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Journal of Traditional Chinese Medicine ›› 2023, Vol. 43 ›› Issue (3): 594-601.DOI: 10.19852/j.cnki.jtcm.20230328.002

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Therapy of replenishing Yin and regulating Yang for manic episode in bipolar disorder: study protocol for a prospective, double-blind, randomized controlled trial

YANG Yang1,2, YUAN Haining1,2, JIA Hongxiao3,4, NING Yanzhe3,4, WANG Di1,2, ZHANG Lei1,2, YAN Kaijuan1,2, GUO Yumeng1,2, WANG Fei1,2, SUN Weishuang1,2, CHEN Pei1,2()   

  1. 1 Beijing Key Laboratory of Mental Disorders, National Clinical Research Center for Mental Disorders and National Center for Mental Disorders, Department of integrated traditional Chinese and Western medicine, Beijing Anding Hospital, Capital Medical University, Beijing, China
    2 Advanced Innovation Center for Human Brain Protection, Capital Medical University, Beijing 100088, China
    3 Beijing Key Laboratory of Mental Disorders, National Clinical Research Center for Mental Disorders and National Center for Mental Disorders, Beijing Anding Hospital, Capital Medical University, Beijing 100088, China
    4 Advanced Innovation Center for Human Brain Protection, Capital Medical University, Beijing 100069, China
  • Received:2022-03-23 Accepted:2022-06-15 Online:2023-06-15 Published:2023-03-28
  • Contact: CHEN Pei, Department of integrated traditional Chinese and Western medicine, Beijing Anding Hospital, Capital Medical University, Beijing 100088, China. bettereveryday@163.com. Telephone: +86-10-58303111
  • Supported by:
    Beijing Municipal Administration of Hospitals Incubating Program(PZ2021031);which plays no role in the design of the study, collection, analysis, and interpretation of data, and in writing the manuscript

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Abstract:

Bipolar disorder (BD) is a chronic and recurrent disorder characterized by biphasic mood episodes of mania or hypomania and depression. It affects more than 1% of the global population and is a leading cause of disability in young people. Currently available treatments for BD are still fairly limited in terms of efficacy, with high rates of non-adherence, non-response, and undesirable side effects. Traditional Chinese medicine (TCM) has a long history and rich experience in stabilizing mania and improving quality of life. Aiming at rebalancing Yin and Yang in BD, therapy of replenishing Yin and regulating Yang (RYRY therapy) has been in clinical use for years in China. The present prospective, double-blind, randomized controlled trial is designed to investigate the efficacy and safety of RYRY therapy for bipolar mania and its possible mechanism from the point of regulating gut microbiota and anti-inflammation. A total of 60 eligible participants will be recruited from Beijing Anding Hospital. They will be randomized to either the study group or the control group in a ratio of 1∶1. Participants allocated to the study group will receive RYRY granule, while placebo granule will be applied in the control group. Participants in both groups will be prescribed conventional therapy for manic episode in BD. Four scheduled visits will be conducted over 4 weeks. Outcome measurements include Young Mania Rating Scale, TCM Symptom Pattern Rating Scale, Treatment Emergent Symptom Scale, levels of C-reactive protein, interleukin-6 and tumor necrosis factor-α and the gut microbial community profile of stool samples. Safety outcomes and adverse events will also be recorded. In this study, we set a number of scientific and objective assessments to evaluate the efficacy of RYRY therapy and study into its possible mechanism, hopefully offering clinicians an alternative approach to BD.

Key words: bipolar disorder, replenishing Yin and regulating Yang, gastrointestinal microbiome, inflammation, clinical protocol

Cite this article

YANG Yang, YUAN Haining, JIA Hongxiao, NING Yanzhe, WANG Di, ZHANG Lei, YAN Kaijuan, GUO Yumeng, WANG Fei, SUN Weishuang, CHEN Pei. Therapy of replenishing Yin and regulating Yang for manic episode in bipolar disorder: study protocol for a prospective, double-blind, randomized controlled trial[J]. Journal of Traditional Chinese Medicine, 2023, 43(3): 594-601.