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Effects of anterior sciatic nerve acupuncture on lower limb paralysis after cerebral infarction:study protocol for a randomized controlled trial

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Journal of Traditional Chinese Medicine 2024年第1期44卷 205-211页

作者： LI Menghan WANG Yu RAN Dawei YANG Xinming DENG Shizhe SHI Lei MENG Zhihong Department of Acupuncture First Teaching Hospital of Tianjin University of Traditional Chinese MedicineTianjin 300193China National clinical Research Center for Chinese Medicine Acupuncture and Moxibustion Tianjin 300193China Graduate department Tianjin University of Traditional Chinese MedicineTianjin 301617China Department of Massage and Rehabilitation Second Affiliated Hospital of Tianjin University of Traditional Chinese MedicineTianjin 300250China

Stroke is the main cause of disability in the middle and old age.Hemiplegia,especially lower limb paralysis,often leads to the loss of self-care ability and a series of secondary injuries.The main method to improve hemiplegic limb movement is exercise therapy,but there are still many patients with disabilities after rehabilitation treatment.As one of the non-pharmacological therapies for stroke,acupuncture has been recognized to improve motor function in patients.Here,we propose a new method,anterior sciatic nerve acupuncture,which can stimulate both the femoral nerve and the sciatic nerve.We designed this study to determine the effect of this method on lower limb motor function.Sixty participants recruited with hemiplegia after cerebral infarction will be randomly assigned to the test group or control group in a 1:1 ratio.The control group will receive Xingnao Kaiqiao acupuncture,and the test group will receive anterior sciatic nerve acupuncture on this basis.All participants will get acupuncture treatment once a day,6 times a week for 2 weeks.The primary outcome is Fugl-Meyer Assessment of Lower Extremity and the secondary outcomes are Modified Ashworth Scale and Modified Barthel Index.Data will be collected before treatment,1week after treatment,and 2 weeks after treatment,and then statistical analysis will be performed.This study can preliminarily verify the effect of anterior sciatic nerve acupuncture on improving lower limb motor function in patients with cerebral infarction,which may provide an alternative approach for clinical treatment of hemiplegia.

关键词： anterior sciatic nerve acupuncture paralysis cerebral infarction Xingnao Kaiqiao clinical protocols

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Efficacy and safety of a sequential treatment with clearing heat and eliminating phlegm and tonifying Qi and activating blood circulation in treating acute ischemic stroke: study protocol for a randomized controlled trial

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Journal of Traditional Chinese Medicine 2022年第4期42卷 604-610页

作者： ZHOU Ziyi WAN Can ZHAO Yuanqi LIU Xiangzhe GAO Ying AN Hongwei LI Lejun ZHANG Huili YU Xiaofei ZHANG Xinchun WANG Huijuan SHI Qing WEI Chunhua CHEN Jie HUANG Wenguo CHEN Junbin GAO Ying HU Mingzhe CAI Yefeng Department of Neurology Guangdong Provincial Hospital of Chinese MedicineGuangzhou 510120China the Second clinical College of Guangzhou University of Chinese Medicine Guangzhou 510120China Department of Neurology The First Affiliated Hospital of Henan University of Traditional Chinese MedicineZhengzhou 450000China Department of Neurology Shenyang Second Hospital of Traditional Chinese MedicineShenyang 110100China Department of Neurology Liuzhou Traditional Chinese Medical HospitalLiuzhou 545001China Department of Neurology Wuxi Traditional Chinese Medicine HospitalWuxi 214071China Department of Neurology Qinhuangdao City Hospital of Traditional Chinese MedicineQinhuangdao 066000China Department of Neurology Shanghai Shuguang HospitalShanghai 200120China Department of Neurology the Second Hospital of Hebei Medical UniversityShijiazhuang 050000China Department of Neurology Jiangmen Wuyi Hospital of Traditional Chinese MedicineJiangmen 529000China Department of Neurology Nanshi Hospital Affiliated to Henan UniversityNanyang 473065China Department of Neurology Shanxi Province Hospital of Traditional Chinese MedicineXi'an 710003China Department of Neurology Maoming Hospital of Traditional Chinese MedicineMaoming 525000China Department of Neurology the Northern Guangdong People's HospitalShaoguan 512025China Department of Neurology and Stroke Center Dongzhimen Hospital affiliated to Beijing University of Chinese MedicineBeijing 100700China

