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. 2015 Jun 30;2015(6):CD001555. doi: 10.1002/14651858.CD001555.pub5

Summary of findings for the main comparison. Intravenous immunoglobulin versus placebo for inclusion body myositis.

Intravenous immunoglobulin versus placebo for inclusion body myositis
Patient or population: people with inclusion body myositis
 Settings:Intervention: intravenous immunoglobulin
 Comparison: placebo
Outcomes Illustrative comparative risks* (95% CI) Relative effect
 (95% CI) No of participants
 (studies) Quality of the evidence
 (GRADE) Comments
Assumed risk Corresponding risk
Placebo Intravenous immunoglobulin
Change in muscle strength at 6 months (%) Not estimable Not estimable Not estimable 78
 (3 studies) See comment 2 of the 3 studies assessed change in muscle strength at 3 months and the other at 6 months. Data were not suitable for meta‐analysis.
Change in muscle strength at 12 months (%) ‐ not measured
Change in muscle mass at 6 months (%) ‐ not measured
Change in handgrip strength at 6 months (%) ‐ not measured
Change in timed walk at 6 months (%)
e.g. 10‐metre or 6‐minute walk test at 6 months ‐ not measured
Significant adverse events Not estimable Not estimable Not estimable 78 (3 studies) See comment Dalakas 1997: unclear whether dropouts from treatment or placebo group. Dalakas 2001: treatment group withdrawals = 0; placebo group withdrawals = 1. Walter 2000: 2 withdrawals but unspecified whether from treatment or placebo group
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
 CI: confidence interval
GRADE Working Group grades of evidence
 High quality: Further research is very unlikely to change our confidence in the estimate of effect.
 Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
 Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
 Very low quality: We are very uncertain about the estimate.