Trials Of Traditional Chinese Medicine Research Articles

Combined traditional Chinese medicine and anti-hypertensive treatments for renal hypertension: A network meta-analysis and systematic review

Background: Traditional Chinese medicine (TCM) demonstrates significant effects on renal function, yet it remains unclear which TCM treatment yields the best clinical outcomes for renal hypertension (RH) management. This study aims to evaluate the safety and effectiveness of various TCM treatments for RH compared to conventional Western medicine (CWM). Methods: Randomized controlled trials (RCTs) of TCM for RH were screened from 9 databases, covering the period up to July 2023. The Cochrane Risk of Bias tool was utilized to assess the risk of bias in the included RCTs. Network meta-analysis was conducted using RevMan 5.3 and Stata 14.0 software. Sensitivity analyses and meta-regression were performed to identify sources of heterogeneity and assess result robustness. Results: This study encompassed 3879 patients from 44 investigations involving 29 TCM interventions. The quality of the studies ranged from moderate to excellent, with well-defined inclusion criteria and generally low potential for biases related to outcome data and selective reporting. Tianma Gouteng Yin combined with Qiju Dihuang Wan + CWM demonstrated the highest total effective rate (relative risk = 1.31, 95% confidence interval (CI): 1.03, 1.66) compared to CWM alone. Bailing capsule + CWM was optimal for improving serum creatinine (mean difference (MD) = −53.78, 95% CI: −96.59, −10.98). Ziyin Pinggan Huayu decoction + CWM had the highest likelihood (surface under the cumulative ranking curves = 56.2%) of improving blood urea nitrogen. Zishen Pinggan prescription + CWM showed the greatest improvement in systolic blood pressure (MD = −46.29, 95% CI: −73.19, −19.38), while Ye Ren Gao decoction + CWM demonstrated the best improvement in diastolic blood pressure (MD = −13.13, 95% CI: −20.12, −6.13). Xifeng Qingnao decoction + CWM achieved the best improvement in 24-hour urinary protein (MD = −2.00, 95% CI: −3.26, −0.74). The combination of TCM and CWM was associated with a lower incidence of adverse effects. Conclusion: Combination therapy of TCM with CWM surpasses CWM alone in treating renal hypertension. This study identifies the most effective combination treatment for RH, as well as optimal treatments for lowering blood pressure (Zishen Pinggan prescription + CWM) and improving renal function (Bailing capsule + CWM).

Reporting characteristics and quality of randomized controlled trial protocols in traditional Chinese medicine: a cross-sectional study.

The impact of the Standard Protocol Items: Recommendations for Interventional Trials of Traditional Chinese Medicine (SPIRIT-TCM) Extension 2018 statement on the reporting quality of randomized controlled trial (RCT) protocols in traditional Chinese medicine (TCM) is not clear. This review aimed to assess the reporting characteristics and quality of RCT protocols involving interventions such as Chinese herbal medicine formulas (CHMF), acupuncture, and moxibustion published in the last 3years. We conducted an extensive search among multiple databases, including All EBM Reviews, Allied and Complementary Medicine (AMED), Embase, Ovid MEDLINE(R), PubMed, Web of Science, Google Scholar, and ClinicalTrials.gov for publications in English from 1 January 2020 to 10 August 2023. Two reviewers independently assessed the eligibility of the publications, extracted predetermined information, and evaluated the reporting based on the SPIRIT-TCM Extension 2018 checklist. Of the 420 eligible protocols (comprising 163 studies on CHMF, 239 on acupuncture, and 18 on moxibustion), the average reporting compliance rate was only 35.4%. Approximately half of the assessed items fell into the category of poorly reported, demonstrating a compliance rate below 65%. Notably, reporting compliance in acupuncture and moxibustion interventional studies exhibited higher scores than compliance in CHMF studies. Continued, concerted, and coordinated efforts are required by journals, editors, reviewers, and investigators to improve the application and promotion of the SPIRIT-TCM Extension 2018 reporting guideline.

Analysis of the Current Status of Outcome Indicators of Randomised Controlled Trials of Traditional Chinese Medicine for the Treatment of Qi and Yin Deficiency in Coronary Heart Disease.

