Effect of Brain-Gut Behavioral Treatments on Abdominal Pain in Irritable Bowel Syndrome: Systematic Review and Network Meta-analysis.

BACKGROUND & AIMS: Some brain-gut behavioral treatments (BGBTs) are beneficial for global symptoms in irritable bowel syndrome (IBS). United States management guidelines suggest their use in patients with persistent abdominal pain, but their specific effect on this symptom has not been assessed systematically. METHODS: We searched the literature through December 16, 2023, for randomized controlled trials (RCTs) assessing efficacy of BGBTs for adults with IBS, compared with each other or a control intervention. Trials provided an assessment of abdominal pain resolution or improvement at treatment completion. We extracted data as intention-to-treat analyses, assuming dropouts to be treatment failures and reporting pooled relative risks (RRs) of abdominal pain not improving with 95% confidence intervals (CIs), ranking therapies according to the P score. RESULTS: We identified 42 eligible randomized controlled trials comprising 5220 participants. After treatment completion, the BGBTs with the largest numbers of trials and patients recruited demonstrating efficacy for abdominal pain, specifically, included self-guided/minimal contact cognitive behavioral therapy (CBT) (RR, 0.71; 95% CI, 0.54-0.95; P score, 0.58), face-to-face multicomponent behavioral therapy (RR, 0.72; 95% CI, 0.54-0.97; P score, 0.56), and face-to-face gut-directed hypnotherapy (RR, 0.77; 95% CI, 0.61-0.96; P score, 0.49). Among trials recruiting only patients with refractory global IBS symptoms, group CBT was more efficacious than routine care for abdominal pain, but no other significant differences were detected. No trials were low risk of bias across all domains, and there was evidence of funnel plot asymmetry. CONCLUSIONS: Several BGBTs, including self-guided/minimal contact CBT, face-to-face multicomponent behavioral therapy, and face-to-face gut-directed hypnotherapy may be efficacious for abdominal pain in IBS, although none was superior to another.

Factors That Predict Magnitude, Timing, and Persistence of Placebo-Like Response in Patients With Irritable Bowel Syndrome.

BACKGROUND AND AIMS: Placebo response impedes the development of novel irritable bowel syndrome (IBS) therapies and the interpretability of randomized clinical trials. This study sought to characterize the magnitude, timing, and durability of IBS symptom relief in patients undergoing a non-drug placebo-like control. METHODS: One hundred forty-five Rome III-diagnosed patients (80% F, M age = 42 years) were assigned to education/nondirective support delivered over a 10-week acute phase. Treatment response was based on the IBS version of the Clinical Global Improvement Scale completed 2 weeks after treatment ended. Candidate predictors were assessed at baseline (eg, emotion regulation, pain catastrophizing, distress, neuroticism, stress, somatization, gastrointestinal-specific anxiety) or clinically relevant points during treatment (patient-provider relationship, treatment expectancy/credibility). RESULTS: Midtreatment response was associated with lower levels of stress and somatization at baseline and greater patient-provider agreement on treatment tasks (P < .001). Treatment response was associated with baseline gastroenterologist-rated IBS severity, anxiety, ability to reappraise emotions to reduce their impact [cognitive reappraisal], and agreement that provider and patient shared goals from provider perspective (P < .001). The day-to-day ability to reappraise emotions at baseline distinguished rapid from delayed placebo responders (P = .011). CONCLUSION: Patient beliefs (eg, perceived stress, cognitive reappraisal) impacted the magnitude, timing, and persistence of placebo response measured at midway point of acute phase and 2 weeks after treatment discontinuation. Baseline beliefs that patients could alter the impact of stressful events by rethinking their unpleasantness distinguished rapid vs delayed placebo responders. Collaborative agreement between doctor and patient around shared tasks/goals from the clinician perspective predicted placebo response.

Somatization Mediates the Relationship Between Childhood Trauma and Pain Ratings in Patients with Irritable Bowel Syndrome.

