Face-to-face interviews versus Internet surveys: Comparison of two data collection methods in the Rome foundation global epidemiology study: Implications for population-based research.

BACKGROUND AND AIMS: The Rome Foundation Global Epidemiology Study (RFGES) assessed the prevalence, burden, and associated factors of Disorders of Gut-Brain Interaction (DGBI) in 33 countries around the world. Achieving worldwide sampling necessitated use of two different surveying methods: In-person household interviews (9 countries) and Internet surveys (26 countries). Two countries, China and Turkey, were surveyed with both methods. This paper examines the differences in the survey results with the two methods, as well as likely reasons for those differences. METHODS: The two RFGES survey methods are described in detail, and differences in DGBI findings summarized for household versus Internet surveys globally, and in more detail for China and Turkey. Logistic regression analysis was used to elucidate factors contributing to these differences. RESULTS: Overall, DGBI were only half as prevalent when assessed with household vs Internet surveys. Similar patterns of methodology-related DGBI differences were seen within both China and Turkey, but prevalence differences between the survey methods were dramatically larger in Turkey. No clear reasons for outcome differences by survey method were identified, although greater relative reduction in bowel and anorectal versus upper gastrointestinal disorders when household versus Internet surveying was used suggests an inhibiting influence of social sensitivity. CONCLUSIONS: The findings strongly indicate that besides affecting data quality, manpower needs and data collection time and costs, the choice of survey method is a substantial determinant of symptom reporting and DGBI prevalence outcomes. This has important implications for future DGBI research and epidemiological research more broadly.

Comparison of the epidemiology of disorders of gut-brain interaction in four Latin American countries: Results of The Rome Foundation Global Epidemiology Study.

BACKGROUND: In Latin America, there are scarce data on the epidemiology of DGBI. The Rome Foundation Global Epidemiology Study (RFGES) Internet survey included 26 countries, four from Latin America: Argentina, Brazil, Colombia, and Mexico, with a 40.3% prevalence of Rome IV DGBI. We aimed at comparing the prevalence of DGBI and associated factors among these countries. METHODS: The frequency of DGBI by anatomical region, specific diagnoses, sex, age, diet, healthcare access, anxiety, depression, and HRQOL, were analyzed and compared. RESULTS: Subjects included Argentina n = 2057, Brazil = 2004, Colombia = 2007, and Mexico = 2001. The most common DGBI were bowel (35.5%), gastroduodenal (11.9%), and anorectal (10.0%). Argentina had the highest prevalence of functional diarrhea (p = 0.006) and IBS-D; Brazil, esophageal, gastroduodenal disorders, and functional dyspepsia; Mexico functional heartburn (all <0.001). Overall, DGBI were more common in women vs. men and decreased with age. Bowel disorders were more common in the 18-39 (46%) vs. 40-64-year (39%) groups. Diet was also different between those with DGBI vs. those without with subtle differences between countries. Subjects endorsing criteria for esophageal, gastroduodenal, and anorectal disorders from Mexico, more commonly consulted physicians for bowel symptoms vs. those from Argentina, Brazil, and Colombia. General practitioners were the most frequently consulted, by Mexicans (50.42%) and Colombians (40.80%), followed by gastroenterologists. Anxiety and depression were more common in DGBI individuals in Argentina and Brazil vs. Mexico and Colombia, and they had lower HRQOL. CONCLUSIONS: The prevalence of upper and lower DGBI, as well as the burden of illness, psychological impact and HRQOL, differ between these Latin American countries.

Assessment of Safety and Efficacy of Tofacitinib, Stratified by Age, in Patients from the Ulcerative Colitis Clinical Program.

