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To our knowledge, this is the largest randomized controlled trial of SZ-A in patients with T2D in the world. In this study, we evaluated the efficacy and safety of SZ-A in the treatment of patients with T2D, using acarbose as positive control, to provide evidence for its clinical application. This suggests that SZ-A has stronger disaccharidase selectivity and may help in reducing GDs, such as flatulence ( 23– 26).Ī placebo-controlled, randomized, double-blind, and multicenter trial showed that change in glycosylated hemoglobin (HbA 1c) was significantly decreased compared with baseline after treatment for 16 weeks, and the effect was much better than that of placebo (data not published). However, the inhibitory effect of SZ-A on amylase is much weaker than acarbose. In vitro experiments have shown that SZ-A imparts a significant inhibitory effect on sucrase and maltase, which is equal to or slightly stronger than that of acarbose.
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However, these drugs are associated with a high incidence of gastrointestinal disorders (GDs), such as abdominal distension, abdominal pain, and diarrhea, because of low selectivity to α-glucosidase ( 5, 21, 22). People in East Asia usually rely on starchy foods as their main source of calories therefore, α-glucosidase inhibitors are often used as the first-line drug for the treatment of patients with diabetes in this region ( 18– 20).
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Of these, intestinal α-glucosidase is the most well-characterized target of SZ-A. Pharmacological studies have suggested that the beneficial effects of SZ-A in the treatment of diabetes may be mediated through several therapeutic targets. In addition, animal experiments have revealed that SZ-A improves insulin resistance, increases basal insulin levels, and enhances glucose-stimulated insulin secretion ( 16, 17). SZ-A has been shown to reduce fasting and nonfasting glucose levels and prolong peak glucose concentrations after sucrose or starch load in alloxan-induced diabetic mice and rats ( 15). Among the active components of alkaloids, the content of 1-DNJ, FA, and DAB account for >90%, and 1-DNJ is the predominant alkaloid ( Supplementary Material 1). The total content of alkaloids is not less than 50% in SZ-A. Studies have shown that mulberry twig alkaloids (Sangzhi alkaloids ) are the active component of alkaloids extracted and isolated from the Chinese herbal medicine “mulberry twig” and are mainly composed of 1-deoxyrijolymycin (1-DNJ), fagomine (FA), 1,4-dideoxy-1,4-imino- d-arabitol (DAB), and other polyhydroxyalkaloids. The main components of mulberry twigs include alkaloids, flavonoids, polysaccharides, coumarin, amino acids, and organic acids ( 12, 14). Previous studies have demonstrated the hypoglycemic effect of some herbs derived from parts of the mulberry tree ( 12, 13). There has been an increasing interest in the use of herbal medicines for the treatment of diabetes ( 10, 11). Herbal medicines often have a wide range of pharmacological effects. The use of herbal medicines for the prevention and treatment of T2D is well documented in China and other countries. Although new hypoglycemic agents have recently been introduced to the market ( 4– 9), these drugs still do not meet the clinical demand for glycemic control. The standardized incidence of diabetes in the Chinese adult population is 10.9–11.2% however, only 32.2–49.0% of these individuals receive treatment, and approximately one-half of all treated patients do not achieve satisfactory glycemic control ( 2, 3). The number of people with diabetes is projected to reach 578 million by 2030 ( 1). According to the International Diabetes Federation’s IDF Diabetes Atlas (9th edition), an estimated 463 million people are currently living with diabetes globally, and ∼90% of these individuals have type 2 diabetes (T2D).