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ObjectiveTo review the drug information and clinical researches on Chinese patent drug in Pharmacopoeia of the People's Republic of China，National Essential Drugs List and Medicine List for National Basic Medical Insurance，Employment Injury Insurance and Maternity Insurance. MethodSearch Chinese patent medicine，which can reduce blood sugar in the three major catalogues above. CNKI，VIP，Wanfang，Embase and PubMed were searched from their inception dates to August 14th，2021 for the clinical researches on Chinese patent drug. A database was established based on the collected Chinese patent drug for the treatment of diabetes. And then，descriptive analysis was performed to analyze the general condition of clinical researches． ResultFrom the three catalogues above，28 kinds of Chinese patent drugs were retrieved， and Supplementing Qi and Nourishing Yin was the basic effect of 22 kinds of Chinese patent drugs. A total of 1 069 clinical researches published and peaked in 2017 before August 14th，2021 were included. Clinical studies have been carried out and published in all 30 provinces and autonomous regions，and the province with the largest number of published literature was Henan.What's more，16.65% of the projects were supported by government funding. The number of research to Shenqi Jiangtang tablets/granules/capsules was the largest，among the 28 kinds of Chinese patent drugs.Besides，the most frequent type of interventions in the 958 two-arm trials was the load test，accounting for 78.91%.Most types of diabetes，including type 1 diabetes，type 2 diabetes and its complications，gestational diabetes，other types of diabetes and pre-diabetes，were covered in in this study. And the results showed that different drugs with different suitable crowd. ConclusionA summary of the current status of clinical research on Chinese patent drug by means of scoping review can provide direction for the next research.
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Health research priority setting， based on the existing disease burden or healthcare needs， screens out specific areas or topics with relatively high research priority by scientific and systematic methods， and optimizes the allocation of health resources by influencing healthcare decision-making， so as to alleviate the imbalance between regional or global health and development. Many developed countries have carried out related research and practical work on different scales， and the World Health Organization （WHO） attaches great importance to the transformation and application of relevant achievements in developing countries. As the largest developing country in the world， China's research in this field started relatively late， and only a small number of scholars have carried out part of the localization methodology research and practice according to the specific national conditions. However， health research priority setting has not yet attracted the attention of large-scale research institutions or government organizations in China. Although the priority setting is rarely mentioned in the research on traditional Chinese medicine （TCM）， the research and decision-making on the diseases responding specifically to TCM can also be regarded as the practical work of exploring the priority of TCM. Policymakers have a sense of priority support in the "priority of TCM research"， but the decisions from the top design are mainly based on the consensus reached by high-level think tanks. There is a lack of extensive research， and moreover， the data of multiple stakeholders are not included. Therefore， it is urgent to introduce appropriate priority setting methods to solve the problem of transparency and scientificity in the decision-making process. Given the perspective of the specific implementation， the present study introduced three international priority setting methods， i.e.， the James Lind Alliance and Priority Setting Partnerships（JLAPSP，）the Child Health and Nutrition Research Initiative（CHNRI）， and the Council on Health Research and Development （COHRED）， and presented relevant recommendations on how to apply them in the research of TCM， which is expected to provide references for the local research.
