Technical recommendations for pragmatic randomized controlled trials of heat-sensitive moxibustion in community (Ⅱ): organization, implementation and follow-up visits / 中国针灸

Based on the community research experience of heat-sensitive moxibustion, this study explained technical recommendations for pragmatic randomized controlled trials (pRCTs) of heat-sensitive moxibustion in community from 7 aspects: selection of community research sites, ethical approval and registration, patient recruitment, training of standard operating procedures, ensuring patient compliance, quality control of follow-up visits and patient safety, which aimed to reduce the difficulty of research execution and improve the quality of pRCTs implementation and follow-up visits of heat-sensitive moxibustion.

Technical recommendation for pragmatic randomized controlled trial of heat-sensitive moxibustion in community (Ⅰ): randomization with consideration of patient preference / 中国针灸

Heat-sensitive moxibustion is the appropriate technique of the external treatment in traditional Chinese medicine and it is widely used in community because of its "easy learning, simple operation and clear curative effect". Pragmatic randomized controlled trial is a main intervention design in the real world study, which provides a high-level evidence for the effectiveness assessment of heat-sensitive moxibustion in community management. Focusing on the key links of randomization, e.g. block randomization, stratified randomization, cluster randomization, sample size allocation, allocation concealment and blinding, the paper elaborates the advantages, disadvantages and technical details of two-stage randomization with consideration of patient preference in pragmatic randomized controlled trials of heat-sensitive moxibustion in community. It facilitates improving the quality of evidence, reproducibility and methodological homogeneity among different trials.

Proposal of Living Evidence-based Guideline for Combination of Traditional Chinese and Western Medicine for Treatment of COVID-19 / 中国中药杂志

In order to standardize the clinical diagnosis and treatment decision-making with traditional Chinese medicine for pa-tients of coronavirus disease 2019(COVID-19) and put the latest clinical study evidence into clinical practice, the international trust-worthy traditional Chinese medicine recommendations( TCM Recs) working group started the compilation of Living Evidence-based Guideline for Combination of Traditional Chinese and Western Medicine for Treatment of COVID-19 on the basis of the standards and re-quirements of WHO handbook, GRADE and RIGHT. This proposal mainly introduces the formulation methods and processes of the living guidelines in details, such as the composition of the working group, the collection and identification of clinical issues and out-comes, the production of the living systematic review and the consensus of recommendations. The guidelines will continue to monitor the clinical study evidences of TCM in the prevention and treatment of COVID-19, and conduct regular evidence updating, retrieval and screening. When there is new study evidence, the steering committee will evaluate the possibility of the evidence to change clinical practice or previous recommendations, so as to decide whether the recommendations for the guidelines shall be implemented or upda-ted. The main criteria considered in the guideline updating are as follows:(1) There are new high-quality randomized controlled trial(RCT) evidences for TCM uninvolved in the previous edition of the guidelines;(2) as for the TCM involved in the guidelines, living sys-tematic review shows that new evidence may change the direction or strength of the existing recommendations. The specific implementation of the living evidence-based guidelines will take this proposal as the study basis and framework, in order to ensure the standardization of the formulation process and methods. This will be the first exploration of the methodology for living guidelines in the field of TCM.

Acupoint selection for cancer pain: based on current evidence and Delphi method / 中国针灸

Based on literature research and Delphi expert consensus method, the important acupoints for cancer pain was summarized to provide evidence basis for the formulation of

Analysis of Pathogenesis and Prescription Formulating Principle of Traditional Chinese Medicine Prevention and Treatment Plan for COVID-19 / 中国实验方剂学杂志

Since the outbreak of coronavirus disease 2019 (COVID-19), the health authorities in various regions have formulated a group of traditional Chinese medicine (TCM) diagnosis and treatment programs based on the consensus analysis of etiology and pathogenesis of TCM experts, and recommended the guiding prescriptions for different syndromes in three stages of prevention, treatment and recovery. In order to effectively summarize the understanding of the pathogenesis of each scheme and the rules of the formulation of various prescriptions, based on 49 TCM prevention and treatment plans issued by the health administration departments, 308 TCM prescriptions were sorted by stages (151 prescriptions in the treatment period, 118 prescriptions in the prevention period and 39 prescriptions in the recovery period). The 2019-nCoV pneumonia prescriptions was further processed by using TCM inheritance platform system. The common syndromes and the frequency of commonly used Chinese medicines were summed up. The commonly used drug pairs and combinations in different stages were extracted, and their association rules were analyzed. The rules of the Chinese herbal prescription for COVID-19 were preliminarily summarized. During the treatment period, the main syndrome types are inner blocking causing collapse, epidemic toxin in the lung, cold dampness in the lung and toxic heat in the lung, involving 187 kinds of herbs, 29 kinds of herbs with single taste frequency more than 20 times.Armeniacae Semen Amarum is the most frequently used, Gypsum Fibrosum-Armeniacae Semen Amarum is the most frequently used drug-pair, the core formula is Maxing Shigan Tang, and the main pathogenesis is cold, wet and heat. There is no unified syndrome type in the prevention period, involving 119 herbs in total. There are 13 kinds of herbs with single taste frequency more than 20 times. The most frequently used is Astragali Radix. The most frequently used medicine pair is Astragali Radix-Saposhnikoviae Radix. The core formula is Yupingfeng San, and the main pathogenesis is Qi deficiency. During the recovery period, the main syndromes are deficiency of lung and spleen Qi deficiency and Qi and Yin deficiency, involving 113 herbs, 12 kinds of herbs with single taste frequency more than 10 times, Poria with the highest frequency of use, Citri Reticulatae Pericarpium-Poria with the highest frequency of drug pairing, Erchentang and Shengmaiyin with the main pathogenesis of deficiency of spleen Qi and Yin. The purpose of this study is to provide multiple references for strengthening clinical precise treatment, improving the effect of TCM treatment and promoting the management of TCM prevention and control resources.

