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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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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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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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Predictors of the placebo response in a nutraceutical Randomized Controlled Trial for depression

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Journal of Integrative Medicine 2024年第1期22卷 46-53页

作者： Rosemary Arnold Jenifer Murphy-Smith Chee H.Ng David Mischoulon Gerard J.Byrne Chad A.Bousman Con Stough Michael Berk Jerome Sarris Professorial Unit the Melbourne ClinicDepartment of PsychiatryUniversity of MelbourneRichmond 3121Australia Depression Clinical and Research Program Department of PsychiatryMassachusetts General HospitalHarvard Medical SchoolBostonMA 02115USA Faculty of Medicine Discipline of PsychiatryCentre for Clinical ResearchRoyal Brisbane&Women’s HospitalHerstonthe University of QueenslandBrisbane 4006Australia Departments of Medical Genetics PsychiatryPhysiology&Pharmacology and Community Health SciencesUniversity of CalgaryCalgaryAB T2N 1N4Canada Department of Psychiatry the University of MelbourneMelbourne 3052Australia Centre for Human Psychopharmacology Swinburne UniversityMelbourne 3122Australia The Institute for Mental and Physical Health and Clinical Translation School of MedicineBarwon HealthDeakin UniversityGeelong 3220Australia The Centre of Excellence in Youth Mental Health the University of MelbourneParkville 3052Australia Florey Institute of Neuroscience and Mental Health the University of MelbourneParkville 3052Australia NICM Health Research Institute Western Sydney UniversityWestmeadNSW 2145Australia

Objective The placebo response in depression studies is the change in symptoms amongst those who receive an inactive treatment.Many well-designed Randomized Controlled Trials(RCTs)of depression have a high proportion of placebo responders,with little understanding as to why.The present study assesses characteristics associated with the placebo response in a nutraceutical trial with a large proportion of placebo responders.Methods This is a secondary analysis of a nutraceutical depression RCT which identified no overall treatment benefit relative to placebo(n=69 in placebo group).We investigated participant characteristics such as socio-demographics,clinical features,and recruitment methods,and their association with the placebo response.Monoaminergic genetic polymorphisms were also assessed.Placebo response was measured based on change in Montgomery-Asberg Depression Rating Scale score.The association of these hypothesis-driven variables of interest and the placebo response was examined using linear mixed effects models.Results Greater levels of education,particularly pursuing post-high school education,better self-reported general health,marriage/de facto,greater improvement in the first trial week,and more failed antidepressant therapies in the current depressive episode were associated with greater placebo response.An increased placebo response was not found in those recruited via social media nor in those with concomitant antidepressant therapy.Single nucleotide polymorphisms from the tryptophan hydroxylase 1(TPH1)gene(A779C and A218C)were weakly associated with greater placebo response,although the evidence was attenuated after accounting for multiple comparisons.Conclusion This is,to our knowledge,the first study within nutraceutical research for depression to assess the association between participant characteristics and variation in the placebo response.Several variables appeared to predict the placebo response.Such findings may encourage future trial designs which could dampen placebo response,improve as

关键词： Randomized Controlled Trial Placebo Depression Nutraceutical Psychiatry

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Transcutaneous electrical acupoint stimulation benefits postoperative pain relief of oocyte retrieval:A Randomized Controlled Trial

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Journal of Integrative Medicine 2024年第1期22卷 32-38页

作者： Li-ying Liu Yang Su Rong-rong Wang Yuan-yuan Lai Lei Huang Yi-ting Li Xin-yue Tao Meng-hua Su Xiao-yan Zheng Shi-chen Huang Yong-na Wu Si-yi Yu Fan-rong Liang Jie Yang Acupuncture and Tuina School Chengdu University of Traditional Chinese MedicineChengdu 610000Sichuan ProvinceChina Traditional Chinese Medicine Department Sichuan Jinxin Xi’nan Women's and Children's HospitalChengdu 610000Sichuan ProvinceChina

