Tinnitus
Conditions
Keywords
tinnitus, zinc
Brief summary
There is widespread belief and some evidence to indicate that zinc can successfully treat tinnitus. Zinc deficiency is more likely to occur in the elderly . The primary objective of this study is to establish the effectiveness of zinc for the treatment of tinnitus in individuals 60 years of age and older. Subjects will be randomly assigned to either receive zinc daily or a placebo. After 4 months and a 1-month wash-out, the subjects will be crossed over to the other group.
Detailed description
There is widespread belief and some evidence to indicate that zinc can successfully treat tinnitus. Zinc deficiency is more likely to occur in the elderly . The primary objective of this study is to establish the effectiveness of zinc for the treatment of tinnitus in individuals 60 years of age and older. Subjects will be randomly assigned to either receive zinc daily or a placebo. After 4 months and a 1-month wash-out, the subjects will be crossed over to the other group. 116 patients were tested. Tinnitus loudness and the Tinnitus Handicap Questionnaire are the outcome measures.
Interventions
DRUGZinc
Zinc taken once daily
DRUGPlacebo oral capsule
Placebo capsules taken once daily
Sponsors
Tinnitus Research Initiative
University of Iowa
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
placebo pill
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 60 years of age or older * Tinnitus for 6 months or more * Normal copper levels * Be generally healthy
Exclusion criteria
* Have a treatable otological disorder * Involved in litigation * Have or are suspected of having a serious psychiatric problem * Involved in other treatments for tinnitus * Are taking drugs which might interact with zinc and result in tinnitus * Have copper deficiency * Have Zinc levels above normal * Are cognitively impaired.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Tinnitus Reaction on the Tinnitus Handicap Questionnaire Scores (0-100) at 4 Months | baseline - 4 months | Validated questionnaire of tinnitus reactions. Scale 0 (no tinnitus reaction)- 100 (worst tinnitus reaction). Our primary outcome was the difference scores between Tinnitus Handicap Questionnaire (THQ) on baseline and end of treatment on zinc and placebo treatment. As stated by Newman et al., the test-retest variability was 20%, and difference scores greater than this should be considered a significant reduction. Therefore, changes on the difference scores of 20 or greater were considered as a statistically significant and therefore clinically meaningful improvement for THQ. The minimum score is zero and the maximum is 100. 0 is better and 100 is worse. This applies to all outcome measures. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes on Baseline Tinnitus Magnitude on Tinnitus Loudness Rating Scores (0-100) at 4 Months Treatment | baseline and 4 months | Participants should rate their tinnitus loudness on a scale of 0 (no perception of tinnitus) to 100 (highest degree of tinnitus perception). |
| Changes on Baseline Tinnitus Reactions on Tinnitus Annoyance Rating Scores (0-100) at 4 Months Treatment | baseline and 4 months | Tinnitus annoyance rate on a scale of 0 (no annoyance) to 100 (maximum degree of annoyance) |
Countries
United States
Participant flow
Recruitment details
recruited from audiology clinic in otolaryngology department
Participants by arm
| Arm | Count |
|---|---|
| Group 1 Zinc First Zinc sulfate 220 mg capsules, (corresponding to 50 mg of elemental zinc) administered once a day for 4 months. Washout period of 30 days. Placebo capsules administered once a day for 4 months. | 58 |
| Group 2 Placebo First Placebo capsules administered once a day for 4 months. Washout period of 30 days. Zinc sulfate 220 mg capsules, (corresponding to 50 mg of elemental zinc) administered once a day for 4 months. | 58 |
| Total | 116 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 2 |
| Overall Study | Lost to Follow-up | 1 | 4 |
| Overall Study | Low copper, other health problems, | 7 | 6 |
| Overall Study | Withdrawal by Subject | 4 | 2 |
Baseline characteristics
| Characteristic | Group 1 Zinc First | Group 2 Placebo First | Total |
|---|---|---|---|
| Age, Continuous | 67.5 years STANDARD_DEVIATION 5.5 | 67.8 years STANDARD_DEVIATION 5.8 | 67.8 years STANDARD_DEVIATION 5.6 |
| Region of Enrollment United States | 58 participants | 58 participants | 109 participants |
| Sex: Female, Male Female | 24 Participants | 20 Participants | 44 Participants |
| Sex: Female, Male Male | 34 Participants | 38 Participants | 72 Participants |
| Tinnitus Annoyance Rating Scale | 60 units on a scale STANDARD_DEVIATION 22.7 | 65.8 units on a scale STANDARD_DEVIATION 23 | 63 units on a scale STANDARD_DEVIATION 23.1 |
| Tinnitus Handicap Questionaire | 28.4 units on a scale STANDARD_DEVIATION 20.3 | 27.4 units on a scale STANDARD_DEVIATION 19.2 | 27.9 units on a scale STANDARD_DEVIATION 19.8 |
| Tinnitus Loudness Rating Scale | 66.7 units on a scale STANDARD_DEVIATION 16.2 | 67.5 units on a scale STANDARD_DEVIATION 15.1 | 67.3 units on a scale STANDARD_DEVIATION 15.6 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 99 | 0 / 101 |
| other Total, other adverse events | 1 / 99 | 2 / 101 |
| serious Total, serious adverse events | 0 / 99 | 0 / 101 |
Outcome results
Primary
Change From Baseline in Tinnitus Reaction on the Tinnitus Handicap Questionnaire Scores (0-100) at 4 Months
Validated questionnaire of tinnitus reactions. Scale 0 (no tinnitus reaction)- 100 (worst tinnitus reaction). Our primary outcome was the difference scores between Tinnitus Handicap Questionnaire (THQ) on baseline and end of treatment on zinc and placebo treatment. As stated by Newman et al., the test-retest variability was 20%, and difference scores greater than this should be considered a significant reduction. Therefore, changes on the difference scores of 20 or greater were considered as a statistically significant and therefore clinically meaningful improvement for THQ. The minimum score is zero and the maximum is 100. 0 is better and 100 is worse. This applies to all outcome measures.
