Os efeitos da educação aprimorada, realizada por enfermeiros na qualidade do preparo intestinal para colonoscopia / Effect of nurse-performed enhanced patient education on colonoscopy bowel preparation quality / Los efectos de la educación perfeccionada, realizada por enfermeros en la calidad de la preparación intestinal para colonoscopia

Resumo Objetivo: avaliar o efeito da educação aprimorada realizada por enfermeiros no preparo intestinal adequado e na taxa de intubação cecal. Método: estudo prospetivo, quasi-experimental e comparativo com abordagem quantitativa. Os pacientes no grupo de intervenção (n=150) receberam a educação aprimorada e telefonemas para lembrá-los do procedimento. O grupo de controle (n=156) recebeu as instruções padrão da clínica por escrito. As taxas de preparo intestinal adequado e outros indicadores da qualidade da colonoscopia foram comparadas entre os grupos. Resultados: as pontuações obtidas na Boston Bowel Preparation Scale e a taxa de preparo intestinal adequado foram maiores no grupo de intervenção do que no grupo de controle (6,76±2,1 vs. 5,56±2,4, p=0,000, e 80% vs. 69,2%, p=0,031). A taxa de intubação cecal foi mais alta no grupo de intervenção (80% vs. 67,3%, p=0,012). A taxa de intubação cecal malsucedida devido ao preparo intestinal inadequado foi de 0% no GI, enquanto que o GC obteve uma taxa de 17,6%. Além disso, a taxa de biópsia foi maior no grupo de intervenção (28% vs. 13,3%, p=0,002). Conclusão: a educação do paciente aprimorada e realizada por enfermeiros aumenta as taxas de preparo intestinal adequado e, consequentemente, as taxas de intubação cecal. Para alcançar os padrões de qualidade de colonoscopia recomendados nas diretrizes, recomendamos que a educação do paciente inclua diferentes ferramentas de treinamento e seja realizada por profissionais da saúde.

Abstract Objective: to evaluate the effect of nurse-performed enhanced patient education sessions on adequate bowel preparation and cecal intubation rates. Method: a prospective, quasi-experimental, comparative study with a quantitative approach. The intervention group (n=150) received education enhanced by a visual presentation and reminder calls. The control group (n=156) received the clinic's standard written instructions. Adequate bowel preparation rates and other colonoscopy quality indicators were compared between the groups. Results: Boston Bowel Preparation scale scores and adequate bowel preparation rates were higher in the intervention group than in the control group (respectively, 6.76±2.1 vs. 5.56±2.4, p=0.000, and 80% vs. 69.2%, p=0.031). The cecal intubation rates were higher in the intervention group (80% vs. 67.3%, p=0.012). Due to inadequate bowel preparation, unsuccessful cecal intubation rates were 0% in the intervention group and 17.6% in the control group. Biopsy rates were higher in the intervention group (28% vs. 13.3%, p=0.002). Conclusion: the nurse-performed enhanced patient education sessions increase adequate bowel preparation rates and, in parallel, cecal intubation rates. To reach the colonoscopy quality standards recommended in the guidelines, it is suggested that patient education be supported by different training tools and given by health professionals.

Resumen Objetivo: evaluar el efecto de la educación perfeccionada realizada por enfermeros en la preparación intestinal adecuada y en las tasas de intubación cecal. Método: estudio prospectivo, casi experimental y comparativo, con abordaje cuantitativo. El grupo de intervención (n=150) recibió la educación perfeccionada y llamadas telefónicas recordatorias. El grupo de control (n=156) recibió las instrucciones estándar de la clínica por escrito. Las tasas de preparación intestinal adecuadas y otros indicadores de la calidad de la colonoscopia fueron comparadas entre los grupos. Resultados: las puntuaciones obtenidas en la Boston Bowel Preparation Scale y las tasas de preparación intestinal adecuadas fueron en el grupo de intervención mayores que en el grupo de control (6,76±2,1 vs. 5,56±2,4, p=0,000, y 80% vs. 69,2%, p=0,031, respectivamente). Las tasas de intubación cecal fueron mayores en el grupo de intervención (80% vs. 67,3%, p=0,012). La tasa de intubación cecal fracasada debido a la preparación intestinal inadecuada fue de 0% en el GI, en cuanto que el GC obtuvo una tasa de 17,6%. Además de eso, las tasas de biopsia fueron mayores en el grupo de intervención (28% vs. 13,3%, p=0,002). Conclusión: la educación del paciente perfeccionada y realizada por enfermeros aumenta las tasas de preparación intestinal adecuadas y, consecuentemente, las tasas de intubación cecal. Para alcanzar los estándares de calidad de colonoscopia recomendados en las directrices, recomendamos que la educación del paciente sea apoyada por diferentes herramientas de entrenamiento y realizada por profesionales de la salud.

Nefropatía aguda por fosfatos secundaria al uso de laxantes con fosfato de sodio: caso clínico-patológico / Acute phosphate nephropathy secondary to the use of oral sodium phosphate laxatives: report of one case

Acute phosphate nephropathy (APN) is an acute renal failure secondary to the use of oral sodium phosphate (OSP) laxatives, with a high risk of progression to chronicity. We report a 60-year-old woman with mixed connective tissue disease whose serum creatinine increased up to 2.0 mg/dL in her regular control tests, without an evident causative factor. Kidney biopsy showed numerous intratubular calcium phosphate deposits, consistent with APN. She had a history of OSP laxative intake, and a sodium phosphate enema was used before a colonoscopy performed six months earlier. The temporal association between the use of OSP laxatives and acute kidney injury, should lead to the suspicion of APN. The urine sediment is generally normal or with mild to moderate proteinuria. The diagnosis is confirmed with a kidney biopsy. Until now, there is no specific treatment for APN, thus prevention is essential. In high-risk patients for developing APN, the administration of these laxatives should be avoided.

Assessment of tolerance and acceptability between mannitol solution and polyethylene glycol as bowel preparation for colonoscopy: a three-center study / Evaluación de tolerancia y aceptabilidad entre la solución de manitol y el polietilenglicol como preparación intestinal para la colonoscopía: un estudio de tres centros

ABSTRACT Introduction: Adequate bowel preparation is one of the most important factors related to the yield of colonoscopy. Low quality bowel preparation has been associated with lower adenoma detection rates and increased healthcare expenses. Bowel preparation is a major impediment to undergo colonoscopy since it is perceived as an unpleasant experience by patients. Objective: This study was aimed to assess tolerance and acceptability of the bowel preparation using either polyethylene glycol (PEG) or mannitol solution. Materials and methods: We enrolled 140 patients with indications of screening for colorectal cancer or with suspected large bowel diseases. They received either mannitol solution or PEG as bowel preparation. Patients were asked to fill a questionnaire about the bowel preparation experience. Results: Patients perceived more burdensome the preparation with PEG than mannitol for the variables nausea overall experience, post-procedure discomfort, disagreeable flavor, volume ingested and cost (p<0.05). A similar tolerance was reported for abdominal pain, bloating and anal irritation (p>0.05). The acceptability was 82.9% and 71.4% in the Mannitol group and in the PEG group, respectively (p=0.10). Conclusion: Acceptance of the bowel preparation between mannitol solution and PEG was comparable. However, mannitol was better tolerated by the patients in regard to most of the evaluated items.

