Randomized, Double‐Blinded, Double‐Dummy, Active‐Controlled, and Multiple‐Dose Clinical Study Comparing the Efficacy and Safety of Mulberry Twig (Ramulus Mori, Sangzhi) Alkaloid Tablet and Acarbose in Individuals with Type 2 Diabetes Mellitus

Li, Mengyi; Huang, X.R.; Ye, Hui; Yao, Chen; Yu, Jing; Yang, Jing; Zhang, Xuezhi

doi:10.1155/2016/7121356

Cited by 24 publications

(18 citation statements)

References 36 publications

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“…The fact that ethnopharmacology can be leveraged to direct and optimize the search for plant derived antidiabetics is evidenced further by the fact that Metformin, a first-line antidiabetic drug, was developed from a biguanide synthesized from Galega officinalis (French lilac) [ 10 ]. In addition, multiple studies have demonstrated that specific phytocompounds have comparable activity to α -amylase and α -glucosidase inhibitors such as Acarbose, Voglibose, and Miglitol [ 8 – 10 ].…”

Section: Introductionmentioning

confidence: 99%

In Vitro Inhibition of α‐Amylase and α‐Glucosidase by Extracts from Psiadia punctulata and Meriandra bengalensis

Kidane

Bokrezion

Mebrahtu

et al. 2018

Evidence-Based Complementary and Alternative Medicine

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Background This research assessed the in vitro antidiabetic activity and phytochemical constituents of the traditionally used medicinal plants, Psiadia punctulata and Meriandra bengalensis. Method The leaves of both plants were subjected to cold extraction method using 70% ethanol and hot Soxhlet extraction using n-hexane, chloroform, methanol, and distilled water. The extracts were studied for their effect on glucose transport across yeast cells and inhibition of α-amylase and α-glucosidase enzyme activities. Thin-layer chromatographic analysis of ethanol extract was also undertaken. Results The results of yeast glucose uptake assay revealed that extracts from both plants had a maximum increase in glucose uptake at the 25mM glucose concentration with a maximum dose of 2000μg/ml plant extract. The ethanol extract of P. punctulata and aqueous extract of M. bengalensis showed a high activity of 68% and 96%, respectively, at 25mM and 2000μg/ml of glucose and extract concentration. P. punctulata exerted peak inhibition activity of α-amylase of 37.5 ± 3% mg/dl (IC50 = 0.523 mg/dl) for methanol and distilled water extract at 0.5 mg/dl, respectively. M. bengalensis methanol extract exhibited the highest inhibition activity of 38 ± 8 % mg/dl (IC50 = 0.543 mg/dl) at 0.5 mg/dl. In the α-glucosidase inhibition assay, the methanolic extract of P. punctulata exhibited the highest inhibitory activity of 17.29 ± 9% mg/dl (IC50 = 0.761 mg/dl) at 0.5mg/dl. The chloroform extract of M. bengalensis had the highest inhibitory activity of 30 ± 5% mg/dl (IC50 = 0.6mg/dl) at 0.5 mg/dL. Phytochemical analysis of the different extracts of P. punctulata and M. bengalensis revealed the presence of flavonoids, alkaloids, tannins, saponins, phytosterols, and carbohydrates. Thin-layer chromatography analysis of ethanolic extract of both plants indicated presence of 15 and 17 spots for P. punctulata and M. bengalensis respectively. Conclusion P. punctulata and M. bengalensis extracts have moderate inhibitory activity against pancreatic α-amylase and relatively low inhibitory activities against α-glucosidase. The observed effects may be associated with the presence of flavonoids, saponins, and alkaloids. Additional in vivo analysis, toxicological studies, isolation, and structural characterization of the phytomolecules identified in this study and molecular docking studies should be undertaken.

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Section: Introductionmentioning

confidence: 99%

In Vitro Inhibition of α‐Amylase and α‐Glucosidase by Extracts from Psiadia punctulata and Meriandra bengalensis

Kidane

Bokrezion

Mebrahtu

et al. 2018

Evidence-Based Complementary and Alternative Medicine

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“…It could decrease the glycated hemoglobin concentration (HbA1c), 1 h and 2 h postprandial plasma glucose levels, but not the fasting plasma glucose levels. Furthermore, the side effects of SZ–A, such as flatulence and diarrhea, was obviously less than acarbose because of its lower inhibition to amylase [ 8 , 9 ].…”

Section: Introductionmentioning

confidence: 99%

Pharmacokinetics, Tissue Distribution, and Elimination of Three Active Alkaloids in Rats after Oral Administration of the Effective Fraction of Alkaloids from Ramulus Mori, an Innovative Hypoglycemic Agent

Yang

Liu

et al. 2017

Molecules

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In this study, we systematically investigated the plasma pharmacokinetics, tissue distribution, and elimination of three active alkaloids after oral administration of the effective fraction of alkaloids from Ramulus Mori (SZ–A)—an innovative hypoglycemic agent—in rats. Moreover, the influences of other components in SZ–A on dynamic process of alkaloids were explored for the first time. The results showed that 1-deoxynojirimycin (DNJ), fagomine (FGM) and 1,4-dideoxy-1,4-imino-d-arabinitol (DAB) exhibited nonlinear pharmacokinetics following oral administration of SZ–A (40–1000 mg/kg). The prolonged t1/2 and greater area under concentration-time curve (AUC) versus time (AUC0–t) of DNJ for SZ–A than for purified DNJ has been observed after both oral and intravenous administration. It was found that other components in SZ–A could enhance the absorption of DNJ through the intestinal barrier. The major distribution tissues of DNJ, FGM, and DAB were the gastrointestinal tract, liver, and kidney. Three alkaloids were mainly excreted into urine and feces, but less into bile. Interestingly, the excess excretion of FGM was revealed to be partly due to the biotransformation of other components in SZ–A via gut microbiota. These information provide a rational basis for the use of SZ–A in clinical practice.

