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Effect of Acupuncture on Endometrial Blood Flow in Women Undergoing in vitro Fertilization Embryo Transfer: A Single Blind, randomized controlled trial

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Chinese Journal of Integrative Medicine 2024年第1期30卷 10-17页

作者： DONG Hao-xu Wu Xiao ZHOU Qin HUANG Dong-mei ZHANG Ming-min HUANG Guang-ying YANG Wei Department of Integrated Traditional Chinese and Western Medicine Tongji HospitalHuazhong University of Science and TechnologyWuhan(430030)China Department of Obstetrics and Gynecoiogy Tongji HospitalHuazhong University of Science and TechnologyWuhan(430030)China Institute of Integrated Traditional Chinese and Western Medicine Tongji HospitalHuazhong University of Science and TechnologyWuhan(430030)China Department of Reproductive Medicine Tongji HospitalHuazhong University of Science and TechnologyWuhan(430030)China

Objective: To evaluate the effect of manual acupuncture on endometrial blood flow parameters by three-dimensional(3D) power Doppler ultrasound in women undergoing in vitro fertilization embryo transfer(IVF-ET). Methods: Seventy patients undergoing IVF-ET were equally randomized into traditional or sham acupuncture treatment group for totally 4 days(from the day of oocyte aspiration to the day of embryo transfer) of treatment by random envelope method at the Reproductive Medicine Center and Outpatient Department of Integrated Traditional Chinese and Western Medicine, Tongji Hospital, Tongji Medicine College, Huazhong University of Science and Technology from January 2013 to December 2015. Patients in the traditional acupuncture group accepted traditional acupuncture methods with manual acupuncture, and Zhongji(CV3), Qihai(CV 6), Sanyinjiao(SP6), Taichong(LR 3), Tianshu(ST 25), Guilai(ST 29) and Zusanli(ST 36) were chosen. Patients at the sham acupuncture group accepted shallow acupuncture methods at 4 non-meridian points at each shoulder and upper arm. Outcome measures included endometrial ultrasonic indices such as vascularization index(VI), flow index(FI) and vascularization flow index(VFI), endometrial thickness and volume, subendometrial VI(sVI), subendometrial FI(sFI), subendometrial VFI(sVFI), implantation rate, clinical pregnancy rate, abortion rate, live birth rate and number of live births. Results: Finally, 34 patients in the traditional acupuncture group and 35 in the sham acupuncture group completed this trial. VI, FI and VFI of the traditional acupuncture group were significantly higher than those in the sham acupuncture group(Ptrial thickness, endometrial volume, sVI, sFI, sVFI, implantation rate, clinical pregnancy rate, abortion rate, live birth rate and number of live births(P>0.05). Conclusions: Manual acupuncture performed after oocyte aspiration and before transplantation improved the endometrial blood flow parametersVI, RI and VFI in women

关键词： acupuncture endometrial blood flow endometrial receptivity in vitro fertilization randomized controlled trial

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Efficacy and Safety of Bufei Jiedu Granules in Treating Multidrug-Resistant Pulmonary Tuberculosis: A Multi-center, Double-Blinded and randomized controlled trial

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CHINESE JOURNAL OF INTEGRATIVE MEDICINE 2024年第7期30卷 579-587页

作者： Zhang, Shao-yan Qiu, Lei Zhang, Shun-xian Xiao, He-ping Chu, Nai-hui Zhang, Xia Zhang, Hui-qiang Zheng, Pei-yong Zhang, Hui-yong Lu, Zhen-hui Shanghai Univ Tradit Chinese Med Longhua Hosp Inst Resp Dis Shanghai 200032 Peoples R China Shanghai Univ Tradit Chinese Med Clin Res Ctr Shanghai 200032 Peoples R China Tongji Univ Shanghai Pulm Hosp Dept TB Shanghai 200433 Peoples R China Capital Med Univ Beijing Chest Hosp Dept TB Beijing 101100 Peoples R China Second Hosp Nanjing Dept TB Nanjing 210003 Peoples R China First Hosp Xinxiang Med Coll Dept TB Xinxiang 453100 Henan Peoples R China

