Marlene Fransen1, Maria Agaliotis1, Lillias Nairn1, Milana Votrubec2, Lisa Bridgett1, Steve Su3, Stephen Jan4, Lyn March5, John Edmonds6, Robyn Norton4, Mark Woodward4, Richard Day7. 1. Faculty of Health Sciences, University of Sydney, Lidcombe, New South Wales, Australia. 2. Graduate School of Medicine, Notre Dame University, Darlinghurst, New South Wales, Australia. 3. Covance Pty Ltd, Sydney, New South Wales, Australia. 4. The George Institute for Global Health, University of Sydney, Camperdown, New South Wales, Australia. 5. Institute of Bone and Joint Research, University of Sydney, Royal North Shore Hospital, St Leonards, New South Wales, Australia. 6. St George Hospital Clinical School, University of New South Wales, Kogarah, New South Wales, Australia. 7. Department of Clinical Pharmacology, St Vincent's Hospital and University of New South Wales, Darlinghurst, New South Wales, Australia.
Abstract
OBJECTIVE: To determine if the dietary supplements, glucosamine and/or chondroitin, result in reduced joint space narrowing (JSN) and pain among people with symptomatic knee osteoarthritis. METHODS: A double-blind randomised placebo-controlled clinical trial with 2-year follow-up. 605 participants, aged 45-75 years, reporting chronic knee pain and with evidence of medial tibio-femoral compartment narrowing (but retaining >2 mm medial joint space width) were randomised to once daily: glucosamine sulfate 1500 mg (n=152), chondroitin sulfate 800 mg (n=151), both dietary supplements (n=151) or matching placebo capsules (n=151). JSN (mm) over 2 years was measured from digitised knee radiographs. Maximum knee pain (0-10) was self-reported in a participant diary for 7 days every 2 months over 1 year. RESULTS: After adjusting for factors associated with structural disease progression (gender, body mass index (BMI), baseline structural disease severity and Heberden's nodes), allocation to the dietary supplement combination (glucosamine-chondroitin) resulted in a statistically significant (p=0.046) reduction of 2-year JSN compared to placebo: mean difference 0.10 mm (95% CI 0.002 mm to 0.20 mm); no significant structural effect for the single treatment allocations was detected. All four allocation groups demonstrated reduced knee pain over the first year, but no significant between-group differences (p=0.93) were detected. 34 (6%) participants reported possibly-related adverse medical events over the 2-year follow-up period. CONCLUSIONS: Allocation to the glucosamine-chondroitin combination resulted in a statistically significant reduction in JSN at 2 years. While all allocation groups demonstrated reduced knee pain over the study period, none of the treatment allocation groups demonstrated significant symptomatic benefit above placebo. TRIAL REGISTRATION CLINICALTRIALSGOV IDENTIFIER: NCT00513422; http://www.clinicaltrials.gov. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
RCT Entities:
OBJECTIVE: To determine if the dietary supplements, glucosamine and/or chondroitin, result in reduced joint space narrowing (JSN) and pain among people with symptomatic knee osteoarthritis. METHODS: A double-blind randomised placebo-controlled clinical trial with 2-year follow-up. 605 participants, aged 45-75 years, reporting chronic knee pain and with evidence of medial tibio-femoral compartment narrowing (but retaining >2 mm medial joint space width) were randomised to once daily: glucosamine sulfate 1500 mg (n=152), chondroitin sulfate 800 mg (n=151), both dietary supplements (n=151) or matching placebo capsules (n=151). JSN (mm) over 2 years was measured from digitised knee radiographs. Maximum knee pain (0-10) was self-reported in a participant diary for 7 days every 2 months over 1 year. RESULTS: After adjusting for factors associated with structural disease progression (gender, body mass index (BMI), baseline structural disease severity and Heberden's nodes), allocation to the dietary supplement combination (glucosamine-chondroitin) resulted in a statistically significant (p=0.046) reduction of 2-year JSN compared to placebo: mean difference 0.10 mm (95% CI 0.002 mm to 0.20 mm); no significant structural effect for the single treatment allocations was detected. All four allocation groups demonstrated reduced knee pain over the first year, but no significant between-group differences (p=0.93) were detected. 34 (6%) participants reported possibly-related adverse medical events over the 2-year follow-up period. CONCLUSIONS: Allocation to the glucosamine-chondroitin combination resulted in a statistically significant reduction in JSN at 2 years. While all allocation groups demonstrated reduced knee pain over the study period, none of the treatment allocation groups demonstrated significant symptomatic benefit above placebo. TRIAL REGISTRATION CLINICALTRIALSGOV IDENTIFIER: NCT00513422; http://www.clinicaltrials.gov. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
Authors: Mario Simental-Mendía; Adriana Sánchez-García; Félix Vilchez-Cavazos; Carlos A Acosta-Olivo; Víctor M Peña-Martínez; Luis E Simental-Mendía Journal: Rheumatol Int Date: 2018-06-11 Impact factor: 2.631