Evaluation of compliance of CONSORT-CHM formula 2017 in randomized controlled trials of Chinese herbal medicine formulas: protocol of a five-year review.

Background: The CONSORT Extension for Chinese Herbal Medicine Formula 2017 (CONSORT-CHM Formula 2017) has established a reporting standard for randomized controlled trials (RCTs) of Chinese Herbal Medicine Formula (CHMF) interventions; however, its adherence and implications for the design and execution of study design remain ambiguous. It is necessary to evaluate the level of compliance with the CONSORT-CHM Formula 2017 in RCTs conducted over the past 5 years, and to determine the reporting quality of clinical trials in this field. Methods: First, a systematic search is conducted for RCTs on CHMF in EBM Reviews, Allied and Complementary Medicine (AMED), Embase, Ovid-MEDLINE(R), Wanfang data, China National Knowledge Infrastructure (CNKI), VIP Chinese Medical Journal Database (VIP) and Chinese Biomedical Literature (CBM) database, that encompassed CHMF interventional RCTs published from 1 January 2018 to 8 June 2022, with language restriction to English or Chinese. Second, a descriptive analysis will be performed regarding the study design and general characteristics of the included trials. Third, for the quality assessment, we have subdivided the CONSORT-CHM Formula 2017 checklist (consisting of 22 extended items) into a total of 42 sub-questions to facilitate scoring, with a specific focus on the description, quality control, and safety assessment of CHMF interventions. Professional training and a pilot test on 100 randomly selected articles will be provided for all reviewers. Throughout this process, a standard operating procedure (SOP) for quality assessment will be developed to ensure consistency. Each item will be assessed by two reviewers in a paired back-to-back manner, and the compliance rate will be calculated to assess inter-rater agreement. Discussion: This review will identify the current reporting characteristics and quality of CHMF interventional studies and further evaluate the impact of CONSORT-CHM Formula 2017. The results may provide suggestions for future application or promotion of the guideline. Registration: The study has been registered on Open Science Framework (https://osf.io/xpn7f).

The Landscape of Gut Microbiota and Its Metabolites: A Key to Understanding the Pathophysiology of Pattern in Chinese Medicine.

Liver Stagnation and Spleen Deficiency (LSSD) is a Chinese Medicine (CM) pattern commonly observed in gastrointestinal (GI) diseases, yet its biological nature remains unknown. This limits the global use of CM medications for treating GI diseases. Recent studies emphasize the role of gut microbiota and their metabolites in the pathogenesis and treatment of LSSD-associated GI diseases. There is increasing evidence supporting that an altered gut microbiome in LSSD patients or animals contributes to GI and extra-intestinal symptoms and affects the effectiveness of CM therapies. The gut microbiota is considered to be an essential component of the biological basis of LSSD. This study aims to provide an overview of existing research findings and gaps for the pathophysiological study of LSSD from the gut microbiota perspective in order to understand the relationship between the CM pattern and disease progression and to optimize CM-based diagnosis, prevention, and therapy.

The double-edged sword effect of indigo naturalis.

Indigo naturalis (IN) is a dried powder derived from plants such as Baphicacanthus cusia (Neeks) Bremek., Polygonum tinctorium Ait. and Isatis indigotica Fork. It has a historical application as a dye in ancient India, Egypt, Africa and China. Over time, it has been introduced to China and Japan for treatment of various ailments including hemoptysis, epistaxis, chest discomfort, and aphtha. Clinical and pre-clinical studies have widely demonstrated its promising effects on autoimmune diseases like psoriasis and Ulcerative colitis (UC). Despite the documented efficacy of IN in UC patients, concerns have been raised on the development of adverse effects with long term consumption, prompting a closer examination of its safety and tolerability in these contexts. This review aims to comprehensively assess the efficacy of IN in both clinical and pre-clinical settings, with a detailed exploration of the mechanisms of action involved. Additionally, it summarizes the observed potential toxicity of IN in animal and human settings was summarized. This review will deepen our understanding on the beneficial and detrimental effects of IN in UC, providing valuable insights for its future application in patients with this condition.

