Purpose: Special nutrients have an impact on common cold infections. In this trial we have investigated the effectiveness of the specific amino acid composition “aminoplus? immun” on the occurrence, duration and sev...Purpose: Special nutrients have an impact on common cold infections. In this trial we have investigated the effectiveness of the specific amino acid composition “aminoplus? immun” on the occurrence, duration and severity of common cold. Material and Methods: Our study is a controlled, randomised completely masked trial comparing genuine trial remedy versus placebo in parallel groups. Eligible subjects were people with recurrent and chronic infections of the ear, nose and pharyngeal area. The treatment period was 90 days. The primary outcome was the mean number of days that the patients had symptoms of infections. Results: From Oct. 2009 to Feb. 2010 a total of 145 patients were recruited, of whom 119 had no major protocol violation and were valid for assessment. Two thirds of the patients were female. The mean age of the patients was 45 years. 65% of participants had come into contact with many people and thereby an increased risk of infection. On average the patients had 11.1 infections during the 12 months before the study. Compliance for the intake of the study preparation was 98.9%. Due to randomisation, the groups were very similar and balanced. The primary and all 6 secondary outcome variables showed a clear superiority of the investigated amino acid composition over placebo (p Conclusion: The specific composition “aminoplus? immun is effective in preventing recurrent and chronic infections of the ear, nose and upper respiratory tract.展开更多
Background:Animal models are widely applied in medical research for different purposes.In particular,results from translational experiments may be used for subsequent clinical development.However,transferability of th...Background:Animal models are widely applied in medical research for different purposes.In particular,results from translational experiments may be used for subsequent clinical development.However,transferability of these findings to the human organism is controversial.Among other factors,this may be traced back to a lack of clear differentiation of the evidence(explorative vs.confirmatory)provided by such experimental results.In general,inferential statistics(i.e.p values)should not be interpreted in as confirmatory unless crucial methodological requirements are met.Methods:Therefore,we propose a phase model which reflects the well-established process of clinical research,and we discuss its potential to improve decision making in translational research.The model aims to clarify the reliability of results derived from animal models.Results:The phase model proposes subdividing translational,pre-clinical research into pilot,exploration,and confirmation phases.Experiments for which there is no valid estimation of the expected effect size are designated as pilot studies.Based on these data,experiments in subsequent phases may be planned using both appropriate design and statistical methods.Conclusion:Separating the entire process of translational animal research into three phases could contribute to improved transparency of the evidence derived from such experiments.展开更多
文摘Purpose: Special nutrients have an impact on common cold infections. In this trial we have investigated the effectiveness of the specific amino acid composition “aminoplus? immun” on the occurrence, duration and severity of common cold. Material and Methods: Our study is a controlled, randomised completely masked trial comparing genuine trial remedy versus placebo in parallel groups. Eligible subjects were people with recurrent and chronic infections of the ear, nose and pharyngeal area. The treatment period was 90 days. The primary outcome was the mean number of days that the patients had symptoms of infections. Results: From Oct. 2009 to Feb. 2010 a total of 145 patients were recruited, of whom 119 had no major protocol violation and were valid for assessment. Two thirds of the patients were female. The mean age of the patients was 45 years. 65% of participants had come into contact with many people and thereby an increased risk of infection. On average the patients had 11.1 infections during the 12 months before the study. Compliance for the intake of the study preparation was 98.9%. Due to randomisation, the groups were very similar and balanced. The primary and all 6 secondary outcome variables showed a clear superiority of the investigated amino acid composition over placebo (p Conclusion: The specific composition “aminoplus? immun is effective in preventing recurrent and chronic infections of the ear, nose and upper respiratory tract.
文摘Background:Animal models are widely applied in medical research for different purposes.In particular,results from translational experiments may be used for subsequent clinical development.However,transferability of these findings to the human organism is controversial.Among other factors,this may be traced back to a lack of clear differentiation of the evidence(explorative vs.confirmatory)provided by such experimental results.In general,inferential statistics(i.e.p values)should not be interpreted in as confirmatory unless crucial methodological requirements are met.Methods:Therefore,we propose a phase model which reflects the well-established process of clinical research,and we discuss its potential to improve decision making in translational research.The model aims to clarify the reliability of results derived from animal models.Results:The phase model proposes subdividing translational,pre-clinical research into pilot,exploration,and confirmation phases.Experiments for which there is no valid estimation of the expected effect size are designated as pilot studies.Based on these data,experiments in subsequent phases may be planned using both appropriate design and statistical methods.Conclusion:Separating the entire process of translational animal research into three phases could contribute to improved transparency of the evidence derived from such experiments.
