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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 ***: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 *** 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 *** 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 *** 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 *** assessment will include the physical examination,laboratory detection,any adverse events or serious adverse events,and the proportion of any complications during ***: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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randomized controlled trial of consensus interferon with or without zinc for chronic hepatitis C patients with genotype 2

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World Journal of Gastroenterology 2006年第6期12卷 945-950页

作者： HideyukiSuzuki KenSato HitoshiTakagi DaisukeKanda NaondoSohara SatoruKakizaki HiroakiNakajima ToshiyukiOtsuka TakeakiNagamine MasatomoMori Department of Medicine and Molecular Science Gunma University Graduate School of Medicine 3-39-15 ShowaMaebashiGunma 371-8511Japan

AIM： The beneficial effect of zinc supplementation on the efficacy of interferon as a treatment for chronic hepatitis C had been demonstrated in hepatitis virus genotype lb of high viral load. This study focused on patients with genotype 2, which is more sensitive to interferon than genotype lb, and used consensus interferon （CIFN） with or without zinc. METHODS： We randomized 83 patients with chronic hepatitis C to CIFN at 18 MIU six times/wk for 4 wk, followed by CIFN at 18 MIU six times/wk for another 20 wk, in combination with polaprezinc 300 mg （regimen A, n = 41） or as monotherapy （regimen B, n = 42）. Thirtyone patients in regimen A and 33 patients in regimen B completed the clinical trial; the remaining patients withdrew because of side effects or a transfer to another hospital. RESULTS： Sustained biochemical response, defined as a normal aminotransferase level at the end of the 6-too post-treatment observation, was 68% and 69%, and sustained virological response, defined as undetectable HCV-RNA at the end of the 6-too post-treatment observation, was 54% and 67% for regimens A and B, respectively. CONCLUSION： CIFN treatment combined with zinc did not enhance the effect of CIFN as shown by biochemical, virological criteria. No side effects related to polaprezinc were noted.

关键词： randomized controlled trial Consensus interferon Zinc Chronic hepatitis C Genotype 2

Effect of Auricular Acupoint Bloodletting plus Auricular Acupressure on Sleep Quality and Neuroendocrine Level in College Students with Primary Insomnia:A randomized controlled trial

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Chinese Journal of Integrative Medicine 2022年第12期28卷 1096-1104页

作者： CHEN Hao ZHANG Ming-jian WU Jia-ai SHE Yan-fen YUAN Xin-ru HUo Yun-xiang SUN Huan LIU Dao-nan SHI Xu-liang College of Acupuncture Moxibustion and Massage Hebei University of Chinese MedicineShijiazhuang 050200China International Joint Research Center for Preponderant Diseases of Acupuncture in Hebei Province Shijiazhuang 050200China

Objective:To evaluate the effects of auricular acupoint bloodletting(AB)and auricular acupressure(AA)on sleep quality and the levels of melatonin(MT),glutamic acid(Glu),and γ-aminobutyric acid(GABA)in college students with primary insomnia,and to explore the possible ***:Totally 74 college students at Hebei University of Chinese Medicine with primary insomnia were selected from October 2019 to October *** patients were assigned to AB+AA group(37 cases,received combination of AB and AA)and AA group(37 cases,received only AA on the same acupoints)by a random number *** group was treated twice a week for 4 *** Pitsburgh Sleep Quality Index(PSQI)score,Chinese medicine(CM)syndrome score,total effective rate,serum concentrations of MT,Glu,and GABA,and Glu/GABA ratio were compared between the two groups after treatment and at *** safety of therapy was also ***:After 4-week treatment,the total scores of PSQI,each PSQI component score,and the CM syndrome scores in both groups all decreased(P0.05).At follow-up,the CM syndrome score in the AB+AA group was significantly lower than that in the AA group(P0.05).Conclusions:Both AB+AA and AA can relieve insomnia symptoms,but a stronger long-term effect were observed for AB+***+AA canpromote the secretion of MT,increase the levelsof Glu and GABA more effective than AA,and regulate their imbalance,and thus it may bebenificial for treating insomnia.

