Corrigendum: 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.

[This corrects the article 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.

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.

Prediction of hearing thresholds: comparison of cortical evoked response audiometry and auditory steady state response audiometry techniques.

The present study evaluated how well auditory steady state response (ASSR) and tone burst cortical evoked response audiometry (CERA) thresholds predict behavioral thresholds in the same participants. A total of 63 ears were evaluated. For ASSR testing, 100% amplitude modulated and 10% frequency modulated tone stimuli at a modulation frequency of 40Hz were used. Behavioral thresholds were closer to CERA thresholds than ASSR thresholds. ASSR and CERA thresholds were closer to behavioral thresholds at higher frequencies than at lower frequencies. Although predictions based on CERA thresholds are slightly more accurate than ASSR thresholds, the differences may not be clinically significant, particularly when the degree of individual variations is considered. Prediction of hearing thresholds became more accurate when hearing loss increased. Due to variations in prediction across participants, a single correction factor cannot be used. Other factors must be considered in selecting whether to use CERA or ASSR in predicting behavioral thresholds.