BACKGROUND: In patients with ulcerative colitis (UC), risks of infection and malignancies increase with age. Tofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of UC. This analysis assessed age as a risk factor for adverse events of special interest (AESI) in the tofacitinib UC clinical program. METHODS: Data were from phase 2 and 3 induction studies, a phase 3 maintenance study, and an open-label, long-term extension study. Efficacy and/or safety outcomes were analyzed in the Induction, Maintenance, and Overall Cohorts (patients who received ≥ 1 dose of tofacitinib), stratified by age. The effects of baseline demographic and disease-related factors on AESI incidence were assessed by Cox proportional-hazards regression analysis. RESULTS: In the Overall Cohort (1157 patients with ≤ 6.8 years' tofacitinib treatment), age was a statistically significant predictor of herpes zoster (HZ), malignancies excluding nonmelanoma skin cancer (NMSC), and NMSC. Other statistically significant predictors included prior tumor necrosis factor inhibitor failure for HZ, NMSC, and opportunistic infection events, and prior duration of UC for malignancies excluding NMSC. In the Induction and Maintenance Cohorts, a higher proportion of tofacitinib-treated than placebo-treated patients (numerical difference) achieved the efficacy endpoints (endoscopic improvement, clinical remission, clinical response) across all age groups. CONCLUSIONS: Older individuals receiving tofacitinib as induction and maintenance therapy to treat UC may have an increased risk of HZ, malignancies (excluding NMSC), and NMSC versus similarly treated younger patients, consistent with findings from the general population. Across all age groups, tofacitinib demonstrated greater efficacy than placebo as an induction and maintenance therapy. CLINICALTRIALS.GOV REGISTRATION NUMBERS: NCT00787202; NCT01465763; NCT01458951; NCT01458574; NCT01470612.

Age was assessed as a risk factor for adverse events of special interest in the tofacitinib ulcerative colitis clinical program. Older individuals receiving tofacitinib may have an increased risk of herpes zoster, malignancies (excluding nonmelanoma skin cancer), and nonmelanoma skin cancer versus similarly treated younger patients.

Worldwide Prevalence and Burden of Functional Gastrointestinal Disorders, Results of Rome Foundation Global Study.

BACKGROUND & AIMS: Although functional gastrointestinal disorders (FGIDs), now called disorders of gut-brain interaction, have major economic effects on health care systems and adversely affect quality of life, little is known about their global prevalence and distribution. We investigated the prevalence of and factors associated with 22 FGIDs, in 33 countries on 6 continents. METHODS: Data were collected via the Internet in 24 countries, personal interviews in 7 countries, and both in 2 countries, using the Rome IV diagnostic questionnaire, Rome III irritable bowel syndrome questions, and 80 items to identify variables associated with FGIDs. Data collection methods differed for Internet and household groups, so data analyses were conducted and reported separately. RESULTS: Among the 73,076 adult respondents (49.5% women), diagnostic criteria were met for at least 1 FGID by 40.3% persons who completed the Internet surveys (95% confidence interval [CI], 39.9-40.7) and 20.7% of persons who completed the household surveys (95% CI, 20.2-21.3). FGIDs were more prevalent among women than men, based on responses to the Internet survey (odds ratio, 1.7; 95% CI, 1.6-1.7) and household survey (odds ratio, 1.3; 95% CI, 1.3-1.4). FGIDs were associated with lower quality of life and more frequent doctor visits. Proportions of subjects with irritable bowel syndrome were lower when the Rome IV criteria were used, compared with the Rome III criteria, in the Internet survey (4.1% vs 10.1%) and household survey (1.5% vs 3.5%). CONCLUSIONS: In a large-scale multinational study, we found that more than 40% of persons worldwide have FGIDs, which affect quality of life and health care use. Although the absolute prevalence was higher among Internet respondents, similar trends and relative distributions were found in people who completed Internet vs personal interviews.

Review of the epidemiology and burden of ulcerative colitis in Latin America.

