Marini Herbert, Minutoli Letteria, Polito Francesca, Bitto Alessandra, Altavilla Domenica, Atteritano Marco, Gaudio Agostino, Mazzaferro Susanna, Frisina Alessia, Frisina Nicola, Lubrano Carla, Bonaiuto Michele, D'Anna Rosario, Cannata Maria Letizia, Corrado Francesco, Adamo Elena Bianca, Wilson Steven, Squadrito Francesco
Azienda Ospedaliera Universitaria Policlinico G. Martino, University of Messina, Messina, Italy.
Ann Intern Med. 2007 Jun 19;146(12):839-47. doi: 10.7326/0003-4819-146-12-200706190-00005.
Observational studies and small trials of short duration suggest that the isoflavone phytoestrogen genistein reduces bone loss, but the evidence is not definitive.
To assess the effects of genistein on bone metabolism in osteopenic postmenopausal women.
Randomized, double-blind, placebo-controlled trial.
3 university medical centers in Italy.
389 postmenopausal women with a bone mineral density (BMD) less than 0.795 g/cm2 at the femoral neck and no significant comorbid conditions.
After a 4-week stabilization period during which participants received a low-soy, reduced-fat diet, participants were randomly assigned to receive placebo (n = 191) or 54 mg of genistein (n = 198) daily for 24 months. Both the genistein and placebo tablets contained calcium and vitamin D.
The primary outcome was BMD at the anteroposterior lumbar spine and femoral neck at 24 months. Secondary outcomes were serum levels of bone-specific alkaline phosphatase and insulin-like growth factor I, urinary excretion of pyridinoline and deoxypyridinoline, and endometrial thickness. Data on adverse events were also collected.
At 24 months, BMD had increased in genistein recipients and decreased in placebo recipients at the anteroposterior lumbar spine (change, 0.049 g/cm2 [95% CI, 0.035 to 0.059] vs. -0.053 g/cm2 [CI, -0.058 to -0.035]; difference, 0.10 g/cm2 [CI, 0.08 to 0.12]; P < 0.001) and the femoral neck (change, 0.035 g/cm2 [CI, 0.025 to 0.042] vs. -0.037 g/cm2 [CI, -0.044 to -0.027]; difference, 0.062 g/cm2 [CI, 0.049 to 0.073]; P < 0.001). Genistein statistically significantly decreased urinary excretion of pyridinoline and deoxypyridinoline, increased levels of bone-specific alkaline phosphatase and insulin-like growth factor I, and did not change endometrial thickness compared with placebo. More genistein recipients than placebo recipients experienced gastrointestinal side effects (19% vs. 8%; P = 0.002) and discontinued the study.
The study did not measure fractures and had limited power to evaluate adverse effects.
Twenty-four months of treatment with genistein has positive effects on BMD in osteopenic postmenopausal women. ClinicalTrials.gov registration number: NCT00355953.
观察性研究和短期小型试验表明，异黄酮类植物雌激素染料木黄酮可减少骨质流失，但证据并不确凿。
评估染料木黄酮对骨质减少的绝经后女性骨代谢的影响。
随机、双盲、安慰剂对照试验。
意大利的3所大学医学中心。
389名绝经后女性，其股骨颈骨矿物质密度（BMD）低于0.795 g/cm²，且无明显合并症。
在为期4周的稳定期内，参与者接受低大豆、低脂饮食，之后将参与者随机分配，使其每日服用安慰剂（n = 191）或54 mg染料木黄酮（n = 198），持续24个月。染料木黄酮片和安慰剂片均含有钙和维生素D。
主要结局是24个月时腰椎前后位和股骨颈的骨密度。次要结局是骨特异性碱性磷酸酶和胰岛素样生长因子I的血清水平、吡啶啉和脱氧吡啶啉的尿排泄量以及子宫内膜厚度。还收集了不良事件的数据。
24个月时，腰椎前后位骨密度在服用染料木黄酮的参与者中有所增加，而在服用安慰剂的参与者中有所下降（变化分别为0.049 g/cm² [95% CI，0.035至0.059] 与 -0.053 g/cm² [CI，-0.058至-0.035]；差异为0.10 g/cm² [CI，0.08至0.12]；P < 0.001），股骨颈骨密度也是如此（变化分别为0.035 g/cm² [CI，0.025至0.042] 与 -0.037 g/cm² [CI，-0.044至-0.027]；差异为0.062 g/cm² [CI，0.049至0.073]；P < 0.001）。与安慰剂相比，染料木黄酮在统计学上显著降低了吡啶啉和脱氧吡啶啉的尿排泄量，提高了骨特异性碱性磷酸酶和胰岛素样生长因子I的水平，且未改变子宫内膜厚度。与安慰剂接受者相比，更多服用染料木黄酮的参与者出现胃肠道副作用（19% 对8%；P = 0.002）并停止了研究。
该研究未测量骨折情况，评估不良反应的能力有限。
对骨质减少的绝经后女性进行24个月的染料木黄酮治疗对骨密度有积极影响。ClinicalTrials.gov注册号：NCT00355953。