Electro-acupuncture for central obesity: a patient-assessor blinded, randomized sham-controlled clinical trial.

BACKGROUND: Central obesity is considered as a significant health threat to individuals. Scientific research has demonstrated that intra-abdominal fat accumulation is associated with higher metabolic and cardiovascular disease risks independent of Body Mass Index (BMI). This study aimed to evaluate the efficacy and safety of electro-acupuncture in treating central obesity compared with sham acupuncture. METHOD: This was a patient-assessor blinded, randomized, sham-controlled clinical trial. One hundred sixty eight participants aged between 18 and 65 years old with BMI ≥ 25 kg/m2 and waist circumference (WC) of men ≥ 90 cm / women ≥ 80 cm were enrolled and allocated to the acupuncture or sham acupuncture group equally. For the acupuncture group, disposable acupuncture needles were inserted into eight body acupoints, including Tianshu (ST-25), Daheng (SP-15), Daimai (GB-26), Qihai (CV-6), Zhongwan (CV-12), Zusanli (ST-36), Fenglong (ST-40), and Sanyinjiao (SP-6) with electrical stimulation. For the control group, Streitberger's non-invasive acupuncture needles were utilized at the same acupoints with identical stimulation modalities. The treatment duration was 8 weeks with 2 sessions per week and the follow-up period was 8 weeks. The primary outcome was the change in WC before and after the treatment. The secondary outcomes were the changes in hip circumference, waist-to-hip circumference ratio, BMI, and body fat percentage during the treatment and follow-up period. RESULTS: The acupuncture group displayed a significant change in WC compared to the sham group both treatment and follow-up period (MD = -1.1 cm, 95% CI = -2.8 to 4.1). Significant change in body fat percentage was recorded for both groups after treatment but no significance was observed during the follow-up period (MD = -0.1%, 95% CI = -1.9 to 2.2). The changes in hip circumference were also significant both treatment and follow-up period for the acupuncture group (MD = -2.0 cm, 95% CI = -3.7 to -1.7). Compared with sham acupuncture, the body weight (MD = -1 kg, 95% CI = -3.3 to 5.3), BMI (MD = -0.5, 95% CI = -0.7 to 1.9) also decreased significantly within and between groups. The incidence of adverse events was similar in the two groups. CONCLUSION: This study provided evidence that electro-acupuncture could be effective in treating central obesity by reducing WC, hip circumference, body weight, BMI, and waist-to-hip circumference ratio. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03815253, Registered 24 Jan 2019.

One-step enrichment of phenolics from Chaenomeles speciosa (Sweet) Nakai fruit using macroporous resin: Adsorption/desorption characteristics, process optimization and UPLC-QqQ-MS/MS-based quantification.

Chaenomeles speciosa (Sweet) Nakai fruit is a good source of phenolics with many health benefits. In this work, the enrichment of C. speciosa fruit total phenolics (CSFTP) using macroporous resins was studied. NKA-Ⅱ resin was selected for enriching CSFTP due to its highest adsorption/desorption quantity. Adsorption characteristics of CSFTP on NKA-Ⅱ resin exhibited a good fit with the Langmuir isotherm model and pseudo-second order kinetics model. This adsorption was spontaneous, exothermic, and entropy-decreasing through a physisorption mechanism. The breakthrough-elution curves were studied to optimize CSFTP enrichment conditions. One-step enrichment increased CSFTP content in the extracts from 26.51 % to 78.63 %, with a recovery of 81.03 %. A UPLC-QqQ-MS/MS method in multiple reaction monitoring (MRM) mode was established and validated for the simultaneous quantification of seven phenolic compounds. This study demonstrates the feasibility of industrial enrichment of CSFTP using NKA-Ⅱ resin and proposes a reliable method for quality control of CSFTP-rich products.