GOALS: To identify potential mechanisms by which childhood trauma may lead to the adult development of abdominal symptoms in patients with irritable bowel syndrome (IBS). BACKGROUND: Patients with IBS frequently report a history of childhood trauma. The pathophysiology by which abdominal pain arises in patients with IBS is multidimensional, consisting of both peripheral factors, such as altered motility, inflammation, and bacterial overgrowth, as well as central factors, such as psychological distress and neuro-hormonal dysregulation. STUDY: Adult psychological factors (anxiety, depression, and somatization) were examined to determine if they mediate the relationship between retrospective reports of childhood trauma and current adult IBS abdominal symptoms in a study of 436 patients (M age=41.6, 79% F) meeting Rome III diagnosis criteria. Childhood trauma was measured using retrospective questions assessing physical and sexual abuse. Psychological factors in adulthood were measured with the subscales of the Brief Symptom Inventory-18. Outcome variables included adult IBS symptoms of abdominal pain, bloating, and satisfaction with bowel habits from the IBS Symptoms Severity Scale. RESULTS: Results indicated that somatization mediated the relationship between childhood abuse and abdominal pain and bloating but not bowel satisfaction. CONCLUSIONS: This study provides insight into the multifactorial nature of IBS-associated abdominal pain in patients with a history of childhood trauma, elucidating the need for a trauma-informed treatment approach for patients with histories of abuse.

Implementation of a longitudinal, near-peer ECG didactic curriculum in an internal medicine residency program and impact on ECG interpretation skills.

BACKGROUND: To determine the impact of a longitudinal, near-peer, dedicated ECG didactic curriculum on internal medicine resident ability to accurately interpret ECGs. METHODS: This study employs a prospective cohort design. Internal medicine residents at University at Buffalo participated in monthly ECG didactic sessions over a 7-month period. Residents were invited to complete pre- and post-curriculum questionnaires. Responses were anonymous and participation voluntary. Data collected included basic demographics, career interest, exposure to clinical cardiology, and number of sessions attended. Residents were asked to interpret sixteen unique ECGs, divided evenly among eight common rhythms into both questionnaires. Pre- and post-curriculum cohorts were compared using t-tests and chi-square analyses. Associations between attendance, comfort level in interpretation, and number of correct interpretations were analyzed using Pearson correlations. Multivariate linear regression determined the strongest predictor of the number of correct ECG interpretations. RESULTS: The post-curriculum cohort correctly interpreted a significantly greater percentage of ECGs compared to pre-curriculum cohort (74.5% vs. 60.9%, p < .001). Didactic attendance was significantly associated with comfort level in interpreting ECGs (r = .328, p = .018) and trended towards an increased number of correct interpretations (r = .248, p = .077). Residents who attended three or more sessions demonstrated increased ECG interpretation skills compared to those who attended two or fewer sessions (80.0% vs. 71.1%, p = .048). Number of clinical cardiology rotations attended was significantly associated with correct interpretations (r = .310, p < .001) and was the strongest predictor of accurately interpreting ECGs (ß = 0.29, p = .037). CONCLUSIONS: Participation in a longitudinal, near-peer ECG didactic curriculum improved resident ability to interpret ECGs. A curriculum which contains both didactic sessions and clinical exposure may offer the greatest benefit in improving ECG interpretation skills.

Pain Catastrophizing and Clinical Outcomes Among Patients Receiving a Novel Cognitive-Behavioral Therapy for Irritable Bowel Syndrome: An Experimental Therapeutics Approach.

Irritable bowel syndrome (IBS) is the most common gastrointestinal (GI) condition treated by GI and primary care physicians. Although IBS symptoms (abdominal pain, bowel problems) are generally refractory to medical therapies, consistent research has shown that they improve following cognitive-behavioral therapy (CBT). Notwithstanding empirical support for CBT, there is less research explicating the reasons for why or how it works. Like other pain disorders, the focus on change mechanisms for behavioral pain treatments has focused on pain-specific cognitive-affective processes that modulate pain experience, few of which are more important than pain catastrophizing (PC). The fact that PC changes are seen across treatments of differing theoretical and technical orientation, including CBT, yoga, and physical therapy, suggests that it may be a nonspecific (vs. theory-based) change mechanism akin to therapeutic alliance and treatment expectancy. Therefore, the current study examined change in PC as a concurrent mediator of IBS symptoms severity, global GI symptom improvement, and quality of life among 436 Rome III-diagnosed IBS patients enrolled in a clinical trial undergoing two dosages of CBT versus a nonspecific comparator emphasizing education and support. Results from structural equation modeling parallel process mediation analyses suggest that reduction in PC during treatment are significantly associated with improvement in IBS clinical outcomes through 3-month follow-up. Results from the current study provide evidence that PC may be an important, albeit nonspecific change mechanism, during CBT for IBS. Overall, reducing the emotional unpleasantness of pain through cognitive processes is associated with improved outcomes for IBS.

