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Predictors of a placebo response in patients with hand osteoarthritis: post-hoc analysis of two randomized controlled trials.


ABSTRACT:

Background

Placebo 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.

Methods

This 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.

Results

The 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).

Conclusions

High 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.

SUBMITTER: Park JK 

PROVIDER: S-EPMC7934539 | biostudies-literature | 2021 Mar

REPOSITORIES: biostudies-literature

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Publications

Predictors of a placebo response in patients with hand osteoarthritis: post-hoc analysis of two randomized controlled trials.

Park Jin Kyun JK   Ahn Se Han SH   Shin Kichul K   Lee Yun Jong YJ   Song Yeong Wook YW   Lee Eun Bong EB  

BMC musculoskeletal disorders 20210304 1


<h4>Background</h4>Placebo 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.<h4>Methods</h4>This 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 w  ...[more]

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