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

Abstract

AbstractPrevious 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.