Willingness to accept risk with medication in return for cure of symptoms among patients with Rome IV irritable bowel syndrome

Abstract

Background: Some drugs for irritable bowel syndrome (IBS) have serious side effects. Aims:To examine the willingness of individuals with IBS to accept risks with medication in return for symptom cure. Methods:We collected demographic, gastrointestinal symptoms, psychological health, quality of life and impact on work and daily activities data from 752 adults with Rome IV-defined IBS. We examined median willingness to accept death in return for cure with a hypothetical medication using a standard gamble, according to these variables.Results: Participants would accept a median 2.0% (IQR 0.0%-9.0%) risk of death in return for a 98.0% (IQR 91.0%-100.0%) chance of permanent symptom cure. The median accepted risk of death was higher in men (5.0% vs 2.0%, P < 0.001), those with continuous abdominal pain (4.0% vs 1.0%, P < 0.001), more severe symptoms (P = 0.005 for trend), abnormal depression scores (P < 0.001 for trend), higher gastrointestinal symptom-specific anxiety (P < 0.001 for trend), and lower IBS-related quality of life (P < 0.001 for trend). Those willing to accept above median risk of death were more likely to be male (17.1% vs 9.1%, P < 0.001), take higher levels of risks in their daily life (P = 0.008 for trend), and report continuous abdominal pain (53.1% vs 39.4%, P < 0.001), and had higher depression (P = 0.004 for trend) and lower quality of life (P < 0.001 for trend) scores. Conclusion:Patients are willing to accept significant risks in return for cure of their IBS symptoms.

Editorial: risky business. What do sufferers' perceptions of risk from interventions for irritable bowel syndrome really mean?

“…Goodoory and colleagues explore the issue of risk in irritable bowel syndrome (IBS), a common disorder that can significantly impair quality of life 1 . Its non‐fatal nature has engendered an attitude of zero tolerance for serious adverse events among regulators and resulted in the withdrawal of drugs such as alosetron 2 and tegaserod 3 .…”

“…In adopting an approach previously employed elsewhere, such as natalizumab in multiple sclerosis, 5–7 to gauge the willingness of sufferers to tolerate risk in return for cure, Goodoory found that IBS sufferers were prepared to accept a median 2% risk of death from a medication in return for a 98% chance of permanent cure 1 . A prior study found that IBS sufferers were prepared to relinquish 15 years of life to achieve perfect health 8…”

Editorial: risky business. What do sufferers' perceptions of risk from interventions for IBS really mean? Authors' reply

“…We thank Dr Quigley for his interest in our article, 1 and raising important discussion points. 2 Although we agree, and have previously demonstrated, that the Rome IV criteria for irritable bowel syndrome (IBS) select a population of individuals with more severe disease, 3,4 we believe that our study population was a representative sample of individuals with IBS according to these criteria.…”

“…The authors' declarations of personal and financial interests are unchanged from those in the original article 1 …”

Editorial: estimating the costs of care in irritable bowel syndrome—a necessary step to enhance value‐based care for a high‐prevalence, low‐cost condition. Authors' reply

“…3 It also creates the false impression that IBS is not burdensome. However, in another recent article from our group, people with IBS were willing to accept a median 2% risk of death in return for a 98% chance of permanent cure of their condition, 4 demonstrating the substantial impact of symptoms on individuals who experience them.…”