A clinical pathway for integrative medicine in the treatment of functional constipation in Hong Kong, China.

OBJECTIVE: Functional constipation (FC) is a common intestinal disease worldwide. Despite the presence of criteria such as Roman IV, there is no standardized diagnosis and treatment algorithm in Hong Kong that combines both Western and Chinese medicine approaches. This study integrates current effective and safe diagnosis and treatment methods for FC and provides a clear and scientific pathway for clinical professionals and patients. METHODS: A systematic search of the PubMed, Cochrane Library, and China National Knowledge Infrastructure databases was performed from their inception to June 30th, 2022, collecting the current evidence about the efficacious integrative management for FC. We organized a meeting of professionals in fields relevant to treatment and management of FC to develop a consensus agreement on clinical pathway process. RESULTS: We developed a clinical pathway for the treatment of FC based on the most recent published guidelines and consultation with experts. This pathway includes a hierarchy of recommendations for every step of the clinical process, including clinical intake, diagnostic examination, recommended labs, diagnostic flowchart, and guidance for selection of therapeutic drugs. CONCLUSION: This pathway establishes clinical standards for the diagnosis and treatment of FC using Chinese medicine and Western medicine; it will help to provide high-quality medical services in Hong Kong for patients with FC. Please cite this article as: Wei DJ, Li HJ, Lyu ZP, Lyu AP, Bian ZX, Zhong LL. A clinical pathway for integrative medicine in the treatment of functional constipation in Hong Kong, China. J Integr Med. 2023; 21(6): 550-560.

Validation of the Cantonese version of the Traditional Chinese Medicine (TCM) Body constitution Questionnaire in elderly people.

BACKGROUND: The Traditional Chinese Medicine (TCM) Body Constitution Questionnaire (For Elderly People) (TCMECQ) is a patient-reported outcome questionnaire developed in Mandarin in 2013 to differentiate the body constitutions of the elderly aged 65 and above. Considering the cultural and linguistic differences between Mainland China and Hong Kong (HK) Special Administrative Region, the TCMECQ was translated into Cantonese following "back translation" policy and validated in proper process. METHODS: Ten Chinese Medicine Practitioners (CMPs) and 30 senior citizens aged 65 or above were recruited to evaluate the first version of the Traditional Chinese Medicine Body Constitution Questionnaire (For Elderly People) (Cantonese version) (TCMECQ-C). Based on their comments, the second version was developed and discussed in the panel meeting to form the third version, validated the third version on 270 recruited seniors. Based on the validation results, a panel of 5 experts finalized the Questionnaire as the final version. The TCMECQ-C developers finalized the Questionnaire as the validated endorsed third version (i.e. final version). RESULTS: The item-level content validity index of most items of the TCMECQ-C (First Version) were ranging from 0.80 to 1.00 in terms of clarity, relevance and appropriateness. Factor loadings of Qi-deficiency Constitution ranging from 0.37 to 0.71, Yang-deficiency Constitution ranging from 0.36 to 0.65, Yin-deficiency Constitution ranging from 0.36 to 0.65, and Stagnant Qi Constitution ranging from 0.68 to 0.82. The chi-squared degree-of-freedom ratio was 2.13 (928.63/436), Goodness-of-Fit Index (0.83), Adjusted Goodness-of-Fit Index (0.79), Normed Fit Index (0.66), Comparative Fit Index (0.78), Incremental Fit Index (0.78), Relative Fit Index (0.61) and Tucker-Lewis Index (0.75), and Root Mean Square Error of Approximation (0.07) and Standardized Root Mean Square Residual (0.07), implied acceptable Confirmatory Factor Analysis model fit of the overall scale. A Pearson correlation coefficient (r) showed the sufficient convergent validity for excessive subscales (Phlegm-dampness Constitution and Dampness-heat Constitution with r = 0.35, p < 0.01). Cronbach's alpha coefficient ranged from 0.56 to 0.89, including Qi-deficiency Constitution (0.67), Yang-deficiency Constitution (0.84), Yin-deficiency Constitution (0.59), Stagnant Blood Constitution (0.56), Stagnant Qi Constitution (0.89), Inherited Special Constitution (0.76) and Balanced Constitution (0.73), indicating acceptable internal consistency for subscales. The intra-class correlation coefficients of the TCMECQ-C ranged from 0.70 to 0.87 (p < 0.001), indicating moderate to good test-retest reliability. CONCLUSION: TCMECQ-C is a valid and reliable questionnaire for assessing the body constitution in Cantonese elderly.

