1.Constructing an integrative Chinese and western medical clinical pathway for knee osteoarthritis based on guideline recommendations
Luping LIU ; Xiyou WANG ; Lingyun ZHANG ; Yuan LEI ; Yi AN ; Yixuan GAO ; Zhendong XING ; Jiaqi LIU ; Changhe YU
International Journal of Traditional Chinese Medicine 2025;47(1):9-17
Knee osteoarthritis (KOA) is a common chronic degenerative disease that not only causes pain and reduces the quality of life for patients but also imposes a significant societal burden. Clinical pathways can be developed by referencing recommendations from clinical practice guidelines to localize guidelines within the context of integrated traditional Chinese and western medical systems. However, existing clinical pathways suffer from shortcomings such as deficiencies in integrated traditional Chinese and western medical diagnosis and treatment, inadequate shared decision-making between healthcare providers and patients, and suboptimal visualization of clinical pathways. This study aimed to address and optimize the clinical pathway of KOA by comprehensively organizing and localizing the recommended guidelines. The concept of integrated traditional Chinese and western medicine was reflected through the construction of a path of joint decision-making between doctors and patients, emphasizing the coexistence of diagnosis and screening, the combination of clinical and imaging staging, joint decision-making between doctors and patients, and treatment stages. This pathway emphasizes patient-centered approach, with pain relief and functional rehabilitation running parallel, achieving the implementation of evidence-based concepts in practical medical practice. It provides a concrete basis for joint decision-making between doctors and patients in the integrated treatment of KOA with traditional Chinese and western medicine, which helps to improve diagnosis and treatment efficiency and patient quality of life.
2.Exploration of the effect and design of placebo manipulation in clinical trials of manipulation
Changhe YU ; Hualong LU ; Zhifeng LIU ; Hui SHAO ; Baolin JIA ; Hao WANG ; Xiyou WANG ; Yanan SUN
International Journal of Traditional Chinese Medicine 2025;47(10):1353-1358
This article summarized the current status and challenges of manipulation therapy for musculoskeletal pain and its placebo effect in clinical trials, analyzing the impact of the placebo effect on the evaluation of therapeutic efficacy. The efficacy of different manual manipulation techniques remains uncertain, and the degree of blinding and patient expectations play a crucial role in efficacy assessment. The article suggested improving trial design through standardized placebo intervention design, comprehensive investigation of patient expectations and psychological states, rigorous training of practitioners, and optimized diagnostic and treatment scenarios and doctor-patient relationship, to ensure consistency between intervention and placebo groups. Specific measures include the application of the DITTO (Deconstruct, Identify, Take out, Think, Optimize) framework, the use of standardized questionnaire tools, and multi-center, large-sample randomized controlled trials to enhance the external validity and statistical power of research results, thereby providing more scientifically reliable evidence for clinical practice.
3.Placebo effect in manual therapy: mechanism, influencing factors, and clinical application
Changhe YU ; Hui SHAO ; Xiyou WANG ; Yanan SUN
International Journal of Traditional Chinese Medicine 2025;47(11):1493-1498
The placebo effect in manual therapy is analyzed, suggesting that it is not only a control tool in experiments but also a key to the success of manual therapy. By analyzing the impact of multiple dimensions of the placebo effect, such as psychological and social factors, behavioral responses, and expectation effects, on treatment outcomes, it is pointed out that the professional image of the therapist and the patients' positive expectations of the treatment are the core elements to activate the placebo effect. At the same time, individual differences in treatment responses are also emphasized as a crucial aspect that cannot be ignored. It is suggested to reposition the placebo effect, incorporate it into the overall framework of manual therapy, and further explore its mechanism to provide a theoretical basis for the scientific and precise development of manual therapy.
4.Thoughts on optimization of STRICTOTM checklist to improve the implementation and reporting quality of Tuina massage clinical trials
Changhe YU ; Hao WANG ; Xiyou WANG ; Yanan SUN
International Journal of Traditional Chinese Medicine 2025;47(12):1645-1651
Tuina massage, as a TCM therapy, plays an important role in the treatment and rehabilitation of various diseases. However, the quality of Tuina massage clinical trials is directly affected by the design, implementation, and reporting quality of the treatment plan. STRICTOTM checklist, developed based on the CONSORT statement, is specifically designed for the reporting of intervention measures in Tuina massage clinical trials. However, there are many problems in its application, such as insufficient guidance on the design of treatment plans, unclear requirements for the control and recording of implementation details, and insufficiently detailed and standardized reporting information. This article reviewed the existing problems in the STRICTOTM checklist through the results of previous studies on the influencing factors of Tuina clinical trials and proposed potential methods and content for improvement. Specifically, this includes refining the assessment of treatment rationality, enriching the description of intervention details, strengthening the consideration of prognostic factors, paying attention to the impact of contextual factors, standardizing sham Tuina control, and enhancing the reporting of implementation fidelity. It is hoped that these improvements and optimization measures will enhance the quality of Tuina massage clinical trial reporting, ensure the transparency and repeatability of the research, and provide important references for the development of Tuina massage clinical research and the optimization of clinical decision-making.
