RESUMO
Objectives: To assess the change in the bone mineral density (BMD) score, bone-specific biomarkers (serum vitamin D3, tartrate-resistant acid phosphatase 5b [TRAP-5b], and osteocalcin), quality of life, Ayurvedic symptoms (Asthikshaya Lakshanas), and fracture risk assessment tool (FRAX) scores following treatment with Panchatikta Ghrita (PG), a classical herbal formulation as add-on therapy to calcium and vitamin D3 supplements. Study design: Randomized, open-labeled, comparative, controlled clinical study. Location: TN Medical College and BYL Nair Hospital, Mumbai, India. Study participants: Eighty adult patients, aged between 40 and 75 years, diagnosed to have osteopenia (BMD T-score between -1 and -2.5 in at least two of the three joints tested-lumbar spine L1-L4, left femur-neck, left forearm-radius total). Study intervention: Treatment group received two tablespoons of PG (10 mL in lukewarm milk) along with calcium and vitamin D3 supplements twice a day, whereas control group received only calcium and vitamin D3 supplements twice a day for a period of 12 months. Outcome measures: BMD, bone-specific biomarkers (vitamin D3, TRAP-5b, and osteocalcin), quality of life, Ayurvedic symptoms, and FRAX scores were evaluated before and at 6 and 12 months. Results: Eighty patients were enrolled; of which, 65 patients completed the study while 15 patients dropped out. Improvement in the BMD scores was observed at 6 and 12 months with the maximum benefit in the lumbar spine region. Significant improvement in the bone-specific biomarkers, namely serum vitamin D3 (p < 0.001), osteocalcin (p < 0.001), and TRAP-5b (p < 0.05), was observed in the PG-treated group compared with the standard treatment group. Improvement in the quality of life, Ayurvedic symptoms scores, and risk reduction in FRAX scores of major osteoporotic fracture risk and hip fracture risk was greater with PG, although not statistically significant. Conclusions: The study findings demonstrate that PG slows down the bone degeneration processes by its stabilizing effect on the bone-specific biomarkers, indicating its potential usefulness as preventive therapy in osteopenia. The positive improvement noted in this study needs to be confirmed in studies with a larger sample size and longer duration.