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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.
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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.
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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.
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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.
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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.
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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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Pediatric Tuina is an important part of traditional Chinese medicine, but the operation technical standard is less developed. It is favored by TCM practitioners in China and abroad, due to its simple operation and clinical effects. The specific acupoint of pediatric tuina is the core of its therapy, but due to the numerous schools of pediatric tuina in China, the consensus of location and operation on some specific acupoints have not been reached. To meet the clinical practice needs of pediatric tuina practitioners and follow the evidence-based principles, we determined to develop International Pediatric Tuina Specific Acupoints and Operation Technical standaeds, considering the diversity of pediatric tuina schools. We hope to lay a foundation for evidence-based practice, trials design and guidelines development of pediatric tuina.
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The standardization of pediatric Tuina is beneficial to pediatric Tuina practitioners in a norm practices. The paper collects the content from teaching textbooks, TCM ancient books and database literature, and tries to develop the technical specifications of pediatric Tuina by four rounds Delphi surveys and expert consensus. This specification covers the manipulation of pediatric Tuina, the position of acupoints, the effects of acupoints and the diagnosis and treatment of pediatric Tuina, including indications, contraindications, cautious use, operation steps and methods.
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Objective:To evaluate the methodological quality and evidence quality of outcome of the systematic reviews/meta analyses on traditional exercise for the improvement of cardiopulmonary function.Methods:By searching for PubMed, Cochrane Library, Web of Science, CNKI, Wanfang, VIP and CBM databases in Chinese or English, the Systematic Reviews/meta analysis of traditional exercises for improving cardiopulmonary function was conducted. The retrieval time was March 8th, 2020. The AMSTAR 2 scale was used to evaluate the methodological quality of the systematic review/meta-analysis that met the inclusion criteria. Since the included studies cannot reflect the overall effect of traditional exercises on improving cardiopulmonary function, and the methodological quality of systematic reviews was generally low, a secondary analysis of the RCT studies included in the systematic reviews was conducted. The methodological quality evaluation of the original RCT study adopted the Cochrane Reviewers’ Handbook Version 5.0.0 bias risk assessment method (Risk of Bias, ROB), and applied the Revman 5.3 software to merge the original RCT data. The GRADE system was used for evidence evaluation.Results:A total of 32 systematic reviews/meta analysis were included, and the AMSTAR2 scale indicated that only one of the 32 systematic reviews/meta included was of high-quality, 1 was of low-quality, and the others were of extremely low quality. A total of 57 RCTs were included in the 32 systematic reviews for bias risk assessment and data consolidation. GRADE evidence quality evaluation showed that 14 evidences were of medium quality, 26 evidences were of low quality, and 5 evidences were of extremely low quality.Conclusions:Traditional exercises can improve cardiopulmonary function, but with low evidence quality. Thus, clinicians should make clinical decisions based on conditions.
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Determining effective traditional Chinese medicine (TCM) treatments for specific disease conditions or particular patient groups is a difficult issue that necessitates investigation because of the complicated personalized manifestations in real-world patients and the individualized combination therapies prescribed in clinical settings. In this study, a multistage analysis method that integrates propensity case matching, complex network analysis, and herb set enrichment analysis was proposed to identify effective herb prescriptions for particular diseases (e.g., insomnia). First, propensity case matching was applied to match clinical cases. Then, core network extraction and herb set enrichment were combined to detect core effective herb prescriptions. Effectiveness-based mutual information was used to detect strong herb-symptom relationships. This method was applied on a TCM clinical data set with 955 patients collected from well-designed observational studies. Results revealed that groups of herb prescriptions with higher effectiveness rates (76.9% vs. 42.8% for matched samples; 94.2% vs. 84.9% for all samples) compared with the original prescriptions were found. Particular patient groups with symptom manifestations were also identified to help investigate the indications of the effective herb prescriptions.
Subject(s)
Adolescent , Adult , Aged , Aged, 80 and over , Child , Female , Humans , Male , Middle Aged , Young Adult , Case-Control Studies , China , Drugs, Chinese Herbal , Therapeutic Uses , Medicine, Chinese Traditional , Propensity Score , Sleep Initiation and Maintenance Disorders , Drug TherapyABSTRACT
Objective The aim of this study is to analyze the factors influencing the outcomes of the traditional Chinese medicine (TCM) percutaneous release treatment for the stenosal tendosynovitis. Methods A total of 119 eligible participants, from outpatient of Dongzhimen Hospital during June, 2014 to April, 2017, were included into the study. The participants received TCM percutaneous release treatment, and were followed-up and assessed outcomes at 27 w. Responders were defined as participants with normal movement in week 27 compared with the baseline period. The NRS assessment in both groups was described, and the baseline characteristics of participants potentially related to cure response were mainly analyzed using Logistic regression analysis. Results Cure group and non-cure group were determined according to the cure response. And the outcomes of pain relief along the timeframe showed the feasibility of criteria of cure response. The uni-factor Logistic regression analysis showed that the factors age,course of disease,interventions and pain severity were significantly different between the cure and non-cure groups,and the multi-factor Logistic regression confirmed the four factors influenced the cure response of the TCM percutaneous release treatment for the stenosal tendosynovitis. The cutting knife was 5.85 fold than the traditional needling knife at increasing the cure response (OR=5.853,95% CI 1.853-18.485;P=0.003).All the factors that age equal to or older than 60 years(OR=6.170, 95% CI 1.890-20.141; P=0.003), course of disease more than six months (OR=4.696, 95% CI 1.371-16.085;P=0.014)and pain severity from 6 to 7(OR=5.184,95% CI 1.416-18.975;P=0.013)were negatively associated with clinical response. Conclusions The patients with increasing age, long course of disease and distinct pain severity may be less likely to respond to the TCM percutaneous release treatment. These findings contribute to guiding clinical practice in terms of pretreatment patient selection. Further research is needed to confirm the association.
