A systematic review and meta-analysis of the response to placebo in clinical trials of inclusion body myositis
Authors' conclusion
Participants with IBM displayed a measurable decline in their muscle strength and IBMFRS during clinical trials, in keeping with the disease's slowly progressive nature.
Study context
- Population
- IBM patients receiving placebo in clinical trials
- Participants
- 257 patients11 trials
- Outcome
- Change in muscle strength (SMD) and IBMFRS (MD) in placebo recipients
Methodological detailsrandomised, double-blinded, placebo-controlled trials, DerSimonian-Laird random effects models, meta-regression
- Randomised, double-blinded, placebo-controlled trials
- DerSimonian-Laird random effects models
- Meta-regression
Pooled result
As reported in the abstract
Change in muscle strength (pooled SMD)
Mean effect size (SMD), 95% CI −0.652, −0.144, P = 0.002
−0.398
SMD change per week (−0.016, −0.002), P = 0.015
−0.009
Further pooled results
Pooled change in IBM Functional Rating Scale (IBMFRS) (0 to 40-point scale) · 12 months
- Pooled change, points (−3.893, −0.485), P = 0.012
- −2.189
- Only three studies reported IBMFRS
- Relatively high heterogeneity
Heterogeneity by strength-testing method
- Manual muscle testing I2
- 67.68%
- Quantitative muscle testing I2
- 0%
Original publication
A systematic review and meta-analysis of the response to placebo in clinical trials of inclusion body myositis. Rheumatology (Oxford). Published 14 March 2025. doi:10.
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