An healthy lifestyle consultant based on Traditional Chinese medicine versus routine patient education in the treatment of idiopathic sudden sensorineural hearing loss after failure of systemic therapy: Study protocol for a clinical randomized trial with a paired design

Abstract Background: Idiopathic sudden sensorineural hearing loss (ISSNHL) is an important cause of deafness. Despite advances of systemic therapy, some ISSNHL patients remains ineffective since the exact etiology for SSNHL is still unclear. Traditional Chinese medicine (TCM) has been used for treating disease for thousands of years. It is popular and widely practiced in Asia. TCM contains guidance on people's healthy lifestyle. In recent decades, the relationship between lifestyle and disease has been emphasized and unhealthy lifestyle may lead to illness. Thus, this study aims to compare the efficacy of the lifestyle modification based on TCM to the usual consultation of the ISSNHL after failure of two weeks systemic therapy, to provide a scientific basis for clinical decisions. Methods: This is a clinical randomized trial with a paired design which will include 58 patients diagnosed with ISSNHL, according to the American Academy of Otolaryngology-Head and Neck Surgery sudden hearing loss clinical guideline published in 2012, but incomplete recovery from ISSNHL after of initial management. Participants will be randomized to either healthy lifestyle modification group based on TCM or control group. All patients will be followed for 3 months. The primary outcome measure is the effective rate of hearing improvement (defined as the proportion of patients with at least 15- dB improvement in the average thresholds by the hearing loss frequency). Secondary outcome measures are the improvements in pure-tone average (PTA) of the impaired frequencies, Word Recognition Score (WRS), Tinnitus Handicap Inventory (THI) and ear blockage. The assessments of the participants will be made at baseline, after lifestyle modification in 1 month and 3 months. Discussion: This trial will determine the efficacy of healthy lifestyle modification based on TCM program for ISSNHL patients with incomplete recovery from after failure of initial systemic therapy. The results, if it is yielding positive results, will provide clinical evidence and TCM based healthy lifestyle could be recommended as salvage therapy for patients with ISSNHL. Trial Registration: ClinicalTrials.gov, ChiCTR-INR-17011459. Registered on May 22 2017. Keywords: ISSNHL, TCM, healthy lifestyle, Study protocol, randomized controlled trial