Objective To study the feasibility of the crossover trial design and the minimal imbalance index random distribution method in the clinical small-sample-size randomized controlled trial(RCT) research of thalamic pai...Objective To study the feasibility of the crossover trial design and the minimal imbalance index random distribution method in the clinical small-sample-size randomized controlled trial(RCT) research of thalamic pain treated with acupuncture under the guidance of evidence-based medicine(EBM).Methods The crossover trial design was adopted.Eleven cases with the definite diagnosis were randomized into a program-I group(6 cases,treated with acupuncture before western medicine) and a program-II group(5 cases,treated with western medicine before acupuncture) according to the minimal imbalance index method.In the statistical analysis,the groups were named as an acupuncture group and a western medicine group separately,11 cases in each one.Acupuncture was applied to Xìmén(郄门 PC 4),Yīnxì(阴郄 HT 6),Xuèhǎi(血海 SP 10),etc.In the control treatment,Carbamazepine was prescribed for oral administration.Either the duration of treatment or the wash-out period was 10 days.The visual analogue scale(VAS) was adopted for the efficacy assessment.Results The total effective was 100.0%(11/11) after treatment in either group.The remarkably effective rates were 63.6%(7/11) and 36.4%(4/11) in the acupuncture group and the western medicine group separately,without statistically significant difference in comparison.Conclusion The crossover trial design and the minimal imbalance index distribution method can accomplish RCT of the clinical acupuncture and moxibustion research with the small sample size involved.They can provide the high-quality evidences for clinical acupuncture research.Acupuncture therapy can achieve the same therapeutic effect as Carbamazepine,the common western medicine,and the efficacy of it is potentially superior to that of western medicine.展开更多
Introduction Climate change is intensifying extreme heat events,positioning heat-related illness as an escalating public health threat.However,multiprovincial,individual-level evidence quantifying the association betw...Introduction Climate change is intensifying extreme heat events,positioning heat-related illness as an escalating public health threat.However,multiprovincial,individual-level evidence quantifying the association between elevated temperatures and heatrelated illness in China remains limited.Methods This multi-provincial study employed a time-stratified case-crossover design.Individual heatrelated illness case data(2013–2022)were obtained from the Heat-related Illness Report System,which collects reports from local healthcare facilities and CDCs across 11 provincial-level administrative divisions(PLADs).We evaluated associations between daily mean and maximum temperatures and heatrelated illness risk across multiple lag periods(lag0 to lag07),with lag01 designated a priori as the primary exposure window.Effect estimates are presented as relative risks(RR)and percentage changes in RR per 1℃ temperature increase.Subgroup analyses examined potential effect modification by sex,age,heat-related illness subtype,heat intensity,and geographic location.Results Between 2013 and 2022,53,061 heatrelated illness cases were recorded across study areas,with annual counts rising throughout the decade and reaching a peak of 14,025 in 2022.Although mild cases predominated each year(maximum 83.0%in 2015),the proportion of severe cases exhibited a concerning gradual increase.Regarding temperature associations,each 1℃ increase in daily mean temperature corresponded to a 21.03%(95%CI:20.59,21.47)elevation in the RR of heat-related illness.Daily maximum temperature demonstrated a comparable pattern,though risk estimates were marginally lower.Conclusion This study demonstrates a clear upward trend in heat-related illness incidence linked to climate change and confirms that elevated temperatures significantly increase disease risk.The escalating health burden necessitates urgent development and implementation of targeted heat-health action plans to protect vulnerable populations.展开更多
基金Supported by research project of "Innovation Engineering" of The First Affiliated Hospital of Tianjin University of TCM:Academy 0804
文摘Objective To study the feasibility of the crossover trial design and the minimal imbalance index random distribution method in the clinical small-sample-size randomized controlled trial(RCT) research of thalamic pain treated with acupuncture under the guidance of evidence-based medicine(EBM).Methods The crossover trial design was adopted.Eleven cases with the definite diagnosis were randomized into a program-I group(6 cases,treated with acupuncture before western medicine) and a program-II group(5 cases,treated with western medicine before acupuncture) according to the minimal imbalance index method.In the statistical analysis,the groups were named as an acupuncture group and a western medicine group separately,11 cases in each one.Acupuncture was applied to Xìmén(郄门 PC 4),Yīnxì(阴郄 HT 6),Xuèhǎi(血海 SP 10),etc.In the control treatment,Carbamazepine was prescribed for oral administration.Either the duration of treatment or the wash-out period was 10 days.The visual analogue scale(VAS) was adopted for the efficacy assessment.Results The total effective was 100.0%(11/11) after treatment in either group.The remarkably effective rates were 63.6%(7/11) and 36.4%(4/11) in the acupuncture group and the western medicine group separately,without statistically significant difference in comparison.Conclusion The crossover trial design and the minimal imbalance index distribution method can accomplish RCT of the clinical acupuncture and moxibustion research with the small sample size involved.They can provide the high-quality evidences for clinical acupuncture research.Acupuncture therapy can achieve the same therapeutic effect as Carbamazepine,the common western medicine,and the efficacy of it is potentially superior to that of western medicine.
基金Supported by the Major Project of Guangzhou National Laboratory(No.GZNL2024A01025)the National Natural Science Foundation of China(Grant No.52272340).
文摘Introduction Climate change is intensifying extreme heat events,positioning heat-related illness as an escalating public health threat.However,multiprovincial,individual-level evidence quantifying the association between elevated temperatures and heatrelated illness in China remains limited.Methods This multi-provincial study employed a time-stratified case-crossover design.Individual heatrelated illness case data(2013–2022)were obtained from the Heat-related Illness Report System,which collects reports from local healthcare facilities and CDCs across 11 provincial-level administrative divisions(PLADs).We evaluated associations between daily mean and maximum temperatures and heatrelated illness risk across multiple lag periods(lag0 to lag07),with lag01 designated a priori as the primary exposure window.Effect estimates are presented as relative risks(RR)and percentage changes in RR per 1℃ temperature increase.Subgroup analyses examined potential effect modification by sex,age,heat-related illness subtype,heat intensity,and geographic location.Results Between 2013 and 2022,53,061 heatrelated illness cases were recorded across study areas,with annual counts rising throughout the decade and reaching a peak of 14,025 in 2022.Although mild cases predominated each year(maximum 83.0%in 2015),the proportion of severe cases exhibited a concerning gradual increase.Regarding temperature associations,each 1℃ increase in daily mean temperature corresponded to a 21.03%(95%CI:20.59,21.47)elevation in the RR of heat-related illness.Daily maximum temperature demonstrated a comparable pattern,though risk estimates were marginally lower.Conclusion This study demonstrates a clear upward trend in heat-related illness incidence linked to climate change and confirms that elevated temperatures significantly increase disease risk.The escalating health burden necessitates urgent development and implementation of targeted heat-health action plans to protect vulnerable populations.