Objective To assess the efficacy and safety of Bufei Jiedu (BFJD) ranules as adjuvant therapy for patients with multidrug-resistant pulmonary tuberculosis (MDR-PTB). Methods A large-scale, multi-center, double-blinded, and randomized controlled trial was conducted in 18 sentinel hospitals in China from December 2012 to December 2016. A total of 312 MDR-PTB patients were randomly assigned to BFJD Granules or placebo groups (1:1) using a stratified randomization method, which both received the long-course chemotherapy regimen for 18 months (6 Am-Lfx-P-Z-Pto, 12 Lfx-P-Z-Pto). Meanwhile, patients in both groups also received BFJD Granules or placebo twice a day for a total of 18 months, respectively. The primary outcome was cure rate. The secondary outcomes included time to sputum-culture conversion, changes in lung cavities and quality of life (QoL) of patients. Adverse reactions were monitored during and after the trial. Results A total of 216 cases completed the trial, 111 in the BFJD Granules group and 105 in the placebo group. BFJD Granules, as an adjuvant treatment, increased the cure rate by 13.6% at the end of treatment, compared with the placebo (58.4% vs. 44.8%, P=0.02), and accelerated the median time to sputum-culture conversion (5 months vs. 11 months). The cavity closure rate of the BFJD Granules group (50.6%, 43/85) was higher than that of the placebo group (32.1%, 26/81; P=0.02) in patients who completed the treatment. At the end of the intensive treatment, according to the 36-item Short Form, the BFJD Granules significantly improved physical functioning, general health, and vitality of patients relative to the placebo group (all P<0.01). Overall, the death rates in the two groups were not significantly different; 5.1% (8/156) in the BFJD Granules group and 2.6% (4/156) in the placebo group. Conclusions Supplementing BFJD Granules with the long-course chemotherapy regimen significantly increased the cure rate and cavity closure rates, and rapidly improved QoL of patients with MDR-PTB (Registration No.

关键词： alternative medicine Chinese herbal formula Bufei Jiedu Granules multidrug-resistant tuberculosis long-course chemotherapy regimen randomized controlled trial PROTEIN

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Effect and Safety of Herbal Medicine Foot Baths in Patients with Diabetic Peripheral Neuropathy:A Multicenter Double-Blind randomized controlled trial

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Chinese Journal of Integrative Medicine 2024年第3期30卷 195-202页

作者： HUANG Hao-yue LIN Yu-ping WEI Hua FU Yu ZHOU Yue-hong FANG Zhao-hui QIU Xiao-tang WANG Mei LI Qing-bo LI Shan-shan WANG Shi-dong DAI Fang LIU Zhen-jie ZHAO Ling WEN Jian-xuan WU Li-yan ZENG Hui-yan ZHANG Jin-ming LU Qi-yun HE Liu SONG Wei SUN Lu LUO Lu-lu HE Jia-li XIE Wen-wen LIANG Qing-shun HUANG Yuan ZHU Sheng-ling LONG Jie-er GAO Zhi-juan WEN Ze-huai LI Chun-ji OUYANG Wen-wei LI Geng WU Ming-hui LI An-xiang HUANG Jin-zhu Sanjoy K Paul TANG Xian-yu FAN Guan-jie Department of Endocrinology Guangdong Provincial Hospital of Chinese MedicineGuangzhou510120China The Second Clinical College of Guangzhou University of Chinese Medicine Guangzhou510120China Department of Endocrinology The Second Affiliated Hospital of Guangzhou University of Chinese MedicineGuangzhou510120China Guangdong Provincial Academy of Chinese Medical Sciences Guangzhou510120China Department of Endocrinology The First Affiliated Hospital of Henan University of Chinese MedicineZhengzhou450000China Department of Endocrinology Liuyang Hospital of Chinese MedicineChangsha410000China Department of Endocrinology The First Affiliated Hospital of Anhui University of Chinese MedicineHefei230000China Department of Endocrinology Hainan Provincial Hospital of Traditional Chinese MedicineHaikou570100China Department of Endocrinology The Affiliated Hospital of Liaoning University of Traditional Chinese MedicineShenyang110000China Department of Geriatric Luoyang No.1 Hospital of Traditional Chinese MedicineLuoyangHenan Province471000China Department of Endocrinology The Second Affiliated Hospital of Guizhou University of Traditional Chinese MedicineGuiyang550000China Department of Endocrinology Beijing University of Chinese Medicine Affiliated Dongzhimen HospitalBeijing100000China Department of Endocrinology The First Affiliated Hospital of Guizhou University of Traditional Chinese MedicineGuiyang550000China Melbourne EpiCentre The University of Melbourne and Melbourne HealthMelbourne3013Australia

