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Gastrointestinal (GI) symptoms are common in patients receiving radiotherapy, chemotherapy, and/or surgery for cancer in the pelvic organs. The aim of the present prospective cohort study was to report the efficacy of dietary intervention in patients with chronic GI sequelae to treatment of cancer in pelvic organs and insufficient symptomatic effect of medical treatment. Eighty-eight patients were offered specialist dietitian guidance. Gastrointestinal symptoms and quality of life were assessed before and after intervention by validated questionnaires. The main dietary interventions were low-fat diet (n = 44; 50%), modification of dietary fiber content (n = 19; 33%), dietary restrictions with a low-FODMAP (fermentable oligosaccharides, disaccharides, monosaccharides, and polyols) diet (n = 18; 20%), gluten-free diet (n = 1; 1%), and other dietary advice (n = 6; 7%). Compared to baseline, dietary intervention improved quality of life (EQ5D scale) (p < 0.01), bowel function for the last four weeks (p < 0.02), stool frequency (p < 0.03), constipation (p < 0.05), incomplete rectal emptying at defecation (p < 0.02), and performing usual activities (p < 0.0). In conclusion, this observational study using tailored dietary intervention showed that symptoms can be reduced and quality of life can be improved in patients with chronic GI sequelae following treatment of cancer in the pelvic organs not responding sufficiently to medical treatment.
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BACKGROUND AND AIM: Physical activity confers health benefits in many diseases but remains almost unstudied for cirrhosis. We investigated whether a period of resistance training affects the subsequent long-term risk of hospitalization or mortality among patients with cirrhosis. METHODS: The study includes 39 participants with cirrhosis Child-Pugh class A/B who participated in a prior clinical trial randomized to either resistance training three times per week for 12 weeks or a control group. We gathered data through medical records from trial entry and the following 3 years. The outcomes were time to first hospitalization and all-cause mortality. We used regression models to examine the associations between trial groups and outcomes, adjusting for Child-Pugh class, age, gender, and comorbidity. RESULTS: Nine patients who trained and 15 controls were hospitalized, resulting in a lower risk of first hospitalization in the training group (adjusted subdistribution hazard ratio of 0.40, 95% confidence interval [CI] [0.17, 0.92]; P = 0.03). One patient who trained and six controls died, resulting in a lower all-cause mortality in the training group (adjusted hazard ratio of 0.06, 95% CI [0.01, 0.66]; P = 0.02). CONCLUSION: Twelve weeks of resistance training was associated with a reduced risk of first hospitalization and mortality among patients with cirrhosis Child-Pugh class A/B 3 years after trial entry. The mechanisms of this effect are not identified, and larger studies are warranted.
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Entrenamiento de Fuerza , Humanos , Estudios de Seguimiento , Cirrosis Hepática/complicaciones , Fibrosis , Hospitalización , HospitalesRESUMEN
AIM: Patients treated with right-sided hemicolectomy for colon cancer may suffer from long-term bowel dysfunction, including loose stools, urgency and faecal incontinence. The underlying causes are poorly understood. The aim of this case-control study was to investigate the aetiology of chronic loose stools among patients with right-sided hemicolectomy curatively operated for cancer. METHOD: Cases with chronic loose stools (Bristol stool type 6-7) after right-sided hemicolectomy were compared with a control group of patients with right-sided hemicolectomy without loose stools. All patients underwent a selenium-75 homocholic acid taurine (SeHCAT) scan to diagnose bile acid malabsorption (BAM) and a glucose breath test to diagnose small intestinal bacterial overgrowth (SIBO). Gastrointestinal transit time (GITT) was assessed with radiopaque markers. In a subgroup of patients, fibroblast growth factor 19 (FGF19) was measured in fasting blood. SIBO was treated with antibiotics and BAM was treated with bile acid sequestrants. RESULTS: We included 45 cases and 19 controls. In the case group, 82% (n = 36) had BAM compared with 37% (n = 7) in the control group, p < 0.001. SIBO was diagnosed in 73% (n = 33) of cases with chronic loose stools and in 74% (n = 14) of controls, p = 0.977. No association between BAM and SIBO was observed. GITT was similar in cases and controls. No difference in median FGF19 was observed between cases and controls (p = 0.894), and no correlation was seen between FGF19 and SeHCAT retention (rs 0.20, p = 0.294). Bowel symptoms among cases were reduced after treatment. CONCLUSION: BAM and SIBO are common in patients having undergone right-sided hemicolectomy for cancer. Chronic loose stools were associated with BAM but not with SIBO.
