Overview
Specific Supplements
Figure 1. Management Strategies
Patient/Clinician Discussion Points
Design and created by Guideline Central in participation with the Consensus and Physician Experts.
Supplements For Management of Bothersome Subjective Tinnitus
Consensus and Physician Experts
Publication Date: August 12, 2019
Overview
Introduction
- Tinnitus is the perception of sound in the absence of an external acoustic stimulus.
- It is a common and potentially debilitating symptom with various etiologies.
- Tinnitus affects over 50 million people in the US and 70 million in Europe.
- To manage tinnitus symptoms effectively, the type of tinnitus must be established.
- Tinnitus can be classified in different ways:
- Subjective tinnitus is most common, and represents an auditory perception only the patient hears.
- Objective tinnitus results from abnormal blood flow or muscle twitching in the middle ear. It can often be heard by the examiner.
- Tinnitus can be further classified as peripheral or central, acute or chronic, primary or secondary.
- This Advisory pertains to use of supplements in patients with subjective tinnitus.
- No medication has been approved by the Food and Drug Administration (FDA) to treat tinnitus. Supplement effectiveness is not evaluated by the FDA.
- However, the use of dietary supplements for tinnitus is widespread, and some patients have reported a reduction of symptoms. For that reason, in the right context, the use of natural supplements for tinnitus may be appropriate for some patients.
- The purpose of this advisory is to create a list of best practices for approaching the management of tinnitus using supplements.
Table 1. Definitions of Tinnitus Terms
| Term | Definition |
|---|---|
| Tinnitus | The perception of sound when there is no external source of the sound. |
| Primary tinnitus | Tinnitus that is idiopathic and may or may not be associated with sensorineural hearing loss. |
| Secondary tinnitus | Tinnitus that is associated with a specific underlying cause (other than sensorineural hearing loss) or an identifiable organic condition. |
| Recent onset tinnitus | <6 months in duration (as reported by the patient). |
| Persistent tinnitus | ≥6 months in duration. |
| Bothersome tinnitus | Distressed patient, impacted quality of life1 and/or functional health status. Patient is seeking active therapy and management strategies to alleviate tinnitus. |
| Non-bothersome tinnitus | Tinnitus that does not have a significant impact on a patient’s quality of life but may result in curiosity or concern about the cause or natural history and how it might progress or change. |
1 Quality of life is the degree to which persons perceive themselves able to function physically, emotionally, mentally, and/or socially.
Pathophysiology of Subjective Tinnitus
- The pathophysiology of tinnitus has been linked to a variety of causes, including noise exposure, aging as well as many other causes of hearing loss; infectious, neurologic, somatosensory and drug related causes to list a few.
- The primary functions potentially affected by tinnitus are 1) thoughts and emotions, 2) hearing, 3) sleep and 4) concentration. These can lead to secondary effects on socialization and work.
- There has been no widespread acceptance of a single classification system of tinnitus, as the variables that lead to disabling tinnitus in some patients have remained elusive.
- A grading system of tinnitus severity is helpful to measure the effects of tinnitus on quality of life. One can use a simple 1-5, 1-10 or 1-100 scale with higher number indicative of more severe tinnitus. There are standardized measures of tinnitus burden (e.g. Tinnitus Handicap Inventory, Tinnitus Handicap Questionnaire, Tinnitus Primary Functions Questionnaire).
Table 2. Causes and Modulators of Tinnitus
| Common causes of tinnitus | Disorders which may cause or exacerbate distress of tinnitus |
|---|---|
| Hearing loss | Anxiety/stress |
| Noise exposure | Depression |
| Medications (Aspirin, acetaminophen, Lasix, aminoglycosides etc…) | TMJ disorders/somatic causes |
| Head trauma/traumatic brain injury | Migraine disorders |
| Vascular – anemia/HTN/atherosclerosis | Autoimmune disorders – e.g. fibromyalgia |
| Vestibular schwannoma | |
| Meniere’s disease/syndrome |
Overview of Management Strategies
- There is no cure for tinnitus, and current treatment strategies focus on managing reactions to symptoms of tinnitus.
- Outside of the supplements covered in this advisory, some of the common management strategies include hearing aids, sound therapy, and counseling, such as tinnitus retraining therapy and tinnitus activities treatment.
- The success of these treatments to help patients with their reactions to their tinnitus varies widely from one individual to another.
- As a rule of thumb, you should utilize less invasive treatment options followed by more invasive strategies if initial treatment fails and the tinnitus is severe.
- Individualization is key in managing tinnitus symptoms. Every patient is different, and what works for some may not work for others.
- Treatment will need to be individualized to the patient taking into account the phase of tinnitus (acute vs. chronic), level of the lesion (peripheral or central) and the type of distress (anxiety, hearing, sleep and/or concentration).
- Management strategies require a multipronged approach with a combination of hearing aids, sound therapies and counseling.