Objective:To evaluate the effect and safety of foot baths with Tangbi Waixi Decoction(TW)in treating patients with diabetic peripheral neuropathy(DPN).Methods:It is a multicenter double-blinded randomized controlled trial.Participants with DPN were recruited between November 18,2016 and May 30,2018 from 8 hospitals in China.All patients received basic treatments for glycemic management.Patients received foot baths with TW herbal granules either 66.9 g(intervention group)or 6.69 g(control group)for 30 min once a day for 2 weeks and followed by a 2-week rest,as a therapeutic course.If the Toronto Clinical Scoring System total score(TCSS-TS)6 points,the patients received a total of 3 therapeutic courses(for 12 weeks)and were followed up for 12 weeks.The primary outcome was change in TCSS-TS score at 12 and 24 weeks.Secondary outcomes included changes in bilateral motor nerve conduction velocity(MNCV)and sensory nerve conduction velocity(SNCV)of the median and common peroneal nerve.Safety was also assessed.Results:Totally 632 patients were enrolled,and 317 and 315 were randomized to the intervention and control groups,respectively.After the 12-week intervention,patients in both groups showed significant declines in TCSSTS scores,and significant increases in MNCV and SNCV of the median and common peroneal nerves compared with pre-treatment(P0.05),and no serious adverse event was related with treatment.Conclusion:Treatment of TW foot baths was safe and significantly benefitted patients with DPN.A low dose of TW appeared to be more effective than a high dose.(Registry No.Chi CTR-IOR-16009331)

关键词： diabetic peripheral neuropathy herbal medicine foot baths Chinese medicine randomized controlled trial Tangbi Waixi Decoction

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Effectivenss of electroacupuncture for skeletal muscle pain in Parkinson's disease:a Clinical randomized controlled trial

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Journal of Traditional Chinese Medicine 2024年第2期44卷 388-395页

作者： WANG Shaosong SUN Jingqing FENG Qingyin LI Bin WANG Xin YUAN Fan CUI Yingxue Department of acupuncture Beijing Hospital of Traditional Chinese MedicineBeijing 100010China

OBJECTIVE:To explore the effect of electroacupuncture on skeletal muscle pain in Parkinson's disease(PD).METHODS:A single-center randomized controlled trial was conducted with sixty patients with Parkinson's disease with skeletal muscle pain were randomly divided into electroacupuncture group and sham acupuncture control group with 30 patients each.The electric acupuncture group was treated with electric acupuncture,while the control group was treated with Park needle pseudoacupuncture.Both groups were treated 5 times a week for a total of 4 weeks,and both groups completed 20 treatments.King's Parkinson's Pain Scale(KPPS)and visual analog scale(VAS)were used before and after treatment to evaluate the pain degree of patients.Realtime shear wave elastography(SWE)and modified Ashworth score(MAS)were used to evaluate the changes of muscle tone.Parkinson's comprehensive Score Scale(MDS-UPDRS,including UPDRS Ⅱ and UPDRS Ⅲ)was used to evaluate exercise ability.Hamilton Depression Scale(HAMD)score was used to evaluate the emotional changes of patients.Spearman correlation analysis was used to explore the correlation between pain degree and muscle tone,exercise ability and emotion.RESULTS:During the study,one case fell off in the control group,and 30 cases were eventually included in the analysis and treatment group and 29 cases in the control group.After treatment,Young's modulus of biceps and quadriceps and shear wave velocity of biceps were decreased in electroacupuncture group compared with before treatment,while KPPS score,VAS score,UPDRS Ⅱ,UPDRS Ⅲ and modified Ashworth score were decreased,with statistical significance(P0.05).After treatment,KPPS score,VAS score,UPDRS Ⅱ and UPDRS Ⅲ,MAS,HAMD score,Young's modulus of biceps and shear wave velocity in electroacupuncture group were significantly lower than those in control group(P<0.05).Spearman correlation analysis showed that KPPS score was positively correlated with UPDRS Ⅲ(r=0.414,P<0.05).KPPS score was

