[Clinical guidelines for diagnosis and treatment of cervical spondylotic myelopathy with the integrated traditional Chinese and Western medicine(2023)].

The "Clinical Guidelines for Diagnosis and Treatment of Cervical Spondylotic Myelopathy with the Integrated Traditional Chinese and Western Medicine" were formulated by the Orthopedic and Traumatology Professional Committee of the Chinese Association of Integrative Medicine in accordance with the principles of evidence-based medicine and expert consensus, and provide clinicians with academic guidance on clinical diagnosis and treatment of CSM. The main content includes diagnostic points, disease grading assessment, TCM syndrome differentiation, surgical indications and timing, integrated traditional Chinese and Western medicine treatment, and postoperative rehabilitation. This guideline proposes for the first time that the treatment of CSM should follow the principle of grading, clarify the timing and methods of surgical treatment, establish common TCM syndrome differentiation and classification, attach importance to postoperative integrated rehabilitation of Chinese and Western medicine, and strengthen daily follow-up management. It hopes to promote the standardization, effectiveness, and safety of clinical treatment of CSM.

Traditional Chinese medicine for frozen shoulder: An evidence-based guideline.

BACKGROUND: Frozen shoulder is a common disorder that can lead to long-lasting impairment in shoulder-related daily activities. Traditional Chinese medicine (TCM) has played an important role in the effort to manage frozen shoulder. PURPOSE: We aimed to develop an evidence-based guideline for treating frozen shoulder with traditional Chinese medicine. STUDY DESIGN: Evidence-based guideline. METHODS: We developed this guideline based on internationally recognized and accepted guideline standards. The guideline development group used the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach to rate the certainty of evidence and the strength of recommendations. The benefits and harms, resources, accessibility, and other factors were fully taken into account, and the GRADE grid method was used to reach consensus on all recommendations. RESULTS: We established a multidisciplinary guideline development panel. Based on a systematic literature search and a face-to-face meeting, nine clinical questions were identified. Finally, twelve recommendations were reached by consensus, comprehensively considering the balance of benefits and harms, certainty of evidence, costs, clinical feasibility, accessibility, and clinical acceptability. CONCLUSION: This guideline panel made twelve recommendations, which covered the use of manual therapy, acupuncture, needle knife, Cheezheng Xiaotong plaster, Gutong plaster, exercise therapy and integrated TCM and Western medicine, such as combined modalities and corticosteroid injections. Most of them were weakly recommended or consensus based. The users of this guideline are most likely to be clinicians and health administrators.

[Expert consensus for diagnosis and treatment of cervical spondylotic myelopathy with the integrated traditional Chinese and western medicine].

Cervical spondylotic myelopathy (CSM) is the most serious subtype, which is characterized by severe clinical symptoms, a high disability rate, and poor prognosis. Traditional Chinese medicine and Western medicine have their own advantages in the diagnosis and treatment of CSM at different stages. In order to further standardize the clinical diagnosis and treatment of CSM and improve the clinical efficacy, based on previous experience and evidence-based medicine, after repeated discussions by the national expert group, the expert consensus on the diagnosis and treatment of integrated traditional Chinese and Western medicine was compiled. This consensus comprehensively introduces the definition, etiology, pathogenesis, diagnosis treatment principles, integrated traditional Chinese and Western medicine treatment, postoperative rehabilitation and nursing care of cervical spondylotic myelopathy, so as to provide reference for clinicians.

Acupuncture-related therapies for the poststroke cognitive impairment patients: A protocol for systematic review and network meta-analysis.

BACKGROUND: To compare and rank the clinical effects of different acupuncture and acupuncture-related therapies on patients with poststroke cognitive impairment. METHODS: We evaluated the direct and indirect evidence from relevant studies using network meta-analysis. Eight databases were examined in order to find randomized controlled trials of acupuncture-related therapies for individuals with poststroke cognitive impairment. After 2 researchers independently scanned the literature, extracted the data, and assessed the risk of bias in the included studies, the data were analyzed using RevMan5.4, Stata15.0, and WinBUGS1.4.3 software. RESULTS: We assess the benefits and drawbacks of various acupuncture-related therapies, rank the efficacy of various acupuncture-related therapies in the treatment of poststroke cognitive impairment, and describe the best acupuncture intervention approaches or combinations based on the available data. CONCLUSION: This study will contribute to the existence of data on the safety and efficacy of acupuncture-related therapies in the treatment of poststroke cognitive impairment, and it may aid clinical guideline makers in selecting the best acupuncture treatment for poststroke cognitive impairment. REGISTRATION NUMBER: INPLASY2021120117.

