be described as the perception of sound in the absence of external acoustic stimulation. For the patient it may be trivial or it may be a debilitating condition (Luxon 1993). The quality of the perceived sound can vary enormously from simple sounds such as whistling or humming to complex sounds such as music. The patient may hear a single sound or multiple sounds. Tinnitus may be perceived in one or both ears, within the head or outside the body. The symptom may be continuous or intermittent. Tinnitus is described in most cases as subjective ‐ meaning that it cannot be heard by anyone other than the patient. While, for the patient, this perception of noise is very real, because there is no corresponding external sound it can be considered a phantom, or false, perception. Objective tinnitus is a form of tinnitus which can be detected by an examiner, either unaided or using a listening aid such as a stethoscope or microphone in the ear canal. This is much less common and usually has a definable cause such as sound generated by blood flow in or around the ear or unusual activity of the tiny muscles within the middle ear. Tinnitus may be associated with normal hearing or any degree of hearing loss and can occur at any age.

It is important to distinguish between clinically significant and non‐significant tinnitus (Davis 2000) and several different classifications have been proposed (Dauman 1992; McCombe 2001; Stephens 1991). Dauman, for example, makes a distinction between 'normal' (lasting less than five minutes, occurring less than once a week and experienced by most people) and 'pathological' tinnitus (lasting more than five minutes, occurring more than once a week and usually experienced by people with hearing loss).

Aetiology

Almost any form of disorder involving the outer, middle or inner ear or the auditory nerve may be associated with tinnitus (Brummett 1980; Shea 1981). However, it is possible to have severe tinnitus with no evidence of any aural pathology. Conversely, tinnitus can even exist without a peripheral auditory system: unilateral tinnitus is a common presenting symptom of vestibular schwannomas (acoustic neuromas), which are rare benign tumours of the vestibulo‐cochlear nerve. When these neuromas are removed by a translabyrinthine route, the cochlear nerve can be severed. Despite the effective removal of their peripheral auditory mechanisms, 60% of these patients retain their tinnitus postoperatively (Baguley 1992). This suggests the fundamental importance of the central auditory pathways in the maintenance of the symptom, irrespective of trigger.

Many environmental factors can also cause tinnitus. The most relevant and frequently reported are:

Pathophysiology

Over 50 years ago, Heller and Bergman demonstrated that if 'normal' people (with no known cochlear disease) were placed in a quiet enough environment, the vast majority of them would experience sounds inside their head. They concluded that tinnitus‐like activity is a natural phenomenon perceived by many in a quiet enough environment (Heller 1953).

Mazurek has shown that pathologic changes in the cochlear neurotransmission, e.g. as a result of intensive noise exposure or ototoxic drugs, can be a factor in the development of tinnitus (Mazurek 2007).

In the 'neurophysiological model' of tinnitus (Jastreboff 1990; Jastreboff 2004) it is proposed that tinnitus results from the abnormal processing of a signal generated in the auditory system. This abnormal processing occurs before the signal is perceived centrally. This may result in 'feedback', whereby the annoyance created by the tinnitus causes the individual to focus increasingly on the noise, which in turn exacerbates the annoyance and so a 'vicious cycle' develops. In this model tinnitus could therefore result from continuous firing of cochlear fibres to the brain, from hyperactivity of cochlear hair cells or from permanent damage to these cells being translated neuronally into a 'phantom' sound‐like signal that the brain 'believes' it is hearing. For this reason tinnitus may be compared to chronic pain of central origin ‐ a sort of 'auditory pain' (Briner 1995; Sullivan 1994).

The relationship between the symptom of tinnitus and the activity of the prefrontal cortex and limbic system has been emphasised. The limbic system mediates emotions. It can be of great importance in understanding why the sensation of tinnitus is in many cases so distressing for the patient. It also suggests why, when symptoms are severe, tinnitus can be associated with major depression, anxiety and other psychosomatic and/or psychological disturbances, leading to a progressive deterioration of quality of life (Lockwood 1999; Sullivan 1989; Sullivan 1992; Sullivan 1993).

Prevalence

Epidemiological data reports are few. The largest single study was undertaken in the UK by the Medical Research Council Institute of Hearing Research and was published in 2000 (Davis 2000). This longitudinal study of hearing questioned 48,313 people; 10.1% described tinnitus arising spontaneously and lasting for five or more minutes at a time and 5% described it as moderately or severely annoying. However, only 0.5% reported tinnitus having a severe effect on their life. This is another of the paradoxes of tinnitus: the symptom is very common but the majority of people who experience it are not particularly concerned by it. These figures from the UK are broadly consistent with data collected by the American Tinnitus Association (ATA) which suggests that tinnitus may be experienced by around 50 million Americans, or 17% of the US population (ATA 2004). Data also exist for Japan, Europe and Australia (Sindhusake 2003), and estimates suggest that tinnitus affects a similar percentage of these populations, with 1% to 2 % experiencing debilitating tinnitus (Seidman 1998). The Oregon Tinnitus Data Archive (Oregon 1995) contains data on the characteristics of tinnitus drawn from a sample of 1630 tinnitus patients. The age groups with the greater prevalence are those between 40 and 49 years (23.9%) and between 50 and 59 years (25.6%).