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ObjectiveTo review the drug information and research progress on oral Chinese patent medicines in the treatment of cardiac arrhythmia to identify existing problems and provide references for follow-up research. MethodChinese patent medicines against cardiac arrhythmia were retrieved from the three major drug catalogues，Yaozh.com，and relevant guidelines with arrhythmia as the retrieval term. The instructions for included Chinese patent medicines were retrieved through Yaozh.com and specific information was extracted. The research articles on Chinese patent medicines included were retrieved from the five databases，and the information meeting the inclusion and exclusion criteria was extracted and displayed in the form of text description and graphs after statistical analysis. ResultSixty-five oral Chinese patent medicines were included in this study，with the main functions of activating the blood and resolving stasis. The average daily cost of medicines was 8.17 yuan，and there were 42 medicines with an average daily cost of less than 10 yuan，showing a moderate medicine cost. A total of 351 research articles on Chinese patent medicines were screened out，including 259 randomized controlled trials （RCTs），16 non-RCTs，eight non-controlled trials，62 systematic reviews，two guidelines，and two expert consensuses. Eighteen types of Chinese patent medicines were involved，whose clinical trials had been conducted in 28 provinces，cities，autonomous regions，and municipalities in China. Wenxin granules and Shensong Yangxin capsules were the top medicines under investigation，accounting for 75.21% of all research articles. Among the included studies，the most common comparison design was Chinese patent medicine combined with western medicine vs western medicine （64.25%）. The outcome evaluation was mainly based on clinical efficacy，symptom efficacy，arrhythmia efficacy，adverse reactions，and heart rate changes. ConclusionThe number of clinical studies of oral Chinese patent medicines against cardiac arrhythmia varies greatly，but traditional Chinese medicine （TCM） syndrome differentiation thinking is less considered in practical application. Due to unstandardized clinical research and low-quality literature，further advancement is required in the future.
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ObjectiveThis study performed a scoping review to comprehensively analyze and report the information on the instructions of Chinese patent medicines and clinical research evidence for the treatment of respiratory diseases in children. MethodChinese patent medicines against respiratory diseases in children were obtained by searching the three major drug catalogues. The Chinese and English databases were searched for relevant literature，followed by data statistics and visualized analysis. ResultAfter screening and analysis，52 Chinese patent medicines were included，involving nine dosage forms. The main drugs were Scutellariae Radix，Armeniacae Semen Amarum，Forsythiae Fructus，etc. The main functions included clearing heat and releasing exterior syndrome，and relieving cough and dissipating phlegm. The indications mainly included common cold with wind-heat syndrome and cough in children. Adverse drug reactions and contraindications were only specified in 19.23% （10/52） of Chinese patent medicines，and the rest only displayed "unclear". A total of 279 articles were included，including 277 articles from Chinese Core Periodicals and two articles from SCIE. In terms of research type，those articles included 253 randomized controlled trials （RCTs，with six dosage form/dose comparisons involved），11 retrospective analyses based on Hospital Information System （HIS） data，one case series，13 systematic reviews/Meta-analyses （with two network Meta-analyses involved），and one economic evaluation article. Among them，72.76% （203/279） of the articles were published in the Core Journals of Chinese Science and Technology. Only 33 Chinese patent medicines were involved，and Xiaoer Feire Kechuan Oral Liquid was the top 1 under investigation，accounting for 15.71% （44/280）. The indicated diseases were mainly infantile pneumonia，bronchitis，respiratory tract infection，cough，asthma，and other western medicine diseases. Xiaoer Chiqiao Qingre Granules and Xiaoer Dingchuan Oral Liquid were used off-label. The sample size was concentrated in 51-150 cases，accounting for 67.17% （178/265）. The interventions in the experimental group were mainly Chinese patent medicine + western medicine + basic treatment or Chinese patent medicine + western medicine. The main outcomes were the effective rate and the improvement of clinical symptoms. The adverse reactions were mainly gastrointestinal reactions，drug-induced skin symptoms，etc.，and two studies have shown that drug doses were associated with adverse reactions. ConclusionIn research years，the research on Chinese patent medicines in the treatment of respiratory diseases in children has advanced rapidly. However，there are still some problems that need to be resolved in the future，such as incomplete information on drug content in the instruction，concentrated drugs to be studied，limited indications，failure to highlight the characteristics of traditional Chinese medicine （TCM） syndromes，unstandardized research design，and an incomplete reflection of Chinese patent medicine.
