Department of Clinical Pharmacology, TN Medical College and BYL Nair Charitable Hospital, Mumbai, India.
Department of Endocrinology, TN Medical College and BYL Nair Charitable Hospital, Mumbai, India.
J Altern Complement Med. 2019 Oct;25(10):1044-1053. doi: 10.1089/acm.2019.0124. Epub 2019 Aug 28.
To assess the change in the bone mineral density (BMD) score, bone-specific biomarkers (serum vitamin D, tartrate-resistant acid phosphatase 5b [TRAP-5b], and osteocalcin), quality of life, Ayurvedic symptoms (), and fracture risk assessment tool (FRAX) scores following treatment with (PG), a classical herbal formulation as add-on therapy to calcium and vitamin D supplements. Randomized, open-labeled, comparative, controlled clinical study. TN Medical College and BYL Nair Hospital, Mumbai, India. 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). Treatment group received two tablespoons of PG (10 mL in lukewarm milk) along with calcium and vitamin D supplements twice a day, whereas control group received only calcium and vitamin D supplements twice a day for a period of 12 months. BMD, bone-specific biomarkers (vitamin D, TRAP-5b, and osteocalcin), quality of life, Ayurvedic symptoms, and FRAX scores were evaluated before and at 6 and 12 months. 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 D ( < 0.001), osteocalcin ( < 0.001), and TRAP-5b ( < 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. 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.
评估骨矿物质密度 (BMD) 评分的变化、骨特异性生物标志物（血清维生素 D、抗酒石酸酸性磷酸酶 5b [TRAP-5b] 和骨钙素）、生活质量、阿育吠陀症状（）和骨折风险评估工具 (FRAX) 评分，在使用 （PG）治疗后，这是一种经典的草药配方，作为钙和维生素 D 补充剂的附加疗法。 随机、开放标签、对照、临床试验。 印度孟买 TN 医学院和 BYL Nair 医院。 80 名年龄在 40 至 75 岁之间的成年患者，被诊断为患有骨质疏松症（至少两个测试关节中的 BMD T 评分在 -1 至 -2.5 之间-腰椎 L1-L4、左侧股骨颈、左侧前臂桡骨总）。 治疗组每天两次服用两汤匙 PG（10 毫升温牛奶中），同时服用钙和维生素 D 补充剂，而对照组每天仅服用钙和维生素 D 补充剂，持续 12 个月。 在基线和 6 个月和 12 个月时评估 BMD、骨特异性生物标志物（维生素 D、TRAP-5b 和骨钙素）、生活质量、阿育吠陀症状和 FRAX 评分。 80 名患者入组；其中，65 名患者完成了研究，而 15 名患者退出了研究。6 个月和 12 个月时观察到 BMD 评分的改善，腰椎区域的获益最大。与标准治疗组相比，PG 治疗组观察到骨特异性生物标志物（血清维生素 D（<0.001）、骨钙素（<0.001）和 TRAP-5b（<0.05））显著改善。PG 治疗可改善生活质量、阿育吠陀症状评分和 FRAX 评分（主要骨质疏松性骨折风险和髋部骨折风险）的风险降低，尽管没有统计学意义。 研究结果表明，PG 通过对骨特异性生物标志物的稳定作用来减缓骨退化过程，表明其在骨质疏松症预防治疗方面具有潜在的用途。在这项研究中观察到的积极改善需要在更大样本量和更长持续时间的研究中得到证实。
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