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
Year: 2023
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: 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-17Δ = − 11.35 ± 5.38, p < 0.001) and St. John’s wort (HDRS-17Δ = − 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.
Institutions: The Affiliated Yongchuan Hospital of Chongqing Medical University, Harbin Medical University, Second Affiliated Hospital of Harbin Medical University, Hebei Medical University, First Affiliated Hospital of Hebei Medical University, Capital Medical University, Beijing Tian Tan Hospital, Shanxi Medical University, First Hospital of Shanxi Medical University, First Hospital of Shijiazhuang, First Hospital of Jilin University, Beijing Friendship Hospital, Third People's Hospital of Chengdu, Anhui Medical University, First Affiliated Hospital of Anhui Medical University, Shanghai Medical College of Fudan University, Fudan University, Huashan Hospital, First Affiliated Hospital of Wenzhou Medical University, Second Military Medical University, Changhai Hospital, First Affiliated Hospital of Harbin Medical University, Kunming Medical University, First Affiliated Hospital of Kunming Medical University, Jinan University, ShenZhen People’s Hospital
Language: English
Subfield: Complementary and alternative medicine
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $3,690
Awards: G1078317984, G3586199485, G5983617465
OpenAlex ID: W4390115265