Summary of findings 3. Methotrexate compared to placebo for inclusion body myositis.
| Methotrexate compared to placebo for inclusion body myositis | ||||||
| Patient or population: people with inclusion body myositis Settings: Intervention: methotrexate 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 | Methotrexate | |||||
| Change in muscle strength at 6 months (%) | Not estimable | Not estimable | Not estimable | 44 (1 study) | See comment | Data collected at 12 months only |
| Change in muscle strength at 12 months (%) ‐ MMT | The mean change in muscle strength (%) in the control group was ‐2.0% | The mean change in muscle strength (%) in the intervention group was 1.5% higher (1.0 lower to 3.9 higher) |
‐ | 44 (1 study) | ⊕⊕⊝⊝ moderate1 | MD in mean change based on intention‐to‐treat data. Per protocol: MD 1.6%, 95% CI ‐2.3 to 5.4. This study was assessed as having a low overall risk of bias. |
| 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 | 43 per 1000 | 381 per 1000 (52 to 1000) | RR 8.76 (1.19 to 64.28) | 44 (1 study) | ⊕⊕⊝⊝ moderate2 |
Badrising 2002: treatment group withdrawals = 8/21; placebo group withdrawals = 1/23 |
| *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; MMT: manual muscle testing; RR: risk ratio | ||||||
| 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. | ||||||
1 Downgraded for imprecision. The single randomised controlled trial of methotrexate was insufficiently powered to exclude a possible benefit from methotrexate.
2 Downgraded for imprecision.