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ObjectiveTo re-evaluate the systematic reviews/Meta-analyses （SRs/MAs） of tonic traditional Chinese medicine （TCM） injections against cerebral ischemic stroke （CIS） and provide evidence support for clinical practice and decision-making. MethodTCM injections of different varieties were obtained after searching the three major drug catalogues. Seven Chinese and English databases were searched from database inception to March 13，2022，for the relevant SRs/MAs. The methodological quality，risk of bias，reporting quality，and quality of evidence were assessed by Assessment of Multiple Systematic Reviews-2 （AMSTAR-2），the Risk of Bias in Systematic Review （ROBIS），the Preferred Reporting Items for Systematic Reviews and Meta-analyses 2020 （PRISMA 2020），and the Grading of Recommendations Assessment，Development，and Evaluation （GRADE）. In addition，the literature overlap matrix was established to calculate the corrected covered area （CCA） and evaluate the rate of overlaps of the original literature. ResultFive types of TCM injections and 18 SRs/MAs were included. AMSTAR 2 evaluation showed that the methodological quality of 18 SRs/MAs was extremely low，and 14 SRs/MAs had a high risk of bias assessed by ROBIS. The quality evaluation results reported by the PRISMA 2020 showed that the scores of the studies included ranged from 19.5 to 28.5，with 10 being of medium quality and eight of low quality. The evaluation with the GRADE system demonstrated that one outcome was moderate-quality evidence，15 outcomes were low-quality evidence，and 41 outcomes were very low-quality evidence. The CCA of the included SRs/MAs was 0.263，indicating a low rate of overlaps of the original literature. ConclusionTonic TCM injections are effective and safe in the treatment of CIS，but this conclusion should be treated with caution because of the low quality of methodology，reports，and evidence in published SRs/MAs. It is recommended to improve the study design，obtain clinical evidence of higher quality，and conduct systematic evaluations in strict accordance with procedures to standardize the reporting of research results.
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The present study explored the effective approaches to realize the leading role of traditional Chinese medicine （TCM） in preventing diseases， the synergistic role in treating serious diseases， the core role in the rehabilitation of diseases and summarized the experience to provide feasible plans for the evaluation of other dominant diseases of TCM. To evaluate the effectiveness， safety， and economy of TCM in the treatment of ischemic stroke， encephalopathy project team of the China Center for Evidence-based Traditional Chinese Medicine（CCEBTCM） established an evaluation group to determine the work plan and complete the evaluation work. The concepts of the evaluation involved high-quality evidence， expert opinion survey， expert interview， and drug catalog. Under the guidance of clinical experts and methodologists， the evaluation work was completed in accordance with four steps， i.e.， plan making， data collection and data extraction， evidence synthesis and evaluation， and report writing with the rapid review method. Through the review of TCM and western medicine experts， the advantage of TCM in the treatment of ischemic stroke was positioned in the convalescence period with the predominant effects of improving the neurological function defect and improving the daily living ability. In the convalescence period of stroke， TCM treatment could improve post-stroke motor dysfunction， post-stroke cognitive impairment， consciousness disorder， swallowing disorder， aphasia， constipation， urinary function， diplopia， etc.， and the advantages of acupuncture， Chinese medicine， and traditional exercise were more prominent. In terms of safety， TCM treatment of ischemic stroke showed lower incidence of adverse reactions， fewer adverse events， and a milder degree of related symptoms. In terms of economic performance， the combined treatment of TCM and western medicine played a synergistic role and made the treatment cost more reasonable. Compared with conventional intervention， the integrated TCM and western medicine rehabilitation program showed more economic and social benefits.
