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Survey on the Effectiveness of Dietary Supplements to Treat Tinnitus

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Purpose: We surveyed the benefit of dietary supplements to treat tinnitus and reported adverse effects. Method: A website was created for people with tinnitus to complete a variety of questions. Results: The 1,788 subjects who responded to questionnaires came from 53 different countries; 413 (23.1%) reported taking supplements. No effect on tinnitus was reported in 70.7%, improvement in 19.0%, and worsening in 10.3%. Adverse effects were reported in 6% (n = 36), including bleeding, diarrhea, headache, and others. Supplements were reported to be helpful for sleep: melatonin (effect size, d = 1.228) and lipoflavonoid (d = 0.5244); emotional reactions: melatonin (d = 0.6138) and lipoflavonoid (d = 0.457); hearing: Ginkgo biloba (d = 0.3758); and concentration Ginkgo biloba (d = 0.3611). The positive, subjective reports should be interpreted cautiously; many might have reported a positive effect because they were committed to treatment and expected a benefit. Users of supplements were more likely to have loudness hyperacusis and to have a louder tinnitus. Conclusions: The use of dietary supplements to treat tinnitus is common, particularly with Ginkgo biloba, lipoflavonoids, magnesium, melatonin, vitamin B12, and zinc. It is likely that some supplements will help with sleep for some patients. However, they are generally not effective, and many produced adverse effects. We concluded that dietary supplements should not be recommended to treat tinnitus but could have a positive outcome on tinnitus reactions in some people.
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AJA
Research Article
Survey on the Effectiveness of Dietary
Supplements to Treat Tinnitus
Claudia Coelho,
a
Richard Tyler,
a
Haihong Ji,
a
Eveling Rojas-Roncancio,
a
Shelley Witt,
a
Pan Tao,
a
Hyung-Jin Jun,
a
Tang Chuan Wang,
a
Marlan R. Hansen,
a
and Bruce J. Gantz
a
Purpose: We surveyed the benefit of dietary supplements
to treat tinnitus and reported adverse effects.
Method: A website was created for people with tinnitus to
complete a variety of questions.
Results: The 1,788 subjects who responded to questionnaires
came from 53 different countries; 413 (23.1%) reported taking
supplements. No effect on tinnitus was reported in 70.7%,
improvement in 19.0%, and worsening in 10.3%. Adverse
effects were reported in 6% (n= 36), including bleeding,
diarrhea, headache, and others. Supplements were reported
to be helpful for sleep: melatonin (effect size, d= 1.228) and
lipoflavonoid (d= 0.5244); emotional reactions: melatonin
(d= 0.6138) and lipoflavonoid (d= 0.457); hearing: Ginkgo
biloba (d= 0.3758); and concentration Ginkgo biloba
(d= 0.3611). The positive, subjective reports should be
interpreted cautiously; many might have reported a positive
effect because they were committed to treatment and
expected a benefit. Users of supplements were more likely
to have loudness hyperacusis and to have a louder tinnitus.
Conclusions: The use of dietary supplements to treat
tinnitus is common, particularly with Ginkgo biloba,
lipoflavonoids, magnesium, melatonin, vitamin B12, and
zinc. It is likely that some supplements will help with sleep
for some patients. However, they are generally not effective,
and many produced adverse effects. We concluded that
dietary supplements should not be recommended to treat
tinnitus but could have a positive outcome on tinnitus
reactions in some people.
Tinnitus is common and can be very debilitating
(Stouffer & Tyler, 1990; Tyler & Baker, 1983). It
often affects four different primary functions: thoughts
and emotions, hearing, sleep, and concentration (Tyler,
Ji, et al., 2014). There are now several excellent counsel-
ing and sound therapy approaches to help patients (e.g.,
Tyler, 2006a 2006b). In our psychological model of tinnitus
(Dauman & Tyler, 1992), we emphasized the importance of
distinguishing the tinnitus and the reactions to the tinnitus.
Counseling and sound therapies focus on the reactions, but
tinnitus sufferers preferential treatment is a pill (Tyler, 2012).
In the 1990s, two reviews (Dobie, 1999; Murai, Tyler,
Harker, & Stouffer, 1992) noted some promising medica-
tions but also identified research-design shortcoming and
suggested strategies for improved future clinical trials (see
also Tyler, Oleson, Noble, Coelho, & Ji, 2007). More
than two decades later, there is still no U.S. Food and Drug
Administrationapproved medication for tinnitus treatment.
Although some studies have suggested benefit for a subgroup
of tinnitus patients, there is still lack of evidences to justify
the routine use of medications in management of tinnitus
(Beebe Palumbo, Joos, De Ridder, & Vanneste, 2015; Hoare,
Kowalkowski, Kang, & Hall, 2011; Tunkel et al., 2014).
Regardless of these findings, patients and physicians
seek mitigation of the symptom and associated distress.
More than 4 million off-label prescriptions, from a wide vari-
ety of drugs, are written each year for tinnitus relief, possibly
with considerable adverse effects (Vio & Holme, 2005).
Dietary Supplements
A dietary supplement, as defined by the Dietary Sup-
plement Health and Education Act of 1994, is a product
that is taken by mouth and is intended to supplement the
diet. It can contain one or more dietary ingredients (in-
cluding vitamins, minerals, herbs or other botanicals, and
amino acids) or their constituents. According to the National
Center for Complementary and Integrative Health, dietary
supplements are the most common substances used among
patients with chronic conditions (National Center for Com-
plementary and Integrative Health, 2012).
a
University of Iowa, Iowa City
Correspondence to Richard Tyler: rich-tyler@uiowa.edu
Editor: Sumitrajit Dhar
Associate Editor: Owen Murnane
Received February 4, 2016
Revision received April 7, 2016
Accepted April 29, 2016
DOI: 10.1044/2016_AJA-16-0021
Disclosure: The authors have declared that no competing interests existed at the time
of publication.
American Journal of Audiology Vol. 25 184205 September 2016 Copyright © 2016 American Speech-Language-Hearing Association184
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Dietary supplements (classified as natural) typically
have low cost, are available over the counter, and are fully
advertised by their manufacturers for their health benefits.
This does not necessarily mean that they are safe and effec-
tive. Because supplements are classified as food, the U.S.
Food and Drug Administration does not require the same
scrutiny for safety and efficacy as is mandatory for pre-
scribed medications (Sax, 2015). There is a limit on the
claims supplements can make on labels, in advertisement,
and in testimonials. They cannot state that they treat or
cure diseases but are allowed to state structure/function
or health maintenanceclaims. Discerning among these
definitions could be a difficult task for consumers (Media,
2014).
As reported by the National Health Interview Survey
in 2012 (also in 2007 and 2002), natural products (dietary
supplements other than vitamins and minerals) were the
most commonly used complementary and alternative
medicine approach and were used by 17.7% of adults and
4.9% of children ages 4 to 17 years (Clarke, Black, Stussman,
Barnes, & Nahin, 2015).
Individuals are widely using supplements without sci-
entific evidence indicating whether those supplements are
helpful or harmful. Such behavior is likely influenced by cost,
treatment beliefs, and/or health system distrust (Kroesen,
Baldwin, Brooks, & Bell, 2002; Pagan & Pauly, 2005).
Dietary Supplements and Tinnitus
Dietary supplements for the treatment of tinnitus are
commonly advertised on the web, on television, and in
magazines. Vitamin B, zinc, magnesium, manganese, bio-
flavonoids, and herbal extracts are the supplements most
commonly used (Seidman & Babu, 2003), but there are few
well-designed investigations testing their efficacy. Available
studies have shown different results, probably explained by
differences in methodology, forms of presentation, dosage,
and purity of the product.
In a review by von Boetticher (2011), the use of Ginkgo
biloba in the form of EGB 761 (standard Ginkgo biloba
leaves extract containing 24% of glycoside flavonoids and
6% of terpene lactones) has shown efficacy in the treatment of
tinnitus when compared with placebo. Hilton, Zimmermann,
and Hunt (2013), in another review, concluded that evidence
supporting the effectiveness of Ginkgo biloba for tinnitus was
limited. They did note, however, a possible positive effect
on cognitive impairment in people without a primary com-
plaint of tinnitus.
Preliminary studies testing vitamin B12 to treat tinnitus
from Shemesh, Attias, Ornan, Shapira, and Shahar (1993)
and Attias, Reshef, Shemesh, and Salomon (2002), have
suggested that replacement with cyanocobalamin could
improve tinnitus, whereas Berkiten, Yildirim, Topaloglu,
and Ugras (2013), concluded that this replacement therapy
was not effective.
A review of melatonin used in tinnitus treatment con-
cluded that it could have a positive effect on sleep disorders
caused by tinnitus (Miroddi et al., 2015).
