1.The Development of Core Outcome Set for Premature Ovarian Insufficiency Treated with Traditional Chinese Medicine
Xue CAO ; Changhe YU ; Xiangran MENG ; Yuning QIN ; Yanke AI ; Jia LIU
Journal of Traditional Chinese Medicine 2024;65(13):1334-1339
ObjectiveTo construct the core outcome set (COS) for premature ovarian insufficiency (POI) treated with traditional chinese medicine (TCM), thereby standardizing the effect evaluation system of POI clinical researches. MethodsDatabases including PubMed, EMbase, Cochrane Library, Web of Science, CNKI, Wanfang, VIP, SinoMed from January 2017 to December 31, 2021, and Chinese Clinical Trials Registry (ChiCTR), ClinicalTrials.gov were searched to collect the outcomes used in clinical studies of POI. Supplemented with the patients preferred outcomes through semi-structured interviews, the outcome pool was then constructed. Finally through the Delphi survey and consensus conference, the COS for POI was obtained. ResultsA total of 554 clinical researches and 14 registered clinical research protocols were included. A semi-structured interview was conducted within 20 patients. A total of 77 outcomes were included in the pool after consolidation. After two rounds of Delphi surveys, 20 outcomes were initially included. The COS, which was finalized through expert consensus conference, consists of 8 outcomes in 3 domains, which were ovarian reserve function (follicle stimulating hormone, estradiol, anti-Mullerian hormone, sinus follicle count), menstruation-related indicators (menstrual symptoms condition) and fertility indicators (pregnancy rate, live birth rate and the numbers of retrieved oocytes). Through expert discussion, the corresponding measurement methods as well as the measurement time points of the COS were determined. ConclusionThis study formed COS for clinical studies of TCM in the treatment of POI, by practicing the general method of developing COS, and exploring the key points of developing COS with TCM features.
2.Epidemiological analysis of the current prevalence of hepatitis B virus infection among pregnant and postpartum women in China from 2021 to 2023
Dongxu HUANG ; Xiaoyan WANG ; Qian WANG ; Ya GAO ; Yu WANG ; Changhe WANG ; Ailing WANG
Chinese Journal of Hepatology 2024;32(5):449-452
Objective:To analyze hepatitis B serologic tests and the current prevalence of hepatitis B virus (HBV) infection among pregnant and postpartum women in China from 2021 to 2023.Methods:Data on managing the prevention of mother-to-child transmission of HIV, syphilis, and hepatitis were retrieved from the National Information System. A positive serum HBsAg test was used to define HBV infection. The χ2 test was used to compare the coverage rate of the hepatitis B serologic test across different years, in early-stage pregnancy, and the current HBV infection in pregnant and postpartum women. A two-sided P value of <0.05 was considered a statistically significant difference. Results:The coverage rate for hepatitis B serological detection in pregnant (including intrapartum) and postpartum women and early-stage pregnancy rose from 99.68% (10?463?059/10?496?883) and 82.96% (8?707?765/10?496?883) to 99.94% (8?678?777/8?684?387, P ?0.001) and 88.87% (7?717?857/8?684?387, P ?0.001) in China between 2021 and 2023. The current prevalence rate of HBV infection decreased from 4.98% (521?479/10?463?059) in 2021 to 4.56% (396?148/8?678?777) in 2023 among pregnant and postpartum women ( P ?0.001). The current prevalence rate of HBV infection ranged from 1.53% to 10.39% among pregnant and postpartum women in various provinces of China in 2023. Conclusion:The coverage rate for hepatitis B serologic tests in China increased significantly between 2021 and 2023 in pregnant and postpartum women. Therefore, the current prevalence rate of HBV infection has decreased significantly in pregnant and postpartum women, but a regional difference still exists.