To analyse the current status of outcome indicators in randomised controlled trials (RCTs) of traditional Chinese medicine (TCM) for the treatment of coronary heart disease (CHD) with deficiency of qi and yin, and to provide a basis for constructing a core indicator set (COS) for TCM treatment of CHD. We searched the database of China National Knowledge Infrastructure (CNKI), PubMed,etc. 8 databases in the last 5 years. RCTs of TCM for CHD included in core journals were evaluated for the risk of bias of the included studies, and the current status of the selection of outcome indicators was statistically analysed. A total of 39 RCTs with a sample size of 44~398 cases were included, and 164 outcome indicators were reported, with a frequency of 383 applications. The outcome indicators were categorised into 6 indicator domains according to their functional attributes, which were, in descending order, safety indicators, physicochemical examination, effective rate, economic assessment, disease evidence score, and quality of life. The top 3 indicators in terms of frequency of application of outcome indicators were safety indicators, physical and chemical examination indicators, and efficiency, among which electrocardiogram, inflammation indicators, and clinical efficacy were the most frequently used; there were many different types of measurement tools for outcome indicators, among which total efficiency and TCM symptom points were the most frequently used; the time point of measurement was not the same. The RCTs of TCM for CHD in the last 5 years have many shortage in the selection of outcome indicators, and should actively promote the construction of the COS of TCM for CHD.

Review and prospect of traditional Chinese medicine in treatment of trauma based on bibliometrics

This study aims to summarize the research hotspots and trends in traditional Chinese medicine(TCM) treatment of trauma and provide suggestions for collaborative research on the treatment of trauma with integrated Chinese and western medicine. The re-levant research articles on TCM treatment of trauma were searched against CNKI, Wanfang, VIP, Web of Science, and PubMed from inception to December 31, 2022 and analyzed using bibliometric. After screening, 315 articles in Chinese and 34 articles in English were included. The articles were mainly published by TCM journals. The core author groups were absent. The author affiliations were dominated by medical institutions and supplemented by universities, research institutions, and government agencies. The research mainly focused on the clinical practice and trials of TCM in trauma treatment. Although the TCM treatment of trauma emerged early, it is still in the initial stage of development. The future research can focus on innovating the service model of trauma treatment, improving clinical research capability, improving medical quality management, and strengthening the TCM talent teams in comprehensive hospitals. Western medicine is precise and effective in the treatment of trauma, while TCM with unique treatment methods and effects can play a complementary role. Therefore, the trauma treatment with integrated Chinese and western medicine demonstrates a promising prospect.

Diagnosis, treatment, and prevention of lower respiratory tract infections in children

<p>Lower Respiratory tract infections (LRTIs) are prevalent and significant in children, which might affect lung development and lung function trajectories leading to chronic obstructive pulmonary disease in adulthood. Despite advances in diagnostic techniques, drug treatments, and vaccine prevention, challenges persist, such as microbial resistance, clinical trials of traditional Chinese medicine in children, and new vaccine for respiratory tract infections. In this era of rapid technological advancement, interdisciplinary collaboration among researchers, clinicians, and policymakers is crucial to enhance precise diagnosis, treatment, prevention, and control in children.</p>

Effectiveness and Safety of Traditional Chinese Medicine in Treatment of Primary Sjögren's Syndrome Patients: A Meta-analysis.

