Herbal medicinal products for inflammatory bowel disease: A focus on those assessed in double‐blind randomised controlled trials

2019 ◽  
Vol 34 (1) ◽  
pp. 77-93 ◽  
Author(s):  
Grainne Holleran ◽  
Franco Scaldaferri ◽  
Antonio Gasbarrini ◽  
Diego Currò
Keyword(s):  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
Randomised Controlled Trials ◽  
Controlled Trials ◽  
Medicinal Products ◽  
Double Blind ◽  
Herbal Medicinal Products ◽  
Inflammatory Bowel ◽  
Herbal Medicinal ◽  
Randomised Controlled

scholarly journals Sample-size estimation is not reported in 24% of randomised controlled trials of inflammatory bowel disease: A systematic review

2020 ◽  
pp. 205064062096789
Author(s):  
Zipporah Iheozor-Ejiofor ◽  
Svetlana Lakunina ◽  
Morris Gordon ◽  
Daniel Akintelure ◽  
Vasiliki Sinopoulou ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Sample Size ◽  
Systematic Reviews ◽  
Bowel Disease ◽  
Randomised Controlled Trials ◽  
Sample Size Estimation ◽  
Controlled Trials ◽  
Size Estimation ◽  
Inflammatory Bowel ◽  
Randomised Controlled

Background Sample-size estimation is an important factor in designing a clinical trial. A recent study found that 65% of Cochrane systematic reviews had imprecise results. Objective This study set out to review the whole body of inflammatory bowel disease (IBD) randomised controlled trials systematically in order to identify the reporting of sample-size estimation. Methods We conducted a comprehensive hand search of the Cochrane Library and Cochrane IBD Specialized Trials Register. We extracted information on relevant features and the results of the included studies. We produced descriptive statistics for our results. Results A total of 242 randomised controlled trials were included from 44 Cochrane systematic reviews. About 25% of the studies failed to report on sample-size estimation. Of those that did report on sample-size estimation, 33% failed to recruit their target sample size. Conclusions Around half of the randomised controlled trials in IBD either do not report sample-size estimation or reach their recruitment target with the level of detail in reporting being limited.

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.

scholarly journals Probiotics, fibre and herbal medicinal products for functional and inflammatory bowel disorders

2016 ◽  
Vol 174 (11) ◽  
pp. 1426-1449 ◽  
Author(s):  
Diego Currò ◽  
Gianluca Ianiro ◽  
Silvia Pecere ◽  
Stefano Bibbò ◽  
Giovanni Cammarota
Keyword(s):  
Medicinal Products ◽  
Herbal Medicinal Products ◽  
Bowel Disorders ◽  
Inflammatory Bowel ◽  
Herbal Medicinal ◽  
Inflammatory Bowel Disorders
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