3.Protocol for the Traditional Chinese Medicine Diagnosis and Treatment Guidelines for Children with Upper Airway cough Syndrome
Lingyun ZHANG ; Xiyou WANG ; Daxin LIU ; Qiang HE ; Xuefeng WANG ; Xun LI ; Yutong FEI ; Yi XIAO ; Xiaoxue LAN ; Yuanwen LIANG ; Xiaoxuan LIN ; Rong ZHOU ; Sirui GU ; Ying ZHANG ; Yue WANG ; Xingzhu YE ; Wenke LIU ; Hong CHEN ; Changhe YU
International Journal of Traditional Chinese Medicine 2024;46(8):961-966
In order to standardize the clinical diagnosis and treatment of upper airway cough syndrome (UACS) for children in China, Dongzhimen Hospital of Beijing University of Chinese Medicine and Affiliated Hospital of Liaoning University of Traditional Chinese Medicine initiated the development of this Traditional Chinese Medicine Diagnosis and Treatment Guidelines for Children with Upper Airway cough Syndrome based on evidence-based medical evidence. This guideline will process registration, write a plan, and develop relevant processes and writing norms, develop and publish official documents. This plan mainly introduces the scope of the guidelines, the purpose and significance, the composition of the guidelines working group, the management of conflicts of interest, the collection, selection and determination of clinical problems, the retrieval, screening and rating of evidence, and the consensus of recommendations. Registration information: This study has been registered in the international practice guidelines registry platform with the registration code of PREPARE-2023CN087.
4.Preparation instructions of the Technical operation specification for TCM health care services (non-medical) foot bath (2024 edition)
Lingyun ZHANG ; Changhe YU ; Changxin LIU ; Luping LIU ; Yixuan GAO ; Jiayu LIU ; Yuhan WANG ; Mengmeng ZHANG ; Yang ZHANG ; Xiyou WANG
International Journal of Traditional Chinese Medicine 2024;46(10):1258-1263
Foot bath technique is booming in daily health care services. In order to develop a more standardized and complete technical operation process, the working group recorded the whole process of document formulation while writing the Technical Operation Specification for TCM Health Care Services (Non-Medical) Foot Bath (2024 edition). Work profile (including task background, task source, drafting unit, participant grouping and responsibilities), main technical content (including the basis and principles of preparation, key technical content of technical specifications), main preparation process (formation of working groups, registration and plan writing, selection and determination of clinical issues, literature research, drafting of the first draft, consensus on the main content of technical specifications, soliciting opinions, testing applications and external review), the relationship of current mandatory national standards or policies and regulations, the treatment process and basis of major differences, publicity and implementation and post-effect evaluation, the proposal to abolish the current relevant guidelines and the corresponding annexes were under detailed and in-depth description, which can assist the relevant practitioners of non-medical institutions to better understand and apply this technical specification.
5.A framework of the influencing factors of the therapeutic effect of Tuina treatment on pain based on the Delphi method
Yanji ZHOU ; Shuangshuang WANG ; Xiyou WANG ; Yi AN ; Ye GUO ; Hejing TANG ; Changxin LIU ; Duoduo LI ; Changhe YU
International Journal of Traditional Chinese Medicine 2023;45(4):391-396
Based on the resutls of literature review and interviews of experts, two rounds of Delphi surveys were conducted. The mean, importance ratio, coefficient of variation and coordination coefficient were used for assessment of survey from multiple perspectives, and finally form a framework model of factors affecting the efficacy of Tuina therapy. A total of 37 experts were selected for questionnaire surveys, the positive coefficients of experts' participatation in the first round and second round were 92.5% and 80.0%, respectively. The overall coordination coefficient in the second round is 0.68. The items were included into the consensus meeting if the importance ratio of items were equal to and more than 80%. After the expert consensus meeting, 22 items were included to form a framework model of factors affecting the efficacy of Tuina therapy, and summarized as 5 major influencing factors, including diagnostic factors, treatment factors, prognostic factors, patient factors, and doctor-patient communication. This framework can guide and help young Tuina practitioners to improve clinical efficacy. It is also clearly pointed out that the effect of Tuina for pain is not only related to disease diagnosis or manipulation, but also related to home exercise, health care, and doctor-patient communication.