The incidence and prevalence of ulcerative colitis (UC) has been reported to be rising in newly industrialised regions, such as Latin America. Here, we review data from published studies reporting demographics and clinical aspects of UC in Latin America to further understand epidemiology and disease burden. The incidence and prevalence of UC in Latin America varied between regions and studies, ranging between 0.04 to 8.00/100,000 and 0.23 to 76.1/100,000, respectively, and generally increased over the period from 1986 to 2015. The majority of patients with UC were female (53.6-72.6%) and urban residents (77.8-97.4%). Extraintestinal manifestations were reported in approximately 26-89.4% of patients. Use of biologic therapies was generally low (0.8-16.2%), with the exception of Mato Grosso do Sul, Brazil, with a greater proportion of patients tending to receive 5-aminosalicylates, immunosuppressants or corticosteroids; colectomy rates varied between studies (1.5-22%). A high proportion of patients had moderate to severe UC (45.9-73.0%) and, in 11 of 19 studies, the greatest proportion of patients had extensive disease (pancolitis). Colorectal cancer (0-1.7%) and mortality rates (0-7.6%) were low. This evaluation of published studies may influence therapeutic approaches and the development of strategies to improve healthcare access and patient outcomes, although further high-quality studies are required in patients with UC in Latin America.

Multicultural Aspects in Functional Gastrointestinal Disorders (FGIDs).

Cross-cultural factors are important in functional gastrointestinal disorders (FGIDs). In the setting of FGIDs, the aims of this review were to: 1) engender interest in global aspects; 2) gain a clearer understanding of culture, race and ethnicity and their effect on patient care and research; 3) facilitate cross-cultural clinical and research competency; and 4) improve and foster the quality and conduct of cross-cultural, multinational research. Cultural variables are inevitably present in the physician-patient context. Food and diets, which differ among cultural groups, are perceived globally as related to or blamed for symptoms. From an individual perspective, biological aspects, such as genetics, the microbiome, environmental hygiene, cytokines and the nervous system, which are affected by cultural differences, are all relevant. Of equal importance are issues related to gender, symptom reporting and interpretation, and family systems. From the physician's viewpoint, understanding the patient's explanatory model of illness, especially in a cultural context, affects patient care and patient education in a multicultural environment. Differences in the definition and use of Complementary and Alternative Medicine and other issues related to healthcare services for the FGIDs are also a relevant cross-cultural issue. This paper highlights the importance of cross-cultural competence in clinical medicine and research.

Portuguese validation of the Rome III diagnostic questionnaire for functional dyspepsia / Validação do questionário diagnóstico de Roma III para dispepsia funcional na língua portuguesa

CONTEXT: Validated questionnaires are essential tools to be utilized in epidemiological research. At the moment there are no Rome III diagnostic questionnaires translated to Portuguese. OBJECTIVE: To validate the Portuguese version of the Rome III Diagnostic Questionnaire for Functional Dyspepsia. METHODS: The questionnaire has been translated following the Rome III recommendations. Hundred and nine consecutive patients with functional dyspepsia answered the questionnaire. The control group comprised 100 healthy consecutive blood donors, without digestive problems. Internal consistency, reproducibility, responsiveness, discriminate validity and content analysis were evaluated. RESULTS: Cronbach's α coefficient was 0.92. The questionnaire showed reliability: the patients answered it in a similar way on two distinct occasions and their responses were substantially very similar (P = 1.00). The questionnaire was able to demonstrate changes when they occur (P<0.01). Two "blinded" gastroenterologists agreed that the questionnaire adequately evaluated Functional Dyspepsia. When we compared the answers between patients and controls, the questionnaire showed that 5.3 percent of controls had Functional Dyspepsia symptoms compared with 91.2 percent of the patients (P<0.01). CONCLUSION: The Rome III Diagnostic Questionnaire for Functional Dyspepsia is ready to be used in clinical researches in lusophone countries, as it has been successfully validated in Portuguese.

