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1.
Artigo em Inglês | MEDLINE | ID: mdl-38418424

RESUMO

BACKGROUND AND AIM: Rectal hyposensitivity (RH) is common in constipation and often coexists with functional defecatory disorder (FDD). Rectal sensory thresholds are routinely evaluated with the anorectal manometry probe; however, the gold standard for the assessment of rectal sensitivity is with a barostat, use of which is limited by time constraints and availability. A novel rapid barostat bag (RBB) may facilitate measurements of rectal sensitivity. The aim is to evaluate the relationship between RH (measured by the RBB) and FDD (defined as any minor disorder of rectoanal coordination by the London classification) in constipated patients. METHODS: Consecutive constipated patients referred for anorectal function testing underwent anorectal manometry with the 3D-HDAM probe as well as rectal sensation testing with the RBB pump. RH was defined by volume to first sensation >30%, urge to defecate >80%, or discomfort >100% (normalized to rectal capacity). RESULTS: Fifty-three percent of constipated patients had RH. Patients with FDD had a significantly increased volume to first sensation (134.5 mL vs 102.0, P = 0.02), urge to defecate (187.0 mL vs 149.0, P = 0.04), and rectal capacity (253.5 mL vs 209.0, P = 0.04) compared to constipated patients without FDD. There was no difference in normalized sensory thresholds (percent of rectal capacity) nor the prevalence of hyposensitivity to each sensory threshold nor overall hyposensitivity. CONCLUSION: Patients with FDD, when measured with the RBB, have increased sensory thresholds on volumetric distension, but RH was not observed when sensory threshold volume were normalized to rectal capacity. This may reflect "secondary" RH due to altered rectal biomechanics.

2.
J Pediatr ; 267: 113922, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38242317

RESUMO

OBJECTIVE: To develop and validate a set of static and animated gastroduodenal symptom pictograms for children. STUDY DESIGN: There were 3 study phases: 1: cocreation using experience design methods to develop pediatric gastroduodenal symptom pictograms (static and animated); 2: an online survey to assess acceptability, as well as face and content validity; and 3: a preference study. Phases 2 and 3 compared the novel pediatric pictograms with existing pictograms used with adult patients. RESULTS: Eight children aged 6-15 years (5 female) participated in phase 1, and 69 children in phase 2 (median age 13 years: IQR 9-15); an additional 49 participants were included in phase 3 (median age 15: IQR 12-17). Face and content validity were higher for the pediatric static and animated pictogram sets compared with pre-existing adult pictograms (78% vs 78% vs 61%). Participants with worse gastric symptoms had superior comprehension of the pediatric pictograms (χ2 [8, N = 118] P < .001). All participants preferred the pediatric static pictogram set was over both the animated and adult sets (χ2 [2, N = 118] P < .001). CONCLUSIONS: The cocreation phase resulted in the symptom concept confirmation and design of 10 acceptable static and animated gastroduodenal pictograms with high face and content validity when evaluated with children aged 6-18. Validity was superior when children reported more problematic symptoms. Therefore, these pictograms could be used in clinical and research practice to enable standardized symptom reporting for children with gastroduodenal disorders.


Assuntos
Compreensão , Adulto , Humanos , Feminino , Criança , Adolescente , Inquéritos e Questionários
3.
Am J Gastroenterol ; 119(2): 331-341, 2024 Feb 01.
Artigo em Inglês | MEDLINE | ID: mdl-37782524

RESUMO

INTRODUCTION: Gastric emptying testing (GET) assesses gastric motility, however, is nonspecific and insensitive for neuromuscular disorders. Gastric Alimetry (GA) is a new medical device combining noninvasive gastric electrophysiological mapping and validated symptom profiling. This study assessed patient-specific phenotyping using GA compared with GET. METHODS: Patients with chronic gastroduodenal symptoms underwent simultaneous GET and GA, comprising a 30-minute baseline, 99m TC-labelled egg meal, and 4-hour postprandial recording. Results were referenced to normative ranges. Symptoms were profiled in the validated GA App and phenotyped using rule-based criteria based on their relationships to the meal and gastric activity: (i) sensorimotor, (ii) continuous, and (iii) other. RESULTS: Seventy-five patients were assessed, 77% female. Motility abnormality detection rates were as follows: GET 22.7% (14 delayed, 3 rapid), GA spectral analysis 33.3% (14 low rhythm stability/low amplitude, 5 high amplitude, and 6 abnormal frequency), and combined yield 42.7%. In patients with normal spectral analysis, GA symptom phenotypes included sensorimotor 17% (where symptoms strongly paired with gastric amplitude, median r = 0.61), continuous 30%, and other 53%. GA phenotypes showed superior correlations with Gastroparesis Cardinal Symptom Index, Patient Assessment of Upper Gastrointestinal Symptom Severity Index, and anxiety scales, whereas Rome IV Criteria did not correlate with psychometric scores ( P > 0.05). Delayed emptying was not predictive of specific GA phenotypes. DISCUSSION: GA improves patient phenotyping in chronic gastroduodenal disorders in the presence and absence of motility abnormalities with increased correlation with symptoms and psychometrics compared with gastric emptying status and Rome IV criteria. These findings have implications for the diagnostic profiling and personalized management of gastroduodenal disorders.