Primary Sjögren's Syndrome (pSS) is an autoimmune disease. It can damage the salivary and lacrimal glands and is characterized by dry mouth and eye symptoms, which seriously affects people's normal life. Both modern medicine and Traditional Chinese medicine (TCM) have certain effects in treating SS. However, there are different theories about which treatment is more appropriate. The aim of this research was to compare the efficacy and safety of TCM to Western Medicine in the treatment of pSS. We collected randomized controlled trials (RCTs) of TCM, integrating traditional Chinese and Western medicine for the treatment of pSS in Chinese and foreign databases. A total of 13 articles were eventually included with 780 cases. The final results were expressed in odds ratio (OR), mean difference (MD), 95% confidence interval (CI), and overall effect (z). The effective rate was 86.03% in the TCM group and 67.75% in the western medicine group. Results of the effective rate were OR = 3.57; 95% CI = 2.44-5.23; z = 6.56; p＜0.00001, ESR were MD = -6.90; 95% CI = -10.76--3.05; z = 3.51; p = 0.0005＜0.05, Schirmer's test were MD = 3.39; 95% CI = 1.92-4.86; z = 4.5; p＜0.00001, salivary flow were MD = 0.62; 95% CI = 0.16-1.07; z = 2.63; p = 0.009＜0.05, and adverse reactions were OR = 0.35; 95% CI = 0.17-0.72; z = 2.84; p = 0.004. TCM has a remarkable effect on the treatment of pSS. Among them Yiguanjian decoction and Liuwei Dihuang decoction were effective prescriptions with the highest frequency of application. Rehmanniae Radix (Rehmannia glutinosa Libosch.) and Ophiopogonis Radix (Ophiopogon japonicus (L. f.) Ker-Gawl.) were the most frequently used TCM.

Blinding assessment in clinical trials of traditional Chinese medicine: Exploratory principles and protocol

As one of the key components of clinical trials, blinding, if successfully implemented, can help to mitigate the risks of implementation bias and measurement bias, consequently improving the validity and reliability of the trial results. However, successful blinding in clinical trials of traditional Chinese medicine (TCM) is hard to achieve, and the evaluation of blinding success through blinding assessment lacks established guidelines. Taking into account the challenges associated with blinding in the TCM field, here we present a framework for assessing blinding. Further, this study proposes a blinding assessment protocol for TCM clinical trials, building upon the framework and the existing methods. An assessment report checklist and an approach for evaluating the assessment results are presented based on the proposed protocol. It is anticipated that these improvements to blinding assessment will generate greater awareness among researchers, facilitate the standardization of blinding, and augment the blinding effectiveness. The use of this blinding assessment may further advance the quality and precision of TCM clinical trials and improve the accuracy of the trial results. The blinding assessment protocol will undergo continued optimization and refinement, drawing upon expert consensus and experience derived from clinical trials.Please cite this article as: Wang XC, Liu XY, Shi KL, Meng QG, Yu YF, Wang SY, Wang J, Qu C, Lei C, Yu XP. Blinding assessment in clinical trials of traditional Chinese medicine: Exploratory principles and protocol. J Integr Med. 2023; 21(6): 528–536.

Quality evaluation of the literature on randomized controlled clinical trials of traditional Chinese medicine for treatment of gastric precancerous lesions in last 20 years.

To evaluate the methodological quality of randomized controlled trials (RCTs) of traditional Chinese medicines for the treatment of gastric precancerous lesions in the past 20 years. The studies of RCTs on traditional Chinese medicines for gastric precancerous lesions were searched from the Chinese full-text journal database, Wanfang database, VIP database, PubMed, and Embase from January 2001 to December 2021. The retrieved articles were screened, extracted and evaluated based on the 2010 edition of CONSORT statement, Cochrane Risk of Bias Assessment Scale and additional indicators. A total of 840 papers were included. According to the Cochrane Risk of Bias Assessment Scale, the high risk of bias in the application of randomized methods was 5.95%; the concealed risk of uncertainty in the allocation scheme was 98.93%; the low risk of bias for blinding of patients or testers was 1.30%; the risk of bias for blinding of the outcome assessor was 100.00%; the risk of bias for completeness of the outcome data was 2.86%; and the risk of uncertainty for selective reporting was 98.44%. The CONSORT statement evaluating the quality of reporting showed that 100.00% of the RCT articles reported the 8 entries of introduction, objectives and interventions; 36.79% of the literature mentioned the method of randomized sequence generation, but only 27.62% of the literature implemented a randomized program, 1.07% of the literature hid the randomized program and 1.31% of the literature was blinded; 36.67% of the literature reported adverse reactions; no literature reported sample size prediction methods; additional evaluation indicators showed that 17.02% of the studies had ethical approval; 43.81% of the literature specified Chinese medicine evidence; 16.55% of the studies excluded severe heterotrophic hyperplasia; 7.26% of the studies conducted follow-up; and 65.12% of the literature used composite efficacy indicators; 46.67% of the literature applied pathological histological evaluation; 2.62% of the literature applied quality of life evaluation, etc. The overall risk of bias in RCTs of traditional Chinese medicines for gastric precancerous lesions is high, and the quality of most of the study reports needs to be improved. In the future, it is necessary to strengthen the study design of RCTs and refer to appropriate traditional Chinese medicines evidence grading standards, select study protocols according to different purposes, provide objective and strong evidence of clinical studies on traditional Chinese medicines, and carry out clinical study design and result reporting suitable for traditional Chinese medicines according to the CONSORT principle.

