Effect of 6-week Treatment with Topical Betamethasone Dipropionate in Patients with Symptomatic Hand Osteoarthritis: A Randomized Double-blind, Placebo-controlled Trial

Overview

Journal Osteoarthr Cartil Open

Date 2023 Jul 10

PMID 37426293

Authors

Yuanyuan Wang

Mahnuma Mahfuz Estee

Desmond Gan

Yuan Z Lim

Stephane Heritier

Anita E Wluka

Sultana Monira Hussain

Natalie L Trevaskis

Flavia M Cicuttini

Affiliations

Soon will be listed here.

Abstract

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.

Citing Articles

Efficacy and safety of non-pharmacological, pharmacological and surgical treatments for hand osteoarthritis in 2024: a systematic review.

Kjeken I, Bordvik D, Osteras N, Haugen I, Fjeldstad K, Skaalvik I RMD Open. 2025; 11(1.

PMID: 39793978 PMC: 11749855. DOI: 10.1136/rmdopen-2024-004963.

Patterns and natural history of hand pain in individuals with symptomatic hand osteoarthritis in a prospective cohort study: A post-hoc analysis of a randomised controlled trial.

Estee M, Wang Y, Lim Y, Wluka A, Cicuttini F Osteoarthr Cartil Open. 2023; 5(4):100413.

PMID: 37920673 PMC: 10618785. DOI: 10.1016/j.ocarto.2023.100413.

References

Keen H, Wakefield R, Grainger A, Hensor E, Emery P, Conaghan P . An ultrasonographic study of osteoarthritis of the hand: synovitis and its relationship to structural pathology and symptoms. Arthritis Rheum. 2008; 59(12):1756-63. DOI: 10.1002/art.24312. View

Bellamy N, Campbell J, Haraoui B, Buchbinder R, Hobby K, MacDermid J . Clinimetric properties of the AUSCAN Osteoarthritis Hand Index: an evaluation of reliability, validity and responsiveness. Osteoarthritis Cartilage. 2002; 10(11):863-9. DOI: 10.1053/joca.2002.0838. View

Sarnes E, Crofford L, Watson M, Dennis G, Kan H, Bass D . Incidence and US costs of corticosteroid-associated adverse events: a systematic literature review. Clin Ther. 2011; 33(10):1413-32. DOI: 10.1016/j.clinthera.2011.09.009. View

Paschoal N, Natour J, Machado F, Oliveira H, Furtado R . Effectiveness of Triamcinolone Hexacetonide Intraarticular Injection in Interphalangeal Joints: A 12-week Randomized Controlled Trial in Patients with Hand Osteoarthritis. J Rheumatol. 2015; 42(10):1869-77. DOI: 10.3899/jrheum.140736. View

Kroon F, Carmona L, Schoones J, Kloppenburg M . Efficacy and safety of non-pharmacological, pharmacological and surgical treatment for hand osteoarthritis: a systematic literature review informing the 2018 update of the EULAR recommendations for the management of hand osteoarthritis. RMD Open. 2018; 4(2):e000734. PMC: 6203105. DOI: 10.1136/rmdopen-2018-000734. View

Kortekaas M, Kwok W, Reijnierse M, Watt I, Huizinga T, Kloppenburg M . Pain in hand osteoarthritis is associated with inflammation: the value of ultrasound. Ann Rheum Dis. 2010; 69(7):1367-9. DOI: 10.1136/ard.2009.124875. View

Jain R, Jain E, Dass A, Wickstrom O, Walter N, Atkinson P . Evaluation of transdermal steroids for trapeziometacarpal arthritis. J Hand Surg Am. 2010; 35(6):921-7. DOI: 10.1016/j.jhsa.2010.02.013. View

Bahadir C, Onal B, Dayan V, Gurer N . Comparison of therapeutic effects of sodium hyaluronate and corticosteroid injections on trapeziometacarpal joint osteoarthritis. Clin Rheumatol. 2009; 28(5):529-33. DOI: 10.1007/s10067-008-1079-6. View

Chung K, Pillsbury M, Walters M, Hayward R . Reliability and validity testing of the Michigan Hand Outcomes Questionnaire. J Hand Surg Am. 1998; 23(4):575-87. DOI: 10.1016/S0363-5023(98)80042-7. View

10.

Visser A, Boyesen P, Haugen I, Schoones J, van der Heijde D, Rosendaal F . Instruments Measuring Pain, Physical Function, or Patient's Global Assessment in Hand Osteoarthritis: A Systematic Literature Search. J Rheumatol. 2015; 42(11):2118-34. DOI: 10.3899/jrheum.141228. View

11.

Iannitti T, McDermott M, Laurino C, Malagoli A, Palmieri B . Corticosteroid transdermal delivery significantly improves arthritis pain and functional disability. Drug Deliv Transl Res. 2016; 7(1):156-161. PMC: 5222900. DOI: 10.1007/s13346-016-0340-9. View

12.

Harris P, Taylor R, Thielke R, Payne J, Gonzalez N, Conde J . Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2008; 42(2):377-81. PMC: 2700030. DOI: 10.1016/j.jbi.2008.08.010. View

13.

Waljee A, Rogers M, Lin P, Singal A, Stein J, Marks R . Short term use of oral corticosteroids and related harms among adults in the United States: population based cohort study. BMJ. 2017; 357:j1415. PMC: 6284230. DOI: 10.1136/bmj.j1415. View

14.

Wang Y, Hussain S, Gan D, Lim Y, Estee M, Heritier S . Topical corticosteroid for treatment of hand osteoarthritis: study protocol for a randomised controlled trial. BMC Musculoskelet Disord. 2021; 22(1):1036. PMC: 8670184. DOI: 10.1186/s12891-021-04921-2. View

15.

Hochman J, Gagliese L, Davis A, Hawker G . Neuropathic pain symptoms in a community knee OA cohort. Osteoarthritis Cartilage. 2011; 19(6):647-54. DOI: 10.1016/j.joca.2011.03.007. View

16.

Kloppenburg M, Maheu E, Kraus V, Cicuttini F, Doherty M, Dreiser R . OARSI Clinical Trials Recommendations: Design and conduct of clinical trials for hand osteoarthritis. Osteoarthritis Cartilage. 2015; 23(5):772-86. DOI: 10.1016/j.joca.2015.03.007. View

17.

Dahaghin S, Bierma-Zeinstra S, Ginai A, Pols H, Hazes J, Koes B . Prevalence and pattern of radiographic hand osteoarthritis and association with pain and disability (the Rotterdam study). Ann Rheum Dis. 2004; 64(5):682-7. PMC: 1755481. DOI: 10.1136/ard.2004.023564. View

18.

Kroon F, Kortekaas M, Boonen A, Bohringer S, Reijnierse M, Rosendaal F . Results of a 6-week treatment with 10 mg prednisolone in patients with hand osteoarthritis (HOPE): a double-blind, randomised, placebo-controlled trial. Lancet. 2019; 394(10213):1993-2001. DOI: 10.1016/S0140-6736(19)32489-4. View

19.

Spies C, Strehl C, van der Goes M, Bijlsma J, Buttgereit F . Glucocorticoids. Best Pract Res Clin Rheumatol. 2012; 25(6):891-900. DOI: 10.1016/j.berh.2011.11.002. View

20.

Kolasinski S, Neogi T, Hochberg M, Oatis C, Guyatt G, Block J . 2019 American College of Rheumatology/Arthritis Foundation Guideline for the Management of Osteoarthritis of the Hand, Hip, and Knee. Arthritis Rheumatol. 2020; 72(2):220-233. PMC: 10518852. DOI: 10.1002/art.41142. View