Dataset Information

Are They Side Effects? Extraintestinal Symptoms Reported During Clinical Trials of Irritable Bowel Syndrome May Be More Severe at Baseline.

ABSTRACT:

Background & aims

Many of the reported adverse events in clinical trials of irritable bowel syndrome are extraintestinal symptoms, which typically are assessed by open-ended questions during the trial and not at baseline. This may lead to misattribution of some pre-existing symptoms as side effects to the treatment.

Methods

The current study analyzed data from a 6-week clinical trial of irritable bowel syndrome. Participants were randomized to receive double-blind peppermint oil, double-blind placebo, or treatment as usual. Extraintestinal symptoms were assessed at baseline and at the end of the study.

Results

This analysis included 173 participants (30 received double-blind peppermint oil, 72 received treatment as usual, and 71 received double-blind placebo). At baseline, each group reported approximately 5 extraintestinal symptoms per participant. The number of symptoms per participant decreased to an average of 3 by the end-of-study visit, and this change was statistically significant in all groups (P < .001 for each group). When evaluating individual extraintestinal symptoms, the majority of participants did not report new/worse symptoms. In fact, between the baseline assessment and the final assessment, the average symptom severity decreased significantly in all 3 groups (P < .001).

Conclusions

Our study suggests that participants with irritable bowel syndrome often experience extraintestinal symptoms at baseline and that these symptoms generally improve in severity over the course of a clinical trial, regardless of the treatment arm. Systematic assessment of extraintestinal symptoms at the beginning of a clinical trial is necessary to determine more definitively whether these symptoms may be considered an adverse event attributable to a study medication.

SUBMITTER: Ballou S

PROVIDER: S-EPMC9500110 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Are They Side Effects? Extraintestinal Symptoms Reported During Clinical Trials of Irritable Bowel Syndrome May Be More Severe at Baseline.

Ballou Sarah S Hassan Rafla R Nee Judy J Iturrino Johanna J Rangan Vikram V Cheng Vivian V Conboy Lisa L Kirsch Irving I Lembo Anthony A Kaptchuk Ted J TJ Kelley John J

Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association 20220323 12

<h4>Background & aims</h4>Many of the reported adverse events in clinical trials of irritable bowel syndrome are extraintestinal symptoms, which typically are assessed by open-ended questions during the trial and not at baseline. This may lead to misattribution of some pre-existing symptoms as side effects to the treatment.<h4>Methods</h4>The current study analyzed data from a 6-week clinical trial of irritable bowel syndrome. Participants were randomized to receive double-blind peppermint oil, ...[more]

PMID: 35339669

Similar Datasets

Project description:BackgroundIrritable bowel syndrome (IBS) is characterized by abdominal pain and altered bowel habits. Further, IBS patients experience a high degree of extraintestinal symptoms.ObjectivesThe aim of this review was to describe the relation between IBS and extraintestinal manifestations and mechanisms and treatments of these extraintestinal manifestations.DesignThe study was performed as a systematic review.Data sources and methodsSearch terms including extraintestinal manifestations or somatization and IBS were used to scrutinize for publications in Pubmed. In total, 630 publications were identified and 80 were finally included in this review.ResultsAbout 50% of all IBS patients have extraintestinal manifestations in addition to gastrointestinal symptoms. Somatic pain, fatigue, and sleeping disturbances are most common, and most often described in women. Both extraintestinal manifestations and psychological distress are associated with exaggerated gastrointestinal symptoms, impaired quality of life, and difficulties to treat IBS symptoms. The extraintestinal manifestations render an excess of healthcare costs. Varying etiology and pathophysiology to IBS are discussed, and many patients express a general hypersensitivity. Extraintestinal symptoms are seldom documented at clinical healthcare or included in the assessment of treatment outcomes. A good patient-physician relationship and strengthening of coping mechanisms have rendered less gastrointestinal symptoms, psychological distress, and somatization. Altered lifestyle habits may improve both gastrointestinal and extraintestinal symptoms. Pharmacological treatment, including antidepressant drugs, should be considered when lifestyle advice fails. Teamwork between different specialists and healthcare providers may be of importance in the wide range of symptoms and extraintestinal manifestations.ConclusionExtraintestinal manifestations are common in IBS patients and is associated with worse suffering and difficulties to treat symptoms. Evaluation and treatment of IBS patients should consider also extraintestinal manifestations and their treatment outcome. Establishment of good relationship, strengthening of coping mechanisms, and education in healthier lifestyle habits are crucial in the management of these patients.

Project description:BackgroundThe intestinal microbiota is thought to be involved in the occurrence of inflammatory bowel disease in remission with irritable bowel syndrome (IBS)-type symptoms, but the specific distinct profile of these bacteria remains unclear. This cross-sectional study aims to investigate the fecal microbiota profiling in patients with these diseases.MethodsFecal samples from 97 subjects, including Crohn's disease patients in remission with IBS-type symptoms (CDR-IBS+) or without IBS-type symptoms (CDR-IBS-), ulcerative colitis patients in remission with IBS-type symptoms (UCR-IBS+) or without IBS-type symptoms (UCR-IBS-), IBS patients and healthy controls, were collected and applied 16S ribosomal DNA (rDNA) gene sequencing. The V4 hypervariable regions of 16S rDNA gene were amplified and sequenced by the Illumina MiSeq platform. The differences in the sample diversity index in groups were analyzed with R software.ResultsThe richness of the intestinal microbiota in the CDR-IBS group was markedly lower than those in the control and IBS groups based on the analysis of observed species and the Chao index (P < 0.05). The observed species index in the CDR-IBS+ group was higher than that in the CDR-IBS- group (median index: 254.8 vs 203, P = 0.036). No difference was found in alpha diversity between UCR patients with IBS-type symptoms and those without related symptoms. At the genus level, the number of Faecalibacterium in CDR patients with IBS-type symptoms increased significantly, while Fusobacterium decreased versus those without such symptoms (mean relative abundance of Faecalibacterium: 20.35% vs 5.18%, P < 0.05; Fusobacterium: 1.51% vs 5.2%, P < 0.05). However, compared with the UCR-IBS- group, the number of Faecalibacterium in the UCR-IBS+ group decreased, while the number of Streptococcus increased, but there was no significant difference in the genus structure. The abundance and composition of the microbiota of IBS patients were not distinct from those of healthy controls.ConclusionsThe IBS-type symptoms in CD patients in remission may be related to an increase in Faecalibacterium and a decrease in Fusobacterium. The IBS-type symptoms in UC patients in remission cannot be explained by changes in the abundance and structure of the intestinal microbiota.

Dataset Information

Are They Side Effects? Extraintestinal Symptoms Reported During Clinical Trials of Irritable Bowel Syndrome May Be More Severe at Baseline.

Background & aims

Methods

Results

Conclusions

Publications

Are They Side Effects? Extraintestinal Symptoms Reported During Clinical Trials of Irritable Bowel Syndrome May Be More Severe at Baseline.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets