AIM:To study the impact of an endoscopy-based long-term study on the quality of life in healthy volunteers(HV).METHODS:Ten HV were included into a long-term prospective endoscopy-based placebo-controlled trial with 15...AIM:To study the impact of an endoscopy-based long-term study on the quality of life in healthy volunteers(HV).METHODS:Ten HV were included into a long-term prospective endoscopy-based placebo-controlled trial with 15 endoscopic examinations per person in 5 different drug phases.Participants completed short form-36(SF-36) and visual analog scale-based questionnaires(VAS) for different abdominal symptoms at days 0,7 and 14 of each drug phase.Analyses wereperformed according to short-and long-term changes and compared to the control group.RESULTS:All HV completed the study with duration of more than 6 mo.Initial quality of life score was comparable to a general population.Analyses of the SF-36 questionnaires showed no significant changes in physical,mental and total scores,either in a short-term perspective due to different medications,or to potentially endoscopic procedure-associated long-term cumulative changes.Analogous to SF-36,VAS revealed no significant changes in total scores for pathological abdominal symptoms and remained unchanged over the time course and when compared to the control population.CONCLUSION:This study demonstrates that quality of life in HV is not significantly affected by a longterm endoscopy-based study with multiple endoscopic procedures.展开更多
Background Patients with chronic pancreatitis often have irreversible pancreatic insufficiency before a clinical diagnosis.Pancreatic cancer is a fatal malignant tumor in the advanced stages.Patients having high risk ...Background Patients with chronic pancreatitis often have irreversible pancreatic insufficiency before a clinical diagnosis.Pancreatic cancer is a fatal malignant tumor in the advanced stages.Patients having high risk of pancreatic diseases must be screened early to obtain better outcomes using new imaging modalities.Therefore,this study aimed to investigate the reproducibility of tomoelastography measurements for assessing pancreatic stiffness and fluidity and the variance among healthy volunteers.Methods Forty-seven healthy volunteers were prospectively enrolled and underwent two tomoelastography examinations at a mean interval of 7 days.Two radiologists blindly and independently measured the pancreatic stiffness and fluidity at the first examination to determine the reproducibility between readers.One radiologist measured the adjacent pancreatic slice at the first examination to determine the reproducibility among slices and measured the pancreas at the second examination to determine short-termrepeatability.The stiffness and fluidity of the pancreatic head,body,and tail were compared to determine anatomical differences.The pancreatic stiffness and fluidity were compared based on sex,age,and body mass index(BMI).Results Bland–Altman analyses(all P>0.05)and intraclass correlation coefficients(all>0.9)indicated near perfect reproducibility among readers,slices,and examinations at short intervals.Neither stiffness(P=0.477)nor fluidity(P=0.368)differed among the pancreatic anatomical regions.The mean pancreatic stiffness was 1.45±0.09 m/s;the mean pancreatic fluidity was 0.83±0.06 rad.Stiffness and fluidity did not differ by sex,age,or BMI.Conclusion Tomoelastography is a promising and reproducible tool for assessing pancreatic stiffness and fluidity in healthy volunteers.展开更多
BACKGROUND Many Ayurvedic preparations are claimed to have immune-boosting properties,as suggested in various published randomized clinical trials(RCTs)AIM To compile evidence on the nature and mechanism of immune sys...BACKGROUND Many Ayurvedic preparations are claimed to have immune-boosting properties,as suggested in various published randomized clinical trials(RCTs)AIM To compile evidence on the nature and mechanism of immune system enhancement by Ayurvedic preparations in healthy and sick individuals.METHODS After prospectively registering study protocol with PROSPERO,we searched PubMed,DOAJ,Google Scholar,three dedicated Ayurveda research portals,two specialty Ayurveda journals,and reference lists for relevant records published until February 6,2021 using appropriate search strategies.Baseline features and data pertaining to the nature and mechanism of immune system function were extracted from all eligible records.Methodological quality was assessed using the Cochrane RoB-2 tool.RESULTS Of 12554 articles screened,19 studies reporting 20 RCTs(17 parallel group design,three crossover design)with 1661 unique patients were included;11/19 studies had Indian first authors.Healthy population was included in nine studies,of which one study included pregnant women and two included pediatric population;remaining studies included patients with different