CONTEXTO: Questionários validados são ferramentas essenciais para serem utilizados em estudos epidemiológicos. No momento não existem questionários diagnósticos de Roma III traduzidos para português. OBJETIVO: Validar a versão em português do Questionário Diagnóstico de Roma III para Dispepsia Funcional. MÉTODOS: O questionário foi traduzido seguindo as recomendações de Roma III. Cento e nove pacientes consecutivos com dispepsia funcional responderam ao questionário. O grupo controle foi composto por 100 doadores de sangue consecutivos, sem problemas digestivos. Consistência interna, reprodutibilidade, sensibilidade, validade discriminante e análise de conteúdo foram avaliadas. RESULTADOS: O coeficiente αde Cronbach foi de 0,92. O questionário mostrou reprodutibilidade: os pacientes responderam-no de forma semelhante em duas ocasiões distintas e suas respostas foram substancialmente semelhantes (P = 1,00). O questionário foi capaz de demonstrar alterações quando elas ocorreram (P<0,01). Dois gastroenterologistas "cegos" concordaram que o questionário avalia a dispepsia funcional adequadamente. Quando comparadas as respostas entre pacientes e controles, o questionário mostrou que 5,3 por cento dos controles e 91,2 por cento dos pacientes tinham sintomas de dispepsia funcional (P<0,01). CONCLUSÃO: O Questionário Diagnóstico de Roma III para Dispepsia Funcional está pronto para ser utilizado em pesquisas clínicas em países lusófonos, como foi validado com sucesso para o português.

Portuguese validation of the Rome III diagnostic questionnaire for functional dyspepsia.

CONTEXT: Validated questionnaires are essential tools to be utilized in epidemiological research. At the moment there are no Rome III diagnostic questionnaires translated to Portuguese. OBJECTIVE: To validate the Portuguese version of the Rome III Diagnostic Questionnaire for Functional Dyspepsia. METHODS: The questionnaire has been translated following the Rome III recommendations. Hundred and nine consecutive patients with functional dyspepsia answered the questionnaire. The control group comprised 100 healthy consecutive blood donors, without digestive problems. Internal consistency, reproducibility, responsiveness, discriminate validity and content analysis were evaluated. RESULTS: Cronbach's α coefficient was 0.92. The questionnaire showed reliability: the patients answered it in a similar way on two distinct occasions and their responses were substantially very similar (P = 1.00). The questionnaire was able to demonstrate changes when they occur (P<0.01). Two "blinded" gastroenterologists agreed that the questionnaire adequately evaluated Functional Dyspepsia. When we compared the answers between patients and controls, the questionnaire showed that 5.3% of controls had Functional Dyspepsia symptoms compared with 91.2% of the patients (P<0.01). CONCLUSION: The Rome III Diagnostic Questionnaire for Functional Dyspepsia is ready to be used in clinical researches in lusophone countries, as it has been successfully validated in Portuguese.

Clinical Bioethics Committees: a Brazilian experience.

Since its beginning, Bioethics has been related to medical decision making. In health settings, difficult dilemmas, critical situations, controversial decisions are problems that clinical Bioethics reflects on. Institutional Ethics Committees is a general and ambiguous denomination to many different activities. In Brazilian hospitals, we have three different kinds of ethics and bioethics committees: Medical Ethics Committees, Research Ethics Committees and Clinical Bioethics Committees. The first implemented committees were the Medical Ethics Committees, whose objective is to evaluate professional ethics conflicts. These committees were proposed by the Conselho Federal de Medicina (Brazilian Medicine Council). In 1988, the Brazilian government, through the Conselho Nacional de Saude (Brazilian National Health Council) proposed the first research guidelines: Resolucao 01/88, updated in 1996 by Resolucao 196/96. One of these guidelines created the Research Ethics Committees. The first one was created in the Hospital Sao Lucas and the second in the Hospital de Clinicas de Porto Alegre, both in Porto Alegre, Rio Grande do Sul. In 1993, the Hospital de Clinicas de Porto Alegre created the first Brazilian Clinical Bioethics Committee. A Clinical Bioethics Committee can be defined as an interdisciplinary group of health professionals and other persons, whose objective is to provide consultancy on ethical questions and suggest institutional ethical guidelines, in a transdisciplinary perspective. In healthcare institutions, especially in hospitals, Clinical Bioethics Committees can help different segments in critical decision-making that involves ethical, moral, legal or social issues. The activities of a Clinical Bioethics Committee can be reactive or proactive. Consultancy is the typical reactive activity. Clinical Bioethics rounds are the example of proactive activity. In this study, we will present two different Brazilian experiences in Clinical Bioethics Committees: Hospital Sao Lucas and Hospital de Clinicas de Porto Alegre.

