Opioids have become the gold standard for treatment of severe pain in advanced disease, but adverse effects can affect the quality of life. Opioid-induced bowel dysfunction can lead to refractory constipation. Methylnaltrexone bromide is a peripherally acting mu antagonist and is indicated for the treatment of opioid-induced constipation in patients with advanced illness, when response to standard laxative therapy has been inefficacious. This pharmacology update will review the etiology, pathophysiology, and treatment of opioid-induced constipation, focused on methylnaltrexone as a novel treatment for refractory cases.

Olsson, S. Föräldrars upplevelse av egenvård och egenvårdsråd vid förstoppning hos barn: En intervjustudie. Examensarbete i omvårdnad 15 högskolepoäng. Avancerad nivå – Magister. Malmö Universitet: Hälsa och samhälle, Institutionen för vårdvetenskap, 2018. Bakgrund: Trots att förstoppningsproblematik hos barn förekommer hos upp till 30 procent av befolkningen är många barn underbehandlade. Vården består i huvudsak av egenvård som ges av föräldrar till barn i hemmet. Vikten av att rätt egenvård initieras i rätt tid påverkar prognosen för om förstoppningsproblematiken utvecklas till att bli mer svårbehandlad eller inte. Föräldrars upplevelse av egenvård och egenvårdsråd torde kunna ge en fingervisning kring om den evidens som finns kommer ut till de barn som är drabbade och vilken roll specialistsjuksköterskan kan spela för att hjälpa föräldrar till barn med förstoppning.Syfte: Att belysa föräldrars upplevelse av egenvård och egenvårdsråd vid förstoppning hos barn.Metod: Kvalitativa semistrukturerade intervjuer genomfördes med nio föräldrar till barn med förstoppningsproblematik. Intervjuernas innehåll analyserades enligt innehållsanalys med induktiv ansats.Resultat: Tre teman framkom i resultatet: innebörden av egenvård och egenvårdsråd, påverkan på det sociala livet och en känsla av utsatthet. Dessa teman reflekterade hur föräldrar till barn med förstoppningsproblematik kunde uppleva svårigheter att definiera hur, när och varför egenvård kunde behöva ges eller förändras till det egna barnet.Slutsats: Resultatet indikerar att relevant kunskap om egenvård vid förstoppning inte når ut till de familjer som behöver den i behandlingen av det förstoppade barnet. Den specialistutbildade sjuksköterskan torde kunna spela en avgörande roll för föräldrar till barn med förstoppningsproblematik i deras upplevelse och behandling av problematiken.Nyckelord: Egenvård, Funktionell förstoppning, Innehållsanalys, Omvårdnad, Pediatrisk vård / Olsson, S. Parents’ experiences of self-care and advice on self-care when handling childhood constipation: an interview study. Degree project, 15 Credit Points One-year Master, Malmö University: Health and society, Department of Care Science, 2018. Background: Despite a prevalence of up to 30 percent many children with childhood constipation are undertreated. Large part of the treatment for constipation consists of self-care administrated to the child by its parents. The importance of proper self-care initiated in time affects the prognosis of whether the constipation will become treatment resistant or not. Parents' perception of self-care and advice on self-care may be an indicator to whether the evidence-based care is offered to the affected children. It could also indicate what role the nurse specialized in pediatric care can play to help parents and their children with constipation. Aim: This study aimed to highlight parents’ perception of self-care and advice on self-care when having a child with constipation.Method: Qualitative semi structured interviews were conducted with 9 parents of constipated children. The interview material was analysed using content analysis.Results: Three themes were identified; meaning of self-care and self-care advice, impact on social life and a sense of vulnerability. These themes reflected how Parents of children with functional constipation experienced difficulties in defining how, when and why self-care might be needed for their child.Conclusion: The studies result implies that relevant knowledge about self-care does not reach the families who need it the most. A nurse specialised in paediatric care could therefore play a crucial role for parents of children with functional constipation in their experience and treatment of the problem.Keywords: Content analysis, Functional Constipation, Nursing, Paediatric care, Self-care.