OBJECTIVE:To investigate the short-term efficacy and safety outcomes following a sequential treatment with clearing heat and eliminating phlegm(CHEP)formula and tonifying Qi and activating blood circulation(TQABC)formula in patients with acute ischemic stroke(AIS)within a 72 h time window.METHODS:In this randomized,multicenter,doubleblinded,placebo-controlled trial,500 participants will be randomly assigned in a ratio of 1∶1 to the CHEP+TQABC group or control group.In addition to guidelinebased standard medical care,participants in the treatment group will receive the CHEP formula for the first 5 consecutive days followed by the TQABC formula for another 10 consecutive days,while those in the control group will receive CHEP formula placebo and TQABC formula placebo consecutively.The primary outcome measure will be the comparison of the change in the National Institutes of Health Stroke Scale score from baseline to 15 days after randomization.The secondary outcome measures will include the scores on the modified Rankin Scale,Barthel Index,Patient-Reported Outcomes,TCM symptom pattern(Zheng-hou)evaluation Scale,and the incidence of in-hospital complications.Safety assessment will include the physical examination,laboratory detection,any adverse events or serious adverse events,and the proportion of any complications during hospitalization.DISCUSSION:The results of this study will provide objective and scientific data with which to assess the efficacy and safety of a sequential treatment based on“integrating disease and symptom pattern”for patients with AIS.

关键词： stroke clearing heat and eliminating phlegm tonifying Qi and activating blood circulation randomized controlled trial clinical protocols

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An international multicentric phaseⅢrandomized controlled trial of time-acupoints-space acupuncture for the prevention of chemotherapy-induced fatigue in patients with early stage breast cancer:a study protocol

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Journal of Traditional Chinese Medicine 2022年第2期42卷 289-295页

作者： Saghachian Mahasti Barry Caroline Asselain Bernard LI Yunfen NIE Jianyun LIU Dequan CHEN Dedian CHEN Chunxin Laura Estevez LI Wenhui Jean-Pierre Armand ZHU Miansheng JU Liya Institute Gustave Roussy ParisFrance Research Center of Epidemiology and public health ParisFrance Institute Curie of Paris ParisFrance Yunnan Cancer Hospital Third Affiliated Hospital of Kunming Medical UniversityKunmingChina PreciMed Platform Europe ParisFrance MD Anderson Cancer Hospital MadridSpain ARIATAS Association pour la Recherche et l’Information de l’Acupuncture Time-Acupoints-Space ParisFrance Yunnan Zhu's expert workstation National famous traditional Chinese medicine expert of Mian-Sheng ZHUKunmingChina

OBJECTIVE:To determine the difference in prevention of chemotherapy-induced fatigue between time-acupointsspace acupuncture(ATAS)administered weekly compared to sham acupuncture and non-acupuncture in patients with early breast cancer receiving adjuvant chemotherapy by epirubicine-cyclophosphamide(EC)followed by paclitaxel,as measured by the multidimensional fatigue inventory(MFI)over the previous week and Visual Analogue Scale measuring fatigue(VAS-F),and to evaluate the effects of ATAS on selfreported neuropathy pain,sleep,anxiety and depression.METHODS:In this multicenter clinical trial,we have randomized patients into 3 groups:ATAS,Sham and nonacupuncture with an unequal randomization of 2∶1∶1.A cloud related electronical clinical report form and smartphone platform was established for data entry.Patients with a history of stageⅠ-Ⅲbreast cancer scheduled to receive adjuvant chemotherapy.Acupuncture will be delivered once a week during chemotherapy with VAS-F evaluation.In order to qualify and quantify the mechanism of fatigue induced by chemotherapy with or without acupuncture,an evaluation of immune profiling was incorporate in this study.RESULTS:The presence and seriousness of chemotherapy-induced fatigue should be considered in therapeutic programs for early breast cancer treatment.Fatigue induced by adjuvant chemotherapy in patients with breast cancer remains a major concern affecting the quality of life significantly.Unfortunately,we do not have effective pharmacological interventions yet.And clinical trials of acupuncture in preventing chemotherapyinduced fatigue in patients with early breast cancer have not been reported.CONCLUSION:The findings of the trial will allow us to determine the effects of acupuncture treatment approach.We will also be able to confirm whether ATAS is better than sham acupuncture and non-acupuncture treatments.