RESUMEN Introducción: La preparación intestinal adecuada es uno de los factores más importantes relacionados con el rendimiento de la colonoscopía. La preparación intestinal de baja calidad se ha asociado con tasas de detección de adenoma más bajas y mayores gastos de atención sanitaria. La preparación intestinal es un impedimento importante para someterse a una colonoscopía, ya que los pacientes la perciben como una experiencia desagradable. Objetivo: Este estudio tuvo como objetivo evaluar la tolerancia y la aceptabilidad de la preparación intestinal utilizando polietilenglicol (PEG) o solución de manitol. Materiales y métodos: Fueron incluidos 140 pacientes con indicación de pesquisa de cáncer colorrectal o con sospecha de enfermedades del intestino grueso. Los pacientes recibieron solución de manitol o PEG como preparación intestinal. Se pidió a los pacientes que completaran un cuestionario sobre la experiencia de preparación intestinal. Resultados: Los pacientes percibieron más agobiante la preparación con PEG que el manitol para las variables náuseas, experiencia general, molestias posteriores al procedimiento, sabor desagradable, volumen ingerido y costo (p<0,05). Se informó una tolerancia similar para el dolor abdominal, distensión abdominal e irritación anal (p>0,05). La aceptabilidad fue de 82,9% y 71,4% en el grupo de manitol y en el grupo de PEG, respectivamente (p=0,10). Conclusión: La aceptación de la preparación intestinal entre la solución de manitol y el PEG fue comparable. Sin embargo, el manitol fue mejor tolerado por los pacientes con respecto a la mayoría de las variables evaluadas.

Eficacia y tolerabilidad de la reducción del volumen de polietilenglicol para la preparación para colonoscopia / Effectiveness and tolerability of low volume bowel cleansing polyethylene glycol solution for colonoscopy

Background: A successful colonoscopy depends, among other factors, on a proper colon cleansing. This variable also affects the acceptance of the patient to carry out the study. Aim: To analyze the efficacy and tolerability of a low volume polyethylene glycol formulation (2 liters), compared to the conventional presentation of 4 liters. Material and Methods: Patients referred for a colonoscopy were randomly divided to receive either two or four liter of polyethylene glycol as bowel cleansing, which was assessed using the Boston score. Raters of the latter were blinded to the volume of polyethylene glycol that the patients used. Results: Seventy-four patients participated in the study. Subjects who received a 4 liters preparation had an average Boston score of 7.78, versus 8.16 for patients who received a volume of 2 liters (p = 0.267). No significant differences in tolerability were observed between both groups. No significant differences in the efficacy and tolerability between a conventional or a reduced volume of polyethylene glycol solution for the preparation of a colonoscopy were observed. These findings may be especially important for subgroups of patients with difficulties for oral administration of fluids.

Efficacy of low residue enteral formula versus clear liquid diet during bowel preparation for colonoscopy: a randomised controlled pilot trial / Eficácia da fórmula enteral pobre em resíduo versus dieta líquida clara durante o preparo intestinal para colonoscopia: um estudo piloto controlado e randomizado

ABSTRACT Objectives: Conventional bowel preparation for colonoscopy confines patient to clear liquid diet the day before and such non-nutritive dietary regimen often caused discomfort and hunger. The purpose of this study is to determine the feasibility of feeding patient with low-residue, lactose-free semi-elemental enteral formula (PEPTAMEN®) compare to conventional clear liquid diet during bowel preparation before colonoscopy. Methods: This was a randomised, endoscopist-blinded study. Patients were randomised into two groups, those receiving oral PEPTAMEN® and mechanical bowel preparation (A) and those receiving clear liquid while undergoing mechanical bowel preparation (B). Documentation was made with regard to the type of bowel cleansing agents used, completeness of the colonoscopy, cleanliness quality score, and hunger score. Results: A total of 97 patients were included in the study, A = 48 and B = 49. Eight patients, who were not compliant to the bowel-cleansing agent or had an incomplete colonoscopic examination, were excluded from the study. In terms of the overall cleanliness score, no statistical significant difference was seen (p = 0.25) between the two groups, A (fair or poor 37.5%, good or excellent 62.5%) and B (fair or poor 49%, good or excellent 51%) whereas the hunger score showed a significant difference (p = 0.016), A (no hunger 41.7%, slight hunger 12.5%, hungry 12.5%) and B (no hunger 24.5%, slight hunger 38.8%, hungry 36.7%). Conclusions: These data suggest that the addition of oral PEPTAMEN® as part of the bowel preparation regimen did not significantly alter the luminal cleanliness score during colonoscopy while alleviating hunger.

RESUMO Objetivo: A preparação intestinal convencional para a colonoscopia confina o paciente à dieta líquida clara no dia anterior; esse regime dietético não nutritivo frequentemente causa desconforto e fome. O presente estudo teve como objetivo determinar a viabilidade de alimentar o paciente com fórmula enteral semielementar sem lactose e pobre em resíduos (PEPTAMEN®) em comparação com a dieta líquida clara convencional no preparo intestinal para colonoscopia. Métodos: Este foi um estudo randomizado no qual o endoscopista foi cego quanto ao tipo de preparo. Os pacientes foram randomizados em dois grupos: aqueles que receberam PEPTAMEN® oral e preparo intestinal mecânico (A) e aqueles que receberam dieta líquida clara e preparo intestinal mecânico (B). Os pacientes foram avaliados quanto ao tipo de agente de limpeza intestinal utilizado, a completude da colonoscopia, o escore de qualidade de limpeza e o escore de fome. Resultados: Um total de 97 pacientes foram incluídos no estudo, 48 no grupo A e 49 no grupo B. Oito pacientes foram excluídos por não aderirem ao agente de limpeza intestinal ou apresentarem um exame incompleto de colonoscopia. Quanto ao escore geral de limpeza, não se observou diferença estatisticamente significativa (p = 0,25) entre os grupos A (resultado regular ou ruim, 37,5%; bom ou excelente, 62,5%) e B (resultado regular ou ruim, 49%; bom ou excelente, 51%). Por outro lado, o escore de fome apresentou diferença significativa (p = 0,016) entre os grupos A (sem fome, 41,7%; fome leve, 12,5%; fome, 12,5%) e B (sem fome, 24,5%; fome leve, 38,8%; fome, 36,7%). Conclusões: Os dados sugerem que a adição de PEPTAMEN® oral como parte do regime de preparo intestinal não altera significativamente o escore de limpeza luminal durante a colonoscopia, mas alivia a fome.