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Ácidos y Sales Biliares , Neoplasias del Colon , Humanos , Estudios de Casos y Controles , Diarrea/etiología , Neoplasias del Colon/complicaciones , Colectomía/efectos adversos , Pruebas RespiratoriasRESUMEN
BACKGROUND: Survival from colon cancer (CC) has improved considerably over the last decades, yet many survivors suffer from late sequelae from treatment. Typical symptoms of bowel dysfunction after treatment of CC are diarrhea, urge for defecation, fecal incontinence, bloating and constipation. Most CC survivors make dietary changes to alleviate bowel symptoms. We aimed to describe the self-perceived effects of diet on bowel function among CC survivors and the level of dietary information given. MATERIALS AND METHODS: In this cross-sectional study, CC patients from four surgical departments in Denmark completed surveys regarding the effects of diet on their bowel function and whether they had previously received dietary advice. Data concerning sociodemographic characteristics and the surgical procedure (right-sided or left-sided hemicolectomy) were collected from the Danish Colorectal Cancer Group database. Forty-four healthcare professionals specialized in CC completed a questionnaire on how they advise CC. Descriptive statistics were applied. RESULTS: Among 1544 patients invited, 1239 (80.4%) responded, and 844 met the inclusion criteria (53% males, median age 72.6 years, median time since surgery 742 days). Among these, 267 (32%) reported that food affected bowel function. Fat was perceived to have a negative effect in 193 (25%), spices in 149 (19%), sweets in 101 (13%) and meat in 99 (13%). There was no association between tumor site and food categories affecting bowel function (p = 0.078). Most healthcare professionals (93%) stated that their unit gave advice about diet, but only 24% of patients remembered such information. CONCLUSION: One-third of CC survivors perceive that food items, especially fat and spices have a negative impact on their bowel function. We found a major discrepancy between healthcare professionals reporting that they provide advice and the proportion of patients remembering this. There is an unmet need for further recognition of the role of diet in CC rehabilitation and for intervention studies of treatment principles.
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Supervivientes de Cáncer , Neoplasias del Colon , Masculino , Humanos , Anciano , Femenino , Estudios Transversales , Dieta/efectos adversos , SobrevivientesRESUMEN
Background: Patients with inflammatory bowel disease (IBD) and symptoms of irritable bowel syndrome (IBS) may be intolerant to fermentable carbohydrates (FODMAPs). The aim of this study was to test the feasibility of eliminating and subsequently reintroducing FODMAPs in patients with IBS symptoms as part of the IBD manifestation and to compare the severity of IBS symptoms and pain, bloating and quality of life (QoL). Methods: An eight-week randomised open-label FODMAP elimination with double-blinded, crossover provocations of FODMAP and placebo. Diet patients were on a low-FODMAP diet for eight weeks with blinded two-week provocations after two and six weeks. Questionnaires, blood and stool samples were collected. Results: Patient enrolment was challenging. Nineteen participants were included in the study. Eliminating low FODMAP for two weeks resulted in significant decreases in pain and bloating scores (p < 0.003), whereas there were no statistical differences in pain scores between diet patients and controls. Pain and bloating scores increased, returning to baseline levels after two weeks of double-blinded provocations with placebo, (p > 0.05). Conclusions: The results document the possibility of performing a randomised controlled study following the gold standard for testing food intolerance with blinding of the Low FODMAP diet. Recruitment of participants was challenging.
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Colitis Ulcerosa , Síndrome del Colon Irritable , Dieta Baja en Carbohidratos/métodos , Estudios de Factibilidad , Fermentación , Humanos , Calidad de VidaRESUMEN
AIM: The aim of the present pilot study was to describe the type and frequency of long-term gastrointestinal symptoms within a well-defined cohort of colon cancer survivors, their wish for clinical evaluation and treatment outcomes. METHOD: A screening survey was sent to colon cancer survivors 12, 24 and 36 months after surgery. Based on their main symptoms, patients who wished to have a consultation were referred to the gastroenterological or surgical unit of our late cancer sequelae clinic. Treatment effect was monitored by questionnaires on bowel symptoms and the EuroQol five-dimensional (EQ-5D) quality-of-life score. RESULTS: Overall, 953 patients who had survived colon cancer received the screening survey and 767 replied (response rate 80.5%). Of these, 76 (9.9%; 95% CI 7.9%-12.2%) were referred for algorithm-based clinical evaluation and treatment of bowel dysfunction. The majority were women (69.7%) who had undergone a right-sided colonic resection (65.8%). Patients reported various symptoms, mainly including urgency, fragmented defaecation, loose stools and incontinence for liquid stools. Patients with emptying difficulties and low anterior resection syndrome-like symptoms were referred to the surgical unit and patients with diarrhoea were referred to the gastroenterological unit for clinical work-up. Our main endpoint, mean EQ-5D index after treatment, was improved compared with baseline (baseline 0.809, after treatment 0.846; p = 0.049). After treatment, self-rated bowel function and several bowel symptoms were improved as well. CONCLUSION: This study highlights the importance of identifying colon cancer survivors in need of treatment of late gastrointestinal sequelae and clinical management in a multidisciplinary team setting.
