Tinnitus
Conditions
Keywords
hearing, magnesium
Brief summary
The purpose of this study was to examine any potential benefit in lessening the severity of tinnitus (ringing or booming sensation in one or both ears) in subjects supplemented with magnesium (532 mg daily).
Detailed description
Descriptions of tinnitus date back to the time of ancient Egypt, yet science has failed to unravel the mysterious underlying mechanisms that produce these subjective auditory perceptions of sound. These perceptions may be manifestations of damage resulting from noise exposure, ototoxicity, or other abnormal conditions of the auditory system. However, many individuals have idiopathic tinnitus for which no specific cause can be determined. Although often presenting in conjunction with hearing loss, the magnitude of hearing loss does not necessarily correspond with the severity of tinnitus. In addition, some individuals reporting tinnitus experience concomitant hyperacusis. This relationship suggests these processes may be linked by underlying imbalances at the level of the hair cell. The possible influence of magnesium (Mg) and its antagonist, calcium, has been discussed in the literature as a contributing factor in the mitigation of noise-induced hearing loss, ototoxicity, and the hyperexcitability of the auditory system. Permanent and temporary changes in auditory function have been linked to nutritional deficiencies of magnesium. Mg deficiency has resulted in increased susceptibility to noise-induced hearing loss, ototoxicity, and hyperexcitability of the auditory system. The recommended daily allowance (RDA) for Mg in adults is 4.5 mg/kg; however, all age groups of Americans fall short of the RDA for Mg by 100 mg daily. This lack of appropriate magnesium intake may have negative consequences. For example, the putative Mg mechanism within the auditory system involves a metabolic cellular cascade of events. Specifically, Mg deficiency leads to increased permeability of the calcium channel in the hair cells with a consequent over-influx of calcium, an increased release of glutamate via exocytosis, and overstimulation of N-methyl-D-aspartate receptors on the auditory nerve fibers. Recent studies of both noise-induced hearing loss and idiopathic sensorineural hearing loss have suggested that Mg supplementation may lessen the severity of tinnitus in patients. Mg improved hearing recovery and lessened tinnitus in patients with idiopathic sudden hearing loss. More recently, a well-controlled study that Mg was a relatively safe and convenient adjunct to corticosteroid treatment for enhancing the improvements of hearing in acute-onset sensorineural hearing loss at a dose of 4 g. The protective effect of Mg in noise-induced hearing loss has been previously reported. Despite these encouraging findings, no controlled study has examined the effect of Mg supplementation for subjects with moderate to severe tinnitus. In this study subjects made 4 visits to the clinic over about 2 months. At the first visit, subjects had a hearing test. Prior to beginning each round of supplements, subjects were asked to rate the severity of their tinnitus on a 1-10 scale, and to complete the Tinnitus Handicap Inventory (THI) questionnaire. Subjects were then randomized to 1 of 2 groups. One group began with 532 mg of Mg for 25 days, the other group began with a placebo supplement for 25 days. At visit 2, the subjects had a hearing test, rated their tinnitus, and completed the THI questionnaire as well as the Treatment Period Survey. Subjects did not take any supplement for 2 weeks, then returned for visit 3. At Visit 3, the subjects had a hearing test, rated their tinnitus, and completed the THI questionnaire they then took the opposite supplement (placebo or Mg) for 25 days. At Visit 4, the subjects had a hearing test, rated their tinnitus, and completed the THI questionnaire as well as the Treatment Period Survey.
Interventions
Magnesium 532 mg a day
matching form/dosage
Sponsors
Study design
Eligibility
Inclusion criteria
* Normal Kidney function (last checked within 6 months). Serum creatinine levels 1.5 mg/dL or below for females, 2.0 mg/dL for males. * An audiogram within the past 6 months * Mayo Clinic patients who live in Phoenix area
Exclusion criteria
* Any participant with decreased kidney function within past 6 months, over 1.5 mg/dL for females and over 2.0 mg/dL for males. * Current treatment with Lithium * Tinnitus rating with 0, 1, or 2 on the 0-10 Tinnitus scale
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tinnitus Distress Rating | Pre-treatment, Post-treatment, up to four weeks | This is a single-item patient-reported distress rating on a 0-10 scale, with 0=no tinnitus to 10=worst possible tinnitus. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Average Tinnitus Handicap Inventory (THI) Across All Subjects | Pre-treatment, Post-treatment, up to four weeks | The Tinnitus Handicap Inventory measures the extent that tinnitus interferes with daily activities and sleep.The questionnaire consists of 25 questions, the score can range from 0 (slight problem) to 100 (catastrophic). The score can be converted to a categorical variable as follows: 0-16=Slight; 18-36=Mild; 38-56=Moderate; 58-76=Severe; 78-100=Catastrophic. |
| Comparison of Average Tinnitus Handicap Inventory (THI) Across All Men | Pre-treatment, Post-treatment, up to four weeks | The Tinnitus Handicap Inventory measures the extent that tinnitus interferes with daily activities and sleep.The questionnaire consists of 25 questions, the score can range from 0 (slight problem) to 100 (catastrophic). The score can be converted to a categorical variable as follows: 0-16=Slight; 18-36=Mild; 38-56=Moderate; 58-76=Severe; 78-100=Catastrophic. |
| Comparison of Average Tinnitus Handicap Inventory (THI) Across All Women | Pre-treatment, Post-treatment, up to four weeks | The Tinnitus Handicap Inventory measures the extent that tinnitus interferes with daily activities and sleep.The questionnaire consists of 25 questions, the score can range from 0 (slight problem) to 100 (catastrophic). The score can be converted to a categorical variable as follows: 0-16=Slight; 18-36=Mild; 38-56=Moderate; 58-76=Severe; 78-100=Catastrophic. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Entire Study Population Includes groups randomized to receive magnesium first and placebo first. | 38 |
| Total | 38 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention | Adverse Event | 2 | 1 |
| Second Intervention | Lack of Efficacy | 1 | 0 |
| Second Intervention | Lost to Follow-up | 1 | 1 |
Baseline characteristics
| Characteristic | Entire Study Population |
|---|---|
| Age, Continuous | 61.45 years STANDARD_DEVIATION 11.58 |
| Region of Enrollment United States | 38 participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 7 / 38 | 3 / 38 |
| serious Total, serious adverse events | 0 / 38 | 0 / 38 |
Outcome results
Tinnitus Distress Rating
This is a single-item patient-reported distress rating on a 0-10 scale, with 0=no tinnitus to 10=worst possible tinnitus.
