ABSTRACT
This observational, open, multicenter clinical trial with a single treatment group aimed to evaluate the effectiveness of a dietary supplement whose main ingredients are hydrolyzed gelatin, chondroitin sulfate, glucosamine sulfate, and devil's claw and bamboo extracts for pain reduction and improvement of functional capacities in patients with osteoarthritis (OA) of the knee and/or hip (REDART study). In all, 130 patients with OA recruited from Spanish hospitals received the dietary supplement for 6 months. The primary outcome was the patients’ global assessment of pain in the affected joint as measured with a visual analogue scale (VAS). Other outcome measurements included the Lequesne Functional Index (subindexes for pain/discomfort, distance walked, and daily living) and the Western Ontario and McMaster Universities Arthritis Index (WOMAC; subindexes for pain, stiffness, and physical function). Scores were taken at months 3 and 6 of the treatment. Patients (N = 78) showed a reduction of pain of 3.77 ± 1.77 points after 6 months (p < .0001) in the VAS. The total reduction in the Lequesne Functional Index was 6.30 ± 4.08 points after 6 months (p < .0001), with significant reductions in all subindexes of the scale. A similar pattern was found for the WOMAC index, with an overall reduction of 22.49 ± 14.03 points after 6 months (p < .0001) and significant reductions in all subindexes. No major adverse events were noted during the treatment. This exploratory study shows that treatment with the dietary supplement significantly reduces pain and improves locomotor function in patients with OA of the knee and/or hip.
Declaration of interest
The authors declare no conflicts of interest. The authors alone are responsible for the content and writing of the article.
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Notes on contributors
Jordi Puigdellivol
Jordi Puigdellivol, MD, is a specialist in Orthopedic Surgery and Traumatology. He is a member of the medical staff of the Barcelona FC and a member of the Spanish Society for Traumatology and Sports.
Carme Comellas Berenger
Carme Comellas Berenguer, MD, is a specialist in Orthopedic Surgery, Traumatology, and Sports medicine.
Miguel Ángel Pérez Fernández
Miguel Ángel Pérez Fernández, MD, is a specialist in Orthopedic Surgery and Traumatology.
Juan M. Cowalinsky Millán
Juan M. Cowalinsky Millán, MD, is a rheumatologist at the Unit for Articular Bio-Reparation and Regenerative Medicine of the Cowalinsky International Rheumatology Medical Center in Barcelona.
Christian Carreras Vidal
Christian Carreras Vidal, MD, is a specialist in Orthopedic Surgery and Traumatology. He is also an Adjunct Physician at the Sports Medicine Unit of the Olivé Gumá Clinic in Barcelona, at Wunder Training Barcelona, at the Emergency Services of Badalona, and attending terminal chronic patients at Sarquavitae.
Inés Gil Gil
Inés Gil Gil, MD, is a family doctor. She works at the Health Services of Arán, Viella. She is a member of the hypertension and cardiovascular diseases Group of the Spanish Society of Primary Care Physicians.
Julio Martínez Pagán
Julio Martínez Pagán, MD, is a specialist in Orthopedic Surgery and Traumatology. He coordinates the medical services of the Southeast Traumatology Institute at the Nuestra Señora de Belén Clinic, and is the head of the Arthroscopy Unit. He is a specialist in trauma surgery of Ibermutuamur and a member of the Spanish Society of Orthopedic Surgery and Traumatology.
Borja Ruiz Nieto
Borja Ruiz Nieto, MD, is a specialist in Traumatology, Orthopedics, and Sports Medicine. He works as a traumatology and orthopedic surgeon at the Hip and Knee Units of the Clinic CEMTRO in Madrid, a FIFA-Excellence accredited institute.
Francisco Jiménez Gómez
Francisco Jiménez Gómez, MD, is a specialist in Orthopedic Surgery and Traumatology.
Francesc X. Comas Figuerola
Francesc X. Comas Figuerola is a specialist in Orthopedic Surgery and Traumatology. He is the Director of Orthodex and Adjunct to the Orthopedic Surgery and Traumatology at the Hospital Josep Trueta. He is Medical Director of Mutua Gerundense.
María E. Aguilar Hernández
Maria Elisa Aguilar Hernández, MD, is a specialist in Orthopedic Surgery and Traumatology, Adjunct Director of Orthodex (Girona, Spain), and deputy medical director of Mutua Gerundense.