[The Latin-American Consensus on Chronic Constipation]. / Consenso Latinoamericano de Estreñimiento Crónico.

The Latin-American Consensus on Chronic Constipation aimed to establish guidelines to improve the identification, diagnosis and treatment of this disorder in the region. Two coordinators and an honorary coordinator established the process and the topics to be discussed, based on a systematic review of the literature published in the previous 10 years, since 1995. Seventeen members participated with the support of their local gastroenterology societies. The members reviewed the different subjects based on the levels of evidence and grades of recommendation; the topics were then discussed in a plenary session. A written report was drafted and the coordinators prepared the final declarations to be submitted to a vote by all the members in October 2006. The consensus concluded that chronic constipation has an estimated prevalence of 5-21% in the region, with a female-to-male ratio of 3:1. Among individuals with constipation, 75% use some type of medication, with more than 50% using home remedies. A diagnosis based on Rome Criteria was recommended and diagnostic testing only in persons older than 50 years or with alarm symptoms. The use of barium enema as an initial investigation was recommended only in countries with a high prevalence of idiopathic megacolon or Chagas' disease. Recommendations on treatment included an increase in dietary fiber of up to 25-30 g/day (grade C). No evidence was found to recommend measures such as exercise, increased water intake, or frequent visits to the toilet. Fiber supplements such as Psyllium received a grade B and pharmacological treatments such as tegaserod and polyethylene glycol, both grade A. There was insufficient evidence to recommend lactulose, but the consensus did not disadvise its use when necessary. Complementary investigations such as colonic transit followed by anorectal manometry and defecography were only recommended to rule out colonic inertia and/or obstructive defecation in patients not responding to treatment. Biofeedback was recommended (grade B) for those with pelvic dyssynergia.

Consenso Latinoamericano de Estreñimiento Crónico / The Latin-American Consensus on Chronic Constipation aimed to establish guidelines to improve the identification, diagnosis and treatment of this disorder in the region. Two coordinators and an honorary coordinator established the process and the topics to be discussed, based on a systematic review

El Consenso Latinoamericano de Estreñimiento Crónico se realizó con el objeto de proveer guías para mejorar la identificación, el diagnóstico y el tratamiento de este trastorno en la región. Dos coordinadores, y uno honorario, establecieron las líneas de consenso, basado en una revisión sistemática de la literatura médica de los últimos 10 años a partir de 1995. Participaron 17 miembros con el aval de sus respectivas sociedades locales de gastroenterología. Éstos revisaron y presentaron los temas con sus niveles de evidencia y grados de recomendación para discutirlos en una reunión plenaria. Tras un informe final de los miembros, los coordinadores prepararon las declaraciones finales para someterlas a votación en octubre de 2006. El consenso concluyó que el estreñimiento crónico tiene una prevalencia estimada del 5-21% en la región, con una relación mujer:varón de 3:1. El 75% de los sujetos que lo presenta utiliza algún tipo de medicamentos y más del 50% usa medicamentos caseros. Se recomendó un diagnóstico basado en los Criterios de Roma y los estudios diagnósticos sólo en pacientes mayores de 50 años o con algún signo de alarma. El uso de enema de colon se recomendó como investigación inicial en países con elevada frecuencia de megacolon idiopático y/o enfermedad de Chagas. En cuanto al tratamiento, se recomendó incrementar la fibra en la dieta a 25-30 g/día (grado C) y no se encontraron evidencias para ciertas medidas, como el ejercicio, el aumento de la ingesta de agua o las visitas programadas al excusado. El Psyllium recibió recomendación grado B y tratamientos farmacológicos, como tegaserod y polietilenglicol grado A. No se encontraron suficientes evidencias para recomendar la administración de lactulosa, pero no se desaprobó su uso cuando fuera necesario. Los estudios complementarios, como el tránsito colónico seguido de manometría anorrectal y defecografía, sólo se recomendaron para descartar la inercia colónica y/o la obstrucción funcional en pacientes que no respondieran al tratamiento. La biorretroalimentación se recomendó (grado B) en la disinergia del suelo pélvico

