Editor's Note: Contains updates and links to articles written after original publication date.

Alternative Medications and Other Treatments
for Tinnitus: Facts From Fiction

Part 1 of 3 Installments
by Michael D. Seidman, MD
and Seilesh Babu, MD

HISTORY

Since the dawn of human existence, nutritional supplements, herbs, and phytonutrients have been used to heal. Forty percent of Americans have used some form of complementary/integrative medicine (CIM) to treat a wide variety of chronic conditions. In 1998, expenditures on CIM in the USA had approached 27 billion dollars and increased to 32 billion in 2000.1 This paradigm shift, to alternative forms of therapy, is gaining acceptance for many reasons including: patients' dissatisfaction with conventional medical care, which is perceived to be too intent on curing rather than preventing disease; traditional medicines having too many side effects and hence, are often ineffective. Conversely, the conventional western physician is typically skeptical of CIM practices because of the lack of double-blind randomized placebo-controlled studies. This is a particularly difficult problem because the pharmaceutical industry is not routinely interested in funding studies to assess the efficacy of herbs and other supplements since patent protection is unlikely. Coupled with the fact that the cost to bring a compound through the US Food and Drug Administration averages $300 million or more, it is no wonder that studies into this arena are rare.2

Conventional medical fields, such as allopathic and osteopathic medicine, were only introduced in the US less than 200 years ago. This subsequently led to the rapid reduction in CIM therapies as these were suddenly viewed as antiquated and a form of quackery. The unfortunate result of this skepticism was the over-emphasis solely on conventional medicine as a means to heal and cure. In the best scenario, tapping into knowledge from both CIM and conventional medicine would likely lead to better overall care of our patients.

The use of medication for treatment of tinnitus has largely been varied and anecdotal. Drugs such as nicotinic acid, carbamezepine, baclofen, and others have been tried and even tested in double-blind placebo-controlled trials (Table 1) .28 Few have been shown to be significantly beneficial in adequately formulated studies. Lidocaine has been studied in several carefully controlled double-blinded studies and shown to be beneficial. However, lidocaine must be given intravenously, has a very short half-life, and is often accompanied by undesirable side effects. Oral analogs of lidocaine, such as tocainide and flecainide acetate did not improve. tinnitus.21 A double blind, placebo-controlled study using Melatonin (3mg at bedtime) was found to have no advantage over placebo in relieving tinnitus. However, among patients reporting difficulty sleeping attributable to their tinnitus, 46.7% reported an overall improvement after melatonin compared with 20.0% for placebo.21 Benzodiazepines also may provide relief, especially for patients with concurrent depression. In one study, 76% of patients taking alprazolam had a reduction in the loudness or their tinnitus while only 5% of the placebo group showed benefit.29 Education, counseling, tinnitus retraining therapy, and medications remain the major modalities in the treatment of tinnitus. Many individuals have reported that these have provided either resolution of, or produced the greatest decrease in, their symptoms.

The objective of this chapter is to discuss treatment alternatives for chronic tinnitus. Examples include variations in diet, vitamin supplementation, herbal medicine, and other modalities. While these options are considered alternative to many traditional physicians, it should be emphasized that there is currently no cure for tinnitus. The treatments discussed in this chapter have been beneficial for some people who have constant tinnitus, especially those whose tinnitus failed to respond to traditional treatment modalities. Altering one's diet has been shown to improve tinnitus in some patients. Many patients with tinnitus report that certain supplements seem to have a variable benefit in reducing their symptoms. Nutrient supplementation to treat tinnitus has been extensively studied. The following have generated the most interest and support: magnesium, calcium, potassium, lipoflavonoids, B vitamins, copper, selenium, zinc, and manganese. Herbal remedies for this ailment include Ginkgo biloba, Black cohosh, mullein, and cornus. Other treatments, such as laser light therapy, enzymatic therapy, tinnitus retraining, and vibrational therapy will also be discussed.