Developing a Core Outcome Set for Assessing Clinical Safety Outcomes of Prostate Cancer in Clinical Trials of Traditional Chinese Medicine: Protocol for a Mixed Methods Study.

Among the common malignant tumors in men worldwide, the incidence of prostate cancer ranks second to lung cancer. This disease will bring an economic burden to patients and their families and can reduce the quality of life of patients. Researchers have conducted numerous clinical trials on the efficacy and safety of different interventions in the treatment of prostate cancer with traditional Chinese medicine (TCM) combined with standard treatment regimens. However, the currently published clinical trials exhibit inconsistent and irregular reporting of outcome measures. The objective of this paper is to emphasize the need for a core outcome set (COS) to facilitate future prostate cancer research, aiming to improve the quality of trials and generate high-quality evidence. This mixed methods project has three phases, as follows: (1) a scoping review of the literature to identify outcomes that have been reported in clinical trials and systematic reviews of interventions involving TCM for the treatment of prostate cancer as well as a qualitative component using interviews to obtain the views of patients with prostate cancer, their families, and their caregivers who have a history of TCM treatment; (2) a Delphi survey among stakeholders to prioritize the core outcomes-Participants will include traditional Chinese and Western medicine clinicians in prostate cancer-related directions, nurses, and methodology experts who will participate in 2 rounds of the Delphi method expert consultation to score each outcome in the list of outcome indicators; and (3) a face-to-face consensus meeting to discuss and agree on the final COS for the application of TCM in the treatment of prostate cancer. The protocol has been registered in PROSPERO (CRD42022356184) before the start of the review process, and we will initiate the review on August 1, 2023; results should be expected by September 1, 2023. The Delphi survey among stakeholders is expected to start in October 2023. The development of a core outcome set for assessing clinical safety outcomes of prostate cancer in clinical trials of TCM will provide a significant first step to assist Chinese doctors, researchers, and policy makers. PROSPERO CRD42022356184; https://tinyurl.com/ysakz74r. PRR1-10.2196/46794.

A cross-sectional study on the application of patient-reported outcome measurements in clinical trials of traditional Chinese medicine in mainland China.

Objectives: Patient-reported outcomes (PROs) provide a global perspective of patient health status which plays an enormous role in evaluating clinical efficacy. However, the application of PROs in traditional Chinese medicine (TCM) was still insufficiently studied in mainland China. Methods: This cross-sectional study was performed based on interventional clinical trials of TCM that were conducted in mainland China from 1 January 2010, to 15 July 2022. Data was retrieved from the ClinicalTrials.gov and Chinese Clinical Trial Registry. We included interventional clinical trials of TCM for which the country of the primary sponsors or recruitment settings in mainland China. For each included trial, data including clinical trial phases, study settings, participant's age, sex, diseases, and the patient-reported outcome measures (PROMs) were extracted. Trials were categorized into four categories according to 1) listed PROs as primary endpoints, 2) listed PROs as secondary endpoints, 3) listed PROs as coprimary outcomes (both primary and secondary endpoints), and 4) did not mention any PROMs. Results: Among a total of 3,797 trials, 680 (17.9%) trials listed PROs as primary endpoints, 692 (18.2%) trials listed PROs as secondary endpoints, and 760 (20.0%) trials listed PROs as coprimary endpoints. Among 675,787 participants included in the registered trials, 448,359 (66.3%) patients' data were scientifically collected by PRO instruments. Neurological diseases (11.8%), musculoskeletal symptoms (11.5%), mental health conditions (9.1%) were the most common conditions evaluated by PROMs. Disease-specific symptoms related concepts were used most frequently (51.3%), followed by health-related quality of life concepts. Visual analog scale, 36-item Short-Form Health Questionnaire, and TCM symptom score were the most common PROMs in these trials. Conclusion: In this cross-sectional study, the use of PROs increased in the past decades according to clinical trials of TCM conducted in mainland China. Considering that the application of PROs in clinical trials of TCM has some existing issues including uneven distribution and lack of normalized PROs of TCM, further study should be focused on the standardization and normalization of TCM-specific scales.