Design and evaluation of rhubarb total free anthraquinones oral colon-specific drug delivery granules to improve the purgative effect

Rhubarb is commonly used as a cathartic in Asian countries. However, researchers have devotedextensive concerns to the quality control and safety of rhubarb and traditional Chinese preparations composed of rhubarb due to the instable purgative effect and potential nephrotoxicity of anthraquinones. In this study, we aimed to prepare rhubarb total free anthraquinones (RTFA) oral colon-specific drug delivery granules (RTFA-OCDD-GN) to delivery anthraquinones to colon to produce purgative effect. RTFA-OCDD-GN were prepared using chitosan and Eudragit S100 through a double-layer coating process and the formulation was optimized. Continuous release studies were performed in a simulated gastric fluid (pH 1.2), followed by a small-intestinal fluid (pH 6.8) and a colonic fluid (pH 7.4, containing rat cecal contents). The purgative effect test was performed in rats. The dissolution profile of RTFA-OCDD-GN showed that the accumulative dissolution rate of RTFA was about 83.0% in the simulated colonic fluid containing rat cecal contents and only about 9.0% in the simulated gastrointestinal fluids. And the RTFA-OCDD-GN could produce the comparative purgative activity as rhubarb, suggesting it could deliver the free AQs to the colon. The RTFA-OCDD-GN was a useful media to enhance the purgative activity of free anthraquinones after administered orally.

Intestinal preparations for colonoscopy. Comparative study: mannitol, picosulphate and macrogol / Preparos intestinais para colonoscopia. Estudo comparativo: manitol, picossulfato e macrogol

ABSTRACT Bowel preparation is mandatory prior to elective colonoscopy and their effectiveness is closely related to the quality of the examination. There are many preparations on the market and there is no consensus on which is best. This study aimed to compare three solutions for colon preparation in patients undergoing colonoscopy. We conducted a prospective study with 61 patients divided randomly into three groups: one that received a standard dose of macrogol, another received a standard dose of 10% mannitol and another received a standard dose of sodium picosulphate. Patients and examining endoscopists responded to questionnaires for compiling data. In the results we noticed that 10% mannitol, despite being less tolerated by the patient when compared to sodium picosulphate, presents better results in colonic cleaning, being therefore superior in this regard. Macrogol was considered as an intermediate in relation to the other two preparations. As for tolerability, preference is given to sodium picosulphate as best tolerated, followed by mannitol and by macrogol, which is poorly tolerated by the patient. We conclude that as the main objective of bowel preparation in colonoscopy is the quality of colonic cleaning, 10% mannitol was superior to the other preparations studied.

RESUMO O preparo intestinal é mandatório antes da realização das colonoscopias eletivas e sua eficácia está intrinsecamente relacionada à qualidade do exame. Existem diversos preparos no mercado e não há consenso sobre qual é melhor. Este estudo teve como objetivo comparar três soluções para preparo de cólon em pacientes submetidos à colonoscopia. Foi realizado um estudo prospectivo com 61 pacientes distribuídos de forma randomizada em três grupos: um recebeu macrogol, outro manitol a 10% e outro picossulfato de sódio em doses padrão. Os pacientes e os endoscopistas examinadores responderam a questionários para compilação de dados. Nos resultados notamos que o manitol a 10%, apesar de ser menos tolerado pelo paciente quando comparado ao picossulfato de sódio, apresenta melhores resultados na limpeza colônica, sendo, portanto, superior neste quesito. O macrogol foi considerado como intermediário em relação aos outros dois preparos. Quanto à tolerabilidade, a preferência recai sobre o picosulfato de sódio como o mais bem tolerado, seguido pelo Manitol; macrogol foi o menos tolerado pelo paciente. Concluímos que, como o principal objetivo do preparo intestinal na colonoscopia é a qualidade da limpeza colônica, o manitol a 10% mostrou-se superior aos demais preparos estudados.

New bowel preparation technique for colonoscopy: clinical trial comparing aquanet and mannitol / Nova técnica de preparo intestinal para colonoscopia: estudo clínico comparativo entre aquanet e manitol

ABSTRACT Background: Fifty-five percent of Americans aged 50-65 are submitted to colonoscopy. For over 65-year, this number increases to 64%. In Brazil, it is forecast that the population submitted to colonoscopy will grow, even though inadequate preparation is still a major problem. Aim: To analyze the quality of a new intestinal preparation technique, Aquanet EC-2000®, compared to oral Mannitol solution. Methods: This prospective longitudinal study enrolled 200 patients with indication for colonoscopy. The sample was randomly allocated to two groups of 100; one group received Aquanet EC-2000® to prepare for colonoscopy and the other Mannitol solution. The Boston scale was used to analyze the results. Results: As expected both preparations produced similar results with the bowel cleansing of the different regions of the colon being classified as Boston scale 3 (excellent) in most patients (p>0.05). Conclusion: The results of bowel preparation using Aquanet EC-2000® were similar to using Mannitol solution.

RESUMO Racional: Cinquenta e cinco por cento dos norte-americanos entre 50-65 anos fazem colonoscopia. Acima de 65 anos o número foi de 64%. No Brasil, estima-se crescente aumento da população submetida à colonoscopia, apesar da preparação inadequada ainda ser um grande problema. Objetivo: Analisar e comparar a qualidade do novo método de preparo intestinal por meio do Aquanet EC-2000® frente ao uso de solução oral de Manitol. Método: Por randomização 200 pacientes foram divididos em dois grupos de 100. Um recebeu Aquanet EC-2000® e o outro Manitol. O presente estudo seguiu modelo prospectivo longitudinal por meio da seleção de 200 pacientes com indicação à colonoscopia, formando dois grupos de 100. Para analisar os resultados foi utilizada a escala de Boston. Resultados: Ambos os preparos foram estatisticamente significativos com p<0,05. A escala 3 de Boston foi a mais frequente para ambos os métodos.Além disso, na estatística aplicada às diferentes regiões do cólon para ambos os procedimentos as proporções observadas concordaram com o esperado (3-excelente). Conclusão: Os resultados do preparo intestinal utilizando Aquanet EC-2000® foram semelhantes aos do Manitol.

Effect of bisacodyl on rats with slow transit constipation

The effect of bisacodyl on the treatment of rats with slow transit constipation (STC) was studied. Forty-five female Wister rats were divided into control group, STC group, and STC bisacodyl group. The immunohistochemical method was used to determine interstitial cells of Cajal (ICC) and the expression of c-Kit protein. Body mass and the number of defecations were significantly decreased in the STC group compared with the control group on the 100th day after diphenoxylate administration, while dry weight of feces was significantly increased and the intestinal transit time was prolonged. There were significant differences in the number of defecations, dry weight of feces, and intestinal transit time among the three groups. The number of defecations was higher, dry weight of feces was lower, and intestinal transit time was shorter in the STC bisacodyl group compared to the STC group. In addition, ICC basement membrane dissolution occurred in the colon wall of the STC group. The connection between ICC and surrounding cells was destroyed, and the nucleus shrunken to different degrees. Moreover, c-Kit expression in the STC group was significantly lower than the control group. The connection between ICC and surrounding cells in the STC bisacodyl group was significantly stronger than the STC group, and the number of ICC and the expression of c-Kit were increased. Bisacodyl could reduce the severity of STC in rats by increasing the number of ICC and the expression of c-Kit.

