Rationale for the use of rifaximin in inflammatory bowel diseases based on clinical trial results

2013 ◽  
Vol 3 (12) ◽  
pp. 1187-1193
Author(s):  
Roberto Lorenzetti ◽  
Cosimo Prantera
2020 ◽  
Vol 14 (5) ◽  
pp. 710-718 ◽  
Author(s):  
Ferdinando D’Amico ◽  
Cedric Baumann ◽  
Hélène Rousseau ◽  
Silvio Danese ◽  
Laurent Peyrin-Biroulet

Abstract In the last few decades several new molecules have been developed in the field of inflammatory bowel diseases. However, the process that leads to the approval and use of a new drug is very long, expensive and complex, consisting of various phases. There is a pre-clinical phase that is performed on animals and a clinical phase that is directed to humans. Each research phase aims to evaluate different aspects of the drug and involves a specific target group of subjects. In addition, many aspects must be considered in the evaluation of a clinical trial: randomization, presence of a control group, blind design, type of data analysis performed, and patient stratification. The objective of this review is to provide an overview of the clinical trial phases of a new drug in order to better understand and interpret their results.


2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S661-S662
Author(s):  
A Rivera Sequeiros ◽  
Y Torres Dominguez ◽  
M Á ◽  
Izquierdo Macías ◽  
M V Ruiz Romero

Abstract Background The main objective in the management of chronic diseases is to maintain and improve the quality of life. In this sense, the involvement of the patient in their self-care should be a priority for nursing, but we know that the results are not always the desired ones. Self-care education and training should focus on social and emotional aspects, identified as predictors of the deterioration of the quality of life. Studies have identified psychosocial profiles (Controlled, Reinforced, Weak, Fragile) of patients with inflammatory bowel diseases (IBD) based on their level of social support and emotional coping. These profiles could predict the effectiveness of these educational workshops. This study aims to compare the effectiveness of a self-management workshop in different patient profiles to identify what type of patient might benefit and which don’t. Methods Non-randomised clinical trial. 61 outpatients were included. Inclusion criteria: Have IBD, be over 18 years old and sign the informed consent. They were included in a self-management training programme to learn about the disease and coping. There were 4 sessions in a month. They completed a questionnaire before the workshop, at the end of the workshop, at 3 months and at 6 months. The variables were sociodemographic, clinical, quality of life, coping, perceived stress, social support and anxiety-depression. Results The characteristics of the sample are shown in Table 1. The four psychosocial profiles described in the literature were identified and the effectiveness of the workshop in each one was analysed. The intrasubject linear analysis showed a linear type increase in the quality of life of patients with Reinforced and Weakening profile, between baseline and third month (−3.81, p = 0.036, CI: (− 7.45; −0.17) and − 6.21, p = 0.004, CI: (− 11.08; −1.35) respectively). The observed power was 91.5% and 93.8% for each case. However, no significant differences were found in patients with Controlled profile and Fragiles. The results found were not associated with other variables of the study. Conclusion Identifying psychosocial profiles allows us to succeed with the type of education we offer to patients. We must customise the information and resources. In the case of patients with a great lack of family support, one would first have to intervene with the family and then offer emotional education and not vice versa.


Sign in / Sign up

Export Citation Format

Share Document