Efficacy and safety of traditional Chinese medicines combined with conventional Western medicines in the treatment of type 2 diabetes mellitus: a network meta-analysis of randomized controlled trials.

Through a comprehensive analysis of the clinical randomized controlled trials of traditional Chinese medicine (TCM) combined with conventional western medicine (CWM) in treating type 2 diabetes(T2DM) in the past ten years, the clinical efficacy and safety of different TCMs combined with CWM were explored. This study aimed to provide specific suggestions for clinical guidance on treating T2DM. A literature search was conducted in CNKI, WanFang, VIP, CBM, PubMed, Embase, and Web of Science. The search time was limited from 2010 to the present time. The literature type was a controlled clinical trial study of TCM combined with CWM intervention in treating T2DM. The outcome indices of the efficacy evaluation included fasting blood glucose (FBG), 2-hour postprandial blood glucose (2hPG), glycosylated hemoglobin (HbA1c), adverse reactions, and clinical efficacy. Stata 15 and RevMan 5.4 software were used to conduct a network meta-analysis and a traditional meta-analysis. The results showed that shenqi jiangtang granule combined with sulfonylurea, shenqi jiangtang granules combined with metformin and jinlida granules combined with insulin had significant effects on reductions in FBG, 2hPG and clinical efficacy compared with western medicines alone, which included fasting blood glucose [MD=-2.17, 95%CI=(-2.50, -1.85)], blood sugar at 2 hours after a meal [MD=-1.94, 95%CI=(-2.23, -1.65)], and clinical curative effect [OR= 1.73, 95%CI=(0.59, 2.87)]. TCM combined with CWM has a very significant effect on treating T2DM compared with CWM alone. According to the network meta-analysis, the best intervention measures of different TCMs for different outcome indicators were obtained. identifier 42022350372.

Current status of outcome reporting in randomized controlled trials of traditional Chinese medicine for mammary gland hyperplasia: A systematic review

Current status of outcome reporting in randomized controlled trials of traditional Chinese medicine for mammary gland hyperplasia: A systematic review

Traditional Chinese medicine in treating Corona Virus Disease 2019: a systematic review and cost-effectiveness analysis

ABSTRACT
 Background: Currently, corona virus disease 2019 (COVID-19) has infected 633,601,048 people worldwide according to World Health Organization, which leads to huge disease burden. A considerable number of trials of traditional Chinese medicine (TCM) have been carried out and have shown the efficacy of TCM in the treatment of COVID-19, but their cost-effectiveness has not been studied, especially in China. Therefore, we plan to perform a systematic review and cost-effectiveness analysis to explore the cost-effectiveness of using TCM in treating COVID-19.
 Methods: A systematic review based on previously published secondary data from randomized controlled trials and observational studies which included TCM as one of the interventions for patients with COVID-19 will be performed. Patients with COVID-19 will be classified into five specific groups (patients without diagnosis; patients with mild, moderate, severe and critical symptoms). TCM versus western medicine on both effectiveness outcomes(cure rate and survival rate) and utility outcome(quality-adjusted life years) will be evaluated. A decision tree model will be established taking the perspective of Chinese health care system since the costs were paid by the Chinese government. Cumulative costs, Qalys, and incremental cost-effectiveness ratio will be selected as the outcome indicator. Sensitivity analysis will also be conducted to evaluate the impact of parameter uncertainty on the base-case analyses results. We will present results at various willingness-to-pay thresholds using a cost-effectiveness acceptability curve.
 Discussion We hope to demonstrate the cost-effectiveness of TCM, see an improvement in the patients' quality of life, achieve a improvement in the cure rate and survival rate of COVID-19. If TCM is cost-effectiveness, it could be applied to clinical practice decision making.
 Ethics and dissemination: Ethics approval is not required for the current study. Because the data used in this study is just the re-use of data which are already in the public domain. The results will be disseminated to general public, clinicians, academics and policy makers.
 Registration number: CRD42021228887
 Keywords: Traditional Chinese medicine; Corona Virus Disease 2019; decision tree model; systematic review; cost-effectiveness analysis

