标题：Healthy lifestyle consultation 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 randomised trial
摘要：BACKGROUND :Idiopathic sudden sensorineural hearing loss (ISSNHL) is a major cause of deafness. Despite the advances in systemic therapy, some cases of ISSNHL are untreated, because the exact ISSNHL aetiology is unclear. Traditional Chinese medicine (TCM) has been used to treat diseases for thousands of years and is popular and widely practiced in Asia. TCM includes guidance on a healthy lifestyle. In recent decades, the relationship between lifestyle and disease has been emphasised; an unhealthy lifestyle may lead to illnesses. Thus, this study aims to compare the efficacy of lifestyle modification based on TCM with the usual consultation of ISSNHL after failure of a 2-week systemic therapy to provide a scientific basis for clinical decisions. METHODS :This study is a clinical randomised trial that involves 56 patients diagnosed with ISSNHL but who have had incomplete recovery after initial management (at least 2 weeks of routine Western medical treatment). The study is performed in accordance with the sudden hearing loss clinical guideline of the American Academy of Otolaryngology-Head and Neck Surgery, published in 2012. Participants are randomly distributed into two groups: the healthy lifestyle modification group based on TCM and the control group (1:1 ratio). Patient follow-up lasts for 3 months. The primary outcome measure is the effective rate of hearing improvement, which is defined as the proportion of patients with at least 15 dB of improvement in the average thresholds of hearing loss frequency. The secondary outcome measures are improvements in word recognition score, Tinnitus Handicap Inventory and visual analogue scale for ear blockage and dizziness. Assessments are made at baseline and after lifestyle modification for 1 and 3 months. DISCUSSION :The efficacy of healthy lifestyle modification based on a TCM programme for patients with ISSNHL with incomplete recovery after failure of initial systemic therapy is determined in this trial. Positive results will provide clinical evidence on the effects of a TCM-based healthy lifestyle, which could be recommended as salvage therapy for patients with ISSNHL. TRIAL REGISTRATION :Chinese Clinical Trial Registry, ChiCTR-INR-17011459. Registered on 22 May 2017.