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Supervivientes de Cáncer , Neoplasias del Colon , Neoplasias del Recto , Neoplasias del Colon/complicaciones , Neoplasias del Colon/terapia , Femenino , Humanos , Masculino , Proyectos Piloto , Complicaciones Posoperatorias , Estudios Prospectivos , Calidad de Vida , Encuestas y Cuestionarios , SíndromeRESUMEN
BACKGROUND AND AIM: Malnutrition and muscle mass loss are complications in liver cirrhosis and alcoholic hepatitis (AH). Hospitalised patients who do not meet nutritional requirements are recommended to be fed enterally or parenterally, but no guidelines recommend a specific type of tube. This study aimed to compare the efficacy of jejunal versus gastric feeding. METHOD: 40 inpatients with liver cirrhosis and/or AH, a nutritional risk score more than 2 and a reduced daily energy intake were included. Half were randomised to nasogastric (NG) and half to nasojejunal (NJ) tube feeding. All received Peptamen AF as a supplement to oral intake. Participants were followed up until discharge or death. FINDINGS: The study evaluated the data for 33 patients for 7 days after tube insertion. Mean daily energy intake for 7 days was 6509 kJ (NG) vs 6605kJ (NJ) (P=0.90). Tubes accidently removed by patients: once (n=16); twice (n=9); three times (n=6), with no differences between NG and NJ. CONCLUSION: There were no significant differences in total nutritional intake between early NG feeding and early NJ feeding 7 days after tube insertion. The number of tube replacements was similar in both groups. Choice of tubes for patients with severe liver disease will depend on individual patient characteristics and needs and local facilities.
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Nutrición Enteral , Hepatitis Alcohólica , Humanos , Intubación Gastrointestinal , Cirrosis Hepática , EstómagoRESUMEN
BACKGROUND: Sodium deficiency in patients with an ileostomy is associated with chronic dehydration and may be difficult to detect. We aimed to investigate if the sodium concentration in a single spot urine sample may be used as a proxy for 24-hour urine sodium excretion. METHODS: In a prospective observational study with 8 patients with an ileostomy and 8 volunteers with intact intestines, we investigated the correlations and agreements between spot urine sodium concentrations and 24-hour urine sodium excretions. Spot urine samples were drawn from every micturition during 24 hours, and relevant blood samples were drawn. All participants documented their food and fluid intakes. RESULTS: There was a high and statistically significant correlation between 24-hour natriuresis and urine sodium concentrations in both morning spot samples (n = 8, Spearman's rho [ρ] = 0.78, P = 0.03) and midday spot samples (n = 8, ρ = 0.82, P = 0.02) in the patients with an ileostomy. The agreement between methods was fair (bias = -1.5, limits of agreement = -32.3 to 29.4). There were no statistically significant associations for evening samples or for samples from volunteers with intact intestines independently of time of day. CONCLUSION: A single spot urine sodium sample obtained in the morning or midday may estimate 24-hour urine sodium excretion in patients with an ileostomy and thus help to identify sodium depletion.
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Ileostomía , Sodio , Femenino , Humanos , Masculino , Estudios Prospectivos , Sodio/orina , Factores de Tiempo , UrinálisisRESUMEN
BACKGROUND & AIMS: Cirrhosis is often complicated by reduced muscle mass and strength, which limits the ability to perform daily activities and affects quality of life. Resistance training can increase muscle strength and mass in elderly and chronically ill patients. We performed a randomized controlled trial to investigate whether resistance training increases muscle strength and size in patients with compensated cirrhosis. METHODS: We performed a prospective study of 39 patients with cirrhosis (Child-Pugh class A or B) seen at an outpatient clinic in Denmark from January 2015 through March 2017. Participants protein intake and activity levels were registered daily. Participants were randomly assigned (1:1) to a group that performed 36 1-hour sessions of physical exercise (supervised progressive resistance training for 1 hour, 3 times weekly for 12 weeks) or a control group (no change in daily activity level). Maximal muscle strength was measured as the peak torque in isokinetic knee extension and muscle size was measured as the cross-sectional area of the quadriceps muscle, assessed by magnetic resonance imaging of the thigh. RESULTS: The exercise group increased their muscle strength by 13% (from a mean 119 Nm to 134 Nm)-an 11 Nm greater gain in mean strength than that of the control group (P = .05). The exercise group increased their quadriceps cross-sectional area by 10% (from a mean 58.5 cm2 to 64.6 cm2)-a 4.4 cm2 greater gain than that of the control group (P < .01). The exercise group had significant increases in whole-body lean mass and body cell mass, and significant increases in 6-minute walking distance and the mental component summary of the short form-36 questionnaire. Adverse events were minor and equal between groups. CONCLUSIONS: In a randomized trial of patients with compensated cirrhosis, we found that 12 weeks of supervised progressive resistance training increased muscle strength and size and had beneficial effects on general performance measures, compared with patients who did not change their daily activity routine (control subjects). ClinicalTrials.gov no: NCT02343653.