A recent study (Rojas-Roncancio et al., 2016) evalu-
ated the use of Lipoflavonoid Plus alone or in association
with manganese; neither was shown to be helpful in reducing
tinnitus. The use of zinc supplementation was also evaluated
among tinnitus sufferers in a few studies. Zinc was proven
to be more effective for treating tinnitus compared with
placebo in a randomized, double-blind, controlled study
among elderly patients (Coelho et al., 2013), although a sub-
group of subjects, presenting with zinc deficiency, might have
had some benefits (Arda, Tuncel, Akdogan, & Ozluoglu,
2003; Coelho et al., 2013; Ochi, Kinoshita, Kenmochi, Nishino,
& Ohashi, 2003).
A recent guideline from the American Academy of
Otolaryngology-Head and Neck Surgery (Tunkel et al.,
2014) stated that clinicians should not recommend Ginkgo
biloba, melatonin, zinc, or other dietary supplements for
treating patients with persistent bothersome tinnitus.
The primary objective of this study was to evaluate
how dietary supplements are being used by tinnitus suf-
ferers and what benefit and adverse effects those sufferers
report.
Method
The methodology for reporting this study followed
the Checklist for Reporting Results of Internet E-Surveys
(Eysenbach, 2004).
Design
A cross-sectional study design was used. The website
address was distributed at our monthly group session to
national tinnitus self-help associations and shared at inter-
national meetings on hearing and tinnitus. Many subjects
likely found the website on their own.
The study protocol was approved by the local ethics
and research committee at the University of Iowa. Subjects
with tinnitus complaints were enrolled if they were at least
18 years old. Data were collected and stored through a web
server at the University of Iowa, which secured the con-
fidentially of all subjectsrecords. Access was restricted to
the clinical investigators.
Protocol
The tinnitus website was divided into several sections
(see Appendix A). The first part included general demo-
graphics and hearing and tinnitus questions. After com-
pleting the initial section, subjects were asked if they had
tried dietary supplements for the treatment of tinnitus, and
if so, they were invited to answer a section focused on issues
related to supplements.
Measurements
Subjects were asked to make magnitude estimates on
scales from 0% to 100% with a variety of different attributes
and appropriate endpoints (see Tyler, Noble & Coelho,
2006):
Coelho et al.: Effectiveness of Supplements on Tinnitus 185
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Hearing: 0 (zero) represents a complete loss of hear-
ing, and 100 represents excellent hearing
Tinnitus severity: 0 (zero) represents no difficulty,
and 100% represents most severe difficulty
Tinnitus loudness: 0 (zero) is very faint; 100% is very loud
Loudness hyperacusis (sounds that others believe are
moderately loud are too loud for me): 0 (zero) is
strongly disagree, 100% is strongly agree
Presence of tinnitus during the time awake: 100%
indicates that tinnitus is present all the time, and (for
example), 25 would indicate that tinnitus is present
one quarter of the time.
We decided to include a question on hyperacusis be-
cause we had previously established a link between tinnitus
and hyperacusis (Tyler & Conrad-Armes, 1983; see also
Tyler, Pienkowski, et al., 2014).
Sample Size
Our main purpose was to describe the supplements
taken and their benefits or adverse effects. We also thought
it might be of interest to compare the two groups (people
who had tried supplements and those who had not) to de-
termine whether there were different characteristics between
the groups. Comparing the different users on the basis of
previously related clinical trials, we expected to observe
a difference of at least 10% in measurement scores. We
anticipated the between-subjects standard deviation for our
metric would be approximately 20%. At 90% power and
5% type I error, we estimated an effect size of 0.5 with a
sample size of 86 subjects per group. Our sample size per
group was appropriate to detect significant differences and
was appropriate for other exploratory analysis.
Statistical Analysis
Subjects who reported oral intake of at least one die-
tary supplement for the treatment of tinnitus were classified
as users. Subjects who did not report taking any dietary
supplement for their tinnitus were classified as nonusers.
Data distribution was assessed for normality by visual
inspection and by ShapiroWilk test ( p> .05; Ghasemi &
Zahediasl, 2012) before further statistical analysis.
The χ
2
test was used to detect differences in prevalence
of qualitative variables between groups, and the Mann
Whitney Utest to compare quantitative variables (Hollander
& Wolfe, 1999). Paired-samples ttest and Wilcoxon signed-
rank test were used to determine whether there were differ-
ences between rating scores before and after supplement use
(Sheskin, 2011). A logistic regression was used to assess
univariate associations with the odds ratios of the likelihood
of dietary supplement use among the subjects. The logistic
regression model included the following variables: age,
gender, tinnitus loudness, percentage of time tinnitus is per-
ceived during waking hours, number of days that tinnitus
is present during the month, duration of tinnitus, loudness
hyperacusis rating, and loudness variation.
Effect size estimates were calculated using Cohensd.
Cohen (1988), reported the following intervals for d:<0
to 0.1, no effect; 0.2 to 0.4, small effect; 0.5 to 0.7, inter-
mediate effect; and 0.8 and higher, large effect.
Statistical analysis was performed with the Statistics
Package for the Social Sciences (IBM SPSS version 23,
SPSS Inc., Chicago, IL) and Microsoft (Redmond, WA)
Excel (version 2011).
Results
The University of Iowa tinnitus survey had 2,123 ac-
cesses between September 2007 and September 2015. Inter-
net protocol (IP) address check was performed to exclude
multiple entries from the same IP address. The view rate of
unique subjects was 2,073 (97.6%). Subjects who had multi-
ple IP address accesses (n= 50, 2.4%) and incomplete data
(n= 285, 13.4%) were excluded.
Questionnaires were completed by 1,788 subjects
(84.2%). Among them, the use of oral dietary supplements
was reported by 413 (23.1%), and 1,375 (76.9%) did not
report taking any supplements. The number of treatments
reported by subjects was 605, with 52 different substances
(see Figure 1).
Geographical Location
Location of subjectsIP that accessed the website
(n= 2,123) was identified. A world wide IP distribution map
(see Figure 2) was obtained by plotting the IP addresses on
a Google Map using Mapcustomizer.com (Ursus Software,
LLC).
Continent and Country Distribution by Group
(Nonusers Versus Users)
Subjects (n= 1,797) from all continents joined in the
survey. Oceania (i.e., the continental region that lies between
Asia and the Americas, with Australia as the major land
mass) accounted for 43.5% of subjects; followed by North
America, 41.3%; and Europe, 12.1%. Distribution over
continents and their respective countries, classified by users
and nonusers, was analyzed (see Table 1 and Appendix B).
Australia (43%), United States (38.5%), and United
Kingdom (8%) were the countries with highest number
of subjects. All were English native-speaking countries, as
expected, because the webpage interface was in English.
The use of dietary supplements was reported across
all continents. The United States had the most users (n= 250),
equaling 60.5% of the users sampled. Twenty-three percent
(n= 413) of the subjects analyzed in this study have used
at least one substance to treat tinnitus.
Data Distribution Analysis: Nonusers and
Users of Supplements
The assumption of normality for nonuser and user
scores was not satisfied for all group combinations of quali-
tative (gender, tinnitus location, tinnitus qualities, loudness
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and pitch variation), and quantitative data (age, tinnitus
duration, tinnitus loudness scores, percentage of time
tinnitus is perceived during waking hours, number of days
tinnitus is present during the month, left and right ear
hearing rating scores, loudness hyperacusis rating scores)
as assessed by visual inspection of their histograms as well
in the ShapiroWilk test ( p< .05).
The MannWhitney Utest was run to determine
whether there were differences in continuous data values
between nonusers and users. Distributions of scores for
Figure 1. Profile of study subjects, excluded data, and treatments.
Figure 2. Subjectslocations on the basis of their Internet protocol (IP) address.
Coelho et al.: Effectiveness of Supplements on Tinnitus 187
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nonusers and users were similar in all variables, as assessed
by visual inspection (see Table 2). Median age values were
significantly higher in users (54 years) than it was in nonusers
(50 years), U=397,z=3.523,p<.0005.Medianduration
of tinnitus) was significantly higher in nonusers (84 months)
than it was in users (48 months), U= 313, z=4.453,
p< .0005. Median tinnitus loudness scores were statisti-
cally significantly higher in users (70) than in nonusers (50),
U= 319, z= 5.202, p< .0005. Median percentage of time
tinnitus was perceived during waking hours was significantly
higher in users than it was in nonusers, U= 294, z= 2.486,
p< .013 (check for mean ranks; see Table 2). Median of
the number of days tinnitus was present during the month
was statistically significantly higher in users than it was in
nonusers, U= 311, z=4.991,p< .0005. Median loudness
hyperacusis rating scores were significantly higher in users
(70) than they were in nonusers (50), U= 288, z=3.571,
p< .0005.
Frequency and percentage of occurrence for categori-
cal variables (gender, tinnitus location, quality, loudness,
and pitch variation) for nonusers and users are described in
Table 3. Pearson χ
2
tests for association were conducted
for all variables between both groups. All expected cell fre-
quencies were > 5. No statistically significant association
was found among categorical variables between users and
nonusers.
