Effect of traditional Chinese medicine combined group psychotherapy on psychological distress management and gut micro-biome regulation for colorectal cancer survivors: a single-arm phase I clinical trial.

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 Hospital and Beijing Cancer Hospital in China. Inclusion criteria included stage I-III CRC survivors after radical surgery with age between 18 and 75. The intervention was a 6-week online TCM combined group psychotherapy intervention including 90-min 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). Fecal 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, symptom burden of 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.

Adjunctive effect of compound Kushen Injection to chemotherapy for non-small cell lung cancer: An evidence map and overview of systematic reviews.

ETHNOPHARMACOLOGICAL RELEVANCE: Extract from Kushen (Sophora flavescens Aiton) and Baituling (Heterosmilax japonica Kunth), Compound Kushen Injection has a long history for cancer treatment in China. As a common adjunctive drug in chemotherapy of non-small cell lung cancer (NSCLC), the evidence of effectiveness and safety of Compound Kushen Injection needs to be synthesized. AIM OF THE STUDY: The objective of this overview is to synthesize recent evidence and assess the methodological quality of systematic reviews (SRs) of Compound Kushen Injection, in treating NSCLC as an adjunctive treatment of chemotherapy. MATERIALS AND METHODS: We searched PubMed, PubMed Central, China National Knowledge Infrastructure, Wanfang Data Knowledge Service Platform and VIP China Science and Technology Journal Database from inception to April 22, 2020. We included SRs of the efficacy and safety of Compound Kushen Injection combined with chemotherapy in the treatment of NSCLC. Two authors assessed eligibility and extracted data. The quality of SRs was assessed using AMSTAR-2. A meta-analysis was conducted for the original trials where good homogeneity was present. Evidence maps using bubble plots illustrated overall results. The quality of the evidence was graded by the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach. RESULTS: Twelve SRs were included, with 91 randomized controlled trials and 7466 participants. Overall, the quality of the included SRs was low. Only six SRs reported specific chemotherapy regimens, three using vinorelbine combined with cisplatin (NP), one using paclitaxel combined with cisplatin (TP), one using gemcitabine combined with cisplatin (GP), and one discussed the three regimens in subgroups. Meta-analysis showed that CKI used as an adjuvant to chemotherapy was superior to chemotherapy alone in promoting tumor complete response rate, tumor partial response rate, Kamofsky score, and relieving some chemotherapy related side effects. Evidence mapping showed that Kushen Injection combined with NP and GP had better effect. The evidence quality of increasing Kamofsky score and decreasing the incidence of leukopenia were moderate, others were low or very low. CONCLUSIONS: There are some favorable effects in improving short-term effectiveness, quality of life and alleviating some side effects of chemotherapy in patients with NSCLC. Results are more promising when Compound Kushen injection is used as an adjunctive to NP and GP. Promising results are however, compromised by the poor quality overall of the clinical trials.

Oral herbal medicine for women with intrahepatic cholestasis in pregnancy: a systematic review of randomized controlled trials.

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.