Evaluación comparativa de efectividad y tolerabilidad con polietilenglicol y picosulfato de sodio-citrato de magnesio como agentes de preparación intestinal para colonoscopia / Comparative evaluation of effectiveness and tolerability with polyethylene glycol and sodium picosulfate-magnesium citrate as intestinal preparation agents for colonoscopy

Resumen Introducción La efectividad de la colonoscopia depende de múltiples factores, destacando la calidad de preparación intestinal y la tolerabilidad que tenga el paciente a la preparación administrada. Objetivo Comparar dos agentes de preparación intestinal, el polietilenglicol (PEG) y el picosulfato de sodiocitrato de magnesio (PSCM) en términos de efectividad y tolerabilidad de la preparación. Pacientes y Método Ensayo clínico aleatorizado en pacientes ambulatorios sometidos a colonoscopia en Clínica INDISA. Evaluando efectividad y tolerabilidad con el Boston Bowel Preparation Score (BBPS) y cuestionario de Lawrence [compuesto por escala Likert, dos preguntas cualitativas y escala visual análoga (EVA)], respectivamente. Resultados 189 pacientes, de los cuales 123 se aleatorizaron a PEG y 66 a PSCM. El BBPS en los pacientes que utilizaron PEG, la media fue 7,51 (DS 1,66) y con PSCM fue 7,12 (DS 1,71) (p = 0,111). Al analizar la tolerabilidad con escala Likert, la media con PEG fue 0,94 (DS 0,68) y con PSCM fue 0,63 (DS 0,61) (p = 0,0004). La EVA con PEG tuvo una media de 7,68 (DS 2,4) y con PSCM de 9,04 (DS 1,59) (p < 0,0001). Al preguntar ausentismo laboral, no hubo diferencias significativas en ambos grupos y al preguntar si ocuparía la misma preparación en una futura colonoscopia, hubo significancia estadística a favor del PSCM (p = 0,026). Conclusión No encontramos diferencias en la efectividad de preparación intestinal al comparar PEG y PSCM, sin embargo, el PSCM es mejor tolerado.

Introduction The effectiveness of colonoscopy depends on multiple factors, being two of the most important ones an adequate bowel preparation and the patient's tolerability to the preparation. Objectives Compare effectiveness and tolerability of two bowel preparation agents, polyethylene glycol (PEG) and sodium picosulfate/magnesium citrate (SPMC). Patients and Methods Randomized clinical trial on outpatients that went into colonoscopy in INDISA Clinic. We evaluated effectiveness and tolerability with Boston Bowel Preparation Score (BBPS) and Lawrence questionnaire [composed by Likert scale, two qualitative questions and Visual Analogue Scale (VAS) for pain], respectively. Results 189 patients, 123 were randomized to PEG and 66 to SPMC. BBPS average in patients in the PEG branch was 7.51 (SD 1.66) and for SPMC 7.12 (SD 1.71) (p = 0.111). Likert scale for evaluating tolerability average for PEG was 0.94 (SD 0.68) and for SPMC 0.63 (SD 0.61) (p = 0.0004). VAS scale for PEG had an average of 7.68 (SD 2.4) and for PSCM 9.04 (SD 1.59) (p < 0.0001). When we asked for workplace absenteeism, there were no significant differences between both groups and when we asked about using the same intestinal preparation in a future colonoscopy there was statistical significance in favor to SPMC (p = 0.026). Conclusions No differences were noted on effectiveness between the PEG and SPMC bowel preparations. Nevertheless, SPMC appeared to be better tolerated by patients.

Tolerancia, seguridad y eficacia de la preparación intestinal con un día de PEG3350 + bisacodilo en comparación con 2 días de PEG3350 + bisacodilo en pacientes pediátricos / Tolerance, safety and efficacy of the one-day preparation of PEG3350 + bisacodyl compared to 2 days of PEG3350 + bisacodyl in pediatric patients

Resumen: Introducción: Múltiples preparaciones intestinales se han utilizado en niños sometidos a una colonoscopia, con limitación variable debido a la aceptación, tolerancia y la limpieza adecuada. El objetivo del estudio fue comparar la tolerancia seguridad y eficacia de la preparación intestinal para colonoscopia de 1 día con PEG 3350 (polietilenglicol) (4 g/kg/día) + bisacodilo y el tratamiento con 2 días de preparación con PEG 3350 (2 g/kg/día) + bisacodilo en pacientes pediátricos. Métodos: Se realizó un ensayo clínico, aleatorizado y ciego. Se incluyeron pacientes de 2 a 18 años, que ameritaron colonoscopia en forma programada. Los pacientes se asignaron de manera aleatoria en dos grupos: 1 día de preparación con PEG 3350 4 g/kg/día + bisacodilo y 2 días de preparación con PEG 3350 2 g/kg/día + bisacodilo. Por medio de un cuestionario, exploración física y valoración endoscópica (escala de Boston), se determinó la tolerancia, seguridad y eficacia de las 2 preparaciones a evaluar. Se realizó una prueba t de Student para variables cuantitativas y χ2 para variables cualitativas. Resultados: No hubo diferencias significativas en las tasas de cumplimiento, los efectos adversos y la extensión de la evaluación colonoscópica. Conclusiones: La tolerancia y seguridad entre la preparación intestinal para colonoscopia de 1 día con PEG 3350 (polietilenglicol) (4 g/kg/día) + bisacodilo y la preparación de 2 días con PEG 3350 (2 g/kg/día) + bisacodilo fue semejante. La calidad de la limpieza fue buena en ambos grupos, siendo parcialmente más eficaz en el grupo de 1 día con PEG 3350 (polietilenglicol) (4 g/kg/día).