Logistic Regression, Nonusers Versus Users
A logistic regression was performed to ascertain the
effects of eight variablesage, tinnitus loudness, percentage
of time tinnitus is perceived when awake, number of days
that tinnitus is present during the month, duration of tinnitus,
loudness hyperacusis rating, gender, and loudness variation
on the likelihood that subjects were dietary users. The Pearson
correlation values are shown in Table 4. The logistic regres-
sion model was significant, χ
2
(6) = 92.7, p<.001.Themodel
with six variables explained 8.4% (NagelkerkesR
2
)ofthe
variance in dietary users and correctly classified 76% of
cases. Increasing age, tinnitus loudness, number of days tin-
nitus is present during the month, and loudness hyperacusis
were associated with an increased likelihood of dietary sup-
plement use, but increasing duration of tinnitus was associ-
ated with a reduction in the likelihood of dietary supplement
use. Tinnitus loudness variation was 1.4 times more likely to
be exhibited among users of dietary supplements.
Dietary and/or Herbal Supplements
Several substances (n= 52) were reportedly used to
treat tinnitus in this survey, such as vitamins, herbs, minerals,
homeopathic compounds, and Chinese phytotherapies. The
use of more than one treatment by a subject was a common
finding. The median use was one, but the range varied from
Table 1. Frequency of nonusers and users (n) and median values for continuous variables. MannWhitney Utest results, mean ranks, and
pvalue (significance p< .05) used to verify differences between both groups.
Continent
Nonusers User Total
n% within continent % of total n% within continent % of total n% of total
Africa 0 0.0 0.0 1 100.0 0.1 1 0.1
Asia 28 71.8 1.6 11 28.2 0.6 39 2.2
Central America 5 71.4 0.3 2 28.6 0.1 7 0.4
Europe 180 83.3 10.1 36 16.7 2.0 216 12.1
North America 473 64.1 26.5 265 35.9 14.8 738 41.3
Oceania 682 87.8 38.1 95 12.2 5.3 777 43.5
South America 7 70.0 0.4 3 30.0 0.2 10 0.6
Total 1,375 76.9 76.9 413 23.1 23.1 1,788 100.0.
Table 2. Frequency of nonusers and users ( n) and median values for continuous variables. MannWhitney Utest results, mean ranks, and
pvalue (significance p< .05) used to verify differences between both groups.
Variables
Nonuser User MannWhitney
UTest, pn Median Mrank n Median Mrank
Age (years) 1,367 50 865.9 411 54 967.7 .000
Duration of tinnitus (months) 1,319 84 893.6 408 48 768.0 .000
Tinnitus loudness (0100 scale) 1,335 60 837.8 409 70 985.5 .000
% of time tinnitus is perceived during
the awake time (0100 scale)
1,336 100 860.8 413 00 920.8 .013
Number of days tinnitus is present
during the month (031)
1,326 31 837.5 409 31 966.6 .000
Hearing rating left ear (0100 scale) 1,330 85 870.4 413 81 877.0 .814
Hearing rating right ear (0100 scale) 1,311 85 854.4 411 85 883.9 .293
Loudness hyperacusis rating (0100) 1,286 50 820.9 402 70 919.7 .000
188 American Journal of Audiology Vol. 25 184205 September 2016
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one to 20 different treatments. The frequency distribution
of treatments is described in Figure 3.
The most used substances were Ginkgo biloba (26.6%),
lipoflavonoid (12.9%), vitamin B12 (8.6%), zinc (8.6%) mag-
nesium (6.6%), and melatonin (4.6%). The period of self-
treatment varied from less than 1 week to 200 weeks, with
a median of 12 weeks. The duration of use and presence
of adverse effects are described in Appendix C, as are the
compounds that were not in the web questionnaire but
were documented in open format by responders.
Adverse Effects
The presence of adverse effects occurred in 8.7% (n= 36)
of the treatments and was associated with 15 substances.
Ginkgo biloba was the most-cited supplement resulting in
adverse effects. Description of the adverse effects was reported
for 11 substances:
Lipoflavonoid: stomach pain, bleeding, skin reaction,
weight gain, trouble sleeping, and blurred vision
Clear Tinnitus: headache
Er ming zuo ci wan: diarrhea, stomach pain, dizziness,
weight gain, and trouble sleeping
Ginkgo biloba: diarrhea, nausea, hearing, dizziness,
headache, bleeding, blood pressure, chest pain, palpi-
tation, and increased urination
Green tea: diarrhea, stomach pain, and increased
urination
Magnesium: diarrhea, headache, and trouble sleeping
Table 3. Gender, tinnitus location, quality, loudness and pitch variation frequencies (n), and percentage within group (%) among nonusers,
users, and total sample.
Variable Response
Nonuser User Total
p
a
n%n%n%
Gender Female 557 40.9 170 41.3 727 41.0 .895
Male 805 59.1 242 58.7 1,047 59.0
Tinnitus location Both ears, but worse in left ear 243 17.9 84 20.4 327 18.5 .107
Both ears, but worse in right ear 195 14.4 63 15.3 258 14.6
Both ears, equally 469 34.6 107 26.0 576 32.6
In the head but no exact place 72 5.3 25 6.1 97 5.5
Left ear 152 11.2 58 14.1 210 11.9
Middle of head 28 2.1 11 2.7 39 2.2
More in the left side of head 37 2.7 18 4.4 55 3.1
More in the right side of head 40 3.0 11 2.7 51 2.9
Outside of head 5 0.4 2 0.5 7 0.4
Right ear 114 8.4 33 8.0 147 8.3
Tinnitus quality Buzzing 90 6.7 27 6.6 117 6.7 .115
Cricket-like 133 9.9 37 9.0 170 9.7
Hissing 224 16.7 89 21.6 313 17.9
Humming 43 3.2 14 3.4 57 3.3
Other 42 3.1 20 4.9 62 3.5
Ringing, whistling 709 53.0 97 7.2 900 51.4
Roaring, shhh, rushing 191 46.4 34 8.3 131 7.5
Loudness variation No 416 32.0 111 27.3 527 30.9 .079
Yes 886 68.0 295 72.7 1,181 69.1
Pitch variation No 747 56.3 223 54.3 970 55.8 .468
Yes 580 3.7 188 45.7 768 44.2
a
Pearson χ
2
test for association (significance p< .05).
Table 4. Pearson correlation analysis for selected variables: X1, age; X2, tinnitus loudness; X3, % of time tinnitus is perceived during the awake
time; X4, number of days tinnitus is present during the month; X5, duration of tinnitus; X6, loudness hyperacusis rating; X7, gender; and X8,
loudness variation); pvalue and n(number).
Statistics
Variables
X1 X2 X3 X4 X5 X6 X7 X8
Pearson correlation 0.082** 0.124** 0.062* 0.147** 0.083** 0.082** 0.003 0.042
Significance (two-tailed) 0.001 0.000 0.01 0.000 0.001 0.001 0.895 0.079
N1,778 1,744 1,749 1,735 1,727 1,688 1,774 1,708
**Correlation is significant at the 0.01 level (two-tailed); *correlation is significant at the 0.05 level (two-tailed).
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Melatonin: nausea, dizziness, headache, blurred vision,
and increased urination
Ring Stop: nausea, dizziness, and skin reaction
Tinniticil: nausea, stomach pain, weight gain, trouble
sleeping, hearing, and palpitation
Vitamin B12: diarrhea, nausea, dizziness, headache,
hearing, blurred vision, and chest pain and palpitations
Vitamin C: diarrhea, dizziness, blood pressure, skin
reactions, and weight gain
Supplement Recommendations
We were also interested to know how subjects were
receiving recommendations for the treatments. Only 19.1%
of all treatments were recommended by a physician and
7.8% by other health professionals (see Figure 4). The Inter-
net was the most frequent supplier of dietary supplements
(40%; see Appendix D for sources, frequencies, and per-
centages). The most frequent recommendations by physicians
were Ginkgo biloba (21.6%), lipoflavonoid (19.3%), vitamin
B12 (13.6%), magnesium (12.5%), zinc (9.1%), melatonin
(4.5%), and vitamin E (3.4%). Nonphysician most frequent
recommendations were Ginkgo biloba (27.5%), lipoflavonoid
(11.8%), zinc (8.5%), vitamin B12 (7.7%), magnesium (5.6%),
melatonin (4.6%), Ring Stop (3.5%), vitamin B1 (3.5%),
vitamin B6 (3.5%), and vitamin C (3.5%).
Effect of Supplements on Tinnitus
Subjects were asked to rate, on a scale from 0% to
100%, whether the treatment had helped (0 representing no
help, and 100 representing a cure) or worsened tinnitus (0 rep-
resenting no worse, and 100 representing worse than it has
ever been). Distribution of responses can be seen on the histo-
grams (see Figure 5). A positive (helped) or negative (wors-
ened) effect on tinnitus was considered for those subjects that
rated scores 10, and no effect on scores was < 10. Data
were available on 300 treatments. No effect on tinnitus
was reported in 70.7% of cases, positive effects were reported
in 19.0% of cases (tinnitus improvement), and a negative
effect (worsened tinnitus) was reported in 10.3% of cases.
