The effect of semelil (angipars®) on bone resorption and bone formation markers in type 2 diabetic patients

Abstract

Background and purpose of the studyDiabetes mellitus has been recognized as a major risk factor for osteoporosis in which bone turnover is affected by different mechanisms. As the morbidity, mortality and financial cost related to osteoporosis are expected to rise in Iran in coming years, and considering the efficacy of Angipars® for improvement of different ulcers which made it a new herbal drug in diabetic foot ulcer, there is a need to evaluate the effect of this new drug on different organs including bone resorption and bone formation markers.MethodsIn this randomized, double- blind clinical trial, 61 diabetic patients were included. The subjects were randomly divided into intervention and control groups. Subjects of intervention group received 100 mg of Angipars® twice a day. Laboratory tests including bone resorption and bone formation markers were performed at baseline and after 3 months.Result31 patients in study group and 30 patients in control group finished the study. The mean age of the study population and the mean disease duration was respectively 51.8 ± 6.2 and 7.5 ± 4.7 years with no significant differences between intervention and control patients. No statistically significant differences between patients and controls were observed in pyridinoline, osteocalcin, urine calcium, bone alkaline phosphatase and tumor necrosis factor (TNF-α). Only urine creatinine level significantly changed between two groups after 3 month of treatment (p-value: 0.029)ConclusionIn conclusion, the findings of this study indicate that Semelil (Angipars®) had no beneficial or harmful effects on bone. It might be other effects of this new component on bone turnover process which need more studies and more time to be discovered.

Effects of some medicinal plants on bone formation and bone resorption in normal and diabetic rats

“…These results indicated that diabetes decreased bone formation. This result is in accordance with those obtained by Abd El-Ghfar (2016) and Hasani-Ranjbar et al (2012) who observed lower level of osteocalcin at diabetic groups compared with control group. Sultan et al (2008) observed lower level of osteocalcin in both diabetic groups (patients who were overweight, with type 2 diabetes) compared with control group.…”

“…The results indicated that diabetes significantly increased serum ALP activity. These results agree with Hasani-Ranjbar et al (2012) who observed that bone serum alkaline phosphatase activities significantly higher with diabetic groups (diabetic patients with chronic disease such as chronic renal failure and diabetic patients) compared with control group. Sultan Entessar et al (2008) showed that PTH level in all diabetic patients was correlated positively with ALP level (r= 0.54, P<0.01) and negatively with serum calcium (r =-0.65 and P<0.01).…”

Effects of medicinal herbs on osteoporosis: a systematic review based on clinical trials

“…Similarly, another study indicated that 200 mg of soy isoflavones daily for 2 years did not prevent bone loss in menopausal women (55). Consistently, some studies have reported that treatment with isoflavones (aglycone equivalents), Trifolium pratense extract, and semelil (Angipars W) could not prevent a decline in BMD and had no significant effect on bone biomarkers and thus bone health (56)(57)(58)(59). According to previous studies and the present one, it seems that differences in the study populations and the lack of controlling for confounding factors such as soy or phytoestrogens consumption in the control group may have led to these inconsistencies.…”

Effect of Semelil, an Herbal Selenium-Based Medicine, on New Bone Formation in Calvarium of Rabbits

“…Our study is the first animal study to assess the efficacy of Semelil (ANGIPARS) in osteogenesis alone and in combination with Bio-Oss, a popular bone graft substitute, in order to assess if this material can promote bone formation. Systemic application of ANGIPARS has no adverse effect on bone formation [ 21 ]. Results of an animal study showed that, during the study period, no significant difference existed in biochemical or hematologic parameters between the test and control groups.…”

“…Melilotus, coumarin, and flavonoids are the main constituents of ANGIPARS. It has been demonstrated that coumarin and vitamin K products increase osteogenic markers, that is, osteocalcin and alkaline phosphatase (ALP), and probably decrease urinary calcium and secretion of hydroxy proline (bone loss markers) [ 21 ].…”