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1.
Trials ; 20(1): 517, 2019 Aug 20.
Artigo em Inglês | MEDLINE | ID: mdl-31429811

RESUMO

BACKGROUND: Irritable bowel syndrome with diarrhoea (IBS-D) affects up to 4% of the general population. Symptoms include frequent, loose, or watery stools with associated urgency, resulting in marked reduction of quality of life and loss of work productivity. Ondansetron, a 5HT3 receptor antagonist, has had an excellent safety record for over 20 years as an antiemetic, yet is not widely used in the treatment of IBS-D. It has, however, been shown to slow colonic transit and in a small randomised, placebo-controlled, cross-over pilot study, benefited patients with IBS-D. METHODS: This trial is a phase III, parallel group, randomised, double-blind, multi-centre, placebo-controlled trial, with embedded mechanistic studies. Participants (n = 400) meeting Rome IV criteria for IBS-D will be recruited from outpatient and primary care clinics and by social media to receive either ondansetron (dose titrated up to 24 mg daily) or placebo for 12 weeks. Throughout the trial, participants will record their worst abdominal pain, worst urgency, stool frequency, and stool consistency on a daily basis. The primary endpoint is the proportion of "responders" in each group, using Food and Drug Administration (FDA) recommendations. Secondary endpoints include pain intensity, stool consistency, frequency, and urgency. Mood and quality of life will also be assessed. Mechanistic assessments will include whole gut transit, faecal tryptase and faecal bile acid concentrations at baseline and between weeks 8 and 11. A subgroup of participants will also undergo assessment of sensitivity (n = 80) using the barostat, and/or high-resolution colonic manometry (n = 40) to assess motor patterns in the left colon and the impact of ondansetron. DISCUSSION: The TRITON trial aims to assess the effect of ondansetron across multiple centres. By defining ondansetron's mechanisms of action we hope to better identify patients with IBS-D who are likely to respond. TRIAL REGISTRATION: ISRCTN, ISRCTN17508514 , Registered on 2 October 2017.

2.
Artigo em Inglês | MEDLINE | ID: mdl-31154027

RESUMO

OBJECTIVES: Few studies have examined the effects of applying the Rome IV criteria for irritable bowel syndrome (IBS) vs the previous standard, the Rome III criteria. We conducted a cross-sectional survey of individuals who self-identify as having IBS to examine this issue. METHODS: We collected complete demographic, symptom, mood, and psychological health data from 1375 adults who self-identified as having IBS, but were not recruited from a referral population. We applied the Rome III and the Rome IV criteria simultaneously to examine what proportion met each of these diagnostic criteria for IBS. We measured the level of agreement between the Rome III and Rome IV criteria, and assessed for presence of an alternative functional bowel disorder in individuals who no longer met diagnostic criteria for IBS with the more restrictive Rome IV criteria. Finally, we compared characteristics of individuals who met only Rome III criteria with those who met Rome IV criteria. RESULTS: In total, 1080 of 1368 individuals (78.9%) with IBS met the Rome III criteria. In contrast, 811 of 1373 individuals (59.1%) with IBS met the Rome IV criteria. Agreement between the criteria was only moderate (Kappa = 0.50). Among those who no longer had IBS according to the Rome IV criteria, 33 (11.5%) met Rome IV criteria for functional constipation, 118 (41.3%) for functional diarrhea, 68 (23.8%) for functional abdominal bloating or distension, and 67 (23.4%) for an unspecified functional bowel disorder. Individuals with Rome IV-defined IBS had more severe symptoms, and a higher proportion had a mood disorder and evidence of poor psychological health, compared with individuals who only met the Rome III criteria for IBS (P < .001). CONCLUSIONS: The characteristics of people who believe they have IBS differ between those who meet criteria as defined by Rome IV vs Rome III, including the spectrum of disease severity. Studies are needed to determine how these changes will affect outcomes of clinical trials.