Effects for each substance are specified in Appendix E.
SubjectsReactions to Tinnitus
We focused on four primary functions affected by
tinnitus (emotions, sleep, concentration, and hearing;
Tyler et al., 2014). Tinnitus severity scores on related re-
actions were evaluated on a scale of 0% to 100%. Zero
percent meant no interference by tinnitus, and 100% meant
total interference.
Subjects were asked to rate their perception on tinnitus
severity before and after using substances. Distribution
scores in the four areas, before treatment, are shown in
histograms (see Figure 6).
A wide range of problems was seen across subjects
(see Figure 7). Some subject were severely affected by sleep;
others were not at all. As discussed previously (Tyler et al.,
2006), we decided sensitivity would be greater if we focused
only on subscales that showed distress pretreatment. Thus, to
evaluate possible effects of substances on tinnitus severity
scores, we included in this analysis only those subjects
Figure 3. Frequency description of the number of supplements used by subjects. Variation from one to 20 treatments per subject.
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whose scores we considered to have at least a minimum degree
of severity on tinnitus reactions (see Figure 7). We established
a minimum of 10 points on the scale rating scores as an
inclusion criteria. Not all selected cases presented complete
data to perform a statistical analysis.
Effect of Substances on Tinnitus Reactions
To analyze possible effects on pre- and posttreatment
scores with enough valid cases, a paired ttest or Wilcoxon
signed-rank test was performed. If a significant decrease
Figure 4. Supplements prescribed by physicians and nonphysicians.
Figure 5. Treatment effects on tinnitus: helped and worsened rating scales (0100).
Coelho et al.: Effectiveness of Supplements on Tinnitus 191
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in score was found, Cohensdwascalculatedtoevaluate
the magnitude of the effect.
Effect of Tinnitus on Thoughts and Emotions
The effect of 15 substances (black cohosh, Clear
Tinnitus, er ming zuo ci wan, Ginkgo biloba, lipoflavonoid,
magnesium, melatonin, Ring Stop, T-Gone, vitamin B12,
vitamin B3, vitamin B6, vitamin C, vitamin E and zinc) on
thoughts and emotions scores was evaluated for 304 subjects.
There was a significant decrease in scores among subjects
taking Ginkgo biloba (n= 103; 23 had a decreased score,
none had an increase, and 80 had no change; z=4.211,
p< .0005, Cohensd= 0.40), lipoflavonoid (n= 49; 6 had
a decreased score, 1 had an increase, and 42 had no change;
z=2.205, p=0.027,Cohensd= 0.457), and melatonin
(n= 20; 6 had a decreased score, none had an increase, and
14 had no change; z=2.207, p= .027, Cohensd= 0.6138)
and group and individual data were evaluated (see Figure 8
and Appendix F).
Effect of Tinnitus on Sleep
Pre- and posttreatment tinnitus scores for sleep differ-
ences (n = 169) were evaluated on subjects taking Clear Tin-
nitus, Ginkgo biloba, lipoflavonoid, magnesium, melatonin,
vitamin B1, vitamin B12, and zinc. There was a significant
decrease in scores among subjects taking Ginkgo biloba
Figure 6. Tinnitus reactions rating scales (0100%) of problems associated to the presence of tinnitus before treatment on emotions, sleep,
concentration, and hearing.
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Figure 8. Individual data on pre- and posttreatment tinnitus emotion severity scores on subjects taking Ginkgo biloba, lipoflavonoids,
magnesium, melatonin, vitamin B12, and zinc.
Figure 7. Selection process of subjects to be included in supplement treatment-effect analysis. Subjects were selected on the basis of
pretreatment minimum scores of 10 points on tinnitus reaction scales for the primary functions affected by tinnitus: emotions, sleep, hearing,
and concentration.
Coelho et al.: Effectiveness of Supplements on Tinnitus 193
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(n= 75; 12 had a decreased scores, 2 had an increase, and 61
had no change; z=2.800, p= .005, Cohensd= 0.4697),
lipoflavonoid (n= 31; 5 had a decreased score, 1 had an in-
crease, and 25 had no change; z=1.997 p= .046, Cohens
d=0.5244),andmelatonin(n= 13; 9 presented a decrease in
scores, none had an increase and 4 had no change; z=2.668
p= .008, Cohensd= 1.228). Group and individual data
analyses are shown in Appendix G and Figure 9.
Effect of Tinnitus on Concentration
Pre- and post-treatment of tinnitus on the scores for
differences in concentration (n= 182) were evaluated for
subjects taking Arches Tinnitus Relief Formula, Clear
Tinnitus, Ginkgo biloba, lipoflavonoid, magnesium, melato-
nin, T-Gone, vitamin B1, vitamin B12, and zinc. There
was a significant decrease in scores among subjects taking
Ginkgo biloba (n= 84; 13 had a decreased score, 2 had
an increase, and 69 had no change; z = 2.302, p= .021,
Cohensd= 0.3611). Group and individual data analyses
are shown in Appendix H and Figure 10.
Effect of Tinnitus on Hearing
The effect of Ginkgo biloba, lipoflavonoid, melatonin,
vitamin B1, vitamin B12, and zinc on tinnitus hearing scores
was evaluated in 147 subjects. There was a significant
decrease in scores among subjects taking Ginkgo biloba
(n= 76; 11 had a decreased score, 4 had an increase, and 61
had no change; z=2.277, p= .023, Cohensd=0.3758).
Group and individual data analyses are shown in Appendix I
and Figure 11.
Discussion
Our primary aim was to document the use and po-
tential effectiveness of supplements for tinnitus. The
most common supplements used included Ginkgo biloba,
lipoflavonoid, magnesium, vitamin B12, zinc, and melatonin.
The median duration of substance use was 12 weeks. Supple-
ments were not considered effective for treating tinnitus by
70.7% of the subjects. Positive effects on tinnitus (tinnitus im-
provement) were related in 19.0% of subjects, and negative
Figure 9. Individual data on pre- and post-treatment tinnitus sleep severity scores on subjects taking Ginkgo biloba, lipoflavonoids, magnesium,
melatonin, vitamin B12, and zinc.
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effects (worsened tinnitus) were reported by 10.3% Although
treatment effects were reported on the basis of the fragile
and biased memories of survey respondents, the reported
efficacy of dietary supplements for tinnitus was universally
poor. These findings are in accordance with previous stud-
ies, which have pointed out that there is still no evidence
to recommend dietary supplements for the treatment of
tinnitus, on the basis of evidence from clinical trials and
reviews.
Several of the supplements resulted in adverse effects.
These included stomach pain, diarrhea, nausea, hearing,
dizziness, headache, bleeding, blood pressure, chest pain,
palpitations, increased urination, skin reactions, weight
gain, sleep disturbance, and blurred vision. Six percent of
subjects taking supplements experienced side effects.
The most effective supplement on tinnitus reactions
was melatonin, which had a large effect (Cohensd=1.228)
on sleep, as previously observed by Miroddi et al. (2015)
and an intermediate effect (Cohensd= 0.6138) on thoughts
and emotions. Lipoflavonoid had an intermediate effect on
sleep (Cohensd= 0.5244) and a small effect on thoughts
and emotions (Cohensd= 0.457). Ginkgo biloba showed a
small effect on sleep (Cohensd= 0.4697), thoughts and
emotions (Cohensd= 0.40), hearing (Cohensd=0.3758),
and concentration (Cohensd= 0.3611). It is likely that most
subjects were attempting to treat their reactions to tinnitus,
which would be comparable to the observations made by
the National Health Interview Survey (Clarke et al., 2015).
That survey suggested that U.S. adults were primarily taking
dietary supplement for wellness reasons (twice as likely)
rather than for treating a specific health condition. The sur-
vey reported that fewer than one in four subjects reported
a reduction in stress, better sleep, or feeling better emotion-
ally as a result of treatment.
We also compared tinnitus sufferers who reported
using supplements with those who reported they did not use
supplements. Generally, people who took supplements for
their tinnitus were older. Their tinnitus has a more recent
onset, was louder, had more loudness variation, tended to
be more frequently perceived over time, and was associated
with the presence of loudness hyperacusis; thus, these sub-
jects appeared to be more bothered by the tinnitus.
Figure 10. Individual data on pre- and posttreatment tinnitus concentration severity scores on subjects taking Ginkgo biloba, lipoflavonoid,
magnesium, melatonin, vitamin B12, and zinc.
Coelho et al.: Effectiveness of Supplements on Tinnitus 195
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Some Concerns About Supplements
The use of dietary supplements was described in a
self-help book for tinnitus sufferers (Coelho, 2016). Atten-
tion focused on the possible serious adverse effects of die-
tary supplements. In addition, self-medication with several
substances that failed to improve tinnitus could generate neg-
ative effects on the subjects emotional well-being. Moreover,
the attention focused on finding a cure could be counter-
productive to accepting and accommodating tinnitus (see
Mohr & Hedelund, 2006).
