Objective: To prevent the deterioration of osteopenia, a triple herb product Bo-gu Ling ( , ELP) was created for a clinical trial on post-menopausal women suffering from osteopenia.
Methods: The design of the clinical trial was of randomized, double-blind, placebo-controlled nature. A total of 150 women aged 40-60 years, who were after menopause for at least 1 year and their lumbar spine bone mineral density (BMD) must be lower than 0.891 g/cm(2), were recruited and randomly divided into the ELP group treated with ELP and the placebo group, with 75 in each group. The primary endpoint was the BMD of the lumbar spine that was assessed at baseline, 6 and 12 months after treatment. Secondary endpoints included peripheral quantitative computed tomography (pQCT) measurements of distal tibia and the changes in the quality of life (QOL).
Results: The spine BMD of the ELP group was increased by 0.69% in the subjects who were more than 10 years after menopause. In contrast, the placebo group of the same stratum decreased by 0.61% (P=0.067). In the subjects with more than 10 years duration of menopause, the hip BMD increased by 0.21% in the ELP group, compared with a decrease of 0.52% in the placebo group (P=0.159). The tibia strength-strain index was increased by 1.94% in the ELP group compared with 0.33% in the placebo group (P=0.047). Physical function of SF-36 QOL questionnaire was remarkably improved compared with the baseline, but did not show dominance over the placebo group.
Conclusion: ELP showed potential benefit in improving BMD on the women who experienced over 10 years of menopause.