3.
BMC Gastroenterol ; 19(1): 69, 2019 May 07.
Artigo em Inglês | MEDLINE | ID: mdl-31064345

RESUMO

BACKGROUND: Irritable bowel syndrome with predominant constipation (IBS-C) is a complex disorder with gastrointestinal and nervous system components. The study aim was to assess the economic burden of moderate to severe IBS-C in six European countries (France, Germany, Italy, Spain, Sweden and the UK). METHODS: An observational, one year retrospective-prospective (6 months each) study of patients diagnosed in the last five years with IBS-C (Rome III criteria) and moderate to severe disease at inclusion (IBS Symptom Severity Scale score ≥ 175). The primary objective was to assess the direct cost to European healthcare systems. RESULTS: Five hundred twenty-five patients were included, 60% (range: 43.1-78.8%) suffered from severe IBS-C. During follow-up 11.1-24.0% of patients had a hospitalisation/emergency room (ER) visit, median stay range: 1.5-12.0 days and 41.1-90.4% took prescription drugs for IBS-C. 21.4-50.8% of employed patients took sick leave (mean: 11.6-64.1 days). The mean annual direct cost to the healthcare systems was €937.1- €2108.0. The total direct cost (combined costs to healthcare systems and patient) for IBS-C was €1421.7-€2487.1. CONCLUSIONS: IBS-C is not a life-threatening condition; however, it has large impact on healthcare systems and society. Direct and indirect costs for moderate to severe IBS-C were high with the largest direct cost driver being hospitalisations/ER visits.


Assuntos
Constipação Intestinal/complicações , Constipação Intestinal/economia , Efeitos Psicossociais da Doença , Custos de Cuidados de Saúde , Síndrome do Intestino Irritável/complicações , Síndrome do Intestino Irritável/economia , Adulto , Idoso , Constipação Intestinal/diagnóstico , Custos de Medicamentos , Europa (Continente) , Utilização de Instalações e Serviços , Feminino , Hospitalização/economia , Hospitalização/estatística & dados numéricos , Humanos , Síndrome do Intestino Irritável/diagnóstico , Masculino , Pessoa de Meia-Idade , Visita a Consultório Médico/economia , Visita a Consultório Médico/estatística & dados numéricos , Estudos Prospectivos , Estudos Retrospectivos , Índice de Gravidade de Doença , Licença Médica/economia
4.
Eur J Gastroenterol Hepatol ; 31(6): 653-660, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31009400

RESUMO

OBJECTIVES: Sacral nerve stimulation (SNS) may provide long-term symptom relief to patients suffering from chronic constipation. Patients are currently selected for SNS using a 2-week peripheral nerve evaluation (PNE) comprising stimulation by temporary leads. However, only 40% of test responders receive long-term benefit from treatment meaning that healthcare costs per successfully treated patient are too high. The primary objective was to assess tined-lead testing to predict benefit from SNS for chronic constipation. PATIENTS AND METHODS: A randomized double-blind sham-controlled cross-over design evaluated enhanced PNE (ePNE) using tined quadripolar electrode leads over 6 weeks. The design differentiated between patients with discriminate and indiscriminate responses to testing. A score improvement of 25% or more was considered to be a positive response within a stimulation period. The primary outcome was the proportion of patients showing a reduction of at least 0.5 in constipation symptom score at 6 months. RESULTS: A total of 45 patients were randomized, of whom 29 (64.4%) were test-phase responders. Of these, 27 were implanted providing permanent SNS. During ePNE, seven (18%) were discriminate responders, 22 (56%) were indiscriminate responders and 10 (26%) were nonresponders. Six patients were withdrawn during the test phase because of infection or noncompliance. At 6 months, there was no significant difference in primary outcome between discriminate and indiscriminate responders (60 vs. 57%, P=0.76). The study was terminated prematurely because of a persistent infection rate of 10 (22%) during ePNE of which nine (20%) were severe. CONCLUSION: ePNE is a poor predictor of treatment response at 6 months. This suggests a strong and persistent placebo response during both SNS PNE and treatment. An extended 6-week PNE poses a high risk of infection.