Olszewski showed in his study that the risk of tinnitus increases in patients over 55 years old who suffer from metabolic conditions and cervical spondylosis (Olszewski 2008).

Diagnosis

Firstly a patient with tinnitus may undergo a basic clinical assessment. This will include the relevant otological, general and family history, and an examination focusing on the ears, teeth and neck and scalp musculature. Referral to a specialist is likely to involve a variety of other investigations including audiological tests and radiology. Persistent, unilateral tinnitus may be due to a specific disorder of the auditory pathway and imaging of the cerebellopontine angle is important to exclude, for example, a vestibular schwannoma (acoustic neuroma) ‐ a rare benign tumour of the cochleo‐vestibular nerve. Other lesions, such as glomus tumours, meningiomas, adenomas, vascular lesions or neuro‐vascular conflicts may also be detected by imaging (Marx 1999; Weissman 2000).

Treatment

At present no specific therapy for tinnitus is acknowledged to be satisfactory in all patients. Many patients who complain of tinnitus, and also have a significant hearing impairment, will benefit from a hearing aid. Not only will this help their hearing disability but the severity of their tinnitus may be reduced.

A wide range of therapies have been proposed for the treatment of tinnitus symptoms. Pharmacological interventions used include cortisone (Koester 2004) vasodilators, benzodiazepines, lidocaine and spasmolytic drugs. The use of anticonvulsants in treating tinnitus is the subject of a forthcoming Cochrane Review (Hoekstra 2009). Antidepressants are commonly prescribed for tinnitus. However, two reviews (Baldo 2006; Robinson 2007) showed that there is no indication that tricyclic antidepressants have a beneficial effect.

Although a number of studies have suggested that Ginkgo biloba may be of benefit in the treatment of tinnitus (Ernst 1999; Holger 1994; Rejali 2004), a Cochrane Review showed that there was no evidence that it is effective where tinnitus was the primary complaint (Hilton 2004).

Hyperbaric oxygen therapy (HBOT) can improve oxygen supply to the inner ear which it is suggested may result in an improvement in tinnitus, however a Cochrane Review found insufficient evidence to support this (Bennett 2007).

Studies have been carried out into the effect of cognitive behavioural therapy (CBT) on tinnitus (Andersson 1999). Another Cochrane Review has shown that CBT can have an effect on the qualitative aspects of tinnitus and can improve patients' ability to manage the condition (Martinez‐Devesa 2007).

Other options for the management of patients with tinnitus include transcranial magnetic stimulation (Meng 2009), tinnitus masking (use of 'white noise' generators) (Hobson 2007), music therapy (Argstatter 2008), reflexology, hypnotherapy, and traditional Chinese medicine (TCM) including acupuncture (Li 2009).

Description of the intervention

Tinnitus Retraining Therapy

Following publication of his Neurophysiological Model in 1990 (Jastreboff 1990), Jastreboff went on to generate a clinical management strategy that combined directive counselling and sound therapy to counteract the pathological positive feedback process and promote habituation to the tinnitus (Jastreboff 1993). This process was subsequently titled Tinnitus Retraining Therapy or TRT (Hazell 1996). Both Jastreboff and Hazell set up educational courses to teach the Neurophysiological Model and Tinnitus Retraining Therapy to interested healthcare professionals and have stressed that proper training is essential before undertaking this technique (Hazell 1999).

Neurophysiological model‐based treatments

Often the principles of Tinnitus Retraining Therapy are followed in many studies but fall short of being defined as true Tinnitus Retraining Therapy. Although based on the Neurophysiological Model (Jastreboff 1990), the exact details of the therapy do not follow the strict definition as described by its creator (Jastreboff 1999). In essence, Tinnitus Retraining Therapy is a neurophysiological model‐based treatment, the factor that separates it from other forms of neurophysiological model‐based treatments is that Tinnitus Retraining Therapy adheres strictly to the format defined by Jastreboff (Jastreboff 1999).

Definition of neurophysiological model‐based treatments

Throughout this review neurophysiological model‐based treatments will be defined as treatments for tinnitus which include both of the following:

  1. directive counselling;

  2. sound therapy.

