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Background The side effects of chemotherapy-induced nausea and vomiting (CINV) and myelosuppression reduce the cancer patients’ adherence to chemotherapy. Many Chinese patients choose Chinese medicine (CM) during chemotherapy to reduce side effects; however, the evidence is lacking. The efficacy of a CM herbal treatment protocol, Jianpi Bushen Sequential Formula (健脾补肾续贯方, JBSF) will be evaluated on chemotherapy completion rate among patients with colon cancer. Methods A multi-center double-blind randomized controlled trial (RCT) will be conducted on 400 patients with colon cancer who will receive 8 cycles of adjuvant chemotherapy with oxaliplatin and capecitabine (CAPEOX). Patients will be randomized 1:1 to receive the JBSF or placebo formula. The primary outcome is the overall chemotherapy completion rate. The secondary outcomes include individual chemotherapy completion rate, 4-cycle completion rate of chemotherapy, time to treatment failure, relative dose intensity and treatment toxicity. Follow-up visits will be scheduled before every and after last chemotherapy. Discussion This study will provide evidence on whether JBSF can improve the chemotherapy completion rate and reduce side effects among patients with colon cancer. (Trial registration: ClinicalTrials.gov, No. NCT03716518)

With the expert consensus during the clinical questions determination in the World Federation of Acupuncture and Moxibustion Societies (WFAS) standard以世界针灸学会联合会（WFAS）标准《女性尿失禁针灸临床实践指南》临床问题确定的专家共识为例，围绕指南研制组专家三轮德尔菲法调研临床问题的具体过程及结果，系统分析改良德尔菲法与针灸类专家共识的契合度以及本次共识过程的反思与不足，以期为同领域针灸指南的研制提供参考。.

In recent years, the real-world studies (RWS) have attracted extensive attention, and the real-world evidence (RWE) has been accepted to support the drug development in China and abroad. However, there is still a lack of standards for the evaluation of the quality of RWE. It is necessary to formulate a quality evaluation and reporting specification for RWE especially in traditional Chinese medicine (TCM). To this end, under the guidance of China Association of Chinese Medicine, the Quality Evaluation and Reporting Specification for Real-World Evidence of Traditional Chinese Medicine (QUERST) Group, including 24 experts (clinical epidemiologists, clinicians, pharmacologists, ethical reviewer and statisticians), was established to develop the specification. This specification contains the listing of classification of RWS design and RWE, the general principles and methods of RWE quality evaluation (26 tools or scales), 25 types of bias in RWS, the special considerations in evaluating the quality of RWE of TCM, and the 19 reporting standards of RWE. This specification aims to propose the quality evaluation principles and key points of RWE, and provide guidance for the proper use of RWE in the development of TCM new drugs.

Objective A systematic review of animal and human studies was conducted on genetically modified (GM) food consumption to assess its safety in terms of adverse effects/events to inform public concerns and future research. Methods Seven electronic databases were searched from January 1st 1983 till July 11th 2020 for in vivo, animal and human studies on the incidence of adverse effects/events of GM products consumption. Two authors independently identified eligible studies, assessed the study quality, and extracted data on the name of the periodical, author and affiliation, literature type, the theme of the study, publication year, funding, sample size, target population characteristics, type of the intervention/exposure, outcomes and outcome measures, and details of adverse effects/events. We used the Chi-square test to compare the adverse event reporting rates in articles funded by industry funding, government funding or unfunded articles. Results One crossover trial in humans and 203 animal studies from 179 articles met the inclusion criteria. The study quality was all assessed as being unclear or having a high risk of bias. Minor illnesses were reported in the human trial. Among the 204 studies, 59.46% of adverse events (22 of 37) were serious adverse events from 16 animal studies (7.84%). No significant differences were found in the adverse event reporting rates either between industry and government funding (χ2 = 2.286, P = 0.131), industry and non-industry funding (χ2 = 1.761, P = 0.185) or funded and non-funded articles (χ2 = 0.491, P = 0.483). We finally identified 21 GM food-related adverse events involving 7 GM events (NK603 × MON810 maize, GTS 40-3-2 soybean, NK603 maize, MON863 maize, MON810 maize, MON863 × MON810 × NK603 maize and GM Shanyou 63 rice), which had all been on regulatory approval in some countries/regions. Conclusion Serious adverse events of GM consumption include mortality, tumour or cancer, significant low fertility, decreased learning and reaction abilities, and some organ abnormalities. Further clinical trials and long-term cohort studies in human populations, especially on GM food-related adverse events and the corresponding GM events, are still warranted. It suggests the necessity of labelling GM food so that consumers can make their own choice.

