Objective:To investigate the feasibility and preliminary effectiveness of Tanxiang prescription(TXP)ointment for alleviating mild to moderate anxiety.Methods:A single-center pilot trial was conducted.Participants were...Objective:To investigate the feasibility and preliminary effectiveness of Tanxiang prescription(TXP)ointment for alleviating mild to moderate anxiety.Methods:A single-center pilot trial was conducted.Participants were randomly assigned to the experimental group or the control group.The experimental group received TXP treatment and health education,while the control group only received health education.The study evaluated the feasibility based on recruitment,retention,adherence,and adverse events.The primary outcome was assessed using the Self-Rating Anxiety Scale(SAS),while the secondary outcomes were evaluated using the Self-Rating Depression Scale(SDS)and Pittsburgh Sleep Quality Index(PSQI).Assessments were conducted at baseline,week 2,and week 4.Results:In all,58 participants were successfully enrolled,with 56 all having finished the whole research,which illustrates a recruitment rate of 33.7%,a randomization rate of 100%,and a loss rate of 3.57%in this study.No adverse events were observed.Both the experimental(n=29)and control(n=29)groups showed a significant decrease in SAS,SDS,and PSQI scores in comparison to their baseline scores at week 4(P<0.05).In addition,the experimental group showed significantly greater reductions in SAS,SDS,and PSQI scores than those in the control group at week 4(P<0.05).Conclusions:TXP may be a promising treatment option for mild to moderate anxiety,offering a duel benefit of alleviating depression and promoting better sleep without any adverse effects.This study also references the effectiveness of traditional Chinese medicine aromatherapy for anxiety management.Further pharmacological and clinical studies are needed to observe the impact of TXP on emotional regulation in patients with anxiety.展开更多
Background:Atopic eczema is the most common type of skin disorder in both children and adults.It is characterized by erythema,pruritus,papules,xeransis,and lichenification.The KangminⅠdecoction,a Chinese herbal medic...Background:Atopic eczema is the most common type of skin disorder in both children and adults.It is characterized by erythema,pruritus,papules,xeransis,and lichenification.The KangminⅠdecoction,a Chinese herbal medicine prepared with several ingredients and used to treat eczema,was formulated according to traditional Chinese medicine theory.Objectives:To investigate the efficacy and safety of KangminⅠdecoction for treating atopic eczema compared to that of loratadine.Methods:90 patients were enrolled at the Yueyang Hospital of Integrated Traditional Chinese and Western Medicine and randomly divided into the KangminⅠdecoction treatment group(n=45)and loratadine control group(n=45).Clinical efficacy was evaluated using the Eczema Area and Severity Index(EASI),Dermatology Life Quality Index(DLQI),adverse events(AEs),and recurrence rates,which were compared between the groups.Results:Compared to the loratadine control group(51.16%,18.60%),the KangminⅠdecoction group(7.72%,4.55%)displayed a significantly reduced effective rate(x^(2)=8.324,P=0.040)and recurrence rate(x^(2)=4.225,P=0.040).The incidence of AEs was similar between the groups(P=0.502).Conclusions:These results support further development of KangminⅠdecoction for the treatment of eczema.The KangminⅠdecoction showed good efficacy with a low recurrence rate and tolerable AEs.The main limitations of this study include the small sample size and the short treatment and follow-up periods.Larger controlled studies are needed to more adequately evaluate both safety and efficacy.展开更多
Objective To conduct a pilot trial to explore the effectiveness and safety of moxibustion robots in treating primary dysmenorrhea(PD)and evaluate its feasibility in clinic.Methods A total of 70 participants with PD we...Objective To conduct a pilot trial to explore the effectiveness and safety of moxibustion robots in treating primary dysmenorrhea(PD)and evaluate its feasibility in clinic.Methods A total of 70 participants with PD were allocated to either moxibustion robot(MR)group(35 cases)or manual moxibustion(MM)group(35 cases)using computer-generated randomization.One acupoint Guanyuan(CV 4)was selected to receive moxa heat stimulation.Two groups of participants were given 3 menstrual cycles of MM and MR treatment respectively(once a day,5 days a session)and received another 3 menstrual cycles follow-up.The degree of pain was evaluated by short-form McGill pain questionnaire(SF-MPQ)and the symptoms of dysmenorrhea were evaluated by Cox Menstrual Symptom Scale(CMSS).The safety was measured by the occurrence rate of adverse events(AEs),including burns(blisters,red and swollen),itching,bowel changes,menstrual cycle disorder,menorrhagia and fatigue,etc.Results A total of 62 patients completed the trial,32 in MR group and 30 in MM group.Compared with baseline,scores of SF-MPQ and CMSS significantly decreased in both groups(P<0.05),and no significant difference was observed between the two groups in the 3rd and 6th menstrual cycles(P>0.05).The total occurrence rate of AEs in MR group was 2.1%,which was significantly lower than MM group(7.2%,P<0.05).Conclusions MR has the same effect as MM at SF-MPQ and CMSS in patients with PD.However,MR is safer than MM(Trial registration No.ChiCTR1800018236).展开更多