A Bibliometric Analysis and Visualization of Current Research Trends in Chinese Medicine for Osteosarcoma.

BACKGROUND: To illustrate the research framework, overall knowledge structure, and development trends of Chinese medicine (CM) treatment for osteosarcoma (OS) by using a bibliometric analysis and newly developed visualization tools. METHODS: Research datasets were acquired from the Web of Science (WOS) database from January 1, 1980 to September 30, 2019. VOS viewer and Citespace software was used to analyze the data and generate visualization knowledge maps. Annual trends of publications, distribution of institutes, distribution of journals, citation and H-index status, co-authorship status, research hotspots and co-citation status were analyzed. RESULTS: A total of 223 publications in the WOS database met the requirement. The number of published articles showed a rise but the citation frequency and the H-index of China were relatively low. The cooperation between the countries, institutes and authors were relatively weak. Most publications were basic researches. Most of the previous researches focused on basic mechanisms of CM in treating OS, and therapy and improvement of dosage form may become a frontier in this research field. CONCLUSIONS: Compared with other fields, the field of CM treatment for osteosarcome is still in infancy. The distribution of researches is imbalanced and cooperation between countries, institutions and authors remains to be strengthened. Furthermore, basic research occupies an absolute dominant position, and the exploration of the molecular mechanism of CM in preventing and treating OS may become a key point in the future.

Clinical control study of traditional Chinese medicine hot compress combined with traction in the treatment of cervical spondylotic radiculopathy: Study protocol.

ABSTRACT: Cervical spondylotic radiculopathy (CSR) is the most common type of cervical spondylosis, accounting for about 60% of the incidence of cervical spondylosis. Both cervical traction and traditional Chinese medicine hot compress are common and effective treatment for CSR. This study will be performed to investigate the effect of a combination of cervical traction and traditional Chinese medicine hot compress on CSR. In this non-blinded, randomized controlled trial, 100 eligible patients will be randomly divided into a treatment group (intermittent cervical traction combines with traditional Chinese medicine hot compress) and a control group (intermittent cervical traction combined with hot compresses). Before and after the intervention, the Visual Analog Scale score, Neck Disability Index score, and 20-score scale of symptoms will be evaluated at baseline and at 7, 14, 21, and 28 days. During the treatment period, any signs of acute adverse events, such as paralysis of aggravated pain, nausea, dizzy, and even syncope, will be recorded at each visit. Although intermittent cervical traction and traditional Chinese medicine hot compress have been used in the treatment of CSR in China for many years, there is no consensus on its effectiveness of combination therapy. This experiment will provide convincing evidence of the efficacy of intermittent cervical traction combined with traditional Chinese medicine hot compress in the treatment of CSR.

A randomized, double-blind, placebo-controlled trial for Yi-Qi Hua-Yu tong-sui granule in the treatment of mild or moderate cervical spondylotic myelopathy.

