AUTHOR=Zhang Hong Wei , Yeung Kammy N. K. , Tong Michael C. F. , Lin Zhi-Xiu , Chang Waitsz W. T. , Ng Iris H-Y. , Sum Chi Him , Leung Ka Chun , Chan Kam Leung , Ngan Kit , Tong Tie Jun 

TITLE=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

JOURNAL=Frontiers in Pharmacology

VOLUME=Volume 13 - 2022

YEAR=2022

URL=https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2022.844730

DOI=10.3389/fphar.2022.844730

ISSN=1663-9812

ABSTRACT=Background: Tinnitus is a common problem in Hong Kong and 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 one 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: To determine the feasibility of a full-scale RCT, and explore whether a TCM formula (BHT) has additional effect on improving tinnitus when compared to informative counselling alone.

Design: An assessor-blinded, randomized, controlled clinical trial.

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 counselling or informative counselling alone. The oral BHT herbal granules will be taken twice one day for continuous 8 weeks.

Main Outcome measures: The primary outcome 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 also to identify if it is feasible to conduct a full-scale RCT of BHT and necessary changes to the protocol if possible.