Effectiveness of Chinese Herbal Medicine in Patients with COVID-19 During the Omicron Wave in Hong Kong: A Retrospective Case-Controlled Study.

SARS-CoV-2 Omicron led to the most serious outbreak of COVID-19 in Hong Kong in 2022. Under the pressure of a high volume of patients and limited medical resources, Chinese herbal medicine (CHM) has been extensively used. This is a case-control study of the infected patients that aims to evaluate the effectiveness of CHM using data extracted from the Hong Kong Baptist University Telemedicine Chinese Medicine Centre database. Patients with COVID-19 confirmed by either a rapid antigen test or a polymerase chain reaction who had completed two consultations and taken CHM within 10 days of the first positive test were included in the study (CHM group, [Formula: see text]). The matched control cases were those who did not take CHM within 10 days of the first positive test and were based on age ([Formula: see text] 3 years), vaccine doses ([Formula: see text] 3 doses, or 3 doses), and gender (no-CHM group, [Formula: see text]). The outcomes included the negative conversion time (NCT, primary outcome), total score of individual symptoms, number of the reported symptoms, and individual symptom disappearance rates. The NCT of the CHM group (median days: 7.0, interquartile range: 6.0-8.0) was significantly shorter than that of the no-CHM group (8.0, 7.0-10.5; [Formula: see text]). CHM treatment significantly reduced the total score of individual symptoms ([Formula: see text]) and the number of the reported symptoms ([Formula: see text]) as compared with that of the no-CHM group. Additionally, the symptom disappearance rates of symptoms such as chills, cough, sputum, dry throat, itching throat, headache, chest tightness, abdominal pain, diarrhea, and fatigue were significantly higher in the CHM group than in the no-CHM group. In conclusion, CHM intervention can significantly reduce NCT and COVID-19 symptoms. Chinese medicine can be accurately prescribed based on a telemedical consultation.

Altered gut microbiota-host bile acid metabolism in IBS-D patients with liver depression and spleen deficiency pattern.

BACKGROUND: Dysregulation of gut microbiota-host bile acid (BA) co-metabolism is a critical pathogenic factor of diarrhea-predominant irritable bowel syndrome (IBS-D). Traditional Chinese Medicine (TCM), instructed by pattern differentiation, is effective in treating IBS-D, in which liver depression and spleen deficiency (LDSD) is the most prevalent pattern. Still, it is unclear the linkage between the LDSD pattern and the BA metabolic phenotype. PURPOSE: This study aimed to uncover the biological basis of the LDSD pattern from the BA metabolic perspective. METHODS: Patients with IBS-D completed questionnaires regarding the irritable bowel severity scoring system (IBS-SSS), stool frequency, Stool Bristol scale, and Self-Rating Scales of mental health. Fasting blood and morning feces were collected to analyze the gut metagenome and BA-related indices/metabolites. RESULTS: IBS-D patients with LDSD had a higher incidence of BA overexcretion (41% vs. 23% non-LDSD) with significant elevations in fecal total BAs and serum BA precursor 7α-hydroxy-4-cholesten-3-one levels. Compared to controls or non-LDSD patients, LDSD patients had a featured fecal BA profile, with higher proportions of deoxycholic acid (DCA), 7-ketodeoxycholic acid, and lithocholic acid. It is consistent with the BA-metabolizing genomic changes in the LDSD gut microbiota characterized by overabundances of 7-dehydroxylating bacteria and BA-inducible genes (baiCD/E/H). The score of bowel symptoms (stool frequency and abdominal pain) showing greater severity in the LDSD pattern were positively correlated with bai-expressing bacterial abundances and fecal DCA levels separately. CONCLUSION: We clarified a differed BA metabolic phenotype in IBS patients with LDSD, which closely correlates with the severity of bowel symptoms. It demonstrates that gut microbiota and host co-metabolism of BAs would provide crucial insight into the biology of the LDSD pattern and its internal relationship with IBS progression.

