ABSTRACT
OBJECTIVE@#To evaluate the efficacy and safety of Jianpi Jieyu Decoction (JJD) for treating patients with mild-to-moderate depression of Xin (Heart)-Pi (Spleen) deficiency (XPD) syndrome.@*METHODS@#In this multi-center, randomized, controlled study, 140 patients with mild-to-moderate depression of XPD syndrome were included from Xiyuan Hospital of China Academy of Chinese Medical Sciences and Botou Hospital of Traditional Chinese Medicine from December 2017 to December 2019. They were randomly divided into JJD group and paroxetine group by using a random number table, with 70 cases in each group. The patients in the JJD group were given JJD one dose per day (twice daily at morning and evening, 100 mL each time), and the patients in the paroxetine group were given paroxetine (10 mg/d in week 1; 20 mg/d in weeks 2-6), both orally administration for a total of 6 weeks. The primary outcome was the change of 17-item Hamilton Depression Rating Scale (HAMD-17) score at week 6 from baseline. The secondary outcomes included the Hamilton Anxiety Scale (HAMA) score, Traditional Chinese Medicine Symptom Scale (TCMSS), and Clinlcal Global Impression (CGI) scores at the 2nd, 4th, and 6th weekends of treatment, HAMD-17 response (defined as a reduction in score of >50%) and HAMD-17 remission (defined as a score of ⩽7) at the end of the 6th week of treatment. Adverse events (AEs) were also recorded.@*RESULTS@#From baseline to week 6, the HAMD-17 scores decreased 10.2 ± 4.0 and 9.1 ± 4.9 points in the JJD and paroxetine groups, respectively (P=0.689). The HAMD-17 response occurred in 60% of patients in the JJD group and in 50% of those in the paroxetine group (P=0.292); HAMD-17 remission occurred in 45.7% and 30% of patients, respectively (P=0.128). The differences of CGI scores at the 6th week were not statistically significant (P>0.05). There were significant differences in HAMD-17 scores between the two groups at 2nd and 4th week (P=0.001 and P=0.014). The HAMA scores declined 8.1 ± 3.0 and 6.9 ± 4.3 points from baseline to week 6 in the JJD and paroxetine groups, respectively (P=0.905 between groups). At 4th week of treatment, there was a significant difference in HAMA between the two groups (P=0.037). TCMSS decreased 11.4 ± 5.1, and 10.1 ± 6.8 points in the JJD and paroxetine groups, respectively (P=0.080 between groups). At the 6th week, the incidence of AEs in the JJD group was significantly lower than that in the paroxetine group (7.14% vs. 22.86%, P<0.05).@*CONCLUSION@#Compared with paroxetine, JJD was associated with a significantly lower incidence of AEs in patients with mild-to-moderate depression of XPD syndrome, with no difference in efficacy at 6 weeks. (Trial registration No. ChiCTR2000040922).
Subject(s)
Humans , Paroxetine/adverse effects , Spleen , Anxiety , Syndrome , Medicine, Chinese Traditional , Treatment Outcome , Double-Blind MethodABSTRACT
OBJECTIVE@#To explore the mechanism of Pi (Spleen)-deficiency-induced functional diarrhea (FD) model rats treated by Shenling Baizhu Powder (, SBP).@*METHODS@#Thirty male Sprague-Dawley rats were randomly divided into 5 groups including control, model, low-, medium-, and high-dose SBP groups (SBPLDG, SBPMDG, SBPHDG), 6 rats in each group, respectively. Pi-deficiency-induced FD rats model was developed through Radix et Rhizoma Rhei gavage for 7 days. After modeling, the rats were treated with 3 doses of SBP [0.93, 1.86, and 3.72 g/(kg·d)], and the rats in the control and model groups were given pure water for 7 days. The diarrhea index was calculated. On the 7th and 14th days, the traveled distance of rat was measured by the open field test. Serum D-xylose content was determined by the phloroglucinol method and interleukin (IL)-10 and IL-17 levels were measured using an enzyme-linked immunosorbent assay kit. The content of Treg cells was determined by flow cytometry.@*RESULTS@#Compared with the control group, the diarrhea index and IL-17 level in the model group were significantly higher and the total exercise distance and D-xylose content significantly decreased (P>0.05). The expression of IL-10 in the SBPHDG group was significantly up-regulated, and serum D-xylose level and Treg cells increased significantly compared with the model group (P>0.05).@*CONCLUSION@#High-dose SBP exhibited ameliorating effects against Pi-deficiency induced FD, which might be attributed to its modulations on intestinal absorption function as well as adaptive immunity in mesenteric lymph nodes of rat.