RESUMEN
The extract of the seeds of Nigella sativa [Ns] has been used therapeutically for centuries as a safe herbal medicine, and has been reported to have beneficial effects in the treatment of diabetic osteopenia and bone healing in animal models. In the present study, we examined the effect of Ns seed oil extract on biochemical bone markers in osteopenic postmenopausal women. In a placebo controlled clinical trial, 30 osteopenic postmenopausal women, aged 49-72 years, were randomized to either 3-month Ns [oil] treatment [3cc, 0.05 cc/kg/day p.o.] or placebo groups. In all subjects, calcium-D supplements [1 tab per day] were administered during the 3 month study period. At baseline and after 3 months CBC diff, liver and kidney function tests, and serum levels of calcium and phosphate and plasma levels of bone markers [including CTX, Osteocalcin and Bone-ALP] were measured. Twenty-two participants completed the 3 month study period [9 in the Ns group and 13 in the placebo group]. Women in the placebo group had relatively higher BMI in comparison with those in the Ns group. Other characteristics and bone markers levels were similar between two groups at the baseline. Plasma levels of bone markers including CTX, Osteocalcin and Bone ALP did not differ significantly between the Ns and placebo groups at the end of the 3 months neither did changes in bone markers over the course of study show statistically significant differences between the two groups. Although Ns oil was safe, no reports of adverse reactions were observed in this study, we found no beneficial effect of Ns treatment on bone turnover markers. Based on our results, we do not recommend it for the prevention or treatment of bone loss. However this needs to be further investigated in the long-term clinical trials and with larger sample sizes