Ginseng polysaccharides ameliorate ulcerative colitis via regulating gut microbiota and tryptophan metabolism.

Ulcerative colitis (UC) is regarded as a recurring inflammatory disorder of the gastrointestinal tract, for which treatment approaches remain notably limited. In this study, we demonstrated that ginseng polysaccharides (GPs) could alleviate the development of dextran sulfate sodium (DSS)-induced UC as reflected by the ameliorated pathological lesions in the colon. GPs strikingly suppressed the expression levels of multiple inflammatory cytokines, as well as significantly inhibited the infiltration of inflammatory cells. Microbiota-dependent investigations by virtue of 16S rRNA gene sequencing, antibiotic treatment and fecal microbiota transplantation illustrated that GPs treatment prominently restored intestinal microbial balance predominantly through modulating the relative abundance of Lactobacillus. Additionally, GPs remarkably influenced the levels of microbial tryptophan metabolites, diminished the intestinal permeability and strengthened intestinal barrier integrity via inhibiting the 5-HT/HTR3A signaling pathway. Taken together, the promising therapeutic potential of GPs on the development of UC predominantly hinges on the capacity to suppress the expression of inflammatory cytokines as well as to influence Lactobacillus and microbial tryptophan metabolites.

Efficacy and safety of Xian-Lian-Jie-Du optimization decoction as an adjuvant treatment for prevention of recurrence in patients with stage IIIB/IIIC colon cancer: study protocol for a multicentre, randomized controlled trial.

INTRODUCTION: Colon cancer remains one of the most prevalent cancers worldwide. Unfortunately, there are no recognized and effective therapeutic strategies to prevent tumor recurrence after radical resection and chemotherapy, and the disease-free survival (DFS) in patients with stage IIIB or IIIC disease remains unsatisfactory. Xian-Lian-Jie-Du optimization decoction (XLJDOD) is a Chinese herbal medicine (CHM) empirical prescription, which has been validated experimentally and clinically that could inhibit the progression of colorectal cancer and ameliorate the symptoms. The purpose of this study is to evaluate the efficacy and safety of XLJDOD in prevention of recurrence of colon cancer. METHODS: This study is a multi-center, double-blind, randomized, placebo-controlled trial conducted at 13 hospitals of China. Following the completion of surgery and adjuvant 5- fluorouracil-based chemotherapy, a total of 730 subjects with stage IIIB or IIIC colon cancer will be randomized in a 1:1 ratio to an intervention group (n = 365; XLJDOD compound granule) and a control group (n = 365; Placebo). Patients will receive 6-month treatments and be followed up with 3 monthly assessments for 2 years. The primary outcome is 2-year DFS rate and the secondary outcomes are 1, 2-year relapse rate (RR), overall survival (OS) and quality of life (QoL). Safety outcomes such as adverse events will be also assessed. A small number of subgroup analysis will be carried out to explore the heterogeneity of effects of XLJDOD. DISCUSSION: The outcomes from this randomized controlled trial will provide objective evidences to evaluate XLJDOD's role as an adjuvant treatment in colon cancer. TRIAL REGISTRATION: www. CLINICALTRIALS: gov , identifier: NCT05709249. Registered on 31 Jan 2023.

Application of electroacupuncture in the prevention of low anterior resection syndrome after rectal cancer surgery.

BACKGROUND: Low anterior resection syndrome (LARS) is one of the common postoperative complications in patients with rectal cancer, which seriously affects their postoperative recovery and quality of life (QoL). Electroacupuncture therapy is one of the characteristic therapies of traditional Chinese medicine. There are few reports on the prevention and treatment of LARS by electroacupuncture therapy. AIM: To explore the clinical effectiveness of electroacupuncture in managing rectal cancer patients with postoperative LARS. METHODS: A total of 50 patients with LARS after rectal cancer surgery were retrospectively selected as the research subjects. According to the treatment methods, they were divided into an observation group (n = 25) and a control group (n = 25). During the four-week treatment period, the control group received standard defecation function training, while the observation group received electroacupuncture care and traditional defecation function training. The anal pressure index (which includes anal resting pressure, anal systolic pressure, and maximum tolerable volume), European Organization of Research and Treatment of Cancer (EORTC) QoL C30 (QLQ-C30) score, LARS Scale (LARSS) score, Wexner anal incontinence scale score, Xu Zhongfa five-item 10-point scale score, and the occurrence of adverse reactions were compared between the two groups before and after treatment. RESULTS: The experimental group showed considerably enhanced LARSS scores compared to those in the control group after four weeks of treatment. In the first week, second week, and fourth week, the LARSS score and Wexner anal incontinence scale score decreased, and the Xu Zhong method five-item 10-point scale score increased, with significant differences (P < 0.05). The experimental group showed substantial improvements in anal resting pressure, anal systolic pressure, and maximum tolerance volume after undergoing 4 wk of therapy in the untreated group (P < 0.05). The experimental group's QLQ-C30 score on the EORTC QoL questionnaire was higher than that of the control group during the 1st, 2nd, and 4th wk (P < 0.05). No significant variation between the groups in the frequency of adverse reactions (P > 0.05) was observed. CONCLUSION: Electroacupuncture positively impacted LARS following rectal cancer surgery, effectively improving clinical symptoms and anal pressure indicators and patients' standard of life.