Characteristics and result reporting of registered COVID-19 clinical trials of Chinese and Indian traditional medicine: A comparative analysis.

To assess the main characteristics and result reporting of registered COVID-19 interventional trials of traditional Chinese medicine and traditional Indian medicine. We assessed design quality and result reporting of COVID-19 trials of traditional Chinese medicine (TCM) and traditional Indian medicine (TIM) registered before 10 February 2021, respectively, on Chinese Clinical Trial Registry (ChiCTR) and Clinical Trial Registry-India (CTRI). Comparison groups included registered COVID-19 trials of conventional medicine conducted in China (WMC), India (WMI), and in other countries (WMO). Cox regression analysis was used to assess the association between time from trial onset to result reporting and trial characteristics. The proportion of COVID-19 trials investigating traditional medicine was 33.7% (130/386) among trials registered on ChiCTR, and 58.6% (266/454) on CTRI. Planned sample sizes were mostly small in all COVID-19 trials (median 100, IQR: 50-200). The proportion of trials that were randomized was 75.4 and 64.8%, respectively, for the TCM and TIM trials. Blinding measures were used in 6.2% of the TCM trials, and 23.6% of the TIM trials. Cox regression analysis revealed that planned COVID-19 clinical trials of traditional medicine were less likely to have results reported than trials of conventional medicine (hazard ratio 0.713, 95% confidence interval: 0.541-0.939; p = 0.0162). There were considerable between-country and within-country differences in design quality, target sample size, trial participants, and reporting of trial results. Registered COVID-19 clinical trials of traditional medicine were less likely to report results than trials of conventional medicine.

Development of a core outcome set in the clinical trials of traditional Chinese medicine for diabetic foot: A study protocol.

Diabetic Foot (DF) is one of the most common complications of diabetes, and it is characterized by high morbidity, disability, lethality and low cure rate. Traditional Chinese medicine treatment has certain characteristics and advantages in diabetic foot. Due to selective reporting bias and heterogeneity of research results, on the one hand, relevant clinical studies are of low quality and poor practicability, and on the other hand, similar studies cannot be included in meta-analysis to form high-quality evidence-based evidence and evaluate the value of studies. Therefore, the development of a core set of outcomes (COS-TCM-DF) for traditional Chinese medicine for the treatment of diabetic foot is an important way to address these issues. The COS-TCM-DF project will refer to the developed COS methodology and the steps are divided into four stages: (1) a scoping review and analysis of enrolled research protocols to collect and analyze all existing outcomes that have been used in trials on the prevention or treatment of diabetic foot with Chinese Medicine; (2) qualitative interviews with Diabetic foot patient and attendants to Collect additional outcomes related to them; (3) Gather opinionest and obtain initial consensus from key stakeholders, including patients, clinicians, researchers, and pharmaceutical company staff, through a Delphi survey; (4) a consensus meeting was held to develop the final COS-TCM-DF. Currently, there is no COS on measuring or monitoring diabetic foot with TCM in trials or clinical practice. The COS-TCM-DF will be developed to advance the synthesis of evidence regarding the prevention and treatment of diabetic foot in TCM and to promote the standardized and consistent application of results in future studies in this field. Registered with the Core Outcome Measures in Effectiveness Trials (COMET) database, December 2019 https://www.comet-initiative.org/Studies/Details/1553.

