Acupuncture at local and distant points for tinnitus: study protocol for a randomized controlled trial
Trials
Acupuncture at local and distant points for tinnitus: study protocol for a randomized controlled trial
Guang-Xia Shi 0
Li-Li Han 0
Li-Ying Liu 0
Qian-Qian Li 0
Cun-Zhi Liu 0
Lin-Peng Wang 0
0 Acupuncture and Moxibustion Department, Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University , 23 Meishuguanhou Street, Dongcheng District, Beijing 100010 , China
Background: Tinnitus is the perception of a sound in the absence of an objective physical source. Up to now, there is no generally accepted view how these phantom sounds come about, and also no efficient treatment. Patients are turning to complementary or alternative medical therapies, such as acupuncture. Based on the theory of traditional Chinese medicine, acupoints located on both the adjacent and distal area of the disease can be needled to treat disease. Furthermore, the way of combining acupoints is for strengthening the curative effect. We aim to evaluate the efficacy of acupuncture at local points in combination with distal points in subjective tinnitus patients. Method: This trial is a randomized, single-blind, controlled study. A total of 112 participants will be randomly assigned to one of four treatment groups receiving acupuncture treatment for 4 weeks. The primary outcome measure is subjective tinnitus loudness and annoyance perception, which is graded using the Visual Analogue Scale (VAS). The assessment is at baseline (before treatment initiation), 4 weeks after the first acupuncture session, and 8 weeks after the first acupuncture session. Discussion: Completion of this trial will help to identify whether acupuncture at local acupoints in combination with distal acupoints may be more effective than needling points separately. Trial registration: International Standard Randomized Controlled Trial Number Register: ISRCTN29230777
Background
Tinnitus
Subjective tinnitus is a frequent auditory sensation (for
example, a tone, hissing, or buzzing sound, and
sometimes combinations of such perceptions) experienced in
the absence of an external or internal acoustic stimulus.
An estimated prevalence in the adult population across
studies is about 10% to 15% [
1-3
], where 1% to 3% of the
population has severe, distressing tinnitus. Among
severe sufferers, tinnitus causes disability associated with
concentration deficits, hypersensitivity to sounds,
anxiety, depression, irritability, agitation, and insomnia.
Often a combination of several complaints could disrupt
daily activities and has a negative impact on quality of
life. It represents a worldwide major healthcare problem
with an enormous social and economic demand for
therapeutic treatment [
4,5
]. Pharmacotherapy
(antidepressants, benzodiazepines), cognitive therapies, or
electronic devices that try to cancel the tinnitus have all
been tried either separately or in combination but the
success rate is not high. Attempts to develop
evidencebased therapies have been thwarted by a poor
understanding of the pathophysiology [
6,7
]. Increasingly,
patients are turning to complementary and alternative
medical therapies. Acupuncture is among the most
popular.
Acupuncture
Acupuncture has been used to treat tinnitus for a long
time. Neuroscience studies related the effects of
acupuncture to neuronal stimulus, activation of endogenous
opioid mechanisms and neuropeptides which stimulate
specific brain structures [
8
]. It has been reported that
acupuncture can yield immediate relief, both from the
loudness and the disturbing quality of tinnitus,
significant improvement in quality of life, less tension, and
better sleep [
9-12
]. In contrast, an analysis of six
randomized clinical trials of acupuncture for tinnitus
failed to demonstrate any efficacy [13]. Based on the
theory of traditional Chinese medicine (TCM),
acupoints located on both the adjacent and distal area of
the disease can be needled to treat disease.
Furthermore, the way of combining these acupoints is often
used for strengthening the curative effect.
Aims
The aim of our study is to evaluate the efficacy of
acupuncture at local points in combination with distal
points in subjective tinnitus patients.
Methods
We perform the study according to common guidelines
for clinical trials (Declaration of Helsinki, International
Conference on Harmonisation (ICH)/WHO Good
Clinical Practice standards (GCP) including certification by
an external audit). The trial protocol has been approved
by the Research Ethical Committee of Beijing Hospital
of Traditional Chinese Medicine Affiliated to Capital
Medical University. This trial was registered with ISR
CTN at Current Controlled Trials (ISRCTN29230777).
Population
Patients will be recruited in acupuncture clinic, Beijing
Hospital of Traditional Chinese Medicine affiliated to
Capital Medical University with a target sample size of
112 subjects. The trial is executed from February 2012
to December 2014.
Inclusion criteria
Patients who require for all (...truncated)