Background: Previous studies have demonstrated psychosocial and physical benefit from exercise for older men treated with androgen deprivation therapy (ADT) for prostate cancer (PCa). To date, different intervention d...Background: Previous studies have demonstrated psychosocial and physical benefit from exercise for older men treated with androgen deprivation therapy (ADT) for prostate cancer (PCa). To date, different intervention delivery methods have not been assessed. This study compared the effect of group-based exercise (GBE) to personal training (PT) in men undergoing ADT for PCa. Methods: 13 participants (mean age = 68.2, SD = 7.2) were randomly assigned to GBE or PT for 8 weeks. Participants exercised for 60 minutes three times per week at a moderate-vigorous intensity. Results: 10 participants completed the intervention. At post-intervention, the PT group improved: fatigue, systolic BP, waist circumference, body fat percentage, and maximal leg strength;participants in the GBE group improved leg strength. At 8 weeks, maximal upper body strength in the PT group was greater than the GBE group. There were no adverse events associated with moderate-high intensity training in this population of older men. Conclusion: PT may be more efficacious than GBE in improving several physical fitness outcomes and fatigue in men with PCa who are androgen deprived. Due to the small sample size and attrition, these results require cautious interpretation and confirmation from adequately powered trials.展开更多
The purpose of this study was to pilot an innovative and supported intervention for individuals with a stroke. A pilot control trial with qualitative interviews was undertaken within a university- community setting. T...The purpose of this study was to pilot an innovative and supported intervention for individuals with a stroke. A pilot control trial with qualitative interviews was undertaken within a university- community setting. Thirteen individuals who had experienced a stroke for periods of least 6 months (6 male, average 71 years) were assigned to the intervention group and 7 individuals (2 male, average age 67.9 years) assigned to the control group. Eight individuals from the intervention group completed a single interview. The procedures that related to recruitment and retention and data collection methods were considered. Outcome measures including;self-efficacy, falls self-efficacy and group membership, for both groups were taken at baseline, 11 weeks, 22 weeks. There was an additional assessment at 52 weeks for the intervention group. The structured interview was designed to focus on experiences of the intervention. Self-efficacy remained stable across time for both groups. An improvement in falls self-efficacy was noted in the intervention group at 11 weeks. Consistent improvement (from baseline) was observed in the identity scale across the 52 weeks. Qualitative data provided additional findings related to identity and confidence. Details considering recruitment and retention are also provided. This pilot study provided data that can be used for a further full-scale trial to be considered.展开更多
OBJECTIVE:To investigate the effect of acupressure on postpartum low back pain(LBP),salivary cortisol,physical limitations,and postpartum depression.METHODS:Participants were 70 postpartum women who were randomly assi...OBJECTIVE:To investigate the effect of acupressure on postpartum low back pain(LBP),salivary cortisol,physical limitations,and postpartum depression.METHODS:Participants were 70 postpartum women who were randomly assigned to either an intervention(n=35)or a control(n=35)group.The intervention group received 10 acupressure sessions(1 session per day,5 d per week).The control group received 10 sham acupressure sessions.Outcomes were assessed using a visual analogue scale(LBP intensity),salivary cortisol values(LBP biomarker),and Chinese versions of the Roland-Morris Disability Questionnaire(daily activity limitations),Oswes-try Disability Index(physical activity limitations),and the Edinburgh Postnatal Depression Scale(postpartum depression).RESULTS:Participants in the intervention group had significantly lower levels of LBP intensity,daily activity limitations,physical activity limitations,and postpartum depression than those in the control group.There was no significant between-group difference in salivary cortisol.CONCLUSION:Acupressure may reduce postpartum LBP intensity and limitations in daily and physical activity,and alleviate postpartum depressive symptoms.Acupressure should be offered in postpartum care settings as an alternative treatment for postpartum women with LBP.展开更多
