Ho Suzanne C, Chan Agnes S Y, Ho Yee Ping, So Edwin K F, Sham Aprille, Zee Benny, Woo Jean L F
Department of Community and Family Medicine, School of Public Health, The Chinese University of Hong Kong, SAR.
Menopause. 2007 May-Jun;14(3 Pt 1):489-99. doi: 10.1097/GME.0b013e31802c4f4f.
To investigate whether soy-derived isoflavone extract improves performance in cognitive function and quality of life in Chinese postmenopausal women.
The study was a 6-month double-blind, randomized, placebo-controlled, parallel group trial. Participants were community-dwelling women aged 55 to 76 years; 191 eligible women were randomly assigned to receive a daily oral intake of 80 mg soy-derived isoflavones or an identical-appearing placebo for 6 months. Standardized neuropsychological tests of memory, executive function, attention, motor control, language, and visual perception and a global cognitive function assessment were administered face-to-face individually at baseline and at 6-months posttreatment. The validated Chinese version of the Short Form-36 was used for quality of life measurements.
Of the participants, 88% (168 women: 80 among the supplementation group and 88 among the placebo group) completed the trial. Intention-to-treat analysis, conducted for 176 participants with 6-month assessment results, revealed no significant differences in outcome measures between treatment groups. Subgroup analysis among the good compliers only (consumed at least 80% of the supplements or placebo; n = 168) and among the age groups younger or older than 65 years also indicated no significant differences for any outcome measures. Types of complaints of adverse events were similar in both treatment groups and included mainly gastrointestinal and musculoskeletal problems.
This 6-month trial indicates that 80-mg soy-derived isoflavone supplementation did not improve performance on standard neuropsychological tests and overall quality of life in generally healthy Chinese postmenopausal women.
探讨大豆来源的异黄酮提取物是否能改善中国绝经后女性的认知功能和生活质量。
该研究为一项为期6个月的双盲、随机、安慰剂对照、平行组试验。参与者为年龄在55至76岁的社区居住女性；191名符合条件的女性被随机分配，每天口服80毫克大豆来源的异黄酮或外观相同的安慰剂，为期6个月。在基线和治疗后6个月时，分别面对面单独进行标准化的神经心理学测试，包括记忆、执行功能、注意力、运动控制、语言和视觉感知以及整体认知功能评估。使用经过验证的中文版简短健康调查问卷（Short Form-36）来测量生活质量。
88%的参与者（168名女性：补充组80名，安慰剂组88名）完成了试验。对176名有6个月评估结果的参与者进行意向性分析，结果显示治疗组之间的结局指标无显著差异。仅在依从性良好的参与者（服用至少80%的补充剂或安慰剂；n = 168）以及年龄小于或大于65岁的年龄组中进行亚组分析，结果也表明任何结局指标均无显著差异。两个治疗组不良事件的投诉类型相似，主要包括胃肠道和肌肉骨骼问题。
这项为期6个月的试验表明，补充80毫克大豆来源的异黄酮并不能改善一般健康的中国绝经后女性在标准神经心理学测试中的表现和整体生活质量。
