Qingre Jiedu recipe in the treatment of bipolar depression with the syndrome of internal stagnation of fire-heat:a randomized double-blind controlled trial
10.3969/j.issn.1006-7795.2025.03.012
- VernacularTitle:清热解郁方治疗双相抑郁火热内郁证的随机双盲对照研究
- Author:
Dongqing YIN
1
;
Hongxiao JIA
1
;
Xue LI
1
;
Sisi ZHENG
1
;
Yanzhe NING
1
Author Information
1. 首都医科大学附属北京安定医院三病区国家精神疾病医学中心国家精神心理疾病临床医学研究中心精神疾病诊断与治疗北京市重点实验室,北京 100088;人脑保护高精尖创新中心,首都医科大学,北京 100069
- Publication Type:Journal Article
- Keywords:
bipolar depression;
bipolar disorder;
traditional Chinese medicine formula of clearing heat and eliminating depression;
randomized controlled trial;
traditional Chinese medicine
- From:
Journal of Capital Medical University
2025;46(3):479-486
- CountryChina
- Language:Chinese
-
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.