关键词： breast neoplasms chemotherapy adjuvant fatigue immunity clinical protocols time-acupoints-space acupuncture

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Bloodletting puncture in the treatment of acute ischemic stroke:protocol for a mixed-method study of a multi-center randomized controlled trial and focus group

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Journal of Traditional Chinese Medicine 2023年第6期43卷 1259-1267页

作者： DAI Zeqi LIAO Xing GUAN Yueyue ZENG Zixiu TANG Jun HU Jing Center for Evidence Based Chinese Medicine Institute of Basic Research in Clinical MedicineChina Academy of Chinese Medical SciencesBeijing 100700China Department of Encephalopathy Chongqing Hospital of Traditional Chinese MedicineChongqing 400021China Evidence-based Medicine Center Beijing Hospital of Traditional Chinese MedicineCapital Medical UniversityBeijing Institute of Traditional Chinese MedicineBeijing 100010China

This study is to investigate the effectiveness and safety of bloodletting puncture(BP)for acute ischemic stroke(AIS)when used in combination with standard treatment,as well as the patients'feelings and attitudes toward the treatment.This is a mixed method research which includes a multi-center,superiority,randomized controlled clinical trial,and focus group interview.A total of 360 AIS participants will be enrolled.They will be randomized into one of the following two groups for 7 d:(a)BP with standard treatment group(n=180);(b)standard treatment group(n=180).The primary outcome will be National Institute of Health stroke scale(NIHSS)score at day 7 after treatment.Secondary outcomes will be changes of Glasgow Coma Scale score,NIHSS score,mRS and Traditional Chinese Medicine syndrome score from baseline to 7,14,and 30 d after treatment,recurrence rate and all-cause mortality rate within 30 d,and the safety assessments.The focus group will be conducted with a purposive sample of 1-2 acupuncturists and 1-2 patients respectively at each center at 7 and 30 d after treatment.We designed a mixed method study to evaluate the effect of BP,an acupuncture therapy for patients with AIS.If the findings of this study confirm the effectiveness of BP to reduce the NIHSS score and other related outcomes and patients are willing to accept the therapy,we believe this study will help the implementation of this therapy in clinical practice,and provide new evidence for the treatment of AIS.

关键词： bloodletting punctures ischemic stroke equivalence trial randomized controlled trial focus groups clinical protocols

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Delivery of acupuncture in clinical trials:Research acupuncturists’perspectives

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Journal of Integrative Medicine 2023年第4期21卷 315-319页

作者： Joyce K.Anastasi Bernadette Capili Jessica Neumaier Londa Hackett Division of Special Studies in Symptom Management New York UniversityNew YorkNY 10010USA Heilbrunn Family Center for Research Nursing the Rockefeller UniversityNew YorkNY 10065USA