Background Transvaginal oocyte retrieval is frequently followed by adverse events related to anesthesia and the procedure.Some research showed that transcutaneous electrical acupoint stimulation(TEAS)can relieve intraoperative pain and postoperative nausea.Objective This study examined whether TEAS can alleviate pain and relieve adverse symptoms after oocyte retrieval.Design,setting,participants and interventions Altogether 128 patients were randomly divided into the TEAS group and the mock TEAS group.The two groups received a 30-minute-long TEAS or mock TEAS treatment that began 30 min after oocyte retrieval.Main outcome measures The primary outcome was the visual analog scale(VAS)pain score.Secondary outcomes were pressure pain threshold,McGill score,pain rating index(PRI),present pain intensity(PPI),VAS stress score,VAS anxiety score,and postoperative adverse symptoms.Results The baseline characteristics of the two groups were comparable(P>0.05).The VAS pain scores of the TEAS group were lower than those of the mock TEAS group at 60 and 90 min after oocyte retrieval(P0.05).The TEAS group was superior to the mock TEAS group for relieving postoperative adverse symptoms(P<0.05).Conclusion TEAS treatment can relieve postoperative pain and postoperative adverse symptoms for patients undergoing oocyte retrieval.

关键词： Transcutaneous electrical acupoint stimulation Fertilization Embryo transfer Oocyte retrieval Pain 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 Institute of Respiratory Diseases Longhua Hospital Shanghai University of Traditional Chinese Medicine Clinical Research Center Shanghai University of Traditional Chinese Medicine Department of Tuberculosis Shanghai Pulmonary HospitalTongji University Department of Tuberculosis Beijing Chest Hospital Capital Medical University Department of Tuberculosis the Second Hospital of Nanjing Department of Tuberculosis the First Hospital Affiliated to Xinxiang Medical College

Objective: To assess the efficacy and safety of Bufei Jiedu(BFJD) Granules 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 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 rate, and rapidly improved QoL of patients with MDR-PTB(Registration No. ChiCTR-TRC-

关键词： alternative medicine Chinese herbal formula Bufei Jiedu Granules multidrug-resistant tuberculosis long-course chemotherapy regimen Randomized Controlled Trial

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Efficacy and safety of Huzhang Granule,a compound Chinese herbal medicine,for acute gouty arthritis:A double-blind,Randomized Controlled Trial

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Journal of Integrative Medicine 2024年第3期22卷 270-278页

作者： Hao Wang Si-ting Chen Xiao-jie Ding Le Kuai Liang Hua Xin Li Yi-fei Wang Ming Zhang Bin Li Rui-ping Wang Mi Zhou Department of Dermatology Yueyang Hospital of Integrated Traditional Chinese and Western MedicineShanghai University of Traditional Chinese MedicineShanghai 200437China Institute of Dermatology Shanghai Academy of Traditional Chinese MedicineShanghai 201203China Department of Dermatology the Affiliated Hospital of Jiangxi University of Chinese MedicineNanchang 330000Jiangxi ProvinceChina Shanghai Skin Disease Hospital School of MedicineTongji UniversityShanghai 200443China Institute of Dermatology School of MedicineTongji UniversityShanghai 200443China

Background:Acute gouty arthritis(AGA)is an inflammatory joint disease with a high prevalence.Typical medical interventions,including nonsteroidal anti-inflammatory drugs,colchicine and glucocorticoids,can have serious adverse reactions.Huzhang Granule(HZG),a compound Chinese herbal medicine,has been used to treat AGA for more than 30 years with satisfactory effects and no significant adverse reactions.However,the efficacy and safety of HZG in AGA patients remains unknown.Objective:The present investigation was designed to examine the efficacy and safety profile of HZG in managing AGA patients.Design,setting,participants and interventions:The current study was conducted as a noninferiority,randomized controlled clinical trial on 180 eligible enrolled participants.Participants were randomly assigned into the HZG and etoricoxib groups.Treatments were administered for 5 d,during which the HZG group received HZG and placebo etoricoxib,while the etoricoxib group received etoricoxib and placebo HZG in the same ratio(1:1).Main outcome measures:The primary outcome was pain experienced by the patient in the gout-afflicted joint from days 2 to 5 of the treatment window.The pain level was measured via a visual analogue scale,ranging from 0 mm to 100 mm.The secondary outcomes comprised joint tenderness and swelling,reduction of inflammatory biomarkers,and the patient’s and investigator’s global evaluations of therapeutic response.Results:The mean reduction in pain was-51.22 mm(95%confidence interval[CI],[-53.42,-49.03]mm)for the HZG and-52.00 mm(95%CI,[-54.06,-49.94]mm)for the etoricoxib groups.The mean difference between the two groups was 0.78 mm(95%CI,[-2.25,3.81]mm).All additional efficacy endpoints,covering decreased inflammation and pain relief,yielded compelling proof of noninferiority.Patients in the HZG group exhibited a comparatively lower rate of adverse events compared to those in the etoricoxib group(4.44%vs 13.33%;P≤0.05).Conclusion:HZG and etoricoxib groups demonstrated similar levels of analgesic effectiveness

