George Annie, Udani Jay, Abidin Nurhayati Zainal, Yusof Ashril
Institute of Biological Sciences, Faculty of Science, University of Malaya, Kuala Lumpur, Malaysia.
Biotropics Malaysia Berhad, Lot 21, Jalan U1/19, Section U1, Hicom-Glenmarie Industrial Park, 40150 Shah Alam, Malaysia.
Food Nutr Res. 2018 Oct 16;62. doi: 10.29219/fnr.v62.1374. eCollection 2018.
The use of alternative and complementary medicines to alleviate stress has increased to avoid the negative effects of pharmaceutical drugs.
This study investigated the safety and efficacy of in combination with multivitamins (EL+MV) versus placebo on improving quality of life (QoL), mood and stress in moderately stressed healthy participants.
This randomised, double-blind, placebo-controlled 24-week study enrolled 93 participants aged 25-65 years, with a body mass index of 18-30 kg/m, scoring ≤18 in tension and ≤14 in fatigue subscale of Profiles of Mood Scores (POMS) questionnaire and supplemented with EL+MV or placebo. The primary endpoints were QoL measured by 12-Item Short Form Health Survey (SF-12) questionnaire and mood measured by POMS. The secondary endpoint was stress measured by Multi-Modal Stress Questionnaire (MMSQ). The safety of the intervention product was measured by complete metabolic panel, lipid and renal analysis including several immune parameters.
While there were no significant between-group differences, within-group improvements were observed in the SF-12 QoL, POMS and MMSQ domains. In the SF-12 domain, improvements were seen in role limitation due to emotional health ( = 0.05), mental component domain ( < 0.001), emotional well-being ( < 0.001), social functioning ( = 0.002) as well as vitality ( = 0.001) at week 12. An increasing trend in POMS-vigour domain was also observed in the EL+MV group at week 12. A 15% decrease in physical stress domain ( < 0.05) compared with 0.7% in the placebo group was also observed in MMSQ. When the subjects were subgrouped according to age, 25-45 and 46-65 years of age, for primary outcomes, between-group significance was observed in the 25-45 year group in the social functioning domain of SF-12 ( = 0.021) and POMS-vigour ( = 0.036) in the 46-65 year group. No significant changes were observed in vital signs and complete metabolic panel. Regarding immune parameters, the lymphocytes increased significantly in the active group (≤0.05). In total, 13 adverse events were reported: six on placebo and seven on EL+MV.
EL+MV may support the QoL, mood, stress and immune parameters in healthy participants.
This study has been registered at clinicaltrials.gov (NCT02865863).
为避免药物的负面影响，使用替代医学和补充医学来缓解压力的情况有所增加。
本研究调查了依兰提取物与多种维生素（EL+MV）联合使用与安慰剂相比，对改善中度压力健康参与者的生活质量（QoL）、情绪和压力的安全性和有效性。
这项随机、双盲、安慰剂对照的24周研究招募了93名年龄在25 - 65岁之间、体重指数为18 - 30 kg/m²、情绪状态量表（POMS）问卷中紧张得分≤18分且疲劳分量表得分≤14分的参与者，给予EL+MV或安慰剂。主要终点是通过12项简明健康调查（SF - 12）问卷测量的生活质量和通过POMS测量的情绪。次要终点是通过多模式压力问卷（MMSQ）测量的压力。通过全代谢指标、血脂和肾脏分析（包括几个免疫参数）来评估干预产品的安全性。
虽然组间没有显著差异，但在SF - 12生活质量、POMS和MMSQ领域观察到了组内改善。在SF - 12领域，第12周时，因情绪健康导致的角色限制（P = 0.05）、心理成分领域（P < 0.001）、情绪幸福感（P < 0.001）、社会功能（P = 0.002）以及活力（P = 0.001）方面均有改善。在第12周时，EL+MV组的POMS - 活力领域也观察到上升趋势。在MMSQ中，与安慰剂组0.7%的下降相比，身体压力领域下降了15%（P < 0.05）。当根据年龄将受试者分为25 - 45岁和46 - 65岁两个亚组时，对于主要结局，在25 - 45岁组的SF - 12社会功能领域（P = 0.021）和46 - 65岁组的POMS - 活力领域（P = 0.036）观察到组间差异具有统计学意义。生命体征和全代谢指标未观察到显著变化。关于免疫参数，活性组的淋巴细胞显著增加（P≤0.05）。总共报告了13例不良事件：安慰剂组6例，EL+MV组7例。
EL+MV可能有助于改善健康参与者的生活质量、情绪、压力和免疫参数。
本研究已在clinicaltrials.gov注册（NCT02865863）。
