MEDICAL ACUPUNCTURE

Volume 00, Number 0, 2020

# Mary Ann Liebert, Inc.
DOI: 10.1089/acu.2019.1367

Acupuncture Treatment in Patients with Chronic Subjective

Tinnitus: A Prospective, Randomized Study

Ihsan Kuzucu, MD,1,2 and Onur Karaca, MD2,3

ABSTRACT
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Objective: This study investigated the effect, onset, duration of action, and short-term outcomes of acupuncture
therapy for treating patients with severe chronic subjective tinnitus.
Materials and Methods: This randomized controlled trial evaluated patients with chronic, idiopathic, and
severe tinnitus. A total of 105 participants were divided into 2 groups using a randomization method: a study
group who received verum acupuncture therapy (n = 53) and a sham acupuncture group (n = 52). Ten acu-
puncture sessions were given over 5 weeks. After treatment, each participant was monitored for up to 3 months
according to changes on a visual analogue Scale (VAS), and Tinnitus Handicap Inventory (THI), and Pure-
Tone Audiometry and Speech Discrimination (Interacoustics AC-40, Denmark) scores.
Results: The VAS and THI scores were evaluated. A statistically significant difference was noted between the
sham and verum acupuncture groups at post-treatment follow-up (P < 0.001). Decreases in the THI and VAS
scores became significant in the second week of treatment (P < 0.001 and P < 0.001, respectively), but these
scores increased again in the third month post-treatment (P < 0.001 and P < 0.001, respectively).
Conclusions: Acupuncture is an effective treatment for patients with severe chronic subjective tinnitus. Patient
complaints, decreased beginning at the second treatment week; however, in the third post-treatment month, the
complaints reappeared. Maintenance acupuncture therapy is necessary for patients with tinnitus; this approach
should be investigated in future studies.

Keywords: complementary and alternative medicine, neurologic disorders, peripheral neuropathy, sham, otology

INTRODUCTION yet known fully. The sound perceived without an external

stimulus is considered to be caused by abnormal neural ac-

T innitus is a common symptom encountered in oto-

laryngology practice; this symptom has a mechanism
that has not yet been elucidated fully.1 Tinnitus is often
tivity along the hearing path from the cochlear apparatus to
the auditory cortex.6
Complementary and alternative medicine treatments are
defined as the perception of sound without an external often used to treat tinnitus, and one of the most frequently
acoustic stimulus. It is seen in *1% of adults, of whom 5%– used options is acupuncture.7 Acupuncture therapy in pa-
15% are reported to have persistent symptoms that do not tients who have tinnitus has been described extensively in
respond to treatment.2 In addition, 1%–3% of the tinnitus books8; however, scientific literature still lacks studies that
population has mental stress, sleep disturbances, and re- support its therapeutic efficacy. Research has shown that
duced work efficiency.3–5 Although many hypotheses have stimulation with needles promotes an electrical conduction
been proposed for tinnitus’ etiology, the mechanism is not that triggers action potentials to rebalance the body’s
1
Department of Otorhinolaryngology, Aksaray University, Aksaray, Turkey.
2
Ankara Numune Training and Research Hospital, Ankara, Turkey.
3
Department of Anesthesiology, Aksaray University, Aksaray, Turkey.

1
 2 KUZUCU AND KARACA

system,8 but the effect of this stimulation on tinnitus re- divided into 2 groups as follows: Participants were ran-
mains unclear. In a literature review, 36 publications on this domly assigned to either a manipulation or a non-
subject were analyzed, but only 6 of them were randomized manipulation group, with an assignment ratio of 1:1
controlled trials.9 The authors of the systematic review according to the random number of an allocation sequence
noted that the points where acupuncture was applied were generated by a computer (using SPSS 21.0 statistical soft-
heterogeneous and that the results were controversial. In ware package, IBM, Chicago, IL). The first group was
addition, it was noted that most studies reporting recovery comprised of patients who received verum manual acu-
after treatment had not followed the patients after treatment. puncture, and the second group, served as a control group
Therefore, it is necessary to conduct further studies de- who received sham acupuncture.
signed according to the highest methodological standards. According to the randomization method, the group to
The goal of this study was to investigate the efficacy of which each participant was assigned was only known to the
acupuncture therapy in patients with severe, chronic sub- researcher who applied the acupuncture. The participants
jective tinnitus, determine the onset of treatment, and report and the remaining researchers who administered the THI to
the short-term follow-up results of acupuncture as a treat- the participants were blinded to the group assignments.
ment for tinnitus. The data were obtained from the patients’ responses to
the VAS and THI. Each participant completed the VAS and
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THI questionnaires 7 times during the course of the 5-week

