Clinical efficacy of Niuhuang Qingxin Pill in the treatment of depressive disorder and its influence on near infrared brain functional imaging
LIU Ting-hui
SU Hui-tao
YUAN Jie
ZHANG Yu-ting
MA Xing-hua
QI Rong-rong
ZHAO Tian
LIANG Li-na
LEI Ya-ling
Abstract：Objective To explore the clinical efficacy of(Jufang)Niuhuang Qingxin Pill combined with paroxetine hydrochloride tablets in the treatment of depressive disorder with"phlegm-heat disturbing the spirit"syndrome and its impact on functional near-infrared spectroscopy(fNIRS).Methods This study adopted a randomized controlled trial(RCT)design,randomly dividing 84 eligible patients in Shaanxi Provincial Hospital of Traditional Chinese Medicine and Xianyang Hospital from March to December December of 2023 into a treatment group and a control group,with 42 patients in each group.The control group was administered paroxetine hydrochloride tablets,while the treatment group received(Jufang)Niuhuang Qingxin Pill in addition to the control group's treatment.The treatment course was 8 weeks.Changes in the Hamilton Depression Rating Scale(HAMD-17),Hamilton Anxiety Rating Scale(HAMA),Traditional Chinese Medicine Syndrome Score,Pittsburgh Sleep Quality Index(PSQI),and mean concentration,integral value,and barycenter value of oxygenated hemoglobin(oxy-Hb)in fNIRS were observed before and after treatment in patients with depressive disorder and"phlegm-heat disturbing the spirit"syndrome.Results General data showed no significant differe-nces in gender,age,and disease duration between the two groups(P＞0.05).Before treatment,there were no significant differences in HAMD-17,HAMA,PSQI scores,Traditional Chinese Medicine Syndrome Score,and fNIRS indicators(P＞0.05).After 8 weeks of treatment,all indicators improved(P＜0.05),with the treatment group showing more significant improvements in HAMD-17,PSQI scores,and oxygenated hemoglobin concentration and integral value in fNIRS(P＜0.05),as well as a more pronounced decrease in barycenter value(P＜0.05).There was no significant difference in the reduction of HAMA scores between the two groups(P＞0.05),but the overall efficacy of the treatment group was still better than that of the control group(P＜0.05).Conclusion The combination of(Jufang)Niuhuang Qingxin Pill and paroxetine hydrochloride tablets in the treatment of depressive disorder with"phlegm-heat disturbing the spirit"syndrome can significantly improve symptoms such as depression,anxiety,and sleep disturbances,increase oxygenated hemoglobin in the prefrontal cortex,activate and enhance cortical excitability,and demonstrate good drug safety.
Keywords：(Jufang)Niuhuang Qingxin Pilldepressive disorderfunctional near-infrared spectroscopyclinical study
Publication Date：2025-10-01
Online Publishing Date：2025-12-04(First online date of this platform, not the publication date of the document)
Pages：6( 881-886 )