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Evidence and value：impact on DEcisionMaking （EVIDEM） framework was developed by EVIDEM collaboration. Its core is the combination of multiple criteria decision analysis （MCDA） model and standardized health technology assessment （HTA） report， which aims to evaluate the overall value of medical interventions. It has been tested and implemented in the real-world evaluation environments. After more than 10 years of development， EVIDEM framework has been updated to version 10， and the relevant operation manuals have been published. More than 40 countries have joined the collaboration and more than 20 countries have carried out relevant studies. The framework is constructed with patients， population and sustainability as the overall goals， combing the evidence and value， forming a relatively complete decision-making framework system composed of 2 levels， 7 dimensions and 20 criteria. The two levels include normative universal criteria and contextual criteria. The normative universal criteria， namely EVIDEM core model， is the quantitative evaluation， consisting of 5 dimensions and 13 criteria. Contextual criteria， namely contextual tools， are qualitative evaluation， consisting of 2 dimensions and 7 criteria. The specific operation steps of EVIDEM framework include selecting and constructing criteria， assigning weights， integrating and evaluating evidence， quantitative and qualitative evaluation of value， comprehensive value estimation and ranking based on value estimation. EVIDEM framework is applicable to disease diagnosis， treatment， management and other fields. Its application scope includes medical insurance reimbursement， clinical practice decision-making， drug selection and so on， which can provide a method for more systematic， transparent and scientific healthcare decision-making. At present， the framework has been introduced into the field of traditional Chinese medicine and can provide a scientific and feasible evaluation tool and methodology system for the clinical comprehensive evaluation of Chinese patent medicine.
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Traditional Chinese medicine （TCM） health technology assessment （HTA） provides scientific information and decision-making basis for decision-makers at all levels to choose TCM health technology reasonably. However， it is still in its infancy. In the future， it is necessary to strengthen top-level design， improve cognition and attention， enhance talent training and cooperation， and speed up the development of evaluation criteria in line with the characteristics of TCM， so as to promote the development of HTA in TCM. Therefore， it is imperative to create a method system and tools suitable for TCM HTA. Evidence and value impact on decisionmaking （EVIDEM） framework is developed by EVIDEM collaboration. It combines evidence and value to form a relatively complete decision-making framework system， which can provide methodological support for medical insurance reimbursement， clinical practice decision-making， drug selection and so on. The introduction of EVIDEM framework into the field of TCM has methodological feasibility and practical operability， but it is still necessary to further integrate and optimize the TCM characteristics. On the basis of theoretical research， pilot studies are carried out with Chinese patent medicine as the breakthrough point， forming a preliminary framework and implementation path for the research of TCM HTA， in order to promote healthcare decision-making and achievement transformation.
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This study systematically evaluated the effectiveness and safety of Dingkundan combined with conventional western medicine in the treatment of female infertility. Four Chinese databases，three English databases， and two clinical trial registration platforms were retrieved from inception to April 2021. Two researchers independently carried out literature screening，data extraction，risk assessment of bias，and grading of evidence quality. RevMan 5.4.1 was used for data analysis. A total of 216 research articles were retrieved and 21 randomized controlled trials （RCTs） were included，involving 2 172 cases. The risks of bias in the included RCTs were high. As unraveled by Meta-analysis results， Dingkundan combined with western medicine for ovulation stimulation was superior to western medicine for ovulation stimulation alone in improving pregnancy rate and progesterone level ［relative risk（RR）pregnancy rate=1.67，95% confidence interval（CI）（1.44，1.93）；standardized mean difference （SMD）progesterone=1.21，95% CI（0.82，1.60）］. Dingkundan combined with western medicine for improving the endometrium was superior to western medicine for improving the endometrium alone in improving the pregnancy rate ［RRpregnancy rate=1.35，95% CI（1.23，1.48）］. Dingkundan combined with clomiphene was more effective than clomiphene alone in regulating endometrial thickness and reducing follicle-stimulating hormone and estradiol levels ［MDendometrial thickness=3.34，95% CI（3.27，3.41）， MDfollicle-stimulating hormone=-0.42，95% CI（-0.65，-0.19）， MDestradiol=-4.33，95% CI （-8.18，-0.48）］. Dingkundan combined with letrozole was superior to letrozole alone in increasing the follicle-stimulating hormone level and reducing the estradiol level ［MD follicle-stimulating hormone=1.14，95% CI（0.49，1.78）， MDestradiol =-33.65，95% CI（-59.13，-8.17）］. The single-study results showed that Dingkundan combined with conventional western medicine had certain advantages in regulating endometrial thickness，reducing follicle-stimulating hormone，luteinizing hormone，and estradiol levels，and increasing progesterone levels. The Grading of Recommendations， Assessment， Development， and Evaluation（GRADE）system was used for the evaluation of outcome indicators. The results showed that the quality of the evidence was graded moderate or low. Based on the existing evidence，Dingkundan combined with western medicine for infertility treatment had certain advantages in increasing the pregnancy rate， improving endometrial thickness， regulating hormone levels， and reducing adverse reactions. However，affected by the quality of the included trials，the results may have limitations，and high-quality RCTs are needed for verification in the future.
