<body><div><img src="https://img.particlenews.com/image.php?type=thumbnail_580x000&amp;url=3CUrKz_0wMTh93R00" alt="https://img.particlenews.com/image.php?url=3CUrKz_0wMTh93R00" width="800" height="600" >Two reviews of recent trials for drugs used to treat inflammatory bowel disease found that patients who received a placebo were at "significantly higher risk" for potential harms, MedPage Today reported Sept. 26. Here are 10 things to know about the findings:1. The research was reported by Alex Ford, MD, of St. James University Hospital in Leeds, U.K., and published in Lancet Gastroenterology &amp; Hepatology. One review and meta-analysis of 47 induction-therapy trials with about 21,000 adults with moderate to severe IBD risk found that worsening disease activity was significantly lower in the treatment versus placebo groups. 2. Patients in active treatment groups were significantly less likely than the placebo groups to experience serious adverse events or venous thromboembolism. 3. The second meta-analysis revealed similar findings, examining 45 maintenance-therapy trials with approximately 16,500 patients. Active treatment groups among these patients were also significantly less likely to experience "serious worsening of IBD, serious adverse events, and withdrawal due to adverse events." 4. A lower risk of adverse outcomes in patients receiving an active drug is likely the cause of harms associated with the placebo, rather than an actual increase in risk associated with placebo. 5. The researchers noted that the results should "prompt reflection" on the current design of clinical trials for IBD and researchers should consider strategies for minimizing placebo exposure. 6. IBD patients who have exhausted medical therapies and looking to enroll in clinical trials are cautioned against "comparing a new active drug head-to-head against an existing gold standard drug," according to the researchers, who instead suggested trying platform studies, Bayesian analysis of existing data on expected placebo response rates or open-label active treatment. 7. Fernando Gomollón, MD, of Zaragoza University in Spain, said in an editorial published alongside the studies that the rising prevalence of IBD could reach approximately 1% of the global population by 2030. This will initiate more drug development and clinical trials. 8. However, the inclusion of a placebo group is a deterrent for many patients looking to participate in clinical trials, which can slow down research, Dr. Gomollón said. 9. Both studies drew from Medline, the Cochrane Central Register of Controlled Trials and other databases for randomized, placebo-controlled drug trials reporting data on adverse events in adults with moderate to severe ulcerative colitis or luminal Crohn's disease. Four weeks for induction therapy was the minimum treatment period, and 20 weeks for maintenance therapy. 10. Both meta-analyses underscored potential harms associated with receiving placebo in placebo-controlled IBD trials, revealing "the need to counsel patients carefully about the possible consequences of enrolling in such studies."</div></body>

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Researchers link placebos to potential harm in IBD trials: 10 things to know

Two reviews of recent trials for drugs used to treat inflammatory bowel disease found that patients who received a placebo were at \"significantly higher risk\" for potential harms, MedPage Today reported Sept. 26. Here are 10 things to know about the findings:. 1. The research was reported by Alex Ford,...

Two reviews of recent trials for drugs used to treat inflammatory bowel disease found that patients who received a placebo were at "significantly higher risk" for potential harms, MedPage Today reported Sept. 26. Here are 10 things to know about the findings:. 1. The research was reported by Alex Ford,...