Study protocol and methods for Easing Pelvic Pain Interventions Clinical Research Program (EPPIC): a randomized clinical trial of brief, low-intensity, transdiagnostic cognitive behavioral therapy vs education/support for urologic chronic pelvic pain syndrome (UCPPS).

BACKGROUND: Urologic chronic pelvic pain syndrome (UCPPS) encompasses several common, costly, diagnoses including interstitial cystitis/bladder pain syndrome and chronic prostatitis/chronic pelvic pain syndrome that are poorly understood and inadequately treated with conventional medical therapies. Behavioral strategies, recommended as a first-line treatment for managing symptoms, are largely inaccessible, time and labor intensive, and technically complex. The Easing Pelvic Pain Interventions Clinical Research Program (EPPIC) is a clinical trial examining the efficacy of low-intensity cognitive behavioral therapy (Minimal Contact CBT or MC-CBT) for UCPPS and its durability 3 and 6 months post treatment. Additional aims include characterizing the operative processes (e.g., cognitive distancing, context sensitivity, coping flexibility, repetitive negative thought) that drive MC-CBT-induced symptom relief and pre-treatment patient variables that moderate differential response. METHODS: UCPPS patients (240) ages 18-70 years, any gender, ethnicity, and race, will be randomized to 4-session MC-CBT or a credible, non-specific education comparator (EDU) that controls for the generic effects from simply going to treatment. Efficacy assessments will be administered at pre-treatment, 2 weeks, and 3 and 6 months post treatment-week acute phase. A novel statistical approach applied to micro-analytic mediator assessment schedule will permit the specification of the most effective CBT component(s) that drive symptom relief. DISCUSSION: Empirical validation of a low-intensity self-management therapy transdiagnostic in scope has the potential to improve the health of chronic pelvic pain patients refractory to medical therapies, reduce social and economic costs, conserve health care resources, as well as inform evidence-based practice guidelines. Identification of change mechanisms and moderators of treatment effects can provide proactive patient-treatment matching fundamental to goals of personalized medicine. TRIAL REGISTRATION: Clinicaltrials.gov NCT05127616. Registered on 9/19/21.

Cognitive flexibility improves in cognitive behavioral therapy for irritable bowel syndrome but not nonspecific education/support.

This study tested the novel hypothesis that CBT-treated IBS patients who learn to self-manage painful GI symptoms by targeting rigid cognitive style show improvement in cognitive flexibility, GI symptoms (e.g., abdominal pain), and quality of life. Participants included 130 Rome-III diagnosed IBS patients (M age = 40.3, F = 83%) with moderate-to-severe symptoms randomly assigned to either cognitive behavioral therapy (CBT; N = 86) or a nonspecific education/support (EDU) comparator (N = 44). Participants completed an assessment battery at baseline and post-treatment 2 weeks after 10-week acute treatment phase. Measures included cognitive flexibility, psychological flexibility, emotion regulation strategies, IBS symptom severity, quality of life (QOL), and distress. CBT but not EDU patients showed significant GI sympton improvement from baseline to post-treatment in cognitive flexibility. For CBT patients, changes in cognitive flexibility were significantly associated with changes in IBS symptom severity, abdominal pain, and IBS QOL. Neither condition showed significant changes in psychological flexibility (Acceptance and Action Questionnaire-II) or use of emotion regulation strategies (Emotion Regulation Questionnaire). The ability to self-manage painful IBS symptoms refractory to conventional medical and dietary treatments is related to the ability to respond flexibly across shifting contexts using cognitive change procedures featured in CBT for IBS.

Do I really have to do my homework? The role of homework compliance in cognitive behavioral therapy for irritable bowel syndrome.

Treatment guidelines identify cognitive behavioral therapy (CBT) as a treatment of choice for irritable bowel syndrome (IBS). As a learning-based treatment, homework assignments are regarded as important for optimizing outcomes for CBT-treated patients. However, their actual benefit for IBS is unknown. This study examined whether homework completion corresponds with immediate and sustained treatment response in IBS patients enrolled in CBT treatment. Subjects were 358 IBS patients receiving clinic-based CBT (10 session), home-based CBT (4 session), or a 4 session, non-specific IBS education comparator as part of a large NIH trial. Homework completion was rated by clinician at each session. IBS symptom improvement was measured with the Clinician Global Improvement Scale at treatment week 5, post-treatment (week 12), and at follow-ups (weeks 22, 34, 46, 62). Homework completion rates over the 10-week acute phase corresponded with greater IBS symptom improvement and patient satisfaction at post-treatment. Early treatment homework completion did not predict early treatment response. Contrary to expectations, homework compliance rates were not greater among in-clinic session patients than home-based patients. Data lend empirical support to the clinical value of homework in teaching patients how to self-manage painful GI symptoms refractory to conventional medical and dietary therapies.