6.The specific outcome Assessment Modal of acupuncture and Tuina treatment for pain
Xiaoxue LAN ; Hong CHEN ; Qianji CHEN ; Ying ZHANG ; Zhiwen WENG ; Hui SHAO ; Baolin JIA ; Junming GUO ; Yanan SUN ; Changhe YU
International Journal of Traditional Chinese Medicine 2023;45(5):521-526
Acupuncture and Tuina are the main non-drug therapies for low back pain, which are recommended by the guidelines. Acupuncture and Tuina can alleviate pain, which is regarded as conditional specific outcome, and improve mental, emotional problems, as non-conditional specific outcomes. There are some problems of the outcome assessment of acupuncture and Tuina treatment for pain such as insufficient evaluation of specific effect and unclear evaluation of characteristic outcome. Therefore, the key to above problems is to construct a Specific ouTcomE Assessment Modal of acupuncture and Tuina treatment for pain (STEAM-A&T) based on the qualitive and quantitative methods. By describing the experience, narrative expression, feelings and needs of patients who receiving acupuncture and Tuina treatment, the item banks of acupuncture and Tuina treatment effect are constructed, and the characteristic outcome of acupuncture and Tuina for pain will be screened, and then the relationship model among outcomes is constructed and optimized, which reflected the characteristics of acupuncture and Tuina for pain from multiple dimensions, multiple levels and multiple views. We reveal the relationship between the outcome of acupuncture and Tuina for pain. It will provide a new theory and methods for the construction of specific outcome assessment modal of Traditional Chinese Medicine.
7.Discussion on the factors influencing the curative effect of Tuina (Chinese massage)
Hejing TANG ; Duoduo LI ; Fuke ZANG ; Yanji ZHOU ; Junming GUO ; Jingyi MA ; Yang ZHANG ; Xiaoming YANG ; Changhe YU
International Journal of Traditional Chinese Medicine 2023;45(9):1065-1069
Tuina (Chinese massage) is an important part of Traditional Chinese Medicine. It is a simple and inexpensive technique, and has shown effectiveness for muscle and bone diseases, visceral diseases, gynecological diseases, and common diseases in children. This paper aims to analyze the factors influencing the effects of Tuina. The factors included the aspects of diagnosis, treatment, prognosis, patient factors and doctor-patient communication. During the treatment of Tuina, doctors should carry out good doctor-patient communication, properly evaluate and exam patients, and clarify diagnosis, take appropriate Tuina techniques according to the patients' constitution, health condition, and comorbidity. Only in such way, could Tuina achieve effectiveness and safety.
8.Analysis on the clinical outcomes and measurement tools of chronic back pain with integrated traditional Chinese and western medicine
Ying WAN ; Changxin LIU ; Ying ZHANG ; Qianji CHEN ; Han SHI ; Yanji ZHOU ; Yi AN ; Yanan SUN ; Changhe YU
International Journal of Traditional Chinese Medicine 2023;45(10):1313-1318
Objective:To summarize the characteristics of the participants (P), interventions (I), control measures (C), outcomes (O) and study design (S) of the clinical study of chronic back pain (CBP) in recent years; To further systematically organize the outcomes of the clinical study of CBP and their corresponding measurement tools.Methods:Clinical studies of CBP were retrieved from various databases including CNKI, Wanfang Database, VIP, SinoMed, Cochrane Library, Pubmed, Embase, Web of Science, etc. The search period was from January 1, 2015 to December 31, 2019. The retrieved literature was extracted and analyzed.The retrieved literatures will be extracted and analyzed. The retrieved literature was subjected to data extraction and analysis, and the quality of outcome indicators was evaluated according to 6 items. The Newcastle-Ottawa Scale ( NOS ) was used to evaluate the quality of cohort studies and case-control studies. Analyze the relationship between outcome indicators and interventions.Results:A total of 3 028 articles were finally included after examination and screening. The top 7 diagnoses of CBP were low back pain, lumbar disc protrusion, lumbar vertebral stenosis, lumbar vertebral slip, lumbar disc degression, non-specific chronic low back pain and post-operative pain syndrome. The top 7 intervention measures in clinical studies of CBP were surgery, acupuncture, physiotherapy, Tuina, exercise therapy, Western medicine painkillers and oral Chinese patent medicines. A total of 47 outcomes and 348 outcome measurement tools were reported in the literature included.Conclusion:In the clinical study of CBP in the recent years, there are problems such as incomplete and low quality of reporting, a wide variety of outcome measurement tools and lack of uniform reporting standards. The characteristics of patients determine the common characteristics of outcomes selection and it is also necessary to consider the specific outcomes related to interventions.