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Entrenamiento de Fuerza , Anciano , Humanos , Cirrosis Hepática , Fuerza Muscular , Estudios Prospectivos , Músculo Cuádriceps , Calidad de VidaRESUMEN
Background: Biologically based complementary medicines (BB-CMs) are popular in patients with cancer. However, there are only limited data for BB-CMs in patients with neuroendocrine tumors (NET). We aimed to identify the prevalence and type of BB-CM use and the association to the nutritional risk score (NRS-2002) in NET patients. Methods: We performed a cross-sectional questionnaire study in NET outpatients at the Department of Hepatology and Gastroenterology at Aarhus University Hospital. The nutritional risk was determined by the NRS-2002. Results: We included 186 patients (51% women, median age 66 years). Sixty-six percent were regular BB-CM users. Forty-two percent used at least two supplements. The most popular BB-CMs were vitamin and mineral supplements (47%), calcium and vitamin D (34%). One-third used non-vitamin non-mineral supplements such as fish oil, herbs, Ginger, Q-10, garlic and probiotics. The use of BB-CMs was associated with female gender (48% vs. 37%, p < .05). Intake was significantly more frequent among patients with an NRS score ≥ 3, (60% vs. 76%) and in patients with change in performance status (58% vs. 76%), (p < .05, all). Patients reporting dietary changes used BB-CMs more frequently than patients without dietary changes (61% vs. 77%) (p < .05). Conclusions: In our study, 66% percent of NET patients use BB-CM and 42% used two or more supplements. Vitamins with and without herbal ingredients, minerals, calcium, vitamin D, and fish oil were the most popular supplements. The use of BB-CMs was associated with an NRS score ≥ 3, change in dietary intake, female gender, and change in ECOG performance status.
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Terapias Complementarias , Suplementos Dietéticos , Tumores Neuroendocrinos/tratamiento farmacológico , Evaluación Nutricional , Anciano , Estudios Transversales , Dinamarca , Femenino , Aceites de Pescado/uso terapéutico , Humanos , Masculino , Persona de Mediana Edad , Minerales/uso terapéutico , Estado Nutricional , Fitoterapia , Encuestas y Cuestionarios , Vitamina D/uso terapéuticoRESUMEN
Polyneuropathy is a common complication to diabetes. Neuropathies within the enteric nervous system are associated with gastroenteropathy and marked symptoms that severely reduce quality of life. Symptoms are pleomorphic but include nausea, vomiting, dysphagia, dyspepsia, pain, bloating, diarrhoea, constipation and faecal incontinence. The aims of this review are fourfold. First, to provide a summary of the pathophysiology underlying diabetic gastroenteropathy. Secondly to give an overview of the diagnostic methods. Thirdly, to provide clinicians with a focussed overview of current and future methods for pharmacological and nonpharmacological treatment modalities. Pharmacological management is categorised according to symptoms arising from the upper or lower gut as well as sensory dysfunctions. Dietary management is central to improvement of symptoms and is discussed in detail, and neuromodulatory treatment modalities and other emerging management strategies for diabetic gastroenteropathy are discussed. Finally, we propose a diagnostic/investigation algorithm that can be used to support multidisciplinary management.
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Background: Chronic gastrointestinal symptoms are common among patients surviving surgery and/or radio-/chemotherapy for cancer in the pelvic organs. However, little is known about the pathophysiology behind symptoms or the effect of treatment. The aim of the present study was to present the results of clinical evaluation and treatment of patients with chronic bowel symptoms after treatment for cancer in the colon or pelvic organs. Material and methods: All patients referred to our department of gastroenterology between May 2016 and June 2018 with chronic bowel symptoms after treatment for cancer in the colon or pelvic organs were prospectively evaluated. Results: In total, 60 patients had been referred. The patients were treated for cancer in the right colon (n = 31), sigmoid colon (n = 1), rectum (n = 14), anal canal (n = 4), cervix uteri (n = 5), corpus uteri (n = 2), ovary (n = 2), and prostate (n = 1). The median time from cancer treatment to referral was 5.5 (range 1-36) years. Symptoms mainly included frequent bowel movements (65%), loose stools (87%), urgency for defecation (57%), and fecal incontinence (50%). A specific cause of bowel dysfunction was found in 48 (80%) of the patients and 21 (35%) had more than one cause of bowel symptoms. Bile acid malabsorption was present in 35 patients and small intestinal bacterial overgrowth was detected in 32. Treatment included bile acid sequestrants (n = 36), antibiotics (n = 33), loperamide (n = 21), and dietary intervention (n = 20). Major improvement in bowel symptoms was reported by 23 (38%) patients, while another 27 (45%) reported some improvement. Conclusion: Most patients with chronic bowel symptoms following cancer in the colon or pelvic organs will benefit from expert clinical evaluation and targeted treatment.