An evidence-based clinical practice guideline was developed to prevent and manage constipation in long-term care (LTC) residents, a vulnerable population not specifically addressed in previous guidelines. A literature review was completed, and evidence was evaluated and included in initial draft recommendations. The guideline was reviewed for content validity using a Delphi committee of clinical experts in gastroenterology, geriatrics, and pharmacy. The updated guideline was presented to an interdisciplinary team that reviewed its clinical applicability. Overall, interdisciplinary team members agreed or strongly agreed the guideline was clinically applicable (n=30). Finally, the guideline was evaluated by a group of doctorally-prepared practicing nurse practitioners using the Appraisal of Guidelines for Research and Evaluation II instrument. Appraiser scores were 85% or higher in every domain, indicating the guideline was perceived as high in quality. Development of this guideline signifies an initial step in the management and prevention of constipation in LTC residents.

Bakgrund: Obstipation är ett vanligt förekommande tillstånd världen över med en varierande prevalens mellan 0,7% - 79%. Symtomen är subjektiva men vanligt beskrivna symtom är buksmärta, illamående och trötthet. En påverkan på det psykologiska och sociala välbefinnandet är uttalat. Syfte: Att beskriva individens upplevelse vid obstipation. Metod: Studien är en litteraturstudie som genererade i nio vetenskapliga artiklar genom sökningar i vetenskapliga databaser. Likheter och olikheter jämfördes i samtliga artiklar och fyra huvudkategorier kunde identifierades. Resultat: Följande huvudkategorier presenterades; (i) individers upplevelser av förståelse från vården, (ii) individers upplevelser kring behandlingsmetoder, (iii) individers upplevelser av fysiska obstipationssymtom (iv) obstipations påverkan på det psykiska och sociala välbefinnandet. Personcentrerad vård beskrivs som bristande då det föreligger ett tabu och känslighet kring ämnet. Kommunikation om obstipation initieras sällan av personal inom hälso-och sjukvården vilket har betydelse för information kring behandlingsmetoder och livsstilsförändringar. Obstipation är en bidragande faktor till ett försämrat psykiskt och socialt välbefinnande. Konklusion: Tillståndet är vanligt förekommande och måste därför normaliseras bland både individer och inom hälso- och sjukvården. Det krävs för att skapa bättre förutsättningar att kunna hantera tillståndet och för ett ökat välbefinnande. / Background: Constipation is a common condition worldwide with a varying prevalence between 0.7% - 79%. The symptoms are subjective but commonly described symptoms are abdominal pain, nausea and fatigue. An impact on psychological and social well-being is pronounced. Aim: To describe the individual's experience of constipation. Method: The study is a literature study that generated nine scientific articles through searches in scientific databases. Similarities and differences were compared in all articles and four main categories could be identified. Results: The following main categories were presented; (i) individuals' experiences of understanding from care, (ii) individuals' experiences of treatment methods, (iii) individuals' experiences of physical constipation symptoms (iv) constipation's impact on psychological and social well-being. Person-centred care is described as lacking as there is a taboo and sensitivity around the subject. Communication about constipation is rarely initiated by health care staff, which is important for information about treatment methods and lifestyle changes. Constipation is a contributing factor to impaired mental and social well-being. Conclusion: The condition is common and must therefore be normalized both among individuals and within health care. It is required to create better conditions to be able to manage the condition and for increased well-being.

