Bojungikgitang and banhabaekchulchonmatang in adult patients with tinnitus, a randomized, double-blind, three-arm, placebo-controlled trial - study protocol

Abstract

BackgroundTinnitus is the perception of hearing a sound for which there is no external acoustic source. It is often associated with sudden, temporary hearing loss and has a clear impact on a patient's quality of life. Despite numerous trials, there are no treatments that can be considered well established in terms of providing replicable long-term tinnitus reduction. Complementary and alternative medical approaches have been employed to relieve symptoms of tinnitus. Bojungikgitang and banhabaekchulchonmatang are among the most strongly preferred and widely used herbal medicines for tinnitus in Korea, as they cause very few serious adverse effects.We aim to establish basic clinical efficacy and safety data for bojungikgitang and banhabaekchulchonmatang, which are approved as herbal medications by the Korea Food and Drug Administration in adult patients with tinnitus.Methods/DesignThis study was a randomised, double-blind, placebo-controlled trial with three parallel arms (bojungikgitang, banhabaekchulchonmatang, and a placebo). Participants included in the study met the following criteria: typical conditions of intermittent or continuous tinnitus, for more than three months, with involuntary perceptions of the concept of a sound in the absence of an external source. Participants received bojungikgitang, banhabaekchulchonmatang, or a placebo-drug for eight weeks. The total duration of each arm was eleven weeks. Each participant was examined for signs and symptoms of tinnitus before and after taking medication. Post-treatment follow-up was performed two weeks after the final administration of medication.DiscussionThis trial provided evidence for the efficacy and safety of bojungikgitang and banhabaekchulchonmatang in adult patients with tinnitus. The primary outcome measure was the Tinnitus Handicap Inventory, an assessment used to identify difficulties that may be experienced due to tinnitus. The secondary measures were included an Acoustic Examination and the Visual Analogue Scale. We employed the Euro-Qol 5-Dimension and the Health Utilities Index Mark 3, a health-related quality of life questionnaire. Safety was assessed by complete blood cell count, erythrocyte sedimentation rate, blood chemistry, urine analysis, PA chest film, brain computed tomography, otologic examination, and vital signs.Trial registrationCurrent Controlled Trials ISRCTN23691284

Herbal Medicine in the Management of Tinnitus

“…The complex mechanism and innate diversity in etiology of tinnitus have made its treatment a dilemma for physicians and specially otolaryngologists. Despite considerable number of researches, none of the so far presented medications and treatments has resulted in a sustained reduction in perception of tinnitus [16]. No appropriately controlled clinical trials have been successful to prove efficacy of a single drug.…”

“…Bojungikgitang and banhabaekchulchonmatang have been approved by Korea Food and Drug Administration and are being widely used in Korea for treatment of Tinnitus because of their very low rate of adverse effects [16]. These two herbal medications have found their places among Korean people and physicians.…”

“…These two herbal medications have found their places among Korean people and physicians. Traditional Korean medicine (TKM) believes that Tinnitus is mainly caused from irregularities in bowel and visceral (zang-fu) functioning [16]. According to TKM, gallbladder deficiency associated with tinnitus is managed by banhabaekchulchonmatang, and bojungikgitang is used to manage the pattern of qi-deficiency [21].…”

A review on medicinal plants used for treating ototoxicity and acoustic trauma induced hearing loss

“…Experiments modeling acoustic trauma induced hearing loss in guinea pigs showed that RA improves auditory function by inhibiting ROS and nitric oxide in cochlear cells. (Kim et al, 2010) Received for publication on 21 st April 2018. Accepted for publication on 27 th June 2018…”

Phytomedizin in der der Hals-Nasen-Ohrenheilkunde – evidenzbasierte Medizin mit Heilpflanzen

“…Eine Studie mit ähnlichem Design, allerdings mit drei Behandlungsarmen, befasste sich mit der Behandlung von Tinnitus durch zwei koreanische Pflanzenpräparate -Ergebnisse wurden allerdings nicht prä-sentiert [18]. Besser sah es aus mit einer Untersuchung [27] der auch im Innenohr durchblutungsfördernd wirkenden Isolate Aescin und Troxerutin.…”