Effect of Nigella Sativa Extract and Curcumin on bone turnover biomarkers in postmenopausal women with primary osteoporosis: a triple blinded randimized controlled trial

Abstract

The use of traditional methods and herbal medicine in the severe treatment of diseases, especially metabolic and systemic options is very valuable. The broad-spectrum effects of many plant compounds and extracts have been confirmed. In this regard, the use of black seed extract or oil and turmeric or curcumin has received much attention due to their broad anti-inflammatory and antioxidant effects. Based on some studies on animal models, significant effects of indo plant extracts on bone density and modulation of processes associated with bone turnover have been observed. What we have done in the present study was to evaluate the effect of plant extract individually or in combination on bone turnover and related biomarkers and evaluation of their safety in menopausal women. Material and Methods: triple-blind randomized controlled trial with factorial design was performed on 120 postmenopausal women aged 50-65 with primary osteoporosis or osteopenia. Subjects were randomly allocated to receive microcrystalline cellulose (placebo), 80 mg nanomicelle CUR, 1000 mg NS oil, or their combination (Nano CUR-NS) for six months. All patients acocording to bone density were also treated with alendronate (70 mg) and calcium (500 mg)-vitamin D (400 IU) supplements. Serum levels of alkaline phosphatase (ALP), osteocalcin (OC), and osteopontin (OP) were measured at baseline and after the intervention. For safety assessment, urea, creatinine, aspartate transaminase, and alanine transaminase levels were evaluated. Results: NS (p=0.029) and CUR-NS (p=0.015) significantly decreased the ALP levels compared to the placebo. After adjustment for confounding variables, this effect was still significant in the CUR-NS group compared to the placebo (p=0.004) and CUR group(p=0.039). The OC levels were decreased in the placebo, CUR, and NS groups, and OP concentration also was attenuated in all groups through the trial. However, the intergroup differences analysis were not significant for both biomarkers. Evaluating key renal metabolites and hepatic enzyme levels indicated no toxicity of the administered doses