关键词： Acute gouty arthritis Huzhang Granule Randomized Controlled Trial Blind

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Efficacy and safety of Yiqi Peiyuan granules for improving the short-term prognosis of patients with acute kidney injury:A multicenter,double-blind,placebo-controlled,randomized trial

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Journal of Integrative Medicine 2024年第3期22卷 279-285页

作者： Jia-jia Wu Tian-yi Zhang Ying-hui Qi Min-yan Zhu Yan Fang Chao-jun Qi Li-ou Cao Ji-fang Lu Bo-han Lu Lu-min Tang Jian-xiao Shen Shan Mou Department of Nephrology Molecular Cell Lab for Kidney DiseaseShanghai Peritoneal Dialysis Research CenterUremia Diagnosis and Treatment CenterRenji Hospital Affiliated to Shanghai Jiaotong University School of MedicineShanghai 200127China Department of Nephrology Shanghai Pudong New Area Punan HospitalShanghai 200125China Department of Nephrology Ningbo Hangzhou Bay HospitalNingbo 315336Zhejiang ProvinceChina

Background:Yiqi Peiyuan(YQPY)prescription,a composite prescription of traditional Chinese medicine,has been used to prevent or delay the continued deterioration of renal function after acute kidney injury(AKI)in some institutions and has shown considerable efficacy.Objective:This is the first Randomized Controlled Trial to assess efficacy and safety of YQPY for improving short-term prognosis in adult patients with AKI.Design,setting,participants and interventions:This is a prospective,double-blind,multicenter,randomized,and placebo-controlled clinical trial.A total of 144 enrolled participants were randomly allocated to two groups according to a randomization schedule.Participants,caregivers and investigators assessing the outcomes were blinded to group assignment.Patients in the YQPY group received 36 g YQPY granules twice a day for 28 days.Patients in the placebo group received a placebo in the same dose as the YQPY granules.Main outcome measures:The primary outcome was the change in the estimated glomerular filtration rate(eGFR)between baseline and after 4 and 24 weeks of treatment.The secondary outcomes were the change of serum creatinine(Scr)level between baseline and after treatment,and the incidence of endpoint events,defined as eGFR increasing by more than 25%above baseline,eGFR>75 mL/min per1.73 m2or the composite endpoint,which was defined as the sum of patients meeting either of the above criteria.Results:Data from a total of 114 patients(59 in the YQPY group and 55 in the control group)were analyzed.The mean changes in eGFR and Scr in weeks 4 and 24 had no difference between the two groups.In further subgroup analysis(22 in the YQPY group and 31 in the control group),the mean change in eGFR after treatment for 4 weeks was 27.39 mL/min per 1.73 m2in the YQPY group and 5.78 mL/min per1.73 m2in the placebo group,and the mean difference between groups was 21.61 mL/min per 1.73 m2(P<0.001).Thirteen(59.1%)patients in the YQPY group and 5(16.1%)in the placebo group reached the composite endpoints(P=0.002).Du

关键词： Chinese herbal medicine Randomized Controlled Trial Acute kidney injury Renal function

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Efficacy of Daoyin combined with lower limb robot as a comprehensive rehabilitation intervention for stroke patients: a Randomized Controlled Trial

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Journal of Traditional Chinese Medicine 2024年第3期44卷 530-536页

作者： TIAN Haolin YANG Yuanbin ZHANG Hu ZHAO Wenjing ZHOU Jing TIAN Jingfeng HE Long LI Xuechao SHEN Qinxuan SHUAI Mei Department of First Rehabilitation Wangjing Hospital of China Academy of Chinese Medical Sciences Department of Rehabilitation Shunyi HospitalBeijing Traditional Chinese Medicine Hospital School of Biological Science and Medical Engineering Beihang University