BACKGROUND: Neck pain, sensory disturbance and motor dysfunction in most patients suffered cervical spondylotic myelopathy (CSM). However, some conservative treatments are limited by their modest effectiveness. In the other hand, surgical treatment is necessary when symptoms are refractory to conservative treatments and neurological function of the patients has deteriorated. Many patients use complementary and alternative medicine, including traditional Chinese medicine, to address their symptoms. The purpose of the present study is to examine effectiveness and safety of Yiqi-Huayu-Tongsui (YQHYTS) granule, a compound traditional Chinese herbal medicine, on symptoms in patients with mild or moderate CSM. METHODS/DESIGN: A randomized, double blinded, placebo-controlled clinical trial to evaluate the efficacy and safety of YQHYTS granule is proposed. 72 patients in Longhua Hospital with the diagnosis of mild or moderate CSM will be randomly allocated into 2 groups, and treated with YQHYTS granule or placebo. The prescription of the trial drugs (YQHYTS granule/placebo) is 20 grams twice a day for 3 months. The primary outcome measurements include visual analog scale, Japanese Orthopedic Association, and Neck Disability Index score. The secondary outcome measurements are electromyogram and Pfirrmann classification. DISCUSSION: YQHYTS granule has been established and applied in Longhua Hospital for many years. As it has a potential benefit in treating mild or moderate CSM, we designed a double-blind, prospective, randomized controlled trial and would like to publish the results and conclusions later. If YQHYTS granule can alleviate neck pain, sensory disturbance, and even motor dysfunction without adverse effects, it may be a unique strategy for the treatment of mild or moderate CSM. TRIAL REGISTRATION: Chinese Clinical Trial Registry ID: ChiCTR1900028192. Registered 15 December 2019, Available at: http://www.chictr.org.cn/edit.aspx?pid=46913&htm=4.

Clinical study on improving postoperative symptoms of cervical spondylotic myelopathy by Qishe pill.

BACKGROUND: Cervical spondylotic myelopathy (CSM) is the most serious type of cervical spondylosis, which is often treated surgically in patients with progressive neurological symptoms following ineffective conservative treatment. However, some patients have residual symptoms such as neck pain, stiffness, and C5 nerve palsy after surgery. The Qishe pill can effectively relieve the symptoms of neck pain and numbness, but there is no evidence showing the efficacy and safety of the Qishe pill in treating symptoms after spinal cord surgery. METHODS/DESIGN: A multicenter, randomized controlled clinical trial will be conducted to evaluate the efficacy and safety of the Qishe Pill. A total of 330 patients with CSM who receive surgical treatment will be randomly divided into 2 groups, treated for 12 weeks and with a 1-year follow-up. The primary outcome will be Japanese Orthopaedic Association score from the baseline to 4 weeks, 12 weeks, 24 weeks, and 48 weeks after surgery. Secondary outcomes will include Visual Analogue Scale score, Neck Disability Index, and imaging indicators (including magnetic resonance imaging and X-ray). Additionally, adverse reactions will be observed and recorded as safety indicators. DISCUSSION: Although the Qishe pill can effectively improve the discomfort of the neck and upper limbs in clinical applications, there is a lack of clinical research on postoperative patients. This study will investigate the efficacy and safety of the Qishe pill in treating postoperative symptoms of CSM. TRIAL REGISTRATION: Clinical Trials.gov ID: ChiCTR1900028173. Registered on 17 December 2019.

The efficacy of Enhanced Recovery after Surgery (ERAS) for elderly patients with intertrochanteric fractures who received surgery: study protocol for a randomized, blinded, controlled trial.

BACKGROUND: Intertrochanteric fracture (ITF) is increasing with the rapid increase in the aging population, often causes a high mortality rate in old patients and increases the economic burden of the family and society. ERAS (Enhanced Recovery after Surgery) is a powerful guarantee for patients to accelerate their recovery after surgery. TCM (traditional Chinese medicine) promotes repair of injured tissues and eliminates traumatic aseptic inflammation. Therefore, this prospective randomized controlled clinical trial aims to evaluate the clinical effect of the evidence-based ERAS pathway of integrating TCM with western medicine on perioperative outcomes in ITF patients undergoing intramedullary fixation and provide reliable evidence-based data for applying the program to clinical practice. METHODS/DESIGN: We will conduct a prospective randomized, blinded, controlled trial to compare the effectiveness of ERAS care pathway with traditional care pathway and to investigate whether the ERAS care pathway can improve the perioperative outcome in ITF patients undergoing intramedullary fixation. A total of 60 patients with ITF will be enrolled and treated with the two care pathway, respectively. Length of stay, economic indicators, Harris score, VAS score, time to get out of bed, 30-day readmission rates, postoperative transfusion rates, discharge to home, and mortality will be evaluated. Any signs of acute adverse reactions will be recorded at each visit during treatment. DISCUSSION: Although an evidence-based process using the best available literature and Delphi expert-opinion method has been used to establish an ERAS pathway of integrating TCM with western medicine, there is a lack of consensus about its effectiveness. This trial will provide convincing evidence about the effect of ERAS pathway. TRIAL REGISTRATION: Registered on 12 October 2019. Trial number is ChiCTR1900026487.