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To clarify the research progress and existing problems in the clinical research on oral Chinese patent medicine in the treatment of breast cancer. National drug catalogs and databases were searched for oral Chinese patent medicines against breast cancer. Chinese and English databases were searched for clinical trials on oral Chinese patent medicines in the treatment of breast cancer. The main functions，drug composition，literature basic characteristics，intervention measures， and outcome indicators of Chinese patent medicines were comprehensively analyzed and evaluated by a scoping review based on visual charts. In 68 Chinese patent medicines included，53% of them were potent in activating blood， resolving stasis， tonifying the kidney， and strengthening the spleen. In terms of frequency， the top drugs were Ligustri Lucidi Fructus， Astragali Radix， Moutan Cortex， Poria， and Olibanum，indicating the importance of the therapeutic principles of activating blood， resolving stasis， tonifying the kidney， and strengthening the spleen for breast cancer treatment. In 161 included clinical trials，70.71% of the intervention measures were Chinese patent medicine combined with chemotherapy. Literature studies mainly reported Xihuang pills and Huaier granules，which may be related to the combination of chemotherapy and the inclusion in the medical insurance. The outcome evaluation was mainly based on immune indexes，tumor markers，Karnofsky score，safety report and objective response rate，while the survival time and characteristic outcome indicators of traditional Chinese medicine （TCM） were insufficient. The application and research on oral Chinese patent medicine in the treatment of breast cancer have advanced in recent years，but most of the clinical research evidence is not robust，and the evaluation of outcome indicators is not standardized，which needs to be improved.
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This study aims to summarize the clinical research evidence on oral Chinese patent medicines for the treatment of influenza with the method of scoping review， and thus clarify the status quo and problems. Specifically， the target medicines were selected from related drug catalogues and diagnosis and treatment protocols， and the basic information of the medicines on the specifications was collected. Articles on these medicines were retrieved from Chinese and English databases for statistical analysis and visualization. Finally， 36 medicines and 87 articles were included. The main efficacy of the medicines is clearing heat and removing toxin， and the main components of the medicines are Lonicerae Japonicae Flos， Forsythiae Fructus， and Isatidis Radix. A total of 12 medicines can be used for the treatment of mumps and acute bronchitis in addition to influenza. Only 6 medicines have contraindications and adverse reactions labeled on the specifications. Papers on oral Chinese patent medicines in the treatment of influenza show an increasing trend， and the authors are from 25 provinces and cities in China. Among them， papers on Lianhuaqingwen preparations take up the largest proportion. The studies were mostly randomized controlled trials， non-randomized controlled trials， and retrospective research. A total of 13 studies were supported by national funding， and only 9 studies included more than 200 cases. The most frequently used method was the comparison of the intervention effect of Chinese patent medicines with western medicine， and the treatment course was generally 3-14 days. A total of 7 outcome indicators were used in the studies and the frequency was in the order of ① composite effective rate，② antipyretic effect， ③ symptom improvement， ④ safety indicator， ⑤ virological examination， ⑥ serum inflammatory factor， and ⑦ traditional Chinese medicine （TCM） syndrome score. The conclusions in the clinical studies show difference from the information in drug catalogues. The drug specifications are generally not standard. The available clinical studies have the limitations of small quantity， low in quality， and no demonstration of TCM advantages. In the future， it is necessary to optimize the specifications of Chinese patent medicines， enhance clinical research， further standardize the design of clinical research， and highlight the characteristics of Chinese patent medicines， thereby providing evidence to support the comprehensive clinical evaluation of oral Chinese patent medicines for influenza.
