UNASSIGNED: A single-center randomized double-blind study with three parallel arms depending on the product consumed. The duration of treatment was 12 weeks. The investigational product, Berelief®, contained a blend of three polyphenolic standardized extracts: rosemary (Rosmarinus officinalis L.), ashwagandha (Withania somnifera L.), and sesame (Sesamum indicum L.) seed. Two doses were tested: low dose (400 mg) and high dose (800 mg). There were 42 subjects in the placebo group, 39 in the low dose and 42 in the high dose groups. Study variables included back pain intensity [VAS score, Patient-Reported Outcomes Measurement Information System (PROMIS-29), and Cornell Musculoskeletal Discomfort Questionnaire; functionality Roland-Morris Disability (RMD) questionnaire]; quality of life (QoL) [36-item Short Form Survey (SF-36), the Beck Depression Inventory-II (BDI-II), the State-Trait Anxiety Inventory (STAI), and the Perceived Stress Scale (PSS)]; sleep quality [accelerometer and Pittsburgh Sleep Quality Index (PSQI)].
UNASSIGNED: The improvement in back pain recorded by the visual analogue scale (VAS) at the study visits after the beginning of treatment, as well as on a weekly basis recorded in the diary card was significantly higher in the intervention group than in the placebo group (p < 0.044 dose-low; p < 0.005 dose-high). Significant differences in pain intensity of the PROMIS-29 (p = 0.002) and upper back pain in the Cornell questionnaire (p = 0.011) in favour of the investigational product were found. Furthermore, benefits in improving health-related quality of life, mood and sleep quality were also detected.
UNASSIGNED: Dietary supplementation for 12 weeks of a blend of polyphenolic standardized extracts of rosemary, ashwagandha, and sesame was effective in reducing the intensity of pain in subjects with chronic myofascial cervical and back pain.
■单中心随机双盲研究,具有三个平行臂,具体取决于所消耗的产品。治疗时间为12周。研究产品,Berelief®,含有三种多酚标准提取物的混合物:迷迭香(迷迭香),阿什瓦甘达(WithaniasomniferaL.),和芝麻(SesamumindicumL.)种子。测试两种剂量:低剂量(400mg)和高剂量(800mg)。安慰剂组有42名受试者,低剂量组39,高剂量组42。研究变量包括背痛强度[VAS评分,患者报告结果测量信息系统(PROMIS-29),和康奈尔肌肉骨骼不适问卷;功能性罗兰-莫里斯残疾(RMD)问卷];生活质量(QoL)[36项简短形式调查(SF-36),贝克抑郁量表-II(BDI-II),状态特质焦虑量表(STAI),和感知压力量表(PSS)];睡眠质量[加速度计和匹兹堡睡眠质量指数(PSQI)]。
■在治疗开始后的研究访视时通过视觉模拟评分(VAS)记录的背痛改善情况,干预组的日记本卡中的每周记录均显著高于安慰剂组(p<0.044低剂量;p<0.005剂量高).在康奈尔问卷(p=0.011)中,PROMIS-29(p=0.002)和上背痛的疼痛强度存在显着差异,有利于研究产品。此外,改善健康相关生活质量的好处,还检测到情绪和睡眠质量。
■迷迭香多酚标准提取物共混物12周的膳食补充剂,ashwagandha,芝麻可有效减轻慢性肌筋膜颈背痛患者的疼痛强度。