Summary of findings 6. Oxandrolone compared to placebo for inclusion body myositis.
Oxandrolone compared to placebo for inclusion body myositis | ||||||
Patient or population: people with inclusion body myositis Settings: Intervention: oxandrolone 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 | Oxandrolone | |||||
Change in muscle strength at 6 months (%) | Not estimable | Not estimable | Not estimable | 16 (1 study) | See comment | Data collected at 12 months only; re‐scaling of data not performed due to uncertainty in the assumption of linear change. There were also insufficient data to calculate percentage change in muscle strength. This study was graded as having an unclear risk of bias |
Change in muscle strength at 12 months (%) ‐ not measured | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ |
Change in muscle mass at 6 months (%) | Not estimable | Not estimable | Not estimable | 16 (1 study) | See comment | Data collected at 12 months only; rescaling of data not performed due to uncertainty in the assumption of linear change. |
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 | Not estimable | See comment | Rutkove 2002: treatment group withdrawals = 1; placebo group withdrawals = 2 |
*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. |