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1.
Gut ; 72(2): 264-274, 2023 02.
Artículo en Inglés | MEDLINE | ID: mdl-35907636

RESUMEN

OBJECTIVE: There are numerous biological therapies and small molecules licensed for luminal Crohn's disease (CD), but these are often studied in placebo-controlled trials, meaning relative efficacy is uncertain. We examined this in a network meta-analysis. DESIGN: We searched the literature to 1 July 2022, judging efficacy according to induction of clinical remission, clinical response and maintenance of clinical remission, and according to previous exposure or non-exposure to biologics. We used a random effects model and reported data as pooled relative risks (RRs) with 95% CIs, ranking drugs according to p-score. RESULTS: We identified 25 induction of remission trials (8720 patients). Based on failure to achieve clinical remission, infliximab 5 mg/kg ranked first versus placebo (RR=0.67, 95% CI 0.56 to 0.79, p-score 0.95), with risankizumab 600 mg second and upadacitinib 45 mg once daily third. However, risankizumab 600 mg ranked first for clinical remission in biologic-naïve (RR=0.66, 95% CI 0.52 to 0.85, p-score 0.78) and in biologic-exposed patients (RR=0.74, 95% CI 0.67 to 0.82, p-score 0.92). In 15 maintenance of remission trials (4016 patients), based on relapse of disease activity, upadacitinib 30 mg once daily ranked first (RR=0.61, 95% CI 0.52 to 0.72, p-score 0.93) with adalimumab 40 mg weekly second, and infliximab 10 mg/kg 8-weekly third. Adalimumab 40 mg weekly ranked first in biologic-naïve patients (RR=0.59, 95% CI 0.48 to 0.73, p-score 0.86), and vedolizumab 108 mg 2-weekly first in biologic-exposed (RR=0.70, 95% CI 0.57 to 0.86, p-score 0.82). CONCLUSION: In a network meta-analysis, infliximab 5 mg/kg ranked first for induction of clinical remission in all patients with luminal CD, but risankizumab 600 mg was first in biologic-naïve and biologic-exposed patients. Upadacitinib 30 mg once daily ranked first for maintenance of remission.


Asunto(s)
Enfermedad de Crohn , Humanos , Enfermedad de Crohn/tratamiento farmacológico , Adalimumab/uso terapéutico , Infliximab/uso terapéutico , Metaanálisis en Red , Terapia Biológica , Inducción de Remisión
2.
Gastroenterology ; 163(1): 190-203.e5, 2022 07.
Artículo en Inglés | MEDLINE | ID: mdl-35339461

RESUMEN

BACKGROUND & AIMS: Symptoms of common mental disorders, such as anxiety or depression, are common in inflammatory bowel disease (IBD) and may affect prognosis. However, unlike clinical or biochemical markers of disease activity, psychological health is not a recommended therapeutic target. We assessed relative contribution of poor psychological health and clinical or biochemical activity to prognosis. METHODS: Demographic features, IBD subtype, treatments, and anxiety and depression scores were recorded at baseline for 760 adults, with clinical activity determined using validated scoring systems. Fecal calprotectin was analyzed in 379 (49.9%) patients (≥250 µg/g used to define biochemical activity). Glucocorticosteroid prescription or flare, escalation, hospitalization, intestinal resection, or death were assessed during 6.5 years of follow-up. Occurrence was compared using multivariate Cox regression across 4 patient groups according to presence of disease remission or activity, with or without symptoms of a common mental disorder, at baseline. RESULTS: In total, 718 (94.5%) participants provided data. Compared with clinical remission without symptoms of a common mental disorder at baseline, need for glucocorticosteroid prescription or flare (hazard ratio [HR], 2.36; 95% confidence interval [CI], 1.58-3.54), escalation (HR, 1.65; 95% CI, 1.14--2.40), and death (HR, 4.99; 95% CI, 1.80-13.88) were significantly higher in those with clinical activity and symptoms of a common mental disorder. Rates in those with clinical remission and symptoms of a common mental disorder at baseline or those with clinical activity without symptoms of a common mental disorder were not significantly higher. Similarly, with biochemical activity and symptoms of a common mental disorder, rates of glucocorticosteroid prescription or flare (HR, 2.48; 95% CI, 1.38-4.46), escalation (HR, 2.97; 95% CI, 1.74-5.06), hospitalization (HR, 3.10; 95% CI, 1.43-6.68), and death (HR, 6.26; 95% CI, 2.23-17.56) were significantly higher. CONCLUSIONS: Psychological factors are important determinants of poor prognostic outcomes in IBD and should be considered as a therapeutic target.


Asunto(s)
Enfermedades Inflamatorias del Intestino , Adulto , Ansiedad/epidemiología , Enfermedad Crónica , Estudios de Seguimiento , Humanos , Enfermedades Inflamatorias del Intestino/diagnóstico , Enfermedades Inflamatorias del Intestino/tratamiento farmacológico , Complejo de Antígeno L1 de Leucocito , Pronóstico
3.
Clin Gastroenterol Hepatol ; 21(13): 3397-3404.e1, 2023 12.
Artículo en Inglés | MEDLINE | ID: mdl-37302448

RESUMEN

BACKGROUND & AIMS: Irritable bowel syndrome (IBS) is a positive diagnosis, made using symptom-based criteria and limited, judicious, investigation. However, this may lead to uncertainty on the part of clinicians regarding potential for a missed diagnosis of organic gastrointestinal disease. Few studies have examined durability of a diagnosis of IBS, and none have used the current gold standard to diagnose IBS, the Rome IV criteria. METHODS: We collected complete symptom data from 373 well-characterized adults meeting Rome IV criteria for IBS referred to a single UK clinic between September 2016 and March 2020. All patients underwent relatively standardized work-up to exclude relevant organic disease before diagnosis. We followed these individuals up to December 2022, assessing rates of rereferral, reinvestigation, and missed organic gastrointestinal disease. RESULTS: During a mean follow-up of 4.2 years per patient (total follow-up in all patients, 1565 years), 62 (16.6%) patients were rereferred. Of these, 35 (56.5%) were rereferred for IBS and 27 (43.5%) for other gastrointestinal symptoms. Among the 35 rereferred with IBS this was caused by a change in symptoms in only 5 (14.3%). Reinvestigation was undertaken in 21 (60.0%) of 35 rereferred with IBS and 22 (81.5%) of 27 rereferred with other symptoms (P = .12). Only 4 (9.3% of those reinvestigated and 1.1% of the entire cohort) new cases of relevant organic disease, which may have been responsible for IBS symptoms at baseline, were identified (1 case of chronic calcific pancreatitis among those rereferred with IBS and 1 case each of inflammatory bowel disease-unclassified, moderate bile acid diarrhea, and small bowel obstruction among those rereferred with other gastrointestinal symptoms). CONCLUSIONS: Despite rereferral for gastrointestinal symptoms among 1 in 6 patients overall, with almost 10% rereferred with ongoing IBS symptoms, and substantial reinvestigation rates, missed organic gastrointestinal disease occurred in only 1%. A diagnosis of Rome IV IBS after limited investigation is safe and durable.


Asunto(s)
Obstrucción Intestinal , Síndrome del Colon Irritable , Adulto , Humanos , Síndrome del Colon Irritable/diagnóstico , Síndrome del Colon Irritable/complicaciones , Atención Secundaria de Salud , Ciudad de Roma , Diarrea/etiología , Encuestas y Cuestionarios
4.
Am J Gastroenterol ; 118(2): 304-316, 2023 02 01.
Artículo en Inglés | MEDLINE | ID: mdl-36227779

RESUMEN

INTRODUCTION: Symptoms of common mental disorders, such as anxiety or depression, are associated with adverse clinical outcomes in inflammatory bowel disease (IBD). We report trajectories of these symptoms in IBD, patient characteristics associated with different trajectories, and effects on healthcare utilization and prognosis. METHODS: We collected demographic, symptom, psychological, and quality-of-life data, with questionnaires at 3-month intervals, over 12 months of follow-up. We collected healthcare utilization and IBD outcomes through notes review. We compared characteristics of those with persistently normal or improving anxiety or depression scores with those with persistently abnormal or worsening scores and the number of flares, glucocorticosteroid prescriptions, escalations of therapy, hospitalizations, or intestinal resections due to IBD activity. RESULTS: Among 771 and 777 patients, respectively, worsening or persistently abnormal anxiety or depression scores were associated with increased antidepressant (28.6% vs 12.3% anxiety, 35.8% vs 10.1% depression, P < 0.001) and opiate use (19.0% vs 7.8% anxiety, P = 0.001 and 34.0% vs 7.4% depression, P < 0.001), compared with those with persistently normal or improving scores. These individuals were also more likely to have been diagnosed with IBD in the last 12 months (16.3% vs 5.0% anxiety, P = 0.001, and 15.1% vs 5.5% depression, P = 0.006), to have clinically active disease at baseline (57.1% vs 26.6% anxiety and 71.7% vs 29.1% depression, P < 0.001) and lower quality-of-life scores ( P < 0.001). Individuals with worsening or persistently abnormal trajectories of anxiety or depression required significantly more outpatient appointments, radiological investigations, and endoscopic procedures for IBD-related symptoms. DISCUSSION: In this 12-month follow-up study, patients with IBD with worsening or persistently high anxiety or depression scores were higher utilizers of health care but were not at an increased risk of future adverse disease outcomes.


Asunto(s)
Depresión , Enfermedades Inflamatorias del Intestino , Humanos , Depresión/epidemiología , Depresión/psicología , Estudios de Seguimiento , Enfermedades Inflamatorias del Intestino/complicaciones , Enfermedades Inflamatorias del Intestino/psicología , Ansiedad/psicología , Trastornos de Ansiedad , Calidad de Vida
5.
Gut ; 71(9): 1773-1780, 2022 09.
Artículo en Inglés | MEDLINE | ID: mdl-34725197

RESUMEN

OBJECTIVE: The role of the brain-gut axis is of increasing interest in IBD, as the link between common mental disorders and GI inflammation may be bidirectional. We performed a systematic review examining these issues. DESIGN: We searched EMBASE Classic and EMBASE, Medline, and APA PsychInfo (to 11 July 2021) for longitudinal follow-up studies examining effect of symptoms of anxiety or depression on subsequent adverse outcomes in IBD, or effect of active IBD on subsequent development of symptoms of anxiety or depression. We pooled relative risks (RRs) and HRs with 95% CIs for adverse outcomes (flare, escalation of therapy, hospitalisation, emergency department attendance, surgery or a composite of any of these) according to presence of symptoms of anxiety or depression at baseline, or RRs and HRs with 95% CIs for new onset of symptoms of anxiety or depression according to presence of active IBD at baseline. RESULTS: We included 12 separate studies, recruiting 9192 patients. All 12 studies examined brain-to-gut effects. Anxiety at baseline was associated with significantly higher risks of escalation of therapy (RR=1.68; 95% CI 1.18 to 2.40), hospitalisation (RR=1.72; 95% CI 1.01 to 2.95), emergency department attendance (RR=1.30; 95% CI 1.21 to 1.39), or a composite of any adverse outcome. Depression at baseline was associated with higher risks of flare (RR=1.60; 95% CI 1.21 to 2.12), escalation of therapy (RR=1.41; 95% CI 1.08 to 1.84), hospitalisation (RR=1.35; 95% CI 1.17 to 1.57), emergency department attendance (RR=1.38; 95% CI 1.22 to 1.56), surgery (RR=1.63; 95% CI 1.19 to 2.22) or a composite of any of these. Three studies examined gut-to-brain effects. Active disease at baseline was associated with future development of anxiety or depression (RR=2.24; 95% CI 1.25 to 4.01 and RR=1.49; 95% CI 1.11 to 1.98, respectively). CONCLUSION: Bidirectional effects of the brain-gut axis are present in IBD and may influence both the natural history of the disease and psychological health.


Asunto(s)
Eje Cerebro-Intestino , Enfermedades Inflamatorias del Intestino , Ansiedad , Estudios de Seguimiento , Humanos , Enfermedades Inflamatorias del Intestino/psicología , Pronóstico
6.
Gut ; 2021 Dec 22.
Artículo en Inglés | MEDLINE | ID: mdl-34937767

RESUMEN

OBJECTIVE: Biological therapies and small molecules continue to be evaluated in moderate to severely active ulcerative colitis, but are often studied in placebo-controlled trials, meaning their relative efficacy and safety is unknown. We examined this in a network meta-analysis. DESIGN: We searched the literature to October 2021 to identify eligible trials. We judged efficacy using clinical remission, endoscopic improvement, or clinical response, and according to previous exposure or non-exposure to antitumour necrosis factor (TNF)-α therapy. We also assessed safety. We used a random effects model and reported data as pooled relative risks (RRs) with 95% CIs. Interventions were ranked according to their P-score. RESULTS: We identified 28 trials (12 504 patients). Based on failure to achieve clinical remission, upadacitinib 45 mg once daily ranked first versus placebo (RR 0.73; 95% CI 0.68 to 0.80, P-score 0.98), with infliximab 5 mg/kg and 10 mg/kg second and third, respectively. Upadacitinib ranked first for clinical remission in both patients naïve to anti-TNF-α drugs (RR 0.69; 95% CI 0.61 to 0.78, P-score 0.99) and previously exposed (RR 0.78; 95% CI 0.72 to 0.85, P-score 0.99). Upadacitinib was superior to almost all other drugs in these analyses. Based on failure to achieve endoscopic improvement infliximab 10 mg/kg ranked first (RR 0.61; 95% CI 0.51 to 0.72, P-score 0.97), with upadacitinib 45 mg once daily, second, and infliximab 5 mg/kg third. Upadacitinib was more likely to lead to adverse events, but serious adverse events were no more frequent, and withdrawals due to adverse events were significantly lower than with placebo. Infections were significantly more likely with tofacitinib than placebo (RR 1.41; 95% CI 1.03 to 1.91). CONCLUSION: In a network meta-analysis, upadacitinib 45 mg once daily ranked first for clinical remission in all patients, patients naïve to anti-TNF-α drugs and patients previously exposed. Infliximab 10 mg/kg ranked first for endoscopic improvement. Most drugs were safe and well tolerated.

7.
Gut ; 70(6): 1110-1116, 2021 06.
Artículo en Inglés | MEDLINE | ID: mdl-32973070

RESUMEN

OBJECTIVES: Despite being proposed 4 years ago, there has been no independent validation study of the Rome IV criteria for IBS. We assessed their performance for the diagnosis of IBS in secondary care and compared them with the previous iteration, the Rome III criteria. DESIGN: We collected complete symptom data from consecutive adult patients with suspected IBS referred to a single UK clinic. All subjects underwent relatively standardised workup, with assessors blinded to symptom status. The reference standard used to confirm IBS was the presence of lower abdominal pain or discomfort in association with altered stool form or frequency, in a patient with no evidence of organic gastrointestinal disease after investigation. Sensitivity, specificity and positive and negative likelihood ratios (LRs), with 95% CIs, were calculated for each of the diagnostic criteria. RESULTS: The level of agreement between the Rome IV and Rome III criteria was good (kappa=0.65). Compared with the reference standard, sensitivity and specificity of the Rome IV criteria in 572 patients (431 (75.3%) women, mean age 36.5 years) were 82.4% and 82.9%, respectively. Positive and negative LRs for the Rome IV criteria were 4.82 (95% CI 3.30 to 7.28) and 0.21 (95% CI 0.17 to 0.26), respectively. The Rome IV criteria performed best in those with IBS with constipation or mixed bowel habits. In 471 patients (350 (74.3%) women, mean age 36.7 years), compared with the reference standard, the sensitivity and specificity of the Rome III criteria were 85.8% and 65.0%; positive and negative LRs were 2.45 (95% CI 1.90 to 3.27) and 0.22 (0.16 to 0.29), respectively. Incorporating mood and extraintestinal symptom reporting into diagnostic criteria did not improve their performance significantly. CONCLUSIONS: The Rome IV criteria performed significantly better than the Rome III criteria in diagnosing IBS in this single centre secondary care study, although the clinical relevance of this is uncertain.


Asunto(s)
Síndrome del Colon Irritable/diagnóstico , Evaluación de Síntomas/métodos , Dolor Abdominal/etiología , Adulto , Estreñimiento/etiología , Diarrea/etiología , Femenino , Humanos , Síndrome del Colon Irritable/complicaciones , Funciones de Verosimilitud , Masculino , Persona de Mediana Edad , Atención Secundaria de Salud , Sensibilidad y Especificidad
8.
Gastroenterology ; 154(6): 1635-1646.e3, 2018 05.
Artículo en Inglés | MEDLINE | ID: mdl-29366841

RESUMEN

BACKGROUND & AIMS: Inflammatory bowel diseases (IBD) are associated with mood disorders, such as anxiety or depression, but it is not clear whether one contributes to development of the other, or if the interaction is bi-directional (anxiety or depression contributes to the progression of IBD, and IBD affects psychological health). We performed a 2-year longitudinal prospective study of patients in secondary to care investigate the bi-directionality of IBD and mood disorders. METHODS: We collected data from 405 adult patients with a diagnosis of Crohn's disease (CD) or ulcerative colitis (UC) from November 2012 through June 2017. Demographic features, subtypes of IBD, treatments, symptoms, somatization, and fecal level of calprotectin were recorded at baseline. IBD activity was determined at baseline and after the follow-up period (2 years or more) using the Harvey-Bradshaw Index for CD and the Simple Clinical Colitis Activity Index for UC (scores ≥5 used to define disease activity). Anxiety and depression data were collected using the Hospital Anxiety and Depression Scale (HADS), at baseline and after the follow-up period. Objective markers of disease activity, including glucocorticosteroid prescription or flare of disease activity, escalation of therapy, hospitalization secondary to IBD activity, and intestinal resection during follow-up were assessed via case note review. A brain-gut direction of disease activity was defined as development of new IBD activity in patients with quiescent IBD and abnormal HADS scores at baseline. A gut-brain direction of disease activity was defined by subsequent development of abnormal HADS scores in patients with active IBD and normal HADS scores at baseline. We performed multivariate Cox regression controlling for patient characteristics and follow-up duration. RESULTS: Baseline CD or UC disease activity were associated with an almost 6-fold increase in risk for a later abnormal anxiety score (hazard ratio [HR], 5.77; 95% CI, 1.89-17.7). In patients with quiescent IBD at baseline, baseline abnormal anxiety scores were associated with later need for glucocorticosteroid prescription or flare of IBD activity (HR, 2.08; 95% CI, 1.31-3.30) and escalation of therapy (HR, 1.82; 95% CI, 1.19-2.80). These associations persisted when normal IBD activity index scores and fecal level of calprotectin <250 µg/g were used to define quiescent disease at baseline. CONCLUSIONS: In a 2-year study of patients with CD or UC, we found evidence for bi-directional effects of IBD activity and psychological disorders. Patients with IBD should be monitored for psychological well-being.


Asunto(s)
Ansiedad/complicaciones , Colitis Ulcerosa/psicología , Enfermedad de Crohn/psicología , Depresión/complicaciones , Adulto , Ansiedad/fisiopatología , Biomarcadores/análisis , Encéfalo/fisiopatología , Colitis Ulcerosa/tratamiento farmacológico , Colitis Ulcerosa/fisiopatología , Enfermedad de Crohn/tratamiento farmacológico , Enfermedad de Crohn/fisiopatología , Depresión/fisiopatología , Progresión de la Enfermedad , Heces/química , Femenino , Estudios de Seguimiento , Glucocorticoides/uso terapéutico , Humanos , Intestinos/fisiopatología , Complejo de Antígeno L1 de Leucocito/análisis , Estudios Longitudinales , Masculino , Persona de Mediana Edad , Análisis Multivariante , Modelos de Riesgos Proporcionales , Estudios Prospectivos , Escalas de Valoración Psiquiátrica , Análisis de Regresión , Índice de Severidad de la Enfermedad , Encuestas y Cuestionarios , Brote de los Síntomas
9.
Am J Gastroenterol ; 113(5): 702-712, 2018 05.
Artículo en Inglés | MEDLINE | ID: mdl-29453384

RESUMEN

OBJECTIVES: The impact of irritable bowel syndrome (IBS)-type symptoms on the natural history of inflammatory bowel disease (IBD) is uncertain. We aimed to address this in a longitudinal study of secondary care patients. METHODS: Longitudinal disease activity was defined by disease flare, escalation of medical therapy, hospitalization, or intestinal resection. The number of investigations performed and clinics attended determined healthcare utilization. Psychological well-being and quality of life were assessed using validated questionnaires. These outcomes were compared over a minimum period of 2 years between patients reporting IBS-type symptoms and patients with quiescent disease, occult inflammation, and active disease at baseline. RESULTS: In 360 IBD patients, there were no differences in longitudinal disease activity between patients with IBS-type symptoms and patients with quiescent disease or occult inflammation. Disease flare and escalation of medical therapy was more common in patients with active disease than in patients with IBS-type symptoms (hazard ratio (HR) = 3.16; 95% confidence interval (CI) 1.93-5.19 and HR = 3.24; 95% CI 1.98-5.31, respectively). A greater number of investigations were performed in patients with IBS-type symptoms than quiescent disease (P = 0.008), but not compared with patients with occult inflammation or active disease. Anxiety, depression, and somatization scores at follow up were higher, and quality-of-life scores lower, in patients with IBS-type symptoms when compared with patients with quiescent disease, but were similar to patients with active disease. CONCLUSIONS: IBS-type symptoms in IBD were associated with increased healthcare utilization, psychological comorbidity, reduced quality of life, but not adverse disease activity outcomes during extended follow-up.


Asunto(s)
Ansiedad/epidemiología , Depresión/epidemiología , Enfermedades Inflamatorias del Intestino/epidemiología , Síndrome del Colon Irritable/epidemiología , Trastornos Somatomorfos/epidemiología , Adulto , Anciano , Ansiedad/psicología , Comorbilidad , Depresión/psicología , Progresión de la Enfermedad , Femenino , Estudios de Seguimiento , Humanos , Enfermedades Inflamatorias del Intestino/complicaciones , Enfermedades Inflamatorias del Intestino/psicología , Enfermedades Inflamatorias del Intestino/terapia , Síndrome del Colon Irritable/complicaciones , Síndrome del Colon Irritable/psicología , Síndrome del Colon Irritable/terapia , Estudios Longitudinales , Masculino , Persona de Mediana Edad , Aceptación de la Atención de Salud/estadística & datos numéricos , Calidad de Vida , Índice de Severidad de la Enfermedad , Trastornos Somatomorfos/psicología , Encuestas y Cuestionarios/estadística & datos numéricos
10.
Scand J Gastroenterol ; 53(6): 700-707, 2018 06.
Artículo en Inglés | MEDLINE | ID: mdl-29687730

RESUMEN

OBJECTIVES: Recently, the infliximab biosimilar (CT-P13) received market authorisation for inflammatory bowel disease (IBD), allowing cost benefits when switching to CT-P13. We aim to assess the efficacy and safety of switching from originator infliximab to CT-P13 for new and existing patients. MATERIAL AND METHODS: Treatment response, remission, primary and secondary loss of response rates, and adverse events in patients who initiated infliximab originator in the 12 months pre-switch (n = 53) were compared with the patients who initiated CT-P13 in the 12 months post-switch (n = 69). Sustained responses were compared for existing infliximab originator patients who switched to CT-P13 (n = 191) and those who continued with the originator (n = 19). RESULTS: There was no difference in remission (58.1% vs. 47.4%, p = .37), response (12.6% vs. 10.5%, p = .80), secondary loss of response (24.6% vs. 42.1%, p = .10), or adverse events (4.7% vs. 0% p = 1.0) between those who switched to CT-P13 and those who continued infliximab originator. There was no difference in remission (42.0% vs. 26.4%, p = .074), response (21.7% vs. 22.6%, p = .91), primary non-response (5.8% vs. 15.1%, p = .09), secondary loss of response (21.7% vs. 22.6%, p = .91), or adverse events (8.7% vs. 11.3%, p = .63) in those who initiated CT-P13 compared with infliximab originator. CONCLUSIONS: There was no difference in the efficacy and safety of infliximab originator and CT-P13 during the first 12 months after switching.


Asunto(s)
Anticuerpos Monoclonales/uso terapéutico , Biosimilares Farmacéuticos/uso terapéutico , Enfermedades Inflamatorias del Intestino/tratamiento farmacológico , Infliximab/uso terapéutico , Adulto , Anticuerpos Monoclonales/efectos adversos , Biosimilares Farmacéuticos/efectos adversos , Sustitución de Medicamentos , Femenino , Humanos , Infliximab/efectos adversos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Inducción de Remisión , Resultado del Tratamiento , Reino Unido , Adulto Joven
13.
Clin Gastroenterol Hepatol ; 15(3): 376-384.e5, 2017 03.
Artículo en Inglés | MEDLINE | ID: mdl-27189912

RESUMEN

BACKGROUND & AIMS: Symptoms compatible with irritable bowel syndrome (IBS) are common in patients with inflammatory bowel disease (IBD), but it is unclear whether this relates to occult IBD activity. We attempted to resolve this issue in a secondary care population by using a cross-sectional study design. METHODS: We analyzed Rome III IBS symptoms, disease activity indices, and psychological, somatization, and quality of life data from 378 consecutive, unselected adult patients with IBD seen in clinics at St James's University Hospital in Leeds, United Kingdom from November 2012 through June 2015. Participants provided a stool sample for fecal calprotectin (FC) analysis; levels ≥250 µg/g were used to define mucosal inflammation. By using symptom data and FC levels we identified 4 distinct groups of patients: those with true IBS-type symptoms (IBS-type symptoms with FC levels <250 µg/g, regardless of disease activity indices), quiescent IBD (no IBS-type symptoms with FC levels <250 µg/g, regardless of disease activity indices), occult inflammation (normal disease activity indices and FC levels ≥250 µg/g, regardless of IBS symptom status), or active IBD (abnormal disease activity indices with FC levels ≥250 µg/g, regardless of IBS symptom status). We compared characteristics between these groups. RESULTS: Fifty-seven of 206 patients with Crohn's disease (27.7%) and 34 of 172 patients with ulcerative colitis (19.8%) had true IBS-type symptoms. Levels of psychological comorbidity and somatization were significantly higher among patients with true IBS-type symptoms than patients with quiescent IBD or occult inflammation. Quality of life levels were also significantly reduced compared with patients with quiescent disease or occult inflammation and were similar to those of patients with active IBD. By using FC levels ≥100 µg/g to define mucosal inflammation, we found a similar effect of IBS-type symptoms on psychological health and quality of life. CONCLUSIONS: In a cross-sectional study, we identified a distinct group of patients with IBD and genuine IBS-type symptoms in the absence of mucosal inflammation. These symptoms had negative effects on psychological well-being and quality of life to the same degree as active IBD. New management strategies are required for this patient group.


Asunto(s)
Enfermedades Inflamatorias del Intestino/complicaciones , Síndrome del Colon Irritable/patología , Síndrome del Colon Irritable/psicología , Calidad de Vida , Estrés Psicológico/epidemiología , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Estudios Transversales , Heces/química , Femenino , Humanos , Complejo de Antígeno L1 de Leucocito/análisis , Masculino , Persona de Mediana Edad , Reino Unido , Adulto Joven
17.
Am J Gastroenterol ; 111(11): 1557-1558, 2016 11.
Artículo en Inglés | MEDLINE | ID: mdl-27808129

RESUMEN

Incorporating patient-reported outcomes (PROs) into clinical practice is advocated by some. However, the benefits remain uncertain. Almario et al. examined the impact of a gastrointestinal (GI) version of the patient-reported outcomes measurement information system (PROMIS) on patient satisfaction, perception of doctors' interpersonal skills, and the likelihood of shared decision-making. Patients were allocated to complete GI PROMIS prior to their outpatient appointment, or usual management. Overall, uptake of GI PROMIS was poor and there was no difference in any outcome measure between those completing the questionnaire and those receiving usual management, suggesting PROs may be of limited utility in this setting.


Asunto(s)
Gastroenterología , Medición de Resultados Informados por el Paciente , Humanos , Evaluación de Resultado en la Atención de Salud , Satisfacción del Paciente , Encuestas y Cuestionarios
18.
Am J Gastroenterol ; 111(10): 1446-1454, 2016 10.
Artículo en Inglés | MEDLINE | ID: mdl-27481310

RESUMEN

OBJECTIVES: Symptom-based criteria to diagnose irritable bowel syndrome (IBS) positively perform only modestly. Our aim was to assess whether including other items from the clinical history and limited diagnostic evaluation improves their performance. METHODS: We collected complete symptom, colonoscopy, and histology data from 318 consecutive, unselected adult patients with lower gastrointestinal (GI) symptoms in secondary care. All participants underwent colonoscopy, with relevant organic findings recorded. The reference standard used to define the presence of true IBS was patient-reported lower abdominal pain or discomfort associated with a change in bowel habit, in the absence of organic GI disease. Sensitivity, specificity, and positive and negative likelihood ratios (LRs), with 95% confidence intervals, were calculated for Rome III criteria, as well as for modifications, incorporating nocturnal stools, results of simple blood tests (hemoglobin and C-reactive protein (CRP)), measures of somatization, and/or affective disorders (hospital anxiety or depression scale (HADS) score). RESULTS: The sensitivity and specificity of the Rome III criteria for identifying IBS was 69.6%, and 82.0%, respectively, with positive and negative LRs of 3.87 and 0.37, respectively. Clinically useful enhancements in positive LRs were provided by combining Rome III criteria with: (a) high level of somatization (7.27); (b) normal hemoglobin and CRP with HADS score of ≥8 (5.04); (c) normal hemoglobin and CRP with a high level of somatization (7.56); or (d) no nocturnal passage of stool with a high level of somatization (17.3). Specificity was ≥95% with each of these modifications. CONCLUSIONS: Incorporating nocturnal stools, somatization, and affective disorders from the clinical history, and hemoglobin and CRP measurements, enhances the positive LR and specificity of symptom-based Rome III criteria for IBS.


Asunto(s)
Ansiedad/psicología , Colonoscopía , Depresión/psicología , Síndrome del Colon Irritable/diagnóstico , Trastornos Somatomorfos/psicología , Dolor Abdominal , Adulto , Anciano , Proteína C-Reactiva/metabolismo , Ritmo Circadiano , Colon/patología , Defecación , Femenino , Hemoglobinas/metabolismo , Humanos , Síndrome del Colon Irritable/metabolismo , Síndrome del Colon Irritable/patología , Síndrome del Colon Irritable/psicología , Masculino , Anamnesis , Persona de Mediana Edad , Sensibilidad y Especificidad , Encuestas y Cuestionarios
19.
Am J Gastroenterol ; 111(4): 541-51, 2016 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-27002800

RESUMEN

OBJECTIVES: There is a move toward patient-reported outcome measures as end points in clinical trials of novel therapies for inflammatory bowel disease (IBD). However, the association between patient-reported symptoms and mucosal inflammation, and the influence of psychological factors, remains unclear. We examined this in a secondary care population. METHODS: Validated patient-reported disease activity indices were used to define clinically active disease in a cohort of 356 patients with ulcerative colitis (UC) or Crohn's disease (CD). A fecal calprotectin ≥250 µg/g was used to define active mucosal inflammation. The hospital anxiety and depression scale (HADS) and patient health questionnaire (PHQ)-15 were used to assess for anxiety, depression, or somatization, respectively. Logistic regression analysis was performed to determine the association between symptoms, mucosal inflammation, and psychological comorbidity. RESULTS: Clinical disease activity was associated with mucosal inflammation in UC (odds ratio (OR) 3.36; 95% confidence interval (CI) 1.34-8.47) but not in CD (OR 1.69; 95% CI 0.74-3.83). Depression in UC (OR 1.21 per 1-point increase in HADS; 95% CI 1.02-1.44) and somatization in UC (OR 1.17 per 1-point increase in PHQ-15; 95% CI 1.03-1.33) and CD (OR 1.31 per 1-point increase in PHQ-15; 95% CI 1.13-1.52) were associated with clinical disease activity. Overall, patient-reported symptoms yielded poor positive predictive values for mucosal inflammation in both CD and UC. CONCLUSIONS: Patient-reported symptoms and the Harvey-Bradshaw index were poor predictors of mucosal inflammation in CD. Psychological comorbidity was associated with gastrointestinal symptom-reporting. A shift in the focus of IBD management toward one addressing both psychological and physical well-being is required.


Asunto(s)
Enfermedades Inflamatorias del Intestino/psicología , Trastornos Mentales/diagnóstico , Trastornos Mentales/psicología , Medición de Resultados Informados por el Paciente , Biomarcadores/análisis , Comorbilidad , Estudios Transversales , Femenino , Humanos , Complejo de Antígeno L1 de Leucocito/análisis , Masculino , Persona de Mediana Edad , Escalas de Valoración Psiquiátrica , Índice de Severidad de la Enfermedad
20.
Scand J Gastroenterol ; 51(10): 1206-12, 2016 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-27243102

RESUMEN

OBJECTIVE: Many patients with diarrhoea undergo colonoscopy. If this is macroscopically normal, random biopsies are obtained to rule out microscopic colitis (MC), but most patients have functional disease. Accurate predictors of MC could avoid the need to take biopsies in a substantial proportion of patients, saving money for the health service. We validated a previously described diagnostic scoring system for MC, and incorporated further variables to assess whether this improved performance. MATERIAL AND METHODS: Consecutive adults with loose stools undergoing colonoscopy in Leeds, UK were included. Demographic and symptom data were collected prospectively. The diagnostic scoring system described previously was applied. In addition, the incorporation of further variables, including drugs associated with MC, number of stools, nocturnal passage of stools, and duration of loose stools, into the scoring system was assessed. Sensitivities, specificities, and positive and negative predictive values were calculated. RESULTS: Among 242 patients (mean age 51.0 years, 163 (67.4%) female), 26 (10.7%) of whom had MC, a cut off of ≥4 on the original scoring system had a sensitivity of 92.3% and specificity of 35.2%. Nocturnal passage of stools and duration of loose stools <6 months were significant predictors of MC. Incorporating these variables in a new scoring system with a cut off of ≥6 identified MC with 95.7% sensitivity and 46.0% specificity. CONCLUSIONS: Incorporating nocturnal passage of stools and duration of loose stools into the scoring system may improve ability to predict MC, and avoid random colonic biopsies in a greater proportion of patients with loose stools.


Asunto(s)
Colitis Microscópica/diagnóstico , Colon/patología , Colonoscopía/métodos , Índice de Severidad de la Enfermedad , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Biopsia , Colitis Microscópica/clasificación , Colitis Microscópica/patología , Diarrea/etiología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Curva ROC , Análisis de Regresión , Sensibilidad y Especificidad , Reino Unido , Adulto Joven
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