Influence of patient-clinician relationship style on acupuncture outcomes in functional dyspepsia: A multi-site randomized controlled trial in Korea.

INTRODUCTION: Research suggests that a warm and empathic "patient-centered" patient-clinician relationship produces better clinical outcomes when compared with a more neutral "disease-centered" relationship. Acupuncturists performed both styles of therapy for patients with functional dyspepsia in Korea. METHODS: The present randomized controlled trial assigned patients (n = 73) to identical acupuncture treatment with either patient-centered augmented care or disease-centered limited care. The Korean version of the Nepean Dyspepsia Index (NDI-K) was the primary outcome measure. Secondary outcome measures included Consultation And Relational Empathy (CARE) scale. RESULTS: Both groups showed improvement in NDI-K. Patient-centered augmented acupuncture produced less effective symptom improvement compared to disease-centered limited acupuncture (NDI-K sum score and frequency; P = 0.008 and P = 0.037 respectively). CARE scores were higher for the augmented versus limited group (P = 0.001), supporting the fidelity of the experimentally controlled patient/clinician relationship. There were no significant differences between the groups in any of other secondary outcomes. CONCLUSION: Patients demonstrated greater improvement following acupuncture conducted with a more neutral, "disease-centered" style of relationship. This result is counter to similar research conducted in Western countries and suggests that cultural factors can significantly shape optimum styles of acupuncture therapy. PRACTICE IMPLICATIONS: Clinicians should consider cultural differences when applying acupuncture therapy.

The Intersection of Disorders of Gut-Brain Interaction With Avoidant/Restrictive Food Intake Disorder.

High rates of overlap exist between disorders of gut-brain interaction (DGBI) and eating disorders, for which common interventions conceptually conflict. There is particularly increasing recognition of eating disorders not centered on shape/weight concerns, specifically avoidant/restrictive food intake disorder (ARFID) in gastroenterology treatment settings. The significant comorbidity between DGBI and ARFID highlights its importance, with 13% to 40% of DGBI patients meeting full criteria for or having clinically significant symptoms of ARFID. Notably, exclusion diets may put some patients at risk for developing ARFID and continued food avoidance may perpetuate preexisting ARFID symptoms. In this review, we introduce the provider and researcher to ARFID and describe the possible risk and maintenance pathways between ARFID and DGBI. As DGBI treatment recommendations may put some patients at risk for developing ARFID, we offer recommendations for practical treatment management including evidence-based diet treatments, treatment risk counseling, and routine diet monitoring. When implemented thoughtfully, DGBI and ARFID treatments can be complementary rather than conflicting.

Positive psychological well-being and clinical characteristics in IBS: A systematic review.

OBJECTIVE: Psychological factors (e.g., depression, anxiety) are known to contribute to the development and maintenance of irritable bowel syndrome (IBS). Less is known, however, about the role of positive psychological well-being (PPWB) in IBS. Accordingly, we completed a systematic review of the literature examining relationships between PPWB and clinical characteristics in IBS. METHOD: A systematic review using search terms related to PPWB and IBS from inception through July 28, 2022, was completed. Quality was assessed with the NIH Quality Assessment Tool. A narrative synthesis of findings, rather than meta-analysis, was completed due to study heterogeneity. RESULTS: 22 articles with a total of 4285 participants with IBS met inclusion criteria. Individuals with IBS had lower levels of PPWB (e.g., resilience, positive affect, self-efficacy, emotion regulation) compared to healthy populations, which in turn was associated with reduced physical and mental health and health-related quality of life (HRQoL). Limited exploration of potential biological mechanisms underlying these relationships has been described. CONCLUSIONS: PPWB is diminished in individuals with IBS compared to other populations, and greater PPWB is linked to superior physical, psychological, and HRQoL outcomes. Interventions to increase PPWB may have the potential to improve IBS-related outcomes. REGISTRATION: Prospective Register of Systematic Reviews CRD42022304767.

Positive psychological well-being: A novel concept for improving symptoms, quality of life, and health behaviors in irritable bowel syndrome.