Directive counselling

Directive  counselling  is  the  process whereby the 'therapist' listens to their client’s  problem and comes to an agreement with the client as to a course of action, encouraging and motivating the client to fulfil the agreed solution. This type of counselling  accomplishes the function of advice, but it may also reassure, give emotional release and, to a minor extent, clarify thinking. Non‐directive, or 'client‐centred counselling', in contrast to directive counselling, involves encouraging the client to explain bothersome problems, to understand these problems and for the client to determine their own solutions. Non‐directive counselling focuses on the client, rather than on the counsellor as a judge and advisor.

Sound therapy

Sound therapy is based on experience that appropriate external sounds can diminish or even render tinnitus inaudible. Sound therapy and masking are two distinct forms of intervention. Masking devices were introduced on the principle of distraction; that if a level of noise, usually 'white noise', is introduced it can reduce the contrast between the tinnitus signal and background activity in the auditory system, with a decrease in the patient's perception of their tinnitus (Vernon 1977). In the early 1980s a large, complex study of sound therapy devices included white noise generators and combination hearing aids and noise generators (Hazell 1985; Stephens 1985). Further work stemming from this study showed that rather than using the volume of noise that would mask tinnitus, a low (minimally appreciable) level of white noise treatment could be used to achieve down‐regulation ("habituation of the disordered auditory perception" (McKinney 1995; Jastreboff 1995)). This was not intended to achieve audiological masking nor immediate residual inhibition. Low‐level white noise is offered regularly as a treatment for tinnitus, rather than sound therapy aimed at 'masking' the tinnitus in the audiological sense of the word.

How the intervention might work

Neurophysiological model‐based treatments combine directive counselling and sound therapy to counteract the pathological positive feedback process and promote habituation to the tinnitus (Jastreboff 1993).

Why it is important to do this review

Tinnitus is a common symptom and associated with significant morbidity in certain patient groups. Neurophysiological model‐based treatments are commonly employed to treat patients with tinnitus, but to date the efficacy of these treatments has not been formally assessed in the format of a structured systematic review.

Objectives

To assess the effectiveness of neurophysiological‐model based treatments (NMT) for the treatment of subjective idiopathic tinnitus.

Methods

Criteria for considering studies for this review

Types of studies

Randomised controlled trials.

Types of participants

Adults (> 16) only.

Types of interventions

Studies where the patient receives neurophysiological‐model based treatment (NMT) versus placebo.

Types of outcome measures

Primary outcomes

Improvement in tinnitus severity and disability, measured by a validated tinnitus‐specific questionnaire. Acceptable tinnitus questionnaires are listed in Table 1.

Table 1.

Tinnitus questionnaires

Title No. of items/factors Psychometrics
Tinnitus Questionnaire (Hallam 1996) 52 items, 5 factors a = 0.91 for total scale; for subscales a = 0.76 to a = 0.94
Tinnitus Handicap Questionnaire (Kuk 1990) 27 items, 3 factors a = 0.93 for total scale
Tinnitus Severity Scale (Sweetow 1990) 15 items Alpha not reported
Tinnitus Reaction Questionnaire (Wilson 1991) 26 items, 4 factors a = 0.96 and a test‐retest correlation of r = 0.88
Subjective Tinnitus Severity Scale (Halford 1991) 16 items a = 0.84
Tinnitus Handicap/Support Scale (Erlandsson 1992) 28 items, 3 factors Alpha not reported
Tinnitus Handicap Inventory (Newman 1996) 25 items, 3 scales a = 0.93 for total scale
Tinnitus Coping Strategy Questionnaire (Henry 1995) 33 a = 0.88
Tinnitus Coping Style Questionnaire (Budd 1995) 40 —
Tinnitus Cognitions Questionnaire (Wilson 1998) — —
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Secondary outcomes

  1. Improvement in tinnitus perception, loudness or intensity (specific auditory disease evaluation).

  2. Improvement/change in depressive symptoms or in depression scores.

  3. Improvement/change in global wellbeing.

Search methods for identification of studies

We will conduct systematic searches for randomised controlled trials. There will be no language, publication year or publication status restrictions. We may contact original authors for clarification and further data if trial reports are unclear and we will arrange translations of papers where necessary.

Electronic searches

Published, unpublished and ongoing studies will be identified by searching the following databases from their inception: the Cochrane Ear, Nose and Throat Disorders Group Trials Register; the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, current issue); PubMed; EMBASE; CINAHL; LILACS; KoreaMed; IndMed; PakMediNet; CAB Abstracts; Web of Science; BIOSIS Previews; CNKI; mRCT (Current Controlled Trials); ClinicalTrials.gov; ICTRP (International Clinical Trials Registry Platform) and Google.

