Acupuncture at local and distant points for tinnitus: study protocol for a randomized controlled trial

Trials, Nov 2012

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

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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)


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Guang-Xia Shi, Li-Li Han, Li-Ying Liu, Qian-Qian Li, Cun-Zhi Liu, Lin-Peng Wang. Acupuncture at local and distant points for tinnitus: study protocol for a randomized controlled trial, Trials, 2012, pp. 224, 13, DOI: 10.1186/1745-6215-13-224