Reporting quality of randomized controlled trials of angina pectoris with integrated traditional Chinese and western medicine interventions: a cross-sectional study.

BACKGROUND AND OBJECTIVE: Integrated traditional Chinese and western medicine (ITCWM), as a representative type of complex intervention, is commonly used for the treatment of angina pectoris (AP) in clinical practice. However, it is unclear whether the details of ITCWM interventions, such as rationale for selection and design, implementation and potential interactions for different therapies, were adequately reported. Therefore, this study aimed to describe the reporting characteristics and quality in randomized controlled trials (RCTs) of AP with ITCWM interventions. METHODS: Through a search of 7 electronic databases, we identified RCTs of AP with ITCWM interventions published in both English and Chinese from 1st Jan 2017 to 6th Aug 2022. The general characteristics of included studies were summarized, further, the quality of reporting was assessed based on three Checklists, including the CONSORT with 36 items (except for one item 1b about abstract), the CONSORT for abstracts (17 items), and a self-designed ITCWM-related checklist (21 items covering rationale and details of interventions, outcome assessment and analysis). The quality of RCTs published in English and Chinese, as well as journals and dissertations were also compared. RESULTS: A total of 451 eligible RCTs were included. For the reporting compliance, the mean score (95% Confidence Interval) of the CONSORT (72 scores in total), CONSORT for abstract (34 scores in total), and ITCWM-related (42 scores in total) checklists was 27.82 (27.44-28.19), 14.17 (13.98-14.37) and 21.06 (20.69-21.43), respectively. More than half items were evaluated as poor quality (reporting rate < 50%) among each Checklist. Moreover, the reporting quality of publications in English journals was higher than that in Chinese journals in terms of the CONSORT items. The reporting of published dissertations was better than that in journal publications regarding both the CONSORT and ITCWM-specific items. CONCLUSION: Although the CONSORT appears to have enhanced the reporting of RCTs in AP, the quality of ITCWM specifics is variable and in need of improvement. Reporting guideline of the ITCWM recommendations should be developed thus to improve their quality.

Acupuncture for post-stroke depression: a systematic review and network meta-analysis.

BACKGROUND: Patients with post-stroke depression (PSD) usually experience anxiety, hopelessness, and insomnia, which have a negative impact on their daily activities and post-stroke rehabilitation. Acupuncture (AC), as a minimally invasive technique, has become a popular choice for improving depression symptoms. However, it is still unclear which therapy is associated with the best outcomes for PSD. In this review, we aimed to explore the impact of AC in alleviating symptoms of PSD and to evaluate the difference in effectiveness between AC combined with pharmacotherapies and various non-pharmacotherapies. METHODS: Six databases and three clinical trials registration platforms were searched from inception to March 2023. Randomized clinical trial comparing needle-based AC with pharmacotherapy, and other non-pharmacotherapy or invalid group were included. Two independent reviewers identified eligible studies, and collected data using a pre-made form. A Bayesian network meta-analysis was conducted to assess and compare different techniques using RStudio 3.6.0 with the package 'GEMTC' V.0.8.1. The primary outcome was the efficacy for PSD assessed by scales measuring depressive symptoms. The secondary outcomes were effectiveness for neurological function and the quality of life. The ranking probabilities for all treatment interventions was performed using the Surface Under the Cumulative Ranking curve (SUCRA). The risk of bias was assessed by using the Revised Cochrane Risk of Bias tool 2. RESULTS: Sixty-two studies, involving 5308 participants published from 2003 to 2022, were included. The results showed that compared with western medicine (WM) (defined as pharmacotherapy for PSD), AC alone or with repetitive transcranial magnetic stimulation (RTMS), Traditional Chinese medicine (TCM) alone or with WM, were superior for alleviating depression symptoms. Compared to Usual Care, AC alone or plus other therapies could significantly decrease scores on the Hamilton Depression Rating scale. According to result of SUCRA, AC plus RTMS had the highest probability of improving depressive symptoms with a probability of 49.43%. CONCLUSIONS: The results of this study indicate that AC alone or combined with other therapies appears to be effective in improving depression symptoms of stroke survivors. Moreover, in comparison to WM, AC alone or plus RTMS, TCM, TCM with WM, or WM, were more effective in improving depression symptoms of PSD. Also, AC with RTMS seems to be the most effective with the highest probability. REGISTRATION: This study was registered in the International Prospective Register of Systematic Reviews (PROSPERO) database in November 2020 and updated in July 2021. The registration number is CRD42020218752.

