Institute of Chinese Medicine, The Chinese University of Hong Kong, Hong Kong, China.
Chin J Integr Med. 2011 Oct;17(10):744-9. doi: 10.1007/s11655-011-0876-y. Epub 2011 Nov 19.
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.
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).
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.
ELP showed potential benefit in improving BMD on the women who experienced over 10 years of menopause.
为了防止骨质疏松症的恶化,研制了一种三草药产品 Bo-gu Ling(骨碎补,ELP),用于治疗患有骨质疏松症的绝经后妇女的临床试验。
临床试验的设计为随机、双盲、安慰剂对照。共招募了 150 名年龄在 40-60 岁之间、绝经至少 1 年且腰椎骨密度(BMD)低于 0.891g/cm(2)的女性,将其随机分为 ELP 组(用 ELP 治疗)和安慰剂组,每组 75 名。主要终点是治疗后 6 个月和 12 个月时腰椎 BMD 的变化。次要终点包括外周定量计算机断层扫描(pQCT)测量的远端胫骨和生活质量(QOL)的变化。
绝经 10 年以上的受试者中,ELP 组的脊柱 BMD 增加了 0.69%,而同一层的安慰剂组则下降了 0.61%(P=0.067)。在绝经 10 年以上的受试者中,ELP 组的髋部 BMD 增加了 0.21%,而安慰剂组则下降了 0.52%(P=0.159)。ELP 组的胫骨强度应变指数增加了 1.94%,而安慰剂组则增加了 0.33%(P=0.047)。SF-36 QOL 问卷的生理功能较基线显著改善,但与安慰剂组相比无优势。
ELP 对绝经 10 年以上的女性有改善 BMD 的潜力。