关键词： Parkinson disease muscle skeletal pain electroacupuncture muscle tention mood disorders randomized controlled trial

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Effects of Bushen Yiqi Huoxue Decoction in Treatment of Patients with Diminished Ovarian Reserve:A randomized controlled trial

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Chinese Journal of Integrative Medicine 2022年第3期28卷 195-201页

作者： ZHOU Jing PAN Xin-yao LIN Jin ZHOU Qi LAN Li-kun ZHU Jun DUAN Ru WANG Lan SUN Yan WANG Ling Laboratory for Reproductive Immuno logy Hospital&Institute of Obstetrics and Gyn ecologyShan ghai Medical CollegeFudan UniversityShanghai(200000)China Shanghai Key Laboratory of Female Reproductive Endocrine Related Diseases Shanghai(200000)China Academy of Integrative Medicine of Fudan University Shanghai(200000)China Yangpu Hospital of Traditional Chinese Medicine Shanghai(200000)China Second Affiliated Hospital of Hexi University ZhangyeGansu Province(743000)China Department of Obstetrics and Gyn ecology Wenling People's HospitalWenzhou Medical UniversityWenzhouZhejiang Provinee(325000)China Regulatory Commissi on Office of the New Cooperative Medical Scheme Eryuan CountyDaliYunnan Province(671000)China

Objective:To explore the therapeutic effect of Bushen Yiqi Huoxue Decoction BYHD)in patients with diminished ovarian reserve(DOR).Methods:A total of 180 patients with DOR diagnosed from December2013 to December 2014 were equally assigned into progynova and duphaston(E+D)group,Zuogui Pill group and BYHD group with 60 cases in each by computerized randomization.Patients received E+D,Zuogui Pill or BYHD for 12 months,respectively.Follicle stimulating hormone(FSH),luteinizing hormone(LH),estradiol(E_(2)),anti-Mullerian hormone(AMH),antral follicle count(AFC),ovarian volume,endometrial thickness,and the resistance indices(Rls)of ovarian arteries and uterine arteries were observed before and after treatment.Results:Nine women(4 from the E+D group,3 from the Zuogui Pill group,and 2 from the BYHD group)withdrew from the study.After 6 months,Zuogui Pill and BYHD significantly decreased FSH and LH and increased endometrial thickness and AMH(all Ptrial thickness(P<0.01)and no significant improvements were observed in the RI of uterine arteries in the three groups.Conclusions:BYHD had a favorable therapeutic effect in patients with DOR by rebalancing hormone levels,promoting ovulation,and repairing the thin endometrium.The combination of tonifying Shen(Kidney),benefiting qi and activating blood circulation may be a promising therapeutic strategy for DOR.

关键词： Bushen Yiqi Huoxue Decoction diminished ovarian reserve randomized controlled trial Chinese medicine

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Safety and effectiveness of electromyography-induced rehabilitation treatment after epidural electrical stimulation for spinal cord injury:study protocol for a prospective,randomized,controlled trial

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Neural Regeneration Research 2023年第4期18卷 819-824页

作者： Xiao-Pei Sun Jie-Jian Shi Yong Bao Jie Zhang Hui-Juan Pan Dian-You Li Yu Liang Qing Xie Ruijin Hospital Shanghai Jiao Tong University School of MedicineShanghaiChina Shanghai Ruijin Rehabilitation Hospital ShanghaiChina