Bakgrund: Obstipation är ett obehagligt och vanligt förekommande tillstånd. Symtom som bukuppspändhet, buksmärta, kräkningar, fatigue och huvudvärk är vanliga vid obstipation. Tidigare forskning har belyst barriärersom ses hindra patienter att förmedla sitt tillstånd samt brister i omvårdnadsdokumentation och bedömning har uppmärksammats vilket kan påverka omvårdnaden negativt. Syfte: Syftet var att belysa sjuksköterskans erfarenheter av omvårdnaden till patienter med obstipation. Metod: En litteraturstudie baserad på nio vetenskapliga artiklar varav tre kvantitativa, två kvalitativa och fyra med mixad metod. Artiklarnas innehåll analyserades enligt Popenoe et al. (2021) och fyra huvudkategorier utformades. Resultat:Resultatet presenterades med fyra huvudkategorier: (i) erfarenheter av gynnsam omvårdnad, (ii) erfarenheter av hinder i omvårdnaden, (iii) erfarenheter av utbildning, kunskap och samarbete vid omvårdnaden och (iv) sjuksköterskans erfarenheter av övriga omvårdnadsåtgärder. Konklusion: Resultatet visar sjuksköterskans erfarenheter av organisatoriska hinder som tidsbrist och att omvårdnaden vid obstipation nedprioriterades samt att det fanns gynnsammaomvårdnadsåtgärder relaterade till livsstilsfaktorer som sjuksköterskan behöver använda i större utsträckning. Det framkom även ett behov av ökad utbildning i obstipation och bedömningsverktyg. Vidare forskning behövs på hur vården kan organiseras för att säkerställa sjuksköterskans förutsättningar att bedriva en personcentrerad vård och minska användandet av laxerande läkemedel. / Background: Constipation is an unpleasant and widespread condition. Symptoms as abdominal distension, abdominal pain, vomiting, fatigue and headache are common with constipation. Previous research shows barriers that prevents patients from communicating their condition, shortcomings in nursing documentation and assessment have been noticed, which negativelyaffect nursing. Aim: The aim was to illustrate the nurse´s experiences of nursing care to patients with constipation. Method: A literature study based on nine scientific articles, three was quantitative, two qualitative and fourmixed methods. The articles were analyzed according to Popenoe et al. (2021) and four main categories was designed. Results: The results were presented in four main categories: (i) experiences of nursing care with positive effect, (ii) experiences of obstacles in the nursing care, (iii) experiences of education, knowledge and cooperation in the nursing care and (iv) experiences of other nursing measures. Conclusion: The results show nurses experiences of organizational obstacles such as lack of time and that nursing care for constipation was de-prioritized and that there also were favorable nursing measures related to lifestyle factors that nurses needto use to a greater extent. There was also a need for increased education in constipation and assessment tools. Further research is needed on how the care can be organized to ensure nurses conditions to provide personcentered care and reduce the use of laxatives.

Bakgrund: Förstoppning orsakar obehag och onödigt lidande med en hög prevalens världen över. Behandlingen av förstoppning är idag främst farmakologisk i form av laxerande. Sjuksköterskan har en begränsad arsenal av omvårdnadsåtgärder till hens förfogande för att behandla förstoppning. En potentiell icke farmakologisk omvårdnadsåtgärd är magmassage. Syfte: Syftet med denna litteraturstudie var att undersöka effekten av magmassage hos vuxna förstoppade individer för att få en bild av dess användbarhet som omvårdnadsåtgärd. Metod: Sökningar utfördes i Pubmed, Web of Science samt Ebscos alla databaser. Åtta empiriska kvantitativa interventionsstudier inkluderades i denna litteraturstudie. Studierna kvalitetsgranskades och analyserades. Effekten av magmassage som mätts i inkluderade studier med signifikansnivå på p<0.05 sammanställdes i resultatdelen. Resultat: Samtliga studier kunde påvisa en positiv effekt gentemot förstoppningssymtom oavsett interventionstid. I flera studier har även andra positiva effekter gått att utläsa kopplat till interventionen magmassage, bland annat ökad livskvalité. Konklusion: Sammanställningen av resultatet tyder på att magmassage har en positiv effekt på förstoppade individer. Det i kombination med den låga kostnaden och avsaknaden av bieffekter gör magmassage till en användbar omvårdnadsåtgärd vid behandling av förstoppning både på lång- och korttidsliggande patienter. / Background: Constipation causes pain and discomfort and is a prevalent problem around the world. Treatment options today concludes mainly of pharmacological interventions in the form of laxatives. As a nurse there are a limited number of care options to treat constipation. One non-pharmacological care option that shows potential is abdominal massage. Aim: The aim of this literature review was to investigate the effects of abdominal massage in constipated adults to determine its viability as a care intervention. Methods: Searches were made in Pubmed, Web of science and all of Ebsco’s databases. Eight empirical quantitative intervention studies were included in this literature review. The studies were graded and analyzed. All results from the included studies that measured the effect of abdominal massage and could prove a statistically significant correlation with a p<0.05 were compiled in the results. Result: All studies showed positive effects towards constipation symptoms, regardless of intervention length. A number of studies also found other positives effects such as improved quality of life. Conclusion: The results indicate that abdominal massage has a positive effect when it comes to treating constipation. That in addition with it being a cost-effective option with a lack of side effects makes it a viable care option to treat constipation whether it’s used on short term or long term stay patients.