Abstract: Background: Multiple intestinal preparations have been used in children undergoing colonoscopy, with variable limitation due to acceptance, tolerance, and proper cleaning. The objective of this study was to compare the tolerability, safety and efficacy of the colonoscopy preparation with 1 day with PEG 3350 (poliethylenglycol) (4 g/kg/day) + bisacodyl compared to 2 days of preparation with PEG 3350 (2 g/kg/day) + bisacodyl in pediatric patients. Methods: A clinical, randomized, and blind trial was performed. Patients aged 2 to 18 years scheduled for colonoscopy were included. Patients were randomized into two groups: 1 day of preparation with PEG 3350 4 g/kg/day + bisacodyl and 2 days of preparation with PEG 3350 2 g/kg/day + bisacodyl. Through a questionnaire, physical examination and endoscopic evaluation (Boston scale), the tolerance, safety and efficacy of the 2 preparations to be evaluated were determined. Student's t test was performed for quantitative variables and χ2 for qualitative variables. Results: There were no significant differences in compliance rates, adverse effects, and extent of colonoscopic evaluation. Conclusions: Tolerance and safety between the intestinal preparation for 1-day colonoscopy with PEG 3350 (4 g/kg/day) + bisacodyl and the 2-day preparation with PEG 3350 (2 g/kg/day) + bisacodyl were similar. The quality of cleanliness was good in both groups, being partially more effective in the 1-day group with PEG 3350 (4 g/kg/day).

Limpieza intestinal para colonoscopia en niños: efectividad, adherencia y efectos adversos de esquemas diferenciados por edad / Intestinal cleaning for colonoscopy in children: effectiveness, adherence and adverse effects of schemes differentiated by age

La adecuada limpieza intestinal (LI) es fundamental para lograr el máximo rendimiento diagnóstico durante una colonoscopia. Existen diversos esquemas de LI, y en pediatría aún no hay consenso respecto al más adecuado. OBJETIVO: Describir la efectividad, adherencia y efectos adversos de protocolos de LI diferenciados por edad en pacientes pediátricos sometidos a colonoscopia. PACIENTES Y MÉTODO: Estudio descriptivo que incluyó pacientes < 18 años sometidos a colonoscopia. Se aplicaron esquemas de LI diferenciados por edad: < 6 meses (supositorio de glicerina); 6 meses-3 años, 11 meses (polietilenglicol [PEG] 3.350 sin electrolitos); 4 años-9 años, 11 meses (PEG 3.350 sin electrolitos + bisacodilo); 10 años-18 años (PEG 3.350 con electrolitos). Se registraron datos demográficos, clínicos, adherencia y efectos adversos. La efectividad fue determinada durante colonoscopia de acuerdo con la escala previamente validada (Boston modificada). RESULTADOS: Se incluyeron 159 pacientes, de los cuales 87 fueron varones (55%), mediana de edad de 4 años (rango un mes-17 años). Se logró LI exitosa en el 78% de los pacientes. La mayor efectividad se alcanzó en < 6 meses (96%) y 10-18 años (91%). El grupo de 4 años-9 años, 11 meses, que evidenció menor efectividad (69%) tuvo mayor proporción de estreñimiento previo (29%). Se obtuvo buena adherencia en el 87% de los pacientes. Se observaron efectos adversos en un tercio de los pacientes (especialmente en el grupo 10-18 años), que fueron leves y no determinaron la suspensión del medicamento. CONCLUSIONES: Con los esquemas de preparación utilizados se lograron resultados satisfactorios, obteniendo LI exitosa en 4 de cada 5 pacientes. Los resultados difirieron entre grupos, lo que podría deberse, al menos en parte, al protocolo utilizado y al hábito intestinal previo.

Adequate intestinal cleanliness is crucial to achieve optimal colonoscopy performance. Several bowel preparation (BP) schemes have been proposed, but there is still no consensus as regards which is the most suitable in paediatric patients. OBJECTIVE: To describe the effectiveness, adherence, and adverse effects of BP protocols differentiated by age group in paediatric patients subjected to colonoscopy. PATIENTS AND METHOD: Prospective, study that included patients < 18 years subjected to colonoscopy. BP protocols differentiated by age group were indicated as follows: < 6 m (glycerine suppository); 6 m-3y 11 m (poly-ethylene-glycol (PEG 3350 without electrolytes); 4y-9y 11 m (PEG 3350 without electrolytes + bisacodyl); 10 y-18 y (PEG 3350 with electrolytes). Demographic, clinical information, adherence and adverse effects were registered. Effectiveness was determined using a validated scale (Boston modified) during colonoscopy. RESULTS: A total of 159 patients were included, of which 87 (55%) were males, and with a median age of 4 years (range 1 m-17 years). Seventy eight percent of patients achieved successful BP. The higher effectiveness was observed in the groups of < 6 m (96%) and 10-18 y (91%). Constipation was significantly more frequent (29%) in the 4 yo-9 yo 11 m in which lower effectiveness was observed (69%). Good adherence was observed in 87% of patients. Adverse effects were observed in a third of patients, although they were mild and did not lead to the suspension of the BP. CONCLUSIONS: Satisfactory results were achieved with the BP schemes used, with a successful BP being obtained in 4 out of 5 patients. Results were different between groups, which is probably related to previous bowel transit and indicated medication.

Estudio comparativo entre el uso de manitol y el picosulfato sódico como preparación para colonoscopía / Comparison of colon-cleansing methods in preparation for colonoscopy- comparative of solutions of mannitol and sodium picosulfate

Objetivos: El objetivo del presente estudio es comparar la preparación adecuada del colon con manitol y picosulfato sódico. Evaluar la aceptación de los pacientes, los efectos secundarios y la capacidad de limpieza. Materiales y métodos: Este es un estudio no aleatorio, prospectivo, ciego, en que el evaluador no tenía información sobre la preparación aplicada. La muestra obtenida se dividió en dos grupos de acuerdo con la preparación adecuada del colon, con 153 pacientes preparados con manitol al 10% y 84 pacientes con picosulfato sódico. La evaluación de la preparación se realizó usando la Escala de Boston (Boston Bowel Preparation Scale - BBP) a través de un sistema de puntuación para cada región del colon puntuada con 3 puntos: derecha, izquierda y colon transverso. Resultados: De los 237 pacientes que fueron evaluados, 146 (61,60%) eran mujeres y 91 (38,4%) eran hombres. En el grupo que utilizó manitol, 98 (64,05%) eran mujeres y 55 (35,95%) eran varones. Entre los pacientes que utilizaron picosulfato sódico, 48 (57,14%)eran mujeres y 36 (42,86%) eran hombres, sin diferencias estadísticas de ambos grupos (p>0,32). Teniendo en cuenta que con la adecuada preparación del colon y con puntuación de 6 puntos en la Escala de Boston, la preparación intestinal fue satisfactoria en ambos grupos. El 93% de los pacientes que utilizaron manitol y el 81% de los pacientes que utilizaron picosulfato sódico tenían preparación adecuada (puntuación de 6). La puntuación media en la preparación con manitol fue de 9 y en la preparación con picosulfato sódico fue de 7. No hubo diferencias significativas entre ambos grupos. Conclusión: Ambas preparaciones, demostraron ser seguras y eficaces para la limpieza del intestino, de acuerdo con la Escala de Boston, así como, la aceptabilidad de los pacientes y libre de complicaciones

