OBJECTIVE:To evaluate the efficacy and safety of Xinfeng capsule in patients suffering rheumatoid arthritis(RA).METHODS:A multi-center parallel-group designed,double-blind,randomized,controlled trial was conducted.Tot...OBJECTIVE:To evaluate the efficacy and safety of Xinfeng capsule in patients suffering rheumatoid arthritis(RA).METHODS:A multi-center parallel-group designed,double-blind,randomized,controlled trial was conducted.Totally 304 RA patients were assigned to two groups:one group was administered Xinfeng capsule(XFC) plus the placebo of leflunomide and the other given leflunomide(LEF) plus the placebo of XFC for twelve weeks.The clinical and laboratory parameters were compared at baseline and fourth,eighth,and twelfth weeks.RESULTS:After twelve-week treatment,patients in two groups all showed some trend of effectiveness when compared in terms of American Rheumatism Association(ACR) recommended 20%,50%,70%improvement criteria,but it was insignificant.The validity in ameliorate modified disease activity score(DAS28) and laboratory indexes as erythrocyte sedimentation rate(ESR),C-reactive protein(CRP),rheumatoid factor(RF) were also found no difference.The score of health assessment questionnaire(HAQ),self-rating anxiety scale(SAS),self-rating depression scale(SDS) and quality of life questionnaire with rheumatoid arthritis(RAQOL)both lower than the first week and the changes showed no difference.However,the score of SDS dropped more in XFC group than in the other.A total of 147 adverse reaction cases were reported,which shows no difference between the two groups.The most common adverse reactions were hepatic impairment,anemia,leukocytopenia,epigastric discomfort and phalacrosis.CONCLUSION:XFC demonstrated better improvement in the scores of SDS and compared with those of LEF group.展开更多
Background： Breast cancer patients experience various side effects during cancer therapy, often resulting in reduced quality of life and poor adherence to treatment. A limited range of proven interventions has been d...Background： Breast cancer patients experience various side effects during cancer therapy, often resulting in reduced quality of life and poor adherence to treatment. A limited range of proven interventions has been developed to target such side effects. While Tai Chi offers benefits for the health and well-being of breast cancer survivors, the effectiveness of Tai Chi across the treatment continuum has not been evalu- ated. Improved patient education and support has been suggested as a priority for breast cancer care. This pilot study assesses the feasibility of a randomized controlled trial （RCT） to evaluate the effectiveness of ＂an integrative Tai Chi＂ （ANITA） program for breast cancer patients undergoing cancer therapy. Methods/design： This is a single-centre, two-arm feasibility RCT. Twenty-four patients with breast cancer who have undergone surgical treatment will be recruited from the Dunedin Hospital （New Zealand） over a 12-month period （from August 2017 to July 2018）. Subject to informed consent, patients will be ran- domized to receive standard cancer treatment alone or standard cancer treatment plus the ANITA pro- gram, consisting of peer support, health education, and Tai Chi Ruler exercise. The program runs alongside the patient＇s adjuvant cancer therapy, which may include chemotherapy, radiation therapy, antibody treatment, and/or antihormonal therapy. Analysis in this study will focus on process evaluation of participant recruitment, retention, treatment fidelity, acceptability of the program, and occurrence of adverse events. Clinical outcomes （i.e., fatigue, sleep quality, anxiety and depression and quality of life） will be assessed at baseline, and at 12 weeks and 24 weeks post-randomization. Discussion： Outcomes from this study will inform the feasibility and methodology for a future fully- powered RCT.展开更多
Sample size re-estimation is essential in oncology studies. However, the use of blinded sample size reassessment for survival data has been rarely reported. Based on the density function of the exponential distributio...Sample size re-estimation is essential in oncology studies. However, the use of blinded sample size reassessment for survival data has been rarely reported. Based on the density function of the exponential distribution, an expectation-maximization（EM） algorithm of the hazard ratio was derived, and several simulation studies were used to verify its applications. The method had obvious variation in the hazard ratio estimates and overestimation for the relatively small hazard ratios. Our studies showed that the stability of the EM estimation results directly correlated with the sample size, the convergence of the EM algorithm was impacted by the initial values, and a balanced design produced the best estimates. No reliable blinded sample size re-estimation inference can be made in our studies, but the results provide useful information to steer the practitioners in this field from repeating the same endeavor.展开更多