5.
Therap Adv Gastroenterol ; 11: 1756284818798791, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-30302125

RESUMO

Background: Linaclotide, a guanylate cyclase C agonist, has been shown in clinical trials to improve symptoms of irritable bowel syndrome with constipation (IBS-C). Here we report data from a real-world study of linaclotide in the UK. Methods: This 1-year, multicentre, prospective, observational study in the UK enrolled patients aged 18 years and over initiating linaclotide for IBS-C. The primary assessment was change from baseline in IBS Symptom Severity Scale (IBS-SSS) score at 12 weeks, assessed in patients with paired baseline and 12-week data. Change from baseline in IBS-SSS score at 52 weeks was a secondary assessment. Adverse events were recorded. Results: In total, 202 patients were enrolled: 185 (91.6%) were female, median age was 44.9 years (range 18.1-77.2) and 84 (41.6%) reported baseline laxative use. Mean (standard deviation) baseline IBS-SSS score was 339 (92), with most patients (n = 129; 66.8%) classified as having severe disease (score ⩾300). In patients with paired data, there was a significant mean (95% confidence interval) decrease in IBS-SSS score from baseline to 12 weeks [-77.0 (-96.3, -57.7); p < 0.001; n = 124] and baseline to 52 weeks [-70.7 (-95.0, -46.5); p < 0.001; n = 76]. Overall, 174 adverse events were reported in 77 (38.1%) patients, most commonly diarrhoea (n = 54; 26.7%), abdominal pain (n = 21; 10.4%) and abdominal distension (n = 13; 6.4%). Conclusion: Linaclotide significantly improved IBS-SSS score at 12 and 52 weeks. These results provide insights into outcomes with linaclotide treatment over 1 year in patients with IBS-C in real-world clinical practice.

6.
J Adv Nurs ; 74(2): 318-328, 2018 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-28792610

RESUMO

AIMS: The aim of this study was to explore the experiences of Clinical Research Nurses, with an emphasis on factors that may have an impact on successful study delivery. BACKGROUND: The Clinical Research Nurse workforce is pivotal to improving health outcomes through supporting research-active health economies. Investment in research infrastructure has led to nurses and midwives increasingly undertaking extended roles to deliver clinical research. Despite such opportunities, the recruitment of sufficient participants into research studies remains problematic. A growing body of literature is exploring barriers to successful study delivery, indicating the emergence of a caring-recruiting dichotomy in clinical research staff. DESIGN: This qualitative study investigates the experiences of Clinical Research Nurses delivering research in the United Kingdom National Health Service. METHODS: Four Focus groups (total 19 participants) were conducted in a large North East National Health Service Foundation Trust from November 2015 - February 2016. FINDINGS: Thematic analysis identified perceptions of the role in the wider context of professional identity. Role transition, altered relationships and workload complexity, affected participants' practice, leading to inconsistency between core clinical values and perceived identities as research delivery staff. A duty of care as patient advocates contrasted elements of the work reflecting that of salespeople. The emotional labour of approaching patients and unease regarding peer perceptions of the Clinical Research Nurse role, affected the positive aspects of research delivery. CONCLUSION: Professional-identity and self-concept appear to have an impact on practice in a research delivery role. Further research should explore these issues further, to enlighten the basis on which such feelings are positioned and to work towards practical solutions.


Assuntos
Pesquisa em Enfermagem Clínica/organização & administração , Papel do Profissional de Enfermagem/psicologia , Recursos Humanos de Enfermagem/psicologia , Seleção de Pacientes , Competência Profissional , Identificação Social , Adulto , Feminino , Grupos Focais , Humanos , Masculino , Pesquisa Qualitativa , Reino Unido
7.
Frontline Gastroenterol ; 8(1): 62-67, 2017 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-28839886

RESUMO

INTRODUCTION: Within the UK, there is anecdotal evidence of disparity in the training, practice, supervision and perception of efficacy among practitioners of biofeedback therapy for chronic constipation. AIMS: To establish the current knowledge, practice and opinions of UK practitioners. METHODS: Between October 2012 and October 2013, a prospective service evaluation was distributed to biofeedback practitioners in the UK through academic conferences or by invitation to complete an on-line assessment form. RESULTS: 76 practitioners responded, consisting of nurses (47%), physiotherapists (35%), physiologists (12%) and others (7%). Only 45% described 'biofeedback' consistent with an accepted definition. 86% use equipment to provide sensory feedback. Methods of biofeedback varied: balloon catheter (54%), brace pump technique (78%), urge resistance (83%), irrigation (16%) and relaxation (12%). Only 65% of practitioners had attended formal training courses, and 52% considered themselves to be self-taught. 36% receive formal supervision and only 38% of those by a senior. Regular audit of outcomes is undertaken by 67%. UK-wide perception of treatment response for chronic constipation is markedly variable (mean response=57% (IQR 50-75%, SD 23%)); there were no differences in perception of treatment response between nurses or physiotherapists. Practitioners' free responses demonstrated strong positive themes of a holistic approach and an overall perception of effectiveness. Negative themes included service restrictions. CONCLUSIONS: There is marked variation in practice, training and supervision of biofeedback therapists throughout the UK. Perceptions of efficacy vary greatly. Development of training and supervision standards is a priority as well as a consensus to standardise therapy.

