TY - JOUR
T1 - Effect of 6-week treatment with topical betamethasone dipropionate in patients with symptomatic hand osteoarthritis
T2 - A randomized double-blind, placebo-controlled trial
AU - Wang, Yuanyuan
AU - Estee, Mahnuma Mahfuz
AU - Gan, Desmond
AU - Lim, Yuan Z.
AU - Heritier, Stephane
AU - Wluka, Anita E.
AU - Hussain, Sultana Monira
AU - Trevaskis, Natalie L.
AU - Cicuttini, Flavia M.
N1 - Funding Information:
The study is funded by an Investigator Grant from the National Health and Medical Research Council of Australia (NHMRC, APP1194829), a Project Grant from the Arthritis Australia, and a Monash University Joint Medicine Pharmacy Grant. YW is the recipient of NHMRC Translating Research into Practice Fellowship (APP1168185). MME is the recipient of Bangabandhu Science and Technology Fellowship from Ministry of Science and Technology, Government of the People's Republic of Bangladesh. YZL is the recipient of NHMRC Clinical Postgraduate Scholarship (APP1133903) and Royal Australasian College of Physicians Woolcock Scholarship. AEW is the recipient of the Royal Australian College of Physicians Fellows Career Development Fellowship. SMH is the recipient of NHMRC Early Career Fellowship (APP1142198). FMC is the recipient of NHMRC Investigator Grant (APP1194829). The funder of the study had no role in the study design and conduct of the study; collection, management, analysis and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Publisher Copyright:
© 2023 The Author(s)
PY - 2023/9
Y1 - 2023/9
N2 - Objective: To examine the efficacy and safety of topical corticosteroid over 6 weeks in patients with symptomatic hand osteoarthritis. Design: In a randomized, double-blind, placebo-controlled trial, community-based participants with hand osteoarthritis were randomly assigned (1:1) to topical Diprosone OV (betamethasone dipropionate 0.5 mg/g in optimised vehicle, n=54) or placebo (plain paraffin, n=52) ointment to painful joints 3 times daily for 6 weeks. Primary outcome was pain reduction [assessed by 100 mm visual analogue scale (VAS)] at 6 weeks. Secondary outcomes included changes in pain and function using the Australian Canadian Osteoarthritis Hand Index (AUSCAN), Functional Index for Hand Osteoarthritis (FIHOA), and Michigan Hand Outcomes Questionnaire (MHQ) at 6 weeks. Adverse events were recorded. Results: Of 106 participants (mean age 64.2 years, 85.9% female), 103 (97.2%) completed the study. Change in VAS at 6 weeks was similar in the Diprosone OV and placebo groups (−19.9 vs. −20.9, adjusted difference 0.6, 95% CI -8.9 to 10.2). There were no significant between-group differences in change in AUSCAN pain [adjusted difference 25.8 (−16.0 to 67.5)], AUSCAN function [21.2 (−55.0 to 97.4)], FIHOA [-0.1 (−1.7 to 1.5)], or MHQ [-1.2 (−6.0 to 3.6)]. Incidence of adverse events was 16.7% in Diprosone OV and 19.2% in placebo group. Conclusions: Topical Diprosone OV ointment, although well-tolerated, was no better than placebo in improving pain or function over 6 weeks in patient with symptomatic hand osteoarthritis. Future studies should consider examining joints with synovitis and whether delivery approaches enhancing transdermal penetration of corticosteroids into joints are effective in hand osteoarthritis. Trial registration: ACTRN 12620000599976. Registered May 22, 2020.
AB - Objective: To examine the efficacy and safety of topical corticosteroid over 6 weeks in patients with symptomatic hand osteoarthritis. Design: In a randomized, double-blind, placebo-controlled trial, community-based participants with hand osteoarthritis were randomly assigned (1:1) to topical Diprosone OV (betamethasone dipropionate 0.5 mg/g in optimised vehicle, n=54) or placebo (plain paraffin, n=52) ointment to painful joints 3 times daily for 6 weeks. Primary outcome was pain reduction [assessed by 100 mm visual analogue scale (VAS)] at 6 weeks. Secondary outcomes included changes in pain and function using the Australian Canadian Osteoarthritis Hand Index (AUSCAN), Functional Index for Hand Osteoarthritis (FIHOA), and Michigan Hand Outcomes Questionnaire (MHQ) at 6 weeks. Adverse events were recorded. Results: Of 106 participants (mean age 64.2 years, 85.9% female), 103 (97.2%) completed the study. Change in VAS at 6 weeks was similar in the Diprosone OV and placebo groups (−19.9 vs. −20.9, adjusted difference 0.6, 95% CI -8.9 to 10.2). There were no significant between-group differences in change in AUSCAN pain [adjusted difference 25.8 (−16.0 to 67.5)], AUSCAN function [21.2 (−55.0 to 97.4)], FIHOA [-0.1 (−1.7 to 1.5)], or MHQ [-1.2 (−6.0 to 3.6)]. Incidence of adverse events was 16.7% in Diprosone OV and 19.2% in placebo group. Conclusions: Topical Diprosone OV ointment, although well-tolerated, was no better than placebo in improving pain or function over 6 weeks in patient with symptomatic hand osteoarthritis. Future studies should consider examining joints with synovitis and whether delivery approaches enhancing transdermal penetration of corticosteroids into joints are effective in hand osteoarthritis. Trial registration: ACTRN 12620000599976. Registered May 22, 2020.
KW - Function
KW - Hand
KW - Osteoarthritis
KW - Pain
KW - Topical corticosteroid
UR - http://www.scopus.com/inward/record.url?scp=85163145772&partnerID=8YFLogxK
U2 - 10.1016/j.ocarto.2023.100382
DO - 10.1016/j.ocarto.2023.100382
M3 - Article
AN - SCOPUS:85163145772
SN - 2665-9131
VL - 5
JO - Osteoarthritis and Cartilage Open
JF - Osteoarthritis and Cartilage Open
IS - 3
M1 - 100382
ER -