A PILOT STUDY TO ASSESS THE EFFICACY AND SIDE EFFECTS OF SILYMARIN ALONE AND IN COMBINATION WITH ALENDRONATE IN TREATMENT OF POSTMENOPAUSAL OSTEOPOROSIS

Background: Currently oral bisphosphonates such as alendronate are the preferred therapeutic option for the treatment of postmenopausal osteoporosis by increasing bone mineral density and decreasing both vertebral and non-vertebral fracture risk. Silymarin is mainly used as hepato-protectant but in recent studies on ovariectomized rats, it was found that silymarin can be a promising antiosteoporotic pharmacological agent and selective estrogen receptor modulator. Objective: To evaluate the clinical outcome of combination therapy of alendronate and silymarin on postmenopausal osteoporotic women compared to the monotherapy of each. Methods: This was prospective, interventional, randomized study. A total of 69 patients were classified into 3 groups: Group1 (n=22) received 70 mg alendronate tablet once weekly for two years, Group 2 (n=23) received 140 mg silymarin capsule three times daily for two years, Group 3 (n=24) received 35 mg alendronate once weekly and 140 mg silymarin three times daily for two years. The bone mineral density of the patients was monitored using DXA scan at 0,1 and 2 years. Results:  Silymarin showed improvement in the mean T-scores of spine, femur and wrist after two years of treatment, this improvement was significantly less than in patients treated with alendronate or combined therapy(p_spine=0.000 p_femur=0.000 p_wrist=0.003) where the p value represents the significance difference between the three groups after two years of treatment. Conclusion: To consider Silymarin alone as an efficient medication for postmenopausal osteoporosis, it requires further studies for longer time frames, dose assessment and larger patient groups