5.The Application of “Diagnosing Diseases with Sinews” in Obstinate Facial Paralysis
Yuyan WANG ; Xiyou WANG ; Duoduo LI ; Eryang LIU ; Baolin JIA ; Changxin LIU ; Yuanyuan GONG
Journal of Traditional Chinese Medicine 2024;65(6):652-656
The theory of “diagnosing diseases with sinews” means that through the diagnosis and examination of the channel sinews at the site of the lesion, the surplus and deficit state of qi and blood in the channel sinews, vessles and channels, and the degree of damage to the organism caused by the disease and evils, can be determined, forming the three elements (the nature of the disease, the location of the disease, and the disease tendency) of the disease diagnosis can be closely integrated to form the trinity of diagnostic modes, which is “examining the disease nature by sinews, identifying the pattern by sinews, and determining the tendency by sinews”. For intractable facial paralysis, the method of “diagnosing diseases with sinews” can be adopted, in which the morphological changes of the channel sinews are judged through diagnosis by observation, the traditional Chinese patterns are identified through diagnosis by palpation, and the points of meridian tendons and the circulation of tendon and treatment lines are determined through diagnosis by circulation. The “diagnosing diseases with sinews” not only helps to accurately determine the disease condition, patterns and development trend, but also helps to adopt targeted treatment for the disease and prevent the disease from spreading, and providing ideas and methods for the clinical diagnosis and treatment of intractable facial paralysis.
6.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.
7.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.
8.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.
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.A experimental study of laparoscopic suture guide set assisted suture
Xiyou WANG ; Cuilong LIU ; Guang GUO ; Yubo ZHAO ; Yi WANG
Journal of Chinese Physician 2021;23(6):882-885
Objective:To design a laparoscopic suture guide set based on the principle that the ends of three struts on the arc of the same center, and to explore the rationality and practicability of the device by suture experiment in an isolated human kidney.Methods:⑴ The device was made. The three struts of the device were arranged on the fixed shaft in sequence. The function structure included the direction limitation device and the needle exit site locating device. The direction limitation device included the U-shaped end of the second strut and arc cylinder of the third strut. The needle exit site locating device was the Y-shaped end of the first strut. The ends of the three struts were on the same circular arc with the fixed axis as the center of the circle. When the long round needle of the same radian entered the curved cylinder (the first direction limitation device), it was restricted by the cylinder to travel to the U-shaped end of the second strut (the second direction limitation device), and was guided by the two devices to the Y-shaped end of the first strut (the needle exit site locating device). A built-in torsion spring clamped the kidney to fix the device. The design of the device was drawn into a 3D figure, printed by a metal 3D printer with titanium alloy, polished and then assembled into a finished product. ⑵ Experiment. Four kidneys of patients underwent retroperitoneal laparoscopic radical nephrectomy was cut open, and 8 needle insertion and exit points were designed along the long axis. The kidney sutured with conventional methods was set as the conventional group. Then the laparoscopic suture guide set was used to assist the suture, which was set as the guide group. For effective suture, the distance between the actual insertion point and the preset insertion point was less than 1.0 cm. If the distance was greater than 1.0 cm, re-suture rate and deviation distance were observed. The distance between the actual injection point and the preset injection point was less than 0.5 cm, which means the point is conformant, and the conformance rate was observed. Single needle suture time was observed in 2 groups.Results:In the experiment, 15 stitches deviated more than 0.5 cm, 10 stitches deviated more than 1.0 cm in the conventional group, the re-suture rate was 31.3%(10/32), the conformance rate was 53.1%(17/32), and the deviation distance was 0.6-1.15(0.41±0.48)cm. In the guide group, 5 stitches deviated more than 0.5 cm, 2 stitches deviated more than 1.0 cm, the re-suture rate was 6.3%(2/32), the conformance rate was 84.4%(27/32), and the deviation distance was 0.6-1.10(0.14±0.34)cm. There were statistically significant differences in the above indicators between the two groups ( P<0.05). The single stitch suture time in the conventional group ranged from 3-12(6.00±3.32)seconds, and that in the guide group ranged from 5-11(5.94±1.41)seconds. There was no significant difference in single stitch suture time between the two groups ( P>0.05). Conclusions:The structure design of laparoscopic suture guider is relatively reasonable. The device can ensure the direction of the surgical needle, reduce the number of times to adjust the surgical needle, and the needle position is accurate. It has a good auxiliary effect for suture in vitro, but the guider needs to be operated under laparoscopy to further verify its rationality and practicability.

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