Assuntos
Duodenopatias , Gastroparesia , Humanos , Feminino , Masculino , Esvaziamento Gástrico/fisiologia , Gastroparesia/diagnóstico por imagem , Cintilografia
4.
BMJ Open ; 13(11): e074462, 2023 11 27.
Artigo em Inglês | MEDLINE | ID: mdl-38011983

RESUMO

INTRODUCTION: The Gastric Alimetry platform offers a multimodal assessment of gastric function through body surface gastric mapping (BSGM) and concurrent symptom-tracking via a validated App. We aim to perform a longitudinal cohort study to examine the impact of Gastric Alimetry, and changes in clinical management on patient symptoms, quality of life and psychological health. METHODS AND ANALYSIS: This is a prospective multicentre longitudinal observational cohort study of participants with chronic gastroduodenal symptoms. Consecutive participants undergoing Gastric Alimetry will be invited to participate. Quality of life will be assessed via EuroQol-5D and the Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life score. Gastrointestinal symptoms will be assessed via the Patient Assessment of Upper Gastrointestinal Symptom Severity index, and the Gastroparesis Cardinal Symptom Index. Psychometrics will be assessed, including anxiety via the General Anxiety Disorder-7, perceived stress using the Perceived Stress Scale 4, and depression via the Patient Health Questionnaire 9. Clinical parameters including diagnoses, investigations and treatments (medication and procedures) will also be captured. Assessments will be made the week after the BSGM test, at 30 days, 90 days, 180 days and 360 days thereafter. The primary outcome is feasibility of longitudinal follow-up of a cohort that have undergone Gastric Alimetry testing; from which patients' continuum of care can be characterised. Secondary outcomes include changes in patient-reported symptoms, quality of life and psychometrics (anxiety, stress and depression). Inferential causal analyses will be performed at the within patient level to explore causal associations between treatment changes and clinical outcomes. The impact of Gastric Alimetry on clinical management will also be captured. ETHICS AND DISSEMINATION: The protocol has been approved in Aotearoa New Zealand by the Auckland Health Research Ethics Committee. Results will be submitted for conference presentation and peer-reviewed publication.


Assuntos
Ansiedade , Qualidade de Vida , Humanos , Estudos Longitudinais , Estudos Prospectivos , Ansiedade/terapia , Transtornos de Ansiedade , Estudos Observacionais como Assunto , Estudos Multicêntricos como Assunto
5.
J Clin Med ; 12(20)2023 Oct 10.
Artigo em Inglês | MEDLINE | ID: mdl-37892572

RESUMO

Chronic gastroduodenal symptoms are prevalent worldwide, and there is a need for new diagnostic and treatment approaches. Several overlapping processes may contribute to these symptoms, including gastric dysmotility, hypersensitivity, gut-brain axis disorders, gastric outflow resistance, and duodenal inflammation. Gastric Alimetry® (Alimetry, New Zealand) is a non-invasive test for evaluating gastric function that combines body surface gastric mapping (high-resolution electrophysiology) with validated symptom profiling. Together, these complementary data streams enable important new clinical insights into gastric disorders and their symptom correlations, with emerging therapeutic implications. A comprehensive database has been established, currently comprising > 2000 Gastric Alimetry tests, including both controls and patients with various gastroduodenal disorders. From studies employing this database, this paper presents a systematic methodology for Gastric Alimetry test interpretation, together with an extensive supporting literature review. Reporting is grouped into four sections: Test Quality, Spectral Analysis, Symptoms, and Conclusions. This review compiles, assesses, and evaluates each of these aspects of test assessment, with discussion of relevant evidence, example cases, limitations, and areas for future work. The resultant interpretation methodology is recommended for use in clinical practice and research to assist clinicians in their use of Gastric Alimetry as a diagnostic aid and is expected to continue to evolve with further development.

