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BACKGROUND: Virtual reality (VR) is an advanced technology that transports users into a virtual world. It has been proven to be effective in pain management via distraction and alteration of pain perception. However, the impact of VR on treating perioperative pain is inconclusive. This systematic review aimed to evaluate the effect of VR on perioperative pain after a gastrointestinal (GI) procedure or surgery. METHODS: A systematic review of randomized controlled trials was conducted from inception to January 31, 2024, following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines. The updated Cochrane risk of bias (RoB 2) assessment tool was used to evaluate the risk of bias. RESULTS: Of 724 articles screened, 8 studies with 678 participants were included in the systematic review. Four studies evaluated the effect of VR on perioperative pain during GI procedure (eg, colonoscopy) focused on its use after GI surgeries (eg, abdominal surgeries). Some studies reported a reduction in pain scores after the procedure; however, the findings of pain difference in before or during vs after the procedure in the VR vs control groups were mixed. CONCLUSION: VR is a promising tool to control perioperative pain after a GI procedure or surgery. Differences in study protocols, pain assessment scales, and pain therapy used were limitations in performing a comprehensive meta-analysis. Further studies are needed to better evaluate the effects of VR on perioperative pain compared with standard of care.
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BACKGROUND: Gastric sensorimotor disorders (functional dyspepsia [FD] and gastroparesis [GP]) are prevalent and burdensome. Prolonged ambulatory recording using a wireless patch may provide novel information in these patients. METHODS: Consecutive adult patients (age ≥ 18 years) referred for gastric emptying scintigraphy (GES) were eligible for study inclusion. Patients were excluded if they had prior foregut surgery; were taking opioids or other medications known to affect gastric emptying; had a HgbA1C > 10; or were recently hospitalized. Three wireless motility patches were applied to the skin prior to GES. Patients wore the patches for 6 days while recording meals, symptoms, and bowel movements using an iPhone app. KEY RESULTS: Twenty-three consecutive adults (87% women; mean age = 43.9 years; mean BMI = 26.7 kg/m2) were enrolled. A gastric histogram revealed three levels of gastric myoelectric activity: weak, moderate, and strong. Patients with delayed gastric emptying at 4 h had weak gastric myoelectrical activity. Patients with nausea and vomiting had strong intestinal activity. Those with FD had weak gastric and intestinal myoelectric activity, and a weak meal response in the stomach, intestine, and colon compared to those with nausea alone or vomiting alone. CONCLUSIONS AND INFERENCES: Patients with FD, and those with delayed gastric emptying, had unique gastrointestinal myoelectrical activity patterns. Reduced postprandial pan-intestinal myoelectric activity may explain the symptoms of FD in some patients. Recording gastrointestinal activity over a prolonged period in the outpatient setting has the potential to identify unique pathophysiologic patterns and meal-related activity that distinguishes patients with distinct gastric sensorimotor disease states.
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Náusea , Vómitos , Humanos , Femenino , Proyectos Piloto , Masculino , Adulto , Persona de Mediana Edad , Náusea/etiología , Vómitos/fisiopatología , Tecnología Inalámbrica , Vaciamiento Gástrico/fisiología , Gastroparesia/fisiopatología , Parche Transdérmico , Enfermedad CrónicaRESUMEN
Increased intestinal permeability has been identified as one of the many pathophysiological factors associated with the development of irritable bowel syndrome (IBS), a common disorder of gut-brain interaction. The layer of epithelial cells that lines the intestine is permeable to a limited degree, and the amount of paracellular permeability is tightly controlled to enable the absorption of ions, nutrients, and water from the lumen. Increased intestinal permeability to macromolecules can be triggered by a variety of insults, including infections, toxins from food poisoning, or allergens, which in turn cause an inflammatory response and are associated with abdominal pain in patients with IBS. This review article discusses increased intestinal permeability in IBS, focusing on IBS with constipation (IBS-C) through the lens of a patient case with a reported prior diagnosis of "leaky gut syndrome" upon initial contact with a gastrointestinal specialist. We review advantages and disadvantages of several methods of measuring intestinal permeability in patients and discuss when measuring intestinal permeability is appropriate in the therapeutic journey of patients with IBS-C. Furthermore, we discuss a possible mechanism of restoring the intestinal barrier to its healthy state through altering intracellular pH by inhibiting sodium-hydrogen exchanger isoform 3 (NHE3). Tenapanor is a minimally absorbed, small-molecule inhibitor of NHE3 that has been approved by the US Food and Drug Administration for the treatment of IBS-C in adults. Preclinical studies showed that tenapanor may restore the intestinal barrier in IBS-C by affecting the conformation of tight junction proteins via NHE3 inhibition to block the paracellular transport of macromolecules from the intestinal lumen. Testing for increased permeability in patients with IBS-C who experience abdominal pain may help inform the choice of therapeutics and alter patients' misconceptions about "leaky gut syndrome".
