Challenges and Developments in IBS Clinical Trials

On Monday we talked about the ways that Irritable Bowel Syndrome (IBS) can affect people’s lives, and be anywhere from mildly annoying to complete debilitating. Today we’ll dive into some of the biggest challenges faced by researchers attempting to run clinical studies on IBS treatments.


One paper examines the work done in IBS clinical trials from the seventies onwards. The research, conducted by Robin C Spiller, underlies one of the most important factors to consider when involving IBS patients in clinical trials: the high variability of the disorder across patients.


Given the way that IBS symptoms manifest differently in patients, presenting as either diarrhea or constipation dominant in different people (or, a combination of both) it can be incredibly difficult to define endpoints that suit a large array of patients. This makes it much harder to find measurable benchmarks in IBS clinical trials.


Further, IBS trials of the last few decades have shown a significant placebo response, averaging 47% according to Spiller. This implies that the non-specific therapeutic effects of entering patients into a clinical trial for their condition are substantial, and even suggests an inadequacy in placebo-control. It also indicated the influence that psychological factors, such as perhaps the stress relief of simply being on a treatment plan, might have on a patient experiencing the disorder. In future studies, this could be a vital factor to explore.


Finally, some of the most recent clinical trials in IBS demonstrate that the above psychological impact is a very valid therapeutic tool. An open-label study that concluded at the end of last month examined those with moderate to severe IBS symptoms, and involved granting the patients awareness that they were receiving an in-active treatment. Even while knowingly taking a placebo, the study reports clinically meaningful improvements in their IBS symptoms. 262 adult patients were enrolled -- 69% of which demonstrated improvement on the IBS-Severity Scoring System within six weeks.


The implications of both the Spiller paper, and the more recent research are promising for the future research into treatments and symptom management for IBS.


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