Sheena Hunt1, Simon Stebbings2, Debra McNamara3. 1. Principal Scientist, Promisia Ltd, Wellington. 2. Associate Professor in Medicine, Rheumatology Research Unit, Department of Medicine, Dunedin School of Medicine, University of Otago, Dunedin. 3. Research Nurse, Department of Medicine, Rheumatology Research Unit, Dunedin School of Medicine, University of Otago, Dunedin.
Abstract
AIMS: This six-month single-centre open-label extension study, conducted at the University of Otago, Dunedin, follows from a previously published 12-week pilot double-blind randomised placebo-controlled study of dietary supplement, Arthrem® (ART) in patients with osteoarthritis (OA) of the hip or knee. The pilot double-blind study showed that treatment with ART 150 mg twice-daily was associated with clinically relevant pain reduction. The extension study aims were to assess longer-term safety and efficacy during six months' treatment following the pilot trial. METHOD: Patients who completed the pilot double-blind study had the option to continue on open-label treatment with ART for a further six months. Safety was assessed by adverse event monitoring and laboratory tests at three and six months. Efficacy was assessed at three and six months using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC®). RESULTS:Thirty-four patients entered the optional extension and 28 completed six months' treatment. ART was well tolerated when taken for up to nine months. Improvements in WOMAC®efficacy parameters reported in the double-blind phase of the study were maintained over six months. CONCLUSION: ART appears to be a safe and effective alternative for managing the symptoms of OA over an extended period.
RCT Entities:
AIMS: This six-month single-centre open-label extension study, conducted at the University of Otago, Dunedin, follows from a previously published 12-week pilot double-blind randomised placebo-controlled study of dietary supplement, Arthrem® (ART) in patients with osteoarthritis (OA) of the hip or knee. The pilot double-blind study showed that treatment with ART 150 mg twice-daily was associated with clinically relevant pain reduction. The extension study aims were to assess longer-term safety and efficacy during six months' treatment following the pilot trial. METHOD:Patients who completed the pilot double-blind study had the option to continue on open-label treatment with ART for a further six months. Safety was assessed by adverse event monitoring and laboratory tests at three and six months. Efficacy was assessed at three and six months using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC®). RESULTS: Thirty-four patients entered the optional extension and 28 completed six months' treatment. ART was well tolerated when taken for up to nine months. Improvements in WOMAC® efficacy parameters reported in the double-blind phase of the study were maintained over six months. CONCLUSION:ART appears to be a safe and effective alternative for managing the symptoms of OA over an extended period.
Authors: James M Gwinnutt; Maud Wieczorek; Javier Rodríguez-Carrio; Andra Balanescu; Heike A Bischoff-Ferrari; Annelies Boonen; Giulio Cavalli; Savia de Souza; Annette de Thurah; Thomas E Dorner; Rikke Helene Moe; Polina Putrik; Lucía Silva-Fernández; Tanja Stamm; Karen Walker-Bone; Joep Welling; Mirjana Zlatković-Švenda; Francis Guillemin; Suzanne M M Verstappen Journal: RMD Open Date: 2022-06
Authors: Ruth L Savage; Geraldine R Hill; Joanne Barnes; Susan H Kenyon; Michael V Tatley Journal: Front Pharmacol Date: 2019-12-20 Impact factor: 5.810