Background:
There is no effective treatment for idiopathic tinnitus. Both acoustic therapy and acupuncture have been used in the treatment of idiopathic tinnitus, but the clinical efficacy is quite different. For there is no clinical study combining the 2, the purpose of this randomized controlled trial is to evaluate the effectiveness and safety of acoustic therapy combined with acupuncture in the treatment of idiopathic tinnitus.
Methods:
This is a prospective randomized controlled trial to study the effectiveness and safety of acoustic therapy combined with acupuncture in the treatment of idiopathic tinnitus, and is approved by the clinical research ethics committee of our hospital. The patients are randomly divided into one of 2 treatment options: (A) acoustic therapy combined with acupuncture group and (B) simple acupuncture group. Patients, doctors, nurses, and data collection assistants are blinded to group allocation. Observation indicators include:
Data is analyzed using the statistical software package SPSS version 25.0 (Chicago, IL).
Discussion:
This protocol will evaluate the efficacy and safety of acoustic therapy combined with acupuncture in the treatment of idiopathic tinnitus. The results of this experiment will provide clinical evidence for the use of acoustic therapy combined with acupuncture in the treatment of idiopathic tinnitus.
Trial registration:
This study protocol is registered in
Ethics and dissemination:
Private information from individuals will not be published. This systematic review also does not involve endangering participant rights. Ethical approval was not required.
OSF Registration number:
DOI 10.17605/OSF.IO/87VFB.
Objectives To explore the long-term efficacy and possible
mechanism of endolymphatic sac decompression (ESD) in the treatment of
Meniere’s disease(MD) by electrocochleography. Design Prospective cohort
study. Setting “Blinded for review” Participants A total of 85
patients with MD who underwent unilateral ESD between June 2015 and
November 2019 at“Blinded for review”were enrolled. Main outcome
measures The Dizziness Handicap Inventory (DHI), Tinnitus Handicap
Inventory (THI), pure tone audiometry, and electrocochleography were
used for assessment. The mean follow-up time was 26 months (range: 7–60
months). Results The number of vertigo episodes was significantly
reduced following ESD compared to before the surgery
(P<0.005), and all patients achieved complete or basic control
of vertigo as evidenced by a decrease in DHI score (P<0.005).
THI scores of patients with tinnitus were also lower after as compared
to before ESD (P<0.005), whereas no significant change in
average hearing threshold of the affected side was observed
(P>0.05). The cochlear summating potential (SP)/auditory
nerve action potential (AP) area ratio in the electrocochleogram of the
affected side was negatively correlated with DHI score (rs=−0.159,
P=0.0074). Conclusions ESD achieved effective long-term control of
vertigo in MD patients and improved the associated tinnitus without any
obvious damage to hearing. Electrocochleography was useful for
postoperative monitoring; the SP/AP area ratio of the affected side was
closely related to the improvement of postoperative vertigo, possibly
reflecting greater relief of pressure in the endolymphatic sac.
Keypoints •ESD provided long-term control of vertigo in MD patients and
improved the accompanying tinnitus without obviously damaging hearing.
•ECochG is useful for monitoring the postoperative outcome of ESD. •The
SP/AP area ratio of the affected side was closely related to the
improvement of postoperative vertigo. •The endolymphatic sac is a
“decompression reservoir” of the membranous labyrinth. •ESD may
provide space for expansion of the endolymphatic sac and relieve
pressure within the membranous labyrinth caused by endolymphatic
hydrops, thereby reducing the risk of sac rupture and restoring pressure
balance to reduce the sensation of vertigo.
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