OBJECTIVE:To evaluate the efficacy,safety,satisfaction,discomfort and patient preference of moxa cones of artemisia vulgaris and charcoal moxa.METHODS:This comparative study of moxibustion treatment with Artemisia vul...OBJECTIVE:To evaluate the efficacy,safety,satisfaction,discomfort and patient preference of moxa cones of artemisia vulgaris and charcoal moxa.METHODS:This comparative study of moxibustion treatment with Artemisia vulgaris and charcoal moxa cone stimulating Zhongwan(CV 12) is a cross-over single-blinded,randomized clinical trial.A total of 40 healthy subjects(24 males and 16females) participated in this study.Two subjects dropped out of the trial.Thirty-eight subjects were treated with Artemisia vulgaris and charcoal moxa cones for 30 min in a cross-over design.After treatment,the patients underwent a 30 minute waiting period,and then the temperatures at Tanzhong(CV 17),Zhongwan(CV 12) and Guanyuan(CV 4) were measured using digital infrared thermal imaging.RESULTS:After the use of Artemisia vulgaris moxa,the patients' body temperatures were slightly lowered at Tanzhong(CV 17),Zhongwan(CV 12)and Guanyuan(CV 4),but the changes were not statistically significant.After the use of charcoal moxa,the patients' body temperatures were somewhat increased at Zhongwan(CV 12) and Guanyuan(CV 4),but the changes were not statistically significant.After Artemisia vulgaris moxa use,the body temperature difference between Zhongwan(CV 12) and Guanyuan(CV 4)was significantly increased.After charcoal moxa use,the body temperature difference between Tanzhong(CV 17) and Zhongwan(CV 12) was significantly decreased in males and in the whole group.This change was caused by the difference in the moxibustion type and by gender differences.CONCLUSION:This pilot study found that moxibustion did not raise the body temperature,but temperature differences between acupoints were affected.Further large-scale randomized controlled trials are needed for the effect of moxibustion on body temperature.展开更多
Two randomized controlled trials of acupuncture concerning polycystic ovary syndrome（PCOS） and stress urinary incontinence（SUI） were published simultaneously in the 24 th issue, 2017 of The Journal of the American...Two randomized controlled trials of acupuncture concerning polycystic ovary syndrome（PCOS） and stress urinary incontinence（SUI） were published simultaneously in the 24 th issue, 2017 of The Journal of the American Medical Association（JAMA）. A trial involving PCOS indicated that active acupuncture did not increase live birth compared with sham acupuncture; meanwhile, another trial referring to SUI showed that electroacupuncture resulted in less urine leakage compared with sham electroacupuncture. With an eye to the negative and positive results of acupuncture, three pivotal factors should be contemplated：（1） proper illness for acupuncture, that is, a problem need to be solved in current medical science, and acupuncture may really work for it;（2） proper pre-studied primary outcome, which is better be objective and repeatedly measurable to reveal the therapeutic effect of acupuncture truly and objectively;（3） proper sham control, which can blind the patients to the upmost extent with minimal biological effects. Through the publication of clinical trials of acupuncture in high-impact journals in recent years, researchers should have confidence in their clinical trials by pondering over these three pivotal factors.展开更多
基金Supported by the Key Projects in the National Science&Technology Pillar Program in the Twelfth Five-Year Plan Period:Clinical Research on Xin'an Medicine Prevention and Treatment of Difficult Diseases of Chinese Medicine(No.2012BA126B02).ClinicalTrials.gov Identifier:NCT01774877
文摘OBJECTIVE:To evaluate the efficacy and safety of Xinfeng capsule in patients suffering rheumatoid arthritis(RA).METHODS:A multi-center parallel-group designed,double-blind,randomized,controlled trial was conducted.Totally 304 RA patients were assigned to two groups:one group was administered Xinfeng capsule(XFC) plus the placebo of leflunomide and the other given leflunomide(LEF) plus the placebo of XFC for twelve weeks.The clinical and laboratory parameters were compared at baseline and fourth,eighth,and twelfth weeks.RESULTS:After twelve-week treatment,patients in two groups all showed some trend of effectiveness when compared in terms of American Rheumatism Association(ACR) recommended 20%,50%,70%improvement criteria,but it was insignificant.The validity in ameliorate modified disease activity score(DAS28) and laboratory indexes as erythrocyte sedimentation rate(ESR),C-reactive protein(CRP),rheumatoid factor(RF) were also found no difference.The score of health assessment questionnaire(HAQ),self-rating anxiety scale(SAS),self-rating depression scale(SDS) and quality of life questionnaire with rheumatoid arthritis(RAQOL)both lower than the first week and the changes showed no difference.However,the score of SDS dropped more in XFC group than in the other.A total of 147 adverse reaction cases were reported,which shows no difference between the two groups.The most common adverse reactions were hepatic impairment,anemia,leukocytopenia,epigastric discomfort and phalacrosis.CONCLUSION:XFC demonstrated better improvement in the scores of SDS and compared with those of LEF group.