Introdução: Os distúrbios funcionais colorretoanais, frequentemente representados por constipação intestinal, incontinência anal e dor anorretal apresentam alta prevalência na população geral. De etiologia multifatorial onde estão envolvidas causas orgânicas, funcionais, culturais e psicológicas. Dados bibliográficos apontam que a depressão, a ansiedade e o estresse estão entre os fatores psicológicos mais presentes nesse grupo de pacientes. Representam um desafio para abordagem gerando impacto significativo na qualidade de vida. Objetivo: Este estudo prospectivo teve como objetivo avaliar o perfil de psicológico de pacientes com distúrbios funcionais colorretais: constipação intestinal crônica (CIC), incontinência anal (IA) e dor anal (DA), utilizando uma versão reduzida, mais aplicáveis do MMPI, o MMPI- IRF (Minnesota Multiphafic Personality Inventory Improved Readability Form). Métodos: Um total de 90 pacientes, sendo 30 de cada grupo sintomático, CIC, AI e DA, respectivamente, e 60 indivíduos controle foram avaliados. Todos os grupos foram igualmente distribuídos por sexo. Os dados foram obtidos através de semi-dirigidas e MMPI-IRF, que consiste de 167 propostas divididas em quatro escalas de validade (\"não posso dizer \", mentira, defensividade) e 10 escalas clínicas (hipocondria, depressão, histeria, desvio- psicopático, masculinidade e feminilidade , paranóia, psicastenia, esquizofrenia, hipomania e introversão-extroversão social). O estudo estatístico incluiu o teste ANOVA, Belferroni e exato de Fisher sendo considerados significativos quando os calores de p<0,05. Resultados: A média de idade os valores foram 48, 52, 49 e 43 anos para o CIC, IA, DA e grupos de controle, respectivamente. O IA se destacou por apresentar menor escolaridade 36% nao concluíram o 1° grau. Quanto aos antecedentes psiquiátricos DA obteve maior porcentagem de pacientes que já estiveram em tratamento psiquiátrico (43%). O início da depressão precedeu o início da queixa funcionais em 36% dos pacientes do CIC, mas em apenas 20% e 23%, respectivamente, IA e pacientes DA. Os escores de depressão, hipocondria e histeria escalas foram significativamente maiores em todos os grupos de pacientes quando comparados aos indivíduos do grupo controle. Conclusão: As elevações nas escalas hipocondria, depressão e histeria são indicativos que os sintomas funcionais colorretoanias são mecanismos de defesa que atuam protegendo os indivíduos da ansiedade e da depressão excessivos. Confirmando a importância de combinar a abordagem psicológica aos cuidados médicos convencionais desses pacientes / Introduction: The functional colorectal disorders frequently represented by constipation, anal incontinence and anorectal pain with a high prevalence in the general population. The multifactorial etiology which are involved in organic, functional, cultural and psychological. Bibliographic conclusions suggest that depression, anxiety and stress are among the psychological factors present in most of this patients. Represent a challenge to approach generating significant impact on quality of life.. Objective: This prospective study aimed to evaluate the psychological profile of patients with colorectal functional disorders: chronic idiophatic constipation (CIC), anal incontinence (AI) and chronic idiopathic rectal pain (CIRP), using a reduced version, the MMPI more applicable, the MMPI- IRF (Minnesota Multiphafic Personality Inventory-Improved Readability Form). Methods: A total of 90 patients, 30 of each symptomatic group, CIC, AI and CIRP, respectively, and 60 control subjects were evaluated. All groups were equally distributed by gender. Data were obtained through semi-directed interviews and MMPIIRF, which consists of 167 proposals divided into four scales of validity (\"I can not say,\" lie, infrequency, defensiveness) and 10 clinical scales (hypochondriasis, depression, hysteria, psychopathic deviate, masculinity- femininity, paranoia, psychaesthenia, schizophrenia, mania, and social introversion-extroversion). Statistical analysis included ANOVA, Fisher\'s exact and Belferroni were considered significant when the heats of p <0.05. Results: Mean age values were 48, 52, 49 and 43 years for the CIC, AI, CIRP and control groups, respectively. The AI was noted for 36% less education have not completed a degree. The psychiatric history\'s got higher percentage of patients who have been in psychiatric treatment (43%). The onset of depression preceded the onset of functional complaints in 36% of patients in the CIC, but in only 20% and 23%, respectively, and AI patients. The scores of depression, hypochondria and hysteria scales were significantly higher in all patient groups compared to control subjects. Conclusion: The elevations on the scales hypochondria, depression and hysteria are indicative that the colorectal functional symptoms are defense mechanisms that act to protect individuals from excessive anxiety and depression. Confirming the importance of combining a psychological approach to conventional medical care for these patients

