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. 2018 Jul 4;19(1):356.
doi: 10.1186/s13063-018-2737-x.

Acupuncture as an early treatment for idiopathic sudden sensorineural hearing loss (ISSNHL) patients with flat or high-frequency drop audiograms: study protocol for a randomized controlled trial

Kai Shang  1 , Xin Ma  2 , Hui-Lin Liu  3 , Yuan-Yuan Jing  2 , Lin Zeng  4 , Nan Li  4 , De-An Zhou  1 , Jia Wei  1 , Chen Zhang  1
Affiliations

Acupuncture as an early treatment for idiopathic sudden sensorineural hearing loss (ISSNHL) patients with flat or high-frequency drop audiograms: study protocol for a randomized controlled trial

Kai Shang et al. Trials. .

Abstract

Background: Idiopathic sudden sensorineural hearing loss (ISSNHL) is a common form of deafness. Acupuncture has been used as a salvage therapy for ISSNHL in China since 200 BCE. However, the efficacy of acupuncture has not been confirmed in strictly controlled trials. We designed a randomized controlled clinical trial to evaluate the efficacy and long-term effects of acupuncture in patients with early ISSNHL.

Methods/design: In this randomized controlled clinical trial, we will enroll 124 participants with ISSNHL diagnosed 2 to 4 weeks prior to enrollment, who have shown little hearing improvement after routine Western medical treatment (i.e., corticosteroids). 62 of these participants will have flat audiogram and the other 62 will have a high-frequency drop audiogram; they will all take Methycobal while half of the flat type and half of the high-frequency drop type will also receive acupuncture treatments for 4 weeks in a four-group design. The primary outcome measure will be the effective rate of hearing improvement (defined as the proportion of patients with at least 15-dB improvement in the hearing loss frequency band). The secondary outcome will measure the improvements in Pure Tone Average, Word Recognition Score, and Tinnitus Handicap Inventory. The assessments of the participants will be made at baseline, after treatment (week 4), and at follow-up (week 28).

Discussion: This study aims to explore the efficacy and long-term effects of acupuncture in patients with ISSNHL. This study will be a randomized controlled trial with strict methodology and few design deficits. If our study yields positive results, acupuncture could be recommended as a salvage therapy for patients with ISSNHL.

Trial registration: Chinese Clinical Trial Registry, ChiCTR-ICR-15006787 . Registered on 12 July 2015.

Keywords: Acupuncture; Flat; High frequency; ISSNHL; Randomized controlled trial; Study protocol.

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Conflict of interest statement

Ethics approval and consent to participate

This protocol has been approved by the Medical Ethical Committee of the Beijing Traditional Chinese Medicine Hospital Affiliated with Capital Medical University. The permission number is 2014BL-063-02. Informed consent will be obtained from all participants in the trial.

Consent for publication

All authors and investigators give their consent for publication.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Trial flow chart. Abbreviation: THI Tinnitus Handicap Inventory
Fig. 2
Fig. 2
Chart of trial processes. **refers to “Specific timepoints in this study”
See this image and copyright information in PMC

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