基金funded by the Breast Cancer Foundation New Zealandsupport of which is gratefully acknowledged+1 种基金This funding source has no role in this study other than providing funding supportLL is funded as the Breast Cancer Foundation New Zealand Belinda Scott Clinical Fellowship 2017
文摘Background： Breast cancer patients experience various side effects during cancer therapy, often resulting in reduced quality of life and poor adherence to treatment. A limited range of proven interventions has been developed to target such side effects. While Tai Chi offers benefits for the health and well-being of breast cancer survivors, the effectiveness of Tai Chi across the treatment continuum has not been evalu- ated. Improved patient education and support has been suggested as a priority for breast cancer care. This pilot study assesses the feasibility of a randomized controlled trial （RCT） to evaluate the effectiveness of ＂an integrative Tai Chi＂ （ANITA） program for breast cancer patients undergoing cancer therapy. Methods/design： This is a single-centre, two-arm feasibility RCT. Twenty-four patients with breast cancer who have undergone surgical treatment will be recruited from the Dunedin Hospital （New Zealand） over a 12-month period （from August 2017 to July 2018）. Subject to informed consent, patients will be ran- domized to receive standard cancer treatment alone or standard cancer treatment plus the ANITA pro- gram, consisting of peer support, health education, and Tai Chi Ruler exercise. The program runs alongside the patient＇s adjuvant cancer therapy, which may include chemotherapy, radiation therapy, antibody treatment, and/or antihormonal therapy. Analysis in this study will focus on process evaluation of participant recruitment, retention, treatment fidelity, acceptability of the program, and occurrence of adverse events. Clinical outcomes （i.e., fatigue, sleep quality, anxiety and depression and quality of life） will be assessed at baseline, and at 12 weeks and 24 weeks post-randomization. Discussion： Outcomes from this study will inform the feasibility and methodology for a future fully- powered RCT.
基金supported by the National Natural Science Foundation of China(81273184)the National Natural Science Foundation of China Grant for Young Scientists (81302512)
文摘Sample size re-estimation is essential in oncology studies. However, the use of blinded sample size reassessment for survival data has been rarely reported. Based on the density function of the exponential distribution, an expectation-maximization（EM） algorithm of the hazard ratio was derived, and several simulation studies were used to verify its applications. The method had obvious variation in the hazard ratio estimates and overestimation for the relatively small hazard ratios. Our studies showed that the stability of the EM estimation results directly correlated with the sample size, the convergence of the EM algorithm was impacted by the initial values, and a balanced design produced the best estimates. No reliable blinded sample size re-estimation inference can be made in our studies, but the results provide useful information to steer the practitioners in this field from repeating the same endeavor.
基金Supported by a grant from the Korean Medicine R&D Project of the Ministry of Health and Welfare(HI13C0530,Evidence-based Korean Medicine in Pattern Identification and Herbal Medicinal Therapeutics for Coldness in hands and feet)
文摘OBJECTIVE:To evaluate the efficacy,safety,satisfaction,discomfort and patient preference of moxa cones of artemisia vulgaris and charcoal moxa.METHODS:This comparative study of moxibustion treatment with Artemisia vulgaris and charcoal moxa cone stimulating Zhongwan(CV 12) is a cross-over single-blinded,randomized clinical trial.A total of 40 healthy subjects(24 males and 16females) participated in this study.Two subjects dropped out of the trial.Thirty-eight subjects were treated with Artemisia vulgaris and charcoal moxa cones for 30 min in a cross-over design.After treatment,the patients underwent a 30 minute waiting period,and then the temperatures at Tanzhong(CV 17),Zhongwan(CV 12) and Guanyuan(CV 4) were measured using digital infrared thermal imaging.RESULTS:After the use of Artemisia vulgaris moxa,the patients' body temperatures were slightly lowered at Tanzhong(CV 17),Zhongwan(CV 12)and Guanyuan(CV 4),but the changes were not statistically significant.After the use of charcoal moxa,the patients' body temperatures were somewhat increased at Zhongwan(CV 12) and Guanyuan(CV 4),but the changes were not statistically significant.After Artemisia vulgaris moxa use,the body temperature difference between Zhongwan(CV 12) and Guanyuan(CV 4)was significantly increased.After charcoal moxa use,the body temperature difference between Tanzhong(CV 17) and Zhongwan(CV 12) was significantly decreased in males and in the whole group.This change was caused by the difference in the moxibustion type and by gender differences.CONCLUSION:This pilot study found that moxibustion did not raise the body temperature,but temperature differences between acupoints were affected.Further large-scale randomized controlled trials are needed for the effect of moxibustion on body temperature.
文摘Two randomized controlled trials of acupuncture concerning polycystic ovary syndrome（PCOS） and stress urinary incontinence（SUI） were published simultaneously in the 24 th issue, 2017 of The Journal of the American Medical Association（JAMA）. A trial involving PCOS indicated that active acupuncture did not increase live birth compared with sham acupuncture; meanwhile, another trial referring to SUI showed that electroacupuncture resulted in less urine leakage compared with sham electroacupuncture. With an eye to the negative and positive results of acupuncture, three pivotal factors should be contemplated：（1） proper illness for acupuncture, that is, a problem need to be solved in current medical science, and acupuncture may really work for it;（2） proper pre-studied primary outcome, which is better be objective and repeatedly measurable to reveal the therapeutic effect of acupuncture truly and objectively;（3） proper sham control, which can blind the patients to the upmost extent with minimal biological effects. Through the publication of clinical trials of acupuncture in high-impact journals in recent years, researchers should have confidence in their clinical trials by pondering over these three pivotal factors.