[A method to create a new rat model of combination of disease and syndrome with cervical vertigo hyperactivity of liver yang syndrome].

OBJECTIVE: To establish a simple and reliable model of cervical vertigo in rats with hyperactivity of liver-yang syndrome, and to establish a simple and feasible method for evaluating the degree of vertigo in animals. METHODS: SPF male SD rats (aged 8 weeks, weighing 280 to 320 g) were randomly divided into 4 groups (6 rats in each group). The model of cervical vertigo of hyperactivity of liver yang syndrome (joint modeling group) was established by combining local injection of lauromacrogol (hardener) and receiving fuzi decoction by gavage. The joint modeling group was compared with the hardener group, the fuzi decoction group and the blank control group. The vertigo degree of rats was measured by the time of passing through a glass tube (running time) before modeling, 2 weeks and 3 weeks after the established model. RESULTS: There was no statistical difference in the running time between control group and fuzi decoction group, between joint modeling group and hardener group. The running time in the hardener group and the joint modeling group was longer than that in the control group (P< 0.05), and was even longer than that in the fuzi decoction group (P<0.01). There was significant difference in running time after modeling compared with that before modeling (P<0.05); there was no significant difference in running time between 2 and 3 weeks after modeling (P>0.05). CONCLUSION: This method can effectively establish a rat model of cervical vertigo with hyperactivity of liver-yang syndrome, and the running time can reflect the degree of vertigo in rats to a certain extent. This experiment provides a simple and feasible animal model and detection method for research of cervical vertigo in the future.

Liraglutide Lowers Body Weight Set Point in DIO Rats and its Relationship with Hypothalamic Microglia Activation.

OBJECTIVE: This study aimed to investigate the effects of liraglutide on the body weight set point (BWSP) in diet-induced obese rats and to determine the relationship between BWSP and hypothalamic arcuate nucleus (ARC) microglial activation. METHODS: Diet-induced obesity (DIO) rats were divided into three groups: continuous high-fat diet (HFD) plus saline, HFD with liraglutide, and HFD with liraglutide pair feeding. Body weight, BWSP, inflammatory cytokines, suppressor of cytokine signaling 3, orexigenic/anorexigenic proteins, apoptosis, and microglia in the ARC were assessed. The effect of liraglutide on the Notch-1 signaling pathway and its relationships with  nuclear factor-κB and p38 mitogen-activated protein kinase were also investigated in a lipopolysaccharide (LPS)-induced microglia activation model. RESULTS: Liraglutide reduced BWSP; reversed adverse changes in hypothalamic inflammation, suppressor of cytokine signaling 3, and apoptosis; and diminished microgliosis in DIO rats. The BWSP showed a linear correlation with ARC microglial density. Liraglutide inhibited LPS-induced M1 microglial polarization and promoted microglial polarization to the M2 phenotype, diminishing inflammatory cytokine expression. Liraglutide inhibited Notch-1 signaling pathway activation and decreased nuclear factor-κB and p38 mitogen-activated protein kinase pathway activation in LPS-stimulated microglia. CONCLUSIONS: Liraglutide can reduce BWSP in DIO rats. There is a linear correlation between hypothalamic microgliosis and BWSP. Liraglutide reduces excessive microglial activation and inflammation, which may contribute to BWSP reduction.

The clinical efficacy of Shi-style lumbar manipulations for symptomatic degenerative lumbar spondylolisthesis: protocol for a randomized, blinded, controlled trial.

