ABSTRACT Aim To analyze the influence of the -31 C/T polymorphism of the interleukin-1β gene on Helicobacter pylori eradication therapy success in patients with functional dyspepsia. Methods Functional dyspepsia was diagnosed according to the Rome III criteria. All patients underwent upper gastrointestinal endoscopy, and gastric biopsies were obtained at screening and 12 months after randomization (last follow-up visit). Urease test and histological examination were performed to define the H. pylori status. Patients received twice-daily amoxicillin, clarithromycin and omeprazole for 10 days. Genotyping of the interleukin-1beta -31 C/T polymorphism (rs1143627) was performed using polymerase chain reaction-restriction fragment length polymorphism. Results One hundred forty-nine patients received treatment with triple therapy for H. pylori eradication. Only one patient was lost to follow-up, and adherence to study medication was 94.6%. A total of 148 patients (mean age 46.08 ± 12.24 years; 81.8% women) were evaluated for the influence of the interleukin-1beta -31 C/T polymorphism on the outcome of H. pylori eradication therapy. After treatment, bacteria were eradicated in 87% of patients (129/148). Genotype frequencies of the polymorphism were as follows: CC, 38/148 (25.7%); CT, 71/148 (47.9%); and TT, 39/148 (26.4%). Successful eradication rate was 78.9%, 94.4% and 82.1% for the CC, CT and TT genotypes, respectively. The CT genotype was significantly associated with successful H. pylori eradication (p= 0.039). Conclusion This study suggests that the CT genotype of the interleukin-1beta -31 C/T polymorphism plays a role in the successful eradication of H. pylori among patients with functional dyspepsia.

Abstract Functional dyspepsia and lactose intolerance (adult-type hypolactasia, ATH) are common conditions that may coexist or even be confounded. Their clinical presentation can be similar, however, lactose intolerance does not form part of the diagnostic investigation of functional dyspepsia. Studies on the association between functional dyspepsia and ATH are scarce. This study aimed to evaluate whether ATH is associated with symptoms of functional dyspepsia. Patients fulfilling the Rome III diagnostic criteria for functional dyspepsia underwent genetic testing for ATH. Dyspeptic symptoms were evaluated and scored according to a validated questionnaire. The diagnostic criteria for ATH was a CC genotype for the -13910C/T polymorphism, located upstream of the lactase gene. The mean scores for dyspeptic symptoms were compared between patients with ATH and those with lactase persistence. A total of 197 functional dyspeptic patients were included in the study. Mean age was 47.7 years and 82.7% patients were women. Eighty-eight patients (44.7%) had a diagnosis of ATH. Abdominal bloating scores were higher in ATH patients compared to the lactase persistent patients (P=0.014). The remaining dyspeptic symptom scores were not significantly different between the two groups. The study results demonstrate an association between ATH and bloating in patients with functional dyspepsia.

RESUMO Contexto A hipolactasia primária é uma condição muito frequente na qual há redução da atividade da lactase na mucosa intestinal.A presença de sintomas abdominais devidos à má absorção da lactose presente em alguns casos caracteriza a intolerância à lactose. Objetivo Avaliar a eficácia de um produto contendo lactase exógena em comprimidos comparativamente a de um produto comparador com eficácia comprovada em pacientes portadores de intolerância à lactose. Métodos Estudo multicêntrico, randomizado, de grupos paralelos, com investigador cego, comparativo de não-inferioridade. Cento e vinte e nove (129) pacientes adultos portadores de intolerância à lactose e teste do hidrogênio no ar expirado compatível com o diagnóstico de hipolactasia foram randomizados para receber o produto experimental (Perlatte(r) - Eurofarma Laboratórios S.A.) ou o produto comparador (Lactaid(r) - McNeil Nutritionals, EUA), por via oral (um comprimido, três vezes ao dia), durante 42 dias consecutivos. Resultados Os dados dos 128 pacientes que efetivamente receberam o tratamento do estudo foram avaliados (66 tratados com o produto experimental e 62 com o produto comparador). Os dois grupos se mostraram homogêneos quanto aos dados demográficos e clínicos basais. A média da concentração do hidrogênio expirado aos 90 minutos no teste realizado ao final do tratamento (Dia 42) foi significativamente menor no grupo tratado com o produto experimental (17±18 ppm versus 34±47 ppm na população por protocolo). A diferença entre as médias dos dois grupos foi de -17 ppm (intervalo de confiança de 95% [IC95%]: -31,03; -3,17). O limite superior do IC95% não ultrapassou a margem de não-inferioridade estipulada a priori (7,5 ppm). As análises secundárias de eficácia confirmaram a semelhança entre os tratamentos (populações por protocolo e com intenção de tratamento). A tolerabilidade foi excelente em ambos os grupos e não houve relato de eventos adversos graves relacionados ao produto. Conclusão O produto experimental se mostrou não-inferior ao produto comparador, indicando sua eficácia no tratamento substitutivo da lactase endógena em pacientes portadores de intolerância à lactose.