treatment and the 3-month follow-up after treatment.
MATERIALS AND METHODS During the acupuncture therapy, the patients were also
examined in terms of possible complications related to
This was a prospective, randomized controlled study, acupuncture, such as infections, nervous system damage,
approved by the local ethics committee (ethics committee of and heart damage. Patients who developed any of these
Ankara Numune Training and Research Hospital, Ankara, complications were excluded from the study.
Turkey) and carried out in a single center in accordance
with the ethical principles of the Helsinki Declaration
(ethics committee no: E-18-2165; registration number Intervention
and name of trial registry: NCT04127708/aksarayUTRH; The acupuncture style used was the Traditional Chinese
tinnitusacupuncture). Medicine model. Acupuncture was performed on 11 acu-
The inclusion criteria of the study for patients were de- puncture points (TE 21, SI 19, GB 2, TE 22, ST 7, TE 17,
termined as: and GB 20 of the affected side, and GB 20, TE 5, KI 3 of
(1) Male or female, ages 18–60 both sides), using sterile, single-use, 0.25 mm thick, 40-mm
(2) Unilateral or bilateral subjective tinnitus long needles (Dongbang Medical Co., Boryeong, Korea).
(3) History of severe subjective tinnitus for at least 1 year The acupuncture points were selected according to a pre-
(4) Severe tinnitus according to the Tinnitus Handicap vious study as a reference.2 The depth of the needle differed
Inventory (THI) questionnaire (more than 38 points)
(5) undetectable etiology of tinnitus in an otolaryngology Table 1. Pretreatment Characteristics
examination of the Participants
(6) No treatment received within the last 6 months.
Verum Sham
Patients who applied to the otorhinolaryngology clinic of acupuncture acupuncture
the Ankara Numune Training and Research Hospital and group group
who fit the criteria were included in the study. The THI and Characteristics (n = 53) (n = 52) P
a visual analogue scale (VAS) were administered to the
Age (yrs – SD) 50.70 – 9.96 47.63 – 11.35 0.144
patients. Severity of each patient’s tinnitus was determined Gender, (n %)
by the THI questionnaire. Female 34 (%64) 35 (%67) 0.289
Exclusion criteria were having: received acupuncture Male 19 (%36) 17 (%33)
therapy during the last 3 months for any reason; a history of Hearing, (n %)
medication/surgery due to heart disease; a disease that could Bilateral loss 43 (%81) 44 (%84)
cause objective tinnitus (such as Meniere’s syndrome, otitis No loss 10 (%19) 8 (%16)
media, and otosclerosis); metal allergy or needle phobia; Hearing loss grade, (n %)
and/or psychotropic drug use. Pregnancy or nursing and not Normal with decrease 15 (%28) 16 (%31)
completing the THI survey were also reasons for exclusion. Mild 12 (%23) 12 (%23)
Moderate 13 (%25) 14 (%27)
A researcher evaluated the patients meeting the sample
Severe 3 (%1) 2 (%1)
criteria, informed them, and received their written consents.
The patients who agreed to participate in the study were yrs, years; SD, standard deviation.
 TINNITUS AND ACUPUNCTURE TREATMENT 3

Table 2. Intergroup and Intragroup Comparisons of THI and VAS scores During Treatment Evaluation Sessions

Verum acupuncture group Sham acupuncture group

(n:53) (n:52)

