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Lookup NU author(s): Professor Fraser Birrell
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© 2018 American College of Physicians. Background: Synovitis is believed to play a role in producing symptoms in persons with hand osteoarthritis, but data on slowacting anti-inflammatory treatments are sparse. Objective: To determine the effectiveness of hydroxychloroquine versus placebo as an analgesic treatment of hand osteoarthritis. Design: Randomized, double-blind, placebo-controlled clinical trial with 12-month follow-up. (ISRCTN registry number: ISRCTN91859104) Setting: 13 primary and secondary care centers in England. Participants: Of 316 patients screened, 248 participants (82% women; mean age, 62.7 years) with symptomatic (pain =4 on a 0-to 10-point visual analogue scale) and radiographic hand osteoarthritis were randomly assigned and 210 (84.7%) completed the 6-month primary end point. Intervention: Hydroxychloroquine (200 to 400 mg) or placebo (1:1) for 12 months with ongoing usual care. Measurements: The primary end point was average hand pain during the previous 2 weeks (on a 0-to 10-point numerical rating scale [NRS]) at 6 months. Secondary end points included selfreported pain and function, grip strength, quality of life, radiographic structural change, and adverse events. Baseline ultrasonography was done. Results: At 6 months, mean hand pain was 5.49 points in the placebo group and 5.66 points in the hydroxychloroquine group, with a treatment difference of 0.16 point (95% CI, 0.73 to 0.40 point) (P = 0.57). Results were robust to adjustments for adherence, missing data, and use of rescue medication. No significant treatment differences existed at 3, 6, or 12 months for any secondary outcomes. The percentage of participants with at least 1 joint with synovitis was 94% (134 of 143) on grayscale ultrasonography and 59% on power Doppler. Baseline structural damage or synovitis did not affect treatment response. Fifteen serious adverse events were reported (7 in the hydroxychloroquine group [3 defined as possibly related] and 8 in the placebo group). Limitation: Hydroxychloroquine dosage restrictions may have reduced efficacy. Conclusion: Hydroxychloroquine was no more effective than placebo for pain relief in patients with moderate to severe hand pain and radiographic osteoarthritis.
Author(s): Kingsbury SR, Tharmanathan P, Keding A, Ronaldson SJ, Grainger A, Wakefield RJ, Arundel C, Birrell F, Doherty M, Vincent T, Watt FE, Dziedzic K, O'Neill TW, Arden NK, Scott DL, Dickson J, Garrood T, Green M, Menon A, Sheeran T, Torgerson D, Conaghan PG
Publication type: Article
Publication status: Published
Journal: Annals of Internal Medicine
Year: 2018
Volume: 168
Issue: 6
Pages: 385-395
Print publication date: 20/03/2018
Online publication date: 20/02/2018
Acceptance date: 02/04/2018
ISSN (print): 0003-4819
ISSN (electronic): 1539-3704
Publisher: American College of Physicians
URL: https://doi.org/10.7326/M17-1430
DOI: 10.7326/M17-1430
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