Subgroups
We note, cautiously, that there are likely different
tinnitus mechanisms, and it is likely that some treatments
might be effective for some types, but not other types.
Likewise, there are different subtypes of tinnitus (Tyler et al.,
2008). Thus, we have argued that appropriate research de-
signs should focus on individuals, not groups (Coelho et al.,
2013; Tyler et al. 2008). Of course, it is possible that a spe-
cific subgroup might clearly benefit from supplements.
However, at this time, we do not know whether this is true,
and if true, we do not know the makeup of the subgroup.
The Placebo Effect
It is possible that if people expect a benefit from a
product, they are more likely to experience a positive effect.
Similarly, if someone purchases a supplement and takes it
for several weeks, they might be more likely to report a ben-
efit. Some aspects of this placebo effect can be used to nur-
ture patient expectations and can have a positive influence
clinically (Tyler, Haskell, Preece, & Bergan, 2001). In addi-
tion, participation in this survey might have been influenced
by peoples expectations or experiences. Nevertheless, we
believe it is important to document what people are taking
for their tinnitus and what they report as their experiences.
Limitations of This Study
This web survey accessed information on the basis
of peoples experience in a real-world context, outside of
an experimental setting, such as a controlled clinical trial.
Figure 11. Individual data on pre- and posttreatment tinnitus hearing severity scores on subjects taking Ginkgo biloba, lipoflavonoid, magnesium,
melatonin, vitamin B12, and zinc.
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Therefore, there were no controls in this survey, and there
were no pre- and posttrial measurement assessments.
Treatment effects, values, and analyses (before and
after the use of a dietary supplement) of tinnitus and associ-
ated problems with emotions, sleep, hearing, and concen-
tration were based on respondentsmemories, which could
be biased. These reports should not be used to document
the effectiveness of these supplements but should be taken
only as rendering subjectsreports of their effectiveness.
Conclusions
The use of dietary supplements to treat tinnitus is
widespread. Some subjects report benefits from supplements,
primarily for sleep. Other subjects report emotional relief.
There is likely a placebo effect influencing those results. It is
also noteworthy that many side effects were reported. Those
using dietary supplements might not be aware of the side
effects, even though warnings might be present on supple-
ment labels. On the basis of these observations, we cannot
recommend that supplements be taken for tinnitus.
References
Arda, H. N., Tuncel, U., Akdogan, O., & Ozluoglu, L. N. (2003).
The role of zinc in the treatment of tinnitus. Otology & Neuro-
tology, 24(1), 8689.
Attias, J., Reshef, I., Shemesh, Z., & Salomon, G. (2002). Support
for the central theory of tinnitus generation: A military epi-
demiological study. International Journal of Audiology, 41(5),
301307.
Beebe Palumbo, D., Joos, K., De Ridder, D., & Vanneste, S. (2015).
The management and outcomes of pharmacological treatments
for tinnitus. Current Neuropharmacology, 13(5), 692700.
Berkiten, G., Yildirim, G., Topaloglu, I., & Ugras, H. (2013).
Vitamin B12 levels in patients with tinnitus and effectiveness
of vitamin B12 treatment on hearing threshold and tinnitus.
B-ENT, 9(2), 111116.
Clarke, T., Black, L., Stussman, B., Barnes, P., & Nahin, R.
(2015). Trends in the use of complementary health approaches
among adults: United States, 20022012. National Health
Statistic Report, 10(79), 116.
Coelho, C. (2016). Medications, supplements and alternative med-
icine. In R. S. Tyler (Ed.), The consumer handbook on tinnitus
(2nd ed.). Sedona, AZ: Auricle Ink Publishers.
Coelho, C., Witt, S. A., Ji, H., Hansen, M. R., Gantz, B., & Tyler, R.
(2013). Zinc to treat tinnitus in the elderly. Otology & Neuro-
tology, 34(6), 11461154.
Cohen, J. (1988). Statistical power analysis for the behavioral sci-
ences (2nd ed.). Mahwah, NJ: Erlbaum.
Dauman, R., & Tyler, R. S. (1992). Some considerations on the
classification of tinnitus. In J. M. Aran & R. Dauman (Eds.),
Proceedings of the fourth International Tinnitus Seminar
(pp. 225229). Amsterdam, the Netherlands: Kugler Publications.
Dobie, R. A. (1999). A review of randomized clinical trials in tin-
nitus. The Laryngoscope, 109, 12021211.
Eysenbach, G. (2004). Improving the quality of web surveys: The
checklist for reporting results of Internet e-surveys (CHERRIES).
Journal of Medical Internet Research, 6(3), 34.
Ghasemi, A., & Zahediasl, S. (2012). Normality tests for statistical
analysis: A guide for non-statisticians. International Journal of
Endocrinology and Metabolism, 10(2), 486489.
Hilton, M., Zimmermann, E., & Hunt, W. (2013). Ginkgo biloba
for tinnitus (Art. No. CD003852). Cochrane Database of Sys-
tematic Reviews. 2013(3), doi:10.1002/14651858.CD003852.
pub3
Hoare, D. J., Kowalkowski, V. L., Kang, S., & Hall, D. A. (2011).
Systematic review and meta-analyses of randomized controlled
trials examining tinnitus management. The Laryngoscope, 121,
15551564.
Hollander, M., & Wolfe, D. A. (1999). Nonparametric statistical
methods (2nd ed.). Hoboken, NJ: Wiley.
Kroesen, K., Baldwin, C. M., Brooks, A. J., & Bell, I. R. (2002).
US military veteransperceptions of the conventional medical
care system and their use of complementary and alternative
medicine. Family Practice, 19(1), 5764.
Media, R. H. (2014, January 30). Supplement claims: Whats
allowed. Unpublished manuscript. Retrieved from http://www.
berkeleywellness.com/supplements/other-supplements/article/
supplement-claims-whats-allowed
Miroddi, M., Bruno, R., Galletti, F., Calapai, F., Navarra, M.,
Gangemi, S., & Calapai, G. (2015). Clinical pharmacology of
melatonin in the treatment of tinnitus: A review. European
Journal of Clinical Pharmacology, 71(3), 263270.
Mohr, A., & Hedelund, U. (2006). Tinnitus person-centered ther-
apy. In R. S. Tyler (Ed.), Tinnitus treatment: Clinical protocols
(pp. 198216). New York, NY: Thieme.
Murai, K., Tyler, R. S., Harker, L. A., & Stouffer, J. L. (1992).
Review of pharmacologic treatment of tinnitus. American
Journal of Otology, 13(5), 454464.
National Center for Complementary and Integrative Health. (2012).
Dietary and herbal supplements. Retrieved from https://nccih.nih.
gov/health/supplements
Ochi, K., Kinoshita, H., Kenmochi, M., Nishino, H., & Ohashi, T.
(2003). Zinc deficiency and tinnitus. Auris Nasus Larynx, 30,
2528.
Pagan, J. A., & Pauly, M. V. (2005). Access to conventional medi-
cal care and the use of complementary and alternative medicine.
Health Affairs, 24(1), 255262.
Rojas-Roncancio, E., Tyler, R., Jun, H. J., Wang, T. C., Ji, H.,
Coelho, C., . . . Gantz, B. (2016). Manganese and lipoflavonoid
plus to treat tinnitus: A randomized controlled trial. Journal
of the American Academy of Audiology. Advance online publi-
cation. doi:10.3766/jaaa.15106
Sax, J. K. (2015). Dietary supplements are not all safe and not
all food: How the low cost of dietary supplements preys on
the consumer. American Journal of Law & Medicine, 41(2/3),
374394.
Seidman, M., & Babu, S. (2003). Alternative medications and other
treatments for tinnitus: Facts from fiction. Otolaryngologic
Clinics of North America, 36(2), 359381.
Shemesh, Z., Attias, J., Ornan, M., Shapira, N., & Shahar, A.
(1993). Vitamin B12 deficiency in patients with chronic-tinnitus
and noise-induced hearing loss. American Journal of Otolaryn-
gology, 14(2), 9499.
Sheskin, D. J. (2011). Handbook of parametric and nonparametric
statistical procedures (5th ed.). Boca Raton, FL: Chapman &
Hall/CRC Press.
Stouffer, J. L., & Tyler, R. S. (1990). Characterization of tinnitus
by tinnitus patients. Journal of Speech and Hearing Disorders,
55(3), 439453.
Tunkel, D. E., Bauer, C. A., Sun, G. H., Rosenfeld, R. M.,
Chandrasekhar, S. S., Cunningham, E. R., . . . Whamond, E. J.
(2014). Clinical practice guideline: Tinnitus. Otolaryngology
Head & Neck Surgery, 151(2 Suppl.), S1S40.