STandards for Reporting Interventions in Clinical Trials Of Tuina/Massage (STRICTOTM): Extending the CONSORT statement.

OBJECTIVES: Massage is a common therapy of nonpharmacological treatments, particularly in Tuina (Chinese massage) as its most common style, detailed guidance in reporting the intervention is warranted for its evaluation and replication. Based on the CONSORT (Consolidated Standards of Reporting Trials), we aimed to develop an Extension for Tuina/Massage, namely "The STandards for Reporting Interventions in Clinical Trials Of Tuina/Massage (STRICTOTM)." METHODS: A group of professional clinicians, trialists, methodologists, developers of reporting guidelines, epidemiologists, statisticians, and editors has developed this STRICTOTM checklist through a standard methodology process recommended by the EQUATOR (Enhancing the QUAlity and Transparency of Health Research) Network, including prospective registration, literature review, draft of the initial items, three rounds of the Delphi survey, consensus meeting, pilot test, and finalization of the guideline. RESULTS: A checklist of seven items (namely Tuina/Massage rationale, details of Tuina/Massage, intervention regimen, other components of the intervention, Tuina/Massage provider background, control or comparator interventions, and precaution measures), and 16 subitems were developed. Explanations and examples (E&E) for each item are also provided. CONCLUSIONS: The working group hopes that the STRICTOTM, in conjunction with both the CONSORT statement and extension for nonpharmacologic treatment, can improve the reporting quality and transparency of Tuina/Massage clinical research.

Promoting the quality and transparency of health research in China.

BACKGROUND AND OBJECTIVES: To review the efforts and progress in promoting quality and transparency of health research in China and to discuss how to improve. METHODS: We focused on three different types of health research: clinical trials, systematic reviews, and clinical practice guidelines, and summarized China's progress from their registration, implementation, and reporting stages. RESULTS: In the last 3 decades, China's major works include the following: 1) For registration, the trials and CPGs registries have been set up, and released policies to mandate registration and submission of protocols for trials. 2) For implementation, multiple clinical research and EBM centers have been established. The ResMan platform for data management has been created and required researchers to share results data. 3) For reporting, the Chinese EQUATOR Center has been set up. Translations and extensions of the CONSORT, PRISMA, and RIGHT have been published. 4) For traditional Chinese medicine (TCM), specific guidelines for the registration and reporting of TCM research have been developed. CONCLUSION: China has made progress in promoting research quality and transparency, especially in research registration and reporting. Nevertheless, more can be done in data management and sharing for research implementation, and good publication practices in TCM.

A framework on developing integrative medicine clinical practice guideline for stroke management and rehabilitation in Hong Kong.