BACKGROUND: Though a growing body of research suggests that greater positive psychological well-being in irritable bowel syndrome (IBS) may be protective, existing brain-gut behavior therapies primarily target negative psychological factors. Little is known about how positive psychological factors in IBS relate to IBS symptoms, health-related quality of life (HRQoL), or adherence to key health behaviors, such as physical activity and diet modification. Accordingly, per the ORBIT model of behavioral treatment development for chronic diseases, we explored potential connections between psychological constructs and IBS symptoms, health behavior engagement (physical activity and dietary modification), and HRQoL in a qualitative study to inform the development of a novel brain-gut behavior therapy. METHODS: Participants with IBS completed self-report assessments and semi-structured phone interviews about relationships between positive and negative psychological constructs, IBS symptoms, health behavior engagement, and HRQoL. KEY RESULTS: Participants (n = 23; 57% female) ranged in age from 25 to 79 (mean age = 54). IBS subtypes were similarly represented (IBS-diarrhea [n = 8], IBS-constipation [n = 7], and IBS-mixed [n = 8]). Participants described opposing relationships between positive and negative psychological constructs, IBS symptoms, health behavior engagement, and HRQoL, respectively, such that experiencing positive constructs largely mitigated IBS symptoms, boosted health behavior participation, and improved HRQoL, and negative constructs exacerbated symptoms, reduced health behavior participation, and worsened HRQoL. CONCLUSIONS AND INFERENCES: Participants with IBS linked greater positive psychological well-being to moderated IBS symptoms and better HRQoL and health behavior participation. An intervention to cultivate greater well-being may be a novel way to mitigate IBS symptoms, boost health behavior participation, and improve HRQoL in IBS.

Psychiatric comorbidities among adult patients with disorders of gut-brain interaction: Prevalence and relationships to treatment outcomes.

BACKGROUND: Little is known about the impact of psychiatric comorbidity on pharmacologic treatment outcomes, including neuromodulators (medications targeting the gut-brain axis), among adult patients with disorders of gut-brain interaction (DGBI). Accordingly, we aimed to examine associations between psychiatric comorbidity and DGBI pharmacologic treatment outcomes. METHODS: In a retrospective study of consecutively referred new patients (N = 410; ages 18-90; 73% female) to a tertiary neurogastroenterology clinic in 2016 with follow-up through 2018, relationships between psychiatric illness (any psychiatric illness, anxiety disorders, depressive disorders) and pharmacologic treatment selection (any medication, neuromodulating medication) and treatment outcomes, respectively, were examined using multivariable logistic regression, adjusting for demographics, gastrointestinal (GI) diagnoses, and pre-existing neuromodulator use. KEY RESULTS: Anxiety disorders (35%) were the most common psychiatric comorbidity, followed by depressive disorders (29%). Patients with anxiety disorders were more likely to be prescribed a neuromodulator by their gastroenterologist (OR = 1.72 [95% CI 1.10-2.75]) yet less likely to respond to neuromodulators (OR = 0.43 [0.21-0.90]) or any GI medication (OR = 0.24 [0.12-0.50]) in fully adjusted analyses. In contrast, depressive disorders were not associated with neuromodulator prescription or response. CONCLUSIONS AND INFERENCES: Anxiety disorders are common among patients with DGBI and significantly reduce the likelihood of GI pharmacologic treatment response to any medication prescribed, including neuromodulators.

Virtual Tai Chi program for patients with irritable bowel syndrome with constipation: Proof-of-concept feasibility trial.

BACKGROUND: Satisfaction with current treatment options for irritable bowel syndrome with constipation (IBS-C) is low, with many patients turning to complementary treatments. Tai Chi is a mind-body medicine practice with proven efficacy in other functional disorders. As a proof-of-concept, we tested the feasibility and preliminary clinical outcomes associated with a Tai Chi program designed for IBS-C. METHODS: A total of 27 IBS-C patients participated in a single-arm trial of 8 sessions of Tai Chi delivered weekly over 7 weeks via live videoconferencing in group format. Clinical improvement was assessed via change in IBS Symptom Severity Score (IBS-SSS) from baseline to 4 weeks posttreatment (week 11) with secondary outcomes exploring symptom ratings, IBS-related quality of life (IBS-QOL), GI-specific anxiety, abdominal distention, and psychological factors. KEY RESULTS: Despite substantial dropout (n = 7; 26%), the treatment protocol had moderate to excellent feasibility for other criteria. Treatment satisfaction was excellent. Exit interviews confirmed high satisfaction with the program among completers, but a high burden of data collection was noted. One participant experienced an adverse event (mild, exacerbation of sciatica). There was a significant improvement in intra-individual IBS-SSS between baseline and posttreatment (average change -66.5, 95% CI -118.6 to -14.3, p = 0.01). Secondary outcomes were notable for improvements in other IBS symptom scoring measures, IBS-QOL, measured abdominal diameter, and leg strength. CONCLUSIONS AND INFERENCES: Our data provide preliminary evidence of the feasibility of a Tai Chi intervention for IBS-C, show promise for improving outcomes, and identify more streamlined data collection as an area for further program improvement.