VITAMIN B COMPLEX

The B complex vitamins are a family of nutrients that have been grouped together due to the interrelationships in their function within human enzyme systems, as well as their distribution in natural food sources. Deficiency in these vitamins has been shown to result in tinnitus18, and supplementation may improve the symptom. The B vitamins are water soluble and easily absorbed, except vitamin B-12, whose absorption is enhanced by intramuscular injection or sublingual application. Nevertheless, oral B-12 supplementation will still lead to increased serum levels. Unlike fat-soluble nutrients, most B complex vitamins cannot be stored in the body, and must therefore be replaced daily from food sources or supplements.

B vitamins function as coenzymes to facilitate human metabolism and energy production. They maintain healthy skin, eyes, muscle tone, and support the functions of the liver and central nervous system. They are also important in helping to deal with depression, stress and anxiety. Normally B vitamins are taken as a complex, but a single B vitamin may be indicated to treat a particular disorder. Deficiency in B vitamins may also result in lethargy, anemia, nervousness, skin and hair problems, lack of appetite, poor night vision, and hearing loss.20

Editor’s Note: Arches Tinnitus Stress Formula contains high potency B-Complex vitamins which are very helpful for maintaining proper functioning of the nervous system, reducing stress and anxiety and, in some people, may help in reducing tinnitus. Of particular importance to our readers is that deficiencies of B vitamins result in hearing loss. Another important study showed that deficiency of B vitamins directly resulted in tinnitus. You can read an article on how B vitamins work in our Tinnitus Info Section. Citrus bioflavonoids found in the Stress Formula have shown to be helpful in reducing tinnitus - Barry Keate

VITAMIN B1 (Thiamine)

Vitamin B-1 (thiamine) is a nutrient with a critical role in maintaining a healthy central nervous system. Adequate thiamine levels can dramatically affect cognitive function by maintaining a positive mental attitude and enhancing learning abilities. Conversely, inadequate levels of B-1 can lead to vision problems, mental confusion, and loss of physical coordination. Vitamin B-1 is required for the production of hydrochloric acid, forming blood cells, and for maintenance of healthy circulation. It also plays a key role in converting carbohydrates into energy, and in maintaining proper muscle tone of the digestive and cardiovascular systems. A chronic deficiency of thiamine will lead to beriberi, a devastating and potentially deadly disease of the central nervous system. Beriberi is diagnosed clinically by peripheral neuropathy, cardiovascular and cerebral dysfunction, which include congestive heart failure and dementia. Due to improved diets and the widespread use of supplements, beriberi is rare in developed countries, with one important exception. Beriberi symptoms are occasionally seen in chronic alcoholics due to the destructive effect alcohol has on B-1. Thiamine levels can also be affected by ingestion of antibiotics, sulfa drugs, caffeine, antacids, and oral contraceptives. A diet high in carbohydrates can also increase the need for B-1.

Food sources high in thiamine include beans, eggs, brewers yeast, whole grains, brown rice, and seafood. In supplemental form, B-1 is generally found in a combination with vitamins B-2, B-3, B-6, pantothenic acid, and folic acid. There are no known toxic effects from vitamin B-1, and any excess is excreted from the body. The Recommended Dietary Intake (RDI) for B-1 is 1.5 milligrams, though more typical daily intake ranges from 50 to 500 milligrams per day.37

Some patients have noted that Vitamin B-1 supplements relieves their tinnitus.16 The mechanism of action seems to be via a stabilization effect on the nervous system, especially in the inner ear. Dosages ranging from 25 to 500 mg per day have been used.

VITAMIN B-3 (NIACIN)

Vitamin B-3 (also called niacin, niacinamide, or nicotinic acid) is an essential nutrient required for proper metabolism of carbohydrates, fats, and proteins, as well as for the production of hydrochloric acid. Vitamin B-3 also supports circulation, healthy skin, and aids in the functioning of the central nervous system. Because of its role in supporting the higher functions of the brain and cognition, vitamin B-3 also plays an important role in the treatment of schizophrenia and other mental illnesses, and stabilizing cognitive functions. Adequate levels of B-3 are vital for the proper synthesis of insulin, and the sex hormones, estrogen, testosterone, and progesterone. Natural food sources for Vitamin B-3 include beef, broccoli, carrots, cheese, corn flour, eggs, fish, milk, potatoes, and tomatoes. However, foods containing vitamin B-3 provide minimal amounts of this vitamin.

