Efficacy and safety of an oral complementary medicine combination in people with symptomatic knee osteoarthritis: Protocol for the double-blind, randomized, placebo-controlled ATLAS trial

Arashi Shahid; Xiaoqian Liu; Karen Bracken; Robin Christensen; Leticia Alle Deveza; Simone Collins; Joanna Harnett; David J. Hunter; Andrew J. McLachlan; Sarah Robbins; Jocelyn L. Bowden

Osteoarthritis and Cartilage Open (Dec 2024)

Efficacy and safety of an oral complementary medicine combination in people with symptomatic knee osteoarthritis: Protocol for the double-blind, randomized, placebo-controlled ATLAS trial

Arashi Shahid,
Xiaoqian Liu,
Karen Bracken,
Robin Christensen,
Leticia Alle Deveza,
Simone Collins,
Joanna Harnett,
David J. Hunter,
Andrew J. McLachlan,
Sarah Robbins,
Jocelyn L. Bowden

Affiliations

Arashi Shahid: Sydney Musculoskeletal Health, Kolling Institute, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia; Rheumatology Department, Royal North Shore Hospital, Northern Sydney Local Health District, Sydney, NSW, Australia; National Institute of Food Science and Technology, University of Agriculture, Faisalabad, Pakistan
Xiaoqian Liu: Sydney Musculoskeletal Health, Kolling Institute, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia; Rheumatology Department, Royal North Shore Hospital, Northern Sydney Local Health District, Sydney, NSW, Australia
Karen Bracken: Sydney Musculoskeletal Health, Kolling Institute, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia; Rheumatology Department, Royal North Shore Hospital, Northern Sydney Local Health District, Sydney, NSW, Australia
Robin Christensen: Section for Biostatistics and Evidence-Based Research, The Parker Institute, Bispebjerg-Frederiksberg Hospital, Copenhagen University Hospital Bispebjerg Frederiksberg, Copenhagen, Denmark; Research Unit of Rheumatology, Department of Clinical Research, University of Southern Denmark, Odense University Hospital; and Cochrane, Denmark; Centre for Evidence-Based Medicine Odense (CEBMO), Department of Clinical Research, University of Southern Denmark, Denmark
Leticia Alle Deveza: Sydney Musculoskeletal Health, Kolling Institute, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia; Rheumatology Department, Royal North Shore Hospital, Northern Sydney Local Health District, Sydney, NSW, Australia
Simone Collins: Sydney Musculoskeletal Health, Kolling Institute, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia; Rheumatology Department, Royal North Shore Hospital, Northern Sydney Local Health District, Sydney, NSW, Australia
Joanna Harnett: Faculty of Medicine and Health, Sydney Pharmacy School, University of Sydney, Sydney, NSW, Australia
David J. Hunter: Sydney Musculoskeletal Health, Kolling Institute, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia; Rheumatology Department, Royal North Shore Hospital, Northern Sydney Local Health District, Sydney, NSW, Australia
Andrew J. McLachlan: Faculty of Medicine and Health, Sydney Pharmacy School, University of Sydney, Sydney, NSW, Australia
Sarah Robbins: Sydney Musculoskeletal Health, Kolling Institute, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia; Rheumatology Department, Royal North Shore Hospital, Northern Sydney Local Health District, Sydney, NSW, Australia
Jocelyn L. Bowden: Sydney Musculoskeletal Health, Kolling Institute, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia; Rheumatology Department, Royal North Shore Hospital, Northern Sydney Local Health District, Sydney, NSW, Australia; Corresponding author. Level 10, Kolling Building, Reserve Road, St Leonards, NSW, 2065, Australia.

Journal volume & issue: Vol. 6, no. 4
p. 100522

Abstract

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Objective: To investigate the efficacy and safety of an oral complementary medicine combination formulation relative to placebo, on changes in pain intensity from baseline to week 12, in people with knee osteoarthritis (OA). Design: A placebo-controlled, double-blind, two-arm, superiority, phase II, Randomized Controlled Trial (RCT) (ACTRN12623000380695). We will recruit 82 participants (∼41 per arm), aged ≥40 years, with a clinical diagnosis of symptomatic knee OA and radiographic change on x-ray (Kellgren-Lawrence Grade ≥2). Participants will be randomly allocated to receive either a complementary medicine formulation containing a daily dose of Boswellia serrata extract (Boswellin® Super, 250 mg/day), pine bark extract (Fenoprolic™ 70 Organic 100 mg/day), curcumin (500 mg/day), piperine (5 mg/day), and methylsulfonylmethane (MSM, 1500 mg/day), or placebo, for 12-weeks. The primary endpoint will be change from baseline in average knee pain intensity at 12-weeks (visual analogue scale). Secondary endpoints will include change in knee pain from baseline to 12-weeks in the Knee Injury and Osteoarthritis Outcome Score (KOOS), global assessment of disease activity, global rating of change, and health-related quality of life (AQoL-8D). Ethics and dissemination: This protocol has been approved by the University of Sydney Human Research Ethics Committee (#2021/877). Dissemination will occur through lay summaries, infographics, conference abstracts, oral presentations, theses, and scientific publications. Conclusion: This RCT will provide credible evidence about the efficacy and safety of this complementary medicine combination and inform updates to international clinical practice standards on the use of complementary medicines in the management of symptomatic knee OA.

Published in Osteoarthritis and Cartilage Open

ISSN: 2665-9131 (Online)
Publisher: Elsevier
Country of publisher: United Kingdom
LCC subjects: Medicine: Internal medicine: Specialties of internal medicine: Diseases of the musculoskeletal system
Website: https://www.journals.elsevier.com/osteoarthritis-and-cartilage-open/

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