RESUMEN
BACKGROUND AND AIMS: Curcumin, an active ingredient of turmeric with anti-inflammatory properties, has been demonstrated to be useful in experimental models of ulcerative colitis (UC). It's efficacy in humans needs to be investigated. METHODS: A randomized, double-blind, single-centre pilot trial was conducted in patients with distal UC (<25 cm involvement) and mild-to-moderate disease activity. Forty-five patients were randomized to either NCB-02 (standardized curcumin preparation) enema plus oral 5-ASA or placebo enema plus oral 5-ASA. Primary end point was disease response, defined as reduction in Ulcerative Colitis Diseases Activity Index by 3 points at 8 weeks, and secondary end points were improvement in endoscopic activity and disease remission at 8 weeks. RESULTS: Response to treatment was observed in 56.5% in NCB-02 group compared to 36.4% (p=0.175) in placebo group. At week 8, clinical remission was observed in 43.4% of patients in NCB-02 group compared to 22.7% in placebo group (p=0.14) and improvement on endoscopy in 52.2% of patients in NCB-02 group compared to 36.4% of patients in placebo group (p=0.29). Per protocol analysis revealed significantly better outcomes in NCB-02 group, in terms of clinical response (92.9% vs. 50%, p=0.01), clinical remission (71.4% vs. 31.3%, p=0.03), and improvement on endoscopy (85.7% vs. 50%, p=0.04). CONCLUSION: In this pilot study we found some evidence that use of NCB-02 enema may tend to result in greater improvements in disease activity compared to placebo in patients with mild-to-moderate distal UC. The role of NCB-02 as a novel therapy for UC should be investigated further.
Asunto(s)
Antiinflamatorios no Esteroideos/uso terapéutico , Colitis Ulcerosa/tratamiento farmacológico , Curcumina/uso terapéutico , Administración Rectal , Adulto , Antiinflamatorios no Esteroideos/administración & dosificación , Colitis Ulcerosa/patología , Curcumina/administración & dosificación , Quimioterapia Combinada , Endoscopía Gastrointestinal , Enema , Femenino , Humanos , Masculino , Mesalamina/uso terapéutico , Persona de Mediana Edad , Proyectos Piloto , Inducción de Remisión/métodos , Índice de Severidad de la Enfermedad , Adulto JovenRESUMEN
OBJECTIVE: Diarrhoeal relapses in patients with ulcerative colitis (UC) may be associated with enteric infections and its diagnosis may lessen avoidable exposure to corticosteroids and/or immunosuppressants. The purpose of this study was to assess the frequency of stool pathogens (parasitic and viral) in patients with active UC. MATERIAL AND METHODS: This prospective cross-sectional study included 49 consecutive patients (32 M, 17 F, mean age 35.8+/-12 years) with active UC. Three stool samples were collected from each patient and examined for parasitic infection. Rectal biopsies were obtained during sigmoidoscopy to demonstrate cytomegalovirus (CMV) inclusion bodies and to conduct qualitative polymerase chain reaction (PCR) for CMV and herpes simplex virus (HSV) DNA detection. RESULTS: Median duration of illness was 3.9+/-3.7 years and 83.7% of the patients had moderate to severe disease. The prevalence of parasitic infections in UC was 12%. The organisms isolated were Strongyloides stercoralis in 4%, Ankylostoma duodenale in 4%, Cryptosporidium in 2% and Entamoeba histolytica in 2% of the patients. The prevalence of CMV and HSV in rectal biopsies using qualitative PCR was 8% and 10%, respectively. No predictive factor was identified with CMV superinfection in patients with active UC. CONCLUSIONS: In India there is a high prevalence of parasitic and viral infections in patients with active UC. The results of the study suggest that, in tropical countries with a known high prevalence of parasitic diseases, aggressive evaluation for parasitic and viral infections should be carried out, as early identification and prompt treatment of such infections can improve the clinical course of patients with active UC.
Asunto(s)
Colitis Ulcerosa/parasitología , Colitis Ulcerosa/virología , Infecciones por Citomegalovirus/epidemiología , Parasitosis Intestinales/epidemiología , Estudios Transversales , Heces/virología , Humanos , India/epidemiología , Reacción en Cadena de la Polimerasa , Prevalencia , Estudios ProspectivosRESUMEN
BACKGROUND: The role of dietary and sociodemographic factors in the healing of duodenal ulcer following H. pylori eradication remains undefined. AIM: To assess the role of diet, sociodemography and body mass index in the healing of duodenal ulcer and eradication of H. pylori. METHODS: A cross-sectional study consisting of 67 consecutive duodenal ulcer patients was undertaken. Sociodemographic factors studied included age, sex, occupation, educational status, religion, type of family, number of family members, per capita income and residence (urban vs. rural). Personal habits studied included alcohol consumption and smoking. Regular dietary intake over a two-month period was assessed using the food frequency questionnaire. All patients had documented H. pylori infection at the time of inclusion and received standard triple eradication therapy. Follow-up endoscopy and testing for H. pylori were done 4 weeks after completion of eradication therapy. RESULTS: The mean age of the 67 patients (60 male, 7 female) was 39.9+/-13.6 years. Healing of duodenal ulcer was documented in 51 patients. H. pylori infection was successfully eradicated in 31 patients but not in the other 36. There was no difference between the groups (Group A1: H. pylori eradicated, Group B1: H. pylori not eradicated) with regard to dietary and socio-demographic variables, except for BMI, which was significantly higher in patients in whom H. pylori had been eradicated. Per capita income was significantly higher in Group A2 (healed duodenal ulcer) as compared to Group B2 (duodenal ulcer not healed) while there was no difference in dietary and socio-demographic variables in these two groups. CONCLUSION: We found that higher body mass index and higher per capita income were associated with successful H. pylori eradication and duodenal ulcer healing, respectively, and that diet had no role to play in either. Further epidemiological studies from different parts of India and studies that control for Helicobacter pylori are required to establish predictive factors.