Levis Silvina, Strickman-Stein Nancy, Ganjei-Azar Parvin, Xu Ping, Doerge Daniel R, Krischer Jeffrey
Geriatric Research, Education, and Clinical Center, Miami Veterans Affairs Healthcare System, USA.
Arch Intern Med. 2011 Aug 8;171(15):1363-9. doi: 10.1001/archinternmed.2011.330.
Concerns regarding the risk of estrogen replacement have resulted in a significant increase in the use of soy products by menopausal women who, despite the lack of evidence of the efficacy of such products, seek alternatives to menopausal hormone therapy. Our goal was to determine the efficacy of soy isoflavone tablets in preventing bone loss and menopausal symptoms.
The study design was a single-center, randomized, placebo-controlled, double-blind clinical trial conducted from July 1, 2004, through March 31, 2009. Women aged 45 to 60 years within 5 years of menopause and with a bone mineral density T score of -2.0 or higher in the lumbar spine or total hip were randomly assigned, in equal proportions, to receive daily soy isoflavone tablets, 200 mg, or placebo. The primary outcome was changes in bone mineral density in the lumbar spine, total hip, and femoral neck at the 2-year follow-up. Secondary outcomes included changes in menopausal symptoms, vaginal cytologic characteristics, N -telopeptide of type I bone collagen, lipids, and thyroid function.
After 2 years, no significant differences were found between the participants receiving soy tablets (n = 122) and those receiving placebo (n = 126) regarding changes in bone mineral density in the spine (-2.0% and -2.3%, respectively), the total hip (-1.2% and -1.4%, respectively), or the femoral neck (-2.2% and -2.1%, respectively). A significantly larger proportion of participants in the soy group experienced hot flashes and constipation compared with the control group. No significant differences were found between groups in other outcomes.
In this population, the daily administration of tablets containing 200 mg of soy isoflavones for 2 years did not prevent bone loss or menopausal symptoms.
clinicaltrials.gov Identifier: NCT00076050.
对雌激素替代疗法风险的担忧导致绝经后女性使用大豆制品的人数显著增加。尽管缺乏此类产品疗效的证据，但这些女性仍寻求绝经激素疗法的替代方法。我们的目标是确定大豆异黄酮片在预防骨质流失和绝经症状方面的疗效。
本研究设计为一项单中心、随机、安慰剂对照、双盲临床试验，于2004年7月1日至2009年3月31日进行。年龄在45至60岁、绝经5年内且腰椎或全髋部骨密度T值为-2.0或更高的女性被等比例随机分配，分别每日服用200毫克大豆异黄酮片或安慰剂。主要结局是2年随访时腰椎、全髋部和股骨颈骨密度的变化。次要结局包括绝经症状、阴道细胞学特征、I型骨胶原N-端肽、血脂和甲状腺功能的变化。
2年后，服用大豆片的参与者（n = 122）和服用安慰剂的参与者（n = 126）在脊柱骨密度变化（分别为-2.0%和-2.3%）、全髋部（分别为-1.2%和-1.4%）或股骨颈（分别为-2.2%和-2.1%）方面未发现显著差异。与对照组相比，大豆组经历潮热和便秘的参与者比例显著更高。在其他结局方面，两组之间未发现显著差异。
在该人群中，每日服用含200毫克大豆异黄酮的片剂2年并不能预防骨质流失或绝经症状。
clinicaltrials.gov标识符：NCT00076050。