8.
Trials ; 18(1): 151, 2017 03 31.
Artigo em Inglês | MEDLINE | ID: mdl-28359279

RESUMO

BACKGROUND: Constipation is common in adults and up to 20% of the population report this symptom. Chronic constipation (CC), usually defined as more than 6 months of symptoms, is less common but results in 0.5 million UK GP consultations per annum. The effect of symptoms on measured quality of life (QOL) is significant, and CC consumes significant health care resources. In the UK, it is estimated that 10% of district nursing time is spent on constipation. Trans-anal irrigation therapy has become a widely used treatment despite a lack of robust efficacy data to support its use. The long-term outcome of treatment is also unclear. A randomised comparison of two different methods of irrigation (high- and low-volume) will provide valuable evidence of superiority of one system over the other, as well as providing efficacy data for the treatment as a whole. METHODS: Participants will be recruited based on predetermined eligibility criteria. Following informed consent, they will be randomised to either high-volume (HV) or low-volume (LV) irrigation and undergo standardised radiological and physiological investigations. Following training, they will commence home irrigation with the allocated device. Data will be collected at 1, 3, 6 and 12 months according to a standardised outcomes framework. The primary outcome is PAC-QOL, measured at 3 months. The study is powered to detect a 10% difference in outcome between systems at 3 months; this means that 300 patients will need to be recruited. DISCUSSION: This study will be the first randomised comparison of two different methods of trans-anal irrigation. It will also be the largest prospective study of CC patients treated with irrigation. It will provide evidence for the effectiveness of irrigation in the treatment of CC, as well as the comparative effectiveness of the two methods. This will enable more cost-effective and evidence-based use of irrigation. Also, the results will be combined with the other studies in the CapaCiTY programme to generate an evidence-based treatment algorithm for CC in adults. TRIAL REGISTRATION: ISRCTN, identifier: ISRCTN11093872 . Registered on 11 November 2015. Trial not retrospectively registered. Protocol version 3 (22 January 2016).


Assuntos
Constipação Intestinal/terapia , Defecação , Irrigação Terapêutica/métodos , Adolescente , Adulto , Idoso , Doença Crônica , Protocolos Clínicos , Constipação Intestinal/diagnóstico , Constipação Intestinal/fisiopatologia , Desenho de Equipamento , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Qualidade de Vida , Recuperação de Função Fisiológica , Projetos de Pesquisa , Inquéritos e Questionários , Irrigação Terapêutica/efeitos adversos , Irrigação Terapêutica/instrumentação , Fatores de Tempo , Resultado do Tratamento , Reino Unido , Adulto Jovem
9.
Gastroenterol Res Pract ; 2017: 3826087, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-28115930

RESUMO

Background. Transanal irrigation (TAI) can successfully treat neurogenic bowel dysfunction (NBD), but patient perception of its use in chronic idiopathic constipation (CIC) is unknown. Objective. To evaluate patient perceptions of the efficacy and safety of TAI for CIC and whether there are predictive factors of perceived treatment response. Methods. Prospective data collection of baseline physiology and symptom severity; retrospective evaluation of efficacy and safety perceptions using a snapshot survey. All patients fulfilling the Rome III criteria for functional constipation with chronic idiopathic aetiology were included. The main outcome measure was the duration of patients' usage of TAI. Results. 102 patients reported 21,476 irrigations over 119 patient years, with a mean duration of therapy use of 60.5 weeks [SD 73.2 : SE 7.3]. Overall symptom improvement included general well-being (65%), rectal clearance (63%), bloating (49%), abdominal pain (48%), and bowel frequency (42%). 68 patients (67%) were "moderately better" or "very much better" on a satisfaction question. Reported complications were minor. No correlation was demonstrated between duration of therapy use and baseline measures. Conclusion. A significant proportion of CIC sufferers use TAI as a long-term or bridging therapy and perceive it as safe. This therapy demands a prospective investigation of efficacy and safety.

