A Chinese Medicine Formula (Bushen Huoxue Tongluo) for the Treatment of Chronic Subjective Tinnitus: A Study Protocol for a Pilot, Assessor-Blinded, Randomized Clinical Trial

Frontiers in Pharmacology

Pharmacology

Tie Jun Tong¹  Waitsz W. T. Chang²  Iris H-Y. Ng²  Kammy N. K. Yeung²  Michael C. F. Tong²  Hong Wei Zhang³  Zhi-Xiu Lin³  Kam Leung Chan³  Chi Him Sum⁴  Ka Chun Leung⁴  Kit Ngan⁵ 

[1] Department of Mathematics, Hong Kong Baptist University, Hong Kong, Hong Kong SAR, China;Department of Otorhinolaryngology, Head and Neck Surgery, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, Hong Kong SAR, China;Faculty of Medicine, School of Chinese Medicine, The Chinese University of Hong Kong, Shatin, Hong Kong SAR, China;Hong Kong Institute of Integrative Medicine, The Chinese University of Hong Kong, Shatin, Hong Kong SAR, China;Hong Kong Institute of Integrative Medicine, The Chinese University of Hong Kong, Shatin, Hong Kong SAR, China;Prime & Naturals Clinic, Hong Kong, Hong Kong SAR, China;

关键词: Chinese medicine;    tinnitus;    randomized controlled trial;    pilot;    clinical trial protocol;    herb;   

DOI  :  10.3389/fphar.2022.844730

 received in 2022-01-06, accepted in 2022-02-09,  发布年份 2022

来源: Frontiers

【 摘 要 】

Background: Tinnitus is a common problem worldwide. There is still no effective method to cure it. Traditional Chinese medicine (TCM) may be a potentially effective treatment approach for tinnitus. However, there is still no clinical trial with scientifically rigorous methodology to evaluate the treatment effect of TCM for tinnitus. Therefore, we propose a pilot study to inform the feasibility of a future full-scale RCT to establish the efficacy of TCM formula for tinnitus.Objectives: The aim of this study is to determine the feasibility of a full-scale RCT and explore whether a TCM formula (BHT) has an additional effect on improving tinnitus when compared to informative counseling alone.Design: An assessor-blinded, randomized, controlled clinical trial is used.Participants: Twenty-four patients with chronic subjective tinnitus will be enrolled.Interventions: The patients will be allocated randomly to receive a TCM formula (BHT, Bushen Huoxue Tongluo) and informative counseling or informative counseling alone. The oral BHT herbal granules will be taken twice per day continuously for 8 weeks.Main outcome measures: The primary outcomes include recruitment rate, intervention completion rate, and data completion rate to evaluate the feasibility. The secondary outcomes include Tinnitus Handicap Inventory, tinnitus functional index, tinnitus sensation level, self-rated visual analogue scale on tinnitus loudness and annoyance, Pittsburgh Sleep Quality Index, Hospital Anxiety and Depression Scale, and adverse event. The outcome measures will be collected at baseline, end of treatment, and 4-week follow-up.Discussion: This trial is currently ongoing and is recruiting patients. The expected study results will find some preliminary evidence about the clinical effectiveness of BHT on chronic tinnitus and will also determine if it is feasible to conduct a full-scale RCT of BHT and identify the necessary changes to the protocol if possible.

【 授权许可】

Unknown   
Copyright © 2022 Zhang, Yeung, Tong, Lin, Chang, Ng, Sum, Leung, Chan, Ngan and Tong.