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Opioid receptors are found throughout the gastrointestinal tract, including the large intestine. Many patients treated with opioids experience opioid-induced constipation (OIC). Laxatives are not effective in most patients, and in those who do initially respond, the efficacy of laxatives generally diminishes over time. In addition, OIC does not spontaneously resolve for most patients. However, complications of opioids extend far beyond simply slowing gastrointestinal transit. Opioid use can affect intestinal permeability through a variety of mechanisms. Toll-like receptors are a crucial component of innate immunity and are tightly regulated within the gut epithelium. Pathologic µ-opioid receptor (MOR) and toll-like receptor signaling, resulting from chronic opioid exposure, disrupts intestinal permeability leading to potentially harmful bacterial translocation, elevated levels of bacterial toxins, immune activation, and increased cytokine production. Peripherally active MOR antagonists, including methylnaltrexone, are effective at treating OIC. Benefits extend beyond simply blocking the MOR; these agents also act to ameliorate opioid-induced disrupted intestinal permeability. In this review, we briefly describe the physiology of the gastrointestinal epithelial border and discuss the impact of opioids on gastrointestinal function. Finally, we consider the use of peripherally active MOR antagonists to treat disrupted intestinal permeability resulting from opioid use and discuss the potential for improved morbidity and mortality in patients treated with methylnaltrexone for opioid-induced bowel disorders.
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INTRODUCTION: Objective assessment of treatment effectiveness using real-world claims data is challenging. This study assessed treatment-free intervals (TFI) as a proxy for treatment effectiveness, and all-cause healthcare costs among adult patients with irritable bowel syndrome with diarrhea (IBS-D) treated with rifaximin or eluxadoline in the USA. METHODS: Adult patients (18-64 years) with IBS-D and ≥ 1 rifaximin or eluxadoline prescription were identified in the IQVIA PharMetrics® Plus database (10/01/2015-12/31/2021) and classified into two mutually exclusive cohorts (i.e., rifaximin and eluxadoline). Index date was the date of rifaximin or eluxadoline initiation. Entropy-balanced baseline characteristics, TFI (periods of ≥ 30 consecutive days without IBS-D treatment), and healthcare costs were reported. Healthcare costs were compared between cohorts using mean cost differences. RESULTS: There were 7094 and 2161 patients in the rifaximin and eluxadoline cohorts, respectively. After balancing, baseline characteristics (mean age 44.1 years; female 72.4%) were similar between cohorts. A higher proportion of patients treated with rifaximin achieved a TFI of ≥ 30 days (76.2% vs. 66.7%), ≥ 60 days (67.0% vs. 47.0%), ≥ 90 days (61.0% vs. 38.7%), ≥ 180 days (51.7% vs. 31.0%), and ≥ 240 days (47.7% vs. 27.9%) compared to eluxadoline. Among patients with a TFI ≥ 30 days, mean TFI durations were 8.3 and 6.0 months for the rifaximin and eluxadoline cohorts. Mean all-cause healthcare costs were lower for rifaximin vs. eluxadoline ($18,316 vs. $23,437; p = 0.008), primarily driven by pharmacy costs ($7348 vs. $10,250; p < 0.001). In a simulated health plan of one million commercially insured lives, initiating 50% of patients on rifaximin instead of eluxadoline resulted in total cost savings of $2.1 million per year or $0.18 per-member-per-month. CONCLUSIONS: This real-world study suggests that TFI is a meaningful surrogate measure of treatment effectiveness in IBS-D. Patients treated with rifaximin had longer treatment-free periods and lower healthcare costs than patients treated with eluxadoline.