Epidural electrical stimulation is a new treatment method for spinal cord injury(SCI).Its efficacy and safety have previously been reported.Rehabilitation treatment after epidural electrical stimulation is important to ensure and improve the postoperative efficacy of epidural electrical stimulation in patients with SCI.Considering that electromyography(EMG)-induced rehabilitation treatment can accurately match the muscle contraction of patients with SCI,we designed a study protocol for a prospective,randomized controlled trial.In this trial,on the premise of adjusting the spinal cord electrical stimulator to obtain the maximum EMG signal of the target muscle,patients with SCI receiving epidural electrical stimulation will undergo EMG-induced rehabilitation treatment.Recovery of muscle strength of key muscles,quality of life,safety and therapeutic effects will be monitored.Twenty patients with SCI who are scheduled to undergo epidural electrical stimulation in Shanghai Ruijin Rehabilitation Hospital will be randomly divided into two groups with 10 patients per group.The control group will receive conventional rehabilitation treatment.The EMG-induced rehabilitation group will receive EMG-induced rehabilitation treatment of the target muscles of the upper and lower limbs based on conventional rehabilitation treatment.After rehabilitation treatment,follow up for all patients will occur at 2 weeks and 1,3 and 6 months.The primary outcome measure of this trial will be evaluation of target muscle recovery using the Manual Muscle Testing grading scale.Secondary outcome measures will include modified Barthel Index scores,integrated EMG values,the visual analogue scale,Spinal Cord Independence Measure scores,and modified Ashworth scale scores.The safety indicator will be the incidence of adverse events.This trial will collect data regarding the therapeutic effects of EMG-induced rehabilitation in patients with SCI receiving epidural electrical stimulation for 6 months after rehabilitation treatment.Findings from this trial

关键词： electromyography-induced rehabilitation epidural electrical stimulation muscle strength pain quality of life randomized controlled trial recovery spinal cord injury

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Effectiveness and safety of Ginkgo biloba extract(GBE50)in the treatment of dizziness caused by cerebral arteriosclerosis:a multi-center,double-blind,randomized controlled trial

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Journal of Traditional Chinese Medicine 2022年第1期42卷 83-89页

作者： SHA Rina TANG Lu DU Yawei WU Shengxian SHI Huawei ZOU Hongxin ZHANG Xuran DONG Xinglu ZHOU Li the First clinical medical college Beijing University of Chinese MedicineBeijing 100029China Department of Neurology Dongzhimen HospitalBeijing University of Chinese MedicineBeijing 100700China

OBJECTIVE:To evaluate the effectiveness and safety of Ginkgo biloba extract(GBE50)in the treatment of dizziness caused by cerebral arteriosclerosis.METHODS:This was a multi-center,double-blind,double-dummy,positive-controlled,parallel randomized controlled clinical trial with 1∶1 allocation.We recruited 404 patients with dizziness caused by cerebral arteriosclerosis(blood stasis symptom pattern)in 10 hospitals in China.GBE50 group received GBE50 and Naoxinqing tablet(NXQ)of mimetic agent,control group received NXQ and GBE50 of mimetic agent.The main outcome was Traditional Chinese Medicine(TCM)symptom pattern score of blood stasis after 6 weeks.The secondary outcomes were changes in the dizziness handicap inventory(DHI)score,vertigo visual analogue scale(VAS)score,the university of California vertigo questionnaire(UCLA-DQ)score and single-item symptom score of TCM from baseline to 2,4 and 6 weeks.Safety indicators included the incidence of adverse events,severe adverse events and laboratory examination including blood routine,liver function,renal function,and so forth.RESULTS:The total effective rate of TCM symptom pattern score in the GBE50 group after 6 weeks of treatment was higher than that in the control group,the difference in rate was statistically significant(92.67%vs 83.07%,P=0.004).Compared with the control group,there was no difference in the incidence of adverse reactions(9.95%vs 14.85%,P=0.136).CONCLUSION:The treatment of dizziness caused by cerebral arteriosclerosis with GBE50 is effective,safe and reliable.