THI VAS THI VAS

Time (Mean – SD) (Mean – SD) (Mean – SD) (Mean – SD) p** p***

T1 61.11 – 12.70 7.26 – 0.98 59.25 – 13.10 6.98 – 1.12 0.461 0.174
T2 47.92 – 13.65 4.92 – 1.17 52.38 – 14.19 6.02 – 1.83 0.104 < 0.001
T3 35.92 – 15.27 2.41 – 1.09 56.52 – 12.08 6.27 – 1.56 < 0.001 < 0.001
T4 33.85 – 14.93 2.20 – 1.09 56.37 – 12.20 6.39 – 1.43 < 0.001 < 0.001
T5 32.30 – 15.40 2.16 – 1.12 57.87 – 13.12 6.19 – 1.57 < 0.001 < 0.001
T6 30.83 – 15.90 2.06 – 1.09 59.01 – 13.35 6.75 – 1.19 < 0.001 < 0.001
T7 40.26 – 16.56 3.66 – 1.38 60.71 – 13.90 6.84 – 1.18 < 0.001 < 0.001
P* < 0.001 < 0.001 0.090 0.078
Times: T1, Pretreatment; T2, treatment 1st week; T3, treatment 2nd week; T4, treatment 3rd week; T5, treatment 4th week; T6, treatment 5th week; T7,
Post-treatment 3rd month.
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P*, repeated measurements analysis of variance; P**, Mann–Whitney-U test (THI); P***, Mann–Whitney-U test (VAS). Significant results are shown
in bold.
THI, Tinnitus Handicap Inventory; VAS, visual analogue scale; SD, standard deviation.

depending on the anatomical structure of the participant and Pure-Tone Audiometry and Speech
the nature of the acupuncture points, but was *5–10 mm. Discrimination
The acupuncture needles were applied until the participant
A Pure-Tone Audiometry (PTA) and Speech Dis-
experienced De Qi and removed after 20 minutes.
crimination test (Interacoustics AC-40, Denmark) was per-
Acupuncture therapy was performed twice per week for 5
formed at the first, sixth, and seventh visits by the same
weeks, for a total of 10 sessions. The acupuncture treatment
clinical audiometrist.
was conducted by an expert who was supervised by other
researchers. None of the participants withdrew from the
planned tinnitus treatment program during the study. Statistical Analysis
In the control group (sham acupuncture), false needles
were used and no stimulation was applied. These needles The data were analyzed descriptively and analytically. As
were harmless to the skin. the assumption of normality was not met, the data were
The patients were given acupuncture therapy by an acu- shown as median and its quartiles (first–third). The cate-
puncturist with an acupuncture certificate and 5 years of gorical variables were obtained as absolute and relative
acupuncture experience. frequencies.
The Shapiro–Wilk test was used to check the normality of
the data. Mann–Whitney-U and Wilcoxon tests were used
Visual Analogue Scale for nonparametric variables. Student’s t-test and a paired
samples t-test were used for parametric variables. All results
This scale was administered verbally to determine the
degree of discomfort caused by tinnitus for the patients. The
scores ranged from 0, indicating no discomfort, to 10, in-
dicating unbearable discomfort.

Tinnitus Handicap Inventory

The THI is a survey of 25 items with scoring based on 3
options: yes (4 points); sometimes (2 points); and no (0
points). The total THI score indicates the degree of tinnitus,
classified as grade 1 (0–16 points), grade 2 (18–36 points),
grade 3 (38–56 points), grade 4 (58–76 points), or grade 5
(78–100 points). Patients with grades 3, 4, or 5 per the THI
score were considered as having severe tinnitus and were FIG. 1. Intergroup comparison of the visual analogue scale
included in the study. (VAS) scores during the treatment evaluation sessions.
 4 KUZUCU AND KARACA