The Latin-American Consensus on Chronic Constipation aimed to establish guidelines to improve the identification, diagnosis and treatment of this disorder in the region. Two coordinators and an honorary coordinator established the process and the topics to be discussed, based on a systematic review of the literature published in the previous 10 years, since 1995. Seventeen members participated with the support of their local gastroenterology societies. The members reviewed the different subjects based on the levels of evidence and grades of recommendation; the topics were then discussed in a plenary session. A written report was drafted and the coordinators prepared the final declarations to be submitted to a vote by all the members in October 2006. The consensus concluded that chronic constipation has an estimated prevalence of 5-21% in the region, with a female-to-male ratio of 3:1. Among individuals with constipation, 75% use some type of medication, with more than 50% using home remedies. A diagnosis based on Rome Criteria was recommended and diagnostic testing only in persons older than 50 years or with alarm symptoms. The use of barium enema as an initial investigation was recommended only in countries with a high prevalence of idiopathic megacolon or Chagas' disease. Recommendations on treatment included an increase in dietary fiber of up to 25-30 g/day (grade C). No evidence was found to recommend measures such as exercise, increased water intake, or frequent visits to the toilet. Fiber supplements such as Psyllium received a grade B and pharmacological treatments such as tegaserod and polyethylene glycol, both grade A. There was insufficient evidence to recommend lactulose, but the consensus did not disadvise its use when necessary. Complementary investigations such as colonic transit followed by anorectal manometry and defecography were only recommended to rule out colonic inertia and/or obstructive defecation in patients not responding to treatment. Biofeedback was recommended (grade B) for those with pelvic dyssynergia (AU)

Eutanasia: una reflexión desde la mirada Bioética / Euthanasia: reflections from the bioethical perspective

El autor discute el tema de la eutanasia en dos aspectos: su significado conceptual y la dimensión actual de los dilemas morales que envuelven al paciente que solicita morir debido a los sufrimientos insoportables por causa de su enfermedad.Los conceptos de Edgard y Graber Veatch, H. Hairy, M. Hairy son presentados y discutidos. También son presentados los conceptos que califican la eutanasia a través de sus formas voluntaria, involuntaria, no voluntaria y pasiva, el concepto deldoble efecto son discutidas y rebatidas. Son analizados los límites de la autonomía del paciente. El autor disiente de la posición de Engelhardt que es un defensor de la autonomía total sin restricciones como un derecho del enfermo y acepta el pensamientode Pellegrino y Thomasma que proponen que tanto el médico como los pacientes tienen compromisos con los principios morales fundamentales. Este es un argumento poderosa por lo cual no se debe aceptar la eutanasia activa.

Psychosocial aspects of the functional gastrointestinal disorders.

This report reviews recent research on the psychosocial aspects of the functional gastrointestinal disorders (FGIDs). A review and evaluation of existing literature was conducted by a multidisciplinary committee of experts in this field. This report is a synopsis of a chapter published in the Rome III book. The committee reached consensus in finding considerable evidence supporting the association between psychological distress, childhood trauma and recent environmental stress, and several of the FGIDs but noted that this association is not specific to FGIDs. There is also considerable evidence that psychosocial variables are important determinants of the outcomes of global well-being, health-related quality of life, and health care seeking. In line with these descriptive findings, there is now increasing evidence that a number of psychological treatments and antidepressants are helpful in reducing symptoms and other consequences of the FGIDs in children and adults. The FGIDs are a result of complex interactions between biological, psychological, and social factors, and they can only be treated satisfactorily when all these factors are considered and addressed. Therefore, knowledge about the psychosocial aspects of FGIDs is fundamental and critical to the understanding, assessment, and treatment of these disorders. More extensive physician training is needed if these aspects of treatment are to be used effectively and widely in clinical practice.