Potential efficacious materials investigation of Yi-Yi Mixture based on Metabolome-oriented network pharmacology strategy.

Yi-Yi Mixture, an efficient Chinese medicine preparation composed of four herbal medicines, has been used in clinical practice in China for the treatment of acute pancreatitis over twenty years. However, its functional materials against acute pancreatitis remains unclear, which is a huge obstacle for quality control. In this study, a metabolome-oriented network pharmacology strategy was proposed to clarify its potential substances and further screen out quality markers. Firstly, an Ultra-High performance liquid chromatography coupled with quadrupole time-of-flight mass spectrometry method was utilized to profile the chemical constituents in Yi-Yi Mixture. Secondly, metabolic exposure of chemical constituents as well as their global metabolites produced in biological systems were profiled and defined as metabolome of Yi-Yi Mixture. Then, the metabolome targets were predicted based on network analysis. As a result, a total of 66 chemical components were characterized, including 6 stilbenes, 21 anthraquinones, 7 phenols, 13 neolignans, 3 naphthalenes and 16 other types. Moreover, metabolic profiles of YYM (32 prototypes and 37 metabolites) were analyzed in rat bio-samples. Among them, resveratrol, emodin, chrysophanol, rhein and their derivatives were detected in multiple tissues/organs, revealing their potential as key pharmacodynamic substances. These were further confirmed by metabolome-oriented network analysis and molecular docking techniques. This is the first comprehensive investigation on chemical and metabolic profiles of Yi-Yi Mixture, and the results provided scientific foundation for further research on quality control and clinical-safe medication administration.

Effects and safety of herbal medicines among community-dwelling residents during COVID-19 pandemic: A large prospective, randomized controlled trial (RCT).

BACKGROUND: Since the declaration of COVID-19 as a global pandemic by the World Health Organization, countries are struggling with a shortage of medical capacities. It would be essential if the risk for preventable comorbidities, such as the common cold, can be reduced or prevented, so that the scarce medical resources and facilities can be focused on COVID-19. PURPOSE: To evaluate the effects of two herbal medicines (Jinhaoartemisia antipyretic granules and Huoxiangzhengqi oral liquids) in reducing the risk of the common cold in community-dwelling residents in China during the COVID-19 outbreak. STUDY DESIGN: A prospective open-label, parallel-group, cluster-randomized controlled trial (RCT), was conducted in Chengdu, China. METHODS: A total of 22,065 participants from 11 communities were recruited during a period of one month. The trial started on 30 January and participants were followed up till 29 February 2020. Participants were randomly assigned to receive either a five-day herbal medicine therapy plus a reference manual or a reference manual only if they were allocated to the control group. The primary endpoint was the occurrence of patient-reported common cold symptoms. The secondary endpoint was the time in days from the receipt of herbal drugs/reference manual and the occurrence of the common cold symptoms. RESULTS: Use of herbal medicine reduced the risk of the common cold by 89.6% (95% CI, 52.9% to 97.7%) in all community-dwelling residents, and by 94.0% (95% CI, 52.1% to 99.2%) in residents aged between 16 and 59 years old. Sensitivity analyses showed similar results. CONCLUSION: This community-based RCT found that the use of a herbal medicine therapy (Jinhaoartemisia antipyretic granules and Huoxiangzhengqi oral liquids) could significantly reduce the risks of the common cold among community-dwelling residents, suggesting that herbal medicine may be a useful approach for public health intervention to minimize preventable morbidity during COVID-19 outbreak.