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Neoplasias Colorrectales/complicaciones , Enfermedades Gastrointestinales/etiología , Enfermedades Gastrointestinales/terapia , Neoplasias Ováricas/complicaciones , Neoplasias de la Próstata/complicaciones , Neoplasias Uterinas/complicaciones , Adulto , Anciano , Antibacterianos/uso terapéutico , Ácidos y Sales Biliares/metabolismo , Resina de Colestiramina/uso terapéutico , Enfermedad Crónica , Neoplasias Colorrectales/terapia , Diarrea/etiología , Diarrea/terapia , Incontinencia Fecal/etiología , Incontinencia Fecal/terapia , Femenino , Enfermedades Gastrointestinales/dietoterapia , Humanos , Masculino , Persona de Mediana Edad , Neoplasias Ováricas/terapia , Estudios Prospectivos , Neoplasias de la Próstata/terapia , Esteatorrea/etiología , Esteatorrea/terapia , Resultado del Tratamiento , Neoplasias Uterinas/terapiaRESUMEN
BACKGROUND: Patients with an ileostomy often experience fluid and electrolyte depletion because of gastrointestinal loss. This study aimed to compare how an iso-osmolar and a hyperosmolar oral supplement affect ileostomy output, urine production, and natriuresis as proxy measurements of water-electrolyte balance. METHODS: In a randomised, double-blinded, active comparator, crossover intervention study, we included eight adult ileostomy patients who were independent of parenteral support. We investigated how an iso-osmolar (279 mOsm/kg) and a hyperosmolar (681 mOsm/kg) oral supplement affected ileostomy output mass, urine volume, and natriuresis. In addition to their habitual diet, each participant ingested 800 mL/day of either the iso-osmolar or hyperosmolar supplement in each of two study periods. Each period started with 24-hour baseline measurements, and the supplements were ingested during the following 48 h. All measurements were repeated in the last 24 h. RESULTS: No statistically significant changes in ileostomy output were detected following the intake of either oral supplement (median (range) 67 (-728 to 290) g/day, p = 0.25) despite increased fluid intake. Compared with the hyperosmolar supplement, the iso-osmolar supplement induced a statistically significant increase in urine volume (470 (0-780) mL/day, p = 0.02) and natriuresis (36 (0-66) mmol/day, p = 0.02). CONCLUSION: Intake of the two oral supplements did not affect ileostomy output during this short intervention. Natriuresis increased following intake of the iso-osmolar supplement compared to that after ingesting the hyperosmolar supplement, indicating that patients with an ileostomy may benefit from increasing their ingestion of iso-osmolar fluids. ClinicalTrials.gov identifier:NCT03348709.
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Fluidoterapia/métodos , Ileostomía , Natriuresis/efectos de los fármacos , Concentración Osmolar , Equilibrio Hidroelectrolítico/efectos de los fármacos , Administración Oral , Estudios Cruzados , Método Doble Ciego , Electrólitos/administración & dosificación , Electrólitos/química , Electrólitos/farmacología , Electrólitos/uso terapéutico , Humanos , Soluciones/administración & dosificación , Soluciones/química , Soluciones/farmacología , Soluciones/uso terapéuticoRESUMEN
BACKGROUND: Malnutrition is frequent among patients with malignancies and associated with impaired function, reduced quality of life and increased mortality. Few data are available in patients with neuroendocrine tumors (NET) on nutritional status, nutritional risk, and nutrition impact symptoms (NIS). We aimed to assess nutritional status (NS) and risk, level of function and associations with NIS in NET patients. METHODS: In a cross-sectional study of NET patients, we measured body mass index (BMI) and handgrip strength (HGS) as markers of NS and muscle function assessed by HGS. The nutritional risk score (NRS) was determined by NRS-2002. NIS was assessed by the eating symptoms questionnaire (ESQ), and disease-related appetite questionnaire (DRAQ). RESULTS: We included 186 patients (51% women), median age 66 years. We observed low BMI (<20.5 kg/m2) in 12%, low HGS in 25%, and impaired level of function in 43% of the patients. About 38% were at nutritional risk, more frequent in patients with residual disease (45% versus 29%, p < .05). Both low HGS, impaired level of function and being at nutritional risk were associated with the NIS: Nausea, vomiting, stomach ache and dry mouth (p < .05) whereas poor appetite and early satiety were only associated with being at nutritional risk and having impaired level of function (p < .05, all). CONCLUSIONS: Almost 40% of NET patients were at nutritional risk; and 25% had impaired HGS associated with specific NIS that preclude food intake. We recommend that NET outpatients are screened with NRS-2002 and that HGS and NIS are determined if NET patients need nutritional therapy.
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Índice de Masa Corporal , Fuerza de la Mano , Desnutrición/diagnóstico , Tumores Neuroendocrinos/complicaciones , Estado Nutricional , Anciano , Estudios Transversales , Dinamarca/epidemiología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Evaluación Nutricional , Calidad de Vida , Encuestas y CuestionariosRESUMEN
Nutrition and food items may improve or worsen symptoms in Crohn's disease and ulcerative colitis. Protein malnutrition and vitamin and mineral deficiencies are common, particularly deficiency of iron and vitamin D. Dietary fibres and omega-3 fatty acids are safe, but no evidence supports their use as treatment. The use of probiotics is not encouraged in patients with Crohn's disease, but it may maintain remission in ulcerative colitis. Curcumin, chamomile, and other herbal extracts are promising in the treatment of mild ulcerative colitis, but validation of products and monitoring of side effects are insufficient.
