Arches Tinnitus Formula™ contains three primary ingredients: pharmaceutical-grade ginkgo biloba extract, zinc picolinate, and deodorized garlic. At least 35 studies, many discussed below, have been published to demonstrate the effectiveness of these ingredients in reducing tinnitus.
GINKGO BILOBA EXTRACT (GBE)
The medical uses of ginkgo biloba can be traced back over 4000 years to the Chen Noung Pen T'sao, China's first pharmacopoeia. The extract of the herb has been clinically studied since the 1960s, when it was first extracted and defined by the Dr. Willmar Schwabe Company in Germany.
More than 400 studies have been published reporting the benefits of ginkgo biloba extract (GBE) related to cerebral insufficiency, memory improvement, depression, dizziness, tinnitus, and headache. GBE contains a complex array of flavonoids, lactones, and bilobalide, which work synergistically to produce a multitude of vascular and neurological effects.
Three primary mechanisms of action of GBE regarding tinnitus have been reported:
(1) Glutamate antagonism and neuroprotection
The primary reason GBE may be helpful for tinnitus is because of its glutamate antagonism and neuroprotection. Glutamate is a neurotransmitter used by the cochlea to transmit signals across the synapse leading to the brain. It is produced by the hair cells of the inner ear when converting vibrational sound into electrical signals. When the hair cells are damaged, they produce excess glutamate, which floods the neuro-receptors in the auditory nerve and brain. Excess glutamate overexcites the receptors and causes them to fire continuously until they become depleted and eventually die. This process is known as glutamate neurotoxicity and is responsible for many neurological diseases, including Parkinson's disease, Alzheimer's disease, ALS, epilepsy, and tinnitus. Tinnitus caused by glutamate toxicity is called cochlear-synaptic tinnitus.
Ginkgo biloba extract is a powerful glutamate antagonist and neuroprotector.1–4 Bilobalide, a component of GBE, has been found to be a potent antagonist to glutamate release. It has also been shown to reduce the rate of GABA uptake, meaning it keeps GABA active in the system, which reduces the effects of increased glutamate. Bilobalide is potently therapeutic in cerebrovascular and neurodegenerative disorders such as tinnitus.
(2) Antioxidant properties
Free radicals are produced in normal metabolism when oxygen is used to burn food for energy. They are also produced in certain disease states and in response to environmental pollution and toxins. Free radicals can do damage to the body. These dangerous molecules are a leading cause of age-related disease, being directly responsible for over 100 human diseases including many types of cancer. Antioxidants neutralize free radicals and preserve tissues from their damaging effects.
In the biochemical process leading to neuroreceptor death, free radicals are generated in very large amounts. Antioxidants can prevent free radical damage in the receptors. The antioxidants can eventually be overwhelmed, however, and the damage continues, eventually leading to the death of the receptor.
The ginkgo flavonoids in GBE are powerful antioxidants and help prevent free radical damage to the auditory pathway.5 The United States Navy has conducted a clinical study on the use of anti-oxidants to prevent noise-induced hearing loss and tinnitus. This study has shown positive effects in sustaining hearing thresholds if antioxidants are given before or shortly after noise exposure occurs.6
(3) Increased circulation
GBE increases circulation, especially in the microcapillaries feeding the brain, ears, and eyes. It does this by acting as a vasodilator, allowing the capillaries to carry more blood. It also inhibits platelet-aggravating factor, which causes the blood platelets to clump together and slow circulation.7,8 By increasing circulation in the inner ear, GBE promotes the uptake of nutrients, primarily glucose and oxygen, and allows built-up toxins to be flushed away, speeding the healing process.
Ginkgo extracts vary
Every bottle of ginkgo biloba sold in the U.S. states that the product is a “standardized extract” and contains at least 24% ginkgo flavone glycosides and 6% terpene lactones. This is how GBE is defined by the German Commission E. However, the commission also defines exact minimum requirements for individual glycosides, lactones, and bilobalide. Independent testing by Consumer Labs of many over-the-counter products found that more than 77% of these products “lacked adequate levels of one or more important compounds expected of clinically effective ginkgo.”