Cognitive behavioral therapy for irritable bowel syndrome induces bidirectional alterations in the brain-gut-microbiome axis associated with gastrointestinal symptom improvement.

BACKGROUND: There is growing recognition that bidirectional signaling between the digestive tract and the brain contributes to irritable bowel syndrome (IBS). We recently showed in a large randomized controlled trial that cognitive behavioral therapy (CBT) reduces IBS symptom severity. This study investigated whether baseline brain and gut microbiome parameters predict CBT response and whether response is associated with changes in the brain-gut-microbiome (BGM) axis. METHODS: Eighty-four Rome III-diagnosed IBS patients receiving CBT were drawn from the Irritable Bowel Syndrome Outcome Study (IBSOS; ClinicalTrials.gov NCT00738920) for multimodal brain imaging and psychological assessments at baseline and after study completion. Fecal samples were collected at baseline and post-treatment from 34 CBT recipients for 16S rRNA gene sequencing, untargeted metabolomics, and measurement of short-chain fatty acids. Clinical measures, brain functional connectivity and microstructure, and microbiome features associated with CBT response were identified by multivariate linear and negative binomial models. RESULTS: At baseline, CBT responders had increased fecal serotonin levels, and increased Clostridiales and decreased Bacteroides compared to non-responders. A random forests classifier containing 11 microbial genera predicted CBT response with high accuracy (AUROC 0.96). Following treatment, CBT responders demonstrated reduced functional connectivity in regions of the sensorimotor, brainstem, salience, and default mode networks and changes in white matter in the basal ganglia and other structures. Brain changes correlated with microbiome shifts including Bacteroides expansion in responders. CONCLUSIONS: Pre-treatment intestinal microbiota and serotonin levels were associated with CBT response, suggesting that peripheral signals from the microbiota can modulate central processes affected by CBT that generate abdominal symptoms in IBS. CBT response is characterized by co-correlated shifts in brain networks and gut microbiome that may reflect top-down effects of the brain on the microbiome during CBT. Video abstract.

Screening for atrial fibrillation in high-risk nursing home residents.

BACKGROUND: Various methods have been implemented for screening of patients for atrial fibrillation (AF), but the yield has generally been low. Targeting high-risk patients may improve detection of asymptomatic AF, which could be of value if appropriate treatment could be initiated before a potential thromboembolic event. OBJECTIVE: The purpose of this study was to test screening of high-risk nursing home residents having ≥2 risk factors for AF and no previous history of AF using a smartphone-based electrocardiographic (ECG) monitoring device to determine whether it is an accurate, easy-to-use method of screening for asymptomatic AF. METHODS: Study participants had ≥2 risk factors, consisting of age ≥75 years, female sex, obstructive sleep apnea, peripheral vascular disease, diabetes mellitus, obesity, hypertension, and congestive heart failure. Using the monitoring device, 30-second heart rhythm recordings were obtained on 4 different occasions. All tracings were reviewed by a cardiologist and, if uncertain, by an electrophysiologist. The nursing facility was notified of any diagnosis of AF, prompting further evaluation by the primary physician. RESULTS: Of the 245 residents screened, 18 (7.4%) had a diagnostic tracing for AF, 15 (83.3%) of whom had AF on the initial screen. There were no significant differences in demographics or individual risk factors between residents with and those without AF. CONCLUSION: Intermittent ECG screening of high-risk nursing home residents using a simple, handheld device provided a diagnostic yield in our population comparable to that observed in past studies. Such screening of high-risk individuals can aid in the early diagnosis of AF and initiation of appropriate treatment.

Higher Emotional Awareness Is Associated With Reduced Pain in Irritable Bowel Syndrome Patients: Preliminary Results.

