藏红花提取物对中度失眠症成人睡眠质量的影响：一项分散、随机、双盲、安慰剂对照试验

Q1 Medicine

Sleep Medicine: X Pub Date : 2025-07-09 DOI:10.1016/j.sleepx.2025.100147

Julius Schuster , Christin Mundhenke , Hannah Nordsieck , Camille Pouchieu , Line Pourtau , Andreas Hahn

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引用次数: 0

摘要

非自然干预睡眠障碍，如藏红花提取物，正在获得科学和临床的兴趣。这项三组随机、双盲、安慰剂对照试验检测了标准藏红花提取物（Safr 'Inside™）对165名报告中度失眠的成年人的睡眠、压力和其他相关心理结果的影响。方法受试者分别服用30 mg、20 mg藏红花提取物或安慰剂，疗程4周。主要终点是失眠症状的改变（雅典失眠量表，AIS）。次要结果为单项睡眠质量量表（SQS）、感知压力量表（PSS）、患者健康问卷-4 （PHQ-4）、积极和消极影响量表（PANAS）、Epworth嗜睡量表（ESS）和世界卫生组织生活质量量表（WHOQOL）。分析采用意向治疗（ITT）方法，并对每个方案（PP）进行确认。结果在150名完成者中，藏红花提取物比安慰剂更能减轻失眠症状(组间校正平均差β = - 0.95 [95% CI: - 1.79, - 0.11], P <；. 05)。在二次分析中，与安慰剂组相比，两组藏红花组的睡眠质量（SQS）在3周后显著改善，并持续到第4周(30 mg vs安慰剂：β = 0.82 [95% CI: 0.22, 1.41], P = 0.004；20 mg vs安慰剂：β = 1.02 [0.43, 1.62], P <；措施)。与安慰剂相比，30 mg或20 mg藏红花提取物显著降低了感知压力（PSS） (30 mg vs安慰剂：β =−1.87 [95% CI:−3.23,−0.53],P = 0.01；20毫克vs安慰剂:β=−1.89(95%置信区间CI:−3.22−0.52),P = .04点)。与安慰剂相比，30 mg藏红花提取物对心理症状（PHQ-4）也有一定改善（β = - 0.79 [- 1.40, - 0.18], P = .03）。其他指标均无显著差异。未发生严重不良事件。结论4周服用20或30毫克藏红花提取物可减轻中年人的失眠和压力。未来的研究应该评估更长时间的干预措施，并探索哪些亚群从藏红花提取物中获益最多。

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Effect of a saffron extract on sleep quality in adults with moderate insomnia: A decentralized, randomized, double-blind, placebo-controlled trial

Aim

Natural interventions for sleep disturbances, such as saffron extract, are gaining scientific and clinical interest. This 3-arm, randomized, double-blind, placebo-controlled trial examined the effect of a standardized saffron extract (Safr’Inside™) on sleep, stress, and other associated psychological outcomes in 165 adults reporting moderate insomnia.

Methods

Participants received 30 mg, 20 mg saffron extract, or placebo for 4 weeks. The primary endpoint was the change in insomnia symptoms (Athens Insomnia Scale, AIS). Secondary outcomes were the Single-Item Sleep Quality Scale (SQS), Perceived Stress Scale (PSS), Patient Health Questionnaire-4 (PHQ-4), Positive and Negative Affect Schedule (PANAS), Epworth Sleepiness Scale (ESS), and World Health Organization Quality of Life (WHOQOL). Analyses followed an intention-to-treat (ITT) approach, with per-protocol (PP) confirmation.

Results

Among 150 completers, saffron extract led to a greater reduction in insomnia symptoms (AIS) than the placebo (between-group adjusted mean difference β = −0.95 [95 % CI: −1.79, −0.11], P < .05). In secondary analyses, sleep quality (SQS) improved significantly after 3 weeks and was sustained at week 4 in both saffron groups compared to placebo (30 mg vs placebo: β = 0.82 [95 % CI: 0.22, 1.41], P = .004; 20 mg vs placebo: β = 1.02 [0.43, 1.62], P < .001). Perceived stress (PSS) was significantly reduced with 30 mg or 20 mg saffron extract compared to placebo (30 mg vs placebo: β = −1.87 [95 % CI: −3.23, −0.53], P = .01; 20 mg vs placebo: β = −1.89 [95 % CI: −3.22, −0.52], P = .04). Some improvement in psychological symptoms (PHQ-4) was also observed with 30 mg saffron extract compared to placebo (β = −0.79 [−1.40, −0.18], P = .03). All other measures showed no significant differences. No serious adverse events occurred.

Conclusions

Four weeks of 20 or 30 mg saffron extract may reduce insomnia and stress in middle-aged adults. Future research should assess longer interventions and explore which subgroups benefit most from saffron extract.

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来源期刊

Sleep Medicine: X Medicine-Medicine (all)

CiteScore

4.00

自引率

0.00%

发文量

审稿时长

25 weeks