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To summarize the status quo of clinical evidence on oral Chinese patent medicine in the treatment of hyperlipidemia through scoping review and thereby provide a reference for clinical application and decision-making in health care. Proprietary Chinese medicines for the treatment of hyperlipidemia （dyslipidemia） were retrieved from relevant catalogs and then screened based on their instructions. Articles on the selected Chinese patent medicines were searched from Chinese and english electronic databases and screened according to the inclusion criteria， followed by data extraction and analysis. The results were described with text and graphs. ①A total of 32 Chinese patent medicines and 1 010 related articles were screened out. ②All the included Chinese patent medicines were made from Chinese medicinal materials， of which 5 were Chinese medicinal extracts，and the remaining 27 were pure Chinese medicinal preparations （the compositions of 1 prescription is confidential）. ③As indicated in the instructions， all the 32 Chinese patent medicines can be used to treat hyperlipidemia with the main syndrome of combined phlegm and blood stasis， and the main effect of them is activating blood and resolving stasis. ④Among the 32 medicines， Xuezhikang tablets （Capsules） and Gypenosides Tablets have the lowest price. ⑤For the 328 key clinical studies， 248 were randomized controlled trials and 80 non-randomized controlled trials. ⑥As for the sample size， randomized controlled trials generally included 28-579 cases， and non-randomized controlled trials 24-152 cases. Clinical studies with more than 200 cases accounted for 9.3% （12/129）. ⑦The most common method was the comparison of the intervention effect of Chinese patent medicine and western medicine （36.5%） and Atorvastatin Calcium Tablets was the preferred western medicine control. The observation duration was generally 56 days （8 weeks）. ⑧In clinical practice， the absolute value of blood lipid decrease and （total） effective rate were often used to evaluate the efficacy， and the effective rate was generally determined based on Clinical Guidelines for New Chinese Medicines. The overall quality of clinical studies on oral Chinese patent medicines is uneven and there is a lack of high-quality clinical evidence. Moreover，there are the risks of unreasonable use and uneasy use of Chinese patent medicine.It is recommended that researchers on proprietary Chinese medicine should further broaden the research ideas，focus on the top-level design of the research plan， and standardize the research process，thereby provide high-quality research evidence for the clinical use of proprietary Chinese medicine. Moreover， more efforts should be made to establish a sound mechanism for information collection and feedback of proprietary Chinese medicine， so as to reduce the risk of uneasy use.We hope that in-depth investigation and discussion should be launched by price， economy， quality evaluation， and other departments headed by the supervision department to make the price of Chinese patent medicine reasonable and fair， thereby promoting the rational use of Chinese patent medicine.
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This scoping review aimed to summarize the application information and clinical studies of oral Chinese patent medicines. The oral Chinese patent medicines in treating lung cancer were screened out by searching pf the drug directory， related guidelines， and medical information websites. The data including functions， application， ingredients， and prices of these medicines were collected. Six public databases were searched with the time interval of establishment to August 22， 2021 for collection of the clinical studies of oral Chinese patent medicines in the treatment of lung cancer. The expert consensuses， systematic reviews， randomized controlled trials， non-randomized controlled trials， and non-controlled trials were selected for analysis. A total of 104 oral Chinese patent medicines were screened out， including 31 capsules， 16 granules， 20 oral liquids， 17 tablets， 17 pills， and 3 ointments， in which altogether 198 herbal medicines were involved. The single-dose prices of 2， 36， and 66 medicines were > CNY 100， CNY 10-100， and < CNY 10， respectively. There were 410 clinical studies associated with 48 oral Chinese patent medicines， which were published from 1986 to 2021. These publications included 1 expert consensus， 21 systematic reviews， 277 randomized controlled trials， 87 non-randomized controlled trials， and 24 non-controlled trials. In the clinical studies， the Chinese patent medicines were usually applied in combination with radiotherapy and chemotherapy. The evaluation of primary outcomes focused on 9 indicators including clinical efficacy， quality of life， and incidence of side effects. In conclusion， the oral Chinese patent medicines demonstrated significant advantages in the treatment of lung cancer， and the relevant clinical trials were increasing year by year， with multiple outcome indicators being evaluated. More comprehensive and standardized clinical studies need to be designed for oral Chinese patent medicines in treating lung cancer in the future.