关键词： auricular acupoint bloodletting auricular acupressure insomnia randomized controlled trial Chinese medicine

Efficacy and Safety of Guihuang Formula in Treating Type Ⅲ Prostatitis Patients with Dampness-Heat and Blood Stasis Syndrome: A randomized controlled trial

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Chinese Journal of Integrative Medicine 2022年第10期28卷 879-884页

作者： LIU Sheng-jing DENG Ying-jun ZENG Yin ZHAO Ming GUO Jun GAO Qing-he Department of Andrology Xiyuan Hospital of China Academy of Chinese Medical SciencesBeijing(100091)China Graduate School of China Academy of Chinese Medical Sciences Beijing(100700)China Department of Andrology Beijing Chinese Medicine Hospital Afﬁliated to Capital Medical UniversityBeijing(100010)China Graduate School Beijing University of Chinese MedicineBeijing(100029)China

Objective: To observe the efficacy and safety of Guihuang Formula(GHF) in treating patients with type Ⅲ prostatitis and Chinese medicine syndrome of dampness-heat and blood stasis. Methods: Sixty-six type Ⅲ prostatitis patients with dampness-heat and blood stasis syndrome were randomly divided into the treatment group(GHF) and the control group(tamsulosin) using a random number table, with 33 cases each group. The treatment group received GHF twice a day, and the control group received tamsulosin 0.2 mg once daily before bedtime. Patients in both groups received treatment for 6 weeks and was followed up for 2 weeks. The outcomes included the National Institute of Health Chronic Prostatitis Symptom Index(NIH-CPSI) score, Chinese Medicine Symptoms Score(CMSS), expressed prostatic secretions(EPS) and adverse events(AEs). Results: After treatment, the NIH-CPSI total score and domain scores of pain discomfort, urination and quality of life decreased significantly from the baseline in both groups(P0.05). In addition, no serious AEs were observed. Conclusion: GHF is effective in treating type Ⅲ prostatitis patients with dampness-heat and blood stasis syndrome without serious AEs.(Registration No. ChiCTR1900026966)

关键词： typeⅢprostatitis dampness-heat and blood stasis syndrome Guihuang Formula Chinese medicine randomized controlled trial

Therapeutic efficacy of traditional Chinese exercises and massage treatment on lumbar instability:a randomized controlled trial

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Journal of Traditional Chinese Medicine 2020年第6期40卷 1026-1032页

作者： Chen Wenjin Wang Jianwei Zhou Zhiyi Ren Yide Hua Zhen Yan Zheng Zhang Yafeng Department of Orthopedics Wuxi Affiliated Hospital of Nanjing University of Chinese MedicineJiangsu 214071China Wuxi Huishan Traditional Chinese Medicine hospital Jiangsu 214071China College of Information Science and Engineering Huaqiao University Fujian 361021China

OBJECTIVE:To determine the effect of traditional Chinese exercises combined with traditional Chinese massage on lumbar ***:Seventy patients with lumbar instability were randomly divided into experimental group and control *** experimental group was treated with traditional Chinese exercises combined with traditional Chinese massage,while the control group was only treated with traditional Chinese *** Japanese Orthopaedic Association(JOA)scores,Oswestry Disability Index(ODI)and dynamic imaging indexes were used to assess treatment ***:After 8 weeks of treatment,the JOA scores of both groups were significantly higher than those before treatment(P<0.05),while ODI was significantly lower(P<0.05).In addition,compared with the control group,the JOA score of the experimental group was significantly increased(P<0.05),and the ODI was significantly decreased(P<0.05).Besides,the dynamic imaging indexes of patients with lumbar instability significantly changed after *** lumbar vertebral laxity was significantly decreased(P<0.05)than those before ***:The traditional Chinese exercises and massage may improve the symptoms of lumbar instability,and traditional Chinese exercises combined with massage treatment may be better than exercises alone.

关键词： Joint instability Exercise therapy Massage Medicine Chinese traditional randomized controlled trial

Efficiency and safety of acupuncture for women with premature ovarian insufficiency:study protocol for a randomized controlled trial

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Journal of Traditional Chinese Medicine 2023年第6期43卷 1268-1274页

作者： XU Yani ZHANG Yutong HE Weile DAI Linglin TANG Ding WANG Jialing ZHANG Xufen CHEN Qin CHEN Lifang WANG Zhanglian ZHAN Mingjie the Third School of Clinical Medicine Zhejiang Chinese Medical UniversityHangzhou 310053China Department of Acupuncture the Third Affiliated Hospital of Zhejiang Chinese Medical UniversityHangzhou 310005China

Acupuncture has been widely used as an alternative and complementary therapy for premature ovarian insufficiency(POI)in ***,research to date has not shown that acupuncture is effective for POI compared with hormone replacement therapy(HRT).We will conduct a randomized,controlled,and outcome assessor-blind trial to evaluate the efficacy and safety of acupuncture on ***-six patients with POI will be randomly assigned to two *** treatment group will receive twenty-eight one-hour sessions of acupuncture treatments,and the control group will receive 12-week *** whole study will consist of a 12-week treatment plan and a 12-week follow-up *** primary outcome is measured by changes in serum anti-Müllerian hormone and follicle-stimulating hormone(FSH)levels at weeks 12 and *** outcome measures include estradiol,luteinizing hormone(LH),LH/FSH ratio,Kupperman index,and menstrual *** trial is expected to clarify whether or not acupuncture is effective and safe for POI compared with HRT.

