Rondanelli Mariangela, Riva Antonella, Allegrini Pietro, Faliva Milena Anna, Naso Maurizio, Peroni Gabriella, Nichetti Mara, Gasparri Clara, Spadaccini Daniele, Iannello Giancarlo, Infantino Vittoria, Fazia Teresa, Bernardinelli Luisa, Perna Simone
IRCCS Mondino Foundation, Pavia 27100, Italy.
Department of Public Health, Experimental and Forensic Medicine, Unit of Human and Clinical Nutrition, University of Pavia, Pavia 27100, Italy.
J Pain Res. 2020 Apr 21;13:761-770. doi: 10.2147/JPR.S214488. eCollection 2020.
To evaluate the efficacy of a new food-grade lecithin formulation of standardized extracts of and on pain and inflammation.
Pilot study with one-group pretest-posttest quasi-experimental design in which 50 subjects with moderate knee osteoarthritis (OA) (mean age: 62.46±8.45) were supplied for four weeks with two tablets/day.
Primary outcomes were 1) the evaluation of pain intensity, by a 30-day visual analogue scale (VAS) and 2) the assessment of knee function by WOMAC (Western Ontario and McMaster Universities Arthritis) Index and by Tegner Lysholm Knee Scoring collected at baseline, at 15 and 30 days after treatment. Secondary outcomes were 3) health-related quality of life, by the ShortForm36 (SF-36); 4) inflammation grade by C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR); and 5) body composition by dual-energy X-ray absorptiometry (DXA) measured at baseline and 30 days after treatment. Data showed significant effects of supplement intake for WOMAC (β=-3.27, p<0.0001), Lysholm (β=1.06, p=0.0003), CRP (β=-0.13, p=0.006), ESR (β=-3.09, p=0.004), physical activity (β=4.3, p=0.009) and fat-free mass (β=376.7, p=0.046). A significant VAS's decrease over time was observed in both knees (left: β=-0.08, p<0.0001; right: β=-0.07, p<0.0001).
The tested formulation seems to be effective and also free of side effects.
评估一种新的食品级卵磷脂配方的标准化提取物对疼痛和炎症的疗效。
采用一组前后测准实验设计的初步研究，为50名中度膝骨关节炎（OA）患者（平均年龄：62.46±8.45岁）提供为期四周的每日两片药物。
主要结果为：1）通过30天视觉模拟量表（VAS）评估疼痛强度；2）在基线、治疗后15天和30天，通过WOMAC（西安大略和麦克马斯特大学关节炎指数）和Tegner Lysholm膝关节评分评估膝关节功能。次要结果为：3）通过简明健康调查问卷（SF-36）评估健康相关生活质量；4）通过C反应蛋白（CRP）和红细胞沉降率（ESR）评估炎症程度；5）在基线和治疗后30天，通过双能X线吸收法（DXA）测量身体成分。数据显示，补充剂摄入对WOMAC（β=-3.27，p<0.0001）、Lysholm（β=1.06，p=0.0003）、CRP（β=-0.13，p=0.006）、ESR（β=-3.09，p=0.004）、身体活动（β=4.3，p=0.009）和去脂体重（β=376.7，p=0.046）有显著影响。观察到双膝VAS随时间显著下降（左膝：β=-0.08，p<0.0001；右膝：β=-0.07，p<0.0001）。
所测试的配方似乎有效且无副作用。
