Qingre Jiedu recipe in the treatment of bipolar depression with the syndrome of internal stagnation of fire-heat: a randomized double-blind controlled trial

doi:10.3969/j.issn.1006-7795.2025.03.012

Abstract

Abstract: Objective To evaluate the efficacy and safety of Qingre Jiedu recipe in the treatment of bipolar depression. Methods A randomized, double-blind, Chinese medicine and western medicine placebo control design was used in this study. Totally 80 subjects with bipolar depression and fiery internal depression that met the enrollment criteria, were divided into the experimental group (EG, 40 cases of western medicine simulation tablets + Chinese medicine formula granules) and the control group (CG, 40 cases of western medicine + Chinese medicine placebo) according to a 1∶1 ratio at last, 7 cases dropped out after enrollment, EG 36 cases, CG 37 cases. TCM Heat Internal Depression Syndrome (TCMHIDS), Hamilton Depression Scale-24 Item (HAMD-24), Hamilton Anxiety Scale (HAMA), Hypomania Checklist-33 (HCL-33), Young Manic Rating Scale (YMRS) and Treatment Emergent Symptom Scale (TESS) scores were assessed at baseline and at the 2nd, 4th and 8th week after treatment. Important signs and adverse events were recorded. Blood routine, hepatic and renal function, urine routine and electrocardiogram were performed during the screening period and the 8th week after treatment. For the patients who dropped out of the examination program, the examination item are identical to those at week 8. The primary outcome measure was the change in HAMD score from baseline to 8th week. Secondary outcome evaluation indicators included the changes of TCMHIDS, HAMA, HCL-33 and YMRS scores from baseline to 8th week. Results The scores of the HAMD-24 between EG and CG decreased significantly compared with the baseline at different time-point, and the difference was statistically significant（P<0.01）. However, the scores of the EG on the HAMD-24 decreased more significantly compared with the CG at the 4th and 8th week, and this difference was statistically significant（P<0.01）. The TCMHIDS and HAMD scores between two groups decreased compared with the baseline at different time-point, and this difference was statistically significant（P<0.01）. However, the TCMHIDS and HAMD scores of the EG decreased more significantly ot the 4th and 8th week, compared with the CG, and this difference was statistically significant（P<0.01）. Both YMRS and HCL-33 scores decreased more significantly between two groups at different time-point, compared with the baseline, and this differences was statistically significant, but there was no difference between two groups. Conclusion TCM Qingre Jiedu recipe could effectively relieve depression and anxiety mood of bipolar depression, with more advantages than western medicine. In addition, it showed a certain effect on hypomania or manic-related symptoms of bipolar disorder, No risk of turning to hypomania or manic, better safety and less adverse reactions were observed.

Key words: bipolar depression, bipolar disorder, traditional Chinese medicine formula of clearing heat and eliminating depression, randomized controlled trial, traditional Chinese medicine

CLC Number:

R749

Yin Dongqing, Jia Hongxiao, , Li Xue, Zheng Sisi, Ning Yanzhe. Qingre Jiedu recipe in the treatment of bipolar depression with the syndrome of internal stagnation of fire-heat: a randomized double-blind controlled trial[J]. Journal of Capital Medical University, 2025, 46(3): 479-486.

References

［1］Cardoso de Almeida J R, Phillips M L. Distinguishing between unipolar depression and bipolar depression: current and future clinical and neuroimaging perspectives［J］. Biol Psychiatry, 2013, 73(2): 111-118.
［2］Nierenberg A A, Agustini B, Köhler-Forsberg O, et al. Diagnosis and treatment of bipolar disorder: a review［J］. JAMA, 2023, 330(14): 1370-1380.
［3］ Judd L L, Schettler P J, Akiskal H, et al. Prevalence and clinical significance of subsyndromal manic symptoms, including irritability and psychomotor agitation, during bipolar major depressive episodes［J］. J Affect Disord, 2012, 138(3): 440-448.
［4］徐文炜, 查富树, 许律西, 等. 单相抑郁与双相情感障碍遗传效应及方式的对照研究［J］. 中华精神科杂志, 1997, 30(4): 199-202.
［5］云维生, 李俊清, 孙福刚. 抑郁反应, 抑郁发作, 双相障碍 (抑郁相) 同异源性的临床研究［J］. 中国民康医学(上半月), 2008,20(17): 1978-1981.
［6］Hirschfeld R M A, Lewis L, Vornik L A. Perceptions and impact of bipolar disorder: how far have we really come? Results of the national depressive and manic-depressive association 2000 survey of individuals with bipolar disorder［J］. J Clin Psychiatry, 2003, 64(2): 161-174.
［7］Rosa A R, Reinares M, Michalak E E, et al. Functional impairment and disability across mood states in bipolar disorder［J］. Value Health, 2010, 13(8): 984-988.
［8］Goodwin G M. Bipolar depression and treatment with antidepressants［J］. Br J Psychiatry, 2012, 200(1): 5-6.
［9］朱虹, 尹冬青, 李自艳, 等. 双相情感障碍中医证素特点的初步探索［J］. 现代中医临床, 2019, 26(4): 29-33.
［10］尹冬青, 贾竑晓, 李自艳, 等. 13372例住院双相情感障碍患者的五运六气禀赋特征［J］. 现代中医临床, 2019, 26(4): 34-39.
［11］尹冬青, 贾竑晓, 周方, 等. 内生火热与双相情感障碍发病的关系探讨［J］. 中华中医药学刊, 2017, 35(2): 482-484.
［12］陈沛, 郭雨萌, 阎锴娟, 等. 单、双相抑郁患者特征性舌象分析研究［J］. 湖南中医药大学学报, 2024, 44(12): 2222-2226.
［13］贾竑晓, 王娣. 叶天士清热解郁法对难治性抑郁证治疗的启示［J］. 中华中医药杂志, 2011, 26(6): 1346-1348.
［14］刘杰, 贾竑晓, 王建琴, 等. 解郁颗粒合并帕罗西汀治疗阴虚内热型难治性抑郁症的疗效观察［J］. 中国中西医结合杂志, 2013, 33(4): 462-465.
［15］美国精神医学学会.理解DSM-5精神障碍［M］.夏雅俐，张道龙，译.北京：北京大学出版社，2016：40-44.
［16］尹冬青, 贾竑晓. 双相情感障碍中医证候辨证分型标准专家共识［J］. 现代中医临床, 2021, 28(6): 1-8.
［17］方贻儒, 刘铁榜. 双相障碍抑郁发作药物治疗专家建议［J］. 中国神经精神疾病杂志, 2013, 39(7): 385-390.
［18］袁铭, 李素敏, 王雪芹, 等. 双相抑郁的特点、危害及药物治疗研究进展［J］. 中国全科医学, 2016, 19(10): 1229-1233.

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