[Effect of acupoint application therapy at different timing points on gastrointestinal function recovery and heart rate variability after laparoscopic resection of colorectal cancer].

OBJECTIVE: To observe the effect of acupoint application therapy at different timing points on the gastrointestinal function recovery and heart rate variability (HRV) after laparoscopic resection of colorectal cancer under the instruction of enhanced recovery after surgery (ERAS). METHODS: A total of 105 patients for the selective laparoscopic resection of colorectal cancer were selected and randomized into a preoperative acupoint application group (35 cases, 3 cases dropped off), a postoperative acupoint application group (35 cases, 1 case dropped out) and a control group (35 cases, 2 cases dropped off). In the control group, ERAS interventions were provided, such as health education, fluid supplementation and multi-mode analgesia. On the base of the treatment as the control group, in the preoperative acupoint application group and the postoperative acupoint application group, 3 days before operation and 6 h after operation, the acupoint application therapy was given respectively. The acupoints were Zusanli (ST 36), Shangjuxu (ST 37), Sanyinjiao (SP 6), Neiguan (PC 6) and Xiajuxu (ST 39). The acupoint application was exerted for 6 h each time, once daily till the first postoperative exhaust and defecation presented. It was to observe the time of the first postoperative exhaust, defecation and food intake, the score of visual analogue scale (VAS) 1 to 3 days after operation, the total score of gastrointestinal symptom rating scale (GSRS) before and 1 week after operation, as well as the related indicators of HRV [standard deviation of NN intervals (SDNN) and the ratio of low-frequency power and high frequency power (LF/HF)] in the three groups successively. Besides, the adverse reactions were recorded during intervention in the three groups. RESULTS: Compared with the control group, the time of the first postoperative exhaust and the time of the first postoperative defecation were all earlier in the preoperative acupoint application group and the postoperative acupoint application group respectively (P<0.05), and VAS scores 1 to 3 days after operation and total GSRS scores 1 week after operation were all reduced (P<0.05); the time of first food intake was earlier after operation (P<0.05), and SDNN and LF/LF were increased 1 day and 3 days after operation in the preoperative acupoint application group (P<0.05). Compared with the postoperative acupoint application group, in the preoperative acupoint application group, the time of the first postoperative exhaust and the time of the first postoperative defecation were all earlier (P<0.05), VAS scores were reduced in 1 to 3 days after operation (P<0.05), and SDNN 1 day and 3 days after operation and LF/HF 1 day after operation were all increased (P<0.05). No adverse reaction was detected in patients of the three groups. CONCLUSION: Under the instruction of ERAS, the preoperative acupoint application effectively promotes the postoperative gastrointestinal function recovery, improves HRV and autonomous nerve function in the patients after laparoscopic resection of colorectal cancer. The therapeutic effect of this therapy is better than the postoperative acupoint application.

[Large- scale prospective clinical study on prophylactic intervention of COVID-19 in community population using Huoxiang Zhengqi Oral Liquid and Jinhao Jiere Granules].

To scientifically evaluate the intervention effect of Chinese medicine preventive administration(combined use of Huo-xiang Zhengqi Oral Liquid and Jinhao Jiere Granules) on community population in the case of coronavirus disease 2019(COVID-19), a large cohort, prospective, randomized, and parallel-controlled clinical study was conducted. Total 22 065 subjects were included and randomly divided into 2 groups. The non-intervention group was given health guidance only, while the traditional Chinese medicine(TCM) intervention group was given two coordinated TCM in addition to health guidance. The medical instructions were as follows. Huoxiang Zhengqi Oral Liquid: oral before meals, 10 mL/time, 2 times/day, a course of 5 days. Jinhao Jiere Granules: dissolve in boiling water and take after meals, 8 g/time, 2 times/day, a course of 5 days, followed up for 14 days, respectively. The study found that with the intake of medication, the incidence rate of TCM intervention group was basically maintained at a low and continuous stable level(0.01%-0.02%), while the non-intervention group showed an overall trend of continuous growth(0.02%-0.18%) from 3 to 14 days. No suspected or confirmed COVID-19 case occurred in either group. There were 2 cases of colds in the TCM intervention group and 26 cases in the non-intervention group. The incidence of colds in the TCM intervention group was significantly lower(P<0.05) than that in the non-intervention group. In the population of 16-60 years old, the incidence rate of non-intervention and intervention groups were 0.01% and 0.25%, respectively. The difference of colds incidence between the two groups was statistically significant(P<0.05). In the population older than 60 years old, they were 0.04% and 0.21%, respectively. The incidence of colds in the non-intervention group was higher than that in the intervention group, but not reaching statistical difference. The protection rate of TCM for the whole population was 91.8%, especially for the population of age 16-60(95.0%). It was suggested that TCM intervention(combined use of Huoxiang Zhengqi Oral Liquid and Jinhao Jiere Granules) could effectively protect community residents against respiratory diseases, such as colds, which was worthy of promotion in the community. In addition, in terms of safety, the incidence of adverse events and adverse reactions in the TCM intervention group was relatively low, which was basically consistent with the drug instructions.