关键词： acupuncture primary ovarian insufficiency hormone replacement therapy randomized controlled trial study protocols

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Naoxueshu Oral Liquid Accelerates Post-Craniotomy Hematoma Absorption in Patients:An Open-Label,Multicenter,and randomized controlled trial

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Chinese Journal of Integrative Medicine 2024年第8期30卷 675-683页

作者： HE Qiu LIN Fu-xin SU Jin-ye ZHUO Ling-yun ZHU Qing SUN Xiao-chuan JIANG Rong-cai YAO Zhi-gang WANG Lei DANG Yan-wei LIU De-zhong LIU Yang FANG Wen-hua WANG Fang-yu LIN Yuan-xiang WANG An-xin WANG Deng-liang KANG De-zhi Department of Neurosurgery Neurosurgery Research InstituteThe First Affiliated Hospital of Fujian Medical UniversityFuzhou350004China Department of Neurosurgery Binhai Branch of National Regional Medical CenterThe First Affiliated HospitalFujian Medical UniversityFuzhou350209China Clinical Research and Translation Center The First Affiliated Hospital of Fujian Medical UniversityFuzhou350004China Fujian Clinical Research Center for Neurological Diseases The First Affiliated Hospital of Fujian Medical UniversityFuzhou350004China Fujian Provincial Institutes of Brain Disorders and Brain Sciences The First Affiliated Hospital of Fujian Medical UniversityFuzhou350004China Department of Neurosurgery The Second Affiliated Hospital of Soochow UniversitySuzhouJiangsu Province215000China Department of Neurosurgery The First Affiliated Hospital of Chongqing Medical UniversityChongqing400000China Department of Neurosurgery Tianjin Medical University General HospitalTianjin300000China Department of Neurosurgery The Third Hospital of ShijiazhuangShijiazhuang050000China Department of Neurosurgery The First College of Clinical Medical ScienceChina Three Gorges UniversityYichangHubei Province443000China Department of Neurosurgery Yichang Central People’s HospitalYichangHubei Province443000China Department of Neurosurgery Xiangyang No.1 People’s Hospital Affiliated to Hubei University of MedicineXiangfanHubei Province441100China Department of Neurosurgery Zhoukou Central HospitalZhoukouHenan Province466000China Department of Neurosurgery The Third Hospital of MianyangMianyangSichuan Province621000China Department of Neurology Beijing Tiantan HospitalCapital Medical UniversityBeijing100000China China National Clinical Research Center for Neurological Diseases Beijing Tiantan HospitalCapital Medical UniversityBeijing100000China Department of Clinical Epidemiology and Clinical trial Capital Medical UniversityBeijing100000China Beijing Municipal Key Laboratory of Clinical

Objective: To investigate whether Naoxueshu Oral Liquid(NXS) could promote hematoma absorption in post-craniotomy hematoma(PCH) patients. Methods: This is an open-label, multicenter, and randomized controlled trial conducted at 9 hospitals in China. Patients aged 18–80 years with post-craniotomy supratentorial hematoma volume ranging from 10 to 30 mL or post-craniotomy infratentorial hematoma volume less than 10 mL, or intraventricular hemorrhage following cranial surgery were enrolled. They were randomly assigned at a 1:1 ratio to the NXS(10 m L thrice daily for 15 days) or control groups using a randomization code table. Standard medical care was administered in both groups. The primary outcome was the percentage reduction in hematoma volume from day 1 to day 15. The secondary outcomes included the percentage reduction in hematoma volume from day 1 to day 7, the absolute reduction in hematoma volume from day 1 to day 7 and 15, and the change in neurological function from day 1 to day 7 and 15. The safety was closely monitored throughout the study. Moreover, subgroup analysis was performed based on age, gender, history of diabetes, and etiology of intracerebral hemorrhage(ICH). Results: A total of 120 patients were enrolled and randomly assigned between March 30, 2018 and April 15, 2020. One patient was lost to follow-up in the control group. Finally, there were 119 patients(60 in the NXS group and 59 in the control group) included in the analysis. In the full analysis set(FAS) analysis, the NXS group had a greater percentage reduction in hematoma volume from day 1 to day 15 than the control group [median(Q1, Q3): 85%(71%, 97%) vs. 76%(53%, 93%), P0.05). Furthermore, no adverse events were reported during the study. In the FAS analysis, the NXS group exhibited a higher percentage reduction in hematoma volume on day 15 in the following subgroups:

关键词： post-craniotomy hematoma Naoxueshu Oral Liquid hematoma absorption randomized controlled trial Chinese medicine

Electroacupuncture in Treatment of Acute Gastrointestinal Injury in Patients with Severe Traumatic Brain Injury:A Multicenter randomized controlled trial

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Chinese Journal of Integrative Medicine 2023年第8期29卷 721-729页

作者： XING Xi JIANG Rong-lin LEI Shu ZHI Yi-hui ZHU Mei-fei HUANG Li-quan HU Ma-hong LU Jun FANG Kun WANG Qiu-yan Department of ICU the First Affiliated Hospital of Zhejiang University of Traditional Chinese MedicineHangzhou(310000)China Department of ICU Tongde Hospital of ZhejiangTongdeZhejiang Province(310000)China Department of ICU Xinhua Hospital of ZhejiangHangzhou(310000)China Department of ICU Zhejiang integrated Traditional Chineseand Western Medicine HospitalHangzhou(310000)China Department of ICU Hangzhou Hospital of Traditional Chinese MedicalHangzhou(310000)China

Objective: To evaluate whether electroacupuncture(EA) would improve gastrointestinal function and clinical prognosis in patients with severe traumatic brain injury(TBI) complicocted by acute gastrointestinal injury(AGI). Methods: This multicenter, single-blind trial included patients with TBI and AGI admitted to 5Chinese hospitals from September 2018 to December 2019. A total of 500 patients were randomized to the control or acupuncture groups using a random number table, 250 cases in each group. Patients in the control group received conventional treatment, including mannitol, nutritional support, epilepsy and infection prevention, and maintenance of water, electrolytes, and acid-base balance. While patients in the acupuncture group received EA intervention at bilateral Zusanli(ST 36), Shangjuxu(ST 37), Xiajuxu(ST 39), Tianshu(ST 25), and Zhongwan(RN 12) acupoints in addition to the conventional treatment, 30 min per time, twice daily,for 7 d. The primary endpoint was 28-d mortality. The secondary endpoints were serum levels of D-lactic acid(D-lac), diamine oxidase(DAO), lipopolysaccharide(LPS), motilin(MTL) and gastrin(GAS), intra-abdominal pressure(IAP), bowel sounds, abdominal circumference, AGI grade, scores of gastrointestinal failure(GIF),Glasgow Coma Scale(GCS), Acute Physiology and Chronic Health Evaluation(APACHE Ⅱ), Sequential Organ Failure Assessment(SOFA), and Multiple Organ Dysfunction Syndrome(MODS), mechanical ventilation time,intense care unit(ICU) stay, and the incidence of hospital-acquired pneumonia. Results: The 28-d mortality in the acupuncture group was lower than that in the control group(22.80% vs. 33.20%, P<0.05). Compared with the control group, the acupuncture group at 7 d showed lower GIF, APACHE Ⅱ, SOFA, MODS scores, D-lac,DAO, LPS, IAP, and abdominal circumference and higher GCS score, MTL, GAS, and bowel sound frequency(all P<0.05). In addition, the above indices showed simillar changes at 7 d compared with days 1 and 3 in the EA grou

关键词： electroacupuncture traumatic brain injury acute gastrointestinal injury multicenter randomized controlled trial

Efficacy and safety of Shenyankangfu Tablet,a Chinese patent medicine,for primary glomerulonephritis:A multicenter randomized controlled trial

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Journal of Integrative Medicine 2021年第2期19卷 111-119页