OBJECTIVE: Recent evidence indicates that interventions designed to improve emotional awareness reduce pain in irritable bowel syndrome. This preliminary study sought to determine whether trait emotional awareness is associated with typical pain in patients with irritable bowel syndrome. METHODS: Healthy volunteers (n = 66) and irritable bowel syndrome patients (n = 50) were asked to self-report their typical levels of pain intensity and complete both the Levels of Emotional Awareness Scale and the Somatization Scale of the Brief Symptom Inventory. RESULTS: Levels of Emotional Awareness Scale scores in irritable bowel syndrome patients did not differ from scores in healthy participants; however, higher Levels of Emotional Awareness Scale scores in irritable bowel syndrome patients predicted lower levels of typical pain intensity (r(45) = -.36, p = .01, 95% CI [-.59, -.08]) and lower levels of somatization (r(45)= -.31, p = .03, 95% CI [-.55, -.02]). CONCLUSIONS: This inverse relationship between emotional awareness and both pain and somatization symptoms is consistent with evidence that irritable bowel syndrome patients experience reduced pain from therapies designed to improve emotional awareness. The Levels of Emotional Awareness Scale could potentially be used to identify patients who could benefit from such therapy and could potentially be a moderator of response to efficacious psychological therapies.

Optimisation of diagnosis and treatment of heart failure in a primary care setting.

BACKGROUND: Heart failure (HF) is one of the leading causes of emergency department visits and hospital admissions in the USA. We identified a gap in the diagnosis and the use of guideline-directed medical therapy in patients with HF at the internal medicine clinic. AIM: To improve the diagnosis and treatment of HF, as well as to reduce emergency department visits and hospitalisation over 12 months in patients aged 40-75 years. METHODS: The multidisciplinary quality improvement (QI) team performed a root cause analysis and identified barriers to optimal guideline-directed medical therapy. Rates of patients on guideline-directed medical therapy with systolic HF diagnosis, emergency department visits and hospital admissions were the outcome measures. The process measures included echocardiogram order and completion rates, and rates of accurate classification of HF from the baseline rate of less than 10%. We used the focus, analyse, develop, execute and evaluate (FADE) model with five improvement cycles. The major components of interventions included (1) leveraging health information technology; (2) optimising teamwork; and (3) providing education to patients, physicians and internal medicine clinic staff. Data were analysed using statistical process control and run charts. RESULTS: We observed a reduction in the total number of emergency department visits (160 vs 108), hospital admissions (117 vs 114) and observation visits (22 vs 16) comparing the 1-year preproject and 1-year postproject periods. An increase in the use of ACE inhibitors or angiotensin receptor blockers occurred from the baseline rate of 20%-37% during the second half of the project and was sustained at 71.4% (median) during 6 months of the postproject period. CONCLUSIONS: We achieved a sustainable increase in the accurate diagnosis of HF and achieved 80% diagnosis during the 6-month poststudy period.

Bacterial regulation of macrophage bacterial recognition receptors in COPD are differentially modified by budesonide and fluticasone propionate.

RATIONALE: Patients with COPD have an increased risk for community-acquired pneumonia, which is further increased by inhaled corticosteroids. OBJECTIVE: To assess effects of the corticosteroids, budesonide and fluticasone propionate, on macrophage bacterial responses in COPD. METHODS: Monocyte-derived macrophages (MDMs) generated from blood monocytes from 10 non-smoker controls (NoS), 20 smokers without COPD (Sm), and 40 subjects with moderate to severe COPD (21 ex-smokers (COPD-ES) and 19 current smokers (COPD-S)) were pre-treated with budesonide or fluticasone (10 nM-1 µM) and challenged with live non-typeable Haemophilus influenzae (NTHI) or Streptococcus pneumoniae (SP). Cell surface bacterial recognition receptor expression (flow cytometry) and cytokine release (bead array) were analyzed. RESULTS: NTHI and SP reduced bacterial recognition receptor expression on MDMs from COPD and Sm, but not NoS (except TLR4). SR-AI and MARCO were reduced by both NTHI and SP, whereas other receptors by either NTHI or SP. Among COPD subjects, COPD-ES demonstrated a greater number of reductions as compared to COPD-S. NTHI reduced SR-AI, MARCO, CD11b, CD35 and CD206 in COPD-ES while only SR-AI and CD11b in COPD-S. SP reduced SRA-1, CD1d, TLR2 and TLR4 in both COPD-ES and COPD-S, and reduced MARCO and CD93 only in COPD-ES. All receptors reduced in COPD by NTHI and most by SP, were also reduced in Sm. Budesonide counteracted the receptor reductions induced by both NTHI (CD206 p = 0.03, MARCO p = 0.08) and SP (SR-AI p = 0.02) in COPD-ES. Fluticasone counteracted only SP-induced reductions in TLR2 (p = 0.008 COPD-ES and p = 0.04 COPD-S) and TLR4 (p = 0.02 COPD-ES). Cytokine release was equivalently reduced by both corticosteroids. CONCLUSIONS: Reduction in macrophage bacterial recognition receptors during bacterial exposure could provide a mechanism for the increased pneumonia risk in COPD. Differential effects of budesonide and fluticasone propionate on macrophage bacterial recognition receptor expression may contribute to the higher pneumonia incidence reported with fluticasone propionate.

