RESUMO
Type 2 diabetes mellitus is prevalent especially in Gulf countries and poses serious long-term risks to patients. A multifaceted treatment approach can include nutritional supplements with antioxidant properties such as 5-aminolevulinic acid (5-ALA) with sodium ferrous citrate (SFC). This prospective, randomized, single-blind, placebo-controlled, dose escalating pilot clinical trial assessed the safety of 5-ALA with SFC at doses up to 200 mg 5-ALA/229.42 mg SFC per day in patients living in Bahrain with type 2 diabetes mellitus that was uncontrolled despite the use of one or more antidiabetic drugs. Fifty-three patients (n = 53) from 3 sites at one center were enrolled by Dr. Feryal (Site #01), Dr. Hesham (Site #02), and Dr. Waleed (Site #03) (n = 35, 5-ALA-SFC; n = 18, placebo). There was no significant difference in incidence of adverse events reported, and the most frequent events reported were gastrointestinal in nature, consistent with the known safety profile of 5-ALA in patients with diabetes. No significant changes in laboratory values and no difference in hypoglycemia between patients receiving 5-ALA and placebo were noted. Overall, the current results support that use of 5-ALA-SFC up to 200 mg per day taken as 2 divided doses is safe in patients taking concomitant oral antidiabetic medications and may offer benefits in the diabetic population. This trial is registered with ClinicalTrials.gov NCT02481141.
Assuntos
Ácido Aminolevulínico/administração & dosagem , Diabetes Mellitus Tipo 2/tratamento farmacológico , Compostos Ferrosos/administração & dosagem , Sódio/administração & dosagem , Dor Abdominal/induzido quimicamente , Ácido Aminolevulínico/efeitos adversos , Barein , Glicemia/metabolismo , Ácido Cítrico , Tosse/induzido quimicamente , Diabetes Mellitus Tipo 2/metabolismo , Diarreia/induzido quimicamente , Feminino , Compostos Ferrosos/efeitos adversos , Hemoglobinas Glicadas/metabolismo , Humanos , Masculino , Pessoa de Meia-Idade , Fosfatos/administração & dosagem , Fosfatos/efeitos adversos , Projetos Piloto , Método Simples-Cego , Sódio/efeitos adversosRESUMO
The use of sedation for routine endoscopic procedures, including colonoscopy, varies widely across cultures. This variation in sedation practice is greater than any other culturally based variation in the technical performance of endoscopy. This article sequentially reviews the technical performance of colonoscopy in patients who undergo unsedated colonoscopy, sedation with narcotics and benzodiazepines, and deep sedation with propofol. For each of these approaches to colonoscopy, the advantages and disadvantages also are listed and discussed.