BACKGROUND: Symptomatic degenerative lumbar spondylolisthesis (DLS) presents spinal problems in daily life. Shi-style lumbar manipulation (SLM), as an alternative treatment for DLS, is popular in China. SLM is based on the channels and collaterals theory of the traditional Chinese medicine, in which the symptoms are believed to result from channel blockage and joint displacement. However, there is no solid evidence to show the effect of the SLM on the management of symptomatic DLS. METHODS/DESIGN: We conduct a prospective randomized, blinded, controlled trial to compare the effectiveness of SLM with mechanical lumbar traction and explore whether it could be a potential therapy for symptomatic DLS. A total of 60 patients with symptomatic DLS will be enrolled and treated with the SLM or mechanical lumbar traction for 2 weeks. VAS score and SF-36 questionnaire were assessed at baseline and at 2, 4, 12, and 24 weeks. Any signs of acute adverse reactions, such as lower limb paralysis or syndrome of cauda equina, will be recorded at each visit during treatment. DISCUSSION: Although the SLM has been used in China for many years to treat symptomatic DLS, there is a lack of consensus about its effectiveness. This trial will provide convincing evidence about the effect of SLM on symptomatic DLS. TRIAL REGISTRATION: Registered on 6 January 2019; the trial number is ChiCTR1900020519 .

Incidence of Spontaneous Resorption of Lumbar Disc Herniation: A Meta-Analysis.

BACKGROUND: Lumbar disc herniation (LDH), a common disease, is often treated conservatively, frequently resulting in spontaneous resorption of the herniated disc. The incidence of this phenomenon, however, remains unknown. OBJECTIVE: To analyze the incidence of spontaneous resorption after conservative treatment of LDH using computed tomography and magnetic resonance imaging. STUDY DESIGN: Meta-analysis and systematic review of cohort studies. SETTING: The work was performed at The Suzhou Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine. METHODS: We initiated a search for the period from January 1990 to December 2015 using PubMed, Embase, and the Cochrane Library. Two independent reviewers examined the relevant reports. The references from these reports were also searched for additional trials using the criteria established in the PRISMA statement. RESULTS: Our results represent the pooled results from 11 cohort studies. The overall incidence of spontaneous resorption after LDH was 66.66% (95% CI 51% - 69%). The incidence in the United Kingdom was 82.94% (95% CI 63.77% - 102.11%). The incidence in Japan was 62.58% (95% CI 55.71% - 69.46%). LIMITATIONS: Our study was limited because there were few sources from which to extract data, either in abstracts or published studies. There were no randomized, controlled trials that met our criteria. CONCLUSIONS: The phenomenon of LDH reabsorption is well recognized. Because its overall incidence is now 66.66% according to our results, conservative treatment may become the first choice of treatment for LDH. More large-scale, double-blinded, randomized, controlled trials are necessary to study the phenomenon of spontaneous resorption of LDH.Key words: Lumbar, disc herniation, spontaneous resorption, conservative treatment, incidence, country, meta-analysis, systematic review, observational studies, study designs.

Bone mass improved effect of icariin for postmenopausal osteoporosis in ovariectomy-induced rats: a meta-analysis and systematic review.

OBJECTIVE: Ovariectomy (OVX)-induced rats are the most frequently used animal model to research postmenopausal osteoporosis. Our objective was to summarize and critically assess the bone mass improved effect of icariin (ICA) for treatment of postmenopausal osteoporosis in an OVX-induced rat model. METHODS: The PUBMED, EMBASE, and Chinese databases were searched from their inception date to February 2015. Two reviewers independently selected animal studies that evaluated the bone mass improved effect of ICA compared with control in OVX-induced rats. Extracted data were analyzed by RevMan statistical software, and the methodological quality of each study was assessed. RESULTS: Seven studies with adequate randomization were included in the systematic review. Overall, ICA seemed to significantly improve bone mass as assessed using the bone mineral density (seven studies, n = 169; weighted mean difference, 0.02; 95% CI, 0.01-0.02, I = 77%, P < 0.00001) using a random-effects model. There is no significant difference between ICA and estrogen (E) (six studies, n = 128; weighted mean difference, 0.00; 95% CI, -0.00 to 0.01, I = 54%, P = 0.01). CONCLUSIONS: Bone mass improved effect of ICA for postmenopausal osteoporosis was observed in OVX-induced rats. Assessment of the methodological quality of studies involving OVX-induced animal models is required, and good methodological quality should be valued in systematic reviews of animal studies.

Effects of Qishe Pill, a compound traditional Chinese herbal medicine, on cervical radiculopathy: study protocol for a randomized controlled trial.