关键词： Ginkgo biloba intracranial arteriosclerosis dizziness treatment outcome randomized controlled trial

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Reyanning Mixture on Asymptomatic or Mild SARS-CoV-2 Infection in Children and Adolescents:A randomized controlled trial

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中国结合医学杂志:英文版 2023年第10期29卷 867-874页

作者： XU Xiang-ru ZHOU Shuang JIN Guo-qiang WU Hong-ze LI Jin-hua ZHOU Jing PENG Wei ZHANG Wen SUN Ding FANG Bang-jiang Department of Emergency Longhua Hospital Affiliated to Shanghai University of Traditional Chinese MedicineShanghai200032China Acupuncture and Massage College Shanghai University of Traditional Chinese MedicineShanghai201203China Department of Health Management The First Affiliated Hospital of Nanchang UniversityNanchang330006China Jiangxi Provincial Traditional Chinese Medicine Nephropathy Clinical Research Center Jiujiang Hospital of Traditional Chinese MedicineJiujiangJiangxi Province332099China Department of Respiratory and Critical Care Medicine The First Affiliated Hospital of Nanchang UniversityNanchang330006China Institute of Critical Care Shanghai University of Traditional Chinese MedicineShanghai200032China

Objective: To assess the effect and safety of Reyanning Mixture(RYN) in treating asymptomatic or mild severe acute respiratory syndrome coronavirus 2(SARS-Co V-2) infection in children and adolescents. Methods: This is a prospective, open-label, randomized control ed trial. Patients aged 1–17 years and diagnosed with asymptomatic or mild coronavirus disease-2019(COVID-19) were assigned to an intervention group(RYN plus standard care) and a control group(standard care) according to a randomization list. The primary outcomes were SARS-Co V-2 negative conversion time. Secondary outcomes included negative conversion rate on days 3 and 7, hospital length of stay, symptom relief rate, new-onset symptoms of asymptomatic infected patients, and progressive disease rate. The cycle threshold(Ct) values of ORF1ab or N genes were also tested. Results: A total of 214 patients in the intervention group and 217 in the control group were analyzed. The SARS-CoV-2 negative conversion time was significantly shortened in the intervention group [5 days(interquartile range(IQR): 5–6) vs. 7 days(IQR: 6–7), P0.05). Symptoms of cough were significantly improved(82.2% vs. 70.0%, P=0.02) and wheezing was significantly reduced(0.7% vs. 12.9%, Ptrial, no disease progression or serious adverse events were reported. Conclusion: Adding RYN to standard care may be a safe and effec

关键词： coronavirus diseases-2019 severe acute respiratory syndrome coronavirus 2 Omicron children Reyanning Mixture randomized controlled trial Chinese medicine

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Effects of Compound Danshen Dripping Pills on Ventricular Remodeling and Cardiac Function after Acute Anterior Wall ST-Segment Elevation Myocardial Infarction(CODE-AAMI):Protocol for a randomized Placebo-controlled trial

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Chinese Journal of Integrative Medicine 2023年第12期29卷 1059-1065页

作者： WU Yu-jie DENG Bo WANG Si-bo QIAO Rui ZHANG Xi-wen LU Yuan WANG Li GU Shun-zhong ZHANG Yu-qing LI Kai-qiao YU Zong-liang WU Li-xing ZHAO Sheng-biao ZHOU Shuang-lin YANG Yang WANG Lian-sheng Department of Cardiology the First Affiliated Hospital of Nanjing Medical UniversityNanjing(210029)China Department of Cardiology Anqing Municipal Hospital Affiliated to Anhui Medical UniversityAnqingJiangsu Province(246003)China Department of Cardiology Huai'an First People's HospitalHuai'anJiangsu Province(223300)China Department of Cardiology the Affiliated Hospital of Xuzhou Medical UniversityXuzhouJiangsu Province(221006)China Department of Cardiology Pukou Branch of Jiangsu People's HospitalNanjing(211899)China Department of Cardiology Hai'an People's HospitalNantongJiangsu Province(226699)China Department of Cardiology the Affliated Jiangning Hospital of Nanjing Medical UniversityNanjing(211199)China Department of Cardiology Qixia District Hospital of Nanjing CityNanjing(210046)China Department of Cardiology the First People's Hospital of Kunshan Affliated to Jiangsu UniversityKunshanJiangsu Province(215300)China Department of Cardiology Nanjing Lishui District Hospital of Traditional Chinese MedicineNanjing(211299)China Department of Cardiology Nanjing Meishan HospitalNanjing(210039)China