[Efficacy of the dosing regimen of pantoprazole 40 mg, amoxicillin 1000 mg and clarithromycin 500 mg, twice daily for 7 days, in the eradication of Helicobacter pylori in patients with peptic ulcer]. / Eficácia do regime terapêutico empregando a associação de pantoprazol, claritromicina e amoxicilina, durante uma semana, na erradicação do Helicobacter pylori em pacientes com úlcera péptica.

AIM: This is an open label, multicenter trial to determine the efficacy of the association of pantoprazole, clarithromycin and amoxicillin to eradicate Helicobacter pylori in patients with peptic ulcer. MATERIAL AND METHODS: Seventy-one patients (36 females, 35 males, average age 41.9 years) from three Brazilian university centers (located in the cities of Belo Horizonte and Porto Alegre), with peptic ulcers confirmed by endoscopy, and infections by H. pylori proven by at least two diagnostic testings were admitted in the trial. An association of pantoprazole 40 mg, clarithromycin 500 mg and amoxicillin 1.0 g was administered to patients twice daily for 7 days. RESULTS: By the end of treatment all patients were examined for digestive symptoms, presence of adverse events, and treatment adherence. Sixty days after the end of the treatment a new endoscopy with biopsies and respiratory function testing with 13C-urea breath test was performed in order to determine the eradication rates of that microorganism. Patients showing negative results at least in the 13C-urea breath test and in one other test (urease or histology) were considered H. pylori-negative. By the end of the trial, 60/69 (87%, CI 95% = 78.9-94.8) patients had the H. pylori eradicated in the per protocol analysis and 60/71 (84.5%, CI 95% = 76-92.9) in the intention-to-treat analysis. One patient was withdrawn from the trial due to a diarrhea. Twelve (16.9%) patients showed adverse symptoms that were deemed as mild symptoms. CONCLUSION: Our conclusion is that the association of pantoprazole, amoxicillin and clarithromycin administered during 7 days is an effective and well-tolerated alternative as regards the eradication of H. pylori in patients with peptic ulcer in Brazil.

Eficácia do regime terapêutico empregando a associação de pantoprazol, claritromicina e amoxicilina, durante uma semana, na erradicação do Helicobacter pylori em pacientes com úlcera péptica / Efficacy of the dosing regimen of pantoprazole 40 mg, amoxicillin 1000 mg and clarithromycin 500 mg, twice daily for 7 days, in the eradication of Helicobacter pylori in patients with peptic ulcer

OBJETIVO: Estudo multicêntrico, aberto, delineado para determinar a eficácia da associação de pantoprazol, claritromicina e amoxicilina, na erradicação do Helicobacter pylori em pacientes portadores de úlcera péptica. MATERIAL E MÉTODOS: Setenta e um pacientes (36 mulheres, 35 homens, idade média 41,9 anos) provenientes de três centros universitários brasileiros (Belo Horizonte e Porto Alegre) com úlcera péptica confirmada à endoscopia e infecção por H. pylori comprovada por, no mínimo, dois testes diagnósticos. Os pacientes foram tratados com a associação de pantoprazol 40 mg, claritromicina 500 mg e amoxicilina 1,0 g, administrada duas vezes ao dia, durante 7 dias. RESULTADOS: Ao final do tratamento, os pacientes foram reexaminados para avaliação dos sintomas gastrointestinais, presença de eventos adversos e aderência ao tratamento. Nova endoscopia com biopsias e teste respiratório com 13C-uréia foram repetidos 60 dias após o término do tratamento para determinação das taxas de erradicação do microrganismo. Foram considerados H. pylori negativos os pacientes com, pelo menos, o teste respiratório com 13C-uréia e mais um teste (teste da urease ou histologia) negativos. Ao final do estudo 60/69 (87 por cento, 95 por cento = 78,9-94,8) pacientes erradicaram o H. pylori na análise por protocolo e 60/71 (84,5 por cento, 95 por cento = 76-92,9) na análise por intenção de tratamento. Um paciente interrompeu o tratamento devido à diarréia. Doze pacientes (16,9 por cento) apresentaram sintomas adversos e considerados de leve intensidade. CONCLUSAO: A associação de pantoprazol, amoxicilina e claritromicina por 7 dias constitui alternativa eficaz e bem tolerada para a erradicação do H. pylori em portadores de úlcera péptica no Brasil.