10.
J Psychosom Res ; 90: 1-9, 2016 11.
Artigo em Inglês | MEDLINE | ID: mdl-27772554

RESUMO

BACKGROUND: The term 'difficult' is pervasively used in relation to medically unexplained symptoms (MUS) and patients with MUS. This article scrutinises the use of the term by analysing interview data from a study of secondary care specialists' experiences with and attitudes towards patients suffering from MUS. DESIGN: Qualitative design employing semi-structured open-ended interviews systematically analysed in three stages: first, data were analysed according to the principles of content analysis. The analysis subsequently focused on the use of the term 'difficult'. Iterations of the term were extracted by summative analysis and thematic coding revealed its different meanings. Finally, alternative expressions were explored. SETTING: Three NHS trust secondary care hospitals in North-East England. PARTICIPANTS: 17 senior clinicians from seven medical and two surgical specialities. RESULTS: Unsolicited use of the term 'difficult' was common. 'Difficult' was rarely used as a patient characteristic or to describe the therapeutic relationship. Participants used 'difficult' to describe their experience of diagnosing, explaining, communicating and managing these conditions and their own emotional reactions. Health care system deficits and the conceptual basis for MUS were other facets of 'difficult'. Participants also reported experiences that were rewarding and positive. CONCLUSIONS: This study shows that blanket statements such as 'difficult patients' mask the complexity of doctors' experiences in the context of MUS. Our nuanced analysis of the use of 'difficult' challenges preconceived attitudes. This can help counter the unreflexive perpetuation of negative evaluations that stigmatize patients with MUS, encourage greater acknowledgement of doctors' emotions, and lead to more appropriate conceptualizations and management of MUS.


Assuntos
Sintomas Inexplicáveis , Médicos/normas , Pesquisa Qualitativa , Atenção Secundária à Saúde/normas , Especialização/normas , Adulto , Assistência à Saúde , Inglaterra/epidemiologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Médicos/psicologia , Atenção Secundária à Saúde/métodos
11.
Ann Neurol ; 80(5): 686-692, 2016 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-27453452

RESUMO

OBJECTIVES: The m.3243A>G MTTL1 mutation is the most common cause of mitochondrial disease; yet there is limited awareness of intestinal pseudo-obstruction (IPO) in this disorder. We aimed to determine the prevalence, severity, and clinical outcome of patients with m.3243A>G-related mitochondrial disease manifesting with IPO. METHODS: In this large, observational cohort study, we assessed the clinical, molecular, and radiological characteristics of patients with genetically determined m.3243A>G-related mitochondrial disease, who presented with severe symptoms suggestive of bowel obstruction in the absence of an occluding lesion. RESULTS: Between January 2009 and June 2015, 226 patients harbouring the m.3243A>G mutation were recruited to the Medical Research Council Centre Mitochondrial Disease Patient Cohort, Newcastle. Thirty patients (13%) presented acutely with IPO. Thirteen of these patients had a preceding history of stroke-like episodes, whereas 1 presented 27 years previously with their first stroke-like episode. Eight patients developed IPO concomitantly during an acute stroke-like episode. Regression analysis suggested stroke was the strongest predictor for development of IPO, in addition to cardiomyopathy, low body mass index and high urinary mutation load. Poor clinical outcome was observed in 6 patients who underwent surgical procedures. INTERPRETATION: Our findings suggest, in this common mitochondrial disease, that IPO is an under-recognized, often misdiagnosed clinical entity. Poor clinical outcome associated with stroke and acute surgical intervention highlights the importance of the neurologist having a high index of suspicion, particularly in the acute setting, to instigate timely coordination of appropriate care and management with other specialists. Ann Neurol 2016;80:686-692.


Assuntos
DNA Mitocondrial/genética , Pseudo-Obstrução Intestinal/diagnóstico por imagem , Pseudo-Obstrução Intestinal/genética , Doenças Mitocondriais/genética , RNA de Transferência de Leucina/genética , Acidente Vascular Cerebral/genética , Adolescente , Adulto , Idoso , Criança , Feminino , Humanos , Pseudo-Obstrução Intestinal/etiologia , Masculino , Pessoa de Meia-Idade , Doenças Mitocondriais/complicações , Avaliação de Resultados (Cuidados de Saúde) , Prevalência , Acidente Vascular Cerebral/etiologia , Adulto Jovem
12.
Dig Dis Sci ; 61(8): 2357-72, 2016 08.
Artigo em Inglês | MEDLINE | ID: mdl-27056037