Effectiveness of gastric electrical stimulation in gastroparesis: Results from a large prospectively collected database of national gastroparesis registries.

BACKGROUND: Gastric electrical stimulation (GES) for treating gastroparesis symptoms is controversial. METHODS: We studied 319 idiopathic or diabetic gastroparesis symptom patients from the Gastroparesis Clinical Research Consortium (GpCRC) observational studies: 238 without GES and 81 with GES. We assessed the effects of GES using change in GCSI total score and nausea/vomiting subscales between baseline and 48 weeks. We used propensity score methods to control for imbalances in patient characteristics between comparison groups. KEY RESULTS: GES patients were clinically worse (40% severe vs. 18% for non-GES; P < .001); worse PAGI-QOL (2.2. vs. 2.6; P = .003); and worse GCSI total scores (3.5 vs. 2.8; P < .001). We observed improvements in 48-week GCSI total scores for GES vs. non-GES: improvement by ≥ 1-point (RR = 1.63; 95% CI = (1.14, 2.33); P = .01) and change from enrollment (difference = -0.5 (-0.8, -0.3); P < .001). When adjusting for patient characteristics, symptom scores were smaller and not statistically significant: improvement by ≥ 1-point (RR = 1.29 (0.88, 1.90); P = .20) and change from the enrollment (difference = -0.3 (-0.6, 0.0); P = .07). Of the individual items, the nausea improved by ≥ 1 point (RR = 1.31 (1.03, 1.67); P = .04). Patients with GCSI score ≥ 3.0 tended to improve more than those with score < 3.0. (Adjusted P = 0.02). CONCLUSIONS AND INFERENCES: This multicenter study of gastroparesis patients found significant improvements in gastroparesis symptoms among GES patients. Accounting for imbalances in patient characteristics, only nausea remained significant. Patients with greater symptoms at baseline improved more after GES. A much larger sample of patients is needed to fully evaluate symptomatic responses and to identify patients likely to respond to GES.

Increased Long-term Dietary Fiber Intake Is Associated With a Decreased Risk of Fecal Incontinence in Older Women.

BACKGROUND & AIMS: Fiber supplements are frequently used as treatment for fecal incontinence (FI), but little is known about the role of dietary fiber in the prevention of FI. METHODS: We performed a prospective study to examine the association between long-term dietary fiber intake and risk of FI in 58,330 older women (mean age, 73 years) in the Nurses' Health Study who were free of FI in 2008. Energy-adjusted long-term dietary fiber intake was determined using food frequency questionnaires starting in 1984 and updated through 2006. We defined incident FI as at least 1 liquid or solid FI episode per month during the past year during 4 years of follow-up using self-administered biennial questionnaires. We used Cox proportional hazards models to calculate multivariable-adjusted hazard ratios and 95% CIs for FI according to fiber intake, adjusting for potential confounding factors. RESULTS: During 193,655 person-years of follow-up, we documented 7,056 incident cases of FI. Compared with women in the lowest quintile of fiber intake (13.5 g/day), women in the highest quintile (25 g/day) had an 18% decrease in risk of FI (multivariable hazard ratio, 0.82; 95% CI, 0.76-0.89). This decrease appeared to be greatest for risk of liquid stool FI, which was 31% lower in women with the highest intake of fiber compared with women with the lowest intake (multivariable hazard ratio, 0.69; 95% CI, 0.62-0.75). Risk of FI was not significantly associated with fiber source. CONCLUSIONS: In an analysis of data from almost 60,000 older women in the Nurses' Health Study, we found higher long-term intake of dietary fiber was associated with decreased risk of FI. Further studies are needed to determine the mechanisms that mediate this association.

Influence of the patient-practitioner interaction context on acupuncture outcomes in functional dyspepsia: study protocol for a multicenter randomized controlled trial.