Despite effective treatment options, more than 40% of cancer patients receive inadequate pain management. Our previous pilot study resulted in substantial adaptations of a cancer pain self-management intervention, the...Despite effective treatment options, more than 40% of cancer patients receive inadequate pain management. Our previous pilot study resulted in substantial adaptations of a cancer pain self-management intervention, the German PRO-Self? Plus Pain Control Program originally developed in the United States. This program will be implemented into clinical practice at the Medical Center-University of Freiburg. The purpose of this multiple methods pilot study is to test the implementation regarding feasibility and effects in clinical practice. In a randomized, wait-list controlled pilot study, adult oncology in-patients of a palliative care consultation service with pain >3/10 will be recruited. The intervention will be performed by a specialized advanced practice nurse with an in-hospital visit and, after discharge, via phone calls and visits. The follow-up will be personalized according to a clinical algorithm that factors in pain intensity, satisfaction with pain management, and patient adherence. The intervention includes structured and tailored components and is based on three key strategies: information, skill building and nurse coaching. The specific aims of this study are threefold: 1) to test the feasibility of the study and intervention procedures;2) to establish effect sizes of main outcome variables (e.g. decrease pain intensity, reduce the number of patients with pain as main symptom) for subsequent power calculation;3) to explore participants’ experiences with pain self-management support and their view of burden and benefit from study participation in a qualitative substudy. During the study period, which includes three data collection time points (T0 before, T1 one week and T2 six weeks after discharge), data will be collected via field notes of study nurses and questionnaires of patients. The results of this pilot study will build the basis for a larger comparative effectiveness study in which long term outcomes of a cancer pain self-management intervention in clinical practice will be evaluated.展开更多
Head and neck squamous cell carcinoma(HNSCC)continues to be a major global health challenge,with limited survival improvements for patients with locally advanced(LA)or recurrent(R)disease[1].Anlotinib,a novel orally a...Head and neck squamous cell carcinoma(HNSCC)continues to be a major global health challenge,with limited survival improvements for patients with locally advanced(LA)or recurrent(R)disease[1].Anlotinib,a novel orally administered small-molecule tyrosine kinase inhibitor(TKI)developed in China,targets a wide range of receptor tyrosine kinases(RTKs)[2].展开更多
基金supported by the Natural Science Foundation of Zhejiang Province under Grant No.LTGY23H270002。
文摘Objective:To investigate the feasibility and preliminary effectiveness of Tanxiang prescription(TXP)ointment for alleviating mild to moderate anxiety.Methods:A single-center pilot trial was conducted.Participants were randomly assigned to the experimental group or the control group.The experimental group received TXP treatment and health education,while the control group only received health education.The study evaluated the feasibility based on recruitment,retention,adherence,and adverse events.The primary outcome was assessed using the Self-Rating Anxiety Scale(SAS),while the secondary outcomes were evaluated using the Self-Rating Depression Scale(SDS)and Pittsburgh Sleep Quality Index(PSQI).Assessments were conducted at baseline,week 2,and week 4.Results:In all,58 participants were successfully enrolled,with 56 all having finished the whole research,which illustrates a recruitment rate of 33.7%,a randomization rate of 100%,and a loss rate of 3.57%in this study.No adverse events were observed.Both the experimental(n=29)and control(n=29)groups showed a significant decrease in SAS,SDS,and PSQI scores in comparison to their baseline scores at week 4(P<0.05).In addition,the experimental group showed significantly greater reductions in SAS,SDS,and PSQI scores than those in the control group at week 4(P<0.05).Conclusions:TXP may be a promising treatment option for mild to moderate anxiety,offering a duel benefit of alleviating depression and promoting better sleep without any adverse effects.This study also references the effectiveness of traditional Chinese medicine aromatherapy for anxiety management.Further pharmacological and clinical studies are needed to observe the impact of TXP on emotional regulation in patients with anxiety.
基金sponsored by the National Key Research and Development Program(No.2024YFC3500314)the National Natural Science Foundation of China(No.82405403)+3 种基金the Shanghai 2022‘Science and Technology Innovation Action Plan’Medical Innovation Research Special Project(No.22Y11922200)the Key Discipline Construction Project of Shanghai’s Three Year Action Plan for Strengthening the Construction of Public Health System(No.GWVI-11.1-24)the Clinical Research plan of Shanghai Shenkang HospitalDevelopment Center(No.SHDC22022302)the High-level Chinese Medicine Key Discipline Construction Project(Integrative Chinese and Western Medicine Clinic)of National Administration of TCM(No.zyyzdxk-2023065).