Coelho et al.: Effectiveness of Supplements on Tinnitus 197
Downloaded from: https://pubs.asha.org University of Iowa - Libraries on 02/21/2021, Terms of Use: https://pubs.asha.org/pubs/rights_and_permissions
Tyler, R., Coelho, C., Tao, P., Ji, H., Noble, W., Gehringer, A.,
& Gogel, S. (2008). Identifying tinnitus subgroups with
cluster analysis. American Journal of Audiology, 17(2),
176184.
Tyler, R., Ji, H., Perreau, H., Witt, S., Noble, W., & Coelho, C.
(2014). Development and validation of the Tinnitus Primary
Function Questionnaire. American Journal of Audiology, 23(3),
260272.
Tyler, R., Oleson, J., Noble, W., Coelho, C., & Ji, H. (2007). Clin-
ical trials for tinnitus: Study populations, designs, measure-
ment variables, and data analysis. Progress in Brain Research,
166, 499509.
Tyler, R. S. (2006a). Neurophysiological models, psychological
models, and treatments for tinnitus. In R. S. Tyler (Ed.),
Tinnitus treatment: Clinical protocols (pp. 122). New York,
NY: Thieme.
Tyler, R. S. (2006b). Tinnitus activities treatment. In R. S. Tyler
(Ed.), Tinnitus treatment: Clinical protocols (pp. 116132).
New York, NY: Thieme.
Tyler, R. S. (2012). Patient preferences and willingness to pay
for tinnitus treatment. Journal of the American Academy of
Audiology, 23(2), 115125.
Tyler, R. S., & Baker, L. J. (1983). Difficulties experienced by
tinnitus sufferers. Journal of Speech and Hearing Disorders,
48(2), 150154.
Tyler, R. S., & Conrad-Armes, D. (1983). The determination of
tinnitus loudness considering the effects of recruitment. Journal
of Speech and Hearing Research, 26(1), 5972.
Tyler, R. S., Haskell, G., Preece, J., & Bergan, C. (2001). Nurtur-
ing patient expectations to enhance the treatment of tinnitus.
Seminars in Hearing, 22(1), 1521.
Tyler, R. S., Noble, W. G., & Coelho, C. (2006). Considerations for
the design of clinical trials for tinnitus. Acta Oto-Laryngologica,
126(1), 4449.
Tyler, R. S., Pienkowski, M., Roncancio, E. R., Jun, H. J., Brozoski,
T., Dauman, N., . . . Moore, B. C. J. (2014). A review of
hyperacusis and future directions: Part I, definitions and mani-
festations. American Journal of Audiology, 23(4), 402419.
Vio, M. M., & Holme, R. H. (2005). Hearing loss and tinnitus:
250 million people and a US$10 billion potential market. Drug
Discovery Today, 10(19), 12631265.
von Boetticher, A. (2011). Ginkgo biloba extract in the treatment
of tinnitus: A systematic review. Neuropsychiatric Disease and
Treatment, 7, 441447.
Appendix A
Iowa Tinnitus Website
Part A: Main Page
We invite you to participate in a survey with the hope of understanding and better treating tinnitus. You must be 18 years
of age or older to complete this survey.
IT IS IMPORTANT TO US THAT YOU COMPLETE EVERY QUESTION!
If you have questions about the rights of research subjects, please contact the Human Subjects Office, 300 College of
Medicine Administration Building, The University of Iowa, Iowa City, IA 52242, (319) 335-6564, or e-mail irb@uiowa.edu Thank
you for your cooperation!
1. What is your age in years?
2. What is your gender? (Male/Female)
3. Where is your tinnitus?
If you hear more than one sound or a different sound in each ear, answer the following questions with regard to the one
most annoying sound.
4. Describe the most prominent PITCH of your tinnitus on a scale from 1 to 100. Where 1 is a VERY LOW pitch (ex. fog horn),
and 100 is a VERY HIGH pitch (ex. whistle).
5. Does the PITCH of the tinnitus vary from day to day? (Yes/No)
6. Describe the LOUDNESS of your tinnitus using a scale from 0-100. (0 = VERY FAINT; 100 = VERY LOUD)
7. Does the LOUDNESS of the tinnitus vary from day to day? (Yes/No)
Left ear In the head but no exact place
Right ear More in the right side of head
Both ears, equally More in the left side of head
Both ears, but worse in left ear Outside of head
Both ears, but worse in right ear Middle of head
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8. Which one of these qualities BEST describes your tinnitus?
9. During the time you are awake, what percentage of the time is your tinnitus present? For example, 100% would indicate that
your tinnitus was present all the time, and 25% would indicate that your tinnitus was present one quarter of the time.
10. On average, how many days per month are you bothered by your tinnitus?
11. How long have you had tinnitus? 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 7 months, 8 months,
9 months. 1 year, 1.5 years, 2 years, 2.5 years, 3 years, 3.5 years, 4 years, 4.5 years, 5 years10 years.
12. How well do you hear? (0 represents a complete loss of hearing and 100 represents excellent hearing)
13. Please rate whether sounds that others believe are moderately loud are too loud for you. (0 = strongly disagree; 100 =
strongly agree)
14. The effect of supplements on tinnitus-related reactions on emotional, concentration, sleep, and hearing problems were
evaluated on a scale 0100 points. (Zero means no improvement and a 100 total improvement)
15. In which ear(s) do you wear hearing aids? None, left, right, both
16. In which ear(s) do you wear cochlear implants? None, left, right, both
If you have tried dietary supplements and herbal supplements for the treatment of your tinnitus, do you want to help us learn
from your experience?
If yes, go to part C.
Part C: Dietary Supplements and Herbal Supplements for the Treatment of Tinnitus
a
1. Have you tried any of the following treatments for your tinnitus?
More questions about: (a specific treatment)
Ringing, whistling Humming
Cricket-like Hissing
Roaring, shhh, rushing Other
Buzzing
Rating
Left ear
Right ear
Rating
Emotional problems
Sleep problems
Hearing problems
Concentration problems
Bioflavonoids Ginkgo biloba Rose Clear Tinnitus
Black cohosh Graphites Vitamin A Lipoflavonoid
Calcarea carbonica Hawthorn Vitamin B1 Sonarx
Carbo vegetabilis Kali Vitamin B6 Ring Stop
Carbonicum Lemon Vitamin C Tinni-Fix
Chininum sulphuricum Lycopodium Vitamin E T-Gone
Cimicifuga cinchona Magnesium Vitamin B12 Tinnitus Relief
Officinalis Melatonin Zinc Other
Coffee Cruda Manganese Arches Tinnitus Relief Formula
Cypress Mullein Arches Tinnitus Stress Formula
Cornus Natrum salicylicum Arches Tinnitus B12
Er ming zuo ci wan Pantothenic acid Formula
Feverfew Potassium
Qi ju di huang wan
Coelho et al.: Effectiveness of Supplements on Tinnitus 199
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2. What is the concentration per tablet (or per unit) (You need to look at the container to determine this) e.g., 39 milligrams
(mg)?
Units? Milligrams = mg, micrograms = μg, ounces = oz., grams = g, pounds = lb. kilograms = kg, carats = karat = k, drams = dr,
grains = 2. How many tablets do you take per day?
3. How many weeks have you taken this medication?
4. Rate the severity of any problems that you attribute to your tinnitus.
(0 represents no difficulty and 100 represents most severe difficulty)
5. How did you find out that this particular treatment might help your tinnitus?
6. On a scale from 0 to 100, how do you consider this treatment has helped your tinnitus? (0 represents no help and 100
represents cured)
7. Did your tinnitus get worse during this treatment? (0 represents no worse and 100 represents worse than it has ever been)
8. Have you experienced any side effects? (Yes/No)
Side effects due to: (a specific treatment)
You only need to rate those side effects that you attribute directly to taking this particular supplement and skip others. (0 represents
no effect and 100 represents worst possible side effect)
a
Part B includes six tinnitus questionnaires and two hyperacusis questionnaires, which were not included in this analysis but
were part of the survey protocol.
Appendix B ( p. 1 of 2)
Country Distribution Among Nonusers and Users of Dietary and/or Herbal Supplements by Internet Protocol (IP)
Before using this treatment After using this treatment
Emotional Problems
Sleep Problems
Hearing Problems
Concentration Problems
Increased bleeding Endocrine problems: Headaches Skin reaction
High blood pressure e.g., thyroid problems, Nausea Sleep problems
Chest pain Weight (gain or loss) Irregular beating of the heart Stomach pain
Diarrhea Hearing got worse Renal pain Blurred vision
Dizziness Frequently urinating
Country
Nonuser User Total
n% within country % of total n% within country % of total n% of total
Argentina 2 66.7 0.1 1 33.3 0.1 3 2.
Australia 675 87.9 37.8 93 12.1 5.2 768 43.