A deficiency in vitamin B-3 can result in pellagra, a disorder characterized by malfunctioning of the nervous system and gastrointestinal upset. Classically, the three cardinal symptoms are diarrhea, dementia, and dermatitis. Recently, niacin has been embraced by the medical community for its ability to safely lower cholesterol and triglyceride serum levels. The dosing required is between 500 to 2000 mg daily. Doses exceeding 1000mg can lead to hepatoxicity and is more common in the timed-release niacin supplements. Thus, when recommending doses in this range, liver function tests need to be monitored.37

Niacin, at any dose, may result in a niacin flush, a natural reaction that is harmless but that can be uncomfortable. A niacin flush will generally result in a burning, tingling, and itching sensation, accompanied by a reddening flush that spreads across the skin of the face, arms, and chest, typically lasting five to sixty minutes.37 A non-flush form of niacin now exists which may be better tolerated by some patients, but this is the form that is more apt to cause potential liver problems.

There is no accepted standard niacin dosing for tinnitus. Typically, the senior author recommends beginning at 50 mg twice per day. After two weeks, if there is no improvement, the patient increases the dose by 50 mg at each interval to a maximum dose of 500 mg twice per day. Higher doses can be recommended, but it is advised to monitor liver function tests. Niacin may provoke migraine headache attacks in some people and appropriate warning is justified. High doses should be used with caution in pregnant women. Mega doses of pure niacin can aggravate health problems, such as stomach ulcers, gout, glaucoma, and diabetes mellitus.

Unfortunately, there is no clinical proof for the effectiveness of niacin in treating tinnitus. This is inherently difficult to prove due to a possible "placebo effect" arising from the niacin flush sensation rather than any therapeutic value of the underlying vasodilation. The senior author has noted a favorable response to niacin in some patients. There have been other anecdotal reports of the benefit of niacin in treating tinnitus.16

Some health care providers advocate taking niacin in combination with thiamine. The 1994 text on myofascial pain, Trigger Points, states that niacin without thiamine seems to provide little relief for tinnitus.35 However, this has not been the senior author's experience. The combination dosing is basically two parts niacinamide for each one-part thiamine. Some supplements will come balanced in this proportion.

There have also been reports of niacin working in combination with lecithin, a group of phospholipids that yield two fatty acid molecules, and one molecule each of glycerophosphric acid and choline after hydrolysis. Lecithin is found in nervous tissue, especially myelin sheaths, and in the plasma membrane of plant and animal cells. The theory is that the lecithin, being an emulsifier, helps disperse the buildup of fats in the capillaries, and the niacin helps dilate the capillaries to allow the lecithin in. The phosphatidyl choline portion of lecithin, however, is a precursor of acetylcholine and should be avoided in people who are manic-depressive because it may worsen the depressive phase. Compelling evidence exists from experiments in our laboratory demonstrating that aged rats supplemented with a diet rich in phosphatidyl choline have improved auditory sensitivity when compared to placebo supplemented rats. Furthermore, study of the subjects' mitochondrial function reveals a statistically significant improvement in mitochondrial energy production in the treated groups compared to placebo.15

VITAMIN B-12

Vitamin B-12, also referred to as cobalamin and cyanocobalamin (see editor's note after this section), is a micronutrient that is water soluble like other B-vitamins. However, unlike the other B-vitamins which are not stored in the body, vitamin B-12 is stored for up to nine months in the liver and kidneys. The RDI for vitamin B-12 is 2 micrograms for adults, 2.2 micrograms for pregnant women, and 2.6 micrograms for nursing mothers.7 Vitamin B-12 is not found in vegetables, but can be found in pork, blue cheese, clams, eggs, herring, kidney, liver, seafood, and milk.

It has been estimated that 5 to 10% of persons over the age of 65 years are deficient in vitamin B-12. With newer and more sensitive tests available, deficiency states have been found in as many as 15-20% of the population.34 This deficiency state is most likely secondary to absorption difficulties as well as a deficient nutritional intake. There may be some correlation between the decline in vitamin B-12 levels and the increasing prevalence of tinnitus in the elderly.