BACKGROUND: Stroke is the second leading cause of death worldwide. In Hong Kong, the proportion of deaths caused by cerebrovascular disease accounted for approximately 6.8% of total deaths. Although integrative medicine approaches are widely adapted by patients, there is a lack of guideline to support the corresponding clinical practice for stroke management and rehabilitation. Therefore, we design this framework for the development of an integrative medicine clinical practice guideline (CPG) for stroke. METHODS: The framework follows the instructions of World Health Organization (WHO) handbook for guideline development, Guideline International Network (GIN), Appraisal of Guidelines for Research and Evaluation Instrument (AGREE II), and Reporting Items for Practice Guidelines in Healthcare (RIGHT). Three stages with ten steps are conducted. CONCLUSION: Clinical practice guidelines are essential to provide optimal recommendations for patients' prognosis. With proper methodology, this framework will facilitate the formation of clinical practice guideline for stroke through synthesizing evidences in the scope of integrative medicine.

A lymphatic route for a hyperbranched heteroglycan from Radix Astragali to trigger immune responses after oral dosing.

Gut barrier makes a huge research gap between in vivo and in vitro studies of orally bioactive polysaccharides: whether/how they contact the related cells in vivo. A hyperbranched heteroglycan RAP from Radix Astragali, exerting antitumor and immunomodulatory effects in vitro and in vivo, is right an example. Here, we determined first that RAP's antitumor activity is immune-dependent. Being undegraded and non-absorbing, RAP quickly entered Peyer's patches (PPs) in 1 h where it directly targeted follicle dendritic cells and initiated antitumor immune responses. RAP was further delivered to mesenteric lymph node, bone marrow, and tumor. By contrast, the control Dendrobium officinale polysaccharide did not enter PPs. These findings revealed a blood/microbiota-independent and selective lymphatic route for orally administrated RAP to directly contact immune cells and trigger antitumor immune responses. This route bridges the research gap between the in vitro and in vivo studies and might apply to many other bioactive polysaccharides.

Chinese herbal medicines in the treatment of ulcerative colitis: a review.

OBJECTIVE: To investigate how the ulcerative colitis (UC) be treated with Chinese herbal medicines (CHM), using Chinese medicine (CM) pattern (zheng) identification, in the current clinical practice. METHODS: A total of 7 electronic databases were systematically searched for UC clinical studies with CHM interventions (including single herbs and CHM formulas) published in English and Chinese from the date of their inception to November 25, 2020. Descriptive statistics were adopted to demonstrate the characteristics of study design, and to collate the commonly CM patterns of UC and frequently used CHM herbs and formulas. Further, IBM SPSS Modeler 18.0 and Cytoscape 3.7.1 software were used to analyze and visualize the associations between different categories of CHM and their zheng indications. RESULTS: A total of 2311 articles were included in this study, of which most (> 90%) were RCTs with CHM formulas. The most common zheng of UC was Large intestine dampness-heat, while the basic type of CM patten was Spleen deficiency. The most frequently used classical formula was Bai-Tou-Weng-Tang, followed by Shen-Ling-Bai-Zhu-San, and the commonly used proprietary CHM was Xi-Lei-San (enema). Sulfasalazine and Mesalazine are commonly used as concomitant western medicines. The most frequently used single medicinals were Huang Lian and Bai Zhu, which also identified as the core herbs for different CM patterns. CONCLUSION: This study examined the application of CHM interventions for UC and summarized their characteristics in clinical practice. These data indicated there were limited information about the safety assessment of CHM formulas and further RCTs including CM pattern(s) with strict design are necessary.

Herbal Medicines for Constipation and Phytochemical Comparison of Active Components.

