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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

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机构: [1]Chongqing Med Univ, Affiliated Hosp 1, Dept Neurol, Chongqing, Peoples R China [2]Chongqing Med Univ, Affiliated Hosp 1, NHC Key Lab Diag & Treatment Brain Funct Dis, Chongqing, Peoples R China [3]Chongqing Key Lab Neurobiol, Chongqing, Peoples R China [4]Harbin Med Univ, Affiliated Hosp 2, Dept Neurol, Harbin, Heilongjiang, Peoples R China [5]First Hosp Hebei Med Univ, Dept Neurol, Shijiazhuang, Hebei, Peoples R China [6]Capital Med Univ, Beijing Tiantan Hosp, Dept Neuropsychiat & Behav Neurol, Beijing, Peoples R China [7]First Hosp Shanxi Med Univ, Dept Neurol, Taiyuan, Shanxi, Peoples R China [8]Shijiazhuang First Hosp, Dept Neurol, Shijiazhuang, Hebei, Peoples R China [9]First Hosp Jilin Univ, Dept Neurol, Changchun, Jilin, Peoples R China [10]Capital Med Univ, Beijing Friendship Hosp, Dept Neurol, Beijing, Peoples R China [11]Third Peoples Hosp Chengdu, Dept Neurol, Chengdu, Sichuan, Peoples R China [12]Anhui Med Univ, Affiliated Hosp 1, Dept Med Psychol, Hefei, Anhui, Peoples R China [13]Fudan Univ, Huashan Hosp, Dept Neurol, Shanghai, Peoples R China [14]Wenzhou Med Univ, Affiliated Hosp 1, Dept Anaesthesiol, Wenzhou, Zhejiang, Peoples R China [15]Capital Med Univ, Xuanwu Hosp, Natl Ctr Neurol Disorders, Natl Clin Res Ctr Geriatr Dis, Beijing, Peoples R China [16]Second Mil Med Univ, Changhai Hosp, Dept Neurol, Shanghai, Peoples R China [17]Harbin Med Univ, Affiliated Hosp 1, Dept Psychiat, Harbin, Heilongjiang, Peoples R China [18]Kunming Med Univ, Affiliated Hosp 1, Dept Neurol, Kunming, Yunnan, Peoples R China [19]Jinan Univ, Clin Med Coll 2, Dept Neurol, Shenzhen, Guangdong, Peoples R China [20]Chongqing Med Univ, Affiliated Hosp 1, Dept Psychiat, Chongqing, Peoples R China
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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.

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大类 | 3 区 医学
小类 | 4 区 精神病学 4 区 心理学:临床 4 区 药物滥用
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出版当年[2023]版:
Q1 SUBSTANCE ABUSE Q1 PSYCHOLOGY, CLINICAL Q2 PSYCHIATRY
最新[2023]版:
Q1 SUBSTANCE ABUSE Q1 PSYCHOLOGY, CLINICAL Q2 PSYCHIATRY

影响因子: 最新[2023版] 最新五年平均 出版当年[2023版] 出版当年五年平均 出版前一年[2022版]

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第一作者机构: [1]Chongqing Med Univ, Affiliated Hosp 1, Dept Neurol, Chongqing, Peoples R China [2]Chongqing Med Univ, Affiliated Hosp 1, NHC Key Lab Diag & Treatment Brain Funct Dis, Chongqing, Peoples R China [3]Chongqing Key Lab Neurobiol, Chongqing, Peoples R China
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通讯机构: [1]Chongqing Med Univ, Affiliated Hosp 1, Dept Neurol, Chongqing, Peoples R China [2]Chongqing Med Univ, Affiliated Hosp 1, NHC Key Lab Diag & Treatment Brain Funct Dis, Chongqing, Peoples R China [3]Chongqing Key Lab Neurobiol, Chongqing, Peoples R China
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