Objectives: The purpose of the present study is to compare intestinal preparation with mannitol and sodium picosulphate, assessing patient’s acceptance, side effects and cleaning capacity. Material and methods: This is a prospective, nom randomized, blind study, in which the evaluator had no information about the preparation applied. The sample obtained was divided into two groups according to the bowel preparation applied, with 153 patients prepared with 10% mannitol and 84 patients with sodium picosulfate. The evaluation of colon preparation was done using the Boston Scale (Boston Bowel Preparation Scale - BBP) through a three-point scoring system for each of the three regions of the colon: right, left and transverse colon. Results: Of the 237 patients that were evaluated, 146 (61.60%) were female and 91 (38.4%) were male. Regarding the group that used mannitol, 98 were female (64.05%) and 55 were male (35.95%). Among the patients who used sodium picosulfate, 48 were female (57.14%) and 36 were male (42.86%), with no statistical differences between both groups (p> 0.32). Considering that an adequate preparation scores ≥ 6 in the Boston Scale, the bowel cleansing preparation was satisfactory in both groups. 93% of the patients who used mannitol and 81% of the patients who used sodium picosulfate had adequate preparation (score of ≥ 6). Moreover, we consider that the average score in the preparation with Mannitol was 9, while the sodium picosulfate score was 7. There were no significant differences between the two groups. Conclusion: There is consensus among authors who state that colonoscopy’s safety and success are highly related to the cleansing outcome, regardless of the method used. The same can be observed in the present study, on which both preparations were proved safe and effective for bowel cleansing, according to the Boston scale, as well as accepted by patients and free of complications

Safety of mannitol use in bowel preparation: a prospective assessment of intestinal methane (CH4) levels during colonoscopy after mannitol and sodium phosphate (NaP) bowel cleansing / Segurança do uso do manitol no preparo para colonoscopia: avaliação prospectiva do nível de metano (CH4) intestinal durante colonoscopia após preparo com manitol e fosfato de sódio (NaP)

ABSTRACT Background - Adequate bowel preparation is critical for the quality of colonoscopy. Despite reported occurrence of colonic explosion due to methane and hydrogen production by bacterial fermentation during colonoscopy, gas exchange during the procedure is believed to be effective in lowering existing methane concentration, allowing for safe utilization of mannitol for bowel preparation. Thus, mannitol is widely used for bowel cleansing prior to colonoscopy, considering its low cost and effectiveness for bowel preparation. Objective - The aim of this study was to assess the safety of mannitol for bowel preparation, when compared to sodium phosphate (NaP). Methods - We conducted a prospective observational study in which 250 patients undergoing colonoscopy at Universidade Federal de São Paulo and Hospital Albert Einstein (São Paulo, Brazil) were approached for inclusion in the study. Patients received either mannitol (n=50) or NaP (n=200) for bowel preparation, based on physician indication. Study was conducted from August 2009 to December 2009. The main outcome of interest was presence of detectable levels of methane (CH4) during colonoscopy and reduction in such levels after gas exchange during the procedure. Methane concentrations were measured in three intestinal segments during scope introduction and withdrawal. Safety was assessed as the absence of high levels of methane, defined as 5%. Measurements were made using a multi-gas monitor (X-am 7000, Dräger Safety AG & Co. KGaA, Lübeck, Germany) connected to a plastic catheter introduced into the working channel of the colonoscope. Additional outcomes of interest included levels of O2. Methane and O2 levels are reported as ppm. Mean, difference and standard deviation of levels of gas measured in both moments were calculated and compared in both groups. Proportions of patients with detectable or high levels of methane in both groups were compared. Continuous variables were analyzed using t test and categorical variables using qui-square tests. The Ethics Committee in both study sites approved the study protocol. Results - Patients in both groups were similar regarding demographics, colonoscopy indication, ASA status and quality of bowel preparation. Seven (3.5%) patients in the NaP group had methane detected during introduction of the endoscope. Methane levels became undetectable during withdrawal of the scope. None of the patients in the mannitol group had detectable levels of methane. O2 levels did not differ in the groups. Conclusion - This is the largest study to assess the safety of mannitol for bowel preparation, considering methane measurements. Our results indicate that mannitol use is as safe as NaP, and gas exchange was efficient in reducing methane concentrations.

RESUMO Contexto - Preparo adequado é fundamental para garantia de boa qualidade em colonoscopia. Apesar de relatos de explosão do cólon durante colonoscopia, secundários à produção de metano e hidrogênio pela fermentação bacteriana, acredita-se que a troca gasosa durante o procedimento diminua a concentração existente de metano, permitindo a utilização com segurança, de manitol para o preparo de cólon. Assim, manitol é largamente utilizado para limpeza dos cólons antes da colonoscopia, especialmente devido ao seu baixo custo e eficácia. Objetivo - O objetivo do estudo foi avaliar a segurança do uso de manitol no preparo dos cólons, quando comparado ao uso de fosfo-soda (NaP). Métodos - Este foi um estudo observacional retrospectivo no qual foram incluídos 250 pacientes submetidos a colonoscopia na Universidade Federal de São Paulo e Hospital Albert Einstein (São Paulo - Brasil). Os pacientes receberam preparo de cólon com manitol (n=50) ou NaP (n=200), de acordo com preferências dos médicos que encaminharam os pacientes. O estudo foi realizado entre agosto e dezembro de 2009. O principal resultado pesquisado foi a presença de níveis detectáveis de metano (CH4) durante a colonoscopia, e a redução nestes níveis após troca gasosa durante o procedimento. As concentrações de metano foram dosadas com detector multi-gas (X-am 7000, Dräger Safety AG & Co., KGaA, Lübeck, Alemanha) conectado a um cateter plástico que foi introduzido no canal de instrumentação do colonoscópio. Outro achado de interesse foram níveis de O2. Níveis de metano e O2 foram relatados em ppm. Média, diferença entre as médias e desvio padrão nos níveis dos gases em ambos momentos foram comparados nos dois grupos. A proporção de pacientes com níveis detectáveis ou altos de metano em ambos os grupos foram comparados. Variáveis contínuas foram analisadas com teste t e variáveis categóricas com o teste do qui-quadrado. Os Comitês de Ética de ambas instituições aprovaram o protocolo do estudo. Resultados - Pacientes nos dois grupos foram comparáveis quanto aos dados demográficos, indicação para colonoscopia, classificação ASA e qualidade do preparo do cólon. Sete (3,5%) pacientes no grupo NaP tinham níveis detectáveis de metano durante a introdução do colonoscópio. Os níveis de metano se tornaram indetectáveis durante a retirada do aparelho. Nenhum dos pacientes no grupo manitol tinha níveis detectáveis de metano. Níveis de O2 foram semelhantes nos dois grupos. Conclusão - Este é o estudo com maior casuística que avaliou a segurança do uso de manitol para preparo de cólon, no que diz respeito a dosagem de metano. Nossos resultados indicam que o emprego do manitol é tão seguro quanto o NaP, e que a troca gasosa é eficaz na redução da concentração de metano.