BACKGROUND: In the treatment of functional dyspepsia, the placebo effect has been reported to be high, and the influence of the patient-practitioner relationship may be a major component of this effect. The specific and non-specific effects of acupuncture cannot be easily distinguished, and the patient-practitioner relationship may influence the total therapeutic effect in clinical practice. There have been no studies that investigate the influence of patient-practitioner relationship on acupuncture treatment for patients with functional dyspepsia. METHODS: Patients with postprandial distress syndrome, a functional dyspepsia subtype, will be recruited at three hospitals (two in Korea and one in USA) for an international, multi-center, randomized, patient/assessor-blinded, clinical trial. The total anticipated sample size is 88. The participants will be randomly allocated into two groups: an augmented interaction group and a limited interaction group. Acupuncture, with total 12 acupoints, will be performed twice weekly for 4 weeks in both groups. Trained practitioners will provide an "augmented" or "limited" interaction context, as determined by random allocation. The primary outcome measure is the proportion of responders, the proportion of participants who answer "yes" to more than half of the adequate relief questions during the study. Secondary outcome measures include questionnaires for quality of life and symptoms of dyspepsia, and maximum tolerable volume of nutrient drink test. Data will be collected at baseline and following 4 weeks of acupuncture. DISCUSSION: This study will evaluate the influence of the patient-practitioner interaction on clinical effects of acupuncture in patients with functional dyspepsia. TRIAL REGISTRATION: CRIS Identifier: ( KCT0002229 ).

Individualized Acupuncture for Symptom Relief in Functional Dyspepsia: A Randomized Controlled Trial.

OBJECTIVES: This study was implemented to evaluate the effect of individualized acupuncture treatment (AT) on functional dyspepsia (FD). METHODS: A randomized, waitlist-controlled, two-center trial was performed. Seventy-six patients with FD were enrolled in the trial with partially individualized AT in a more realistic clinical setting performed twice a week for 15 minutes a session over 4 weeks. The participants were randomly allocated to a group receiving 8 sessions of AT for 4 weeks or a waitlist control group. After 4 consecutive weeks, the AT group was followed up without AT and the control group received the identical AT. The proportion of responders with adequate symptom relief, Nepean Dyspepsia Index (NDI), FD-related quality of life, Beck Depression Inventory, State-Trait Anxiety Inventory, Acupuncture Belief Scale, and acupuncture credibility test were assessed. RESULTS: After the first 4 weeks, the proportion of responders significantly improved (59% in AT group [n = 37] versus 3% in control group [n = 39]; p < 0.001). The difference was no longer significant at 8 weeks, at which point the waitlist control group showed similar improvement after receiving AT (68% in the AT group versus 79% in the control group). Total NDI scores were significantly reduced in the AT group compared with the waitlist group (p = 0.03). Among NDI items, discomfort (p = 0.01), burning (p = 0.02), fullness after eating (p = 0.02), and burping (p = 0.02) were significantly improved in the AT group compared with the control group. No significant differences were observed between groups in other secondary variables. CONCLUSION: Individualized AT adequately relieves symptoms in patients with FD, and this effect may persist up to 8 weeks.

Genomic and clinical effects associated with a relaxation response mind-body intervention in patients with irritable bowel syndrome and inflammatory bowel disease.

INTRODUCTION: Irritable Bowel Syndrome (IBS) and Inflammatory Bowel Disease (IBD) can profoundly affect quality of life and are influenced by stress and resiliency. The impact of mind-body interventions (MBIs) on IBS and IBD patients has not previously been examined. METHODS: Nineteen IBS and 29 IBD patients were enrolled in a 9-week relaxation response based mind-body group intervention (RR-MBI), focusing on elicitation of the RR and cognitive skill building. Symptom questionnaires and inflammatory markers were assessed pre- and post-intervention, and at short-term follow-up. Peripheral blood transcriptome analysis was performed to identify genomic correlates of the RR-MBI. RESULTS: Pain Catastrophizing Scale scores improved significantly post-intervention for IBD and at short-term follow-up for IBS and IBD. Trait Anxiety scores, IBS Quality of Life, IBS Symptom Severity Index, and IBD Questionnaire scores improved significantly post-intervention and at short-term follow-up for IBS and IBD, respectively. RR-MBI altered expression of more genes in IBD (1059 genes) than in IBS (119 genes). In IBD, reduced expression of RR-MBI response genes was most significantly linked to inflammatory response, cell growth, proliferation, and oxidative stress-related pathways. In IBS, cell cycle regulation and DNA damage related gene sets were significantly upregulated after RR-MBI. Interactive network analysis of RR-affected pathways identified TNF, AKT and NF-κB as top focus molecules in IBS, while in IBD kinases (e.g. MAPK, P38 MAPK), inflammation (e.g. VEGF-C, NF-κB) and cell cycle and proliferation (e.g. UBC, APP) related genes emerged as top focus molecules. CONCLUSIONS: In this uncontrolled pilot study, participation in an RR-MBI was associated with improvements in disease-specific measures, trait anxiety, and pain catastrophizing in IBS and IBD patients. Moreover, observed gene expression changes suggest that NF-κB is a target focus molecule in both IBS and IBD-and that its regulation may contribute to counteracting the harmful effects of stress in both diseases. Larger, controlled studies are needed to confirm this preliminary finding. TRIAL REGISTRATION: ClinicalTrials.Gov NCT02136745.