Alterações gastrointestinais em pacientes com doença renal crônica são queixas comuns, sendo a constipação considerada um dos sintomas mais prevalentes. O tratamento deste sintoma é limitado nesta população, devido às modificações dietéticas impostas pela perda da função renal e métodos dialíticos, especialmente na hemodiálise. Dados locais sobre a prevalência e fatores associados à constipação são pouco conhecidos em nosso meio. Neste estudo transversal, foram incluídos 57 participantes que realizam hemodiálise há pelo menos 3 meses no Hospital Moinhos de Vento em Porto Alegre, Brasil. Um questionário foi utilizado para avaliar dados sociodemográficos e clínicos potencialmente associados à constipação, a qual foi definida utilizando os critérios de ROMA III. Foi diagnosticada constipação em 28 pacientes nesta amostra (49,1%). Do total da amostra, 34 indivíduos (59,6%) relataram estar utilizando ou já terem utilizado laxantes em algum momento. Entre os constipados, 23 (82%) relataram esse uso. Outros 11 indivíduos usam laxativos cronicamente, ainda que não tenham sido classificados como constipados pelos critérios de ROMA III. Considerando a autopercepção, relataram “dificuldade para evacuar” 21/57 (36,8%). A concordância entre a autopercepção de “dificuldade para evacuar” e constipação pelos critérios de ROMA III ocorreu em 34 (59,6%) dos indivíduos. Entre os 28 pacientes constipados, 17 (77,3%) referem que sintomas gastrointestinais interferem no seu bem-estar, enquanto que entre os 29 pacientes não constipados, somente 5 (22,7%) referem esta interferência (p = 0,01) Quando investigado os fatores potencialmente associados à constipação,a inatividade física (Razão de prevalência 53,4; Teste exato de Fisher p = 0,052) e o sexo feminino (Razão de Prevalência 1,6; Pearson X2 p = 0,07) apresentaram tendênciaà associação significativa. No entanto, não foi encontrada associação significativa entre constipação e escolaridade, faixa etária, utilização de carbonato de cálcio, presença de 8 diabetes, estado nutricional e consumo de fibras atual. Conclusões: A constipação intestinal é um sintoma frequente em pacientes em hemodiálise no nosso meio. A utilização dos critérios de ROMA III para o diagnóstico de constipação permite diagnosticar um maior número de casos quando comparado apenas à autopercepção. A maior parte dos pacientes da amostra faz ou já fez uso crônico de laxantes, ainda que boa parte destes não se considere constipado, ou seja, classificados como constipados pelos critérios de ROMA III. Considerando-se a alta prevalência e interferência no bem-estar, a abordagem sobre a presença de constipação deve ser rotineira nessa população, a fim de alcançar-se um diagnóstico e manejo corretos. / Seventeen (77.3%) of the 28 constipated patients reported that their gastrointestinal symptoms interfered with their wellbeing, whereas just 5 (22.7%) of the 29 patients without constipation reported the same interference (p = 0.01). Investigation of factors potentially associated with constipation detected that inactivity (Prevalence ratio 53.4; Fisher’s exact test p = 0.052) and female sex (Prevalence ratio 1.6; PearsonX2 p = 0.07) exhibited tendencies towards a significant association. However, there were no significant associations between constipation and educational level, age group, use of calcium carbonate, presence of diabetes, nutritional status, or current fiber consumption. 10 Conclusions: Constipation is a common symptom among patients on hemodialysis in our country. Use of the ROMA III criteria diagnoses a higher number of cases of constipation than patients’ own perception alone. The majority of patients in the sample have used or were still using laxatives chronically, even though a considerable proportion of these patients were not considered constipated,they were not classified as constipated according to the ROMA III criteria. Considering its high prevalence and its impact on wellbeing, whether patients have constipation should be routinely investigated in this population, to enable correct diagnosis and management.