Filiform needle acupuncture (FNA), the most classical and widely applied acupuncture method based on traditional Chinese medicine theory, has shown a promising effect in the treatment of allergic rhinitis (AR).To evaluate the efficacy, safety, cost-effectiveness, and patient preference of FNA in the treatment of AR by comparing FNA with sham acupuncture, no treatment, and conventional medication.Eight electronic databases were systematically searched from inception to October 14, 2021. Additional studies were acquired from clinical trial registration platforms and reference lists.Randomized controlled trials were included if they compared FNA with either sham acupuncture, no treatment or conventional medication for AR.Two researchers extracted data independently of each other using a predesigned data acquisition form, and results were cross-checked after completion. The primary outcome was symptom score (Total Nasal Symptom Score or Visual Analogue Scale), and the secondary outcomes were the AR control questionnaire, quality of life (QoL) score (Different versions of Rhinoconjunctivitis Quality of Life Questionnaire), medication score (use of rescue medication), mental health score, total IgE, adverse event rate, clinical economic indicators, and patient satisfaction score. Standardized mean difference (SMD) or mean difference (MD) with 95% confidence interval was used to calculate the effect size for continuous data, while risk ratio with 95% CI was used for dichotomous data.Thirty studies were included in this review. Compared with sham acupuncture, FNA significantly reduced the symptom score (SMD: -0.29 [-0.43, -0.15]), AR's impact on QoL (SMD: -0.23 [-0.37, -0.08]) and medication score (SMD: -0.3 [-0.49, -0.11]). Compared with no treatment, FNA dramatically reduced the symptom score (SMD: -0.8 [-1.2, -0.39]) and AR's impact on QoL (SMD: -0.82 [-1.13, -0.52]). There were no increased rates of adverse events with FNA compared to sham acupuncture and no treatment. FNA increased patient satisfaction and may be cost-effective. Most pieces of evidence from the above two comparisons were of high confidence. Moreover, FNA significantly outperformed conventional medication in reducing the symptom score (SMD: -0.48 [-0.85, -0.1]) and displayed a lower rate of adverse events, but the quality of evidence was very low.FNA is an effective and safe intervention for AR and can help with symptom relief, QoL improvement, reducing medication usage, and increasing patient satisfaction. Further studies are needed to verify its cost-effectiveness and superiority over conventional medication and the best therapeutic strategies.

Purpose To assess the effectiveness and safety of acupuncture for erectile dysfunction (ED). Materials and methods We searched six major English and Chinese databases included randomized controlled trials (RCTs) testing acupuncture alone or in combination for ED. Dichotomous data were presented as risk ratio (RR) and continuous data were presented as mean difference (MD) both with 95% confidence interval (CI). The Revman (v.5.3) was used for data analyses. Quality of evidence across studies was assessed by the online GRADEpro tool. Results We identified 22 RCTs, fourteen of them involving psychogenic ED. Most of the included RCTs had high or unclear risk of bias. There was no difference between electro-acupuncture and sham acupuncture with electrical stimulation on the rate of satisfaction and self-assessment (RR, 1.50; 95% CI, 0.71-3.16; 1 trial). Acupuncture combined with tadalafil appeared to have better effect on increasing cure rate (RR, 1.31; 95% CI, 1.00-1.71; 2 trials), and International Index of Erectile Function-5 scores (MD, 5.38; 95% CI, 4.46-6.29; 2 trials). When acupuncture plus herbal medicine compared with herbal medicine alone, the combination therapy showed significant better improvement in erectile function (RR, 1.68; 95% CI, 1.31-2.15; 7 trials). Only two trials reported facial red and dizziness cases, and needle sticking and pruritus cases in acupuncture group. Conclusions Low quality evidence shows beneficial effect of acupuncture as adjunctive treatment for people mainly with psychogenic ED. Safety of acupuncture was insufficiently reported. The findings should be confirmed in large, rigorously designed and well-reported trials.

