Efficacy and safety of a supplement combination on hand pain among people with symptomatic hand osteoarthritis an internet-based, randomised clinical trial the RADIANT study

X Liu; S Robbins; J Eyles; T Fedorova; S Virk; L A Deveza; A J McLachlan; D J Hunter

doi:10.1016/j.joca.2021.01.011

Efficacy and safety of a supplement combination on hand pain among people with symptomatic hand osteoarthritis an internet-based, randomised clinical trial the RADIANT study

Osteoarthritis Cartilage. 2021 May;29(5):667-677. doi: 10.1016/j.joca.2021.01.011. Epub 2021 Feb 19.

Authors

X Liu¹, S Robbins², J Eyles³, T Fedorova⁴, S Virk⁵, L A Deveza⁶, A J McLachlan⁷, D J Hunter⁸

Affiliations

¹ Rheumatology Department, Royal North Shore Hospital, Northern Clinical School, Faculty of Medicine and Health, The University of Sydney Institute of Bone and Joint Research, Kolling Institute of Medical Research, The University of Sydney, Australia. Electronic address: xliu2328@uni.sydney.edu.au.
² Rheumatology Department, Royal North Shore Hospital, Northern Clinical School, Faculty of Medicine and Health, The University of Sydney Institute of Bone and Joint Research, Kolling Institute of Medical Research, The University of Sydney, Australia. Electronic address: sarah.robbins@sydney.edu.au.
³ Rheumatology Department, Royal North Shore Hospital, Northern Clinical School, Faculty of Medicine and Health, The University of Sydney Institute of Bone and Joint Research, Kolling Institute of Medical Research, The University of Sydney, Australia. Electronic address: jillian.eyles@sydney.edu.au.
⁴ Rheumatology Department, Royal North Shore Hospital, Northern Clinical School, Faculty of Medicine and Health, The University of Sydney Institute of Bone and Joint Research, Kolling Institute of Medical Research, The University of Sydney, Australia. Electronic address: tatyana.fedorova@sydney.edu.au.
⁵ Rheumatology Department, Royal North Shore Hospital, Northern Clinical School, Faculty of Medicine and Health, The University of Sydney Institute of Bone and Joint Research, Kolling Institute of Medical Research, The University of Sydney, Australia. Electronic address: sonika.virk@sydney.edu.au.
⁶ Rheumatology Department, Royal North Shore Hospital, Northern Clinical School, Faculty of Medicine and Health, The University of Sydney Institute of Bone and Joint Research, Kolling Institute of Medical Research, The University of Sydney, Australia. Electronic address: leticia.alle@sydney.edu.au.
⁷ School of Pharmacy, Faculty of Medicine and Health, The University of Sydney, Australia. Electronic address: andrew.mclachlan@sydney.edu.au.
⁸ Rheumatology Department, Royal North Shore Hospital, Northern Clinical School, Faculty of Medicine and Health, The University of Sydney Institute of Bone and Joint Research, Kolling Institute of Medical Research, The University of Sydney, Australia; Clinical Research Centre, Zhujiang Hospital, Southern Medical University, Guangzhou, China.

PMID: 33617972
DOI: 10.1016/j.joca.2021.01.011

Abstract

Objective: The RADIANT study aimed to investigate the efficacy and safety of a complementary medicine supplement combination in people with hand osteoarthritis (HOA).

Method: This was an internet-based, double-blind, randomised, placebo-controlled trial. Participants aged over 40 years with symptomatic HOA with radiographic confirmation (Kellgren Lawrence grade ≥ 2) throughout Australia were recruited and randomly assigned (1:1) to receive either a supplement combination composed of Boswellia serrata extract 250 mg/day, pine bark extract 100 mg/day, methylsulfonylmethane 1,500 mg/day and curcumin 168 mg/day or placebo for 12 weeks. The primary outcome was change in hand pain assessed using a visual analogue scale (VAS 0-100) from baseline to week 12. A range of secondary outcomes and additional measures were recorded. Adverse events were monitored weekly.

Results: One hundred and six participants were included with mean age 65.6 years and 81% were women. 45% of the participants were graded as KLG 4, 40% KLG three and 39 (37%) had erosive OA. There was no significant difference in pain VAS reduction between groups. The adjusted between group difference in means (95%CI) was 5.34 (-2.39 to 13.07). Five participants (10%) in the supplement combination group discontinued study treatment due to AE vs four participants (7%) in the placebo group.

Conclusion: There were no significant differences in symptomatic relief between the two groups over 12 weeks. These findings do not support the use of the supplement combination for treating hand pain in people with HOA.

Registration: Prospectively registered (Australian New Zealand Clinical Trials Registry ACTRN12619000835145, 31/05/2019).

Keywords: And curcumin; Boswellia serrata extract; Hand osteoarthritis; MSM; Pine bark extract; Supplement combination.

Publication types

Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Aged
Anti-Inflammatory Agents / therapeutic use*
Boswellia
Curcumin / therapeutic use
Dimethyl Sulfoxide / therapeutic use
Double-Blind Method
Drug Therapy, Combination
Female
Hand / physiopathology*
Humans
Male
Osteoarthritis / drug therapy*
Osteoarthritis / physiopathology
Pinus
Plant Bark
Plant Extracts / therapeutic use*
Sulfones / therapeutic use
Visual Analog Scale

Substances

Anti-Inflammatory Agents
Plant Extracts
Sulfones
dimethyl sulfone
Curcumin
Dimethyl Sulfoxide