Delivery of acupuncture in the setting of a clinical trial is a unique practice that diverges significantly from the delivery of acupuncture in a real-world clinical setting. Research acupuncturists, particularly those trained in traditional Chinese medicine(TCM), are often required to set aside valued precepts of traditional care, including diagnosing imbalances, individualizing treatment, and forging a therapeutic relationship with patients. TCM-trained acupuncturists express mixed feelings about participating in clinical trials. Many are eager to play a vital role in the advancement of acupuncture science and appreciate the need for strict protocol adherence to minimize bias. However, the acupuncturist(s) may also have concerns about clinical trial methodology, including but not limited to the delivery of a control condition, e.g., sham acupuncture. Investigators should anticipate certain questions and even a level of resistance to the requirements of research among acupuncturists and be prepared to address them. This manuscript presents a brief review of the subjective experience of the research acupuncturist within the available scientific literature as it pertains to the delivery of active and sham clinical research protocols. Our goals are to better understand the perspectives of acupuncturists who may participate in clinical research, so that their concerns may be addressed in study design and methodology. To that end, we suggest the creation of a novel training program specifically for clinical trial acupuncturists, intended for qualified TCM-and Western-trained practitioners, that would help to standardize the research acupuncturist’s role and help to strengthen the design and execution of acupuncture studies.

关键词： Acupuncture Traditional Chinese medicine clinical protocols Health knowledge,attitudes,practice Researcher-subject relationship Placebos

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Effectiveness and safety of Chinese herbal medicines for hepatitis B virus-related acute-on-chronic liver failure:study protocol for a multicenter randomized controlled trial

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Journal of Traditional Chinese Medicine 2020年第6期40卷 1052-1059页

作者： Zhang Ning Zhou Chao Wang Lifu He Tingting Wang Yao Wang Yan Bai Yunfeng Li Jun Xiao Xiaohe Gong Man Integrated Traditional Chinese Medicine&Western Medicine Department the Fifth Medical CenterGeneral Hospital of PLABeijing 100039China

OBJECTIVE:To conduct a multicenter randomized controlled trial of the efficacy of standardized Chinese herbal medicines(CHMs)against acuteon-chronic liver failure(ACLF)and provide reproducible and high-level evidence for clinical practice.METHODS:This is a prospective,multicenter,centrally randomized controlled trial.Patients diagnosed with hepatitis B virus-related ACLF(n=510)will be allocated to the standard medical therapy or CHM group at a 1∶1 ratio.Two CHMs will be used on the basis of the traditional Chinese medicine syndrome:Liangxue Jiedu granules for excess syndromes and Yiqi Jiedu granules for deficiency syndromes.The primary outcome is transplant-free survival at week 12.The secondary outcomes are(a)transplant-free survival at week 24,(b)liver function as assessed using the model for end-stage liver disease score at week 12,(c)liver function as assessed using the Child-Pugh score at week 12,and(d)the incidence of complications at week 12.DISCUSSION:The effectiveness and safety of CHM formulations will be assessed following treatment for ACLF.TRIAL REGISTRATION:The trial was registered at clinical Trials.gov(NCT03577938)on June 24,2018.

关键词： Acute-on-chronic liver failure Hepatitis B chronic Drugs Chinese herbal Randomized controlled trial clinical protocols

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Chinese herbal medicine Xinfeng Capsule in treatment of rheumatoid arthritis:study protocol of a multicenter randomized controlled trial

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Journal of Integrative Medicine 2013年第6期11卷 428-434页

作者： Jian Liu Chuan-bing Huang Yuan Wang Gui-qin Xu Yuan-yuan Cheng Yun-xia Feng Lei Liu Ya-jun Qi Department of Rheumatology the First Affiliated HospitalAnhui University of Chinese Medicine