Belgium 6 100 0.3 0 0 0 6 0.3
Brazil 1 33.3 0.1 2 66.7 0.1 3 0.2
Canada 34 69.4 1.9 15 30.6 0.8 49 2.7
China 1 50 0.1 1 50 0.1 2 0.1
Colombia 2 100 0.1 0 0 0 2 0.1
Dominican Republic 1 100 0.1 0 0 0 1 0.1
Egypt 0 0 0 1 100 0.1 1 0.1
Finland 3 60 0.2 2 40 0.1 5 0.3
France 4 66.7 0.2 2 33.3 0.1 6 0.3
Germany 8 88.9 0.4 1 11.1 0.1 9 0.5
Gibraltar 1 100 0.1 0 0 0 1 0.1
Greece 0 0 0 1 100 0.1 1 0.1
Hong Kong 1 100 0.1 0 0 0 1 0.1
Iceland 1 100 0.1 0 0 0 1 0.1
India 5 71.4 0.3 2 28.6 0.1 7 0.4
Iran 1 100 0.1 0 0 0 1 0.1
200 American Journal of Audiology Vol. 25 184205 September 2016
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Appendix C ( p. 1 of 2)
Frequency of Substance Use ( n), Period of Treatment (Weeks), and Related Adverse Effects
Appendix B ( p. 2 of 2)
Country Distribution Among Nonusers and Users of Dietary and/or Herbal Supplements by Internet Protocol (IP)
Country
Nonuser User Total
n% within country % of total n% within country % of total n% of total
Ireland 4 80 0.2 1 20 0.1 5 0.3
Israel 2 66.7 0.1 1 33.3 0.1 3 0.2
Italy 4 80 0.2 1 20 0.1 5 0.3
Japan 5 100 0.3 0 0 0 5 0.3
Jersey 1 100 0.1 0 0 0 1 0.1
Korea 1 100 0.1 0 0 0 1 0.1
Mexico 2 100 0.1 0 0 0 2 0.1
Mongolia 1 100 0.1 0 0 0 1 0.1
Nepal 1 100 0.1 0 0 0 1 0.1
Netherlands 6 100 0.3 0 0 0 6 0.3
New Zealand 7 77.8 0.4 2 22.2 0.1 9 0.5
Norway 3 75. 0.2 1 25 0.1 4 0.2
Pakistan 1 100 0.1 0 0 0 1 0.1
Panama 0 0 0 1 100 0.1 1 0.1
Peru 1 100 0.1 0 0 0 1 0.1
Philippines 1 50 0.1 1 50 0.1 2 0.1
Poland 1 100 0.1 0 0 0 1 0.1
Portugal 2 50 0.1 2 50 0.1 4 0.2
Puerto Rico 2 66.7 0.1 1 33.3 0.1 3 0.2
Romania 1 100 0.1 0 0 0 1 0.1
Russia 1 100 0.1 0 0 0 1 0.1
Serbia 1 50 0.1 1 50 0.1 2 0.1
Singapore 2 100 0.1 0 0 0 2 0.1
Spain 4 66.7 0.2 2 33.3 0.1 6 0.3
Sweden 6 60 0.3 4 40 0.2 10 0.6
Switzerland 1 100 0.1 0 0 0 1 0.1
Taiwan 1 33.3 0.1 2 66.7 0.1 3 0.2
Thailand 0 0 0 1 100 0.1 1 0.1
Trinidad and Tobago 1 100 0.1 0 0 0 1 0.1
Turkey 0 0 0 1 100 0.1 1 0.1
United Arab Emirates 3 75 0.2 1 25 0.1 4 0.2
United Kingdom 123 86.6 6.9 19 13.5 1.1 142 8.0
United States 438 63.7 24.5 250 36.3 14 688 38.5
Venezuela 1 100 0.1 0 0 0 1 0.1
Viet Nam 1 100 0.1 0 0 0 1 0.1
Total 1,375 76.9 76.9 413 23.1 23.1 1,788 100.
Substance
Frequency Weeks taken Adverse effects
n% Median n%
Acetylcysteine* 1 0.2 40
Arches Tinnitus B12 Formula 1 0.2 .0
Arches Tinnitus Relief Formula 10 1.7 26
Arches Tinnitus Stress Formula 2 0.3 .0
Black cohosh 6 1.0 8
Cannabis* 1 0.2 2 1 2.8
Chinese herb* 1 0.2 26
Clarity2* 2 0.3 3
Clear Tinnitus 10 1.7 8 1 2.8
Coffee Cruda 1 0.2 8
Er ming zuo ci wan 3 0.5 2 1 2.8
Feverfew 1 0.2 100
Folate* 1 0.2 50
Ginkgo biloba 161 26.6 10 10 27.8
Coelho et al.: Effectiveness of Supplements on Tinnitus 201
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Appendix D ( p. 1 of 2)
Description of TreatmentsSources by Frequency (n) and Percentage (%).
Appendix C ( p. 2 of 2)
Frequency of Substance Use ( n), Period of Treatment (Weeks), and Related Adverse Effects
Substance
Frequency Weeks taken Adverse effects
n% Median n%
Graphite 1 0.2
Green tea* 1 0.2 24 1 2.8
Happy Camper* 1 0.2 1
Hawthorn 1 0.2 10
Herbal treatment* 1 0.2 64
Homeopathy* 2 0.3 5
Lemon 4 0.7 28
Lipoflavonoid 78 12.9 8 4 11.1
Lycopodium 1 0.2 8
Manganese 3 0.5 13.5
Magnesium 40 6.6 15 4 11.1
Melatonin 28 4.6 12 1 2.8
Natura 1 0.2 7
Pantothenic acid 2 0.3 12 1
Potassium 7 1.2 40
Pycnogenol 1 0.2 52
Qi ju di huang wan 2 0.3 2
Ring Relief 1 0.2 8
Ring Stop 18 3.0 6 4 11.1
Rose 1 0.2 .0
Rosemary 1 0.2 .0
Salicylicum acidum 2 0.3 .0
Sonarx 1 0.2 13
T-Gone 7 1.2 14
Tinniticil 1 0.2 24 1 2.8
Tinnitus Relief 9 1.5 5
Tryptophan* 1 0.2 10
Vitamin A 7 1.2 28
Vitamin B complex* 2 0.3 9
Vitamin B1 18 3.0 10
Vitamin B12 52 8.6 16 3 8.3
Vitamin B3* 2 0.3 7 2 5.6
Vitamin B6 20 3.3 21 1 2.8
Vitamin C 19 3.1 24 1 2.8
Vitamin E 14 2.3 38
Xiang sha liu jun zi tang* 1 0.2 6
Xiao Yao Sa* 1 0.2 12
Zinc 52 8.6 12
Total 605 100 12
Note. Asterisks (* ) are compounds that were not listed in the survey questions but which were added in open format by the responder.
Source n%
Acupuncturist 1 0.2
American Tinnitus Association 1 0.2
Audiologist 2 0.4
Chinese medicine practitioner 1 0.2
Friend 50 10.9
Internet 183 39.8
Nurse 4 0.9
Paper/magazine 53 11.5
Pharmacist 28 6.1
Pharmacy 6 1.3
Physician 88 19.1
Radio 2 0.4
Reading 12 2.6
202 American Journal of Audiology Vol. 25 184205 September 2016
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Appendix E
SubjectsImpression of Substances Effects on Tinnitus, Classified on a Rating Scale (0100)
Appendix D ( p. 2 of 2)
Description of TreatmentsSources by Frequency (n) and Percentage (%).
Source n%
Referral 1 0.2
Research abstract 3 0.7
Store 15 3.3
Television 8 1.7
TRI Newsletter 2 0.4
Total 460 100.
Substance
Effects on tinnitus
TotalNo effect Improved Worsened
n%n%n%n%
Acetylcysteine 1 100 0 0 0 0 1 100
Arches Tinnitus Relief Formula 1 33.3 1 33.3 1 33.3 3 100
Black cohosh 4 80.0 1 20.0 0 0 5 100
Cannabis 0 0 1 100 0 0 1 100
Chinese herb 0 0 1 100 0 0 1 100
Clarity2 2 100 0 0 0 0 2 100
Clear Tinnitus 5 71.4 2 28.6 0 0 7 100
Er ming zuo ci wan 1 50.0 1 50.0 0 0 2 100
Feverfew 1 100 0 0 0 0 1 100
Folate 1 100 0 0 0 0 1 100
Ginkgo biloba 78 69.0 28 24.8 7 6.2 113 100
Happy Camper natural supplement 1 100 0 0 0 0 1 100
Herbal treatment 1 100 0 0 0 0 1 100
Homeopathy 2 100 0 0 0 0 2 100
Lipoflavonoid 26 65.0 5 12.5 9 22.5 40 100
Lycopodium 1 100 0 0 0 0 1 100
Magnesium 16 88.9 1 5.6 1 5.6 18 100
Melatonin 10 76.9 2 15.4 1 7.7 13 100
Natura 1 100 0 0 0 0 1 100
Pantothenic acid 1 100 0 0 0 0 1 100
Potassium 0 0 0 0 1 100 1 100
Qi ju di huang wan 0 0 1 100 0 0 1 100
Ring Stop 6 85.7 1 14.3 0 0 7 100
Sonarx 1 100 0 0 0 0 1 100
T-Gone 4 80.0 1 20.0 0 0 5 100
Tinnitus Relief 2 100 0 0 0 0 2 100
Vitamin A 1 100 0 0 0 0 1 100
Vitamin B complex 1 100 0 0 0 0 1 100
Vitamin B1 2 40.0 1 20.0 2 40.0 5 100
Vitamin B12 15 71.4 3 14.3 3 14.3 21 100
Vitamin B3 2 100 0 0 0 0 2 100
Vitamin B6 3 60.0 1 20.0 1 20.0 5 100
Vitamin C 3 60.0 0 0 2 40.0 5 100
Vitamin E 4 100 0 0 0 0 4 100
Xiang sha liu jun zi tang 0 0 1 100 0 0 1 100
Zinc 15 65.2 5 21.7 3 13.0 23 100
Total 212 70.7 57 19.0 31 10.3 300 100
Note. For improvement and worsened scores rated 10, and for no effect, scores <10.