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“…All of the 10 included diabetes-focused RCTs were focusing upon patients diagnosed with Type 2 diabetes mellitus and all these RCTs were conducted in China [ 30 – 39 ]. Amongst the 10 RCTs examining the efficacy of CHM on controlling the glucose level of patients with diabetes, four RCTs compared ‘CHM’ intervention to ‘placebo’ [ 32 ], ‘CHM plus biomedicine’ intervention to ‘placebo plus biomedicine’ intervention [ 39 ], and further, ‘CHM plus lifestyle’ intervention to ‘placebo plus lifestyle’ intervention [ 30 , 35 ]. These four trials indicated more significant decreased glucose level [e.g.…”

Section: Resultsmentioning

confidence: 99%

“…The side effects of CHM products reported in the diabetes-focused RCTs are generally moderate, such as constipation, gastrointestinal disorders, and urinary tract infection. However, three diabetes-focused RCTs showed that CHM interventions caused slightly abnormal liver and kidney function after 3, 6, and 12 months, respectively [ 31 , 32 , 39 ]. Six diabetes-focused RCTs have specified their study limitations, with a short study period being the most common issue, followed by small sample size and no/short follow-up period [ 32 , 33 , 35 , 36 , 38 , 39 ].…”

Section: Resultsmentioning

confidence: 99%

“…However, three diabetes-focused RCTs showed that CHM interventions caused slightly abnormal liver and kidney function after 3, 6, and 12 months, respectively [ 31 , 32 , 39 ]. Six diabetes-focused RCTs have specified their study limitations, with a short study period being the most common issue, followed by small sample size and no/short follow-up period [ 32 , 33 , 35 , 36 , 38 , 39 ]. As for risk of bias of the diabetes-focused RCTs, one trial failed to use the random sequence generation method [ 34 ], three trials did not report information on allocation concealment [ 32 , 34 , 35 ], four trials failed to apply a double-blinding method [ 31 , 33 , 34 , 37 ], and four trials did not provide details on the blinding outcome assessment [ 33 – 35 , 37 ].…”

Section: Resultsmentioning

confidence: 99%

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Efficacy of Chinese herbal medicine for stroke modifiable risk factors: a systematic review

et al. 2017

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BackgroundThe vast majority of stroke burden is attributable to its modifiable risk factors. This paper aimed to systematically summarise the evidence of Chinese herbal medicine (CHM) interventions on stroke modifiable risk factors for stroke prevention.MethodsA literature search was conducted via the MEDLINE, CINAHL/EBSCO, SCOPUS, and Cochrane Database from 1996 to 2016. Randomised controlled trials or cross-over studies were included. Risk of bias was assessed according to the Cochrane Risk of Bias tool.ResultsA total of 46 trials (6895 participants) were identified regarding the use of CHM interventions in the management of stroke risk factors, including 12 trials for hypertension, 10 trials for diabetes, eight trials for hyperlipidemia, seven trials for impaired glucose tolerance, three trials for obesity, and six trials for combined risk factors. Amongst the included trials with diverse study design, an intervention of CHM as a supplement to biomedicine and/or a lifestyle intervention was found to be more effective in lowering blood pressure, decreasing blood glucose level, helping impaired glucose tolerance reverse to normal, and/or reducing body weight compared to CHM monotherapy. While no trial reported deaths amongst the CHM groups, some papers do report moderate adverse effects associated with CHM use. However, the findings of such beneficial effects of CHM should be interpreted with caution due to the heterogeneous set of complex CHM studied, the various control interventions employed, the use of different participants’ inclusion criteria, and low methodological quality across the published studies. The risk of bias of trials identified was largely unclear in the domains of selection bias and detection bias across the included studies.ConclusionThis study showed substantial evidence of varied CHM interventions improving the stroke modifiable risk factors. More rigorous research examining the use of CHM products for sole or multiple major stroke risk factors are warranted.

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Randomized, Double‐Blinded, Double‐Dummy, Active‐Controlled, and Multiple‐Dose Clinical Study Comparing the Efficacy and Safety of Mulberry Twig (Ramulus Mori, Sangzhi) Alkaloid Tablet and Acarbose in Individuals with Type 2 Diabetes Mellitus

Cited by 24 publications

References 36 publications

In Vitro Inhibition of α‐Amylase and α‐Glucosidase by Extracts from Psiadia punctulata and Meriandra bengalensis

In Vitro Inhibition of α‐Amylase and α‐Glucosidase by Extracts from Psiadia punctulata and Meriandra bengalensis

Pharmacokinetics, Tissue Distribution, and Elimination of Three Active Alkaloids in Rats after Oral Administration of the Effective Fraction of Alkaloids from Ramulus Mori, an Innovative Hypoglycemic Agent

Efficacy of Chinese herbal medicine for stroke modifiable risk factors: a systematic review

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