Made available in DSpace on 2014-07-29T15:25:19Z (GMT). No. of bitstreams: 1 Tese Arminda C de A Leite.pdf: 1276473 bytes, checksum: 523ec1cf9ec873a814b205b4cce56e0e (MD5) Previous issue date: 2012-02-02 / Chagas disease remains as an important public health challenge in South America. The Chagas colopathy is considered the second clinical digestive manifestation most common of the disease and constipation chronic, its main symptom. The general objective was to investigate the presence of achalasia, through electromanometry of the internal anal sphincter, in constipated chagasic patients with and without megacolon. This study evaluated clinical and electromanometry parameters of 64 patients with symptoms of constipation, attended on the service of coloproctologya on a university hospital in Brazil, central region. The achalasia was present in 91.3% (IC95% 74.13 to 98.52) of patients with megacolon and/or megarecto (Group 1), in 47.29% (IC95% 27.29 to 68.57) without megacolon and/or megarecto (Group2), and was not present in patients of the control group (Group 3). The rectal capacity was 309.1, 159.2 and 150.1 ml in the groups 1, 2 and 3 respectively. In conclusion the electromanometry detects achalasia of the internal anal sphincter in almost totality of patients with megacolon and/or megarecto. The megacolon presence in constipated patients with Chagas Disease alert to the possibility of occurrence of achalasia on the internal anal sphincter. In chronically constipated patients with positive serology for Chagas Disease, without megacolon the a finding of absence of the recto anal inhibitory reflex, by electromanometry, can definitively prove the Chagas colopathy, while the presence of reflection departs, at the time, this diagnosis, should these patients be followed and treated like other patients with constipation due to other causes The comparison of clinical manifestations in the three groups not evidenced differences that could distinguish patients with Chagas colopathy those with functional constipation, reaffirming the importance of holding the electromanometry in Chagasic and constipated patients. / A doença de Chagas permanece um importante desafio para a saúde pública no continente sul americano. A colopatia chagásica é considerada a segunda manifestação clínica digestiva mais comum da doença e a obstipação intestinal crônica, seu principal sintoma. O objetivo geral foi investigar a presença de acalásia, por meio da eletromanometria do esfíncter anal interno, em pacientes chagásicos obstipados com e sem megacolo. O presente estudo avaliou parâmetros clínicos e eletromanométricos de 64 pacientes com sintoma de obstipação intestinal, atendidos no serviço de coloproctologia de um hospital universitário da região central do Brasil HC/UFG. A acalásia esteve presente em 91,3% dos pacientes com megacolo e/ou megarreto (Grupo 1), em 47,29% dos sem megacolo e/ou megarreto (Grupo 2) e em nenhum dos pacientes do grupo controle (Grupo 3). A capacidade retal foi de 309,1, 159,2 e 150,1 mL nos Grupos 1, 2 e 3 respectivamente. O presente estudo concluiu que a presença de megacolo em pacientes obstipados chagásicos alerta para a possibilidade de ocorrência de acalásia do esfincter anal interno, uma vez que foi detctada na grande maioria dos pacientes. Em pacientes obstipados crônicos, com sorologia positiva para doença de Chagas, sem megacolo a constatação da ausência do reflexo inibitório retoanal, pela eletromanometria, pode de forma definitiva comprovar a colopatia chagásica. Por outro lado, a presença do reflexo afastaria, naquele momento, esse diagnóstico, devendo esses pacientes serem seguidos e tratados como os demais portadores de obstipação por outras causas. A comparação das manifestações clínicas nos três grupos não evidenciou diferenças que pudessem distinguir pacientes com colopatia chagásica daqueles com obstipação funcional, reafirmando a importância da realização da eletromanometria em pacientes chagásicos e obstipados. Todo paciente portador de obstipação intestinal, com sorologia positiva para doença de Chagas no qual o enema opaco não revele megacolo e/ou megarreto, deverá ser submetido à eletromanometria para pesquisa de acalásia do esfíncter interno do ânus, para a conclusão do diagnóstico e condução do tratamento.