Effect of Bicarbonate-Buffered Dialysate on Ventricular Arrhythmias in Hemodialysis Patients.

BACKGROUND: The etiology of sudden cardiac death in patients with end-stage renal disease (ESRD) on hemodialysis (HD) is largely unknown, though there is evidence to suggest that metabolic alkalosis induced by HD with a high-bicarbonate dialysate/prescription may play a role. METHODS: We investigated the effects of metabolic alkalosis induced by HD with an acetate-containing bicarbonate-buffered dialysate on frequency of ventricular arrhythmia in 47 patients with ESRD on chronic HD using 48-h Holter monitoring in 3 phases: intra-HD, post-HD day 1, and post-HD day 2. Serum levels of bicarbonate, calcium, and potassium along with hemodynamics were measured pre-HD, post-HD, 20-h post-HD, and 44-h post-HD. Correlations were performed to verify the association between bicarbonate prescription and change in serum bicarbonate levels post-HD and to determine if the HD-induced change in serum bicarbonate level (metabolic alkalosis) had any direct association with ambient ventricular arrhythmia (premature ventricular contractions per hour) or indirect associations with ambient ventricular arrhythmia by affecting electrolytes or hemodynamics that are known to increase the risk of ventricular arrhythmia. RESULTS: Mean pre-HD serum bicarbonate level was 21.3 mEq/L. Dialysate bicarbonate prescription (mean of 36.4 mEq/L) correlated with changes in serum bicarbonate levels immediately post-HD 26.7 mEq/L (r = 0.46, p < 0.01), 20-h post-HD 25.2 mEq/L (r = 0.38), and 44-h post-HD 23.2 mEq/L (r = 0.35, p = 0.01). No statistically significant correlations were found between the post-HD change in serum bicarbonate levels (metabolic alkalosis) with ambient ventricular arrhythmia, changes in serum calcium, potassium, or hemodynamics in any phase. CONCLUSIONS: High-bicarbonate dialysate prescription is associated with metabolic alkalosis following the HD procedure. A mild metabolic alkalosis induced by HD with an acetate-containing bicarbonate-buffered dialysate solution had no direct association with ambient ventricular arrhythmia on Holter monitoring and was not associated with changes in hemodynamics or changes in serum total calcium or potassium levels. This study helps to provide guidance for the safe use of high bicarbonate dialysate/prescription in patients with ESRD on HD.

Durability and Decay of Treatment Benefit of Cognitive Behavioral Therapy for Irritable Bowel Syndrome: 12-Month Follow-Up.

BACKGROUND: There is a need for safe and effective IBS treatments that provide immediate and sustained improvement of IBS symptoms, particularly among more severe patients. The aim was to assess long-term clinical response of cognitive behavioral therapy (CBT) with reference to IBS education. METHODS: A total of 436 Rome III-diagnosed IBS patients (80% F, M age = 41 years) were randomized to: 4 session home-based CBT (minimal contact (MC-CBT)), 10 session clinic-based CBT (standard (S-CBT)), or 4 session IBS education (EDU). Follow-up occurred at 2 weeks and 3, 6, 9, and 12 months following treatment completion. Treatment response was based a priori on the Clinical Global Improvement Scale (global IBS symptom improvement) and IBS Symptom Severity Scale (IBS-SSS). RESULTS: Post-treatment CGI gains were generally maintained by MC-CBT patients at quarterly intervals through 12-month follow-up with negligible decay. For MC-CBT and S-CBT, 39 and 33% of respondents maintained treatment response at every follow-up assessment. The corresponding percent for EDU was 19%, which was significantly lower (p < 0.05) than for the CBT groups. On the IBS-SSS, therapeutic gains also showed a pattern of maintenance with trends towards increased efficacy over time in all conditions, with the mean unit reductions between baseline and follows-up being approximately -76 at immediate and approximately -94 at 12 months (-50 = clinically significant). CONCLUSIONS: For treatment-refractory IBS patients, home- and clinic-based CBT resulted in substantial and enduring relief of multiple IBS symptoms that generally extended to 12-month post treatment.