- Future treatments might include neuromodulation [direct (DBS, DCS) or indirect (VNS, somatic stimulation)], prescribed drugs or cochlear implants.
Overarching Principles for Use of Supplements
- A recent guideline from the American Academy of Otolaryngology-Head and Neck Surgery recommended against the use of supplements for tinnitus.
- Despite this lack of recommendations in clinical guidelines, dietary supplements for the management of tinnitus are used by some healthcare providers.
- Commonly used supplements for tinnitus are Ginkgo biloba, bioflavonoids, zinc, and magnesium. Melatonin is often used to aid sleep in patients with tinnitus.
- In some cases, certain supplements may be effective in managing the distress associated with reactions to tinnitus.
- This advisory provides one view on which supplements may or may not be appropriate in management of tinnitus, and the situations in which it may be appropriate to undertake a trial of supplements.
When it may be appropriate to try a supplement
- Ensure proper medical and audiological evaluation.
- Explore counseling, hearing aids, and sound therapy prior.
- Understand the goal of management is to help manage reactions and symptoms, including sleep and mood, and improve overall quality of life.
- Understand supplements are not likely to help all patients.
- Ensure you know what is in the supplement.
- Clear understanding of the costs and trial period (e.g. some supplements provide a money-back guarantee).
- Identify all reasonably possible side effects ahead of time based on the type of supplement you decide to start with and identify recommended restrictions while taking supplement.
- Have a plan for performing a “controlled trial”, as it is important to have a baseline approach. If you are going to try supplements, you should keep everything else as constant/status quo as possible (see Table 3).
When it is NOT appropriate to try a supplement
- Patients who have not received medical and audiological evaluation.
- When tinnitus is non-bothersome.
- Patients taking medications or other supplements that might interact with the chosen supplement.
- Patients unable or unwilling to adhere to recommended dosing strategies.
Table 3. Examples of Common Factors Which Should Be Kept Consistent for Controlled Trial
| Diet |
| Caffeine intake |
| Alcohol intake |
| Prescription medications |
| Other medications and supplements |
| Sleep schedule |
Specific Supplements
Bioflavonoids
- Bioflavonoids are one of the most commonly-used supplements for managing tinnitus symptoms.
- Lemon bioflavonoid (eriodictyol glycoside) is an active ingredient in some bioflavonoids.
- Bioflavonoids also include a mix of Vitamins B1, B2, B6, B12, C and more.
- The mechanism of action remains unknown. Some have speculated that eriodictyol glycoside helps block histamine production in the inner ear, a likely cause of inner ear disturbances. Others believe that the lipotropic agents contained in bioflavonoids may help to prevent abnormal accumulation of fatty deposits, thereby improving circulation.
- Vitamin B1 plays an important role in a healthy central nervous system. It may have benefit in cognitive function and maintaining a positive mental attitude. Vitamin B6 is involved in metabolism of carbohydrates, fats and proteins. They are also involved in higher cognitive function.
- While benefits have been noted in some case studies for patients with tinnitus and Meniere’s Syndrome, there are no controlled studies proving efficacy of bioflavonoids in tinnitus.
- There are no major side effects or contraindications of bioflavonoids, and as such, it may be appropriate to try for some patients.
Ginkgo biloba
- While Ginkgo biloba extracts have been used in traditional Chinese medicine for over 500 years, recently its use has become more common in Western countries.
- There are several different preparations available - most common is EGb761 followed by LI 1370.
- The active ingredients in gingko are flavonoids and terpenoids.
- The proposed mechanisms of action are: a vasoregulatory effect increasing blood flow, suppression of platelet activating factor, changes in neuron metabolism and prevention of oxygen radical damage to cell membranes.
- The most common side effects are gastrointestinal disturbance. Serious side effects such as bleeding and seizures are rare.
- There are several reports in literature suggesting efficacy of Gingko in management of tinnitus symptoms. Ginkgo biloba, EGb761 form, has been shown to be effective in treatment of tinnitus vs. placebo. Other studies, however, revealed inconsistent results.
- Ginkgo biloba may be appropriate to try for some patients, however given the rare potential side effects and contraindications, caution must be taken.
Magnesium
- Magnesium plays an important role in enzymatic activities of the brain and is a key regulator of calcium channels involved in neurotransmission.
- The mechanism of action of magnesium supplementation in tinnitus is unclear.
- Magnesium supplementation improves microcirculation and contributes to reduction of inflammatory cytokines and oxidative stress in the cochlea.
- Some studies of magnesium supplementation in noise induced hearing loss and idiopathic hearing loss has shown beneficial effects.
- Overall, the studies have shown some benefit in tinnitus associated with noise induced hearing loss. However, the studies are limited in the size of the patient population.
- Research utilizing controlled studies is needed before magnesium can be recommended in patients with tinnitus.
Melatonin(*Note - specifically for sleep reaction to tinnitus)
- Melatonin is a hormone produced by the pineal gland and regulates the sleep/wake cycle.
- It is commonly used as an over the counter sleep aid.
- Some studies have shown that melatonin is useful in treatment of subjective tinnitus and sleep disturbances, and for that reason, it may be appropriate to try for some patients.
Other B Vitamins (B1, B3, B6)
- Vitamin B1 plays an important role in a healthy central nervous system.
- Vitamin B1 may have benefits in cognitive function and maintaining a positive mental attitude.
- Vitamins B3 and B6 are involved in metabolism of carbohydrates, fats and proteins. Vitamins B3 and B6 are also involved in higher cognitive function.
- There are currently no studies proving the efficacy of vitamins B1, B3 and B6 alone in the management of tinnitus.
Vitamin B12
- Vitamin B12 deficiency has been noted in patients with chronic tinnitus compared to normal population.
- Deficiency may be associated with demyelination of the neurons in the auditory nerve contributing to hearing loss and tinnitus.
- Studies of Vitamin B12 treatment for tinnitus has had mixed results.
- Patients with hearing loss and tinnitus also had higher rates of B12 deficiency compared to patients with hearing loss and no tinnitus. Further research is needed with a larger population to confirm these findings, but the results are promising in patients with tinnitus and B12 deficiency.
Zinc
- There is a high content of zinc in the inner ear of humans and there is a correlation between low zinc levels and tinnitus.
- Studies on the effectiveness of zinc for managing tinnitus have had mixed results.
- It should be noted that chronic ingestion of zinc may result in copper deficiency and that zinc toxicity can be induced by doses of >200 milligrams of zinc in a single day.
- Zinc is not recommended in the management of subjective tinnitus at this time, because the risks outweigh any possible benefits.
Table 4. Common Supplements Used for Bothersome Tinnitus
| Bioflavonoids | Possible circulation improvement | Minimal (allergies, upset stomach) | 2 capsules TID at onset for 60 days, then 1 capsule TID for maintenance | Yes |
| Ginkgo biloba (EGb761) | Vasoregulatory antioxidant suppression of platelet activating factor change in neuron metabolism | GI side effects, bleeding, seizures, headache/dizziness, nausea | 120–160 to start up to 240 mg BID | Yes |
| Magnesium | Possible improved microcirculation, reduced oxidative stress | Diarrhea, headache, sleep disturbance | 532 mg daily shown to be effective in one study (Cevette) | No |
| Melatonin | Sleep | Increased urination, headache, dizziness | 3 mg nightly | Yes |
| Vitamin B1, B3, B6 | Effects on CNS and higher cognitive function | Bleeding, sleep disturbance, GI upset | N/A | No |
| Vitamin B12 | Deficiency noted in patients with tinnitus | Headache, dizziness, blurred vision, GI upset | >2500 mcg intramuscular/week | Sometimes |
| Zinc | Zinc present in inner ear | Zinc toxicity, copper deficiency | N/A | No |
BID, twice per day; mg, milligram; TID, three times per day
a None of the above supplements have a completely confirmed mechanism of action.
a None of the above supplements have a completely confirmed mechanism of action.
Figure 1. Management Strategies
Patient/Clinician Discussion Points
Topics
- Types of tinnitus
- Because there are many types of tinnitus with varying causes and degrees of severity, a proper assessment and diagnosis should be made prior to initiating any treatment, including supplements.
- Shared decision-making
- Patients and clinicians should discuss all available management strategies, including level of invasiveness and risk for side effects, prior to choosing an initial treatment path or management plan.
- Economic factors
- While many over the counter supplements are relatively inexpensive, cost (both initial and long-term) should be factored in ahead of time. It is worth noting that some manufacturers offer a money-back trial period, which may reduce the cost barrier for some patients.
- Adherence
- Some supplements must be taken multiple times per day, so it is important that the patient understands this ahead of time.
- Specific supplement/ingredients
- You should read the full list of ingredients prior to taking any supplement. Even when taking the same supplement, that list can vary by manufacturer.
- Medications/side-effects
- It is important to discuss all medications and supplements (both prescribed and over the counter) being taken BEFORE initiating supplements for tinnitus. Some supplements can interact with medications and lead to unwanted side effects.
- Controlled trials
- Patients should understand all of the factors that may affect the efficacy of supplements, and attempt to keep all of these external factors consistent throughout the trial period. See Table 3 for a list of common factors.
- Defined trial period
- In addition to controlling external factors, a predefined trial period should be discussed and agreed upon prior to initiating supplements. The most common periods are between 30–90 days, with the average being 60 days.
- Understanding expectations
- Prior to starting treatment patients should understand that there is no cure for tinnitus, and that expectations should be geared around reducing severity of symptoms and improving overall quality of life.
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