ABSTRACT Background Primary hypolactasia is a common condition where a reduced lactase activity in the intestinal mucosa is present. The presence of abdominal symptoms due to poor absorption of lactose, which are present in some cases, is a characteristic of lactose intolerance. , Objective Evaluate the efficacy of a product containing exogenous lactase in tablet form compared to a reference product with proven effectiveness in patients with lactose intolerance. Methods Multicentre, randomized, parallel group, single-blind, comparative non-inferiority study. One hundred twenty-nine (129) adult lactose intolerance patients with hydrogen breath test results consistent with a diagnosis of hypolactasia were randomly assigned to receive the experimental product (Perlatte(r) - Eurofarma Laboratórios S.A.) or the reference product (Lactaid(r) - McNeilNutritionals, USA) orally (one tablet, three times per day) for 42 consecutive days. Results Data from 128 patients who actually received the studied treatments were analysed (66 were treated with the experimental product and 62 with the reference product). The two groups presented with similar baseline clinical and demographic data. Mean exhaled hydrogen concentration tested at 90 minutes after the last treatment (Day 42) was significantly lower in the experimental product treated group (17±18 ppm versus 34±47 ppm) in the per protocol population. The difference between the means of the two groups was -17 ppm (95% confidence interval [95% CI]: -31.03; -3.17). The upper limit of the 95% CI did not exceed the a priori non-inferiority limit (7.5 ppm). Secondary efficacy analyses confirmed that the treatments were similar (per protocol and intention to treat population). The tolerability was excellent in both groups, and there were no reports of serious adverse events related to the study treatment. Conclusion The experimental product was non-inferior to the reference product, indicating that it was an effective replacement therapy for endogenous lactase in lactose intolerance patients.

RACIONAL: A limpeza do cólon para o exame de colonoscopia deve ser completa de modo a permitir a visualização e inspeção do lúmen intestinal. O agente de limpeza ideal deveria ser de fácil administração, com baixo custo e com o mínimo de efeitos colaterais. O picosulfato de sódio juntamente com o citrato de magnésio é um estimulante catártico e o manitol é um laxativo osmótico, ambos geralmente utilizados para este propósito. OBJETIVOS: Verificar a limpeza do cólon comparando o uso de manitol e picosulfato de sódio assim como avaliar o nível de satisfação do paciente, presença de espuma, dor e distensão abdominal em pacientes hospitalizados submetidos a colonoscopia. MÉTODOS: Estudo prospectivo, randomizado, simples-cego com 80 pacientes que comparou dois grupos: manitol (40) e picosulfato de sódio (40). Ambos os grupos receberam a mesma orientação dietética. O estudo foi aprovado pelo Comitê de Ética do hospital e pelo Comitê de Pesquisa. O endoscopista foi cego para o tipo de preparo. Desfechos avaliados: nível de limpeza do cólon, satisfação do paciente, presença de espuma, dor e distensão abdominal e tempo de duração do exame. Os dados foram analisados pelas médias de testes qui-quadrado para proporções e Mann-Whitney para amostras independentes. RESULTADOS: Não houve diferença significativa entre os grupos em relação ao nível de limpeza do cólon, satisfação do paciente, presença de espuma, dor abdominal e tempo de exame. Quinze porcento dos exames do grupo manitol foram interrompidos enquanto que grupo picosulfato de sódio foi de 5%. A presença de espuma foi similar em ambos os grupos. A média de duração do exame foi de 28h 44min para o grupo manitol e 35h 59min para o grupo picosulfato de sódio. A distensão abdominal foi mais freqüente no grupo manitol. Se eles tivessem que repetir o exame, a resposta foi de 80% disse sim do grupo manitol e 92,5% do grupo picosulfato de sódio. CONCLUSÕES: A qualidade do preparo de cólon, formação de espuma, tempo de exame, efeitos colaterais (náuseas, vômitos e dor abdominal) foi similar em ambos os tipos de preparo. A distensão abdominal foi maior no grupo manitol. Ambos os métodos de preparo foram bem aceitos pelos pacientes hospitalizados.

BACKGROUND: The cleansing of the colon for a colonoscopy exam must be complete so as to allow the visualization and inspection of the intestinal lumen. The ideal cleansing agent should be easily administered, have a low cost, and minimum collateral effects. Sodium picosulfate together with the magnesium citrate is a cathartic stimulant and mannitol is an osmotic laxative, both usually used for this purpose. AIMS: Assess the colon cleanliness comparing the use of mannitol and sodium picosulfate as well as evaluate the level of patient satisfaction, the presence of foam, pain, and abdominal distension in hospitalized patients undergoing colonoscopy. METHODS: A prospective, randomized, single-blind study with 80 patients that compared two groups: mannitol (40) and sodium picosulfate (40). Both groups received the same dietary orientation. The study was approved by the hospital’s Ethics and Research Committee. The endoscopist was blind to the type of preparation. Outcomes evaluated: level of the colon’s cleanliness, patient’s satisfaction, the presence of foam, abdominal pain and distension, and the duration of the exam. The data was analyzed by means of the chi-squared test for proportions and Mann-Whitney for independent samples. RESULTS: There were no statistically significant differences between the groups in relation to the level of the colon’s cleanliness, patient’s satisfaction, the presence of foam, abdominal pain, and the duration of the exam. Fifteen percent of the exams of the mannitol group were interrupted while from the sodium picosulfate group it was 5%. The presence of foam was similar for both groups. The average duration for carrying out the exam was 28.44 minutes for the mannitol group and 35.59 minutes for the sodium picosulfate group. Abdominal distension was more frequent in the mannitol group. If they would have to do the same exam, the answer was that 80% said yes from the mannitol group and 92.5% from the sodium picosulfate group. CONCLUSION: The quality of the colon preparation, foam formation, exam duration, and the collateral effects (nauseas, vomiting, and abdominal pain) were similar in both kinds of preparations. Abdominal distension was greater in the mannitol group. Both methods of preparation were well accepted by the hospitalized patients.