Absence seizure associated with coloprep consumption in colonoscopy / Convulsão de ausência com o uso de Coloprep em colonoscopia

Coloprep is a bowel preparatory solution given before endoscopic procedures to get a unobscured internal vision. It has among its constituent's sodium sulphate, potassium sulphate and magnesium sulphate which produce an osmotic effect in the bowel. However, the use of such agents in hyponatremic and patients predisposed to seizures can have adverse ramifications. The current case outlines manifestation of absence seizure in a 52-year-old male patient who was administered Coloprep for colonoscopy. There was absence of other predisposing factors and the symptoms were ameliorated using timely identification and rectification of the underlying derangements.

Coloprep é uma solução preparatória intestinal administrada antes de procedimentos endoscópicos, com o objetivo de se ter uma visão interna não obscurecida. Entre os constituintes de Coloprep, observa-se sulfato de sódio, sulfato de potássio e sulfato de magnésio, que provocam efeito osmótico no intestino. Mas o uso de tais agentes em pacientes hiponatrêmicos e com predisposição para convulsões pode ter ramificações adversas. O caso em tela delineia uma manifestação de convulsão de ausência em paciente do gênero masculino com 52 anos e que recebeu Coloprep para colonoscopia. Não havia outros fatores predisponentes e os sintomas melhoraram graças à oportuna identificação e correção dos transtornos subjacentes.

BOWEL PREPARATION BEFORE COLONOSCOPY FOR CHILDREN: comparison of efficacy of three different methods

Background - Colonoscopy is an important diagnostic and therapeutic procedure. Adequate bowel preparation is mandatory. Several regimens were discussed in the literature. Among the drugs which has recently used, polyethylene glycol is one of the most popular agents. Objectives - The aim of this study was to compare efficacy of three different methods for 1 day preparation before colonoscopy. Methods - This study included children with the range of ages (2-21) who had an indication of colonoscopy. Exclusion criteria were based on the history of previous surgery, parental disagreement, and patients who did not use preparation protocol. Three methods for bowel preparation were studied: 1- Polyethylene glycol only; 2- Polyethylene glycol and bisacodyl suppositories; 3- Polyethylene glycol plus normal saline enema. Boston Bowel Preparation Score was used for evaluation of preparation. SPSS version 16.0 (Chicago, IL, USA) were used for data analysis. Results - In this study 83 cases completed the bowel preparation completely. Acceptable bowel preparation was seen in 24 (85.71%), 36 (94.73%), and 14 (82.35%) of cases in PEG, PEG + bisacodyl, and PEG + normal saline enema groups respectively. PEG + bisacodyl suppositories was more effective than PEG + normal saline for the preparation of the first segment ( P=0.05). For second and third segment of colon, BPPS score was higher in PEG + bisacodyl suppositories compared to other regimens, but this difference was not statistically significant. Conclusion - There was no significant difference between 1 day colonoscopy regimens in terms of bowel preparation score. Lowest score was seen in PEG + enema group compared to other group.

Contexto - A colonoscopia é um procedimento diagnóstico e terapêutico importante. A preparação intestinal adequada é obrigatória. Vários esquemas são discutidos na literatura. Dentre as drogas que se têm usado recentemente, o polietilenoglicol é um dos agentes mais utilizados. Objetivo - O objetivo deste estudo foi comparar a eficácia de três métodos diferentes para a preparação feita 1 dia antes de colonoscopia. Métodos - Este estudo incluiu crianças com a gama de idades entre 2 e 21 anos, que tinham indicação de colonoscopia. Os critérios de exclusão foram baseados em história da cirurgia anterior, não aprovação dos pais e pacientes que não utilizaram o protocolo de preparação. Três métodos para a preparação do intestino foram estudados: 1-polietilenoglicol; 2 - polietilenoglicol e bisacodil supositórios; 3 - polietilenoglicol e enema de solução salina. O escore de Boston para preparação intestinal foi usado para a avaliação e os dados foram analisados pelo SPSS versão 16.0 (Chicago, Il, USA). Resultados - Um total de 83 pacientes concluiu completamente o preparo intestinal. Houve preparo aceitável em 24 (85,71%), 36 (94,73%) e 14 (82,35%) dos casos, nos grupos PEG, PEG + bisacodil e PEG + enema salino, respectivamente. PEG + bisacodil supositórios foi mais eficaz do que a PEG + solução salina para a preparação do primeiro segmento ( P=0,05). Para segundo e terceiro segmento do cólon, a pontuação de BPPS foi maior no grupo PEG + bisacodil supositórios em comparação com outros regimes, mas essa diferença não foi estatisticamente significativa. Conclusão - Não houve nenhuma diferença significativa entre os regimes de preparo para colonoscopia de um dia em termos de pontuação de preparação do intestino. A nota mais baixa foi vista no grupo PEG + enema em comparação com outros grupos.

Melanose coli / Melanose coli

Paciente do sexo feminino, de 60 anos, portadora de constipação intestinal crônica, com evolução desde a sua adolescência, tendo realizado tratamento com inúmeros laxantes. Recentemente teve piora do quadro intestinal, associado à presença de dor abdominal e, por vezes, secreção mucosanguinolenta acompanhando as evacuações, situações que motivaram a realização de uma colonoscopia, que evidenciou a presença de melanose cólica, com preservação da válvula ileocecal . O surgimento de Melanose coli é causado pelo acúmulo de lipofucsina, que é um pigmento acastanhado-enegrecido nos lissosomos dos macrófagos subepiteliais localizados na mucosa cólica. A intensidade da pigmentação não é uniforme, sendo mais intensa no ceco e no cólon proximal em comparação ao encontrado no cólon distal. Fato relacionado à maior concentração de substâncias agressivas presentes no cólon proximal, na absorção diferenciada ao longo da mucosa do cólon ou devido a diferenças na distribuição de macrófagos ao longo do cólon. A Melanose coli presente no cólon proximal, envolvendo a mucosa do ceco, apresenta um limite bem definido com a transição para a mucosa ileal. Frequentemente, a pigmentação pode estender-se através de todo o cólon, englobando o apêndice cecal e mais raramente a região de transição íleo-cecal. Está condição é frequentemente encontrada durante a investigação endoscópica da constipação intestinal crônica, principalmente quando ocorre a associação com o uso crônico de catárticos à base de antraquinona, como a cascara sagrada, senne, aloés e ruibarbo. A característica marcante na colonoscopia é a coloração da mucosa que varia de um tom acinzentado até completamente preto, que pode ser visualizado em aglomerados de manchas ou em faixas. Nota-se ainda uma nítida demarcação na válvula ileocecal, com a preservação da coloração do intestino delgado e o comprometimento da mucosa cólica. O tratamento da Melanose coli não está bem definido sendo, entretanto, recomendado a suspensão do uso de catárticos. Após a interrupção do laxante à base de antraquinona, a coloração enegrecida da mucosa desaparece gradualmente em vários meses.

