A Clinical Study of a Standardized Extract of Leaves of Dalbergia sissoo (Roxb ex DC) in Postmenopausal Osteoporosis

Abstract

Context: Dalbergia sissoo had shown anti-osteoporotic and fracture-healing activities in animal models of postmenopausal osteoporosis (PMO). Standardized extract of leaves of D. sissoo (SEL-Ds) was clinically evaluated for osteoporosis. Aims: To investigate the anti-osteoporotic activity of D. sissoo in PMO by dual-energy X-ray absorptiometry (DXA), biochemical markers, and effect on clinical profile. Tolerability was assessed by organ function tests and adverse events. Settings and Design: An open-labeled prospective clinical study in ambulant settings was conducted at the menopausal health-care facility of a women s hospital. Materials and Methods: Thirty women (45–69 years) were enrolled for this 1-year study. Evaluations were basally, fortnightly twice, and three monthly four times. SEL-Ds (300 mg) twice daily was administered orally. Calcium (250 mg) and Vitamin D (200 IU) were given twice a day. The efficacy of SEL-Ds was assessed by DXA-scan (spine, femur), by biochemical markers, alkaline phosphatase (ALP), tumor necrosis factor-alpha (TNF-α), and anti-inflammatory marker high-sensitivity C-reactive protein (hs-CRP). Baseline symptom changes and adverse events were carefully recorded. Statistical Analysis: Summary statistics (n, mean, standard deviation, median, and maximum and minimum values) of changes from baseline values and Student s “t-” test for P values were used. Results and Discussion: SEL-Ds was well tolerated at given dose for 1 year. Anti-osteoporotic and anti-inflammatory activities of SEL-Ds were demonstrated by reduction in TNF-α (12.04 ± 2.81–2.35 ± 1.08 pg/ml), ALP (208.75 ± 45.88–154.52 ± 37.25 IU/L), and hs-CRP (6.1 ± 0.77–3.9 ± 0.47 mg/L). BMD-score on DXA-scan also remained unchanged at majority of the bone locations (increased 13/75, unchanged 51/75, and decreased 08/75). Conclusions: D. sissoo has demonstrated anti-osteoporotic and anti-inflammatory activities as indicated by decline in circulating TNF-α along with concurrent reduction in ALP. The nondecline in BMD index in the majority confirms the anti-osteoporotic activity.