The Use of a New Food-Grade Lecithin Formulation of Highly Standardized Ginger (Zingiber officinale) and Acmella oleracea Extracts for the Treatment of Pain and Inflammation in a Group of Subjects with Moderate Knee Osteoarthritis
Received 6 May 2019
Accepted for publication 25 February 2020
Published 21 April 2020 Volume 2020:13 Pages 761—770
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 2
Editor who approved publication: Dr Michael Schatman
Mariangela Rondanelli,1,2 Antonella Riva,3 Pietro Allegrini,3 Milena Anna Faliva,4 Maurizio Naso,4 Gabriella Peroni,4 Mara Nichetti,4 Clara Gasparri,4 Daniele Spadaccini,4 Giancarlo Iannello,5 Vittoria Infantino,6 Teresa Fazia,7 Luisa Bernardinelli,7 Simone Perna8
1IRCCS Mondino Foundation, Pavia 27100, Italy; 2Department of Public Health, Experimental and Forensic Medicine, Unit of Human and Clinical Nutrition, University of Pavia, Pavia 27100, Italy; 3Research and Development Unit, Indena, Milan 20146, Italy; 4Endocrinology and Nutrition Unit, Azienda di Servizi alla Persona “Istituto Santa Margherita”, University of Pavia, Pavia 27100, Italy; 5General Management, Azienda di Servizi alla Persona “Istituto Santa Margherita”, Pavia 27100, Italy; 6Department of Biomedical Science and Human Oncology, University of Bari Aldo Moro, Bari 70121, Italy; 7Department of Brain and Behavioral Science, University of Pavia, Pavia, Italy; 8Department of Biology, College of Science, University of Bahrain, Sakhir Campus, Kingdom of Bahrain
Correspondence: Vittoria Infantino
University of Bari Aldo Moro, Department of Biomedical Science and Human Oncology, Bari, c/o Azienda di Servizi alla Persona “Istituto Santa Margherita”, Via Emilia 12, Pavia 27100, Italy
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.
Keywords: pain, knee osteoarthritis, dietary supplements, Phytosome®
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