文摘Background:Atopic eczema is the most common type of skin disorder in both children and adults.It is characterized by erythema,pruritus,papules,xeransis,and lichenification.The KangminⅠdecoction,a Chinese herbal medicine prepared with several ingredients and used to treat eczema,was formulated according to traditional Chinese medicine theory.Objectives:To investigate the efficacy and safety of KangminⅠdecoction for treating atopic eczema compared to that of loratadine.Methods:90 patients were enrolled at the Yueyang Hospital of Integrated Traditional Chinese and Western Medicine and randomly divided into the KangminⅠdecoction treatment group(n=45)and loratadine control group(n=45).Clinical efficacy was evaluated using the Eczema Area and Severity Index(EASI),Dermatology Life Quality Index(DLQI),adverse events(AEs),and recurrence rates,which were compared between the groups.Results:Compared to the loratadine control group(51.16%,18.60%),the KangminⅠdecoction group(7.72%,4.55%)displayed a significantly reduced effective rate(x^(2)=8.324,P=0.040)and recurrence rate(x^(2)=4.225,P=0.040).The incidence of AEs was similar between the groups(P=0.502).Conclusions:These results support further development of KangminⅠdecoction for the treatment of eczema.The KangminⅠdecoction showed good efficacy with a low recurrence rate and tolerable AEs.The main limitations of this study include the small sample size and the short treatment and follow-up periods.Larger controlled studies are needed to more adequately evaluate both safety and efficacy.
基金Supported by Traditional Chinese Medicine Administration of Sichuan Province(No.2018KF013)Health Commission of Sichuan Province(No.2000IF10)Self-determined Project of Sichuan University(No.2016CDDY-S19-SCU)。
文摘Objective To conduct a pilot trial to explore the effectiveness and safety of moxibustion robots in treating primary dysmenorrhea(PD)and evaluate its feasibility in clinic.Methods A total of 70 participants with PD were allocated to either moxibustion robot(MR)group(35 cases)or manual moxibustion(MM)group(35 cases)using computer-generated randomization.One acupoint Guanyuan(CV 4)was selected to receive moxa heat stimulation.Two groups of participants were given 3 menstrual cycles of MM and MR treatment respectively(once a day,5 days a session)and received another 3 menstrual cycles follow-up.The degree of pain was evaluated by short-form McGill pain questionnaire(SF-MPQ)and the symptoms of dysmenorrhea were evaluated by Cox Menstrual Symptom Scale(CMSS).The safety was measured by the occurrence rate of adverse events(AEs),including burns(blisters,red and swollen),itching,bowel changes,menstrual cycle disorder,menorrhagia and fatigue,etc.Results A total of 62 patients completed the trial,32 in MR group and 30 in MM group.Compared with baseline,scores of SF-MPQ and CMSS significantly decreased in both groups(P<0.05),and no significant difference was observed between the two groups in the 3rd and 6th menstrual cycles(P>0.05).The total occurrence rate of AEs in MR group was 2.1%,which was significantly lower than MM group(7.2%,P<0.05).Conclusions MR has the same effect as MM at SF-MPQ and CMSS in patients with PD.However,MR is safer than MM(Trial registration No.ChiCTR1800018236).
文摘Background: Previous studies have demonstrated psychosocial and physical benefit from exercise for older men treated with androgen deprivation therapy (ADT) for prostate cancer (PCa). To date, different intervention delivery methods have not been assessed. This study compared the effect of group-based exercise (GBE) to personal training (PT) in men undergoing ADT for PCa. Methods: 13 participants (mean age = 68.2, SD = 7.2) were randomly assigned to GBE or PT for 8 weeks. Participants exercised for 60 minutes three times per week at a moderate-vigorous intensity. Results: 10 participants completed the intervention. At post-intervention, the PT group improved: fatigue, systolic BP, waist circumference, body fat percentage, and maximal leg strength;participants in the GBE group improved leg strength. At 8 weeks, maximal upper body strength in the PT group was greater than the GBE group. There were no adverse events associated with moderate-high intensity training in this population of older men. Conclusion: PT may be more efficacious than GBE in improving several physical fitness outcomes and fatigue in men with PCa who are androgen deprived. Due to the small sample size and attrition, these results require cautious interpretation and confirmation from adequately powered trials.
