Study of the effect of the herbal composition SR2004 on hemoglobin A1c, fasting blood glucose, and lipids in patients with type 2 diabetes mellitus

Abstract

BackgroundType 2 diabetes mellitus (T2DM) is a metabolic disorder characterized by raised blood glucose levels and peripheral insulin resistance. It is an increasingly prevalent global healthcare concern. Conventional treatment options are limited and in this context, there is renewed interest in evaluating the clinical and biological effects of traditional therapies. We assess the effect of a new herbal composition SR2004 on the hemoglobin A1c (HbA1c), fasting blood glucose, and lipid profiles of patients with T2DM.MethodsThis is a single center, unblinded, prospective interventional study conducted in Israel. The composition SR2004 includes Morus alba, Artemisia dracunculus, Urtica dioica, Cinnamomum zeylanicum, and Taraxacum officinale. One hundred and nineteen patients with diagnosed T2DM were enrolled and received SR2004 in addition to their usual medications. HbA1c, fasting blood glucose, and lipid profiles at 12 weeks were compared with baseline. In addition, the tolerability and side effects of SR2004 were recorded.ResultsOne hundred and three patients completed 12 weeks of follow-up (87%) and were included in the results. At 12 weeks, HbA1c reduced from 9.0% to 7.1% (22%; p < 0.0001), mean blood glucose decreased from 211 mg/dL to 133 mg/dL (37% reduction; p < 0.0001), mean total cholesterol to 185 mg/dL (13% reduction; p < 0.01) and mean serum triglycerides to160 mg/dL (a reduction of 40% from baseline; p < 0.001). Twelve patients (12%) had no response with SR2004 supplementation. In addition, of thirteen patients who took insulin at baseline, five required only oral hypoglycemics and another five reduced their daily insulin requirements by 30% at 12 weeks. Clinical observations included improvements in vasculopathy, including reversal of established retinopathic changes in two patients.No major adverse effects were observed, with minor abdominal symptoms reported in sixteen patients (16%).ConclusionSR2004 supplementation significantly reduced HbA1c, blood glucose, and lipids with good tolerability and no observed adverse interactions with conventional medications. Some interesting findings relating to the reversal of microvascular phenomena warrant further research to elucidate the mechanisms of action of this novel composition.

The Effects of Nettle Extract Consumption on Liver PPARs, SIRT1, ACOX1 and Blood Lipid Levels in Male and Female C57Bl6 Mice

“…It seems, according to the results, that within 15 days and with a specified intake dose, the nettle extract can increase the HDL lipoprotein cholesterol particles (the good cholesterol) significantly ( p ≤ 0.05) in males but not in female C57BL6 mice. Similar as in this mouse model, in humans, there are reported clinical trials that show a similar HDL increase due to nettle consumption [ 35 , 36 ]. However, human clinical studies also show a general decrease in the cholesterol level in blood and sometimes even decrease in the total serum triglycerides in pathologic states, which were not recorded here.…”

“…Samakar et al [ 1 ], in his review, summarized a total of seven antihyperlipidaemic studies with an HDL increase in rat models and five studies using rat models [ 1 ]. It is important to note that the main difference from the named human or animal studies [ 1 , 16 , 35 , 36 , 37 , 38 , 39 ] and our study was that, in our experiment, we used metabolically unchallenged and uncompromised healthy animals. The clinical and animal studies, as a difference from our experimental design, were conducted in metabolically disturbed, diabetic subjects and reported dyslipidaemia reductions occurred in patients or animals with the pathologically high lipid levels that are usually present in metabolic illnesses or accompany diabetes and metabolic syndrome.…”

“…Another unblinded prospective interventional study included 119 diabetic patients receiving the composition (1 g TDS) but with the addition to their usual medications. After 12 weeks, their lipid condition showed decreased levels of mean total cholesterol and mean serum TG [ 36 ].…”

Cholesterol Accumulation as a Driver of Hepatic Inflammation Under Translational Dietary Conditions Can Be Attenuated by a Multicomponent Medicine

“…For instance, Silybum marianum (milk thistle) and its main constituent silymarin (rich in flavolignans) ( 14 ) have been shown to reduce plasma and liver markers of inflammation in high-fat diet (HFD)-fed mice ( 15 ). Similarly, Taraxacum officinale (dandelion) extracts have been shown to reduce LPS-induced inflammation in endothelial cells ( 16 ) and macrophages ( 17 ) and have cholesterol-modulating effects in rodents ( 18 , 19 ) and type 2 diabetic patients ( 20 ). Likewise, Avena sativa (oat) is well-known for its anti-inflammatory and its hypocholesterolaemic effects ( 21 ).…”

“Ceylon cinnamon”: Much more than just a spice

“…(1) lowering of blood glucose (Akilen et al, 2010(Akilen et al, , 2013Crawford et al, 2016;Davis & Yokoyama, 2011;Ranasinghe et al, 2017;Zhu et al, 2017); (2) blood pressure control (Akilen et al, 2010(Akilen et al, , 2013Azimi et al, 2016); (3) lowering of serum cholesterol (Chatterji & Fogel, 2018;Gupta et al, 2017;Maierean et al, 2017); (4) antimicrobial activity (Condo et al, 2018;Husain et al, 2018;Mamajiwala et al, 2018;Rangel et al, 2018;Raybaudi-Massilia et al, 2006;Sethi et al, 2019;Shahina et al, 2018); (5) antiparasitic activity (Yang et al, 2014); (6) antioxidative properties and related free radical scavenging action (Dhuley, 1999;Khaki et al, 2014;Panickar et al, 2009;Ranasinghe et al, 2013;Shahid et al, 2018;Sharma et al, 2017);…”