Vitamin B-12 is an important coenzyme required for the proper synthesis of DNA and new cell formation. It also works synergistically with vitamin C to aid in proper digestion and absorption of foods, protein synthesis, and the normal metabolism of carbohydrates and fats. Additionally, B-12 prevents nerve damage by contributing to the formation of the myelin sheath. Vitamin B-12 also maintains fertility, and helps promote normal growth and development in children.

Metabolites, including cobalamin, are involved in stabilizing neural activity. Vitamin B-12 is an essential cofactor for methylation of myelin basic protein and cell membrane phospholipids. Cobalamin deficiency has been shown to be a factor involved in neuronal dysfunction. It is therefore logical to assume that a relationship between tinnitus, which might involve neuronal dysfunction, and vitamin B-12 deficiency may exist. In the senior author's experience, several patients who were motivated to attempt nutritional supplementation with B-12 noted significant improvement in their tinnitus. However, still others have reported no such benefit. A deficiency of vitamin B-12 can result in pernicious anemia, characterized by megaloblastic anemia, lack of intrinsic factor, inability to absorb vitamin B-12, and increased risk for esophageal webs and cancer. Since vitamin B-12 can easily be stored in the body and is only required in minute amounts, symptoms of severe deficiency usually take three to five years to appear. When symptoms do arise, usually in mid-life, it is likely that deficiency was due to digestive disorders or malabsorption rather than poor diet. However, it is well known that the elderly have a reduced dietary intake, which may predispose them to nutritional deficiencies. Furthermore, strict vegetarians (vegans) who do not consume any foods of animal origin need to supplement their diets with this nutrient since B-12 comes almost exclusively from animal sources.

Vitamin B-12 is available in supplemental form. Due to relatively poor gastric absorption, B-12 can be taken as a sublingual tablet or by injection. Supplements range in strength from 50 micrograms to 2 milligrams. Mega dose vitamin B-12 toxicity is unknown, and any excess is excreted from the body.31 One can measure serum B-12 or serum methylmalonic acid for levels of this vitamin. The normal range of B-12 in a healthy population is 150 to 900pg per milliliter.

Experimental studies and clinical observations have related tinnitus to demyelination of nerve fibers and to a distorted resting state of spontaneous neural activity. Shemesh et al. showed a high prevalence (47%) of vitamin B-12 deficiency in patients with chronic tinnitus when a criterion of deficiency is set at 250 pg/mL and lower.31 Serum cobalamin deficiency was more widespread and severe in the tinnitus group associated with noise exposure. This suggested a relationship between vitamin B-12 deficiency and dysfunction of the auditory pathway. Deficiency also results in peripheral and central neurological pathology. Decreased methionine production due to cobalamin deficiency can lead to a sensory demyelinating neuropathy.

Abnormalities of the nervous system in the absence of hematologic disorders and normal results of the Schilling test have been reported in 28% of 141 consecutive patients with abnormally low serum cobalamin. The Schilling test assesses the absorption of free cobalamin and also the absorption of free cobalamin with intrinsic factor. In many instances, the actual cause of the deficiency is difficult to identify. It might be a result of inadequate dietary intake, a minor alimentary dysfunction, or a nutrition-metabolic disturbance. Supplemental cobalamin was found to show some relief in several patients with severe tinnitus.32

Editor’s Note: Since the initial publication of this article, researchers have found that the form of Vitamin B-12 utilized by the body is methylcobalamin. Widely uses and less costly cyanocobalamin must be converted to methylcobalamin in the liver for proper utilization. Methylcobalamin has been shown to protect against glutamate-induced excitotoxic neuronal damage. Neuronal damage caused by excess glutamate is one of the primary causes of tinnitus and worsens existing tinnitus. You can view an article on B-12 and methlycobalamin in our Tinnitus Info Section. Arches Tinnitus B-12 Formula contains 1000 mcg of methylcobalamin, the superior form - Barry Keate

VITAMIN B-6 (PYRIDOXINE)