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Suplementos Dietéticos , Enfermedades Inflamatorias del Intestino/dietoterapia , Enfermedad Celíaca/complicaciones , Manzanilla , Curcuma , Dieta , Fibras de la Dieta/uso terapéutico , Ácidos Grasos Omega-3/uso terapéutico , Ácidos Grasos Omega-6/efectos adversos , Humanos , Enfermedades Inflamatorias del Intestino/complicaciones , Enfermedades Inflamatorias del Intestino/etiología , Intolerancia a la Lactosa/complicaciones , Micronutrientes/deficiencia , Estado Nutricional , Vitamina D/uso terapéuticoRESUMEN
BACKGROUND: Hepatic encephalopathy is a brain dysfunction with neurological and psychiatric changes associated with liver insufficiency or portal-systemic shunting. The severity ranges from minor symptoms to coma. A Cochrane systematic review including 11 randomised clinical trials on branched-chain amino acids (BCAA) versus control interventions has evaluated if BCAA may benefit people with hepatic encephalopathy. OBJECTIVES: To evaluate the beneficial and harmful effects of BCAA versus any control intervention for people with hepatic encephalopathy. SEARCH METHODS: We identified trials through manual and electronic searches in The Cochrane Hepato-Biliary Group Controlled Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, Science Citation Index Expanded and Conference Proceedings Citation Index - Science, and LILACS (May 2017). SELECTION CRITERIA: We included randomised clinical trials, irrespective of the bias control, language, or publication status. DATA COLLECTION AND ANALYSIS: The authors independently extracted data based on published reports and collected data from the primary investigators. We changed our primary outcomes in this update of the review to include mortality (all cause), hepatic encephalopathy (number of people without improved manifestations of hepatic encephalopathy), and adverse events. The analyses included random-effects and fixed-effect meta-analyses. We performed subgroup, sensitivity, regression, and trial sequential analyses to evaluate sources of heterogeneity (including intervention, and participant and trial characteristics), bias (using The Cochrane Hepato-Biliary Group method), small-study effects, and the robustness of the results after adjusting for sparse data and multiplicity. We graded the quality of the evidence using the GRADE approach. MAIN RESULTS: We found 16 randomised clinical trials including 827 participants with hepatic encephalopathy classed as overt (12 trials) or minimal (four trials). Eight trials assessed oral BCAA supplements and seven trials assessed intravenous BCAA. The control groups received placebo/no intervention (two trials), diets (10 trials), lactulose (two trials), or neomycin (two trials). In 15 trials, all participants had cirrhosis. We classed seven trials as low risk of bias and nine trials as high risk of bias (mainly due to lack of blinding or for-profit funding). In a random-effects meta-analysis of mortality, we found no difference between BCAA and controls (risk ratio (RR) 0.88, 95% confidence interval (CI) 0.69 to 1.11; 760 participants; 15 trials; moderate quality of evidence). We found no evidence of small-study effects. Sensitivity analyses of trials with a low risk of bias found no beneficial or detrimental effect of BCAA on mortality. Trial sequential analysis showed that the required information size was not reached, suggesting that additional evidence was needed. BCAA had a beneficial effect on hepatic encephalopathy (RR 0.73, 95% CI 0.61 to 0.88; 827 participants; 16 trials; high quality of evidence). We found no small-study effects and confirmed the beneficial effect of BCAA in a sensitivity analysis that only included trials with a low risk of bias (RR 0.71, 95% CI 0.52 to 0.96). The trial sequential analysis showed that firm evidence was reached. In a fixed-effect meta-analysis, we found that BCAA increased the risk of nausea and vomiting (RR 5.56; 2.93 to 10.55; moderate quality of evidence). We found no beneficial or detrimental effects of BCAA on nausea or vomiting in a random-effects meta-analysis or on quality of life or nutritional parameters. We did not identify predictors of the intervention effect in the subgroup, sensitivity, or meta-regression analyses. In sensitivity analyses that excluded trials with a lactulose or neomycin control, BCAA had a beneficial effect on hepatic encephalopathy (RR 0.76, 95% CI 0.63 to 0.92). Additional sensitivity analyses found no difference between BCAA and lactulose or neomycin (RR 0.66, 95% CI 0.34 to 1.30). AUTHORS' CONCLUSIONS: In this updated review, we included five additional trials. The analyses showed that BCAA had a beneficial effect on hepatic encephalopathy. We found no effect on mortality, quality of life, or nutritional parameters, but we need additional trials to evaluate these outcomes. Likewise, we need additional randomised clinical trials to determine the effect of BCAA compared with interventions such as non-absorbable disaccharides, rifaximin, or other antibiotics.