health conditions,including one study with coronavirus disease 2019 patients.A total of 21 Ayurvedic interventions were studied,out of which five were composite mixtures.The predominant route of administration was oral;dose and frequency of administration of the intervention varied across the studies.The results reported with five RCTs exploring five Ayurvedic interventions were incomplete,ambiguous,or confusing.Of the remaining 16 interventions,indirect evidence of immune enhancement was reported with four interventions,while lack of the same was reported with two interventions.Enhancement of T helper cells and natural killer cells was reported with three and four interventions,respectively,while the pooled results did not clearly point toward enhancement of other components of the immune system,including cytotoxic T cells,B lymphocytes,immunoglobulins,cytokines,complement components,leucocyte counts,and other components.Nine of the 20 RCTs had a high risk of bias,and the remaining 11 RCTs had some concerns according to RoB-2.CONCLUSION Various Ayurvedic preparations appear to enhance the immune system,particularly via enhancements in natural killer cells and T helper cells.展开更多
The potential benefit of probiotics on the gut microbiota and on various gastrointestinal disorders is well documented. It has become clear that these probiotic effects are strain-specific, underlying the necessity fo...The potential benefit of probiotics on the gut microbiota and on various gastrointestinal disorders is well documented. It has become clear that these probiotic effects are strain-specific, underlying the necessity for a well-founded strain selection for research and clinical practice. Whether probiotics also have a positive effect on parameters of gastrointestinal function in a healthy population is less investigated. The objective of this in vivo observational study was to investigate the effect of a 6-week intervention with a multispecies probiotic product on gut health and quality of life (QoL) in a population of otherwise healthy adults and to evaluate the feasibility of conducting a controlled trial on probiotic effects in this population. A total of 40 participants from 3 different health centres were included in the study. After a 1-week inclusion phase, participants were supplemented for a 6-week period with Winclove 500/BactoSan pro FOS. During the run-in phase and each week during the observational period, gastrointestinal functional parameters were documented by an adapted version of the Eypasch questionnaire. Data on QoL was collected at baseline and at the end of the intervention period. The total gastrointestinal (GI) symptom score was reduced from 10 (4 - 21) at baseline to 6 (0 - 15) (p < 0.05) after 6 weeks intervention. More specifically, after the probiotic intervention the percentage of participants which were fully resolved of a particular symptom significantly increased to 27.5% (p < 0.02) for gastrointestinal pain, to 25% (p < 0.03) for epigastric fullness/bloating and to 20% (p < 0.02) for flatulence, compared to baseline. The treatment was well-tolerated. This observational study provides important information on the ability to investigate potential effects of a probiotic product in otherwise healthy adults. The promising results Winclove 500/BactoSan pro FOS showed on gut health and QoL in this target group should be further investigated in a randomized, placebo-controlled study.展开更多
基金Supported by A Research Grant of Astra-Zeneca (Wedel,Germany)
文摘AIM:To study the impact of an endoscopy-based long-term study on the quality of life in healthy volunteers(HV).METHODS:Ten HV were included into a long-term prospective endoscopy-based placebo-controlled trial with 15 endoscopic examinations per person in 5 different drug phases.Participants completed short form-36(SF-36) and visual analog scale-based questionnaires(VAS) for different abdominal symptoms at days 0,7 and 14 of each drug phase.Analyses wereperformed according to short-and long-term changes and compared to the control group.RESULTS:All HV completed the study with duration of more than 6 mo.Initial quality of life score was comparable to a general population.Analyses of the SF-36 questionnaires showed no significant changes in physical,mental and total scores,either in a short-term perspective due to different medications,or to potentially endoscopic procedure-associated long-term cumulative changes.Analogous to SF-36,VAS revealed no significant changes in total scores for pathological abdominal symptoms and remained unchanged over the time course and when compared to the control population.CONCLUSION:This study demonstrates that quality of life in HV is not significantly affected by a longterm endoscopy-based study with multiple endoscopic procedures.
基金supported by the National Natural Science foundation of China[grant number 81801761 to Y.L.].
