A randomized, double-blind, placebo-controlled investigation of BCc1 nanomedicine effect on survival and quality of life in metastatic and non-metastatic gastric cancer patients

Background: Currently, the main goal of cancer research is to increase longevity of patients suffering malignant cancers. The promising results of BCc1 in vitro and vivo experiments made us look into the effect of BCc1 nanomedicine on patients with cancer in a clinical trial. Methods: The present investigation was a randomized, double-blind, placebo-controlled, parallel, and multicenter study in which 123 patients (30-to-85-year-old men and women) with metastatic and non-metastatic gastric cancer, in two separate groups of BCc1 nanomedicine or placebo, were selected using a permuted block randomization method. For metastatic and non-metastatic patients, a daily dose of 3000 and 1500 mg was prescribed, respectively. Overall survival (OS) as the primary endpoint and quality of life (measured using QLQ-STO22) and adverse effects as the secondary endpoints were studied. Results: In metastatic patients, the median OS was significantly higher in BCc1 nanomedicine (174 days 95% confidence interval (CI) 82.37-265.62) than in placebo (62 days 95% CI 0-153.42); hazard ratio (HR): 0.5 95% CI 0.25-0.98; p = 0.046. In non-metastatic patients, the median OS was significantly higher in BCc1 nanomedicine (529 days 95% CI 393.245-664.75) than in placebo (345 days 95% CI 134.85-555.14); HR: 0.324 95% CI 0.97-1.07; p = 0.066. The QLQ-STO22 assessment showed a mean difference improvement of 3.25 and 2.29 (p value > 0.05) in BCc1 nanomedicine and a mean difference deterioration of - 4.42 and - 3 (p-value < 0.05) in placebo with metastatic and non-metastatic patients, respectively. No adverse effects were observed. Conclusion: The findings of this trial has provided evidence for the potential capacity of BCc1 nanomedicine for treatment of cancer. Trial registration IRCTID, IRCT2017101935423N1. Registered on 19 October 2017, http://www.irct.ir/ IRCT2017101935423N1 © 2019 The Author(s)

Prevalence of goiter and thyroid disorders in diabetic children

Diabetes Mellitus is the most common endocrine disorders in children. There is a close association between diabetes and other autoimmune disease especially thyroid disorders. As many as 20 percent of Insulin dependent diabetic patients may have thyroid antibodies in their serum. The prevalence is 2-20 times greater than observed in normal populations. In this study, 122 patients with Diabetes Mellitus type I who referred to Institute of Endocrine &amp;amp; Metabolism and private office during a 3 years period were studied. A complete history was taken and physical examination was done in al patients by Endocrinologist. The diabetic patients due to major thalassemia excluded from this study. The grading of the goiter was determined by WHO classification and T4 and TSH were measured by RIA method in all patients. All patients were on Insulin treatment. There were 64 girls (52.4 percent) and 58 boys (47.6 percent) in 2-16 years age group (mean age 11.2 years). The mean duration of diabetes was 4.2 years. Prevalence of goiter was 53.2 percent and 7.3 percent of patients with goiter had hypothyroidism and 1.6 percent, had hypothyroidism. Most of the patients with goiter were euthyroid (91.9 percent). The patients with hypothyroidism had marked growth retardation and frequent episodes of hypoglycemia. The findings of this study indicate that the risk of development of goiter and thyroid disorders is higher in our diabetic patients and decelebration of growth and brittle diabetes may be due to thyroid disorders. It is suggested that all of the diabetic children should be screened yearly for thyroid disorders