BACKGROUND： Rheumatoid arthritis （RA）, as a common systemic inflammatory autoimmune disease, affects approximately 1 in 100 individuals. Effective treatment for RA is not yet available because current research does not have a clear understanding of the etiology and pathogenesis of RA. Xinfeng Capsule, a patent Chinese herbal medicine, has been used in the treatment of RA in recent years. Despite its reported clinical efficacy, there are no large-sample, multicenter, randomized trials that support the use of Xinfeng Capsule for RA. Therefore, we designed a randomized, double-blind, multicenter, placebo-controlled trial to assess the efficacy and safety of Xinfeng Capsule in the treatment of RA. METHODS AND DESIGN： This is a 12-week, randomized, placebo-controlled, double-blind, multicenter trial on the treatment of RA. The participants will be randomly assigned to the experimental group and the control group at a ratio of 1：1. Participants in the experimental group will receive Xinfeng Capsule and a pharmaceutical placebo （imitation leflunomide）. The control group will receive leflunomide and an herbal placebo （imitation Xinfeng Capsule）. The American College of Rheumatology （ACR） Criteria for RA will be used to measure the efficacy of the Xinfeng Capsule. The primary outcome measure will be the percentage of study participants who achieve an ACR 20% response rate （ACR20）, which will be measured every 4 weeks after randomization. Secondary outcomes will include the ACR50 and ACR70 responses, the side effects of the medications, the Disease Activity Score 28, RA biomarkers, quality of life, and X-rays of the hands and wrists. The first four of the secondary outcomes will be measured every 4 weeks and the others will be measured at baseline and after 12 weeks of treatment. DISCUSSION： The result of this trial will help to evaluate whether Xinfeng Capsule is effective and safe in the treatment of RA. TRIAL REGISTRATION： This trial has been registered in clinicalTrials.gov. The identifier is N CT01774877.

关键词： Xinfeng Capsule rheumatoid arthritis double-blind method placebos ACRcriteria quality of life randomized controlled trials clinical protocols

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Evaluation on the efficacy and safety of Chinese herbal medication Xifeng Dingchan Pill in treating Parkinson's disease: study protocol of a multicenter, open-label, randomized active-controlled trial

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Journal of Integrative Medicine 2013年第4期11卷 285-290页

作者： Jie Zhang Yun-zhi Ma Xiao-ming Shen Department of Cerebropathy Dongzhimen Hospital Beijing University of Chinese Medicine Department of Cerebropathy the First Affiliated Hospital Henan University of Traditional Chinese Medicine

BACKGROUND： Parkinson＇s disease （PD） is a complicated disease, commonly diagnosed among the elderly, which leads to degeneration of the central nervous system. It presently lacks an effective therapy for its complex pathogenesis. Adverse effects from Western drug-based medical intervention prevent long-term adherence to these therapies in many patients. Traditional Chinese medicine （TCM） has long been used to improve the treatment of PD by alleviating the toxic and adverse effects of Western drug-based intervention. Therefore, the aim of this study is to evaluate the efficacy and safety of Xifeng Dingchan Pill （XFDCP）, a compound traditional Chinese herbal medicine, taken in conjunction with Western medicine in the treatment of PD patients at different stages in the progression of the disease. METHODS AND DESIGN： This is a multicenter, randomized controlled trial. In total, 320 patients with early- （n = 160） and middle-stage PD （n = 160） will be enrolled and divided evenly into control and trial groups. Of the 160 patients with early-stage PD, the trial group （n = 80） will be given XFDCP, and the control group （n = 80） will be given Madopar. Of the 160 patients with middle-stage PD, the trial group （n = 80） will be given XFDCP combined with Madopar and Piribedil, and the control group （n = 80） will be given Madopar and Piribedil. The Unified Parkinson＇s Disease Rating Scale scores, TCM symptoms scores, quality of life, change of Madopar＇s dosage and the toxic and adverse effects of Madopar will be observed during a 3-month treatment period and through a further 6-month follow-up period. DISCUSSION： It is hypothesized that XFDCP, combined with Madopar and Piribedil, will have beneficial effects on patients with PD. The results of this study will provide evidence for developing a comprehensive therapy regimen, which can delay the progress of the disease and improve the quality of life for PD patients in different stages. TRIAL REGISTRATION： This trial has been registered in the Chinese clinical Trial Registry with

关键词： Parkinson disease levodopa drugs, Chinese herbal drug toxicity randomized controlled trial clinical protocols

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Assessment of load-sharing thoracolumbar injury: A modified scoring system

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World Journal of clinical Cases 2020年第21期8卷 5128-5138页

作者： Qi-Hang Su Yong-Chao Li Yan Zhang Jun Tan Biao Cheng Department of Orthopedics Shanghai Tenth People's HospitalTongji University School of MedicineShanghai 200072China Department of Orthopedics Shanghai East HospitalTongji University School of MedicineShanghai 200120China

