Randomized controlled trials in inflammatory bowel diseases: The case for the positive control

1996 ◽  
Vol 2 (4) ◽  
pp. 260-264
Author(s):  
A. Hillary Steinhart
Keyword(s):  
Randomized Controlled Trials ◽  
Inflammatory Bowel Diseases ◽  
Positive Control ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Bowel Diseases ◽  
Inflammatory Bowel

Any Future for Fecal Microbiota Transplantation as Treatment Strategy for Inflammatory Bowel Diseases?

2016 ◽  
Vol 34 (Suppl. 1) ◽  
pp. 74-81 ◽  
Author(s):  
Patrizia Kump ◽  
Christoph Högenauer
Keyword(s):  
Randomized Controlled Trials ◽  
Inflammatory Bowel Diseases ◽  
Fecal Microbiota Transplantation ◽  
Case Series ◽  
Fecal Microbiota ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Bowel Diseases ◽  
Inflammatory Bowel

Fecal microbiota transplantation (FMT) is a novel therapeutic procedure aiming at restoring a normal intestinal microbiota by application of fecal microorganisms from a healthy subject into the gastrointestinal tract of a patient. FMT is the most effective treatment for recurrent Clostridium difficile infections (CDI). These infections also occur in patients with inflammatory bowel diseases (IBDs), where case series demonstrated a successful treatment of CDI by FMT in 83-92% of patients. The effect of FMT on the activity of IBD has mainly been investigated in ulcerative colitis (UC) patients, including 3 randomized controlled trials. So far, 2 randomized controlled trials showed a superiority of FMT compared to placebo in inducing remission in UC, while 1 study found no significant difference to placebo. The variation in response to FMT between these studies as well as in the uncontrolled trials might be explained by many differences in the way of FMT application, patient pretreatment and patient and donor selection. The data for the use of FMT in Crohn's disease and pouchitis are sparse; currently, no conclusion can be drawn regarding the effectiveness of FMT in these indications. It needs to be noted that cases of IBD activation after FMT have been reported. So far, FMT can only be recommended to be used for the treatment of concomitant CDI in IBD in clinical practice. For treating IBD irrespective of CDI, FMT should be only used in clinical trials. Current forms of FMT, especially protocols using repeated application, are very time and personnel consuming. Future trends are the use of defined stable microbiota preparations, in particular oral preparations, which will enable better and larger controlled trails for investigating FMT in IBD.

scholarly journals Acupuncture and Moxibustion for Inflammatory Bowel Diseases: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

2013 ◽  
Vol 2013 ◽  
pp. 1-11 ◽  
Author(s):  
Jun Ji ◽  
Yuan Lu ◽  
Huirong Liu ◽  
Hui Feng ◽  
Fuqing Zhang ◽  
...  
Keyword(s):  
Systematic Review ◽  
Randomized Controlled Trials ◽  
Moxibustion Therapy ◽  
Inflammatory Bowel Diseases ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Acupuncture And Moxibustion ◽  
Bowel Diseases ◽  
Inflammatory Bowel

Background. Inflammatory bowel diseases (IBD) are recurrent and refractory which include ulcerative colitis (UC) and Crohn’s disease (CD). Clinical researches about acupuncture and moxibustion treatments for IBD are increasing, while systematic reviews about their efficacy remains in a shortage. This study sought to evaluate the efficacy of acupuncture and moxibustion for IBD.Methods. Seven significant databases both in and abroad were searched for randomized controlled trials (RCTs) which compared acupuncture and moxibustion as the main intervention to pharmacotherapy in treating IBD. A meta-analysis was performed.Results. A total of 43 RCTs were included. Among the 43 included trials, 10 trials compared oral sulphasalazine (SASP) with acupuncture and/or moxibustion treatments. A meta-analysis of the 10 trials indicated that acupuncture and moxibustion therapy was superior to oral SASP.Conclusion. Acupuncture and moxibustion therapy demonstrates better efficacy than oral SASP in treating IBD. However, given the limitations of this systematic review and the included literature, definitive conclusions regarding the exact efficacy of acupuncture and moxibustion treatment for IBD cannot be drawn. Extant RCTs still cannot provide sufficient evidence and multicentre, double-blind RCTs with large sample sizes are needed to provide higher-quality evidence.

scholarly journals Head-to-head comparison of biological drugs for inflammatory bowel disease: from randomized controlled trials to real-world experience

2021 ◽  
Vol 14 ◽  
pp. 175628482110106
Author(s):  
Fabio Salvatore Macaluso ◽  
Marcello Maida ◽  
Mauro Grova ◽  
Federica Crispino ◽  
Giulia Teresi ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Randomized Controlled Trials ◽  
Real World ◽  
Bowel Disease ◽  
Quality Data ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Therapeutic Algorithms ◽  
Inflammatory Bowel

During past years, the increasing knowledge of molecular mechanisms of inflammatory bowel disease (IBD) have led to the development of several targeted biological therapies. This great expansion of available medical options has prompted the need for comparative data between drugs. For years, given that most randomized controlled trials (RCTs) were performed only versus placebo, this demand has clashed with the absence of head-to-head trials comparing two or more treatments. The quality of evidence coming from real-world experience was low overall, so it was extremely difficult to clarify the correct positioning of the biologicals inside the therapeutic algorithms for IBD. Fortunately, times are changing: head-to-head comparative RCTs have been conducted or are ongoing, and the methodological quality of real-world studies is gradually increasing, mainly thanks to a higher rate of application of statistical methods capable of reducing the selection bias, such as the propensity score. In this evolving scenario, the increasing number of comparative RCTs is providing high-quality data for a correct drug positioning in IBD. In parallel, real-world observational studies are supporting the data coming from RCTs, and covering those comparisons not performed in the RCT setting. We believe that there is moderate evidence already available to support clinicians in the correct choice between different biologicals, and data will certainly be more robust in the near future.

Challenges to the Design, Execution, and Analysis of Randomized Controlled Trials for Inflammatory Bowel Disease

2012 ◽  
Vol 143 (6) ◽  
pp. 1461-1469 ◽  
Author(s):  
Geert D'Haens ◽  
Brian Feagan ◽  
Jean–Frédéric Colombel ◽  
William J. Sandborn ◽  
Walter Reinisch ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Randomized Controlled Trials ◽  
Bowel Disease ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Inflammatory Bowel
Sign in / Sign up

Export Citation Format

Share Document