Vitamin B-6 is a coenzyme involved in the metabolism of carbohydrates, fats, and proteins and the manufacturing of hormones, red blood cells, neurotransmitters, enzymes and prostaglandins. It is also required for the production of serotonin, a neurotransmitter that controls our moods, appetite, sleep patterns, and sensitivity to pain. A deficiency of vitamin B-6 can quickly lead to insomnia and profound malfunctioning of the central nervous system. Common symptoms of deficiency can include depression, vomiting, anemia, renal stones, dermatitis, lethargy, and increased susceptibility to diseases due to a weakened immune system.37 Among its many benefits include helping to maintain healthy immune system functions, protecting the heart from cholesterol deposits, and preventing renal stone formation. It is also beneficial in the treatment of carpal tunnel syndrome, premenstrual syndrome, night leg cramps, allergies, asthma, arthritis, and dizziness.37

Supplemental B-6 is commonly used as a treatment for nausea, morning sickness, depression, and tinnitus. Natural foods that are highest in vitamin B-6 include brewers yeast, carrots, chicken, eggs, fish, avocados, bananas, brown rice, and whole grains. The RDI for vitamin B-6 is 2 mg per day. Most B-complex formulas contain between 10 to 100 mg of vitamin B-6. Vitamin B-6 is one of the few vitamins that can be toxic. Doses up to 500 mg per day are uncommon but safe. However, doses above 2 grams per day can lead to irreversible neurological damage. Doses exceeding this level should not be used unless the patient is under the treatment of a physician. Vitamin B-6 supplements should not be taken by Parkinson's disease patients treated with L-dopa, since vitamin B-6 can diminish the effects of L-dopa in the brain. Most of the vitamin B-complex supplements appear to work on tinnitus in some patients by providing a stabilizing effect on the nerves centrally and peripherally. Only anecdotal evidence exists regarding this treatment method.

FOLIC ACID

Folic acid is a water-soluble nutrient belonging to the B-complex family. The name is derived from the Latin word "folium," since this essential nutrient was first extracted from green leafy vegetables, or foliage. Sometimes referred to as Vitamin M, folic acid was originally extracted from spinach in 1941 and was found to be an effective treatment for macrocytic anemia.20

Folic acid is a vital coenzyme required for RNA and DNA synthesis. Adequate levels are essential for energy production and protein metabolism, for the formulation of red blood cells, and for the proper functioning of the intestinal tract. Furthermore, studies have demonstrated that folic acid reduces homocysteine levels and therefore reduces the risk of heart disease.37

Additional studies revealed that maternal folic acid intake leads to a significant reduction in the incidence of fetal neural tube defects such as spina bifida. This effect was noted with a daily folic acid intake of at least 400 micrograms, the current RDI. Folic acid may also prove to be effective in the prevention and treatment of uterine cancer.3

Folic acid deficiency affects all cellular functions, but most importantly it reduces the body's ability to repair damaged tissues and grow new cells. Tissues with the highest rate of cell replacement, such as red blood cells, are affected first, leading to anemia. Deficiency leads to sore tongue, cracking at the corners of the mouth, gastrointestinal distress, diarrhea, and poor nutrient absorption, leading to stunted growth, weakness and apathy.37 Folic acid deficiency is common and can develop within a few weeks to months of lowered dietary intake. The greatest need for increased folic acid intake is in those who are under mental and physical stress, such as alcoholics, and people taking oral contraceptives, aspirin, or anticonvulsants. Foods highest in folic acid include barley, beans, beef, bran, brewers yeast, brown rice, cheese, chicken, green leafy vegetable, milk, salmon, tuna, wheat germ, and whole grains.

Though not generally regarded as toxic, large doses of folic acid can cause allergic skin reactions, and should be avoided by people being treated for hormone-related cancers. High doses of folic acid can also cause problems in those taking phenytoin for a convulsive disorder. Folic acid seems to also have a stabilization effect on the nervous system. This might explain the anecdotal evidence regarding the supplementation of folic acid in certain patients to alleviate their tinnitus. The dosages ranged from 400 to 800 mcg per day and usually required 2 to 3 months of trial to achieve results.16

To Be Continued, August 2007. Dr. Seidman discusses mineral treatments in part two.

REFERENCES