9.A Clinical Study on the Intervention of a Comprehensive Program of Traditional Chinese Medicine on Degenerative Lumbar Spinal Stenosis
Yanji ZHOU ; Yi AN ; Yuan LEI ; Yang ZHANG ; Xiaoming YANG ; Hui SHAO ; Naiwen ZHANG ; Zhiwen WENG ; Changxin LIU ; Xiyou WANG ; Changhe YU
World Science and Technology-Modernization of Traditional Chinese Medicine 2023;25(6):2188-2195
Objective To preliminarily verify the effectiveness and safety of bloodletting combined with drug bamboo cups in intervention of degenerative lumbar spinal stenosis,and to explore the prognostic factors that affect the efficacy of TCM regimens in the treatment of DLSS.Methods 64 consecutive patients with degenerative lumbar spinal stenosis were enrolled.Bloodletting combined with drug bamboo cup intervention was used.Acupoints were selected and treated with the same length of the governor channel of the lumbar spine,the first and second side lines of the bladder meridian and Ashi point,weekly 2 times,8 times per course,2 consecutive courses of treatment.Before treatment,after treatment,and 1 month follow-up,the changes of the patient's lumbar spinal stenosis specific scale(SSM),modified Oswestry dysfunction index(ODI),and 12 health survey summary scores(SF-12)were observed.Using SSM symptom or function score≥0.5,the criteria for grouping were first single-factor analysis,and then logistic regression was used to analyze the prognostic factors of the treatment.Results After 2 courses of treatment,the patient's SSM symptom score(2.25±0.56),SSM function score(2.06±0.67),ODI index(15.49±8.72),and SF-12 physiological score(36.31±7.35)were more significant than before treatment Improved,the difference was statistically significant(P<0.05),the SF-12 psychological score(49.70±9.47),the difference was not statistically significant compared with before treatment(P>0.05);the patient's SSM symptom score(2.22±0.54)was followed up for one month,SSM function score(2.09±0.66),ODI index(15.53±8.23),SF-12 physiological score(36.55±7.25),SF-12 psychological score(50.62±9.17),which are significantly better than before treatment,and the difference is statistically significant(P<0.05),the difference was not statistically significant(P>0.05)after 2 courses of treatment.The univariate logistic regression analysis of each influencing factor showed that:BMI,baseline symptom dimension,baseline functional dimension,foraminal stenosis,lateral recess stenosis,and two-stage stenosis had statistically significant differences between the effective and ineffective groups(P<0.05).Conclusion Bloodletting combined with drug bamboo cups has a certain clinical effect on degenerative lumbar spinal stenosis.
10.Theoretical Exploration of Intervention Component Analysis(ICA)Identifying the Critical Features of Traditional Chinese Medicine Complex Interventions——Application of ICA on Tuina Treatment for Knee Osteoarthritis as an Example
World Science and Technology-Modernization of Traditional Chinese Medicine 2023;25(8):2851-2857
Complex intervention of traditional Chinese medicine has the characteristics of individuality,dynamic and time space view.That how to implement process standardization,how to explain the mechanism of action of different interventions in complex treatment and how to establish the theoretical basis of the complex intervention become the key point of TCM complex intervention study.Intervention Component Analysis(ICA)is a qualitative Analysis technique to identify key characteristics of different interventions affecting outcome changes.It is suitable for situations where existing theories cannot explain the impact of Intervention schemes on outcome,or intervention information description is incomplete in methodological evaluation.ICA could not solve complex intervention in clinical trials of traditional Chinese medicine report fully and analyzes in-depth problems such as insufficient understanding,background factors,to assist the key feature of complex intervention affect curative effect of traditional Chinese medicine and its theoretical basis.In this paper,the application of ICA in the treatment of knee osteoarthritis by Tuina was explored,the evidence of the effectiveness of Tuina in the treatment of KOA was comprehensively compared,the characteristics of Tuina in the treatment of KOA were identified,and the mechanism of Tuina in the treatment of KOA was elucidated,and the key elements of Tuina in the treatment of KOA were clarified.Among them,the targeted areas,the purpose of treatment and the application of corresponding manipulations were the key factors affecting the efficacy.The strength of manipulations during treatment,the changes of the patient's condition and the risk factors after treatment were the key factors to maintain the efficacy and ensure the safety.However,the application of acupuncture points and complex traditional Chinese medicine prescriptions in ICA has not been carried out.Therefore,researchers need to further improve the ICA to suit the best conditions for the research and analysis of TCM interventions.Criticism and corrections from academic colleagues are welcome.

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