6.
J Psychosom Res ; 175: 111516, 2023 12.
Artigo em Inglês | MEDLINE | ID: mdl-37832277

RESUMO

OBJECTIVE: Cognitive behavioural therapy (CBT) is increasingly used to manage Disorders of Gut-Brain Interaction (DGBIs). This systematic review aimed to review the evidence for the effectiveness of CBT-based interventions for patients with gastroduodenal DGBIs. METHODS: Medline, Embase, PubMed, Cochrane Central, and Scopus were searched in July 2022. Studies were included if they investigated the effects of a CBT-based intervention on gastrointestinal symptoms and/or psychological outcomes pre- and post-intervention in patients with gastroduodenal DGBIs. Case studies, studies not in English, and studies with patients under 18 years were excluded. Results were synthesised narratively, and standardised effect sizes were calculated where possible. RESULTS: Nine studies (seven RCTs and two pre/post studies) were identified, with data reported in 10 articles (total N = 602). The studies investigated patients with functional dyspepsia (n = 7), rumination syndrome (n = 1), and supragastric belching (n = 1). The studies had heterogeneous interventions, methodologies, and outcomes, precluding meta-analysis, as well as a moderate-high risk of bias and high drop-outs rates. Findings demonstrated decreased gastrointestinal symptoms and improved anxiety, depression, and quality of life, from pre- to post-intervention, with medium to large effect sizes for symptoms and small to large effect sizes for psychological outcomes. Efficacy was maintained at follow-up, up to one year later. CONCLUSIONS: This review suggests promising evidence that CBT effectively improves gastrointestinal symptoms and psychological outcomes in patients with gastroduodenal DGBIs. However, heterogeneity, risk of bias, and lack of statistical reporting were noted, indicating the need for more robust research and standardisation.


Assuntos
Terapia Cognitivo-Comportamental , Psicoterapia , Adolescente , Humanos , Transtornos de Ansiedade/terapia , Encéfalo , Terapia Cognitivo-Comportamental/métodos , Psicoterapia/métodos , Qualidade de Vida
7.
Clin Rheumatol ; 42(12): 3267-3274, 2023 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-37702810

RESUMO

INTRODUCTION: Systemic sclerosis (SSc) is associated with esophageal dysmotility. Autologous hematopoietic cell transplantation (HCT) results in improvement of skin tightness and lung function. Whether esophageal motility improves after HCT is unknown. METHODS: Esophageal motility was studied using high-resolution esophageal manometry in 21 SSc patients before and at multiple time points after autologous HCT. Median posttransplant follow-up was 2 years (range, 6 months to 5 years). RESULTS: Prior to HCT, all 21 patients had abnormal motility-10 (48%) had unmeasurable and 11 (52%) had measurable peristalsis. Manometric diagnosis in the former 10 patients was "absent contractility" and in the latter 11 patients "ineffective esophageal motility (IEM)." After HCT, among the 10 patients with absent contractility, 9 continued to have absent contractility and one demonstrated weak measurable peristalsis. Of the 11 patients with IEM, 5 experienced SSc relapse, and 2 out of these 5 patients developed absent contractility. Among the 6 non-relapsed patients, 4 continued to have IEM, and 2 developed normal motility. CONCLUSIONS: HCT appears to have no beneficial effect on motility in patients with unmeasurable peristalsis. In patients with measurable peristalsis, HCT appears to stabilize and in some normalize motility, unless relapse occurs. Key Points • In patients with systemic sclerosis, esophageal dysmotility is a significant contributor to morbidity and so far, there has been no data describing the effects of hematopoietic cell transplantation on esophageal motility. • Our work demonstrated that in patients with systemic sclerosis and unmeasurable esophageal peristalsis prehematopoietic cell transplantation, there was no measurable beneficial effect of transplantation on esophageal motility. • In patients with systemic sclerosis and measurable peristalsis prehematopoietic cell transplantation, esophageal motility stabilized, except in relapsed patients.


Assuntos
Transtornos da Motilidade Esofágica , Transplante de Células-Tronco Hematopoéticas , Escleroderma Sistêmico , Humanos , Transtornos da Motilidade Esofágica/diagnóstico , Escleroderma Sistêmico/complicações , Recidiva
8.
Sci Rep ; 13(1): 14987, 2023 09 11.
Artigo em Inglês | MEDLINE | ID: mdl-37696955

RESUMO

Electrogastrography (EGG) non-invasively evaluates gastric motility but is viewed as lacking clinical utility. Gastric Alimetry® is a new diagnostic test that combines high-resolution body surface gastric mapping (BSGM) with validated symptom profiling, with the goal of overcoming EGG's limitations. This study directly compared EGG and BSGM to define performance differences in spectral analysis. Comparisons between Gastric Alimetry BSGM and EGG were conducted by protocolized retrospective evaluation of 178 subjects [110 controls; 68 nausea and vomiting (NVS) and/or type 1 diabetes (T1D)]. Comparisons followed standard methodologies for each test (pre-processing, post-processing, analysis), with statistical evaluations for group-level differences, symptom correlations, and patient-level classifications. BSGM showed substantially tighter frequency ranges vs EGG in controls. Both tests detected rhythm instability in NVS, but EGG showed opposite frequency effects in T1D. BSGM showed an 8× increase in the number of significant correlations with symptoms. BSGM accuracy for patient-level classification was 0.78 for patients vs controls and 0.96 as compared to blinded consensus panel; EGG accuracy was 0.54 and 0.43. EGG detected group-level differences in patients, but lacked symptom correlations and showed poor accuracy for patient-level classification, explaining EGG's limited clinical utility. BSGM demonstrated substantial performance improvements across all domains.


Assuntos
Diabetes Mellitus Tipo 1 , Humanos , Estudos Retrospectivos , Estômago , Mapeamento Potencial de Superfície Corporal , Consenso
9.
Front Psychol ; 14: 1232871, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37637892

RESUMO

Background: Chronic gastroduodenal disorders including, chronic nausea and vomiting syndrome, gastroparesis, and functional dyspepsia, are challenging to diagnose and manage. The diagnostic and treatment pathways for these disorders are complex, costly and overlap substantially; however, experiences of this pathway have not been thoroughly investigated. This study therefore aimed to explore clinician and patient perspectives on the current clinical pathway. Methods: Semi-structured interviews were conducted between June 2020 and June 2022 with 11 patients with chronic nausea and vomiting syndrome alone (based on Rome IV criteria) and nine gastroenterologists who treat these conditions. Interviews were recorded, transcribed, and thematically analyzed using a reflexive, iterative, inductive approach. Five key patient themes were identified: (1) the impacts of their chronic gastroduodenal symptoms, (2) the complexity of the clinical journey, (3) their interactions with healthcare providers, (4) the need for advocacy, and (5) their experience of treatments. Five key clinician themes were also identified: (1) these conditions were seen as clinically complex, (2) there is an uncertain and variable clinical pathway, (3) the nuance of investigations, (4) these conditions were difficult to therapeutically manage, and (5) there are barriers to developing a therapeutic relationship. Conclusion: Findings indicate that both patients and clinicians are dissatisfied with the current clinical care pathways for nausea and vomiting syndromes. Recommendations included the development of more clinically relevant and discriminant tests, standardization of the diagnostic journey, and the adoption of a multidisciplinary approach to diagnosis and treatment.

10.
Am J Gastroenterol ; 118(10): 1787-1796, 2023 10 01.
Artigo em Inglês | MEDLINE | ID: mdl-37410911

RESUMO

INTRODUCTION: Esophageal food bolus impactions (FBI) are a common gastrointestinal emergency. Appropriate management includes not only index endoscopy for disimpaction but also medical follow-up and treatment for the underlying esophageal pathology. We evaluated the appropriateness of postendoscopy care for patients with FBI and assessed patient-related, physician-related, and system-related factors that may contribute to loss to follow-up. METHODS: We conducted a retrospective, population-based, multicenter cohort study of all adult patients undergoing endoscopy for FBI in the Calgary Health Zone, Canada, from 2016 to 2018. Appropriate postendoscopy care was defined by a composite of a clinical or endoscopic follow-up visit, appropriate investigations (e.g., manometry), or therapy (e.g., proton-pump inhibitors or endoscopic dilation). Predictors of inappropriate care were assessed using multivariable logistic regression. RESULTS: A total of 519 patients underwent endoscopy for FBI: 25.2% (131/519) did not receive appropriate postendoscopy care. Half of the patients (55.3%, 287/519) underwent follow-up endoscopy or attended clinic, and among this group, 22.3% (64/287) had a change in their initial diagnosis after follow-up, including 3 new cases of esophageal cancer. Patients in whom a suspected underlying esophageal pathology was not identified at the index endoscopy were 7-fold (adjusted odds ratio 7.28, 95% confidence interval 4.49-11.78, P < 0.001) more likely to receive inappropriate postendoscopy follow-up and treatment, even after adjusting for age, sex, rural residence, timing of endoscopy, weekend presentation, and endoscopic interventions. DISCUSSION: One-quarter of patients presenting with an FBI do not receive appropriate postendoscopy care. This is strongly associated with failure to identify a potential underlying pathology at index presentation.


Assuntos
Doenças do Esôfago , Adulto , Humanos , Estudos Retrospectivos , Estudos de Coortes , Endoscopia Gastrointestinal , Alimentos
11.
medRxiv ; 2023 May 25.
Artigo em Inglês | MEDLINE | ID: mdl-37292604

RESUMO

Objectives: Gastric emptying testing (GET) assesses gastric motility, however is non-specific and insensitive for neuromuscular disorders. Gastric Alimetry® (GA) is a new medical device combining non-invasive gastric electrophysiological mapping and validated symptom profiling. This study assessed patient-specific phenotyping using GA compared to GET. Methods: Patients with chronic gastroduodenal symptoms underwent simultaneous GET and GA, comprising a 30-minute baseline, 99m TC-labelled egg meal, and 4-hour postprandial recording. Results were referenced to normative ranges. Symptoms were profiled in the validated GA App and phenotyped using rule-based criteria based on their relationships to the meal and gastric activity: i) sensorimotor; ii) continuous; and iii) other. Results: 75 patients were assessed; 77% female. Motility abnormality detection rates were: GET 22.7% (14 delayed, 3 rapid); GA spectral analysis 33.3% (14 low rhythm stability / low amplitude; 5 high amplitude; 6 abnormal frequency); combined yield 42.7%. In patients with normal spectral analysis, GA symptom phenotypes included: sensorimotor 17% (where symptoms strongly paired with gastric amplitude; median r=0.61); continuous 30%; other 53%. GA phenotypes showed superior correlations with GCSI, PAGI-SYM, and anxiety scales, whereas Rome IV Criteria did not correlate with psychometric scores (p>0.05). Delayed emptying was not predictive of specific GA phenotypes. Conclusions: GA improves patient phenotyping in chronic gastroduodenal disorders in the presence and absence of motility abnormalities with improved correlation with symptoms and psychometrics compared to gastric emptying status and Rome IV criteria. These findings have implications for the diagnostic profiling and personalized management of gastroduodenal disorders. Study Highlights: 1) WHAT IS KNOWN Chronic gastroduodenal symptoms are common, costly and greatly impact on quality of lifeThere is a poor correlation between gastric emptying testing (GET) and symptomsGastric Alimetry® is a new medical device combining non-invasive gastric electrophysiological mapping and validated symptom profiling 2) WHAT IS NEW HERE Gastric Alimetry generates a 1.5x higher yield for motility abnormalities than GETWith symptom profiling, Gastric Alimetry identified 2.7x more specific patient categories than GETGastric Alimetry improves clinical phenotyping, with improved correlation with symptoms and psychometrics compared to GET.

12.
Clin Gastroenterol Hepatol ; 21(12): 3041-3050.e3, 2023 11.
Artigo em Inglês | MEDLINE | ID: mdl-37164113

RESUMO

BACKGROUND & AIMS: Patients with poorly controlled eosinophilic esophagitis (EoE) may require unplanned emergency department (ED) visits for the management of dysphagia or food impactions. We evaluated the epidemiologic burden of EoE on ED utilization in the United States. METHODS: Data from the US Nationwide Emergency Department Sample were used to estimate weighted annual EoE-associated ED visits from 2009 to 2019. Temporal trends in population-adjusted rates of EoE visits were assessed using joinpoint regression. Autoregressive integrated moving average models were used to project EoE-associated ED visits to 2030. We also evaluated endoscopic utilization, requirement for hospitalization, and ED-related charges in patients with EoE presenting to the ED. RESULTS: A total of 11,125 unweighted (49,507 weighted) ED visits for EoE were included (69.0% male; mean age, 32.4 y). The annual volume of EoE-associated ED visits increased from 2934 (95% CI, 2437-3431) in 2009 to 8765 (95% CI, 7514-10,015) in 2019, and is projected to reach 15,445 (95% prediction interval, 14,672-16,218) by 2030. From 2009 to 2019, the number of EoE-associated ED visits increased by an average of 11.5% per year (95% CI, 10.3%-12.7%). The proportion of patients admitted to the hospital from the ED decreased from 25.6% in 2009 to 2011 to 14.0% in 2017 to 2019. Half of EoE patients presenting to the ED required an endoscopy, and nearly 40% required an esophageal foreign body removal. Total mean inflation-adjusted charges for an EoE-associated ED visit were $9025 US dollars in 2019. CONCLUSIONS: The volume of EoE-associated ED visits tripled between 2009 and 2019 and is projected to further double by 2030. This represents a substantial burden of unanticipated health care resource utilization and highlights a potential opportunity to optimize outpatient EoE care.


Assuntos
Serviço Hospitalar de Emergência , Esofagite Eosinofílica , Adulto , Feminino , Humanos , Masculino , Esofagite Eosinofílica/epidemiologia , Esofagite Eosinofílica/terapia , Hospitalização , Hospitais , Aceitação pelo Paciente de Cuidados de Saúde , Estados Unidos/epidemiologia
13.
Neurogastroenterol Motil ; 35(10): e14556, 2023 10.
Artigo em Inglês | MEDLINE | ID: mdl-36989183

RESUMO

BACKGROUND AND PURPOSE: Chronic gastric symptoms are common, however differentiating specific contributing mechanisms in individual patients remains challenging. Abnormal gastric motility is present in a significant subgroup, but reliable methods for assessing gastric motor function in clinical practice are lacking. Body surface gastric mapping (BSGM) is a new diagnostic aid, employs multi-electrode arrays to measure and map gastric myoelectrical activity non-invasively in high resolution. Clinical adoption of BSGM is currently expanding following studies demonstrating the ability to achieve specific patient subgrouping, and subsequent regulatory clearances. An international working group was formed in order to standardize clinical BSGM methods, encompassing a technical group developing BSGM methods and a clinical advisory group. The working group performed a technical literature review and synthesis focusing on the rationale, principles, methods, and clinical applications of BSGM, with secondary review by the clinical group. The principles and validation of BSGM were evaluated, including key advances achieved over legacy electrogastrography (EGG). Methods for BSGM were reviewed, including device design considerations, patient preparation, test conduct, and data processing steps. Recent advances in BSGM test metrics and reference intervals are discussed, including four novel metrics, being the 'principal gastric frequency', BMI-adjusted amplitude, Gastric Alimetry Rhythm Index™, and fed: fasted amplitude ratio. An additional essential element of BSGM has been the introduction of validated digital tools for standardized symptom profiling, performed simultaneously during testing. Specific phenotypes identifiable by BSGM and the associated symptom profiles were codified with reference to pathophysiology. Finally, knowledge gaps and priority areas for future BSGM research were also identified by the working group.


Assuntos
Motilidade Gastrointestinal , Estômago , Humanos , Motilidade Gastrointestinal/fisiologia , Eletromiografia/métodos , Mapeamento Potencial de Superfície Corporal , Eletrodos
14.
Aliment Pharmacol Ther ; 57(8): 837-850, 2023 04.
Artigo em Inglês | MEDLINE | ID: mdl-36825479

RESUMO

BACKGROUND: Effective medical therapies for patients with microscopic colitis (MC) who fail budesonide are lacking. However, conducting randomised controlled trials (RCTs) in MC has been challenging due to small sample sizes. Understanding placebo responses can help inform more efficient future trials. AIMS: The aim of this study is to estimate clinical and histologic placebo response rates and to determine factors associated with placebo response in MC. METHODS: EMBASE, MEDLINE, and CENTRAL were searched until 7 January 2022, to identify placebo-controlled RCTs in adult patients with MC. Clinical and histologic response in the placebo arms were pooled using random-effects models. Stratified analyses based on disease- and trial-level characteristics, leave-one-out meta-analysis, and cumulative meta-analysis were performed. RESULTS: Twelve RCTs enrolling a total of 391 patients (placebo n = 163) with MC were included. Pooled clinical and histologic placebo response rates were 24.4% (95% CI: 12.4%-38.4%), I2  = 60.8%, p < 0.01, and 19.9% (95% CI: 5.3%-39.0%), I2  = 66.4%, p = 0.01 (tests for heterogeneity), respectively. Clinical response to placebo was numerically higher in patients with lymphocytic compared to collagenous colitis (39.9% vs. 19.8%, p = 0.08). Heterogeneity in clinical response to placebo was significantly reduced when the Miehlke 2014 RCT was excluded in the leave-one-out meta-analysis or when a more stringent secondary definition of response based on the Hjortswang criteria was applied. CONCLUSIONS: Approximately one-quarter of patients in MC trials respond to placebo, although with substantial heterogeneity, reflecting the need for standardised outcome definitions and study designs for MC. This analysis also serves to inform future MC trials that may consider incorporating an external, historical placebo control arm, rather than directly randomising patients to placebo.


Assuntos
Colite Colagenosa , Colite Microscópica , Adulto , Humanos , Budesonida/uso terapêutico , Colite Microscópica/tratamento farmacológico , Colite Colagenosa/tratamento farmacológico , Ensaios Clínicos Controlados Aleatórios como Assunto
15.
Neurogastroenterol Motil ; 35(2): e14418, 2023 02.
Artigo em Inglês | MEDLINE | ID: mdl-35699340

RESUMO

BACKGROUND: Disorders of gastric function are highly prevalent, but diagnosis often remains symptom-based and inconclusive. Body surface gastric mapping is an emerging diagnostic solution, but current approaches lack scalability and are cumbersome and clinically impractical. We present a novel scalable system for non-invasively mapping gastric electrophysiology in high-resolution (HR) at the body surface. METHODS: The system comprises a custom-designed stretchable high-resolution "peel-and-stick" sensor array (8 × 8 pre-gelled Ag/AgCl electrodes at 2 cm spacing; area 225 cm2 ), wearable data logger with custom electronics incorporating bioamplifier chips, accelerometer and Bluetooth synchronized in real-time to an App with cloud connectivity. Automated algorithms filter and extract HR biomarkers including propagation (phase) mapping. The system was tested in a cohort of 24 healthy subjects to define reliability and characterize features of normal gastric activity (30 m fasting, standardized meal, and 4 h postprandial). KEY RESULTS: Gastric mapping was successfully achieved non-invasively in all cases (16 male; 8 female; aged 20-73 years; BMI 24.2 ± 3.5). In all subjects, gastric electrophysiology and meal responses were successfully captured and quantified non-invasively (mean frequency 2.9 ± 0.3 cycles per minute; peak amplitude at mean 60 m postprandially with return to baseline in <4 h). Spatiotemporal mapping showed regular and consistent wave activity of mean direction 182.7° ± 73 (74.7% antegrade, 7.8% retrograde, 17.5% indeterminate). CONCLUSIONS AND INFERENCES: BSGM is a new diagnostic tool for assessing gastric function that is scalable and ready for clinical applications, offering several biomarkers that are improved or new to gastroenterology practice.


Assuntos
Motilidade Gastrointestinal , Estômago , Humanos , Masculino , Feminino , Reprodutibilidade dos Testes , Motilidade Gastrointestinal/fisiologia , Estômago/fisiologia , Eletrodos , Eletrônica
16.
Am J Gastroenterol ; 118(6): 1047-1057, 2023 06 01.
Artigo em Inglês | MEDLINE | ID: mdl-36534985

RESUMO

INTRODUCTION: Body surface gastric mapping (BSGM) is a new noninvasive test of gastric function. BSGM offers several novel and improved biomarkers of gastric function capable of differentiating patients with overlapping symptom profiles. The aim of this study was to define normative reference intervals for BSGM spectral metrics in a population of healthy controls. METHODS: BSGM was performed in healthy controls using Gastric Alimetry (Alimetry, New Zealand) comprising a stretchable high-resolution array (8 × 8 electrodes; 196 cm 2 ), wearable Reader, and validated symptom-logging App. The evaluation encompassed a fasting baseline (30 minutes), 482 kCal meal, and 4-hour postprandial recording. Normative reference intervals were calculated for BSGM metrics including the Principal Gastric Frequency, Gastric Alimetry Rhythm Index (a measure of the concentration of power in the gastric frequency band over time), body mass index (BMI)-adjusted amplitude (µV), and fed:fasted amplitude ratio. Data were reported as median and reference interval (5th and/or 95th percentiles). RESULTS: A total of 110 subjects (55% female, median age 32 years [interquartile range 24-50], median BMI 23.8 kg/m 2 [interquartile range 21.4-26.9]) were included. The median Principal Gastric Frequency was 3.04 cycles per minute; reference interval: 2.65-3.35 cycles per minute. The median Gastric Alimetry Rhythm Index was 0.50; reference interval: ≥0.25. The median BMI-adjusted amplitude was 37.6 µV; reference interval: 20-70 µV. The median fed:fasted amplitude ratio was 1.85; reference interval ≥1.08. A higher BMI was associated with a shorter meal-response duration ( P = 0.014). DISCUSSION: This study provides normative reference intervals for BSGM spectral data to inform diagnostic interpretations of abnormal gastric function.


Assuntos
Jejum , Estômago , Humanos , Feminino , Adulto , Masculino , Valores de Referência , Estômago/diagnóstico por imagem , Índice de Massa Corporal , Período Pós-Prandial
18.
Artigo em Inglês | MEDLINE | ID: mdl-36269560

RESUMO

Background and Aims: Given the underlying properties of cannabinoids, we aimed to assess associations between cannabinoid use and sedation requirements for esophagogastroduodenoscopy (EGD) and colonoscopy. Methods: A prospective cohort study was conducted at three endoscopy units. Adult outpatients undergoing EGD or colonoscopy with endoscopist-directed conscious sedation (EDCS) were given questionnaires on cannabinoid use and relevant parameters. Outcomes included intraprocedural midazolam, fentanyl, and diphenhydramine use, procedural tolerability, and adverse events. Multivariable logistic regression was performed to yield adjusted odds ratios (AORs) of outcomes. Results: A total of 419 patients were included. Baseline cannabinoid use was associated with high midazolam use, defined as ≥5 mg, during EGD (AOR 2.89, 95% confidence interval, CI: 1.19-7.50), but not during colonoscopy (AOR 0.89, 95% CI 0.41-1.91). Baseline cannabinoid use was associated with the administration of any diphenhydramine during EGD (AOR 3.04, 95% CI: 1.29-7.30) with a similar nonsignificant trend for colonoscopy (AOR 2.36, 95% CI: 0.81-7.04). Baseline cannabinoid use was associated with increased odds of requiring high total sedation, defined as any of midazolam ≥5 mg, fentanyl ≥100 mcg, or any diphenhydramine during EGD (AOR 3.72, 95% CI: 1.35-11.68). Cannabinoid use was not independently associated with fentanyl use, intraprocedural awareness, discomfort, or adverse events. Conclusions: Baseline cannabinoid use was associated with higher sedation use during endoscopy with EDCS, particularly with midazolam and diphenhydramine. Given increasingly widespread cannabinoid use, endoscopists should be equipped with optimal sedation strategies for this population. As part of the informed consent process, cannabis users should be counseled that they may require higher sedation doses to achieve the same effect.

19.
Aliment Pharmacol Ther ; 56(11-12): 1532-1542, 2022 12.
Artigo em Inglês | MEDLINE | ID: mdl-36307209

RESUMO

BACKGROUND: Cannabinoid hyperemesis syndrome (CHS) is a poorly understood vomiting disorder associated with chronic cannabis use. AIMS: To characterise patients experiencing CHS in North America and to obtain a population-based estimate of CHS treatment prevalence in Canada before and during the Covid-19 pandemic METHODS: Internet survey of 157 CHS sufferers in Canada and the United States. Administrative health databases for the province of Alberta (population 5 million) were accessed to measure emergency department (ED) visits for vomiting, with a concurrent diagnostic code for cannabis use. Three time periods of 1 year were assessed: prior to recreational cannabis legalisation (2017-2018), after recreational legalisation (2018-2019) and during the first year of the Covid-19 pandemic (2020-2021). RESULTS: Problematic cannabis use (defined as a CUDIT-R score ≥8) was universal among the survey cohort, and 59% and 68% screening for moderate or worse anxiety or depression, respectively. The overall treatment prevalence of CHS across all ages increased from 15 ED visits per 100,000 population (95% CI, 14-17) prior to legalisation, to 21 (95% CI, 20-23) after legalisation, to 32 (95% CI, 31-35) during the beginning of the Covid-19 pandemic (p < 0.001). Treatment prevalence among chronic cannabis users was as high as 6 per 1000 in the 16-24 age group. CONCLUSION: Survey data suggest patients with CHS almost universally suffer from a cannabis use disorder, which has significant treatment implications. Treatment prevalence in the ED has increased substantially over a very short time period, with the highest rates seen during the Covid-19 pandemic.


Assuntos
COVID-19 , Canabinoides , Humanos , Canabinoides/efeitos adversos , Prevalência , COVID-19/epidemiologia , Pandemias , Vômito/induzido quimicamente , Vômito/epidemiologia , Síndrome , América do Norte
20.
Sci Transl Med ; 14(663): eabq3544, 2022 Sep 21.
Artigo em Inglês | MEDLINE | ID: mdl-36130019

RESUMO

Chronic nausea and vomiting syndromes (NVSs) are prevalent and debilitating disorders. Putative mechanisms include gastric neuromuscular disease and dysregulation of brain-gut interaction, but clinical tests for objectively defining gastric motor function are lacking. A medical device enabling noninvasive body surface gastric mapping (BSGM) was developed and applied to evaluate NVS pathophysiology. BSGM was performed in 43 patients with NVS and 43 matched controls using Gastric Alimetry (Alimetry), a conformable high-resolution array (8 × 8 electrodes; 20-mm interelectrode spacing), wearable reader, and validated symptom-logging app. Continuous measurement encompassed a fasting baseline (30 minutes), 482-kilocalorie meal, and 4-hour postprandial recording, followed by spectral and spatial biomarker analyses. Meal responses were impaired in NVS, with reduced amplitudes compared to controls (median, 23.3 microvolts versus 38.0 microvolts, P < 0.001), impaired fed-fasting power ratios (1.1 versus 1.6, P = 0.02), and disorganized slow waves (spatial frequency stability, 13.6 versus 49.5; P < 0.001). Two distinct NVS subgroups were evident with indistinguishable symptoms (all P > 0.05). Most patients (62%) had normal BSGM studies with increased psychological comorbidities (43.5% versus 7.7%; P = 0.03) and anxiety scores (median, 16.5 versus 13.0; P = 0.035). A smaller subgroup (31%) had markedly abnormal BSGM, with biomarkers correlating with symptoms (nausea, pain, excessive fullness, early satiety, and bloating; all r > 0.35, P < 0.05). Patients with NVS share overlapping symptoms but comprise distinct underlying phenotypes as revealed by a BSGM device. These phenotypes correlate with symptoms, which should inform clinical management and therapeutic trial design.


Assuntos
Esvaziamento Gástrico , Náusea , Esvaziamento Gástrico/fisiologia , Humanos , Estômago , Síndrome , Vômito
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