Os motivos e as expectativas dos pacientes com dispepsia não ulcerosa frente à consulta médica / Reasons and expectations of patients with ulcer-like dyspepsia at the medical visit

O termo dispepsia refere-se a sintomas que se originam no trato gastrintestinal superior, geralmente usado para definir dor ou desconforto abdominal superior. Os critérios de Roma I para o diagnóstico de dispepsia não-ulcerosa são dor ou desconforto abdominal superior crônico ou recorrente, por um período mínimo de um mês, com sintomas presentes em mais de 25por cento do tempo, sem evidências clínicas ou laboratóriais de doença orgânica. Objetivo: avaliar os motivos que trazem os pacientes com dispepsia não-ulcerosa ao médico e identificar suas expectativas frente as possíveis abordagens terapêutica, além de avaliar alguns aspectos psicológicos dos dispépticos e sua relação com a procura dos serviços de saúde. Métodos: Este é um estudo de caso de controles; os casos constituíram-se por 45 pacientes com critérios diagnósticos de dispepsia não-ulcerosa submetidos a endoscopia digestiva alta para excluir doenças orgânicas; os controles foram compostos por 46 pacientes com diversas doenças acompanhados no ambulatório de medicina interna. Os dados foram recolhidos através da aplicação de um questionário padronizado.Resultado: No que se refere aos problemas do cotidiano (estressants ambientais), na época da aconsulta, uma proporção significativa dos casos referiu ter dois (27por cento), o que ocorreu somente em 6 por cento dos controles (OR = 5,2; IC95por cento = 1,22-25,5). Em relação aos motivos que levaram os pacientes a procurar ajuda médica, a exacerbação recente dos sintomas foi mais frequente entre os controles (OR = 0,21;IC95por cento =0,06-0,6) enquanto a "cacerofobia" foi o principal motivo entre os pacientes com dispepsia ( OR = 11,0;IC95por cento = 2,12-76,4), seguido por dúvidas com relação a diagnósticos prévios (OR = 5,5; IC95por cento = 1,03-54,5). Conclusões: A maior prevalência de estressantes ambientais e de comportamento de medo ou dúvida diagnóstica do doente dispéptico sugere a importância dos fatores psicossociais na modulação dos sintomas das doenças funcionais do tubo digestivo, podendo influenciar os objetivos da consulta médica e ter desdobramentos na abordagem terapêutica

Úlceras de ceco secundárias a antiinflamatórios não-esteroidais / Cecal ulcers associated to nonsteroidal anti-inflammatory drugs

Tradicionalmente, os antiinflamatórios não-esteroidais (AINE) são associados a lesões gastroduodenais. Este estudo relata dois casos de úlcera de ceco causadas por AINE que se apresentam clinicamente por hemorragia digestiva

Um breve histórico do consentimento informado / A Brief Background on Informed Consent

A questäo ética de consentimento se desenvolve historicamente em dois contextos distintos mas interligados: no contexto terapêutico, no qual há um relacionamento entre o médico e o paciente e, no contexto de pesquisas em seres humanos doentes e saudáveis. Há uma preocupaçäo neste artigo de mostrar a evoluçäo histórica do compromisso com o consentimento como maneira de salvaguardar e proteger a dignidade do ser humano, seja como paciente, seja como sujeito de pesquisa. As regulamentações internacionais e nacionais na área de pesquisa em seres humanos todos insistem fortemente sobre a necessidade de consentimento adequado