RESUMO
PURPOSE: To evaluate the safety and efficacy of methanol extract of Berberis integerrima root on type 2 diabetes compared to metformin. METHODS: In a parallel triple blind clinical trial, 80 type 2 diabetic patients,, were randomized into two groups (treated with Berberis integerrima root, 480 mg (oral), compared to control group treated with metformin 1000 mg daily). Efficacy was evaluated by fasting and prandial glucose and HbA1c and side effects confirmed by physical examination, biology and hematology tests and urinalysis on days 15, 45 and 90. They were followed for 3 months. RESULTS: Two hundred and eighteen patients were recruited and 80 (55female and 25 male) patients randomized in two groups and 60 patient were analysed. The mean age of patients was 51.8 ± 9.3 and 46.5 ± 10 in the experimental (Berberis integerrima ) and control (metformin) groups respectively (P = 0.02). The mean HbA1c at baseline was 8.1 ± 1.6% and 7.9 ± 1.6% for B. integerrima and metformin group respectively (P = 0.53), and there was no significant difference between the two groups (7.5 vs. 7.2) after 3 months (P = 0.34).Weight loss was observed in both groups compared to baseline.No adverse event led to preventing the study was reported. CONCLUSION: Berberis integerrima root not only was effective as much as metformin in reducing blood glucose and controlling type 2 diabetes but also, no specific side effect was reported (in short term).So, it might be an effective and safe complementary therapy in diabetic patients.Iranian Research and Clinical Trial (IRCT) registeration number; 201,207,191,774 N5.Funding: Vice chancellor for research, Physiology Research Center of Kerman University of Medical Sciences and the Exir pharmaceutical company.
RESUMO
BACKGROUND: Iran (I.R.) is suffering the growing problem of opiate abuse. In evaluation of the treatment plan for opium dependent patients, a valid and reliable instrument is needed to measure patients' severity of dependence. This study aimed to assess the reliability and validity of the Persian version of the "Substance Dependence Severity Scale" (SDSS). METHODS: After translating the English version of SDSS to Persian and then back translating it to English, a structured interview with 200 opium dependent patients was conducted to collect data. Then, reliability (internal consistency and test-retest procedure) and construct validity were tested. FINDINGS: The alpha coefficient was 0.77 and the correlation between test and retest results showed a high correlation coefficient (0.97) which confirmed the reliability. Construct validity was assessed by a cross-check against General Health Questionnaire (GHQ) and the results were in favor of its validity. But the correlation between the amount of substance usage and scores of the 1(st) and 2(nd) questions were not within the acceptable range. CONCLUSION: The results support the reliability of the Persian version of SDSS, but to confirm its validity further studies are needed.