Coelho et al.: Effectiveness of Supplements on Tinnitus 203
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Appendix F
Treatment Effect of Substances of Tinnitus on Thoughts and Emotions Scores.
Appendix G
Treatment Effect of Substances on Tinnitus Sleep Scores (0100 Scale)
Substance
Tinnitus sleep scores scale
Paired
ttest, p
Wilcoxon
signed
ranks, pCohensd
Before treatment After treatment
nMSDMedian nMSDMedian
Clear Tinnitus 6 79.8 10.5 75 6 76.6 5.1 75 .363
Ginkgo biloba 77 53 29.4 50 75 51.4 30.4 50 .005 0.4697
Lipoflavonoid 31 58.6 29 50 31 53.9 29.8 50 .046 0.5244
Magnesium 15 64.6 26.8 60 15 56.4 28.5 50 .191
Melatonin 13 66.3 33.5 80 13 45.6 31.5 45 .008 1.228
Vitamin B1 4 58 42.9 56 4 55 45.9 55 .344
Vitamin B12 13 59.4 35.2 50 12 60.2 36.7 65 1.00
Zinc 13 57.6 28 52 13 55.5 25.2 52 .374
Note. Description of frequency (n), M,SD, and median before and after treatment, with paired statistical tests and Cohensdresults.
Substance
Tinnitus thoughts and emotions scores scale
Paired
ttest, p
Wilcoxon
signed
ranks, pCohensd
Before treatment After treatment
nMSDMedian nMSDMedian
Black cohosh 5 34.3 52 60 5 34 50 50 .374
Clear Tinnitus 8 27.1 73.1 80 8 33.9 63.1 60 .351
Er ming zuo ci wan 2 .0 30 30 2 3.5 27.5 27.5 .500
Ginkgo biloba 104 29.5 55.7 60 103 29.7 52.2 50 .0005 0.40
Lipoflavonoid 49 29.9 53.3 50 49 29.4 50.3 50 .027 0.457
Magnesium 24 25.3 62.5 65 24 26.4 59.8 55.5 .283
Melatonin 20 27.2 63.6 77.5 20 27.2 60 67.5 .027 0.6138
Ring Stop 8 28.1 53.7 45 7 32.5 53.4 40 .317
T-Gone 4 25 62.5 65 4 29.4 60 65 .391
Vitamin B12 29 29.2 60.6 70 28 28.7 60.5 70 .596
Vitamin B3 2 24.7 67.5 67.5 2 23.3 66.5 66.5 .500
Vitamin B6 7 30.8 64.2 70 7 32.5 62.1 70 .356
Vitamin C 8 27.5 69.3 75 8 27.4 69.2 75 .351
Vitamin E 9 36.6 62.8 70 9 37.6 51.7 50 .326
Zinc 28 27.3 57 50 28 27.1 56.2 50 .303
204 American Journal of Audiology Vol. 25 184205 September 2016
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Appendix H
Treatment Effect of Substances on Tinnitus Concentration Scores (0100 scale)
Appendix I
Country Distribution Among Nonusers and Users of Dietary and/or Herbal Supplements by Internet Protocol (IP)
Substance
Tinnitus concentration scores scale
Paired
ttest, p
Wilcoxon
signed
ranks, pCohensd
Before treatment After treatment
nMSDMedian nMSDMedian
Arches Tinnitus
Relief Formula 2 82.5 3.3 82.5 2 90 14.1 90 .500
Clear Tinnitus 6 64 30.2 72.5 6 55.6 33.3 60 .363
Ginkgo biloba 84 52.1 28.9 50 84 50.2 29.5 50 .021 0.3611
Lipoflavonoid 27 49.4 28.4 50 27 47.8 28.4 50 .593
Magnesium 14 52.4 25.6 45 14 49.5 23.2 45 .336
Melatonin 12 54.6 34.4 70 12 52.1 33.2 67.5 .102
T-Gone 4 33.7 41.1 15 4 38.7 40 25 .317
Vitamin B1 3 60 17.3 50 3 43.3 40.4 50 .317
Vitamin B12 17 60.1 35.4 80 16 57.6 35 75 1.0
Zinc 14 39.9 28.3 34 14 39.2 29.4 34 .423
Note. Description of frequency (n), M,SD, and median before and after treatment, with paired statistical tests and Cohensdresults.
Substance
Tinnitus hearing scores scale
Paired
ttest p
Wilcoxon
signed
ranks pCohensd
Before treatment After treatment
nMSDMedian nMSDMedian
Ginkgo biloba 76 46.6 27.4 40 76 44.2 27.2 35 .023 0.3758
Lipoflavonoid 32 49.6 28.6 50 32 49.6 28.6 50 1.0
Melatonin 9 55 23.1 65 9 54.4 24.7 65 .347
Vitamin B1 5 49 31.8 50 5 47.2 34.4 50 .374
Vitamin B12 10 61.5 26.4 70 10 62.5 27.4 70 .343
Zinc 15 43.8 27.9 30 15 43.8 27.8 30 1.0
Note. Description of frequency (n), M,SD, and median before and after treatment, with paired statistical tests and Cohensdresults.
Coelho et al.: Effectiveness of Supplements on Tinnitus 205
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... In contrast, despite the general lack of prescribing of GABA modulators for tinnitus patients, the number of studies of GABA and tinnitus are relatively large (Fig. 1). The large medical need combined with the lack of therapies that are reliable and produce significant changes in the number and severity of symptoms has given rise to internet sales of non-FDA-approved treatments [11]. Some of these products might not be any more efficacious or safer than those suggested 140 years ago: "A fluid drachm of the compound tincture of gentian every four hours in a wineglassful of water is an elegant preparation, which, perhaps, answers the purpose best. ...
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Background: Several tinnitus sufferers suggest that manganese has been helpful with their tinnitus. Purpose: We tested this in a controlled experiment where participants were committed to taking manganese and Lipoflavonoid Plus(®) to treat their tinnitus. Research design: Randomized controlled trial. Study sample: 40 participants were randomized to receive both manganese and Lipoflavonoid Plus(®) for 6 months, or Lipoflavonoid Plus(®) only (as the control). Data collection and analysis: Pre- and postmeasures were obtained with the Tinnitus Handicap Questionnaire, Tinnitus Primary Functions Questionnaire, and tinnitus loudness and annoyance ratings. An audiologist performed the audiogram, the tinnitus loudness match, and minimal masking level. Results: Twelve participants were dropped out of the study because of the side effects or were lost to follow-up. In the manganese group, 1 participant (out of 12) showed a decrease in the questionnaires, and another showed a decrease in the loudness and annoyance ratings. No participants from the control group (total 16) showed a decrease in the questionnaires ratings. Two participants in the control group reported a loudness decrement and one reported an annoyance decrement. Conclusions: We were not able to conclude that either manganese or Lipoflavonoid Plus(®) is an effective treatment for tinnitus.
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Purpose: Hyperacusis can be extremely debilitating, and at present, there is no cure. We provide an overview of the field, and possible related areas, in the hope of facilitating future research. Method: We review and reference literature on hyperacusis and related areas. We have divided the review into 2 articles. In Part I, we discuss definitions, epidemiology, different etiologies and subgroups, and how hyperacusis affects people. In Part II, we review measurements, models, mechanisms, and treatments, and we finish with some suggestions for further research. Results: Hyperacusis encompasses a wide range of reactions to sound, which can be grouped into the categories of excessive loudness, annoyance, fear, and pain. Many different causes have been proposed, and it will be important to appreciate and quantify different subgroups. Reasonable approaches to assessing the different forms of hyperacusis are emerging, including psychoacoustical measures, questionnaires, and brain imaging. Conclusions: Hyperacusis can make life difficult for many, forcing sufferers to dramatically alter their work and social habits. We believe this is an opportune time to explore approaches to better understand and treat hyperacusis.