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Does Timing of Colon Procedures Affect Outcomes in D-IBS Trials?

ABSTRACT: BACKGROUND:Sigmoidoscopy/colonoscopy is usually performed prior to enrollment into clinical trials of irritable bowel syndrome (IBS). Two main reasons are to rule out alternative diagnoses and to ensure that colitis is not present. However, the possible impact of a recent versus remote colon procedure on symptoms in IBS trials has not been evaluated. The aim of this study was to evaluate the effect of timing of colon procedures on symptoms in IBS trials. METHODS:Post hoc analyses were conducted using placebo patients with diarrhea-predominant IBS in a phase 2 trial. Pain, frequency, consistency, and urgency were analyzed using repeated measures models during the first 7 days of treatment and over the entire 12-week treatment period. RESULTS:Fifty-two placebo patients were grouped by whether they had a colon exam performed between screening and randomization (Group 1) or had a normal colon procedure during the 3 years prior to screening for this trial (Group 2). Average screening symptom scores were comparable between the two groups. Evaluation of various symptoms showed that there were no consistent significant differences between the two groups in pain, frequency, consistency, or urgency. CONCLUSIONS:After the required 3-day post-procedure recovery period, there was no evidence that colonoscopy timing affected subsequent IBS symptoms.

SUBMITTER: Wang J

PROVIDER: S-EPMC5139714 | biostudies-literature | 2010 Oct

REPOSITORIES: biostudies-literature

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Does Timing of Colon Procedures Affect Outcomes in D-IBS Trials?

Wang Jianmin J Sherrill Beth B Hamm Lynne A LA Mangel Allen W AW

Gastroenterology research 20100920 5

<h4>Background</h4>Sigmoidoscopy/colonoscopy is usually performed prior to enrollment into clinical trials of irritable bowel syndrome (IBS). Two main reasons are to rule out alternative diagnoses and to ensure that colitis is not present. However, the possible impact of a recent versus remote colon procedure on symptoms in IBS trials has not been evaluated. The aim of this study was to evaluate the effect of timing of colon procedures on symptoms in IBS trials.<h4>Methods</h4>Post hoc analyses ...[more]

PMID: 27956995

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Project description:Very little research has assessed how measures of negative and positive affect (NA and PA) derived from assessments at multiple time points per day (e.g., via ecological momentary assessment [EMA]), as opposed to questionnaires that rely on recall over a longer period, are related to levels of peripheral inflammation. We examined how different indicators of NA and PA predicted concentrations of C-reactive protein (CRP) and seven peripheral inflammatory cytokines (IL-1?, IL-6, TNF-?, IL-8, IL-4, IL-10, and IFN-?) that were examined in the form of an inflammatory composite. A community-based sample of 220 adults (62% Black/African-American and 25% Hispanic/Latino; aged 25-65; 65% female) completed questionnaires at baseline (including recalled affect "over the past month") and then provided EMA reports 5x/day for 14?days. Blood was drawn from each participant after completion of EMA and used to determine plasma levels of CRP and cytokines. Analyses examined if indicators of affect predicted inflammation, controlling for age, gender, body mass index, education, health conditions, and statin use. Neither recalled NA or PA nor momentary NA or PA (aggregated across the 14?days of EMA) were significantly associated with the cytokine composite or CRP. Negative mood more proximal to the blood draw (i.e., aggregated momentary NA in week 2 of EMA) was associated with the cytokine composite but not CRP. Exploratory moderation analyses revealed that the cytokine composite was also associated with PA in week 2 for men only, and with recalled NA for those with lower education. Exploratory analyses around temporal dynamics suggested that the timing of NA measurement relative to the blood draw mattered: Specifically, there were stronger trends of association between momentary NA and inflammatory cytokines when NA was assessed closer in time to blood collection. Future investigation of the relevance of temporal proximity and other measurement details may improve understanding of how affect relates to inflammation.

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Does Timing of Colon Procedures Affect Outcomes in D-IBS Trials?

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Does Timing of Colon Procedures Affect Outcomes in D-IBS Trials?

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