Traditional Chinese medicines(TCMs) have certain limitations in the clinical research design in their post-marketing evaluation, so that randomized controlled programs cannot be strictly implemented in some studies, while the objective performance criteria is a reasonable external controlled research method that has been gradually recognized at home and abroad in recent years in addition to randomized controlled trial(RCT) method. It is more mature in medical devices, surgery and other research fields, but there is no relevant report in the field of post-marketing evaluation of Chinese patent medicines. In this paper, the application prospect of the objective performance criteria and the problems were discussed in the field of post-marketing evaluation of TCM. The characteristics of as TCM are more consistent with the scope of the objective performance criteria, the application of the objective performance criteria in post-marketing evaluation of Chinese patent medicines, especially in single arm research, can break through the limitations of existing conventional clinical research methods, and improve the level of evidence, with good feasibility and advantages. However, in the application process, we should pay attention to the key issues such as the selection of index, research population, follow-up period and the reference selection, to ensure the quality of research. This research group has carried out some exploration and practice in the field of post-marketing evaluation of TCM injections by using single arm combined with the objective performance criteria, hoping to establish the key technology in this field, and provide certain research and design reference for the secondary development of Chinese patent medicines.

Background To evaluate the possibility and impact of performance and detection bias in randomized controlled trials due to lack of the blinding method. MethodsTrials assessing acupuncture for depression published by March 2020 were searched from China National Knowledge Infrastructure database. Through matching, we reassembled the trials of comparing experimental acupuncture and control acupuncture. Meta-analysis with post-treatment HAMD (Hamilton Depression Scale) of the newly reassembled trials was conducted. Changes of HAMD of all included groups were also analyzed, the between groups difference was then analyzed by t-test. All statistical analyses were performed using RevMan 5.3 software. ResultsThirteen pairs of studies were matched from 63 included trials. Re-analysis from the paired studies showed obvious difference of HAMD scales between the experimental and control acupuncture (Mean Difference was -2.95 for HAMD-17, -5.55 for HAMD-24). Re-analysis from all the included groups also showed the statistical difference between groups at four weeks of HAMD-17 (P=0.01), and four/six weeks of HAMD-24 (PConclusion Effectiveness of acupuncture for decreasing the severity of depression was superior in trials that considered acupuncture as experimental treatment, showing performance and detection bias caused by the absence of blinding method is of great significance in acupuncture trials.

To overview the systematic review/meta-analysis on acupoint application for bronchial asthma.A computerized retrieval was performed from 6 databases, named CNKI, CBM, VIP, WF, PubMed and Cochrane Library. The time of retrieval was from the establishment of the database to April 1, 2019. According to the inclusion and exclusion criteria, the two researchers independently selected articles and extracted data. In case of disagreement, a third party was adopted to solve it. Using AMSTAR2, PRISMA and GRADE, the literature quality and evidence grade were assessed.A total of 19 articles relevant with systematic evaluation/meta-analysis were included, 16 articles of which were in Chinese and 3 articles in English, published in the period from 2007 to 2018. Forty-two outcome indicators were included. It was found that the quality of methodology was very low, the quality of literature report has some or serious flaws and the quality level of evidence is mostly low or very low.Currently, regarding the articles of systematic review/meta-analysis on acupoint application for bronchial asthma, it is quite low in methodological quality and literature report quality and is not high in the grade of outcome indicators. The clinical research should be intensively specified in association with the characteristics of traditional Chinese medicine so as to provide more reliable clinical evidence.

Background Laparoscopic hepatectomy (LH) is growing in popularity, but its efficacy and safety are still controversial. Few multicenter, large, population-based, prospective, randomized studies have compared LH with open hepatectomy (OH). We performed a meta-analysis to compare the treatment outcome of patients undergoing LH versus OH. Methods We searched PubMed, EMBASE, Cochrane Central Register, CNKI, and WanFang Med Online databases to November 30th, 2016 for randomized controlled trials (RCTs) that compared treatment outcome for LH and OH. Eligibility criteria included evaluation of operation time, blood loss, complications, and hospital stay after surgery for adult patients who underwent LH or OH. Reviewers in pairs independently screened the studies, extracted data and assessed the risk of bias of included studies. Agreement was achieved. RevMan 5.3 was used to conduct meta-analysis. Complete case analysis was used as primary analysis. Predefined subgroup analysis includes benign and malignant disease. Results Eight RCTs with a total of 554 patients were included in the meta-analysis, 275 types of LH and 279 types of OH. LH reduced the hospital stay after surgery (8 trials, 554 patients, MD = −3.84 days, 95%CI: −5.05 to −2.63, P Conclusions Laparoscopy is more effective in terms of hospital stay after surgery and time to first flatus with fewer blood loss and complication rate for hepatic resection compared with open surgery.

Background: Peri-procedural myocardial injury (PMI) during percutaneous coronary intervention (PCI) will result in an unfavorable clinical prognosis in patients, thus urgently necessitating effective drug treatment measures. Shen-Yuan-Dan (SYD) capsules are a traditional Chinese medicine (TCM) preparation that have been found to have potential myocardial protection effects during the peri-procedural phase of PCI in previous clinical and basic research; however, there is a lack of rigorous, randomized, and controlled studies. The aim of this study is to evaluate the efficacy and safety of SYD in decreasing PMI. Methods: This is a randomized, double-blind, placebo-controlled clinical trial. A total of 284 patients with unstable angina will be randomized into test and control groups. The two groups will be given SYD or a placebo (three times each day, four capsules each time) 3 days before PCI on the basis of conventional treatment. Twelve hours before PCI, an additional 4 capsules will be given, and drug treatment is planned to be maintained for 1 month after surgery. Dynamic changes in the myocardial enzyme in four time-points (before PCI, and 4, 24, 48 hours after PCI) in both groups of patients that will be observed. The follow-up period will be 1 month. The primary observation markers are planned to evaluate the efficacy and safety of SYD in decreasing PMI. The secondary observation markers will be to evaluate the major adverse cardiovascular events (MACEs) status at day 30 after PCI, (all-cause mortality, non-fatal myocardial infarction, repeated revascularization of target blood vessel) and Seattle Angina Questionnaire scores. GRACE scores will be used for risk stratification, and the intervention efficacy of SYD on PMI patients with different risks will be retrospectively evaluated. Discussion: This study will provide a rigorous clinical evidence to evaluate the efficacy and safety of SYD in decreasing PMI and the results are worth anticipating. Trial registration: The design of this trial has been registered with the Chinese Clinical Trial Registry (No. ChiCTR-IPR-17011069).

In order to improve the quality of reporting Chinese herbal medicine (CHM) trials, an elaborated checklist was developed according to the basic characteristics of traditional Chinese medicine (TCM) and on the basis of the Reporting Randomized Controlled Trials of Herbal Interventions: An Elaborated CONSORT Statement. This checklist adopted the 22 items of the Herbal CONSORT Statement with some necessary elaboration and modification in the detailed contents of 11 items, among which, the items of Participants, Intervention, Control group and Outcomes were elaborated and modified accordingly to adapt TCM characteristics. Since the design and reporting of trials on Chinese proprietary medicine and herbal decoctions are different in some aspects, the checklist provided two sets of elaborated item 4 (interventions). We hope that authors, journal editors and peer reviewers find this checklist instructive.

To evaluate the effectiveness and safety of Chinese herbs as an adjuvant treatment for hepatitis virus B (HBV)-related hepatic failure.Data were retrieved through the Cochrane Hepato-Biliary Group Controlled Trials Register, The Cochrane Library, PubMed, CNKI, VIP, Wanfang Database, and ChiCTR by key words or free words such as hepatic failure, severe hepatitis, HBV, Chinese medicine, randomization, and control. Appendix references of related papers were taken as supplementary indices. According to requirement for Cochrane systematic evaluation, randomized clinical trials on assessing the effectiveness and safety of Chinese herbs as main or adjuvant treatment in treating HBV-related hepatic failure were methodologically assessed, data extracted and analyzed.Totally 21 trials on Chinese herbal medicine therapy versus standard medical therapy (involving 1 881 patients) were included. Most trials had unclear risk bias. In 5 studies on the mortality, 3 trials showed that the mortality was lower in the test group than in the control group [RR 0.40, 95% CI (0.20, 0.79), P = 0.0002]. In 6 randomized control trials, totally 20 papers reported the control of complications. Eight results showed Chinese herbal medicine therapy had better effect in controlling complications. The recurrence rate and assessment of the survival quality were reported. Considering secondary indicators, four trials showed Chinese herbal medicine therapy had better effect in lowering the ineffective rate, decreasing total bilirubin (TBIL), and elevating prothrombin activity (PTA). Other prescriptive analyses found that the overall effect on secondary indicators was better in the test group than in the control group, but not all the indicators were statistically different. Adverse reactions were only reported in two papers, showing no severe adverse reaction.According to present evidence, till now, we could not judge whether Chinese herbs, as an adjuvant treatment, could do any favor for lowering the incidence and recurrence of hepatic failure patients, and improving their survival qualities.