Balloon expulsion test as a screen for outlet obstruction in children with chronic constipation.

OBJECTIVE: Chronic constipation (CC) is a common problem in pediatrics and is often the result of obstructed defecation. The aim of the present study was to study the feasibility and efficacy of the balloon expulsion test (BET) in the diagnosis and management of children with CC. METHODS: Retrospective study comparing BET and high-resolution anorectal manometry (ARM). The BET was done together with ARM in 29 children, ages 8 to 19 years, with CC. For BET, a 60-mL balloon was used. Passage of balloon in 1 minute or less was considered normal. RESULTS: Fifteen of the 29 children had a normal BET. Of these, 14 also had an ARM, all of which were normal (except for 2 cases with a hypertonic baseline anal sphincter). Thus 12 of 14 with BET and ARM were normal on both (correlation between the tests 86%). Of the 14 children that failed BET, 10 had distal abnormalities by ARM, contrast studies, EMG, or assessment by a pelvic physical therapist. All of the patients with a nonrelaxing sphincter or outlet obstruction were treated with laxatives, anal sphincter Botox, and/or pelvic physical therapy and biofeedback. In follow-up of at least 3 months, all of the patients with a failed BET were improved. CONCLUSIONS: We found a high correlation between a normal ARM and BET. If the BET is abnormal and the ARM does not identify a cause for the distal obstruction, additional studies may be needed, including contrast enema, defecography, or electromyography. BET appears to be a safe, reliable, and useful test in the evaluation and management of CC in children.

Bioluminescence imaging of heme oxygenase-1 upregulation in the Gua Sha procedure.

Gua Sha is a traditional Chinese folk therapy that employs skin scraping to cause subcutaneous microvascular blood extravasation and bruises. The protocol for bioluminescent optical imaging of HO-1-luciferase transgenic mice reported in this manuscript provides a rapid in vivo assay of the upregulation of the heme oxygenase-1 (HO-1) gene expression in response to the Gua Sha procedure. HO-1 has long been known to provide cytoprotection against oxidative stress. The upregulation of HO-1, assessed by the bioluminescence output, is thought to represent an antioxidative response to circulating hemoglobin products released by Gua Sha. Gua Sha was administered by repeated strokes of a smooth spoon edge over lubricated skin on the back or other targeted body part of the transgenic mouse until petechiae (splinter hemorrhages) or ecchymosis (bruises) indicative of extravasation of blood from subcutaneous capillaries was observed. After Gua Sha, bioluminescence imaging sessions were carried out daily for several days to follow the dynamics of HO-1 expression in multiple internal organs.

Neuromodulatory processes of the brain-gut axis.

Brain-gut axis represents a complex reflex circuit that integrates the communication between cortex and the digestive system. Disturbances of the neuromodulatory processes in the brain-gut axis generate functional digestive disorders mainly centered on the pain symptoms and motility disorders. This article reviews structural and patho-physiological aspects of the brain-gut axis and explains how the neuromodulatory interventions currently used in order to treat GI conditions related to the brain-gut axis disturbances. The neuromodulation can be realized by pharmacological targeting mainly receptors in the periphery or using electrical stimulation applied at different levels of the nervous system or directly in the muscular layers of the bowels resulting in modulation of the digestive system activity. The efficacy of the methods using electrostimulation is dependent on the parameters of the physical system used: amplitude, frequency, burst time of the electrical current and also the positioning of the electrodes. While pharmacological interventions are largely used at the moment, neuromodulatory interventions involving electrical stimulation showed clinical efficacy in research trials and have promise.