Biotransformation effect of Bombyx Mori L. may play an important role in treating diabetic nephropathy / 中国结合医学杂志

Compared with herbal drugs, medicine processed from animals (animal medicine) was thought to have more bioactive substances and higher activities. Biotransformation effect often plays an important role in their effect. However, researches about effect of animal medicine on diabetic nephropathy and applying animal medicine as natural bio-transformer were seldom reported. The purpose of this paper was to reveal the use of Bombyx Mori L. on diabetic nephropathy from ancient to modern times. The classical literature indicated that Saosi Decoction (), which contains Bombyx Mori L. or silkworm cocoon, was applied to treat disorders congruent with modern disease diabetic nephropathy from the Ming to Qing Dynasty in ancient China. Modern studies showed that Bombyx Mori L. contains four main active constituents. Among these, 1-deoxynojirimycin (1-DNJ) and quercetin showed promising potential to be new agents in diabetic nephropathy treatment. The concentrations of 1-DNJ and the activities of quercetin in Bombyx Mori L. are higher than in mulberry leaves, because of the biotransformation in the Bombyx Mori L. body. However, these specifific components need further human and mechanistic studies to determine their therapeutic potential for this challenging condition.

Effect of Danlou Tablet () on peri-procedural myocardial injury among patients undergoing percutaneous coronary intervention for non-ST elevation acute coronary syndrome: A study protocol of a multicenter, randomized, controlled trial / 中国结合医学杂志

<p><b>BACKGROUND</b>It has been shown that administration of statins reduced the risk of peri-procedural myocardial damage. However, it remains unclear whether Chinese medicine Danlou Tablet (), similar to statins, may protect patients undergoing percutaneous coronary intervention (PCI) from peri-procedural myocardial damage.</p><p><b>OBJECTIVE</b>To demonstrate the hypothesis whether treatment with Danlou Tablet would improve clinical outcome in patients undergoing selective PCI with non-ST elevation acute coronary syndrome (NSTE-ACS) in China.</p><p><b>METHODS</b>Approximately 220 patients with unstable angina or non-ST-segment elevation myocardial infarction undergoing PCI will be enrolled and randomized to Danlou Tablet treatment (4.5 g/day for 2 days before intervention, with a further 4.5 g/day for 90 days thereafter) or placebo. All patients will not receive Danlou Tablet before procedure. The primary end point is to evaluate the incidence of cardiac death, myocardial infarction or unplanned re-hospitalization and revascularization after 30 days in patients undergoing selective PCI treated with Danlou Tablet compared with placebo. Secondary endpoints include the incidence of peri-procedural myocardial injury, 3-month clinical outcomes, the quality of life and Chinese medicine syndromes assessment.</p><p><b>CONCLUSION</b>This study protocol will provide important evidence of Danlou Tablet treatment on the peri-procedural myocardial injury in patients with NSTE-ACS undergoing selective PCI, which may support a strategy of routine Danlou Tablet therapy to improve the clinical outcomes.</p>

Effectiveness and safety of acupuncture for supraventricular tachycardia: a systematic review and meta-analysis / 中国针灸

The effectiveness and safety of acupuncture for the treatment of supraventricular tachycardia were systematically reviewed. The randomized controlled trials (RCTs) regarding acupuncture for supraventricular tachycardia were searched in domestic and overseas databases, and the evaluation tool of bias risk in Cochrane Handbook 5.1.0 software was used to perform the evaluation of bias risk in literature, and RevMan 5.2 software was applied for statistics and Meta-analysis. Five RCTs involving 323 patients were included. The results showed that compared with the blank control group, the acupuncture reduced the heart rate by 18.8 times/min [95% CI (12.68, 24.92)]; the clinical effective rate in the acupuncture group was superior to that in the diltiazem group [OR= 3.11, 95% CI (1.50, 6.46)]; the difference of immediate effect between propafenone and acupuncture was not significant. No reports regarding adverse events was described in 5 RCTs. As was shown in the present evidence, acupuncture is safe and effective for the treatment of supraventricular tachycardia, but the level of evidence was low and the intensity of conclusion needed to be improved.