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Aminoácidos de Cadena Ramificada/uso terapéutico , Encefalopatía Hepática/tratamiento farmacológico , Administración Oral , Aminoácidos de Cadena Ramificada/efectos adversos , Sesgo , Diarrea/etiología , Femenino , Encefalopatía Hepática/mortalidad , Humanos , Inyecciones Intravenosas , Masculino , Náusea/etiología , Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
BACKGROUND: The prognosis for men with non-aggressive prostate cancer is good, and several studies have investigated the impact of lifestyle changes including physical activity and diet on the prognosis. Despite positive results in animal studies and a few human interventions with whole-grain rye on markers of prostate cancer progression, the feasibility of trials investigating such dietary changes in combination with physical activity remains largely unstudied. The primary aim was to investigate the feasibility of an intervention with high whole-grain rye intake and vigorous physical activity for 6 months in men diagnosed with prostate cancer. METHODS: In total, 26 men (53-72 years) recently diagnosed with non-aggressive prostate cancer and on active surveillance, were enrolled in 2011-2012 and randomly assigned to an intervention or a control group. The intervention included 170 g/day of whole-grain rye and 3 × 45 minutes/week of vigorous physical activity. The duration of the intervention was 6 months and end of follow-up 12 months after baseline. Clinic visits were scheduled at baseline and 3, 6 and 12 months after baseline. Compliance with the intervention was evaluated by diaries, food frequency questionnaires, biomarkers, and heart rate monitor data. The effect of the intervention was evaluated by linear multiple regression analysis. RESULTS: In the intervention group, the mean daily intake of whole-grain rye measured from diaries was 146 g (SD: 19) for the first 3 months and 125 g (SD: 40) for the last 3 months of the intervention. The median level (5th and 95th percentiles) of vigorous physical activity was 91 (17, 193) min/week for the first 3 months and 66 (13, 259) min/week for the last 3 months. No recordings of physical activity were done for the control group. Aerobic fitness (VO2 peak) increased in the intervention group compared to the control group after the intervention. No effects were found on other cardio-metabolic outcomes or prostate cancer progression. CONCLUSIONS: The lifestyle intervention appeared feasible for 6 months among Danish men and the results are encouraging for conducting full-scale studies, where the impact of whole-grain rye and vigorous physical activity on prostate cancer progression and metabolic parameters can be evaluated. TRIAL REGISTRATION: ClinicalTrials.gov, NCT01300104 . Registered on 18 February 2011.
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Dieta Saludable , Terapia por Ejercicio , Ejercicio Físico , Estilo de Vida Saludable , Neoplasias de la Próstata/dietoterapia , Conducta de Reducción del Riesgo , Secale , Espera Vigilante , Granos Enteros , Anciano , Dinamarca , Terapia por Ejercicio/efectos adversos , Estudios de Factibilidad , Humanos , Análisis de los Mínimos Cuadrados , Modelos Lineales , Masculino , Persona de Mediana Edad , Neoplasias de la Próstata/patología , Neoplasias de la Próstata/fisiopatología , Factores Protectores , Factores de Riesgo , Encuestas y Cuestionarios , Factores de Tiempo , Resultado del TratamientoRESUMEN
Rye bread contains high amounts of benzoxazinoids, and in vitro studies have shown suppressive effects of selected benzoxazinoids on prostate cancer cells. Thus, research into benzoxazinoids as possible suppressors of prostate cancer is demanded. A pilot study was performed in which ten prostate cancer patients received a rye-enriched diet 1 week prior to prostatectomy. Plasma and urine samples were collected pre- and postintervention. Ten prostate biopsies were obtained from each patient and histologically evaluated. The biopsies exhibited concentrations above the detection limit of seven benzoxazinoids ranging from 0.15 to 10.59 ng/g tissue. An OPLS-DA analysis on histological and plasma concentrations of benzoxazinoids classified the subjects into two clusters. A tendency of higher benzoxazinoid concentrations toward the benign group encourages further investigations. Benzoxazinoids were quantified by an optimized LC-MS/MS method, and matrix effects were evaluated. At low concentrations in biopsy and plasma matrices the matrix effect was concentration-dependent and nonlinear. For the urine samples the general matrix effects were small but patient-dependent.
Asunto(s)
Benzoxazinas/análisis , Neoplasias de la Próstata/dietoterapia , Neoplasias de la Próstata/patología , Secale , Benzoxazinas/sangre , Benzoxazinas/orina , Biopsia con Aguja Gruesa , Cromatografía Líquida de Alta Presión/métodos , Humanos , Límite de Detección , Masculino , Reproducibilidad de los ResultadosRESUMEN
BACKGROUND: A prostate cancer diagnosis affects the patient and his spouse. Partners of cancer patients are often the first to respond to the demands related to their husband's illness and thus are likely to be the most supportive individuals available to the patients. It is therefore important to examine how spouses react and handle their husband's prostate cancer diagnosis. OBJECTIVE: The aim of this study was to explore how the prostate cancer diagnosis and the participation in their partners' behavioral lifestyle intervention program influenced the spouses' life, their relationship with their partner, and how they handle the situation. METHODS: Interviews were recorded with 8 spouses of potential low-risk prostate cancer patients on active surveillance as part of a clinical self-management lifestyle trial. RESULTS: We identified 3 phases that the spouses went through: feeling insecure about their situation, coping strategies to deal with these insecurities, and feeling reassured. CONCLUSIONS: The framework of a clinical trial should include mobilizing spousal empowerment so that they can take on an active and meaningful role in relation to their husband's disease. The observations here substantiate that the framework of active surveillance in combination with a lifestyle intervention in 1 specific prostate cancer clinical trial can mobilize spousal empowerment. IMPLICATIONS FOR PRACTICE: Creating well-designed clinical patient programs that actively involve the spouse appears to promote empowerment (meaning, self-efficacy, positive impact, and self-determination) in spouses. Spousal participation in clinical patient programs can give spouses relief from anxieties while recognizing them as a vital support for their husband.
