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

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

doi:10.3389/fphar.2022.844730

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

Front Pharmacol. 2022 Mar 30:13:844730. doi: 10.3389/fphar.2022.844730. eCollection 2022.

Authors

Hong Wei Zhang^{1

2}, Kammy N K Yeung³, Michael C F Tong³, Zhi-Xiu Lin^{1

2}, Waitsz W T Chang³, Iris H-Y Ng³, Chi Him Sum², Ka Chun Leung², Kam Leung Chan^{1

2}, Kit Ngan⁴, Tie Jun Tong⁵

Affiliations

¹ Faculty of Medicine, School of Chinese Medicine, The Chinese University of Hong Kong, Shatin, Hong Kong SAR, China.
² Hong Kong Institute of Integrative Medicine, The Chinese University of Hong Kong, Shatin, Hong Kong SAR, China.
³ Department of Otorhinolaryngology, Head and Neck Surgery, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, Hong Kong SAR, China.
⁴ Prime & Naturals Clinic, Hong Kong, Hong Kong SAR, China.
⁵ Department of Mathematics, Hong Kong Baptist University, Hong Kong, Hong Kong SAR, China.

Abstract

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.

Keywords: Chinese medicine; clinical trial protocol; herb; pilot; randomized controlled trial; tinnitus.

Grants and funding

This study is supported by Health and Medical Research Fund (HMRF), Food and Health Bureau, Hong Kong, China (No. 17180941).