文摘Background Patients with chronic pancreatitis often have irreversible pancreatic insufficiency before a clinical diagnosis.Pancreatic cancer is a fatal malignant tumor in the advanced stages.Patients having high risk of pancreatic diseases must be screened early to obtain better outcomes using new imaging modalities.Therefore,this study aimed to investigate the reproducibility of tomoelastography measurements for assessing pancreatic stiffness and fluidity and the variance among healthy volunteers.Methods Forty-seven healthy volunteers were prospectively enrolled and underwent two tomoelastography examinations at a mean interval of 7 days.Two radiologists blindly and independently measured the pancreatic stiffness and fluidity at the first examination to determine the reproducibility between readers.One radiologist measured the adjacent pancreatic slice at the first examination to determine the reproducibility among slices and measured the pancreas at the second examination to determine short-termrepeatability.The stiffness and fluidity of the pancreatic head,body,and tail were compared to determine anatomical differences.The pancreatic stiffness and fluidity were compared based on sex,age,and body mass index(BMI).Results Bland–Altman analyses(all P>0.05)and intraclass correlation coefficients(all>0.9)indicated near perfect reproducibility among readers,slices,and examinations at short intervals.Neither stiffness(P=0.477)nor fluidity(P=0.368)differed among the pancreatic anatomical regions.The mean pancreatic stiffness was 1.45±0.09 m/s;the mean pancreatic fluidity was 0.83±0.06 rad.Stiffness and fluidity did not differ by sex,age,or BMI.Conclusion Tomoelastography is a promising and reproducible tool for assessing pancreatic stiffness and fluidity in healthy volunteers.
文摘BACKGROUND Many Ayurvedic preparations are claimed to have immune-boosting properties,as suggested in various published randomized clinical trials(RCTs)AIM To compile evidence on the nature and mechanism of immune system enhancement by Ayurvedic preparations in healthy and sick individuals.METHODS After prospectively registering study protocol with PROSPERO,we searched PubMed,DOAJ,Google Scholar,three dedicated Ayurveda research portals,two specialty Ayurveda journals,and reference lists for relevant records published until February 6,2021 using appropriate search strategies.Baseline features and data pertaining to the nature and mechanism of immune system function were extracted from all eligible records.Methodological quality was assessed using the Cochrane RoB-2 tool.RESULTS Of 12554 articles screened,19 studies reporting 20 RCTs(17 parallel group design,three crossover design)with 1661 unique patients were included;11/19 studies had Indian first authors.Healthy population was included in nine studies,of which one study included pregnant women and two included pediatric population;remaining studies included patients with different health conditions,including one study with coronavirus disease 2019 patients.A total of 21 Ayurvedic interventions were studied,out of which five were composite mixtures.The predominant route of administration was oral;dose and frequency of administration of the intervention varied across the studies.The results reported with five RCTs exploring five Ayurvedic interventions were incomplete,ambiguous,or confusing.Of the remaining 16 interventions,indirect evidence of immune enhancement was reported with four interventions,while lack of the same was reported with two interventions.Enhancement of T helper cells and natural killer cells was reported with three and four interventions,respectively,while the pooled results did not clearly point toward enhancement of other components of the immune system,including cytotoxic T cells,B lymphocytes,immunoglobulins,cytokines,complement components,leucocyte counts,and other components.Nine of the 20 RCTs had a high risk of bias,and the remaining 11 RCTs had some concerns according to RoB-2.CONCLUSION Various Ayurvedic preparations appear to enhance the immune system,particularly via enhancements in natural killer cells and T helper cells.
文摘The potential benefit of probiotics on the gut microbiota and on various gastrointestinal disorders is well documented. It has become clear that these probiotic effects are strain-specific, underlying the necessity for a well-founded strain selection for research and clinical practice. Whether probiotics also have a positive effect on parameters of gastrointestinal function in a healthy population is less investigated. The objective of this in vivo observational study was to investigate the effect of a 6-week intervention with a multispecies probiotic product on gut health and quality of life (QoL) in a population of otherwise healthy adults and to evaluate the feasibility of conducting a controlled trial on probiotic effects in this population. A total of 40 participants from 3 different health centres were included in the study. After a 1-week inclusion phase, participants were supplemented for a 6-week period with Winclove 500/BactoSan pro FOS. During the run-in phase and each week during the observational period, gastrointestinal functional parameters were documented by an adapted version of the Eypasch questionnaire. Data on QoL was collected at baseline and at the end of the intervention period. The total gastrointestinal (GI) symptom score was reduced from 10 (4 - 21) at baseline to 6 (0 - 15) (p < 0.05) after 6 weeks intervention. More specifically, after the probiotic intervention the percentage of participants which were fully resolved of a particular symptom significantly increased to 27.5% (p < 0.02) for gastrointestinal pain, to 25% (p < 0.03) for epigastric fullness/bloating and to 20% (p < 0.02) for flatulence, compared to baseline. The treatment was well-tolerated. This observational study provides important information on the ability to investigate potential effects of a probiotic product in otherwise healthy adults. The promising results Winclove 500/BactoSan pro FOS showed on gut health and QoL in this target group should be further investigated in a randomized, placebo-controlled study.