Time frame: Pre-treatment, Post-treatment, up to four weeks
Population: Not all subjects completed the distress rating scale.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Magnesium | Tinnitus Distress Rating | Pre-treatment | 5.71 units on a scale | Standard Deviation 1.94 |
| Magnesium | Tinnitus Distress Rating | Post-treatment | 5.36 units on a scale | Standard Deviation 2.3 |
| Placebo | Tinnitus Distress Rating | Pre-treatment | 5.82 units on a scale | Standard Deviation 1.94 |
| Placebo | Tinnitus Distress Rating | Post-treatment | 5.46 units on a scale | Standard Deviation 1.99 |
Comparison of Average Tinnitus Handicap Inventory (THI) Across All Men
The Tinnitus Handicap Inventory measures the extent that tinnitus interferes with daily activities and sleep.The questionnaire consists of 25 questions, the score can range from 0 (slight problem) to 100 (catastrophic). The score can be converted to a categorical variable as follows: 0-16=Slight; 18-36=Mild; 38-56=Moderate; 58-76=Severe; 78-100=Catastrophic.
Time frame: Pre-treatment, Post-treatment, up to four weeks
Population: Not all male subjects completed the THI questionnaire.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Magnesium | Comparison of Average Tinnitus Handicap Inventory (THI) Across All Men | Pre-treatment | 29.1 units on a scale | Standard Deviation 24.7 |
| Magnesium | Comparison of Average Tinnitus Handicap Inventory (THI) Across All Men | Post-treatment | 27.8 units on a scale | Standard Deviation 21.5 |
| Placebo | Comparison of Average Tinnitus Handicap Inventory (THI) Across All Men | Pre-treatment | 27.2 units on a scale | Standard Deviation 22 |
| Placebo | Comparison of Average Tinnitus Handicap Inventory (THI) Across All Men | Post-treatment | 25.3 units on a scale | Standard Deviation 19.6 |
Comparison of Average Tinnitus Handicap Inventory (THI) Across All Subjects
The Tinnitus Handicap Inventory measures the extent that tinnitus interferes with daily activities and sleep.The questionnaire consists of 25 questions, the score can range from 0 (slight problem) to 100 (catastrophic). The score can be converted to a categorical variable as follows: 0-16=Slight; 18-36=Mild; 38-56=Moderate; 58-76=Severe; 78-100=Catastrophic.
Time frame: Pre-treatment, Post-treatment, up to four weeks
Population: Not all subjects completed the THI questionnaire.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Magnesium | Comparison of Average Tinnitus Handicap Inventory (THI) Across All Subjects | Pre-treatment | 25.7 units on a scale | Standard Deviation 22.2 |
| Magnesium | Comparison of Average Tinnitus Handicap Inventory (THI) Across All Subjects | Post-treatment | 24.1 units on a scale | Standard Deviation 19.9 |
| Placebo | Comparison of Average Tinnitus Handicap Inventory (THI) Across All Subjects | Pre-treatment | 25.7 units on a scale | Standard Deviation 19.4 |
| Placebo | Comparison of Average Tinnitus Handicap Inventory (THI) Across All Subjects | Post-treatment | 23.2 units on a scale | Standard Deviation 17.4 |
Comparison of Average Tinnitus Handicap Inventory (THI) Across All Women
The Tinnitus Handicap Inventory measures the extent that tinnitus interferes with daily activities and sleep.The questionnaire consists of 25 questions, the score can range from 0 (slight problem) to 100 (catastrophic). The score can be converted to a categorical variable as follows: 0-16=Slight; 18-36=Mild; 38-56=Moderate; 58-76=Severe; 78-100=Catastrophic.
Time frame: Pre-treatment, Post-treatment, up to four weeks
Population: Not all the female subjects completed the THI questionnaire.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Magnesium | Comparison of Average Tinnitus Handicap Inventory (THI) Across All Women | Post-treatment | 16.4 units on a scale | Standard Deviation 14.4 |
| Magnesium | Comparison of Average Tinnitus Handicap Inventory (THI) Across All Women | Pre-treatment | 18.7 units on a scale | Standard Deviation 14.7 |
| Placebo | Comparison of Average Tinnitus Handicap Inventory (THI) Across All Women | Pre-treatment | 22.6 units on a scale | Standard Deviation 12.7 |
| Placebo | Comparison of Average Tinnitus Handicap Inventory (THI) Across All Women | Post-treatment | 18.4 units on a scale | Standard Deviation 10.9 |