Abstract
BackgroundPlacebo can have a significant therapeutic effect in patients with hand osteoarthritis (OA). This aim of the study is to identify factors associated with a clinically meaningful placebo response in patients with hand OA.MethodsThis post-hoc analysis of two double-blind, placebo-controlled, randomized trials (RCTs) investigating the efficacy of GCSB-5 or diacerein as treatments for hand OA analyzed the efficacy of a placebo. Clinical and laboratory factors associated with a clinically meaningful response, defined as an improvement in the Australian/Canadian Osteoarthritis Hand Index (AUSCAN) pain score > 10 at 4 weeks relative to baseline, were identified.ResultsThe mean improvement in the AUSCAN pain score was − 6.0 ± 20.3, with marked variation between 143 hand OA patients (range: − 76.4 to 33.2). A clinically meaningful improvement was observed in 54 (37.8%) patients. Placebo responders had worse AUSCAN pain scores (55.7 ± 19.7 vs. 43.6 ± 21.6, p = 0.001) and a worse AUSCAN stiffness (68.2 ± 20.5 vs. 57.5 ± 24.5, p = 0.008) at baseline than non-responders. Improvements in pain correlated with the baseline pain level (Pearson r = − 427, p < 0.001). Structural joint changes such as tender, swollen, enlarged, or deformed joint counts did not differ between placebo responders and non-responders. In a multivariable analysis, only baseline AUSCAN pain was associated with a clinically meaningful placebo response (OR: 1.054, 95% CI [1.019–1.089], p = 0.002).ConclusionsHigh levels of pain at baseline are predictive of a clinically meaningful placebo response in patients with hand OA. Further studies are needed to optimize and utilize the benefit of placebo responses in patients with hand OA.
Highlights
Placebo can have a significant therapeutic effect in patients with hand osteoarthritis (OA)
In the first randomized clinical placebo-controlled trial (RCT), 220 patients with hand OA according to the 1990 American College of Rheumatology (ACR) criteria for hand OA [15], all of whom were aged > 40 years and had pain exceeding 30/100 mm on a visual analog scale in the preceding 48 h, were randomly assigned to receive oral GCSB-5 (600 mg) or placebo twice a day for 12 weeks [10]
The post-hoc analysis included 102 patients with hand OA that were in the placebo group of the first RCT and 41 patients that were in the placebo group of the second RCT; patients with available clinical and laboratory parameters at baseline and at Week 4 were included in the analysis group (n = 143) (Fig. 1)
Summary
Placebo can have a significant therapeutic effect in patients with hand osteoarthritis (OA). Oral nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen, or opioid-based analgesics constitute the mainstay of treatment targeting pain control. Inflammatory cytokines such as interleukin-1 (IL-1), tumor necrosis factor alpha (TNF-α) may contribute to the degeneration of articular cartilage matrix [5]. A short-term treatment with low dose corticosteroid improved pain and signs of inflammation in patients who experience a flare-up of hand OA [6] They and other medications, including anti-tumor necrosis factor inhibitors and antiinterleukin-1 antibody, show only minimal to moderate effect sizes, emphasizing an unmet need for better treatment modalities for hand OA [7,8,9]
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