Subject strategies for databases will be modelled on the search strategy designed for CENTRAL (see Appendix 1). Where appropriate, we will combine subject strategies with adaptations of the highly sensitive search strategy designed by the Cochrane Collaboration for identifying randomised controlled trials and controlled clinical trials (as described in The Cochrane Handbook for Systematic Reviews of Interventions Version 5.0.1, Box 6.4.b. (Handbook 2008)).

Searching other resources

We will scan the reference lists of identified publications for additional trials and contact trial authors if necessary. PubMed, TRIPdatabase, NHS Evidence ‐ ENT & Audiology and Google will be searched to retrieve existing systematic reviews possibly relevant to this systematic review, so that we can scan their reference lists for additional trials.

Data collection and analysis

Selection of studies

The two authors will independently assess the studies to be included to identify studies which meet the criteria outlined above. We will resolve any differences of opinion by discussion.

Data extraction and management

We will extract data onto standardised, pre‐piloted forms. We will contact study authors if necessary for clarification. If there is disagreement this will be resolved by discussion.

Assessment of risk of bias in included studies

Both authors will independently assess the included trials for risk of bias. Assessment of the risk of bias of the included trials will be undertaken independently by JP and DM with the following to be taken into consideration, as guided by the Cochrane Handbook for Systematic Reviews of Interventions (Handbook 2008):

  • sequence generation;

  • allocation concealment;

  • blinding;

  • incomplete outcome data;

  • selective outcome reporting; and

  • other sources of bias.

We will use the Cochrane ‘Risk of bias’ tool in RevMan 5, which involves describing each of these domains as reported in the trial and then assigning a judgement about the adequacy of each entry. This involves answering a pre‐specified question whereby a judgement of ‘Yes’ indicates low risk of bias, ‘No’ indicates high risk of bias, and ‘Unclear’ indicates unclear or unknown risk of bias.

Data synthesis

We will perform statistical analysis using Review Manager 5.0 (RevMan 2008). We will use both the Chi2 and I2 tests to formally assess statistical heterogeneity. It is hoped that data will be pooled for meta‐analysis, however this will only be performed in the absence of clear clinical and statistical heterogeneity. If it is not possible to pool data, we will present a narrative synthesis of the included studies. For dichotomous outcomes we will calculate a risk ratio (RR). We will use the mean difference (MD) or standardised mean difference (SMD) for continuous outcomes as appropriate.

Data allowing, we plan to conduct subgroup analysis of Tinnitus Retraining Therapy (TRT) versus non‐TRT forms of neurophysiological model‐based treatment for tinnitus.

Acknowledgements

We would like to acknowledge the work done on antidepressants for patients with tinnitus (Baldo 2006). This review shares a similar format to both the work done on antidepressants (Baldo 2006) and Tinnitus Retraining Therapy (Phillips 2008) to conserve clarity with respect to the review of tinnitus.

Appendices

Appendix 1. CENTRAL search strategy

1. TINNITUS single term (MeSH) 2. TINNIT* 3. #1 OR #2 4. COGNITIVE THERAPY single term (MeSH) 5. PERCEPTUAL MASKING single term (MeSH) 6. HABITUATION, PSYCHOPHYSIOLOGIC single term (MeSH) 7. CONDITIONING, CLASSICAL single term (MeSH) 8. COUNSELING single term (MeSH) 9. ADAPTATION, PSYCHOLOGICAL single term (MeSH) 10. PSYCHOTHERAPY GROUP single term (MeSH) 11. JASTREBOFF OR HAZELL OR NEUROPHYSIOLOGICAL* OR TRAINING NEXT WORKSHOP* OR TRAINING NEXT CLINIC* OR SOUND NEXT ENRICHMENT OR SOUND NEXT THERAP* 12. COUNSEL* NEAR EDUCATION* OR COUNSEL* NEAR STRUCTURED OR COUNSEL* NEAR DIRECTIVE 13. RETRAIN* OR RELEARN* OR RECONDITION* OR HABITUAT* OR TRT 14. #4 OR #5 OR #6 OR #7 OR #8 OR #9 OR #10 OR #11 OR #12 OR #13 15. #3 AND #14

What's new

Date Event Description
8 January 2019 Amended Protocol withdrawn from Issue 1, 2019.
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Contributions of authors

JP: Lead author, protocol development, design of search strategy, review preparation, quality assessment, data extraction and analysis.

DM: Protocol development, review preparation, quality assessment, data extraction and analysis.

Declarations of interest

Don McFerran does occasional work at the Tinnitus and Hyperacusis Centre which was one of the departments that developed TRT. However, he was not involved in that development process and has not published specifically on the topic of TRT. He has also conducted research into a possible drug treatment for tinnitus with Glaxo SmithKline.

Notes

Protocol withdrawn from Issue 1, 2019. Review could not be completed.

Withdrawn from publication for reasons stated in the review

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