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Hydroxychloroquine effectiveness in reducing symptoms of hand osteoarthritis (HERO): study protocol for a randomized controlled trial.

Kingsbury SR, Tharmanathan P, Adamson J, Arden NK, Birrell F, Cockayne S, Dickson J, Doherty M, Dziedzic KS, Grainger A, Hewitt CE, O'Neill TW, Scott DL, Vincent TL, Wakefield RJ, Watt FE, Torgerson DJ, Conaghan PG - Trials (2013)

Bottom Line: Osteoarthritis (OA) is the most common type of arthritis, causing significant joint pain and disability.We propose that treating patients with symptomatic hand OA with hydroxychloroquine will be a practical and safe treatment to reduce synovitis and pain.ISRCTN91859104.

View Article: PubMed Central - HTML - PubMed

Affiliation: Division of Rheumatic and Musculoskeletal Disease and National Institute of Health Research (NIHR) Leeds Musculoskeletal Biomedical Research Unit, University of Leeds, Leeds LS7 4SA, UK.

ABSTRACT

Background: Osteoarthritis (OA) is the most common type of arthritis, causing significant joint pain and disability. It is already a major cause of healthcare expenditure and its incidence will further increase with the ageing population. Current treatments for OA have major limitations and new analgesic treatments are needed. Synovitis is prevalent in OA and is associated with pain. Hydroxychloroquine is used in routine practice for treating synovitis in inflammatory arthritides, such as rheumatoid arthritis. We propose that treating patients with symptomatic hand OA with hydroxychloroquine will be a practical and safe treatment to reduce synovitis and pain.

Methods/design: HERO is an investigator-initiated, multicentre, randomized, double-blind, placebo-controlled trial. A total of 252 subjects with symptomatic hand OA will be recruited across primary and secondary care sites in the UK and randomized on a 1:1 basis to active treatment or placebo for 12 months. Daily medication dose will range from 200 to 400 mg according to ideal body weight. The primary endpoint is change in average hand pain during the previous two weeks (measured on a numerical rating scale (NRS)) between baseline and six months. Secondary endpoints include other self-reported pain, function and quality-of-life measures and radiographic structural change at 12 months. A health economics analysis will also be performed. An ultrasound substudy will be conducted to examine baseline levels of synovitis. Linear and logistic regression will be used to compare changes between groups using univariable and multivariable modelling analyses. All analyses will be conducted on an intention-to-treat basis.

Discussion: The HERO trial is designed to examine whether hydroxychloroquine is an effective analgesic treatment for OA and whether it provides any long-term structural benefit. The ultrasound substudy will address whether baseline synovitis is a predictor of therapeutic response. This will potentially provide a new treatment for OA, which could be of particular use in the primary care setting.

Trial registration: ISRCTN91859104.

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Related in: MedlinePlus

Overview of systematic review of hydroxychloroquine use in osteoarthritis. Databases: PubMed, MEDLINE and Embase. Search terms: MeSH headings #1 ‘osteoarthritis’ and #2 ‘hydroxychloroquine’ or ‘chloroquine’. Limits: Humans.
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Figure 1: Overview of systematic review of hydroxychloroquine use in osteoarthritis. Databases: PubMed, MEDLINE and Embase. Search terms: MeSH headings #1 ‘osteoarthritis’ and #2 ‘hydroxychloroquine’ or ‘chloroquine’. Limits: Humans.

Mentions: Although hydroxychloroquine has been used on an anecdotal basis for the treatment of OA, there have been few studies to assess its efficacy and these studies have contained only small numbers of patients. A summary of these studies is presented in Figure 1 and Table 1. The small numbers of patients, different inclusion criteria and outcome measures used in these trials allow limited conclusions to be drawn. However, the reported improvement in patient symptoms compared with control arms in the majority of these studies suggests a need for a properly designed and well-powered trial to be performed.


Hydroxychloroquine effectiveness in reducing symptoms of hand osteoarthritis (HERO): study protocol for a randomized controlled trial.

Kingsbury SR, Tharmanathan P, Adamson J, Arden NK, Birrell F, Cockayne S, Dickson J, Doherty M, Dziedzic KS, Grainger A, Hewitt CE, O'Neill TW, Scott DL, Vincent TL, Wakefield RJ, Watt FE, Torgerson DJ, Conaghan PG - Trials (2013)

Overview of systematic review of hydroxychloroquine use in osteoarthritis. Databases: PubMed, MEDLINE and Embase. Search terms: MeSH headings #1 ‘osteoarthritis’ and #2 ‘hydroxychloroquine’ or ‘chloroquine’. Limits: Humans.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3716636&req=5

Figure 1: Overview of systematic review of hydroxychloroquine use in osteoarthritis. Databases: PubMed, MEDLINE and Embase. Search terms: MeSH headings #1 ‘osteoarthritis’ and #2 ‘hydroxychloroquine’ or ‘chloroquine’. Limits: Humans.
Mentions: Although hydroxychloroquine has been used on an anecdotal basis for the treatment of OA, there have been few studies to assess its efficacy and these studies have contained only small numbers of patients. A summary of these studies is presented in Figure 1 and Table 1. The small numbers of patients, different inclusion criteria and outcome measures used in these trials allow limited conclusions to be drawn. However, the reported improvement in patient symptoms compared with control arms in the majority of these studies suggests a need for a properly designed and well-powered trial to be performed.

Bottom Line: Osteoarthritis (OA) is the most common type of arthritis, causing significant joint pain and disability.We propose that treating patients with symptomatic hand OA with hydroxychloroquine will be a practical and safe treatment to reduce synovitis and pain.ISRCTN91859104.

View Article: PubMed Central - HTML - PubMed

Affiliation: Division of Rheumatic and Musculoskeletal Disease and National Institute of Health Research (NIHR) Leeds Musculoskeletal Biomedical Research Unit, University of Leeds, Leeds LS7 4SA, UK.

ABSTRACT

Background: Osteoarthritis (OA) is the most common type of arthritis, causing significant joint pain and disability. It is already a major cause of healthcare expenditure and its incidence will further increase with the ageing population. Current treatments for OA have major limitations and new analgesic treatments are needed. Synovitis is prevalent in OA and is associated with pain. Hydroxychloroquine is used in routine practice for treating synovitis in inflammatory arthritides, such as rheumatoid arthritis. We propose that treating patients with symptomatic hand OA with hydroxychloroquine will be a practical and safe treatment to reduce synovitis and pain.

Methods/design: HERO is an investigator-initiated, multicentre, randomized, double-blind, placebo-controlled trial. A total of 252 subjects with symptomatic hand OA will be recruited across primary and secondary care sites in the UK and randomized on a 1:1 basis to active treatment or placebo for 12 months. Daily medication dose will range from 200 to 400 mg according to ideal body weight. The primary endpoint is change in average hand pain during the previous two weeks (measured on a numerical rating scale (NRS)) between baseline and six months. Secondary endpoints include other self-reported pain, function and quality-of-life measures and radiographic structural change at 12 months. A health economics analysis will also be performed. An ultrasound substudy will be conducted to examine baseline levels of synovitis. Linear and logistic regression will be used to compare changes between groups using univariable and multivariable modelling analyses. All analyses will be conducted on an intention-to-treat basis.

Discussion: The HERO trial is designed to examine whether hydroxychloroquine is an effective analgesic treatment for OA and whether it provides any long-term structural benefit. The ultrasound substudy will address whether baseline synovitis is a predictor of therapeutic response. This will potentially provide a new treatment for OA, which could be of particular use in the primary care setting.

Trial registration: ISRCTN91859104.

Show MeSH
Related in: MedlinePlus