OBJECTIVE: To assess the effectiveness of a comprehensive rehabilitation approach combining Traditional Chinese Medicine Daoyin with lower limb robotics during the recovery phase of stroke patients.METHODS: Stroke patients meeting the specified criteria were randomly assigned to one of four groups using a random number table: Control group, Daoyin group, lower limb robot group(LLR group), and Daoyin and lower limb robot group(DLLR group). Each group received distinct treatments based on conventional rehabilitation training.The treatment duration spanned two weeks with two days of rest per week. Pre-and post-intervention assessments included various scales: Fugl-Meyer Assessment(FMA),Berg balance scale(BBS), Barthel index(BI), Fatigue Scale-14(FS-14), Pittsburgh sleep quality index(PSQI),Hamilton Anxiety Scale(HAMA), and Hamilton Depression Scale(HAMD).RESULTS: Statistically significant differences were observed in the lower limb function measured by FAM between the Control group(15 ± 5) and the DLLR group(18 ± 5)(P = 0.049). In the Barthel index, a statistically significant difference was noted between the Control group(54 ± 18) and the DLLR group(64 ± 11)(P = 0.041).Additionally, significant differences were found in the Berg balance scale between the Control group(21 ± 10)and the DLLR group(27 ± 8)(P = 0.024), as well as between the Control group(21 ± 10) and the LLR group(26 ± 10)(P = 0.048).CONCLUSION: The findings of this study suggest that the combined use of Daoyin and robotics not only enhances motor function in stroke patients but also has a positive impact on fatigue, sleep quality, and mood. This approach may offer a more effective rehabilitation strategy for stroke patients.

关键词： Daoyin lower limb robot Randomized Controlled Trial rehabilitation stroke

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Effectiveness and safety of Jiawei Xiaoyao pill(加味逍遥丸)in the treatment of premenstrual syndrome(liver depression,spleen deficiency,and blood-heat syndrome):a multi-center,randomized,placebo-controlled trial

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Journal of Traditional Chinese Medicine 2024年第2期44卷 373-380页

作者： LI Xiyu YANG Yanhong SUN Jian NIE Quanfang LIU Lifen LI Guifen YU Junping ZHANG Zhuangjin XU Yi ZOU Ting SHI Yun Department of Gynecology Dongzhimen HospitalBeijing University of Chinese MedicineBeijing 100700China Department of Gynecology Luoyang 1st Hospital of TCMLuoyang 471099China Department of Gynecology Zaozhuang Hospital of TCMZaozhuang 277099China Department of Gynecology and Obstetrics Loudi Central HospitalLoudi 417099China Department of Gynecology and Obstetrics Yiyang 1st Hospital of TCMYiyang 413002China Department of Gynecology Harrison International Peace HospitalHengshui 053000China Department of Gynecology and Obstetrics Shanxi Fenyang HospitalFenyang 032299China Department of Gynecology and Obstetrics Hengyang Chinese Medicine HospitalHengyang 421001China Scientific Research Institute of Beijing Tongrentang Technology Development Co. Ltd.Beijing 100061China Female Reproductive and Health Medicine Research Committee of Chinese Traditional Medicine Association Beijing 100061China

OBJECTIVE:To investigate the effectiveness and safety of Jiawei Xiaoyao pill(加味逍遥丸,JXP)in the treatment of symptoms associated with premenstrual syndrome(PMS).METHODS:A total of 144 regularly menstruating women with PMS were recruited at 8 sites in China from August 2017 to December 2018,and randomized to receive either a JXP or a matching placebo(12 g/d,6 g twice a day)for 3 menstrual cycles.The primary indicator was the reduced Daily Record of Severity of Problems(DRSP)scores in the luteal phase after 3 months of treatment.The safety outcomes included clinical adverse events(AEs),adverse reactions(ARs),changes in vital signs,and laboratory tests.RESULTS:JXP surpassed the placebo in reducing DRSP scores(psychological/somatic dysfunction)in the luteal phase over 3 menstrual cycles of treatment(PFAS=0.002,PPPS=0.001).Additionally,there were no significant differences in the incidence of AEs,severe AEs,withdrawal due to AEs and ARs between the two groups(all P>0.05),and no clinically significant adverse medical events related to the test drug observed.CONCLUSIONS:JXP was superior to the placebo in relieving the symptoms associated with PMS,which signified that JXP may be effective,safe,and welltolerated as an alternative therapy.

关键词： premenstrual syndrome Randomized Controlled Trial double-blind method Jiawei Xiaoyao pill

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