文摘The purpose of this study was to pilot an innovative and supported intervention for individuals with a stroke. A pilot control trial with qualitative interviews was undertaken within a university- community setting. Thirteen individuals who had experienced a stroke for periods of least 6 months (6 male, average 71 years) were assigned to the intervention group and 7 individuals (2 male, average age 67.9 years) assigned to the control group. Eight individuals from the intervention group completed a single interview. The procedures that related to recruitment and retention and data collection methods were considered. Outcome measures including;self-efficacy, falls self-efficacy and group membership, for both groups were taken at baseline, 11 weeks, 22 weeks. There was an additional assessment at 52 weeks for the intervention group. The structured interview was designed to focus on experiences of the intervention. Self-efficacy remained stable across time for both groups. An improvement in falls self-efficacy was noted in the intervention group at 11 weeks. Consistent improvement (from baseline) was observed in the identity scale across the 52 weeks. Qualitative data provided additional findings related to identity and confidence. Details considering recruitment and retention are also provided. This pilot study provided data that can be used for a further full-scale trial to be considered.
基金Supported by the Chang Gung Memorial Hospital:the Effects of Acupressure on Postpartum Low Back Pain(No.CMRPG8G0941).
文摘OBJECTIVE:To investigate the effect of acupressure on postpartum low back pain(LBP),salivary cortisol,physical limitations,and postpartum depression.METHODS:Participants were 70 postpartum women who were randomly assigned to either an intervention(n=35)or a control(n=35)group.The intervention group received 10 acupressure sessions(1 session per day,5 d per week).The control group received 10 sham acupressure sessions.Outcomes were assessed using a visual analogue scale(LBP intensity),salivary cortisol values(LBP biomarker),and Chinese versions of the Roland-Morris Disability Questionnaire(daily activity limitations),Oswes-try Disability Index(physical activity limitations),and the Edinburgh Postnatal Depression Scale(postpartum depression).RESULTS:Participants in the intervention group had significantly lower levels of LBP intensity,daily activity limitations,physical activity limitations,and postpartum depression than those in the control group.There was no significant between-group difference in salivary cortisol.CONCLUSION:Acupressure may reduce postpartum LBP intensity and limitations in daily and physical activity,and alleviate postpartum depressive symptoms.Acupressure should be offered in postpartum care settings as an alternative treatment for postpartum women with LBP.
文摘Despite effective treatment options, more than 40% of cancer patients receive inadequate pain management. Our previous pilot study resulted in substantial adaptations of a cancer pain self-management intervention, the German PRO-Self? Plus Pain Control Program originally developed in the United States. This program will be implemented into clinical practice at the Medical Center-University of Freiburg. The purpose of this multiple methods pilot study is to test the implementation regarding feasibility and effects in clinical practice. In a randomized, wait-list controlled pilot study, adult oncology in-patients of a palliative care consultation service with pain >3/10 will be recruited. The intervention will be performed by a specialized advanced practice nurse with an in-hospital visit and, after discharge, via phone calls and visits. The follow-up will be personalized according to a clinical algorithm that factors in pain intensity, satisfaction with pain management, and patient adherence. The intervention includes structured and tailored components and is based on three key strategies: information, skill building and nurse coaching. The specific aims of this study are threefold: 1) to test the feasibility of the study and intervention procedures;2) to establish effect sizes of main outcome variables (e.g. decrease pain intensity, reduce the number of patients with pain as main symptom) for subsequent power calculation;3) to explore participants’ experiences with pain self-management support and their view of burden and benefit from study participation in a qualitative substudy. During the study period, which includes three data collection time points (T0 before, T1 one week and T2 six weeks after discharge), data will be collected via field notes of study nurses and questionnaires of patients. The results of this pilot study will build the basis for a larger comparative effectiveness study in which long term outcomes of a cancer pain self-management intervention in clinical practice will be evaluated.
基金supported by funding from the National Natural Science Foundation of China(No.82173041,82372868,82173362,81872409,82304069,82403184,and 823B2079)Guangzhou Municipal Science and Technology Bureau(No.2024B03J1384)+2 种基金China Postdoctoral Science Foundation(No.2023M734003)Natural Science Foundation of Guangdong Province(No.2024A1515012316)Basic and Applied Basic Research Foundation of Guangdong Province(No.2023A1515110475).
文摘Head and neck squamous cell carcinoma(HNSCC)continues to be a major global health challenge,with limited survival improvements for patients with locally advanced(LA)or recurrent(R)disease[1].Anlotinib,a novel orally administered small-molecule tyrosine kinase inhibitor(TKI)developed in China,targets a wide range of receptor tyrosine kinases(RTKs)[2].