The commission has specified that bilobalide must be present in the amount of at least 2.6% to be a standardized extract. The ginkgo used in Arches Tinnitus Formula contains 3.6% bilobalide, but most of the retail ginkgo products sold in the U.S. contain less than 0.5%.
Also, some manufacturers adulterate their raw material with rutin, an inexpensive extract of buckwheat that contains ineffective, but similar, compounds to GBE. It is impossible to tell the two apart without using advanced diagnostics.
Holstein conducted a literature survey of 19 clinical trials investigating the effects of tinnitus treatment with GBE.9 Eight were controlled studies using placebo or reference medications; they included 687 patients. Those in placebo-controlled studies included 348 patients. Those that controlled with nicergoline, a vasodilator, included 319 subjects, and those that controlled with cinnarizine, an antihistamine, included 20 subjects.
One study of 60 subjects using nicergoline as a control found improvement in both groups with no difference between them. The other 7 studies showed clear improvement with ginkgo over placebo or other referenced medications, including one study of 259 patients who controlled with nicergoline.
The 11 studies that were open (uncontrolled) included 5 that were multi-center. The total number of patients was 3244. One study with 23 patients using a low dosage of 120 mg showed no improvement. All other studies showed improvement varying from a low of 18 out of 68 patients to a high of 82% good or very good efficacy.
In addition to the two small studies reviewed by Holstein that did not show efficacy, a large, double-blind, placebo-controlled study did not show GBE to be effective in treating tinnitus.10 This study was published in 2001 and included 978 patients. While the methodology was generally appropriate, the study had two significant flaws. First, only 150 mg of GBE was used daily, less than a third of the 480 mg recommended by the German Commission E. Second, the study was conducted entirely by postal questionnaire with no personal interface with a healthcare provider. This leaves open the very real possibility of non-compliance by many participants.
Some nutritionists consider zinc to be the single most important mineral supplement because it is commonly deficient in the diet and it is essential for normal functioning of the immune system. It is a strong antioxidant and is commonly used, in lozenge form, for helping the body fight off colds and the flu and to recover from illness, injury, and surgery.
The highest concentration of zinc in the human body is found in the cochlea. Zinc deficiency can lead to many problems, including a weakened immune system, poor healing, loss of appetite, and diminished sense of taste and smell. A slight to moderate zinc deficiency can also cause tinnitus.11 Several studies have shown a link between zinc deficiency and tinnitus and have found that zinc supplementation is helpful for it.12,13
The Journal of Otology and Neurotology published an important clinical study on zinc and tinnitus in 2003. The researchers treated the patients with 50 mg of zinc daily for 3 months. Post-treatment, they found that 82% of tinnitus patients reported their tinnitus had improved by an average of 45%. They found that even patients who were not zinc-deficient showed improvement from the treatment. It is believed that this is due to the antioxidant properties of zinc.14
It is important to use zinc in a form that is bioavailable and easy to absorb. Zinc in its basic form is extremely difficult to absorb from the stomach or intestines. Less expensive over-the-counter multivitamins often use zinc oxide, of which only about 35% is absorbed. The use of zinc picolinate improves the absorption rate to around 90%.
Zinc must be taken with great care. Up to 100 mg per day can be used for a short period to correct imbalances. However, it should not be consumed continuously in quantities of over about 50 mg a day. Zinc competes with copper and manganese for absorption so a person who uses it can become deficient in these two important minerals. Use of more than 50 mg of zinc a day should be supplemented with 2–3 mg of copper and 5–10 mg of manganese.
The study cited above used 50 mg daily. We originally intended to use that dosage in our Tinnitus Formula. However, our consulting physician, Michael Seidman, MD, cautioned that since many people take other supplements that contain zinc, we should set the dosage at 30 mg. If people are not taking other zinc products they can add up to 20 mg to their daily regimen.