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Diarrea , Fármacos Gastrointestinales , Costos de la Atención en Salud , Síndrome del Colon Irritable , Rifaximina , Humanos , Síndrome del Colon Irritable/tratamiento farmacológico , Síndrome del Colon Irritable/economía , Adulto , Femenino , Masculino , Rifaximina/uso terapéutico , Diarrea/tratamiento farmacológico , Diarrea/economía , Persona de Mediana Edad , Fármacos Gastrointestinales/uso terapéutico , Fármacos Gastrointestinales/economía , Adolescente , Adulto Joven , Resultado del Tratamiento , Costos de la Atención en Salud/estadística & datos numéricos , Fenilalanina/uso terapéutico , Fenilalanina/análogos & derivados , Fenilalanina/economía , Estados Unidos , Estudios Retrospectivos , ImidazolesRESUMEN
Background: Constipation is characterized by symptoms of straining, hard stool, difficult evacuation, and infrequent bowel movements. Online surveys provide valuable information about patients' perspectives, symptoms, management, treatment satisfaction, and risk factors. Methods: This survey explored subject experiences involving 20 gastrointestinal (GI) conditions. In total, 20,099 respondents in seven countries with varied cultural and socioeconomic backgrounds participated. Post hoc analysis of 'self-reported constipation' and related symptoms experienced within the past 6 months and the last episode of constipation provided data on prevalence, demographics, frequency and duration of episodes and related symptoms, impact on quality of life (QoL), management with or without laxatives, and resulting treatment satisfaction. Results: In total, 10,425 subjects reported constipation within 6 months and 2637 at the last episode. Prevalence was highest in females and younger adults. Most subjects reported various coexisting GI symptoms. Almost 80% of 6865 episodes reported by 5337 subjects occurred every 2-3 months to every 2-3 weeks. A higher frequency of constipation correlated with a greater impact on QoL. On a 10-point scale, the mean impact was 6.4. More than 90% of respondents had episodes ranging from 1 day to 1 week. More than 90% took action; 16% used laxatives, of whom 80.3% were satisfied. Conclusion: Constipation, a highly prevalent disorder, spans cultures and socioeconomic classes. Its chronic recurrence has a significant impact on QoL, resulting in symptom self-management in >90% of subjects. Significantly higher satisfaction rates in subjects treated with than without laxatives reflect subjects' reports that self-reported constipation can be treated effectively with laxatives.
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Disorders of gut-brain interaction are characterized by chronic gastrointestinal symptoms in the absence of abnormal endoscopic or radiologic findings or objective biomarkers that can be identified during routine clinical evaluation. The assessment of the symptom pattern and severity, therefore, is the key modality to evaluate the presence, impact, and evolution of these conditions, for both clinical and regulatory purposes. Patient-reported outcomes are structured symptom assessment questionnaires designed to evaluate symptom patterns, quantify severity of symptoms, and evaluate response to treatment at follow-up. This review provides an overview of currently available patient-reported outcomes for evaluating the main disorders of gut-brain interaction, specifically, functional dyspepsia; irritable bowel syndrome; and chronic constipation. It summarizes their content, level of validation for clinical practice and for research, and the regulatory approach to these conditions. Expected future developments and need for further research on patient-reported outcomes for these and other disorders of gut-brain interaction are highlighted.
