The Effect of Curcumin, Nigella Sativa Extract and Combined Curcumin and Nigella Sativa Extract on Bone Mass Density and Quality of Life in Postmenopausal Women with Primary Osteoporosis: A controlled randomised clinical trial

Abstract

Abstract Background: Considering the scarcity of evidence, this study aimed to assess the effect of Curcumin and/or Nigella sativa‎ on bone density parameters (primary outcome) and quality of life (secondary outcome) in postmenopausal women with primary osteoporosis or osteopenia. Methods: In this randomized trial, 120 postmenopausal women aged 50 to 65 years with primary osteoporosis or osteopenia were equally randomized into four groups receiving daily capsules for six months; 1) Curcumin nanomicelle 80 mg, 2) Nigella sativa‎ oil 1000 mg, 3) both, 4) placebo. All groups also received routine treatments. In addition to the baseline assessment, bone mineral density, T-score, and Z-score were assessed at six months and quality of life (using the menopausal questionnaire of quality of life) at two, four and six months of the intervention. Results: Five cases were lost to follow-up. No significant complication was reported. After intervention, there was no statistically significant difference between the groups in terms of bone density parameters and overall quality of life score. Compared to the placebo group, quality of life score in the Curcumin group in vasomotor dimension (adjusted difference -0.90, 95% CI -1.62 to -0.18) and in the Nigella sativa‎ group in vasomotor (-0.76, -1.50 to -0.03) and physical (-0.61, -1.09 to -0.14) dimensions were significantly better. Conclusion: The addition of Curcumin, Nigella sativa‎ oil, or their combination do not significantly improve bone density parameters and overall quality of life of postmenopausal women with primary osteoporosis or osteopenia compared to routine treatment, but may improve some dimensions of quality of life.