Constipation is a very common medical condition worldwide, negatively affecting patients' quality of life and healthcare system. Rhubarb, senna leaf, and aloe are three frequently used herbal medications for achieving regular bowel movement. Rhubarb is also a key ingredient in MaZiRenWan, a Chinese medicine formula used every so often for constipation in oriental countries. We reviewed and summarized the major chemical components from these three botanicals, including dianthrones, anthraquinone glycosides, free anthraquinones, and other polyphenols. The purgative actions of these constituents have been compared. Anthraquinone, especially its dianthrone compounds such as sennoside A and sennoside B, as natural stimulant laxatives, possesses significant effects to promote gastrointestinal motility and relieve functional constipation. Furthermore, the safety, reported side effects, and other benefits of anthraquinone compounds are presented. To date, many anti-constipation natural products are being used but their research is relatively limited, and thus, more investigations in this field are indeed needed.

A pilot randomized placebo-controlled study on modified MaZiRenWan: a formulated Chinese medicine to relieve constipation for palliative cancer patients.

BACKGROUND: Constipation is a common problem among advanced cancer patients; however, many of them find limited effective from current therapies. Thus, we aimed to test the effect of a traditional Chinese herbal formula, modified MaZiRenWan (MZRW), by comparing with placebo among palliative cancer patients with constipation. METHODS: This is a randomized, double-blind, placebo-controlled trial. Participants aged over 18 were recruited and randomized to MZRW or placebo group in addition to current prescriptions (including ongoing laxatives treatment) for two weeks. Exclusion criteria included cognitive impairment, presence of a colostomy or gastrointestinal obstruction and estimated life expectancy of less than one month. Individualized modification of MZRW was allowed according to the traditional Chinese medicine (TCM) pattern of patient. The primary outcome was the global assessment of improvement, which reflected whether the constipation had improved, remained the same or worsened. RESULTS: Sixty patients, with mean age 75.2 years (range 47-95 years), were randomized to MZRW or placebo group. Among the MZRW group, 59.3% (16/27) had improvement in the global assessment score, as compared with 28.6% (8/28) of the placebo group (p-value = 0.022). Besides, the MZRW group had significant increase in stool frequency, and reduction in constipation severity and straining of defecation (p-value < 0.05). No serious adverse event was reported due to the research medication. CONCLUSION: This pilot trial suggests modified MZRW is well-tolerated and effective for relief of constipation in patients with advance cancer. It could be considered as a potential treatment option for constipation in palliative care. TRIAL REGISTRATION: The trial had been registered in ClinicalTrials.gov with identifier number NCT02795390 [ https://clinicaltrials.gov/ct2/show/NCT02795390 ] on June 10, 2016.

Therapeutic effects and mechanisms of Zhen-Wu-Bu-Qi Decoction on dextran sulfate sodium-induced chronic colitis in mice assessed by multi-omics approaches.

BACKGROUND: Zhen-Wu-Bu-Qi Decoction (ZWBQD), a traditional Chinese medicine formula comprising Poria, Radix Paeoniae Alba, Rhizoma Atractylodis Macrocephalae, Rhizoma Zingiberis Recens, Radix Codonopsis and Rhizoma Coptidis, is used for treating ulcerative colitis (UC). In a previous study, we have reported ZWBQD mitigates the severity of dextran sulfate sodium (DSS)-induced colitis in mice. HYPOTHESIS: In this study, we aimed to understand the systemic actions and underlying mechanisms of ZWBQD on experimental colitis in mice. METHODS: We used multi-omics techniques and immunoblotting approach to study the pharmacological actions and mechanisms of ZWBQD in DSS-induced chronic colitic mice. RESULTS: We showed that ZWBQD exhibited potent anti-inflammatory properties and significantly protected DSS-induced colitic mice against colon injury by regulating the PI3K-AKT, MAPK signaling pathway and NF-κB signaling pathways. We also revealed that ZWBQD significantly ameliorated gut microbiota dysbiosis and abnormalities of tryptophan catabolites induced by DSS. CONCLUSIONS: We demonstrated that the therapeutic effects of ZWBQD on experimental colitis are mediated by regulating multiple signaling pathways and modulation of gut microbiota. Our study employed an integrative strategy to elucidate novel mechanisms of ZWBQD, which provides new insights into the development of Chinese herbal medicine-based therapeutics for UC.