Asunto(s)
Terapia Conductista , Relaciones Interpersonales , Neoplasias de la Próstata/psicología , Neoplasias de la Próstata/terapia , Esposos/psicología , Adaptación Psicológica , Dinamarca , Femenino , Estudios de Seguimiento , Conductas Relacionadas con la Salud , Humanos , Estilo de Vida , Masculino , Neoplasias de la Próstata/diagnóstico , Investigación Cualitativa , Resultado del TratamientoRESUMEN
BACKGROUND: Hepatic encephalopathy is a brain dysfunction with neurological and psychiatric changes associated with liver insufficiency or portal-systemic shunting. The severity ranges from minor symptoms to coma. A Cochrane systematic review including 11 randomised clinical trials on branched-chain amino acids (BCAA) versus control interventions has evaluated if BCAA may benefit people with hepatic encephalopathy. OBJECTIVES: To evaluate the beneficial and harmful effects of BCAA versus any control intervention for people with hepatic encephalopathy. SEARCH METHODS: We identified trials through manual and electronic searches in The Cochrane Hepato-Biliary Group Controlled Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, and Science Citation Index (August 2015). SELECTION CRITERIA: We included randomised clinical trials, irrespective of the bias control, language, or publication status. DATA COLLECTION AND ANALYSIS: The authors independently extracted data based on published reports and collected data from the primary investigators. We changed our primary outcomes in this update of the review to include mortality (all cause), hepatic encephalopathy (number of people without improved manifestations of hepatic encephalopathy), and adverse events. The analyses included random-effects and fixed-effect meta-analyses. We performed subgroup, sensitivity, regression, and trial sequential analyses to evaluate sources of heterogeneity (including intervention, and participant and trial characteristics), bias (using The Cochrane Hepato-Biliary Group method), small-study effects, and the robustness of the results after adjusting for sparse data and multiplicity. We graded the quality of the evidence using the GRADE approach. MAIN RESULTS: We found 16 randomised clinical trials including 827 participants with hepatic encephalopathy classed as overt (12 trials) or minimal (four trials). Eight trials assessed oral BCAA supplements and seven trials assessed intravenous BCAA. The control groups received placebo/no intervention (two trials), diets (10 trials), lactulose (two trials), or neomycin (two trials). In 15 trials, all participants had cirrhosis. We classed seven trials as low risk of bias and nine trials as high risk of bias (mainly due to lack of blinding or for-profit funding). In a random-effects meta-analysis of mortality, we found no difference between BCAA and controls (risk ratio (RR) 0.88, 95% confidence interval (CI) 0.69 to 1.11; 760 participants; 15 trials; moderate quality of evidence). We found no evidence of small-study effects. Sensitivity analyses of trials with a low risk of bias found no beneficial or detrimental effect of BCAA on mortality. Trial sequential analysis showed that the required information size was not reached, suggesting that additional evidence was needed. BCAA had a beneficial effect on hepatic encephalopathy (RR 0.73, 95% CI 0.61 to 0.88; 827 participants; 16 trials; high quality of evidence). We found no small-study effects and confirmed the beneficial effect of BCAA in a sensitivity analysis that only included trials with a low risk of bias (RR 0.71, 95% CI 0.52 to 0.96). The trial sequential analysis showed that firm evidence was reached. In a fixed-effect meta-analysis, we found that BCAA increased the risk of nausea and vomiting (RR 5.56; 2.93 to 10.55; moderate quality of evidence). We found no beneficial or detrimental effects of BCAA on nausea or vomiting in a random-effects meta-analysis or on quality of life or nutritional parameters. We did not identify predictors of the intervention effect in the subgroup, sensitivity, or meta-regression analyses. In sensitivity analyses that excluded trials with a lactulose or neomycin control, BCAA had a beneficial effect on hepatic encephalopathy (RR 0.76, 95% CI 0.63 to 0.92). Additional sensitivity analyses found no difference between BCAA and lactulose or neomycin (RR 0.66, 95% CI 0.34 to 1.30). AUTHORS' CONCLUSIONS: In this updated review, we included five additional trials. The analyses showed that BCAA had a beneficial effect on hepatic encephalopathy. We found no effect on mortality, quality of life, or nutritional parameters, but we need additional trials to evaluate these outcomes. Likewise, we need additional randomised clinical trials to determine the effect of BCAA compared with interventions such as non-absorbable disaccharides, rifaximin, or other antibiotics.