RESUMO

BACKGROUND: Prucalopride, a selective, high-affinity 5-hydroxytryptamine 4 receptor agonist, stimulates gastrointestinal and colonic motility and alleviates common symptoms of chronic constipation (CC) in adults. The relative efficacy by gender has not been evaluated. AIM: To evaluate the global efficacy and safety of prucalopride 2 mg daily in men and women with CC using data from six large, randomized, controlled clinical trials. METHODS: Data were combined from six phase 3 and 4, double-blind, randomized, placebo-controlled, parallel-group trials. The primary efficacy endpoint was the percentage of patients with a mean of ≥3 spontaneous complete bowel movements (SCBMs) per week over 12 weeks of treatment. Safety was assessed throughout all the trials. RESULTS: Overall, 2484 patients (597 men; 1887 women; prucalopride, 1237; placebo, 1247) were included in the integrated efficacy analysis and 2552 patients were included in the integrated safety analysis. Significantly more patients achieved a mean of ≥3 SCBMs/week over the 12 weeks of treatment in the prucalopride group (27.8 %) than in the placebo group [13.2 %, OR 2.68 (95 % CI 2.16, 3.33), p < 0.001]. Prucalopride had a favorable safety and tolerability profile. Efficacy and safety outcomes were not significantly different between men and women. CONCLUSION: The integrated analysis demonstrates the efficacy and safety of prucalopride in the treatment of CC in men and women.


Assuntos
Benzofuranos/uso terapêutico , Constipação Intestinal/tratamento farmacológico , Agonistas do Receptor 5-HT4 de Serotonina/uso terapêutico , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Doença Crônica , Ensaios Clínicos Fase III como Assunto , Ensaios Clínicos Fase IV como Assunto , Método Duplo-Cego , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento , Adulto Jovem
13.
BMC Gastroenterol ; 15: 139, 2015 Oct 16.
Artigo em Inglês | MEDLINE | ID: mdl-26474758

RESUMO

BACKGROUND: Trans-anal irrigation (TAI) is used widely to treat bowel dysfunction, although evidence for its use in adult chronic functional constipation remains unclear. Long-term outcome data are lacking, and the effectiveness of therapy in this patient group is not definitively known. METHODS: Evidence for effectiveness and safety was reviewed and the quality of studies was assessed. Primary research articles of patients with chronic functional constipation, treated with TAI as outpatients and published in English in indexed journals were eligible. Searching included major bibliographical databases and search terms: bowel dysfunction, defecation, constipation and irrigation. Fixed- and random-effect meta-analyses were performed. RESULTS: Seven eligible uncontrolled studies, including 254 patients, of retrospective or prospective design were identified. The definition of treatment response varied and was investigator-determined. The fixed-effect pooled response rate (the proportion of patients with a positive outcome based on investigator-reported response for each study) was 50.4 % (95 % CI: 44.3-56.5 %) but featured substantial heterogeneity (I(2) = 67.1 %). A random-effects estimate was similar: 50.9 % (95 % CI: 39.4-62.3 %). Adverse events were inconsistently reported but were commonplace and minor. CONCLUSIONS: The reported success rate of irrigation for functional constipation is about 50 %, comparable to or better than the response seen in trials of pharmacological therapies. TAI is a safe treatment benefitting some patients with functional constipation, which is a chronic refractory condition. However findings for TAI vary, possibly due to varying methodology and context. Well-designed prospective trials are required to improve the current weak evidence base.


Assuntos
Canal Anal , Constipação Intestinal/terapia , Irrigação Terapêutica/estatística & dados numéricos , Adulto , Doença Crônica , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Estudos Retrospectivos , Irrigação Terapêutica/métodos , Resultado do Tratamento
14.
Am J Gastroenterol ; 110(5): 741-8, 2015 May.
Artigo em Inglês | MEDLINE | ID: mdl-25869393

