1. For radiographic osteoarthritis and hand pain that is moderate to severe, hydroxychloroquine (HCQ) does not show any greater effectiveness than placebo for reducing overall hand pain.
2. There was also no significant difference between HCQ and placebo for secondary end points including function, grip strength, radiographic structural damage, and quality of life.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Up to 31% of adults over 70 years of age are affected by symptomatic hand osteoarthritis, which can cause chronic pain and problems with completing daily activities. Unfortunately, there are few effective treatments, which has led to some off-label use of HCQ to treat osteoarthritis. In a randomized controlled trial, researchers compared the effectiveness of HCQ to placebo as an analgesia for hand osteoarthritis. Patients (n = 248) with symptomatic and radiographic hand osteoarthritis were randomly assigned to HCQ (200 to 400 mg) or placebo for 12 months along with usual care. At 6 months, HCQ did not show any greater effectiveness for the primary end point of average hand pain for the 2-week duration prior to data collection. There was also no significant difference between HCQ and placebo for secondary end points including function, grip strength, radiographic structural damage, and quality of life. These study results do not support the use of HCQ for treating hand osteoarthritis.
A strength of the study is that it provides data for an off-label treatment method for which there is limited information regarding efficacy. A limitation of the study is that dosage restrictions for HCQ may have decreased efficacy.
In-Depth [randomized controlled trial]: Patients were recruited from 13 National Health Service hospitals located in England. Researchers screened 316 patients and enrolled 248 patients with hand osteoarthritis of at least moderate severity. Moderate severity was defined as hand pain rated ≥4 on a visual analogue scale ranging from 0 to 10 points. Participants also met American College of Rheumatology osteoarthritis criteria and had radiographic changes within the past 5 years that were consistent with osteoarthritis.
Of the participants, 82% were women, and the mean age was 62.7 years. To evaluate the effectiveness of HCQ compared to placebo as an analgesia for hand osteoarthritis, patients were randomly assigned to HCQ (200, 300, or 400 mg based on body weight for a dose no greater than 6.5 mg/kg per day) or placebo for 12 months along with usual care. At 6 months, the primary end point of average hand pain was measured (on a scale from 0 to 10) for the 2-week duration prior to data collection. For the placebo and HCQ group, the average hand pain at 6 months was 5.49 and 5.66, respectively. This end point was also measured at baseline, 3 months, and 12 months. Between baseline and 3 months, patients in both groups had improvement in severity of hand pain by approximately 1 point. This improvement was continued up to 12 months. There was no significant difference between HCQ and placebo for secondary end points at 3, 6, or 12 months. Seven patients in the HCQ group reported serious adverse events (AEs), with three events determined to be HCQ-related. Eight patients in the placebo group reported serious AEs.
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