Chaihu Shugan San (CHSGS) is a traditional Chinese herbal formula that is often used in clinical practice to treat live Qi stagnation syndrome and depression. Fluoxetine is one of the commonly used drugs for the clinical treatment of depression. This study involved a comparison of CHSGS and fluoxetine on antidepression and regulating blood rheology effects with chronic restraint stress- (CRS-) induced depression rat models. Rats were induced depression models by CRS for 4 weeks. Upon successful induction of depression in the rats, the animal was administered CHSGS at 0.6 g/kg/d, 1.2 g/kg/d, or fluoxetine 1.8 mg/kg/d to corresponding groups by gavage for 2 weeks. The changes of CRS rats were determined by behavior observations and sucrose preference test and hypothalamic-pituitary-adrenal cortex (HPA) axis functional status. The changes in monoamine neurotransmitters and related indicators of blood status were detected by enzyme-linked immunosorbent assay (ELISA), blood rheometer, and other methods. The outcome shows that CHSGS is superior to fluoxetine in regulating the appearance and HPA axis function of model rats. In addition, CHSGS and fluoxetine have similar effects in improving blood rheology, and both can alleviate the hypercoagulable state of blood via the platelet 5-hydroxytryptamine receptor 2A (5-HT2A) pathway in rats of depression. It was also observed that CHSGS can improve the blood state of depressed rats by restoring liver coagulation-anticoagulation balance and endothelium-related functions.
Objective: To evaluate the efficacy and feasibility of utilizing Traditional Chinese Medicine(TCM) combined group psychotherapy intervention on psychological distress management and gut micro-biome regulation for colorectal(CRC) survivors.
Methods: A single-arm phase I clinical trial was conducted between December 2020 and December 2021 in Xiyuan and Beijing Cancer Hospital in China. Inclusion criteria was stage I-III CRC survivors after radical surgery with age between 18-75. The intervention was a six-week online TCM combined group psychotherapy intervention including 90 minutes’ communication, TCM lifestyle coaching, self-acupressure guidance and mindfulness practice led by TCM oncologist and psychiatrist each week. Outcomes were measured by Self-Rating Anxiety Scale (SAS), Self-Rating Depression Scale (SDS), Fear of Cancer Recurrence Inventor (FCRI), and Quality of Life Questionnaire(QLQ-C30). Fetal samples before and after intervention were collected for 16Sr RNA analysis.
Results: We recruited 40 CRC survivors and 38 of them finally completed all interventions with average age of 58±13 years’ old. Paired t-test showed that SAS at week 2(35.4±5.8), week 4(37.9±10.5) and week 6(31.3±6.4) during the intervention was significantly lower than baseline (42.1±8.3, p<0.05 respectively). SDS score also declined substantially from baseline (38.8±10.7) to week 2(28.3±8.8, p<0.001) and week 6(25.4±7.7, p<0.001). FCRI decreased from 19.4±7.2 at baseline to 17.5±7.1 at week 4(p=0.038) and 16.3±5.8 at week 6(p=0.008). Although changes of QLQ-C30 were not statistically prominent, insomnia and fatigue significantly alleviated. The abundances of gut microbiota Intestinibacter, Terrisporobacter, Coprobacter and Gordonibacter were all significantly elevated after intervention.
Conclusions: TCM combined group psychotherapy intervention is feasible and effective to reduce CRC survivors’ psychological distress and modulate certain gut bacteria which might be associated with brain-gut axis effect. It is necessary to carry out with phase II randomized controlled clinical trial.
Background
Intrahepatic cholestasis of pregnancy (ICP) is a pregnancy complication whose range has been calculated to be between 0.01 and 15.6% all around the world. We wanted to systematically evaluate the effect and safety of oral herbal medicine on treatment for ICP.
Methods
Details of the methods could be found in the registered protocol on PROSPERO (CRD42018096013). Trials assessing the effectiveness of herbal medicine for ICP were searched from seven electronic databases from inception to 28th February 2020. RevMan 5.3 software was used to perform all statistical analysis. Meta-analysis, additional analysis, Trial Sequential Analysis (TSA) and Grading of Recommendations Assessment, Development and Evaluation (GRADE) were conducted if data permitted.
Results
Totally 43 randomized controlled trials with 3556 patients were included. Meta-analysis showed potential good adjunctive effect of herbal medicine on decreasing the pruritus scores (MD -0.58, 95% CI − 0.79 to − 0.36), the serum TBA scores (MD − 3.99 μmol/L, 95% CI − 4.24 to − 3.74) on the basis with Ursodesoxycholic acid. Compared to the medicine alone, significantly lower incidence of fetal distress (RR 0.41, 95% CI 0.32 to 0.51), asphyxia neonatorum (RR 0.35, 95%CI 0.25 to 0.49), cesarean section (RR 0.73, 95% CI 0.63 to 0.85), postpartum hemorrhage (RR 0.45, 95% CI 0.28 to 0.72) were observed in the combination group. But the comparison between herbal medicine and medicine showed inconsistent results among trials. Insufficient information could be used to evaluate the safety of herbal medicine for ICP.
Conclusion
This review found the current evidence may support the effectiveness of combination of herbal medicine and conventional medicine for decreasing the maternal pruritus scores, the serum TBA, and the number of fetal distress, or asphyxia neonatorum events related to this condition (which was supported by TSA results). Since there were obvious statistical and clinical heterogeneity among trials, and the methodological quality of the included studies was poor, the level of the evidence could only be defined as “very low” according to the GRADE criteria. Further high quality studies are still needed to testify the effectiveness and safety of herbal medicine for ICP.
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