Systematic analysis on clinical safety of Shuxuetong injection / 中国中药杂志

<p><b>OBJECTIVE</b>To evaluate the clinical adverse drug reactions (ADR) of Shuxuetong Injection (SXTI) comprehensively for its proper use and post-marketing reevaluation.</p><p><b>METHOD</b>Electronic searching of the online Chinese and English medical databases were carried out from their inception to Feb. 2012, studies were screened and data were extracted according to inclusion and exclusion criteria; total number of ADR were calculated by study type respectively, ADR incidence rate was calculated by number of ADRs in experimental arm of clinical trials with control groups divided by total number of experimental groups.</p><p><b>RESULT</b>Eighty and eight papers published concerning ADRs report of SXTI were included, including 65 clinical trials, 20 case reports, and 3 ADRs surveillance or analysis report. 174 ADRs were reported, mainly in circulation system, nervous system, the digestive system, skin and appendages. Adverse reaction type is mainly rash (44.3%) and the digestive system response (23.0%). The incidence rate calculated by data extracted from 65 clinical trials was 4.3%.</p><p><b>CONCLUSION</b>Allergic reaction is the most common ADR type of SXTI. Incidence rate of different studies varies, so a rigorously designed prospectively ADR surveillance study is needed to reevaluate its incidence rate, and analyze reasons of the heterogeneity. Information concerning ADR in literatures is always absent, the quality of reporting is relative poor, thus it is suggested that active, standardized, and systematic ADR reporting should be focused on in clinical trials.</p>

Establishment and initial evaluation of health scale of traditional Chinese medicine / 中国中西医结合杂志

Viewing from some TCM concepts and basic characteristics of health, assimilating the operationalization concerning thinking and procedure of modern scientific research, the pilot form of Health Scale of TCM--initial health scale of TCM (iHSTCM) based upon TCM theory was developed. From November 2002 to January 2003, the domain, facets and items of HSTCM were finally established by analyzing the data from a survey of 652 persons in Guangzhou City using iHSTCM. In conclusion, the HSTCM has its theoretical ratio-nality and is applicable. It could be further applied in TCM clinical practice.

Surrogate outcomes, intermediary outcomes and their application in TCM clinical efficacy evaluation / 中国中西医结合杂志

In this paper, the concepts of surrogate outcomes and intermediary outcomes, their correlation with the primary outcome, how to select surrogate outcomes and intermediary outcomes and the particular requirements for using surrogate outcomes in assessing TCM clinical efficacy were discussed and described. It is difficult to evaluate clinical efficacy objectively and thoroughly by means of a single surrogate outcome for reason of the global characteristics of TCM, therefore, to rationally select such intermediary outcomes as important clinical symptoms, combination of several syndromes, patients' subject feeling, patients' satisfaction for treatment and quality of life, should be beneficial for objectively evaluating the efficacy of TCM intervention approaches.

How to analyze and interpret the effective values in clinical trials / 中国中西医结合杂志

The analysis of the effective value obtained in clinical trails should take account of both sides of its size and precision, for its interpretation, the general principles of: accuracy, explicitness and quantification should be complied. Criteria such as relative risk (RR), relative risk reducing rate (RRR), absolute risk reducing rate (ARR) and number needed to treat (NNT) an important clinical event, etc. are commonly used in the primary outcomes interpretation, while the methods to express the effective size and precision of surrogate outcomes and intermediary outcomes are needed to be further studied. Many problems for give expression to the outcome of TCM clinical trail still remain to be solved.

Preliminary study on outcome assessment system of treatment of stroke / 中国中西医结合杂志

<p><b>OBJECTIVE</b>In order to scientifically reflect the real efficacy of TCM treatment and to preliminarily establish a definitely valid and reliable assessment system of stroke treatment, with multi-dimensional outcome assessment indexes, including efficacy evaluation system of conventional western medicine, syndrome evaluation criteria in TCM and quality of life assessment system.</p><p><b>METHODS</b>An integrative approach of cross-sectional survey and prospective follow-up was adopted. Two hundred and forty-five case-episodes of stroke patients were assessed by determining such parameters as nerve functional deficit scale, grading of total status of living ability, activity of daily living (ADL), TCM stroke criteria of diagnosing-treatment, TCM syndrome related symptoms/signs, Health Survey Questionnaire (Short form 36, SF-36), and index of quality of life (QOL), and their construction and relation were analyzed by such methods as multivariate relation, partial relation, linear regression, factor analysis, Cronbach's alpha coefficients, and the responsiveness estimation.</p><p><b>RESULTS</b>The multi-dimensional assessment system of stroke treatment, containing 57 indexes with clarified constructions and classification, was created, and its validity and reliability confirmed after assessement. Various degrees of relationship were found between different TCM Syndromes and different domains of QOL.</p><p><b>CONCLUSION</b>The assessment system of stroke treatment preliminarily created has satisfied reliability and validity. It could be expected to reflect the real efficacy of TCM treatment more inclusive and accurate. TCM Syndrome indexes are considered to be the factor related to both domains of mental and physical health, particularly with the former, therefore, to improve the TCM Syndrome would imply improvement of the mental health, physical health and QOL of the patients.</p>