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Adhering to Chinese culture and philosophy, the development of traditional Chinese medicine(TCM) should be cooperative and open. TCM should learn from the achievements of ancient and modern scientific and technological civilization in human history and promote cultural exchange. TCM advocates unity, harmony, and interaction, and keeps going in a new information and digital era with Big Science and Extensive Health. The disciplinary development of TCM should embrace inheritance and innovation, and explore the scientific research and transformation of clinical experience. The dual attributes of science and humanity of TCM should be followed. In terms of education, "reading classics, acquiring clinical experience, and consulting experienced tutors" cannot be ignored. Underpinned by Xiang-thinking, TCM development should highlight the originality and learn from the failures of excessive westernization in the past with an inclusive attitude to forge through disciplines to the leading position.
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Humans , Medicine, Chinese TraditionalABSTRACT
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.
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Follow-Up Studies , Hot Temperature , Humans , Moxibustion/methods , Randomized Controlled Trials as TopicABSTRACT
Objective@#To evaluate the effect of high-intensity interval somatosensory training combined with neuromuscular acupoint electrical stimulation on blood glucose and motor function among patients with type 2 diabetes mellitus (T2DM), so as to provide insights into prevention of daily life disability among T2DM patients.@*Methods@#T2DM patients treated in Zhejiang Hospital during the period from January 2019 to October 2021 were enrolled and randomly assigned into four groups. Patients in the K group received Kinect somatosensory interaction technology-assisted high-intensity interval training, patients in the N group received neuromuscular acupoint electrical stimulation, and patients in the KN group received high-intensity interval somatosensory training combined with neuromuscular acupoint electrical stimulation, while patients in the C group were given no interventions. The 2 h postprandial plasma glucose and glycated haemoglobin (HbA1c) levels were measured prior to interventions and 4 and 12 weeks post-interventions, and seven physical fitness tests were performed. The blood glucose levels and motor activity were compared among four groups using generalized estimating equations to evaluate the effectiveness of interventions.@*Results@#Totally 199 T2DM patients were enrolled, including 51 patients in the KN group, 49 patients in the K group, 52 patients in the N group and 47 patients in the C group. There were no significant differences in gender, age, course of disease, duration of daily exercises, waist-to-hip ratio, vital capacity or maximal oxygen uptake among the four groups prior to interventions (all P>0.05). There were time-group interaction effects in blood glucose and exercise parameters among the four groups post-interventions (all P>0.05), with the largest changes seen in the KN group. The HbA1c, 2 h postprandial plasma glucose, 2.4 m standing and detour test and back scratch test results reduced by 17.06%, 27.01%, 36.52% and 20.94% 12 weeks post-interventions as compared to those prior to interventions, while 2 min stepping test, 30 s sit-ups, 30 s loading and elbow flexion test, 6 min walking test and sit and reach test results increased by 18.85%, 34.69%, 15.41%, 7.22% and 112.37%, respectively.@*Conclusion@#High-intensity interval somatosensory training combined with neuromuscular acupoint electrical stimulation may improve the blood glucose and motor activity among patients with T2DM.