Background:Ventricular remodeling after acute anterior wall ST-segment elevation myocardial infarction(AAMI)is an important factor in occurrence of heart failure which additionally results in poor prognosis.Therefore,the treatment of ventricular remodeling needs to be further optimized.Compound Danshen Dripping Pills(CDDP),a traditional Chinese medicine,exerts a protective effect on microcirculatory disturbance caused by ischemia-reperfusion injury and attenuates ventricular remodeling after myocardial infarction.Objective:This study is designed to evaluate the efficacy and safety of CDDP in improving ventricular remodeling and cardiac function after AAMI on a larger scale.Methods:This study is a multi-center,randomized,doubleblind,placebo-controlled,parallel-group clinical trial.The total of 268 patients with AAMI after primary percutaneous coronary intervention(pPCI)will be randomly assigned 1:1 to the CDDP group(n=134)and control group(n=134)with a follow-up of 48 weeks.Both groups will be treated with standard therapy of ST-segment elevation myocardial infarction(STEMI),with the CDDP group administrating 20 tablets of CDDP before pPCI and 10 tablets 3 times daily after pPCI,and the control group treated with a placebo simultaneously.The primary endpoint is 48-week echocardiographic outcomes including left ventricular ejection fraction(LVEF),left ventricular end-diastolic volume index(LVEDVI),and left ventricular end-systolic volume index(LVESVI).The secondary endpoint includes the change in N terminal pro-B-type natriuretic peptide(NT-proBNP)level,arrhythmias,and cardiovascular events(death,cardiac arrest,or cardiopulmonary resuscitation,rehospitalization due to heart failure or angina pectoris,deterioration of cardiac function,and stroke).Investigators and patients are both blinded to the allocated treatment.Discussion:This prospective study will investigate the efficacy and safety of CDDP in improving ventricular remodeling and cardiac function in patients undergoing pPCI for a first AAMI.Patients in the CD

关键词： Compound Danshen Dripping Pills acute anterior myocardial infarction randomized controlled trial ventricular remodeling cardiac function trial design

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A randomized controlled trial of Mindfulness in Recovery from Colorectal Cancer

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Chinese Journal of Integrative Medicine 2023年第7期29卷 590-599页

作者： Andrew McCombie Jennifer Jordan Roger Mulder Kishion Dee Ee Lin Ong Fernanda Fernandez Zimmermann Chris Frampton Frank Frizelle Te Whatu Ora(Health New Zealand)Waitaha Canterbury Christchurch 8011New Zealand University of Otago Christchurch 8140New Zealand The Psychology Hub Christchurch 8011New Zealand Oxford Mindfulness Centre University of OxfordOxfordOX12JDUnited Kingdom Nature and Nurture Sparks Christchurch 8013New Zealand University of Otago Dunedin(9016)New Zealand

Objective:This study examined whether a 4-week group-based mindfulness intervention would be superior in reducing psychological distress in colorectal cancer(CRC)patients compared to a psychoeducation and cognitive behavioural skills learning support active control group.Methods:Patients with CRC were randomized via Computerised Permuted Block Randomisation to mindfulness or active control groups(2-h weekly sessions over 4 weeks).Outcomes were measured pre-intervention,and 8 weeks and 6 months post-baseline.The primary outcome was psychological distress measured by the Hospital Anxiety and Depression Scale.Secondary outcomes were generic quality of life(QoL),disease specific QoL,mindfulness,and intervention credibility and acceptability.Results:Sixty-eight participants were randomized to mindfulness(n=35)or active control group(n=33).Uptake of potentially eligible patients consenting was low(28.0%)and the dropout rate was 33.8%.Depression scores were reduced in both groups at week 8(P=0.020).Control participants had greater improvement in generic mental QoL scores at week 8 than mindfulness(P=0.023).In disease specific QoL,there was reduction in impotence symptom in the mindfulness group(P=0.022)and reduction in faecal incontinence in the control group(P=0.019).The embarrassment symptom had a significantly lower increase in the mindfulness group at week 8 compared to the control group(P=0.009).Both groups rated the treatments as credible and acceptable.Conclusions:Mindfulness was not superior to the active control group in terms of alleviating psychological distress but both treatments were associated with some improvements in depression.There was low uptake of both interventions.(trial registration number:ACTRN12616001033437)

关键词： anxiety colorectal cancer depression distress mindfulness psychoeducation psychology psychological distress randomized controlled trial quality of life

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