nÃo hà / ConstipaÃÃo à um problema clÃnico comum que compreende uma constelaÃÃo de sintomas como excessivo esforÃo, fezes duras, sensaÃÃo de evacuaÃÃo incompleta, uso de manobras digitais, ou defecaÃÃo infreqÃente. Seu tratamento emprega medicamentos que aumentem a freqÃÃncia e facilitem as evacuaÃÃes, bem como mudanÃas nos hÃbitos de vida. O objetivo desse estudo foi avaliar seguranÃa, eficÃcia terapÃutica e validar um mÃtodo analÃtico para a gelÃia TamarineÂ, um fitoterÃpico largamente utilizado como laxante, em pacientes com constipaÃÃo intestinal funcional. Foi realizado o perfil cromatogrÃfico da gelÃia Tamarine para confirmaÃÃo dos seus constituintes e anÃlise de estabilidade empregando cromatografia lÃquida de alta eficiÃncia (CLAE), onde seus principais constituintes foram identificados atravÃs dos tempos de retenÃÃo caracterÃsticos. A anÃlise de estabilidade da formulaÃÃo foi executada comparando os cromatogramas de lotes recÃm-fabricados com lotes apÃs 2 anos de fabricaÃÃo. O mÃtodo desenvolvido comprovou a qualidade das amostras testadas e sua estabilidade apÃs 2 anos de armazenamento. O estudo de toxicologia clÃnica foi do tipo aberto, realizado em 24 voluntÃrios saudÃveis de ambos os sexos que receberam diariamente a administraÃÃo de 5g da gelÃia Tamarine por 28 dias consecutivos. Os voluntÃrios foram avaliados antes, durante e ao final do perÃodo de administraÃÃo atravÃs de histÃria mÃdica, exame fÃsicos e laboratoriais. A formulaÃÃo foi bem tolerada e foram observados feitos adversos como cÃlicas (83,3%), aumento de evacuaÃÃes (58,3%), diarrÃia (20,8%), flatulÃncia e nÃuseas (12,5%). Os parÃmetros hematolÃgicos, metabÃlicos, funÃÃo renal e hepÃtica sofreram variaÃÃes pontuais ao longo do estudo, entretanto, consideradas sem significado clÃnico. O estudo de eficÃcia terapÃutica foi do tipo controlado, paralelo, aberto e randomizado empregando 124 voluntÃrios com constipaÃÃo intestinal funcional, selecionados de acordo com os critÃrios de Roma II e distribuÃdos aleatoriamente entre os grupos de tratamento com a gelÃia Tamarine (TAM) ou Metamucil (MET). Os pacientes em tratamento eram avaliados quinzenalmente para levantamento de efeitos adversos e avaliaÃÃo da eficÃcia feita pelo registro das evacuaÃÃes diÃrias, consistÃncia das fezes e pela melhora global referida pelos mesmos. A maioria dos pacientes apresentou dieta pobre em fibras e baixa ingestÃo de lÃquidos, entretanto, suas dietas nÃo foram alteradas durante o tratamento, as orientaÃÃes nutricionais foram realizadas ao final do estudo para nÃo interferir nos resultados. O uso do TAM aumentou o nÃmero de evacuaÃÃes nos pacientes apÃs 14 e 28 dias de tratamento, quando comparado com o perÃodo inicial de seleÃÃo. No 7o, 14 o, 21 o e 28 o dias a resposta dos pacientes que faziam seu uso foi maior do que o grupo tratado com MET (p&#61500;0,001), bem como a taxa de melhora 166,7% (p=0,003). A consistÃncia das fezes tambÃm melhorou, tornando-se mais amolecidas nos dois grupos. Tratamento com TAM reduziu a consistÃncia das fezes em todo o perÃodo de tratamento (p<0,001) enquanto que o controle teve reduÃÃo apenas na terceira semana (p<0,05). A avaliaÃÃo global dos pacientes (p=0,01 e 0,0367) e do investigador (p=0,0083 e 0,0193) realizadas no 14 e 28 dias de tratamento mostrou melhor aceitaÃÃo para o grupo tratado com TAM nos dois perÃodos de avaliaÃÃo. Nenhum sinal de toxicidade clÃnica ou laboratorial foi observado em todo o perÃodo de tratamento. O presente ensaio clÃnico conclui que a administraÃÃo de 5g da gelÃia Tamarine à segura e eficaz no tratamento da constipaÃÃo intestinal. / Constipation is a common clinical problem