Study on efficacy and safety of Huangqi Guizhi Wuwu decoction treatment for oxaliplatin induced peripheral neurotoxicity: A protocol for a randomized, controlled, double-blind, multicenter trial.

BACKGROUND: Oxaliplatin can cause severe peripheral neurotoxicity, which is an important reason for clinical oxaliplatin reduction and cessation of treatment. Oxaliplatin induced peripheral neurotoxicity (OIPN) can cause paresthesia and dysesthesia, even affect the quality life of patients. So far, there are no recognized and effective measures to prevent OIPN. Huangqi Guizhi Wuwu decoction is a classical prescription of ancient Chinese medicine recorded in "the synopsis of the Golden Chamber," which can be used in the treatment of various neurotoxicity. However, there is a lack of large-scale and high-quality clinical studies on the prevention of OIPN by Huangqi Guizhi Wuwu decoction. The purpose of this study is to evaluate the efficacy and safety of Huangqi Guizhi Wuwu decoction on preventing OIPN. METHODS/DESIGN: This study is a randomized, controlled, double-blind, and multicenter clinical trial. Three hundred sixty patients will be randomly assigned into Huangqi Guizhi Wuwu decoction group and Huangqi Guizhi Wuwu decoction mimetic agent group. Patients will receive chemotherapy with FOLFOX of 8 cycles of 3 weeks with Traditional Chinese Medicine (TCM) for 6 months and 1-year follow-up. The primary outcome measure is the differences in the incidence of chronic neurotoxicity of grade 2 and above during and after treatment. The secondary outcome measure is the improvement in other symptoms associated with chemotherapy. Four methods will be used to evaluate the efficacy of neurotoxicity, including oxaliplatin specific toxicity grading standard (Levi classification); CTCAE4.02 version; EORTC QLQ-CIPN20 scale, EORTC QLQ C30 scale, and EORTC QLQ-CR29 scale are used at the same time; Electromyography. DISCUSSION: This study will provide objective evidences to evaluate the efficacy and safety of Huangqi Guizhi Wuwu Decoction on preventing OIPN. TRIAL REGISTRATION: Clinical Trials.gov (Identifier: NCT04261920).

The impact of nutritional status, nutritional risk, and nutritional treatment on clinical outcome of 2248 hospitalized cancer patients: a multi-center, prospective cohort study in Chinese teaching hospitals.

To better understand the impact of undernutrition, nutritional risk, and nutritional treatment on the clinical outcomes of hospitalized cancer patients in China, the authors conducted a multicenter, cross-sectional study with 2248 cancer patients from 20 hospitals from January to June 2010. The authors defined 19.7% and 26.8% patients as undernourished at baseline and reassessment, respectively. Patients with gastrointestinal malignancies had a higher rate of undernutrition than other patients. The nutritional risk rate was 24.6% and 40.2% at baseline and reassessment, respectively. For patients with nutritional risk, the relative risk (RR) of adverse events (AEs) significantly increased with and without nutritional treatment. In comparison with the nonnutritional treatment subgroup, patients who received enteral nutrition (EN) or total parenteral nutrition (TPN) significantly reduced the RR of AE development. The RR of AEs for EN and TPN were 0.08 (95% CI: 0.01-0.62) and 0.56 (95% CI: 0.33-0.96), respectively. Separated nutrient infusion increased the risk of AEs. The authors concluded that undernutrition and nutritional risk are general problems that impact the outcomes of hospitalized cancer patients in China. Higher NRS2002 scores are related to AE risk but not weight loss. In nutritional treatment, EN and TPN can significantly reduce the risk of AEs.