Tinnitus, Subjective Clinical Trial
Official title:
Akasaray University
Objective: This study aimed to investigate the effect, onset and duration of action, and
short-term outcomes of acupuncture therapy in the treatment of patients with severe chronic
subjective tinnitus.
Methods: This study is a randomized, controlled trial evaluating patients with chronic,
idiopathic and severe tinnitus. A total of 105 participants were divided into two groups
using the randomization method: the study group that received real acupuncture therapy (n =
53) and the sham acupuncture group. Ten acupuncture sessions were applied over five weeks.
After treatment, each participant was monitored for up to three months according to the
changes in the Visual Analog Scale (VAS), Tinnitus Handicap Inventory (THI), Pure-Tone
Audiometry and Speech Discrimination scores.
This was a prospective, randomized, controlled study, approved by the local ethics committee
and carried out in a single center in accordance with the ethical principles of the Helsinki
Declaration (E-18-2165).
The inclusion criteria of the study for patients were determined as; (a) male and female
patients aged 18 to 60 years, (b) unilateral or bilateral subjective tinnitus, (c) with a
history of severe subjective tinnitus for at least one year, (d) patients with severe
tinnitus according to the THI questionnaire result (over 38 points), (e) the patients who
could not detect etiology of tinnitus in the otolaryngology examination, (f) not having
received any treatment within the last six months. The patients who applied to the
otorhinolaryngology clinic of our hospital were included in the study.
According to the randomization method, the group to which each participant was assigned was
only known to the researcher who applied acupuncture therapy. The participants and the
remaining researchers that administered THI to the participants were blinded to the groups.
The data were obtained from the patients' responses to VAS and THI questionnaires. Each
participant completed the VAS and THI questionnaires seven times during the course of the
five-week treatment and the three-month follow-up after treatment.
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