Time frame: baseline - 4 months
Population: For data analysis purposes subjects were recombined in 2 groups (Zinc and Placebo). Group ZINC: subjects who completed 4 months with Zinc 50 mg daily either from baseline to month 4, or after washout (from month 5 to 9). Group PLACEBO: subjects who completed 4 months with placebo either from baseline to month 4, or after washout (from month 5 to 9)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Zinc | Change From Baseline in Tinnitus Reaction on the Tinnitus Handicap Questionnaire Scores (0-100) at 4 Months | THQ scores at Baseline | 22.03 units on a scale | Standard Deviation 22 |
| Zinc | Change From Baseline in Tinnitus Reaction on the Tinnitus Handicap Questionnaire Scores (0-100) at 4 Months | THQ scores at 4 months | 23.7 units on a scale | Standard Deviation 18.7 |
| Placebo | Change From Baseline in Tinnitus Reaction on the Tinnitus Handicap Questionnaire Scores (0-100) at 4 Months | THQ scores at Baseline | 24.9 units on a scale | Standard Deviation 20.7 |
| Placebo | Change From Baseline in Tinnitus Reaction on the Tinnitus Handicap Questionnaire Scores (0-100) at 4 Months | THQ scores at 4 months | 25.4 units on a scale | Standard Deviation 21.3 |
p-value: >0.05Chi-squared
Secondary
Changes on Baseline Tinnitus Magnitude on Tinnitus Loudness Rating Scores (0-100) at 4 Months Treatment
Participants should rate their tinnitus loudness on a scale of 0 (no perception of tinnitus) to 100 (highest degree of tinnitus perception).
Time frame: baseline and 4 months
Population: Subjects that complete 4 months treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Zinc | Changes on Baseline Tinnitus Magnitude on Tinnitus Loudness Rating Scores (0-100) at 4 Months Treatment | Baseline tinnitus loudness rating scores (SD) | 67.7 units on a scale | Standard Deviation 18.7 |
| Zinc | Changes on Baseline Tinnitus Magnitude on Tinnitus Loudness Rating Scores (0-100) at 4 Months Treatment | 4 months tinnitus loudness rating scores (SD) | 68.1 units on a scale | Standard Deviation 21.4 |
| Placebo | Changes on Baseline Tinnitus Magnitude on Tinnitus Loudness Rating Scores (0-100) at 4 Months Treatment | Baseline tinnitus loudness rating scores (SD) | 66 units on a scale | Standard Deviation 18.4 |
| Placebo | Changes on Baseline Tinnitus Magnitude on Tinnitus Loudness Rating Scores (0-100) at 4 Months Treatment | 4 months tinnitus loudness rating scores (SD) | 67.6 units on a scale | Standard Deviation 20.2 |
p-value: 0.89paired t test
p-value: 0.36paired t test
Secondary
Changes on Baseline Tinnitus Reactions on Tinnitus Annoyance Rating Scores (0-100) at 4 Months Treatment
Tinnitus annoyance rate on a scale of 0 (no annoyance) to 100 (maximum degree of annoyance)
Time frame: baseline and 4 months
Population: Subjects that complete 4 months treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Zinc | Changes on Baseline Tinnitus Reactions on Tinnitus Annoyance Rating Scores (0-100) at 4 Months Treatment | Baseline tinnitus annoyance rating scores | 59.67 units on a scale | Standard Deviation 25.4 |
| Zinc | Changes on Baseline Tinnitus Reactions on Tinnitus Annoyance Rating Scores (0-100) at 4 Months Treatment | 4 months tinnitus annoyance rating scores | 61 units on a scale | Standard Deviation 30.5 |
| Placebo | Changes on Baseline Tinnitus Reactions on Tinnitus Annoyance Rating Scores (0-100) at 4 Months Treatment | Baseline tinnitus annoyance rating scores | 57.7 units on a scale | Standard Deviation 30.85 |
| Placebo | Changes on Baseline Tinnitus Reactions on Tinnitus Annoyance Rating Scores (0-100) at 4 Months Treatment | 4 months tinnitus annoyance rating scores | 57.9 units on a scale | Standard Deviation 26.7 |
p-value: 0.64paired t test
p-value: 0.93paired t test