BACKGROUND: Neck pain is a common symptom in most patients suffering from cervical radiculopathy. However, some conservative treatments are limited by their modest effectiveness. On the other hand, surgical intervention for cervical disc disorders is indicated when symptoms are refractory to conservative treatments and neurological symptoms are progressive. Many patients use complementary and alternative medicine, including traditional Chinese medicine, to address their symptoms. The purpose of the present study is to examine the efficacy and safety of Qishe Pill, a compound traditional Chinese herbal medicine, for neck pain in patients with cervical radiculopathy. METHODS/DESIGN: A multicenter, double-blind, randomized, placebo-controlled trial to evaluate the efficacy and safety of the Qishe Pill is proposed. The study will include 240 patients from five sites across China and diagnosed with cervical radiculopathy, according to the following inclusion criteria: age 18 to 65 with pain or stiffness in the neck for at least 2 weeks (neck disability index score 25 or more) and accompanying arm pain that radiates distally from the elbow. Qualified participants will be randomly allocated into two groups: Qishe Pill group and placebo group. The prescription of the trial medications (Qishe Pill/placebo) are 3.75 g each twice a day for 28 consecutive days. The primary outcome is pain severity. Secondary outcomes are functional status, patient satisfaction, and adverse events as reported in the trial. DISCUSSION: Qishe Pill is composed of processed Radix Astragali, Muscone, Szechuan Lovage Rhizome, Radix Stephaniae Tetrandrae, Ovientvine, and Calculus Bovis Artifactus. According to modern research and preparation standards, Qishe Pill is developed to improve on the various symptoms of cervical radiculopathy, especially for neck pain. As it has a potential benefit in treating patients with neck pain, we designed a double-blind, prospective, randomized-controlled trial and would like to publish the results and conclusions later. If Qishe Pill can alleviate neck pain without adverse effects, it may be a unique strategy for the treatment of cervical radiculopathy. TRIAL REGISTRATION: This study is registered at ClinicalTrials.gov, NCT01274936.

[Regulation effects of Gegen Recipe and Guizhi Recipe on expression of IL-1beta, iNOS, TNFalpha, TGFbeta mRNA in degenerated cervical intervertebral disk in rabbits].

OBJECTIVE: To study the effects of Gegen Recipe and Guizhi Recipe regulating the expression of IL-1beta, iNOS, TNFalpha and TGFbeta mRNA in degenerated intervertebral disk caused by stimulation of wind, cold and damp. METHODS: Thirty-six rabbits were randomly separated into six groups, viz. control group, stimulation by wind, cold and damp group, head in low-location group, compound model group (head in low-location plus stimulation of wind, cold and damp), Gegen Recipe group and Guizhi Recipe group. The gene expression of IL-1beta, iNOS, TNFalpha and TGFbeta mRNA in degenerated cervical intervertebral disks were assayed by RT-PCR. RESULTS: Compared with the control group, IL-1beta mRNA and iNOS mRNA expression were up-regulated in each model group(P<0.01). Both Gegen Recipe and Guizhi Recipe down-regulated IL-1beta mRNA, iNOS mRNA expression, which had significant differences compared with the stimulation model group(P<0.01 or <0.05). TNFalpha mRNA expression was significantly enhanced in the compound model group compared with the control group (P<0.01). There was no significant difference between the head in low-location group and the stimulation model group. Gegen Recipe down-regulated TNFalpha mRNA expression compared with the stimulation group(P<0.01),while the effect of Guizhi Recipe was not significant. Compared with the control group, TGFbeta mRNA expression went down in each model group(P<0.01). Gegen Recipe up-regulated TGFbeta mRNA expression(P<0.01), while the effect of Guizhi Recipe on adjusting TGFbeta mRNA was not significant. CONCLUSION: Stimulation by wind, cold and damp, head in low-location, and compound of both can down-regulate the expressions of IL-1beta, iNOS, TNFalpha mRNA, and up-regulate the expression of TGFbeta mRNA. These researches certify that these factors take part in the progression of intervertebral disk degeneration. IL-1beta, iNOS, TNFalpha accelerate the degeneration and TGFbeta defers the degeneration. Gegen Recipe down-regulates the expression of TNFalpha mRNA and up-regulates the expression of TGFbeta mRNA. The effect on regulating the cell factors expressions by Guizhi Recipe is lower than that of Gegen Recipe.