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Dispepsia , Enfermedades Gastrointestinales , Síndrome del Colon Irritable , Humanos , Síndrome del Colon Irritable/diagnóstico , Síndrome del Colon Irritable/terapia , Enfermedades Gastrointestinales/diagnóstico , Enfermedades Gastrointestinales/terapia , Estreñimiento , Encéfalo/diagnóstico por imagen , Medición de Resultados Informados por el PacienteRESUMEN
INTRODUCTION: This post hoc analysis evaluated the efficacy of tenapanor on abdominal symptoms in patients with irritable bowel syndrome with constipation. Abdominal symptoms assessed included pain, discomfort, bloating, cramping, and fullness. METHODS: The abdominal symptom data were pooled from 3 randomized controlled trials (NCT01923428, T3MPO-1 [NCT02621892], and T3MPO-2 [NCT02686138]). Weekly scores were calculated for each abdominal symptom, and the Abdominal Score (AS) was derived as the average of weekly scores for abdominal pain, discomfort, and bloating. The overall change from baseline during the 12 weeks was assessed for each symptom weekly score and the AS. The AS 6/12-week and 9/12-week response rates (AS improvement of ≥2 points for ≥6/12- or ≥9/12-week) were also evaluated. The association of weekly AS response status (reduction of ≥30%) with weekly complete spontaneous bowel movement (CSBM) status (=0 and >0) was assessed. RESULTS: Among 1,372 patients (684 tenapanor [50 mg twice a day] and 688 placebo), the least squares mean change from baseline in AS was -2.66 for tenapanor vs -2.09 for placebo ( P < 0.0001). The 6/12-week AS response rate was 44.4% for tenapanor vs 32.4% for placebo ( P < 0.0001), and for 9/12-week AS, 30.6% for tenapanor vs 20.5% for placebo ( P < 0.0001). A significant association between weekly CSBM status and weekly AS response status was observed each week ( P < 0.0001), with a greater proportion achieving an AS reduction in patients with >0 CSBMs in a week. DISCUSSION: Tenapanor significantly reduced abdominal symptoms in patients with irritable bowel syndrome with constipation, particularly pain, discomfort, and bloating measured by AS, compared with placebo.
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Dolor Abdominal , Estreñimiento , Síndrome del Colon Irritable , Isoquinolinas , Sulfonamidas , Humanos , Síndrome del Colon Irritable/complicaciones , Síndrome del Colon Irritable/tratamiento farmacológico , Estreñimiento/etiología , Estreñimiento/tratamiento farmacológico , Femenino , Masculino , Persona de Mediana Edad , Dolor Abdominal/etiología , Dolor Abdominal/tratamiento farmacológico , Adulto , Sulfonamidas/uso terapéutico , Isoquinolinas/uso terapéutico , Resultado del Tratamiento , Defecación , Método Doble CiegoRESUMEN
PURPOSE OF REVIEW: Irritable bowel syndrome (IBS) is a chronic, often bothersome disorder of gut-brain interaction (DGBI) characterized by abdominal pain associated with a change in stool frequency and/or caliber. Recent advancements have improved our understanding of the underlying pathophysiology, thus opening new avenues for therapeutic intervention. The purpose of this review is to summarize the current literature regarding treatment modalities for IBS. RECENT FINDINGS: Altering the gut microbiome via probiotic and antibiotic administration, avoiding dietary triggers, and modulating the gut-brain axis have all proven efficacious for the management of IBS symptoms. Several gut-specific pharmacotherapies are approved for the treatment of IBS, many of which primarily address either diarrhea or constipation, although many patients remain symptomatic despite appropriate use. Brain-gut behavioral therapies (BGBTs) are increasingly used to treat symptoms of IBS, particularly in those who do not respond to traditional therapies. Virtual reality represents an exciting new approach to treating DGBIs, like IBS, though data are limited. SUMMARY: As our understanding of IBS continues to evolve, so should our therapeutic approach. Individualizing the therapeutic approach is of utmost importance.