While garlic is said to have a myriad of beneficial effects, its main reported benefits for tinnitus are to improve blood circulation, reduce plaque buildup on the walls of blood vessels, minimize arteriosclerosis (hardening of the arteries), and lower lipid (fat) levels in the blood. Since blood flow to the cochlea is supplied by the cochlear artery, plaque formations in this artery will severely reduce blood flow, which is necessary to repair damage and flush toxins from the cochlea. Several studies have shown that garlic reduces plaque and improves blood flow. It also improves the antioxidant properties of the blood.15,16
There are clinical studies that show that the ingredients used in Arches Tinnitus Formula are an effective and very well tolerated treatment for ear noises of varying origin and duration. Holstein found in his overview that the prognosis was more favorable for recent-onset tinnitus. He concluded, “The clinically relevant conclusion to be drawn from this is to begin treatment as early as possible.”
The product is designed to be used for 3 to 4 months. In his endorsement on the company web site (www.tinnitusformula.com), Michael Seidman, our consulting physician, writes, “It has been my experience in treating tinnitus with Arches Tinnitus Formula that approximately 5% of my patients enjoy a complete reduction of tinnitus, 75% experience a varying reduction of symptoms, and 20% remain unchanged. Approximately half my patients are satisfied with their results and elect to continue taking the products, requiring no further treatment from me.”
1. Chandrasekaran K. Mahrabian Z, Spinnewyn B, et al.: Neuroprotective effects of bilobalide, a component of the Ginkgo biloba extract (EGb 761), in gerbil global brain ischemia. Brain Res 2001;922(2):282–292.
2. Ahlemeyer B, Krieglestein J: Neuroprotective effects of Ginkgo biloba extract. Cell Molecu Life Sci 2003;60(9):1779–1792.
3. Davies JA, Johns L, Jones FA: Effects of Bilobalide on cerebral amino acid neurotransmission. Pharmacopsychiatr 2003;36(Suppl 1):584–588.
4. Smith PF, Kaclennan K, Darlington C: The neuroprotective properties of the Ginkgo biloba leaf: A review of the possible relationship to platelet-activating factor (PAF). J Ethnopharmacol 1996;50(3):131–139.
5. Marcossi L, Packer L, Droy-Lefaix MT, et al.: Antioxidant action of Ginkgo biloba extract EGb 761. Methods Enzymol 1994;234:462–75.
6. Kopke R, Bielefeld E, Liu J, et al.: Prevention of impulse noise-induced hearing loss with antioxidants. Acta Otolaryngol 2005;125(3):235–243.
7. P Halama, Bartsch G, Meng G, et al.: Gingko biloba extract with cerebral insufficiency. Fortschr. Med 1988;106(19):408–412.
8. Vorberg G: Ginkgo Biloba Extract (GbE): A long-term study of chronic cerebral insufficiency in geriatric patients. Clinical Trials J 1985;22(2):149–157.
9. Holstein N: Ginkgo Special Extract EGb 761 in the treatment of tinnitus. Fortschr Med 2000;118:157–164.
10. Drew S, Davies E: Effectiveness of gingko biloba in treating tinnitus: Double blind, placebo-controlled trial. Brit Med J 2001;322(7278):1–6.
11. Shambaugh G: Zinc: The neglected nutrient. Am J Otol 1989;10(2):156–160.
12. Ochi K, Ohashi T, Akagi M, et al.: Serum zinc levels in patients with tinnitus. Nippon Jibiinkoka Gakkai Kaiho 1997;100:915–919.
13. Ochi K, Kinoshita H, et al.: Zinc deficiency and tinnitus. Auris, Nasus, Larynx 2003;30(Suppl.):S25-28.
14. Arda HN, Tuncel U, Akdogan O, Ozluoglu LN: The role of zinc in the treatment of tinnitus. Otol Neurotol 2003;24(1):86–89.
15. Siegel G, Malmsten M, Pietzsch A, et al.: The effect of garlic on arteriosclerotic nanoplaque formation and size. Phytomed 2004;11(1):24–35.
16. Durak I, Kavutcu M, Aytak B, et al.: Effects of garlic extract consumption on blood lipid and oxidant/antioxidant parameters in humans with high blood cholesterol. J Nutrit Biochem 2004;15(6):373–377.
© 2010 Lippincott Williams & Wilkins, Inc.