Traditional Chinese medicine combined with Moxibustion in the treatment of "long-COVID": A protocol for systematic review and meta-analysis.

From the end of 2019 to now, COVID-19 is still prevalent, which poses a great threat to international public health. With the increasing number of people infected, the number of patients with COVID-19 sequelae is also increasing, but there is no specific drug for COVID-19 sequelae. In China, traditional Chinese medicine combined with acupuncture has been widely used in COVID-19 sequelae, but there is still a lack of evidence-based medicine evaluation. The purpose of this study was to evaluate the efficacy and safety of traditional Chinese medicine combined with moxibustion in the treatment of COVID-19 sequelae. According to the retrieval strategy, the "long COVID" randomized controlled trial of traditional Chinese medicine combined with moxibustion will be search in eight databases composed of PubMed, Embase, Web of Science, China National knowledge Infrastructure Database, China Biomedical Database and China Science and Technology Journal Database, regardless of publication date or language. The study was screened according to the inclusion and exclusion criteria, and the Cochrane risk bias assessment tool was used to evaluate the quality of the study. Meta-analysis was carried out using RevMan5.3 and STATA12.0 software. Finally, the level of evidence of the results will be evaluated. This study will evaluate whether traditional Chinese medicine combined with moxibustion can effectively treat the symptoms of COVID-19 sequelae. This study will provide evidence whether there is benefit of traditional Chinese medicine combined with moxibustion in the treatment of COVID-19 sequelae. At the same time, our research results will provide a reference for clinical decision-making and guiding development in the future.

Development of a core outcome set for hypertensive intracerebral hemorrhage in clinical trials of traditional Chinese medicine: a study protocol

BackgroundIntracerebral hemorrhage (ICH) is a devastating disease, its mortality and disability rate are high. In China, hypertensive intracerebral hemorrhage (HICH) is responsible for 75% of all the cases of primary ICH. A lot of randomized controlled trials (RCTs) of traditional Chinese medicine (TCM) for treating HICH have been carried out. However, these RCTs have a lot of problems, such as heterogeneous outcomes, non-uniform point of measurement. These lead to systematic review/meta-analysis only can include a small number of studies. And outcome measures did not take the wishes of patients and other stakeholders into account. The aim of this study is to establish the core outcome set (COS) for future TCM clinical trials of HICH.Methods and analysisFirst, we will develop a long list of general outcomes by making systematic literature review and semi-structured interviews. Then healthcare professionals and patients with HICH will be invited to participate in two rounds of the Delphi survey to determine the importance of the outcome. Finally, a face-to-face consensus meeting will be conducted to determine the final COS of HICH, including what outcomes should be measured and when and how to measure the outcomes.ResultsWe aim to develop a COS that includes TCM core syndrome for HICH to determine what outcomes should be reported and when and how to measure them.ConclusionBy doing this, we can increase the reporting consistency and reduce the reporting bias in the outcome, which leads to the reuse of research data in meta-analysis and the making of informed healthcare decisions.Ethics and disseminationThe entire project has received approval from the Ethics Committee of Xiyuan Hospital, China Academy of Chinese Medical Sciences. The final COS will be published and reported at the national and international conferences.Trial registrationThis study is registered with the Core Outcome Measures in Effectiveness Trials database as study 1475. Registered on December 2019.

Rehmanniae Radix Preparata (RRP) improves pain sensitization and suppresses PI3K/Akt/TRPV1 signaling pathway in estrogen deficient rats

Rehmanniae Radix Preparata (RRP) has been used to management of osteoporotic pain in traditional Chinese medicine trials. However, how RRP exhibits the anti-nociceptive effect remains largely unknown. To this end, estrogen-deficient rats were orally gavaged with aqueous RRP extracts for 12 weeks. The tail flick latency, Von-Frey and formalin assays were employed to evaluate pain sensitization. The administration of RRP alleviates allodynia and hyperalgesia in estrogen-deficient rats. These alterations were associated with a decrease in the expression of substance P (SP), neurokinin-1 receptor (NK-1R), phospho (p)-PI3K, p-protein kinase B (Akt), and transient receptor potential cation channel subfamily V member 1 (TRPV1) in the spinal cord. In addition, RRP improves bone quality in the rats. These results suggest RRP could attenuate pain sensitization and improve bone quality through regulation of PI3K/Akt/TRPV1 signaling pathway during menopause stages. And RRP is considered a novel source of anti-osteoporotic pain drug candidates.