作者： Jie Wu Shu-wei Duan Hong-tao Yang Yue-yi Deng Wei Li Ya-ni He Zhao-hui Ni Yong-li Zhan Shan Lin Zhi-yong Guo Jun Zhu Jing-ai Fang Xu-sheng Liu Li-hua Wang Rong Wang Nian-song Wang Xiao-hong Cheng Li-qun He Ping Luo Shi-ren Sun Ji-feng Sun Ai-ping Yin Geng-ru Jiang Hong-yu Chen Wen-hu Liu Hong-li Lin Meng Liang Lu Ma Ming Chen Li-qun Song Jian Chen Qing Zhu Chang-ying Xing Yun Li Ji-ning Gao Rong-shan Li Ying Li Hao Zhang Ying Lu Qiao-ling Zhou Jun-zhou Fu Qiang He Guang-yan Cai Xiang-mei Chen Department of Nephrology Chinese People’s Liberation Army General HospitalChinese People’s Liberation Army Institute of NephrologyState Key Laboratory of Kidney Diseases(2011DAV00088)National Clinical Research Center for Kidney DiseasesBeijing 100853China Department of Nephrology First Teaching Hospital of Tianjin University of Traditional Chinese MedicineTianjin 300192China Department of Nephrology Longhua HospitalShanghai University of Traditional Chinese MedicineShanghai 200032China Department of Nephrology Shandong University of Traditional Chinese Medicine Affiliated HospitalJinan 250011.Shandong ProvinceChina Department of Nephrology Daping HospitalArmy Medical UniversityChongqing 400042China Department of Nephrology Renji HospitalShanghai Jiao Tong UniversityShanghai 200127China Department of Nephrology Guang’anmen HospitalChina Academy of Traditional Chinese Medical SciencesBeijing 100053China Department of Nephrology Tianjin Medical University General HospitalTianjin 300052China Department of Nephrology Changhai Hospital of ShanghaiNaval Medical UniversityShanghai 200433China Department of Nephrology West China HospitalChengdu 610083Sichuan ProvinceChina Department of Nephrology First Affiliated Hospital of Shanxi Medical UniversityTaiyuan 030001Shanxi ProvinceChina Department of Nephrology Guangdong Provincial Hospital of Chinese MedicineGuangzhou 510120Guangdong ProvinceChina Department of Nephrology Shanxi Medical University Second Affiliated HospitalTaiyuan 030001Shanxi ProvinceChina Department of Nephrology Shandong Provincial HospitalJinan 250021Shandong ProvinceChina Department of Nephrology and Rheumatology Affiliated Sixth People’s HospitalShanghai Jiao Tong UniversityShanghai 200233China Department of Nephrology Shaanxi Traditional Chinese Medicine HospitalXi'an 710003Shaanxi ProvinceChina Department of Nephrology Shuguang HospitalShanghai University of Traditional Chinese MedicineShanghai 200021China Department of Nephrology Jilin University Se

Background:Shenyankangfu Tablet(SYKFT)is a Chinese patent medicine that has been used widely to decrease proteinuria and the progression of chronic kidney ***:This trial compared the efficacy and safety of SYKFT,for the control of proteinuria in primary glomerulonephritis patients,against the standard drug,losartan ***,setting,participants and intervention:This was a multicenter,double-blind,randomized,controlled clinical *** glomerulonephritis patients,aged 18-70 years,with blood pressure≤140/90 mmHg,estimated glomerular filtration rate(eGFR)>45 mL/min per 1.73 ㎡,and 24-hour proteinuria level of 0.5-3.0 g,were recruited in 41 hospitals across 19 provinces in China and were randomly divided into five groups:SYKFT,losartan potassium 50 mg or 100 mg,SYKFT plus losartan potassium 50 mg or 100 *** outcome measu res:The primary outcome was change in the 24-hour proteinuria level,after 48 weeks of ***:A total of 735 participants were *** percent decline of urine protein quantification in the SYKFT group after 48 weeks was 8.78%±2.56%(P=0.006)more than that in the losartan 50 mg group,which was 0.51%±2.54%(P=1.000)less than that in the losartan 100 mg *** with the losartan potassium 50 mg group,the SYKFT plus losartan potassium 50 mg group had a 13.39%±2.49%(P<0.001)greater reduction in urine protein *** with the losartan potassium 100 mg group,the SYKFT plus losartan potassium 100 mg group had a 9.77%±2.52%(P=0.001)greater reduction in urine *** a superiority threshold of 15%,neither was statistically ***,serum creatinine and serum albumin from the baseline did not change statistically *** average change in TCM syndrome score between the patients who took SYKFT(-3.00[-6.00,-2.00])and who did not take SYKFT(-2.00[-5.00,0])was statistically significant(P=0.003).No obvious adverse reactions were observed in any ***:SYKFT decreased the proteinur

关键词： Herbal medicine,Chinese Shenyankangfu Tablet Primary glomerulonephritis randomized controlled trial Double blind Double dummy