BACKGROUND Many classification systems of thoracolumbar spinal fractures have been proposed to enhance treatment protocols,but none have achieved universal adoption.AIM To develop a new patient scoring system for cases with thoracolumbar injury classification and severity score(TLICS)=4,namely the load-sharing thoracolumbar injury score(LSTLIS).METHODS Based on thoracolumbar injury classification and severity score,this study proposes the use of the established load-sharing classification(LSC)to develop an improved classification system(LSTLIS).To prove the reliability and reproducibility of LSTLIS,a retrospective analysis for patients with thoracolumbar vertebral fractures has been conducted.RESULTS A total of 102 cases were enrolled in the study.The scoring trend of LSTLIS is roughly similar as the LSC scoring,however,the average deviation based on the former method is relatively smaller than that of the latter.Thus,the robustness of the LSTLIS scoring method is better than that of LSC.LSTLIS can further classify patients with TLICS=4,so as to assess more accurately this particular circumstance,and the majority of LSTLIS recommendations are consistent with actual clinical decisions.LSTLIS is a scoring system that combines LSC and TLICS to compensate for the lack of appropriate inclusion of anterior and middle column compression fractures with TLICS.Following preliminary clinical verification,LSTLIS has greater feasibility and reliability value,is more practical in comprehensively assessing certain clinical circumstances,and has better accuracy with clinically significant guidelines.

关键词： Retrospective analysis Thoracolumbar fractures Load-sharing classification Thoracolumbar injury classification and severity score Scoring system clinical protocols

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Efficacy and safety of the Qiguiyin formula in severe pneumonia: study protocol for a randomized, double-blind, placebo-controlled clinical trial

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Journal of Traditional Chinese Medicine 2020年第2期40卷 317-323页

作者： Huang Po Guo Yuhong Zhao Jingxia Li Bo Wu Yanqing Liu Qingquan Department of Emergency Medicine Beijing Hospital of Traditional Chinese MedicineClinical Medical College of Traditional Chinese MedicineCapital Medical UniversityBeijing 100010China Laboratory of Infection and Immunity Beijing Institute of Traditional Chinese MedicineBeijing 100010China

OBJECTIVE: To evaluate the clinical efficacy and safety of Qiguiyin(QGY) formula in patients with severe pneumonia in China compared with a placebo.METHODS: This is a multicenter double-blind, placebo-controlled, randomized clinical trial with two parallel arms. There will be 530 patients enrolled and randomized into either the experimental group(QGY formula) or the control group(placebo). Therapies for patients in the two groups above will be based on the conventional therapy. The primary outcome is 28-day mortality. Secondary outcomes include:(a) duration of hospital stay;(b) duration of time in the intensive care unit(ICU) stays;(c) duration of mechanical ventilation;(d) antibiotic DDD value(which means the doses of antibotics during the treatment period);(e) serum procalcitonin(PCT) level;(f) serum C-reactive protein(CRP)level;(g) Pneumonia severity index(PSI) score;(h)Sequential Organ Failure Assessment(SOFA) score;(i) sputum culture results;(j) blood routine examination results;(k) routine urine test results;(l) stool routine examination results;(m) electrocardiogram results;(n) alanine aminotransferase levels;(o) aspartate amino transferase levels;(p) total bilirubin;(q) creatinine levels;(r) urea nitrogen levels;and(s)adverse events.ETHICS AND DISSEMINATION: The protocol has been approved by the Research Ethics Committee of Beijing Hospital of Traditional Chinese Medicine,Affiliated with Capital Medical University(2018 BL-053-02). This trial aims to provide evidence for QGY formula combined with conventional therapy in treating patients with severe bacterial pneumonia,and to verify the clinical effectiveness and safety of QGY formula in China compared with placebo. Additionally, this trial will reveal the effect of QGY formula on delaying/reversing the characteristics of drug-resistant bacteria.Trial registration number: Chi CTR1800019785.

关键词： Drug resistance Pneumonia Pseudomonas aeruginosa Treatment outcome Safety clinical protocols

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