"A Randomized, Double-Blind, Positive-Controlled, Multicenter Clinical Trial on the Efficacy and Safety of ShuganJieyu Capsule and St. John's Wort for Major Depressive Disorder with Somatic Complaints"

作者全名："Xiang, Yajie; Wang, Lihua; Gu, Ping; Wang, Chunxue; Tian, Yuling; Shi, Wanying; Deng, Fang; Zhang, Yongbo; Gao, Li; Wang, Kai; Wang, Yi; He, Jincai; Zhao, Wenfeng; Bi, Xiaoying; Hu, Jian; Zhong, Lianmei; Guo, Yi; Zhou, Xinyu; Wang, Hongxing; Xie, Peng"

作者地址："[Xiang, Yajie; Xie, Peng] Chongqing Med Univ, Affiliated Hosp 1, Dept Neurol, Chongqing, Peoples R China; [Xiang, Yajie; Zhou, Xinyu; Xie, Peng] Chongqing Med Univ, Affiliated Hosp 1, NHC Key Lab Diag & Treatment Brain Funct Dis, Chongqing, Peoples R China; [Xiang, Yajie; Zhou, Xinyu; Xie, Peng] Chongqing Key Lab Neurobiol, Chongqing, Peoples R China; [Wang, Lihua] Harbin Med Univ, Affiliated Hosp 2, Dept Neurol, Harbin, Heilongjiang, Peoples R China; [Gu, Ping] First Hosp Hebei Med Univ, Dept Neurol, Shijiazhuang, Hebei, Peoples R China; [Wang, Chunxue] Capital Med Univ, Beijing Tiantan Hosp, Dept Neuropsychiat & Behav Neurol, Beijing, Peoples R China; [Tian, Yuling] First Hosp Shanxi Med Univ, Dept Neurol, Taiyuan, Shanxi, Peoples R China; [Shi, Wanying] Shijiazhuang First Hosp, Dept Neurol, Shijiazhuang, Hebei, Peoples R China; [Deng, Fang] First Hosp Jilin Univ, Dept Neurol, Changchun, Jilin, Peoples R China; [Zhang, Yongbo] Capital Med Univ, Beijing Friendship Hosp, Dept Neurol, Beijing, Peoples R China; [Gao, Li] Third Peoples Hosp Chengdu, Dept Neurol, Chengdu, Sichuan, Peoples R China; [Wang, Kai] Anhui Med Univ, Affiliated Hosp 1, Dept Med Psychol, Hefei, Anhui, Peoples R China; [Wang, Yi] Fudan Univ, Huashan Hosp, Dept Neurol, Shanghai, Peoples R China; [He, Jincai; Wang, Hongxing] Wenzhou Med Univ, Affiliated Hosp 1, Dept Anaesthesiol, Wenzhou, Zhejiang, Peoples R China; [Zhao, Wenfeng] Capital Med Univ, Xuanwu Hosp, Natl Ctr Neurol Disorders, Natl Clin Res Ctr Geriatr Dis, Beijing, Peoples R China; [Bi, Xiaoying] Second Mil Med Univ, Changhai Hosp, Dept Neurol, Shanghai, Peoples R China; [Hu, Jian] Harbin Med Univ, Affiliated Hosp 1, Dept Psychiat, Harbin, Heilongjiang, Peoples R China; [Zhong, Lianmei] Kunming Med Univ, Affiliated Hosp 1, Dept Neurol, Kunming, Yunnan, Peoples R China; [Guo, Yi] Jinan Univ, Clin Med Coll 2, Dept Neurol, Shenzhen, Guangdong, Peoples R China; [Zhou, Xinyu] Chongqing Med Univ, Affiliated Hosp 1, Dept Psychiat, Chongqing, Peoples R China"

通信作者："Xie, P (通讯作者)，Chongqing Med Univ, Affiliated Hosp 1, Dept Neurol, Chongqing, Peoples R China.; Xie, P (通讯作者)，Chongqing Med Univ, Affiliated Hosp 1, NHC Key Lab Diag & Treatment Brain Funct Dis, Chongqing, Peoples R China.; Xie, P (通讯作者)，Chongqing Key Lab Neurobiol, Chongqing, Peoples R China.; Wang, HX (通讯作者)，Wenzhou Med Univ, Affiliated Hosp 1, Dept Anaesthesiol, Wenzhou, Zhejiang, Peoples R China."

来源：INTERNATIONAL JOURNAL OF MENTAL HEALTH AND ADDICTION

ESI学科分类：PSYCHIATRY/PSYCHOLOGY

WOS号：WOS:001130296000002

JCR分区：Q1

影响因子：3.2

年份：2023

卷号：　

期号：　

开始页：　

结束页：　

文献类型：Article; Early Access

关键词：Major depressive disorder; Somatic complaints; Randomized controlled trial; ShuganJieyu capsule; St. John's wort

摘要："Previous studies have found the effect of ShuganJieyu capsule and St. John's wort on the treatment of depression and explored their potential benefits for somatic symptoms, while the evidence of comparison of them for depression with somatic complaints is lacking. In this multicenter randomized controlled trial, 198 major depressive disorder (MDD) patients with somatic complaints were randomly allocated, 92 in the ShuganJieyu capsule group, and 91 in the St. John's wort group completed 8 weeks treatment. Primary outcome was the change score of the 17-item Hamilton Depression Rating Scale (HDRS-17) at week 8. Secondary outcomes included other indices of depression, somatic symptoms, anxiety, insomnia, quality of life, and adverse events. The change scores of HDRS-17 were not significantly difference between the two groups, but the reduction in HDRS-17 was significantly improved in both the ShuganJieyu capsule (HDRS-17 Delta = - 11.35 +/- 5.38, p < 0.001) and St. John's wort (HDRS-17 Delta = - 11.20 +/- 5.71, p < 0.001) groups. The other outcomes showed similar results. Compared with St. John's wort, the ShuganJieyu capsule induced significantly greater HDRS-17 reductions in male (SMD, - 0.55; 95% CI, - 1.08 to - 0.02) but not in female. Overall, The ShuganJieyu capsule was comparable to St. John's wort as a complementary and alternative intervention for MDD patients with somatic complaints in the acute treatment, especially for male patients."

基金机构："National Key R&D Program of China; Society of Neuropsychological and Affective Disorders, Chinese Neurology Association"

基金资助正文："The authors thank the clinical research staff and patients who participated in the study. The authors thank the Society of Neuropsychological and Affective Disorders, Chinese Neurology Association, Chinese Medical Doctor Association for the acquisition of data and technical guidance. The authors thank Sichuan Jishengtang Pharmaceutical Co., Ltd., for donating the study agents, matching simulants, and packaging in the form of calendar packs."