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In order to form the expert consensus which researched on the comprehensive individualized protocol of Tuina therapy for Knee osteoarthritis, the preliminary protocol was summarized and formed by analyzing the interviews and published paper. And then the expert consensus method was applied for the protocols of Tuina therapy for KOA. After discussions, the consensus of three protocols according to the classification of KOA main symptomes was researched. In the protocols, 75%~80% of the entries were considered as strong recommendation, and the others were weak recommended. Thus, it is believed that the comprehensive protocols for the treatment of KOA with different Tuina manipulations is feasible and reproducible after standardization.
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On the basis of relevant literature, according to the clinical experience of Tuina specialists, a preliminary plan of Tuina for nonspecific low back pain has been formed. An expert consensus meeting was used to form a non-specific low back pain assessment program and 3 modern Gongting Lijinshu (Tuina massage) for the treatment of nonspecific low back pain. The treatment has showed to be clinically repeatable and suitable for the RCT study.
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Objective The purpose of study was to evaluate the safety and effectiveness of theblood-letting and herbal-cupping therapy for lumbar spinal stenosis.Methods A multi-center prospective case series was performed.The LSS patients meeting the inclusion criteria received 8 treatments as a course and 4 courses in total.The primary outcomes were the symptom severity and physical function scale ofthe Swiss Spinal Stenosis Measurement (SSM,total score 0-5 for each domain).The secondary outcomes were thethe 12-item short form health survey (SF-12,total score 0-100),and Oswestry disability index (ODI,total score 0-100) at time of baseline,completion of last treatment of each course.The minimal clinically important differences (MCIDs) were calculated for estimating the percentage of improvement in the population.The adverse events were reported at any time of the intra-and post-operation.This was a phrase analysis of the studyat seven months.Results Forty-eight patientswere included,with 64.6% (31/48) of LSS showing neurogenic claudication (walking distance ≤200 m).The average age was 63.1 ± 11.7 years,19 (39.6%) female,and the average BMI was 25.3 ± 3.3 kg/m2.The scores of symptom severity scale of SSM were 2.8 ± 0.6,2.6 ± 0.7,2.3 ± 0.6,1.9 ± 0.2 at baseline,1st,2nd,3rd course,and the scores of physical function scale were 2.5 ± 0.8,2.4 ± 0.7,2.1 ± 0.5,1.8 ± 0.3,and all the changes between baseline and each course showed significant improvement.The patient satisfaction of SSM,ODI and SF-12 showed significantimprovements after the 1st,2nd,3rd course (P<0.05).The SF-12 subgroup physical composite scores after 3rd course and mental composite score after 1st showed no significant improvement.The minimal clinically important difference for the “SymptomSeverity scale” in the SSM was achieved withimprovement of 18.8%,40.6%,83.3% in the LSS patient population after 1st,2nd,3rd course;and the "physical function scale" in SSM was achieved withimprovement of 22.9%,31.3%,50.0%.A total of 15 patients felt pain when they were micro-punctured with little blood at first time,but the symptom wereimmediately relieved without any treatment.Conelusions The Blood-letting and herbal-cupping therapy could benefit patients with lumbar spinal stenosis after third course of treatment in the fields of symptom relief and quality of life with no severe adverse event.However,this was a phrase analysis,so more evidence of this study and large comparative researches should be warranted in future.
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Recently, more systemic reviews and randomized controlled trials were published to prove the effectiveness of TCM,and some of those were included by Cochrane Library. But due to the potential selective reporting bias and publication bias, few trials were included in the meta analysis, which failed to prove the evidence for the TCM treatment. The difference of reported outcomes comes to the big problem of the comparison between interventions. Such problem of difference was gradually brought to the attention. Therefore, Core Outcome Sets(COS), which stands for that the minimum standardized outcome set that must be repoted, may be the solusion to that problem. In this research we've introduced the formation and development of core outcome sets in TCM.
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This study was aimed to compare the criteria on quality of questionnaire development and psychometric property evaluation. The references listed in the ISOQOL and consequent included criteria were searched. Two reviewers independently screened papers to include articles with inclusion criteria as follows: fully evaluating the questionnaire development and/or psychometric property; published or unpublished, but not book. Two reviewers independently extracted the information which contained criteria name, types of questionnaire assessed, criteria purpose, research methods, content, evaluation method and etc. Qualitative analysis was conducted to synthesize common characteristics of criteria, and to compare what each criterion emphasized on. The results showed that 9 included criteria sharing the same purpose which evaluated the questionnaire development process and/or psychometric properties of the health related quality of life questionnaire or patient reported outcome. Experts consensus based on previous studies were the criteria development methods. The standard content included conceptual framework, targeted population, content validity, internal consistency, test-retest reliability, structure validity and responsiveness with interpretability. Assessment scoring system used in the criteria was categorized as 2- or 4-point Likert scales. Or document of evaluation evidence was required to be provided. It was concluded that nine criteria can be used to develop new questionnaires, evaluate existed/new questionnaires, or choose the right questionnaires for clinic, based on the following elements such as their research purpose, trials types, questionnaire types or questionnaire administrations.