RESUMO

OBJECTIVES: Prucalopride is effective at alleviating symptoms of chronic constipation in women. The aim of this study was to assess the efficacy of 12 weeks of prucalopride treatment compared with placebo in men with chronic constipation. METHODS: This was a multicenter, stratified, randomized, parallel-group, double-blind, placebo-controlled, phase 3 study (ClinicalTrials.gov identifier: NCT01147926). The primary end point was the proportion of patients with a mean of three or more spontaneous complete bowel movements (SCBMs) per week across the treatment period. Efficacy end points were assessed using daily electronic diaries, global assessment of the severity of constipation and efficacy of treatment, and Patient Assessment of Constipation-Symptoms (PAC-SYM) and Patient Assessment of Constipation-Quality of Life (PAC-QOL) questionnaires. RESULTS: In total, 374 patients were enrolled in the study. Significantly more patients achieved a mean of three or more SCBMs per week in the prucalopride group (37.9%) than in the placebo group (17.7%, P<0.0001). The proportion of patients rating their constipation treatment as "quite a bit" to "extremely" effective at the final on-treatment visit was 46.7 and 30.4% in the prucalopride and placebo groups, respectively. The difference between treatment groups was statistically significant (P<0.0001). The proportion of patients with an improvement of at least 1 point in PAC-QOL satisfaction subscale score was 52.7 and 38.8% in the prucalopride and placebo groups, respectively (P=0.0035). Prucalopride had a good safety profile and was well tolerated. CONCLUSIONS: Prucalopride is effective, has a good safety profile, and is well tolerated for the treatment of men with chronic constipation.


Assuntos
Benzofuranos/uso terapêutico , Agonistas do Receptor 5-HT4 de Serotonina/uso terapêutico , Dor Abdominal/induzido quimicamente , Adulto , Idoso , Benzofuranos/efeitos adversos , Doença Crônica , Defecação , Diarreia/induzido quimicamente , Método Duplo-Cego , Cefaleia/induzido quimicamente , Humanos , Masculino , Registros Médicos , Pessoa de Meia-Idade , Náusea/induzido quimicamente , Qualidade de Vida , Agonistas do Receptor 5-HT4 de Serotonina/efeitos adversos , Índice de Gravidade de Doença , Inquéritos e Questionários
15.
United European Gastroenterol J ; 1(5): 375-84, 2013 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-24917986

RESUMO

BACKGROUND: Data on factors affecting treatment satisfaction in European women with chronic constipation are limited. OBJECTIVE: To assess factors associated with treatment satisfaction among European women with chronic constipation. METHODS: A 2011-2012 internet survey was conducted in men and women from 12 European countries. Respondents analysed were female with self-reported chronic constipation (≥1 symptoms for ≥6 months of lumpy/hard stools, feeling of incomplete evacuation, and pain during defecation, as well as <3 bowel movements/week). For laxative users, satisfaction with treatment, factors affecting satisfaction, and interactions with healthcare professionals were collected. RESULTS AND CONCLUSIONS: In total, 4805/50,319 participants fulfilled the inclusion criteria (female with chronic constipation). Of the laxative users (1575/4805), 57% (n = 896) were satisfied with their treatment, while 26% were neutral, and 17% dissatisfied. Dissatisfied respondents visited their GP less frequently in the past 12 months, were more likely to obtain over-the-counter laxatives, and took a dose higher than recommended more frequently than those satisfied. Respondents were most satisfied with ease of use of treatment and least satisfied with relief from bloating. Newer treatments aimed at alleviating symptoms, particularly bloating, are required for respondents neutral or dissatisfied with their current treatment.

16.
Frontline Gastroenterol ; 3(2): 66-71, 2012 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-28839636

RESUMO

The Clinical Research Networks of the National Institute of Health Research have transformed clinical research in the UK, leading to a doubling in the number of patients involved in clinical research studies over the past 3 years. This has been achieved by streamlining the trials approvals process, by providing local infrastructure such as research nurse support for clinical trials recruitment and through recognition of the time and funding necessary for clinicians to contribute to clinical research. Here, we describe the structure and roles of the Comprehensive Clinical Research Networks in gastrointestinal disease and hepatology, particularly in England. We will explain how the networks have already accelerated clinical research in gastrointestinal and liver disease, as well as provide a simple guide about how individual clinicians can contribute to ongoing studies via the networks.

17.
Frontline Gastroenterol ; 3(Suppl 1): i33-i35, 2012 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-28839690
18.
Qual Health Res ; 21(12): 1643-57, 2011 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-21788647

RESUMO

In this article we discuss the results of an ethnographic study of professionals' and patients' experiences within a specialist constipation clinic in England. Chronic constipation tends to be poorly understood and inadequately treated. Eleven patients were followed through their illness trajectory during a 5-month fieldwork period, involving 21 home interviews, clinic-based interviews, participant observation, and a focus group. Professionals were likewise observed and interviewed. The clinic could be broadly described as biopsychosocial in its approach. However, professionals expressed uncertainty about how best to provide biopsychosocial care and suggested that some patients were not "open" to psychosocial therapies or to discussing psychosocial aspects of their disease. Patients' concerns were with being taken seriously, receiving treatment, and narrating intersections of life events, emotional well-being, and the bowels. We situate these findings within the discourse of "functional" disorders and discuss why implementing a biopsychosocial approach is problematic in this case.