group’s pre- and post-treatment scores were compared, and

the group’s post-treatment scores were significantly decreased
(P < 0.001). In this group, there was a significant difference
between baseline VAS scores and VAS scores obtained im-
mediately after treatment and at the 12th week post-treatment
(P < 0.001; Table 2). In both groups, the data showed an al-
most 50% reduction in tinnitus intensity when comparing
pretreatment and post-treatment scores (Table 2; Fig. 1).
The THI score, which was the secondary outcome, re-
presented improvement in the patients’ quality of life. When
the sham acupuncture and verum acupuncture groups were
compared in terms of THI, the verum acupuncture group was
found to have statistically significant improvement after the
FIG. 2. Intergroup comparison of Tinnitus Handicap Inventory
(THI) scores during the treatment evaluation sessions. 2nd week of treatment (P < 0.001). A detailed comparison of
the groups in terms of THI is given in Table-2. Within the
verum acupuncture group, there was a statistically significant
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were analyzed with the intention-to-treat technique, using difference between pretreatment and post-treatment THI
SPSS software version 21.0. Statistical significance was set scores (p < 0.001; Table 2). According to the THI scores, the
at 5% (P £ 0.05). severity of tinnitus in the verum acupuncture group decreased
Given that there were 52 and 53 patients in the control from grade 4 at baseline to grade 2 after treatment. In the shame
and study groups, respectively, the power of this study was acupuncture group, the THI values did not differ statistically
0.95044 (95%). significantly before and after treatment (P = 0.090; Table 2).
There was no statistically significant difference between the 2
groups concerning baseline THI scores (P = 0.461). However,
when the two groups were compared in terms of post-treatment
RESULTS THI scores, the results in favor of the verum acupuncture group
were statistically significant (P < 0.001; Table 2; Fig. 2).
A total of 179 subjects with chronic severe subjective Evaluation of the third outcome (i.e., PTA and Speech
tinnitus were initially evaluated. After applying the relevant
Discrimination values) revealed no statistically significant
criteria, 70 patients (39.1%) were excluded from the study.
difference within the verum acupuncture group before and
Of the remaining 109 participants (60.9%), 105 (92%)
after treatment (P = 0.159 and P = 0.176, respectively; Ta-
completed the study. The descriptive characteristics of the ble 3). Similarly, the pretreatment PTA and Speech Dis-
sample are shown in Table 1.The verum acupuncture group crimination values did not significantly differ between the
consisted of 53 participants, 19 males and 34 females, with a verum and sham acupuncture groups (P = 0.805; P = 0.519,
mean age of 50.70 – 9.96 years. In the control (sham acu- respectively; Table 3).
puncture) group, there were 52 participants, 17 males and 35
females, with a mean age of 47.63 – 11.35 years.
When VAS score was evaluated as the primary outcome,
a statistically significant difference was observed between DISCUSSION
the control group and the verum acupuncture group in the
post-treatment follow-up (P < 0.001). This follow-up by Ten sessions of acupuncture therapy were applied to pa-
weeks is given in detail in Table-2. The verum acupuncture tients with severe chronic subjective tinnitus over 5 weeks,

Table 3. Intergroup and Intragroup Comparison of PTA and Speech Discrimination Scores

Verum acupuncture group Sham acupuncture group

(n = 53) (n = 52)

PTA Speech discrimination PTA Speech discrimination

(Mean – SD) (Mean – SD) (Mean – SD) (Mean – SD) p** p***

T1 31.47 – 20.53 80.86 – 15.52 30.25 – 21.72 81.11 – 15.60 0.768 0.935
T7 31.03 – 19.99 81.47 – 15.66 30.03 – 21.15 79.54 – 14.94 0.805 0.519
p* 0.159 0.176 0.129 0.615
Times: T1, pretreatment; T7, post-treatment 3rd month.
P*, repeated measurements analysis of variance; P**, Mann–Whitney-U test (PTA); P***, Mann–Whitney-U test (Speech Discrimination).
PTA, Pure Tone Audiometry (Interacoustics AC-40, Denmark); SD, standard deviation.
 TINNITUS AND ACUPUNCTURE TREATMENT 5

and the patients were followed up for 3 months after treatment. FUNDING INFORMATION
The THI and VAS scores were significantly lower in the group
who received verum acupuncture compared to the group who No funding was provided for this research.
received sham acupuncture. However, the THI and VAS
scores began to increase again at the third follow-up month.
One of the parameters commonly used in studies to monitor REFERENCES
the severity of tinnitus is VAS score. In a previous study, VAS
score was reported to decrease from 9.56 to 2.88 in tinnitus 1. Deniz M, Bayazıt YA, Celenk F, et al. Significance of sero-
patients who underwent acupuncture therapy.10 In another tonin transporter gene polymorphism in tinnitus. Otol Neu-
study, the mean pretreatment VAS score was 8, which was rotol. 2010;31(1):19–24.
reduced to 4 after treatment.8 Similarly, in the current study, the 2. Moon YK, Kim MH, Nam HJ. Comparison of the effective-
ness between [sic] transcutaneous electrical nerve stimula-
mean post-treatment VAS score of the study group was sta-
tion, manual acupuncture, and electroacupuncture on tinnitus:
tistically significantly reduced compared to the baseline value.
Study protocol for a randomized controlled trial. Trials. 2018;
Another parameter used to determine the severity of tin- 27;19(1):342.
nitus complaints is theTHI.2,5,8 THI score has also been 3. Canals P, Pérez Del Valle B, Lopez F, Marco A. The efficacy of
evaluated in studies investigating the effectiveness of acu- individual treatment of subjective tinnitus with cognitive behav-
Downloaded by Queen Mary & Westfield Coll from www.liebertpub.com at 01/12/20. For personal use only.