Development of a Core Outcome Set in the Clinical Trials of Traditional Chinese Medicine for Stroke: A Study Protocol.

IntroductionStroke, an acute cerebrovascular disease, is mainly caused by the sudden rupture or occlusion of blood vessels, and is subdivided into ischemic stroke and hemorrhagic stroke. It has become the second leading cause of death worldwide. In Chinese clinical practice, traditional Chinese medicine (TCM)/Integrative Medicine has been widely used for the treatment of stroke. Numerous randomized controlled trials (RCTs) of TCM/Integrative Medicine for stroke have been conducted to improve the efficacy and safety outcomes. However, their conclusions should be treated with caution because of the methodological quality defects in the clinical research. Pervasive inconsistencies are present in the outcomes collected and reported across these studies, which may lead to the pooling of discrepant data and preclude meta-analysis. The issue could be addressed by developing a core outcome set (COS).AimThe aim of this study is to develop a COS in the clinical trials of TCM/Integrative Medicine in the treatment of stroke.Method and AnalysisA steering group will be set up to organize and guide the development of the COS. The study contains three phases: (I) development of an initial outcome list covering all relevant outcomes, via two steps: (i) systematic reviews of outcomes for clinical trials of TCM/ Integrative Medicine for stroke; (ii) semi-structured interviews with patients suffering from stroke; (II) conduction of three round of Delphi surveys with different stakeholder groups to prioritize important outcomes; (III) integration of outcomes into a core outcome set by a consensus meeting.Ethics and DisseminationThis study has been granted by the Ethics Committee of Tianjin University of Traditional Chinese Medicine (TJUTCM-EC20210003). When the COS is completed, we will publish it in an appropriate journal to promote further widespread use.RegistrationThis study has been registered at the Core Outcome Measures in Effectiveness Trials initiative, COMET database (Registration #1678).

Registration of intervention trials of Traditional Chinese Medicine for four neurological diseases on Chinese Clinical Trial Registry and ClinicalTrials.gov: a narrative review.

To analyze the current status of clinical trial registration of Traditional Chinese Medicine (TCM) for the treatment of neurological diseases. Interventional clinical trials of TCM treatment for ischemic stroke, hemorrhagic stroke, vascular cognitive impairment, tension-type headache before September 22, 2020 on the platform of Chinese Clinical Trial Registry (ChiCTR), and ClinicalTrials.gov were searched. Two researchers independently selected the literature and extracted data. A total of 180 interventional clinical trials were included for analysis. Out of 180 trials, 127 were from ChiCTR and 53 from ClinicalTrials.gov. The countries primary sponsoring the included trials were China (176, 97.8%), and the common categories of primary sponsors were hospital (131, 72.8%). Among the study design, the largest proportion of allocation was randomized (172, 95.6%), interventional model assignment was parallel (163, 90.6%), masking was double blind 49 (27.2%), and the sample size was ≤ 400 (144, 80.0%). The trials were most carried out at a single center (102, 56.7%). Among the included studies, 112 (62.2%) registered on ChiCTR attached the ethical approval documents. In terms of trial stages, 50 (27.7%) studies were in phase IV. The mostly used intervention was Chinese herbal medicines (99, 55%), acupuncture (68, 37.8%) was the second. By searching the registration number on China National Knowledge Infrastructure Database and PubMed, 38 (21.1%) registered trials were published, including 25 protocol studies and 14 research results with one (NCT02275949) published both the protocol and the results. Irregular and inadequate reporting, untimely update and publication, insufficient information on traditional medicine unique characteristics, and lack of international collaborations are the problems existing in the interventional clinical registration trials of traditional medicine treatment on neurological diseases. More efforts need to be made from the above aspects to standardize and improve the registration of traditional medicine trials.