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Síndrome del Colon Irritable , Humanos , Estreñimiento , Diarrea/terapia , Diarrea/tratamiento farmacológico , Antibacterianos/uso terapéutico , DietaRESUMEN
PURPOSE OF REVIEW: Gastroparesis (GP) is a syndrome defined by symptoms and delayed gastric emptying in the absence of mechanical obstruction. Typical symptoms include nausea, vomiting, abdominal pain, and early satiety. Only one medication is currently FDA-approved for the treatment of GP. This review highlights recent research findings pertaining to GP and provides evidence to support a change in the current GP diagnostic and treatment paradigm. RECENT FINDINGS: An analysis of GP trials over the past four decades demonstrates the power of placebo and the need to perform longer studies with clearly defined patient populations. Two studies highlight the need to evaluate patients with suspected GP carefully and to perform gastric emptying studies properly. The misdiagnosis of GP symptoms is reviewed, preceded by a discussion of whether GP should be considered a disorder of gut-brain interaction. Finally, new data on therapies that target the pylorus are highlighted. SUMMARY: Gastroparesis is frequently over-diagnosed and incorrectly diagnosed. Performing a proper gastric emptying study which adheres to standard protocol, and accurately interpreting the results in the context of the individual patient, are critical to making an accurate diagnosis of GP. The treatment paradigm needs to shift from simply aiming to accelerate gastric emptying to treating global symptoms of a chronic syndrome that may represent gut-brain dysfunction in many patients.
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Gastroparesia , Humanos , Gastroparesia/diagnóstico , Gastroparesia/terapia , Vómitos , Náusea , Dolor Abdominal/diagnóstico , Dolor Abdominal/etiología , Píloro , Vaciamiento GástricoRESUMEN
LEARNING OBJECTIVES: At the end of the activity, participants will be able to: Implement a staged strategy for the diagnostic evaluation of irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) based on history and physical examination, including the Rome IV criteria. Discuss the evidence and guideline recommendations for self-care as well as over-the-counter (OTC) and prescription therapies to treat IBS-C and CIC, Individualize treatment for IBS-C and CIC emphasizing patient-centered care to address patient concerns, improve outcomes, and enhance quality of life.
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Síndrome del Colon Irritable , Humanos , Síndrome del Colon Irritable/diagnóstico , Síndrome del Colon Irritable/terapia , Calidad de Vida , Estreñimiento/diagnóstico , Estreñimiento/etiología , Estreñimiento/terapiaRESUMEN
Gastroparesis (GP), a historically vexing disorder characterized by symptoms of nausea, vomiting, abdominal pain, early satiety, and/or bloating, in the setting of an objective delay in gastric emptying, is often difficult to treat and carries a tremendous burden on the quality of patients' lives, as well as the healthcare system in general. Though the etiology of GP has been fairly well defined, much work has been done recently to better understand the pathophysiology of GP, as well as to identify novel effective and safe treatment options. As our understanding of GP has evolved, many myths and misconceptions still abound in this rapidly changing field. The goal of this review is to identify myths and misconceptions regarding the etiology, pathophysiology, diagnosis, and treatment of GP, in the context of the latest research findings which have shaped our current understanding of GP. Recognition and dispelling of such myths and misconceptions is critical to moving the field forward and ultimately advancing the clinical management of what will hopefully become a better understood and more manageable disorder in the future.