Improvement in Gastrointestinal Symptoms After Cognitive Behavior Therapy for Refractory Irritable Bowel Syndrome.

BACKGROUND & AIMS: There is an urgent need for safe treatments for irritable bowel syndrome (IBS) that relieve treatment-refractory symptoms and their societal and economic burden. Cognitive behavior therapy (CBT) is an effective treatment that has not been broadly adopted into routine clinical practice. We performed a randomized controlled trial to assess clinical responses to home-based CBT compared with clinic-based CBT and patient education. METHODS: We performed a prospective study of 436 patients with IBS, based on Rome III criteria, at 2 tertiary centers from August 23, 2010, through October 21, 2016. Subjects (41.4 ± 14.8 years old; 80% women) were randomly assigned to groups that received the following: standard-CBT (S-CBT, n = 146, comprising 10 weekly, 60-minute sessions that emphasized the provision of information about brain-gut interactions; self-monitoring of symptoms, their triggers, and consequences; muscle relaxation; worry control; flexible problem solving; and relapse prevention training), or 4 sessions of primarily home-based CBT requiring minimal therapist contact (MC-CBT, n = 145), in which patients received home-study materials covering the same procedures as S-CBT), or 4 sessions of IBS education (EDU, n = 145) that provided support and information about IBS and the role of lifestyle factors such as stress, diet, and exercise. The primary outcome was global improvement of IBS symptoms, based on the IBS-version of the Clinical Global Impressions-Improvement Scale. Ratings were performed by patients and board-certified gastroenterologists blinded to treatment allocation. Efficacy data were collected 2 weeks, 3 months, and 6 months after treatment completion. RESULTS: A higher proportion of patients receiving MC-CBT reported moderate to substantial improvement in gastrointestinal symptoms 2 weeks after treatment (61.0% based on ratings by patients and 55.7% based on ratings by gastroenterologists) than those receiving EDU (43.5% based on ratings patients and 40.4% based on ratings by gastroenterologists) (P < .05). Gastrointestinal symptom improvement, rated by gastroenterologists, 6 months after the end of treatment also differed significantly between the MC-CBT (58.4%) and EDU groups (44.8%) (P = .05). Formal equivalence testing applied across multiple contrasts indicated that MC-CBT is at least as effective as S-CBT in improving IBS symptoms. Patients tended to be more satisfied with CBT vs EDU (P < .05) based on immediate posttreatment responses to the Client Satisfaction Questionnaire. Symptom improvement was not significantly related to concomitant use of medications. CONCLUSIONS: In a randomized controlled trial, we found that a primarily home-based version of CBT produced significant and sustained gastrointestinal symptom improvement for patients with IBS compared with education. Clinicaltrials.gov no.: NCT00738920.

Validation of a smartphone-based event recorder for arrhythmia detection.

INTRODUCTION: Ambulatory cardiac monitoring devices such as external loop recorders (ELRs) are often used in the outpatient clinic to evaluate palpitations. However, ELRs can be bulky and uncomfortable to use, especially in public, at work, or in social situations. An alternative approach is a smartphone-based electrocardiographic (ECG) recorder/event recorder (Kardia Mobile [KM]), but the comparative diagnostic yield of each approach has not been studied. METHODS: Thirty-three patients with palpitations wore an ELR and carried a KM for a period of 14-30 days. They were instructed to transmit ECGs via KM and also to activate the ELR whenever they had symptoms. The tracings obtained from both devices were independently analyzed by two cardiologists, and the overall arrhythmia yield, as well as patient preference and compliance, were evaluated. The paired binomial data obtained from both devices were compared using an unconditional test of noninferiority. RESULTS: Of the 38 patients enrolled in the study, more patients had a potential diagnosis for their symptoms (i.e., at least one symptomatic recording during the entire monitoring period) with KM than with the ELR (KM = 34 [89.5%] vs ELR = 26 [68.4%]; χ2  = 5.1, P = 0.024). In the per protocol analysis, all 33 patients (100%) had a potential diagnosis using the KM device, which was significantly higher compared to 24 patients (72.2%) using the ELR (χ2  = 10.4, P = 0.001). CONCLUSIONS: KM is noninferior to an ELR for detecting arrhythmias in the outpatient setting. The ease of use and portability of this device make it an attractive option for the detection of symptomatic arrhythmias.

Beyond Abdominal Pain: Pain Beliefs, Pain Affect, and Distress as Determinants of Quality of Life in Patients With Chronic Pancreatitis.

