Abstract
PURPOSE: To evaluate the efficacy of a new food-grade lecithin formulation of standardized extracts of Zingiber officinale and Acmella oleracea on pain and inflammation. PATIENTS AND METHODS: 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. RESULTS: 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). CONCLUSION: The tested formulation seems to be effective and also free of side effects.