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PURPOSE: Rifaximin is indicated for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults. The current aim was to evaluate rifaximin efficacy on individual and composite IBS-D symptoms using definitions not previously examined. METHODS: Phase III post hoc analyses of two randomized, double-blind, placebo-controlled trials and the open-label phase of a randomized, double-blind, placebo-controlled trial were conducted. Adults with IBS-D received a 2-week course of rifaximin 550 mg TID. Individual and composite responses for abdominal pain (mean weekly improvements from baseline of ≥30%, ≥40%, or ≥50%), bloating (mean weekly improvements from baseline of ≥1 or ≥2 points; or ≥30%, ≥40%, or ≥50%), stool consistency (mean weekly average stool consistency score <3 or <4), and urgency (improvement from baseline of ≥30% or ≥40% in percentage of days with urgency) for ≥2 of the first 4 weeks after treatment, and weekly for 12 weeks, were assessed. FINDINGS: Overall, 1258 patients from the double-blind trials (rifaximin [nâ¯=â¯624]; placebo [nâ¯=â¯634]) and 2438 from an open-label trial were analyzed. The percentage of bloating or urgency responders was significantly greater with double-blind rifaximin versus placebo (P ≤ 0.03). A significantly greater percentage of the double-blind group were composite abdominal pain and bloating responders versus placebo for all thresholds analyzed (P < 0.05). A significantly greater percentage of the double-blind group were tri-symptom composite end point responders (abdominal pain, bloating, and fecal urgency) versus placebo (P = 0.001). A significantly greater percentage of patients achieved response (≥30% composite tri-symptom threshold) with double-blind rifaximin versus placebo as early as 1 week posttreatment, with significance maintained through ≥5 weeks after treatment. Open-label results were consistent with those of the double-blind study. IMPLICATIONS: Rifaximin significantly improved multiple, concurrent IBS-D symptoms, using clinically relevant definitions of treatment response. Using a novel tri-symptom composite end point (ie, abdominal pain, bloating, fecal urgency), adults with IBS-D treated with a 2-week course of rifaximin were significantly more likely to be composite end point responders than those receiving placebo (≥30% or ≥40% threshold) for the three symptoms. Thus, rifaximin not only met current standard thresholds used for adjudication of responders in clinical trials but also achieved higher thresholds for many of these symptoms, suggesting potential for even more robust clinical improvements. CLINICALTRIALS: gov identifiers: NCT00731679, NCT00724126, and NCT01543178.
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Síndrome del Colon Irritable , Adulto , Humanos , Rifaximina/uso terapéutico , Síndrome del Colon Irritable/complicaciones , Síndrome del Colon Irritable/tratamiento farmacológico , Síndrome del Colon Irritable/diagnóstico , Diarrea/tratamiento farmacológico , Diarrea/etiología , Método Doble Ciego , Dolor Abdominal/tratamiento farmacológico , Dolor Abdominal/etiología , Resultado del TratamientoRESUMEN
Disorders of gut-brain interaction (DGBIs), previously called functional bowel disorders, are prevalent, reduce patients' quality of life, and impose a significant negative economic impact on the health care system. Functional dyspepsia and irritable bowel syndrome (IBS) are 2 of the most common DGBIs. An overlying, and in many cases unifying, symptom for many of these disorders is the presence of abdominal pain. Chronic abdominal pain can be difficult to treat, as many antinociceptive agents are associated with side effects that limit their use and other agents may only partially improve, but not completely relieve, all aspects of the pain. Novel therapies to alleviate chronic pain and the other symptoms that characterize DGBIs are thus needed. Virtual reality (VR), a technology that immerses patients in a multisensory experience, has been shown to relieve pain in burn victims and other instances of somatic pain. Two recent novel studies have demonstrated that VR has the potential to play an important role in the treatment of functional dyspepsia and IBS. This article examines the development of VR, its role in the treatment of somatic and visceral pain, and its potential position in the treatment of DGBIs.
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INTRODUCTION: Functional dyspepsia (FD) is a prevalent, but frequently overlooked and/or under diagnosed disorder of gut-brain interaction (DGBI). Functional dyspepsia frequently co-exists with other DGBIs, and persistent symptoms have a significant impact on patients' quality of life. A variety of therapies (e.g. diet, probiotics, antibiotics, acid suppressants, neuromodulators, prokinetics) are employed to treat the multiple symptoms of FD, although none are uniformly effective. AREAS COVERED: This review covers currently available therapies for the treatment of FD in addition to novel and emerging therapies that may change the treatment paradigm in the near future. PubMed, Embase and the Cochrane data bank were searched from 1990 to October 2022 for relevant articles. EXPERT OPINION: Dietary intervention, eradication of H. pylori, and/or a trial of acid suppression are reasonable initial treatment options for patients with FD. Neuromodulators and fundic accommodation agents are underemployed and should be used more routinely by healthcare providers, especially for patients with moderate-severe symptoms. Alternative therapies, such as cognitive behavioral therapy and hypnotherapy, are gaining recognition as safe and effective treatments for FD and can be used alone or in combination with medications. Virtual reality has the potential to significantly improve global FD symptoms.