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一项针对认知功能正常的老年人样本进行的蔓越莓汁神经心理学功效的双盲、安慰剂对照、随机试验:初步研究结果。

A double-blinded, placebo-controlled, randomized trial of the neuropsychologic efficacy of cranberry juice in a sample of cognitively intact older adults: pilot study findings.

作者信息

Crews W David, Harrison David W, Griffin Melanie L, Addison Katherine, Yount Alyssa M, Giovenco Maria A, Hazell Jessica

机构信息

Virginia Polytechnic Institute and State University, Blacksburg, Virginia, USA.

出版信息

J Altern Complement Med. 2005 Apr;11(2):305-9. doi: 10.1089/acm.2005.11.305.

Abstract

OBJECTIVES

The aim of this research was to conduct the first known clinical trial of the short-term (i.e., 6 weeks) efficacy of cranberry juice on the neuropsychologic functioning of cognitively intact older adults.

PARTICIPANTS

Fifty (50) community-dwelling, cognitively intact volunteers, > or = 60 years old, who reported no history of dementia or significant neurocognitive impairments, participated in this study.

DESIGN

A 6-week, double-blind, placebo-controlled, randomized, parallel-group, clinical trial was utilized. Participants were randomly assigned to receive either 32 ounces/day of a beverage containing 27% cranberry juice per volume (n = 25) or placebo (n = 25) for 6 weeks, and administered a series of neuropsychologic tests at both pretreatment baseline and again after 6 weeks of either cranberry juice or placebo treatment to assess treatment-related changes.

OUTCOME MEASURES

Efficacy measures consisted of participants' raw scores on the following standardized neuropsychologic tests: Selective Reminding Test, Wechsler Memory Scale-III Faces I and Faces II subtests, Trail Making Test (Parts A and B), Stroop Color and Word Test, and the Wechsler Adult Intelligence Scale- III Digit Symbol-Coding subtest. A subjective Follow-up Self-report Questionnaire was also administered to participants at the conclusion of the end-of-treatment phase assessments.

RESULTS

Two-factor, mixed analyses of variance (ANOVA) revealed no significant group (cranberry juice and placebo) by trial (pretreatment baseline and end-of-treatment assessments) interactions across all of the neuropsychologic tests and measures utilized in this study when a Bonferroni corrected alpha level was used to correct for multiple comparisons (i.e., .05/17 group by trial comparisons = .003). Pearson Chi-Square analyses of the groups' self-reported changes over the 6-week treatment phase in their abilities to remember, thinking processes, moods, energy levels, and overall health on the Follow-up Self-report Questionnaire revealed no significant relationships. However, a nonsignificant trend (X2(1) = 2.373, p = 0.123) was noted for participants' self-reported overall abilities to remember from pretreatment baseline to the end-of-treatment assessment. Specifically, more than twice as many participants in the cranberry group (n = 9, 37.5%) rated their overall abilities to remember by treatment end as "improved" as compared to placebo controls (n = 4, 17.4%).

CONCLUSIONS

Taken together, no significant interactions were found between the cranberry and placebo groups and their pretreatment baseline and end-of-treatment phase (after 6 weeks) standardized neuropsychologic assessments. A nonsignificant trend was noted, however, on a subjective, self-report questionnaire where twice as many participants in the cranberry group rated their overall abilities to remember by treatment end as "improved" compared to placebo controls.

摘要

目的

本研究旨在对蔓越莓汁对认知功能正常的老年人神经心理功能的短期(即6周)疗效进行首次已知的临床试验。

参与者

五十(50)名居住在社区、认知功能正常的志愿者,年龄≥60岁,报告无痴呆病史或明显神经认知障碍,参与了本研究。

设计

采用为期6周的双盲、安慰剂对照、随机、平行组临床试验。参与者被随机分配,连续6周每天饮用32盎司含27%(按体积计)蔓越莓汁的饮料(n = 25)或安慰剂(n = 25),并在治疗前基线期和蔓越莓汁或安慰剂治疗6周后再次进行一系列神经心理测试,以评估与治疗相关的变化。

结果测量

疗效测量包括参与者在以下标准化神经心理测试中的原始分数:选择性提醒测试、韦氏记忆量表第三版面孔I和面孔II子测试、连线测验(A部分和B部分)、斯特鲁普颜色和文字测试以及韦氏成人智力量表第三版数字符号编码子测试。在治疗结束阶段评估结束时,还向参与者发放了一份主观的随访自我报告问卷。

结果

当使用Bonferroni校正的α水平校正多重比较时(即0.05/17组×试验比较 = 0.003),双因素混合方差分析(ANOVA)显示,在本研究中使用的所有神经心理测试和测量中,试验组(蔓越莓汁和安慰剂)与试验(治疗前基线和治疗结束评估)之间没有显著的交互作用。对两组在随访自我报告问卷中关于6周治疗阶段记忆能力、思维过程、情绪、能量水平和总体健康状况的自我报告变化进行Pearson卡方分析,未发现显著关系。然而,在参与者自我报告的从治疗前基线到治疗结束评估的总体记忆能力方面,观察到一个不显著的趋势(X2(1) = 2.373,p = 0.123)。具体而言,与安慰剂对照组(n = 4,17.4%)相比,蔓越莓组中认为到治疗结束时其总体记忆能力“有所改善”的参与者人数是安慰剂对照组的两倍多(n = 9,37.5%)。

结论

总体而言,在蔓越莓组和安慰剂组及其治疗前基线和治疗结束阶段(6周后)的标准化神经心理评估之间未发现显著的交互作用。然而,在一份主观的自我报告问卷上观察到一个不显著的趋势,即与安慰剂对照组相比,蔓越莓组中认为到治疗结束时其总体记忆能力“有所改善”的参与者人数是安慰剂对照组的两倍。

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