Department of Pathology, Texas Tech University Health Sciences Center, Lubbock, Texas, USA.
BMC Musculoskelet Disord. 2009 Sep 4;10:110. doi: 10.1186/1471-2474-10-110.
Osteoporosis is a major health problem in postmenopausal women. Evidence suggests the importance of oxidative stress in bone metabolism and bone loss. Tea consumption may be beneficial to osteoporosis due to its antioxidant capability. However, lack of objective data characterizing tea consumption has hindered the precise evaluation of the association between tea ingestion and bone mineral density in previous questionnaire-based epidemiological studies. On the other hand, although published studies suggest that Tai Chi (TC) exercise can benefit bone health and may reduce oxidative stress, all studies were conducted using a relatively healthy older population, instead of a high-risk one such as osteopenic postmenopausal women. Therefore, this study was designed to test an intervention including green tea polyphenol (GTP) and TC exercise for feasibility, and to quantitatively assess their individual and interactive effects on postmenopausal women with osteopenia.
METHODS/DESIGN: One hundred and forty postmenopausal women with osteopenia (defined as bone mineral density T-score at the spine and/or hip between 1 to 2.5 SD below the reference database) were randomly assigned to 4 treatment arms: (1) placebo group receiving 500 mg medicinal starch daily, (2) GTP group receiving 500 mg of GTP per day, (3) placebo+TC group receiving both placebo treatment and TC training (60-minute group exercise, 3 times per week), and (4) GTP+TC group receiving both GTP and TC training for 24 weeks. The outcome measures were bone formation biomarker (serum bone alkaline phosphatase), bone resorption biomarker (serum tartrate resistant acid phosphatase), and oxidative DNA damage biomarker (urinary 8-hydroxy-2'-deoxyguanosine). All outcome measures were determined at baseline, 4, 12, and 24 weeks. Urinary and serum GTP concentrations were also determined at baseline, 4, 12, and 24 weeks for bioavailability. Liver function was monitored monthly for safety. A model of repeated measurements with random effect error terms was applied. Traditional procedures such as ANCOVA, chi-squared analysis, and regression were used for comparisons.
We present the rationale, design, and methodology of a placebo-controlled randomized trial to investigate a new complementary and alternative medicine strategy featuring a dietary supplement and a mind-body exercise for alleviating bone loss in osteopenic postmenopausal women.
骨质疏松症是绝经后妇女的主要健康问题。有证据表明，氧化应激在骨代谢和骨质流失中起着重要作用。由于具有抗氧化能力，饮茶可能对骨质疏松有益。然而，由于缺乏描述饮茶情况的客观数据，以前基于问卷调查的流行病学研究难以准确评估饮茶与骨密度之间的关系。另一方面，尽管已发表的研究表明，太极拳（TC）运动有益于骨骼健康，并可能降低氧化应激，但所有研究均使用相对健康的老年人进行，而不是使用绝经后骨质疏松症等高危人群。因此，本研究旨在测试包括绿茶多酚（GTP）和 TC 运动的干预措施的可行性，并定量评估它们对骨质疏松症绝经后妇女的单独和相互作用效果。
方法/设计：将 140 名患有骨质疏松症的绝经后妇女（定义为脊柱和/或臀部的骨矿物质密度 T 评分在参考数据库的 1 到 2.5 个标准差以下）随机分配到 4 个治疗组：（1）安慰剂组，每天服用 500mg 药用淀粉；（2）GTP 组，每天服用 500mg GTP；（3）安慰剂+TC 组，同时接受安慰剂治疗和 TC 训练（60 分钟小组运动，每周 3 次）；（4）GTP+TC 组，同时接受 GTP 和 TC 训练 24 周。结果指标为骨形成生物标志物（血清碱性磷酸酶）、骨吸收生物标志物（血清耐酒石酸酸性磷酸酶）和氧化 DNA 损伤生物标志物（尿 8-羟基-2'-脱氧鸟苷）。所有结果指标均在基线、4、12 和 24 周时进行测定。基线、4、12 和 24 周时还测定了尿和血清中的 GTP 浓度，以评估生物利用度。每月监测肝功能以确保安全性。应用具有随机效应误差项的重复测量模型。传统的程序，如协方差分析、卡方检验和回归，用于比较。
我们提出了一项安慰剂对照随机试验的基本原理、设计和方法学，该试验旨在研究一种新的补充和替代医学策略，该策略包括饮食补充剂和身心锻炼，以缓解绝经后骨质疏松症妇女的骨质流失。