Through introduction of the methodological mechanism and comparison with classic randomized controlled trial, the status and the applicability of the expertise-based randomized controlled trials in clinic are explored, and its characteristics in acupuncture clinical application are analyzed. It is held that expertise-based randomized controlled trial is more suitable for the acupuncture clinical research, especially for acupuncture practice which emphasizes manipulations and different schools.

To observe the effect of scalp-acupuncture on the expression of matrix metalloproteinase 9 (MMP-9) in the endothelium of the microvessels in the hippocampal CA 3 area in local cerebral ischemia (CI) rats, so as to study its underlying mechanism in improving CI.Eighty male Wistar rats were randomized into normal control (n = 8), sham-operation (n = 8), CI model (n = 32), and scalp-acupuncture (n = 32) groups. The later two groups were further equally and respectively divided into 1, 3, 5 and 10 d subgroups. CI model was established by occlusion of the middle cerebral artery (MCAO). "Baihui" (GV 20) and "Qubin"(GB 7) were punctured with filiform needles and stimulated by twirling the needle at a frequency of about 200 revolutions/min for 1 min. The needles were retained for 30 min and re-manipulated once again every 10 min. The treatment was given once daily, continuously for 1, 3, 5 and 10 days respectively in different subgroups. MMP-9 immunoactivity of hippocampal CA 3 area was assayed by immunohistochemistry (SABC).Following CI, the CI rats' neural deficit scores in the model and scalp-acupuncture (treatment) groups had no apparent difference (P0.05). After acupuncture, the neural deficit score in the treatment group decreased gradually, and was significantly lower than that in the 10 d subgroup of model group (P0.05). Compared with the 1, 3, 5 and 10 d subgroups of control group, the total area and integral optical density (IOD) values of MMP-9 immunoactivity of hippocampal CA 3 area were all increased significantly in the corresponding 4 subgroups of model group (P0.01). Compared with the 3, 5 and 10 d subgroups of the model group, the total area and IOD values of MMP-9 immunoreaction positive products in the corresponding 3 subgroups of scalp-acupuncture group were decreased significantly (P0.05, P0.01).Scalp-acupuncture can effectively down-regulate MMP-9 expression in the hippocampal CA 3 area in focal cerebral ischemia rats, which may contribute to its effect in improving the neural deficit.

Based on detailed explanation of the herbal CONSORT statement, and the consideration of the character of traditional Chinese drugs, to discuss the standardization of reporting traditional Chinese drug trials. The standards of reporting traditional Chinese drug trials are not consolidated yet. In the year 2006, Reporting Randomized, Controlled Trials of Herbal Interventions: An Elaborated CONSORT Statement was developed by the CONSORT group and published. This herbal CONSORT statement includes 5 parts, and totally 22 items, in which the items of participant criteria, intervention, control setting and outcomes, et al. are elaborated to be adaptable to herbal intervention trials. This herbal CONSORT statement has provided valuable basis for the development of standards of reporting traditional Chinese drug trials, though it is not completely adaptive to be the reporting standards in consideration of the background theory and the animal drugs and mineral drugs that traditional Chinese drugs contain. The proper reporting standards of traditional Chinese drug trials should take the different types of drugs and the different purposes of trials into consideration. The trial reports of drugs that must be applied under the instruction of traditional Chinese medicine (TCM) theory should report participant criteria that include TCM syndrome differentiation and other important characters of TCM interventions.

Qualitative research methods are becoming more and more important in medical research area. Some qualitative researches played important roles in the exploration and the spread of core ideas of Chinese medicine. The report of qualitative research should be transparent and credible according to the standardized report criterion. On the basis of 22 criteria, the Consolidated Criteria for Reporting Qualitative Research (COREQ) was developed and published in September 2007. This introduction to COREQ will be helpful to Chinese qualitative researchers and readers in the implementation of high quality of medical qualitative research in China.

To find out the dominant diseases in the clinic of modern acupuncture.By means of bibliometrics, clinical acupuncture study literatures from 1978 to 2004, searched from CBM database, were sorted and counted to show the different clinical utilizing quantities and developing trends of different disease groups in the acupuncture clinic.Obviously dominant type: nervous system diseases; mature type: motor system diseases; developing type: 3 kind of diseases including psychosis; premature type: diseases related with surgery; steady type: 3 kind of diseases including digestive system diseases (diseases of liver and gallbladder are not included); pre-developing diseases: 5 kind of diseases including otorhinolaryngologic diseases.Among all these types, obvious advantage type and mature type are the most distinguishing. Developing type has the most significant ascending trend. Premature type has relatively strong developing potentiality.