Double-blind prospective randomized study comparing polyethylene glycol to lactulose for bowel preparation in colonoscopy / Estudo prospectivo randomizado duplo-cego comparando polietilenoglicol com lactulose para preparo de colon em colonoscopia

Background: Colonoscopy is the most frequent exam used to evaluate colonic mucosa, allowing the diagnosis and treatment of many diseases. The appropriate bowel preparation is indispensable for the realization of colonoscopy. Therefore, it is necessary the use of laxative medications, preferentially by oral administration. Aim: To compare two medications used in bowel preparation in adult patients going to ambulatory colonoscopy and to analyze the patients' profile. Methods: A double-blind prospective study with 200 patients, randomized in two groups: one that received polyethilene glycol and another that received lactulose. The patients answered to questionnaires to data compilation, as tolerance, symptoms and complications related to preparation. Besides, it was also evaluated the prepare efficacy related to the presence of fecal residue. Results: Intestinal habit alterations and abdominal pain were the main reasons to realize the exams and hypertension was the most prevalent comorbidity. Ten percent of the ones who received lactulose didn't get to finish the preparation and 50% considered the taste "bad, but tolerable". The most common subjective symptom after the medication was nausea, especially after lactulose. During the exam, most of the patients who used lactulose had a "light discomfort" and the ones who used polyethilene glycol considered the discomfort as "tolerable". The quality of the preparation was good in 75%, undependable of the medication that was used. Conclusion : Polyethilene glycol was more tolerable when compared to lactulose, without difference on the quality of the preparation. .

Racional - A colonoscopia é o exame mais utilizado atualmente para avaliação da mucosa colônica, permitindo diagnóstico e tratamento de diversas doenças. O preparo de cólon adequado é imprescindível para a realização do exame. Para tanto, é necessária a utilização de laxantes, cuja via preferencial de preparo é a oral. Objetivo - Comparar duas soluções para preparo de cólon nos pacientes adultos a serem submetidos à colonoscopia em regime ambulatorial e o perfil destes pacientes. Métodos - Estudo prospectivo duplo-cego com 200 pacientes distribuídos aleatoriamente em dois grupos: um que recebeu dose padrão de polietilenoglicol e o outro que recebeu dose padrão de lactulose. Os pacientes responderam a questionários para compilação de dados, como tolerância, sintomas e complicações relacionadas ao preparo. Além disso, foi avaliada também a eficácia do preparo com relação à presença de resíduos fecais. Resultados - Alteração do hábito intestinal e dor abdominal foram os principais motivos para o exame, sendo que hipertensão a comorbidade mais prevalente. Dez por cento dos que receberam lactulona não conseguiram completar o preparo e 50% consideraram o gosto do preparo "ruim, mas tolerável". O sintoma subjetivo mais comum após o preparo foi náusea, principalmente após a lactulona. Durante o exame, a maioria dos usuários da lactulona teve desconforto "leve", sendo que os que usaram polietilenoglicol consideraram o desconforto como "tolerável". A qualidade do preparo foi boa em 75%, independentemente do preparo utilizado. Conclusão - O polietilenoglicol apresentou melhor tolerância quando comparado à lactulona, não havendo diferença na qualidade do preparo. .

Avaliação comparativa de eficácia clínica e tolerabilidade para a combinação de Cassia fistula e Senna alexandrina Miller em pacientes com constipação intestinal funcional crônica / Comparative evaluation of clinical efficacy and tolerability for the combination of Cassia fistula and Senna alexandrina Miller in patients with chronic functional constipation

JUSTIFICATIVA E OBJETIVO: A constipação intestinal é um problema crônico, frequente, que afeta a Qualidade de Vida dos indivíduos. O objetivo deste estudo foi avaliar a eficácia clínica e a tolerabilidade da composição Cassia fistula e Senna alexandrina Miller, na apresentação geleia sem açúcar, em pacientes diagnosticados com constipação intestinal funcional crônica. MÉTODOS: Estudo envolvendo 96 voluntários com diagnóstico de constipação intestinal funcional crônica, conforme Critérios de Roma III, randomizados em grupos ativo e placebo. A avaliação da eficácia primária foi realizada por meio da frequência média de evacuações, consistência média das fezes e melhora global da constipação. Foram realizadas ainda avaliações secundárias, como número de dias seguidos sem evacuação, proporção de evacuações com dor, esforço, sensação de evacuação incompleta ou bloqueio, uso de manobras manuais, sujeitos de pesquisa que aderiram às recomendações de hábitos de vida, uso de fármacos de resgate e melhora da constipação segundo avaliação do sujeito de pesquisa. RESULTADOS: A proporção de sujeitos da pesquisa que apresentou melhora global da constipação foi de 65,1% no grupo ativo e de 22,0% grupo placebo (p<0,0001). Para a maioria das avaliações secundárias de eficácia, o grupo ativo apresentou melhor desempenho quando comparado ao grupo pesquisa. De acordo com a avaliação dos sujeitos de pesquisa sobre a melhora da constipação, o grupo ativo apresentou melhor desempenho do que o grupo pesquisa. Quanto à segurança, os dois grupos apresentaram resultados similares. CONCLUSÃO: A geleia sem açúcar composta de Cassia fistula e Senna alexandrina Miller apresentou um comportamento seguro e eficaz, sendo uma alternativa para tratamento da constipação intestinal funcional crônica.

BACKGROUND AND OBJECTIVE: Intestinal constipation is a chronic and frequent problem that affects Quality of Life. The aim of this study was to evaluate the efficacy and tolerability of the composition Cassia fistula and Senna alexandrina Miller, as sugar free jelly, in patients diagnosed with chronic functional constipation. METHODS: We evaluated 96 volunteers diagnosed with functional constipation according to Rome III criteria. Volunteers were randomized into active and placebo groups. Primary efficacy endpoint was evaluated by mean frequency of bowel movements, consistency of stools and global improvement of constipation. Secondary endpoints were evaluated, such as number of days without bowel movements, proportion of bowel movements with pain, with strain, sensation of incomplete or blocked bowel movement, use of, manual maneuvers to facilitate defecation, subjects who adhered to the diet recommendation, use of rescue medication, and level of constipation improvement, according to subject evaluation. RESULTS: Global improvement of constipationwas observed in 65.1% of subjects enrolled in active group versus 22% in placebo group (p<0.0001). For most secondary efficacy evaluations, the active group performed better when compared to placebo group. According to the evaluation of the subjects on the improvement of constipation, the active group performed better than the placebo group. As for security, the two groups showed similar results. CONCLUSION: Cassia fistula and Senna alexandrina Miller sugar free jelly demonstrated to be safe and effective and it can be used as an alternative for the treatment of functional constipation.