Kim NK, Lee DH, Lee JH, et al. Bojungikgitang and banhabaekchulchonmatang in adult patients with tinnitus, a randomized, double-blind, three-arm, placebo-controlled trial–study protocol. Trials. 2010
Mar 28;11:34. PubMed PMID: 20346181.
Investigators at Wonkwang University undertook a randomised, double-blind, placebo-controlled trial to determine the efficacy and safety of the herbal medications bojungikgitang and banhabaekchulchonmatang in the treatment of tinnitus.
Neither the US Food and Drug Administration (FDA) nor the European Medicines Agency (EMA) have approved treatments for this disorder, defined as a perception of hearing a sound for which there is no external acoustic source and that is often associated with sudden, temporary hearing loss.
Bojungikgitang and banhabaekchulchonmatang are herbal preparations used in Traditional Korean Medicine. Both are approved by the Korea Food and Drug Administration as herbal medications for adults with tinnitus.
In this study, Bojungikgitang was prepared from extracts of Astragali radix, white ginseng, Atractylodes rhizome white, Glycyrrhizae resina, Angelicae gigantis radix, Fraxini cortex, Cimicifugae rhizoma, and Bupleuri radix. Banhabaekchulchonmatang was prepared from extracts of Pinelliae rhizoma, Hordei fructus germinatus, Fraxini cortex, Atractylodes rhizome white, Massa medicata fermentata, Atractylodis rhizoma, Zingiber officinale, Astragali radix, Ginseng radix alba, Ginseng radix alba, Gastrodiae rhizoma, Polyporus, Alismatis rhizoma, Zingiberis rhizoma siccus, and Phellodendri cortex.
Participants received bojungikgitang, banhabaekchulchonmatang, or a placebo for eight weeks, prepared as a tea with tepid water. Each participant was examined for signs and symptoms of tinnitus before and after taking their medication. Posttreatment follow-up was performed two weeks after the final administration.
The authors found evidence for the efficacy of bojungikgitang and banhabaekchulchonmatang, based on the Tinnitus Handicap Inventory, an acoustic examination and visual analogue scale. Safety was demonstrated by complete blood cell count, erythrocyte sedimentation rate, blood chemistry, urine analysis, PA chest film, brain computed tomography, otologic examination, and vital signs.
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