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The existing problems in the outcomes of randomized controlled trials (RCTs) of acupuncture for vascular cognitive impairment (VCI) during recent five years are analyzed and suggestions are proposed. The RCTs of acupuncture for VCI were selected in PubMed, EMbase, Cochrane Library, Clinical Trials, CNKI database, Wanfang database, VIP database, SinoMed database and Chinese Clinical Trial Registry (ChiCTR) from January 1, 2015 to September 14, 2020. The outcomes were extracted and analyzed. As a result, 21 RCTs were included and the outcomes used were divided into 9 categories: clinical symptom/sign indexes, quality of life indexes, neuroimaging indexes, neuroelectrophysiology indexes, blood biochemical indexes, hemorheology indexes, TCM syndrome score indexes, clinical efficacy indexes, and safety indexes. Among them, the top three of the most used outcomes were clinical symptoms/signs indexes (21, 100.0%), clinical efficacy indexes (14, 66.7%) and quality of life indexes (12, 57.1%). In the RCTs of acupuncture for VCI, attention should be paid to distinguish the primary outcomes and secondary outcomes, adopt objective and standardized efficacy evaluation, and give consideration to report the outcomes of safety, health economic and TCM characteristic indexes.
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Acupuncture Therapy , Cognitive Dysfunction/therapy , Humans , Randomized Controlled Trials as Topic , Treatment OutcomeABSTRACT
OBJECTIVE@#To overview the methodological quality, report quality and evidence quality of the systematic review (SR) of acupuncture for vascular cognitive impairment ( VCI ).@*METHODS@#The SRs regarding acupuncture for VCI were searched in PubMed, Cochrane Library, EMbase, CNKI, SinoMed, Wanfang and VIP databases. The retrieval period was from the establishment of the database to September 24, 2020. The report quality, methodological quality and evidence quality of the included SRs were evaluated by PRISMA statement, the AMSTAR 2 tool and the GRADE system.@*RESULTS@#A total of 22 SRs were included, including 102 outcome indexes. The methodological quality was generally low, with low scores on items 2, 5, 7, 10, 14, 15 and 16. The report quality was good, with scores ranging from 19 points to 24.5 points. The problems of report quality were mainly reflected in the aspects of structural abstract, program and registration, other analysis and funding sources. The level of outcome indexes of SRs was mostly low or very low, and the main leading factor was limitation, followed by inconsistency and inaccuracy.@*CONCLUSION@#Acupuncture for VCI is supported by low quality evidence of evidence-based medicine, but the methodological quality and evidence body quality of relevant SRs are poor, and the standardization is needed to be improved.
Subject(s)
Acupuncture Therapy , Cognitive Dysfunction/therapy , Databases, Factual , Humans , Research Report , Systematic Reviews as TopicABSTRACT
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.
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Hot Temperature , Humans , Moxibustion , Patient Preference , Random Allocation , Reproducibility of ResultsABSTRACT
To understand the development status and provide the basis for the construction and development of health technology assessment （HTA） institutions/organizations in China， this paper systematically reviewed the status of international HTA institutions/organizations and the HTA institutions/organizations in western developed countries and some Asian countries. This study was based on the results of the second round of global survey on HTA conducted by the World Health Organization （WHO） in 2020/2021. The websites of WHO， International HTA Database （INAHTA）， international HTA institutions/organizations， and the HTA institutions/organizations in different countries were searched. After data extraction and classification， we summarized the status of 9 international HTA institutions/organizations （including Decide： Health Decision Hub， Health Technology Assessment International， HTAsiaLink， International Network of Agencies for Health Technology Assessment， European Network for Health Technology Assessment， Health Technology Assessment Network of the Americas， International Society for Pharmacoeconomics and Outcomes Research， Southern African Health Technology Assessment Society， International Information Network on New and Emerging Health Technologies）， 11 HTA institutions/organizations in western developed countries and Asian countries （including Canada， France， Germany， the United Kingdom， Australia， the United States， Japan， Malaysia， South Korea， Singapore， and Thailand）， and 6 HTA organizations/teams in China. The use of HTA varies greatly because of different medical and health systems among different countries， and thus the role of HTA in health decision-making varies among different countries. The international HTA institutions/organizations have greatly strengthened the communication between HTA institutions/organizations and the pharmaceutical industry and facilitated the promotion and practice of evidence-based health decision-making.