Zaida Herrador Ortiz1, Aurora Llanos Méndez. 1. Agencia de Evaluación de Tecnologías Sanitarias de Andalucía, Sevilla, España. zaida.herrador.ext@juntadeandalucia.es
Abstract
OBJECTIVE: To evaluate the efficacy and safety of administering oral/buccal insulin. DESIGN: Systematic review. DATA SOURCES: Reference databases, MEDLINE, EMBASE, Scopus, Current Contents, Web of Science, and Cochrane Library, European Drugs Agency, Food and Drug Administration, International Network of Technological Evaluation Agencies, European Network for New and Emerging Technologies (EuroScan), and gravel research registers. SELECTION OF THE STUDIES: Two clinical trials were found. Those studies that did not compare oral/buccal insulin with the standard treatment with injected insulin in terms of clinical parameters in a population with diabetes were excluded. EXTRACTION OF DATA: Critical reading according to the method proposed by the CASPe program and the Jadad scale. RESULTS: Buccal insulin produced a greater and earlier reduction in post-prandial blood glucose at 30 min in the intervention group compared to the control group (decrease of 55 mg/dl) and a higher and more rapid peak blood insulin (98 compared to 65 microU/mL). The postprandial levels with oral insulin were similar to those obtained with injected insulin, and had a higher maximum insulin concentration (110+/-130 vs. 96.3+/-69.7 microU/mL). CONCLUSIONS: Oral/buccal insulin gives, at least, results similar to the standard treatment. However, the studies had methodological problems of internal and external validity. Studies of longer duration are required to evaluate the long-term efficacy and safety. Copyright 2008 Elsevier España, S.L. All rights reserved.
OBJECTIVE: To evaluate the efficacy and safety of administering oral/buccal insulin. DESIGN: Systematic review. DATA SOURCES: Reference databases, MEDLINE, EMBASE, Scopus, Current Contents, Web of Science, and Cochrane Library, European Drugs Agency, Food and Drug Administration, International Network of Technological Evaluation Agencies, European Network for New and Emerging Technologies (EuroScan), and gravel research registers. SELECTION OF THE STUDIES: Two clinical trials were found. Those studies that did not compare oral/buccal insulin with the standard treatment with injected insulin in terms of clinical parameters in a population with diabetes were excluded. EXTRACTION OF DATA: Critical reading according to the method proposed by the CASPe program and the Jadad scale. RESULTS: Buccal insulin produced a greater and earlier reduction in post-prandial blood glucose at 30 min in the intervention group compared to the control group (decrease of 55 mg/dl) and a higher and more rapid peak blood insulin (98 compared to 65 microU/mL). The postprandial levels with oral insulin were similar to those obtained with injected insulin, and had a higher maximum insulin concentration (110+/-130 vs. 96.3+/-69.7 microU/mL). CONCLUSIONS: Oral/buccal insulin gives, at least, results similar to the standard treatment. However, the studies had methodological problems of internal and external validity. Studies of longer duration are required to evaluate the long-term efficacy and safety. Copyright 2008 Elsevier España, S.L. All rights reserved.