that comprises a constellation of symptoms that include excessive straining, hard stools, feeling of incomplete evacuation, use of digital maneuvers, or infrequent defecation. The treatment is composed by behavioral measures and a therapeutic approach. Initial intervention should include dietary measures and fiber supplements; however, if fiber supplement action is ineffective, substances that increase the fecal bolus, lubricants, osmotic agents and laxatives can be used. The aim of the present study was to establish the efficacy, safety and validate an analytical method. Tamarine jelly, a phytotherapic product from Barrenne IndÃstria FarmacÃutica Ltda. a phytomedicine used as laxative. The research project with the experimental protocol and informed consent, were submitted to and approved by the Research Ethics Committee of UFC. The chromatographic profiles of Tamarine jelly was done for confirmation of their constituents and stability analysis using high performance liquid chromatography (HPLC). The method showed the quality of the samples tested and its stability after 2 years of storage. The toxicology clinical trial consisted of an open study with 24 healthy volunteers of both sexes, with a mean age of 26.8 &#61617;&#61472;7.8 years, who orally received a daily dose of 5g Tamarine for 28 uninterrupted days. The volunteers were included in the study only when considered healthy after clinical evaluation, physical examination and laboratory tests which preceded the study. The laboratory tests included: heamatologic, biochemical and serologic analysis. This evaluation was repeated after the first, second, third and fourth week of treatment and at post-study. The jelly was well tolerated, however, some adverse gastrointestinal events were observed. Twenty volunteers (83.3%) reported episodes of light intestinal colic followed by hyperdefecation, five (20.8%) reported diarrhea and three (12.5%) flatulence and nausea. The clinical, electrocardiographic and laboratory tests did not show evidence of toxicity in the various organs and systems evaluated. The efficacy was evaluated in 124 constipated patients selected by Rome II criteria. The investigation was designed as a controlled, parallel and opened. After the selection period, Tamarine (TAM) or Metamucil (MET) was administered. Patients were provided with diary sheets to record each bowel movement and associated subjective symptoms rating stool consistency, abdominal pain and flatus. The efficacy and safety analyzed after each 14 days of treatment by the information recorded on diary and a global assessment of efficacy. Volunteers continuing with their routine activities and maintaining their normal general diets even showing a low consumption of fiber and liquids. The nutritional guidelines were implemented at the end of the study not to interfere in the results. TAM increased bowel frequency after 14 and 28 days when compared with no treatment period and on 7o, 14 o, 21o and 28o days was higher the MET (p<0,001). The stool consistency was changed and became softer in both groups. The alterations improved by TAM was observed in all treatment period (p<0,001) and MET changed only on the third week (p<0,05) . The patientâs global efficacy score (p=0,01 e 0,0367) and investigatorâs (p=0,0083 e 0,0193) realized that on 14 and 28 days of treatment was superior for the TAM group compared with MET. No signs of clinical or laboratory toxicity was observed throughout the treatment period. Confirming their traditional use, the administration of 5g of jelly Tamarine  phytotherapic proved to be safe and effective in the treatment of constipation.