Sini powder with paroxetine ameliorates major depressive disorder by modulating circadian rhythm: A randomized, double-blind, placebo-controlled trial.

Circadian rhythm disorder is a significant risk factor for mental diseases, and the recovery of circadian rhythm function has gradually become a signal of effective antidepressant therapy. Sini powder (SNP) is a classical, traditional Chinese formula for depression treatment. However, few clinical reports have been recorded. This randomized, double-blinded, controlled trial (ChiCTR1900022700) aimed to explore the efficacy of SNP on depression via regulating circadian rhythm. In total, 36 patients with major depressive disorder (MDD) were enrolled for 4-weeks medication and 6-weeks follow-up. HAMD-24 score and circadian rhythm index, including dim light melatonin onset (DLMO) and phase angle difference (PAD), were included in the assessment. DLMO and PAD were statistically significant in the SNP group after 4 weeks of treatment (p < .05) and with greater improvement in DLMO (p = .03). In addition, DLMO and the HAMD-24 score showed a positive correlation (p < .05); the HAMD-24 score degree decreased significantly over time (p < .001). Similarly, interaction effects were shown significantly between group and time (p = .049). The duration of SNP supplementation was relatively short, and the sample size was relatively small. SNP granules combined with paroxetine tablets have definite efficacy in improving the circadian rhythms of MDD patients, reflecting the therapeutic advantages of traditional Chinese medicine as antidepressants.

[Post-stroke speech disorder treated with acupuncture and psychological intervention combined with rehabilitation training: a randomized controlled trial].

OBJECTIVE: To assess the clinical efficacy on post-stroke speech disorder treated with acupuncture and psychological intervention combined with rehabilitation training. METHODS: The multi-central randomized controlled study was adopted. One hundred and twenty cases of brain stroke were divided into a speech rehabilitation group (control group), a speech rehabilitation plus acupuncture group (observation group 1) and a speech rehabilitation plus acupuncture combined with psychotherapy group (observation group 2), 40 cases in each one. The rehabilitation training was conducted by a professional speech trainer. In acupuncture treatment, speech function area in scalp acupuncture, Jinjin (EX-HN 12) and Yuye (EX-HN 13) in tongue acupuncture and Lianquan (CV 23) were the basic points. The supplementary points were selected according to syndrome differentiation. Bloodletting method was used in combination with acupuncture. Psychotherapy was applied by the physician in psychiatric department of the hospital. The corresponding programs were used in each group. Examination of Aphasia of Chinese of Beijing Hospital was adopted to observe the oral speech expression, listening comprehension and reading and writing ability. RESULTS: After 21-day treatment, the total effective rate was 92.5% (37/40) in observation group 1, 97.5% (39/40) in observation group 2 and 87.5% (35/40) in control group. The efficacies were similar in comparison among 3 groups. The remarkable effective rate was 15.0% (6/40) in observation group 1, 50.0% (20/40) in observation group 2 and 2.5% (1/40) in control group. The result in observation group 2 was superior to the other two groups (P<0.01, P<0.001). In comparison of the improvements of oral expression, listening comprehension, reading and writing ability, all of the 3 groups had achieved the improvements to different extents after treatment (P<0.01, P<0.001). The results in observation group 2 were better than those in observation group 1 and control group. CONCLUSION: Acupuncture and psychological intervention combined with rehabilitation training is obviously advantageous in the treatment of post-stroke speech disorder.