puncture therapy.2,8 For example, in a randomized controlled ioral therapy. Acta Otorinolaringol Esp. 2016;67(4):187–192.
study by Laureano et al., the efficacy of acupuncture therapy 4. Park SN, Bae SC, Kim DK, Park YS, Yeo SW, Park SY.
for patients with tinnitus was compared based on the THI Small-group counseling in a modified tinnitus retraining
scores of treated and untreated groups, and a statistically therapy for chronic tinnitus. Clin Exp Otorhinolaryngol.
significant decrease was observed after treatment compared to 2013;6(4):214–218.
the baseline values.11 In another study including 50 patients 5. Kim SH, Byun JY, Yeo SG, Park MS. Tinnitus retraining
therapy in unilateral tinnitus patients with single side deaf-
with tinnitus,8 the severity of the disease was monitored using
ness. J Int Adv Otol. 2016;12(1):72–76.
the THI. The authors of that study reported that the THI score
6. Ulusoy B, Bozdemir K, Akyol M, Mis xe HI, Kutluhan A,
of the acupuncture group was reduced from 56 at baseline to Korkmaz MH. Investigation of neutrophil-to-lymphocyte ra-
28 after treatment.8 Similarly, in the verum acupuncture tio, platelet-to-lymphocyte ratio and mean platelet volume in
group of the current study, the mean THI score before treat- patients with tinnitus. J Laryngol Otol. 2018;132(2):129–132.
ment was 61, which was decreased to 30 after treatment. 7. Kim JI, Choi JY, Lee DH, Choi TY, Lee MS, Ernst E.
Unlike other studies in the literature, the THI measure was Acupuncture for the treatment of tinnitus: A systematic re-
also utilized to determine the onset of action of acupuncture; view of randomized clinical trials. BMC Complement Altern
the decrease in the THI score became significant in the second Med. 2012;12:97.
week of treatment. Increases in THI scores were also detected 8. Doi MY, Tano SS, Schultz AR, Borges R, Marchiori LL.
at the third follow-up month after treatment. Thus, acupunc- Effectiveness of acupuncture therapy as treatment for tinnitus:
A randomized controlled trial. Braz J Otorhinolaryngol.
ture therapy was an effective treatment for tinnitus, but the
2016;82(4):458–465.
effect appeared to be temporary, diminishing over time.
9. Park J, White AR, Ernst E. Efficacy of acupuncture as a
treatment for tinnitus: A systematic review. Arch Otolaryngol
Head Neck Surg. 2000;126(4):489–492.
CONCLUSIONS 10. Naderinabi B, Soltanipour S, Nemati S, Saberi A, Parastesh S.
Acupuncture for chronic nonpulsatile tinnitus: A randomized
Based on the results of this study, verum acupuncture is clinical trial. Caspian J Intern Med. 2018;9(1):38–45.
an effective treatment, compared to sham acupuncture for 11. Laureano MR, Onishi ET, Bressan RA, et al. The effective-
treating severe chronic subjective tinnitus. However, despite ness of acupuncture as a treatment for tinnitus: A randomized
the significant benefits of this acupuncture therapy, the pa- controlled trial using (99m)Tc-ECD SPECT. Eur Radiol.
tients’ tinnitus symptoms began to increase again at 3 2016;26(9):3234–3242.
months after treatment. Therefore, in future studies, the
Address correspondence to:
current authors recommend that maintenance acupuncture
Ihsan Kuzucu, MD
sessions be added to the 5-week acupuncture therapy for
Department of Otorhinolaryngology
patients with tinnitus to investigate the effectiveness of this
Aksaray University
treatment over a long-term follow-up.
Yukarı Öveçler Mahallesi
1238 Street, 8/11 Gül Apartment
Aksaray 68100
AUTHOR DISCLOSURE STATEMENT
Turkey
No financial conflicts of interest exist. E-mail: [email protected]