GOALS: To assess the relationship between pain, psychological processes, and quality of life (QOL) in chronic pancreatitis (CP). BACKGROUND: CP is a progressive inflammatory disorder of the pancreas characteristically resulting in abdominal pain and impairing QOL. Pain due to CP is poorly understood and frequently difficult to treat. This pain has historically been understood as a peripheral process originating from the pancreas itself, but a growing body of literature is revealing an important role offered by central influences. Viewed through the perspective of the biopsychosocial model of illness, cognitive variables strongly influence QOL. However, there is little understanding of variables that influence QOL in CP. STUDY: Patients with CP from the University of Alabama at Birmingham were administered a 165-question test battery which was comprised of questionnaires evaluating pain beliefs, disease-specific QOL, psychological distress, pain sensation, pain affect, and long-term suffering. RESULTS: Sixty-eight subjects completed the question battery between February 28, 2011 and January 16, 2014. Almost all (91.2%) reported taking pain medication. QOL was significantly associated with reported levels of pain intensity (r=-0.52, P<0.01) as well as perceived self-blame. CONCLUSIONS: The significant predictors of QOL impairment in CP are pain intensity and perceived self-blame for pain. Further research is needed to elucidate this relationship while also evaluating the effectiveness of systematic modification of these variables in an attempt to improve pain and QOL in CP.

Predictors of medical and mental health care use in patients with irritable bowel syndrome in the United States.

Because health care demand among IBS patients imposes a heavy economic burden, identifying high utilizers has potential for improving quality and efficiency of care. Previous research has not identified reliable predictors of utilization of IBS patients. We sought to identify factors predictive of health care utilization among severe IBS patients. 291 IBS patients completed testing whose content mapped onto the Andersen model of health care utilization. 2-stage hurdle models were used to determine predictors of health care use (probability and frequency). Separate analyses were conducted for mental health and medical services. Whether patients used any medical care was predicted by diet and insurance status. Tobacco use, education, and health insurance predicted the probability of using mental health care. The frequency of medical care was associated with alcohol use and physical health status, while frequency of mental health services was associated with marital status, tobacco use, education, distress, stress, and control beliefs over IBS symptoms. For IBS patients, the demand for health care involves a complex decision-making process influenced by many factors. Particularly strong determinants include predisposing characteristics (e.g., dietary pattern, tobacco use) and enabling factors (e.g., insurance coverage) that impede or facilitate demand. Which factors impact use depends on whether the focus is on the decision to use care or how much care is used. Decisions to use medical and mental health care are not simply influenced by symptom-specific factors but by a variety of lifestyle (e.g., dietary pattern, education, smoking) and economic (e.g., insurance coverage) factors.

High-risk carotid plaques identified by CT-angiogram can predict acute myocardial infarction.

Prior studies identified the incremental value of non-invasive imaging by CT-angiogram (CTA) to detect high-risk coronary atherosclerotic plaques. Due to their superficial locations, larger calibers and motion-free imaging, the carotid arteries provide the best anatomic access for the non-invasive characterization of atherosclerotic plaques. We aim to assess the ability of predicting obstructive coronary artery disease (CAD) or acute myocardial infarction (MI) based on high-risk carotid plaque features identified by CTA. We retrospectively examined carotid CTAs of 492 patients that presented with acute stroke to characterize the atherosclerotic plaques of the carotid arteries and examined development of acute MI and obstructive CAD within 12-months. Carotid lesions were defined in terms of calcifications (large or speckled), presence of low-attenuation plaques, positive remodeling, and presence of napkin ring sign. Adjusted relative risks were calculated for each plaque features. Patients with speckled (<3 mm) calcifications and/or larger calcifications on CTA had a higher risk of developing an MI and/or obstructive CAD within 1 year compared to patients without (adjusted RR of 7.51, 95%CI 1.26-73.42, P = 0.001). Patients with low-attenuation plaques on CTA had a higher risk of developing an MI and/or obstructive CAD within 1 year than patients without (adjusted RR of 2.73, 95%CI 1.19-8.50, P = 0.021). Presence of carotid calcifications and low-attenuation plaques also portended higher sensitivity (100 and 79.17%, respectively) for the development of acute MI. Presence of carotid calcifications and low-attenuation plaques can predict the risk of developing acute MI and/or obstructive CAD within 12-months. Given their high sensitivity, their absence can reliably exclude 12-month events.