Assuntos
Constipação Intestinal/psicologia , Constipação Intestinal/terapia , Aceitação pelo Paciente de Cuidados de Saúde , Qualidade de Vida/psicologia , Adulto , Antropologia Cultural , Doença Crônica , Inglaterra , Feminino , Humanos , Entrevistas como Assunto , Laxantes/uso terapêutico , Masculino , Pessoa de Meia-Idade , Ambulatório Hospitalar , Aceitação pelo Paciente de Cuidados de Saúde/psicologia , Relações Profissional-Paciente , Encaminhamento e Consulta , Adulto Jovem
19.
Br J Hosp Med (Lond) ; 70(6): 339-43, 2009 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-19516211

RESUMO

Biliary imaging has changed as a result of technological advances, but the timing and modality of preoperative biliary tree imaging is controversial. An ideal imaging modality would be risk free and have a high sensitivity and specificity, a role fulfilled by magnetic resonance cholangiopancreatography (MRCP).


Assuntos
Sistema Biliar/patologia , Colangiopancreatografia por Ressonância Magnética/métodos , Coledocolitíase/diagnóstico , Adulto , Idoso , Idoso de 80 Anos ou mais , Estudos de Viabilidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Cuidados Pré-Operatórios/métodos , Sensibilidade e Especificidade
20.
Scand J Gastroenterol ; 43(3): 262-9, 2008 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-18266173

RESUMO

OBJECTIVE: Patients with functional constipation can be classified according to symptoms and physiological parameters as either having a disorder of defecation or having normal defecation. It is hypothesized that the disordered defecation, where it exists, is a causative factor of the constipation. However, the utility of this classification has yet to be proven in terms of predicting response to therapy. The definitions are non-specific and based on tests that are done in an artificial setting and with derived normal ranges. It is therefore possible that the symptoms and physiological parameters of a defecatory disorder may occur as a continuous spectrum in these patients, rather than defining a discrete entity or subtype. The aim of this study was to use cluster analysis and factor analysis of defecatory symptoms and physiological parameters to look for evidence of subgroups in patients with functional constipation. MATERIAL AND METHODS: Consecutive patients presenting to a specialist constipation clinic and satisfying the inclusion criteria were assessed to determine the severity of defecatory symptoms, and underwent isotope defecating proctography and the Sitzmark transit study. Assessments were made contemporaneously and results of any test not performed within 6 weeks of the initial assessment were excluded. Principle components analysis and cluster analysis were performed to look for evidence of subgroups. Relationships between evacuatory symptoms, index parameters, and test results were explored. The detailed and unselected nature of the analyses produced hundreds of test results, and statistically significant results were critically evaluated in this context. RESULTS: A total of 116 patients were studied (age range 18-73 years, mean 40.5 years). Based on the results of the transit study and proctography, 38% of patients showed evidence of slow transit constipation, 20% FDD (functional defecation disorder), 29% both, and 12% neither. Principle components analysis did not demonstrate an obvious dimension reduction for the variables tested. Cluster analysis (over 150 solutions tested) failed to show evidence of clustering. There were no useful predictive relationships between evacuatory symptoms, index parameters and test results. CONCLUSIONS: We used multiple statistical analyses to look for clustering and predictive relationships between clinical and physiological parameters in consecutive patients with functional constipation and found no evidence of the existence of a subgroup of patients with a defecatory disorder. This may be due to weaknesses in the study design, poor validity of the assessments performed, or that defecatory features do not identify a distinct pathophysiological entity, but rather are manifested variably as a continuous spectrum.


Assuntos
Canal Anal/fisiopatologia , Doenças Funcionais do Colo/complicações , Constipação Intestinal/complicações , Defecação/fisiologia , Adolescente , Adulto , Idoso , Doença Crônica , Doenças Funcionais do Colo/diagnóstico , Doenças Funcionais do Colo/fisiopatologia , Constipação Intestinal/diagnóstico , Constipação Intestinal/fisiopatologia , Defecografia , Feminino , Seguimentos , Trânsito Gastrointestinal/fisiologia , Humanos , Masculino , Pessoa de Meia-Idade , Prognóstico , Adulto Jovem
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