8. Subcutaneous somatotropin versus placebo outcomes (Kirschner 2014).
| Total number of participants randomised (cross‐over setting) | 20 | — | — | |
| Somatropin | Placebo | Difference (95% CI) | P value | |
| Number of participants completing phase 1 of study protocol | 9/10 | 10/10 | — | — |
| Number of participants completing phase 2 of study protocol | 8/10 | 9/10 | — | — |
| Number (%) of participants evaluable for intention‐to‐treat analysis | 17 (90%) | 17 (80%) | — | — |
| Mean (SD) change in muscle strength of upper limb (hand‐held myometry in megascore of biceps and handgrip) (Newton) | ‐1.05 (6.42) | 0.30 (10.6) | ‐1.35 (‐7.12 to 4.42) | 0.97 |
| Number (%) of participants evaluable for analysis disability score (HFMSE) | 19 (95%) | 19 (95%) | — | — |
| Median (SD) change in disability score (HFMSE) | 0.05 (3.19) | ‐1.05 (5.28) | 0.25 (‐1 to 2.5) | 0.58 |
| Number (%) of participants evaluable for analysis arm megascore | 19 (95%) | 19 (95%) | — | — |
| Mean (SD; range) change in arm megascore (Newton) | ‐1.05 (6.42; ‐11 to 19) | 0.30 (10.60; ‐18 to 34.3) | 0.08 (‐3.79 to 3.95) | 0.97 |
| Number (%) of participants evaluable for analysis leg megascore | 19 (95%) | 19 (95%) | — | — |
| Mean (SD; range) change in leg megascore (Newton) | 2.96 (7.64; ‐10 to 24.5) | 0.95 (9.93; ‐18 to 22) | 2.23 (‐2.19 to 6.63) | 0.30 |
| Number (%) of participants evaluable for analysis muscle strength (MRC) | 19 (95%) | 19 (95%) | — | — |
| Mean (SD) change MRC (% of maximum score) | ‐2.31 (5.1) | 0.43 (7.0) | ‐2.74 (‐6.7 to 1.29) | 0.19 |
| Number (%) of participants evaluable for analysis pulmonary function (FVC) | 19 (95%) | 19 (95%) | — | — |
| Mean (SD; range) change in pulmonary function (FVC improvement in litres) | 0.12 (0.25; ‐0.4 to 0.5) | ‐0.11 (0.40; ‐1.4 to 0.36) | 0.23 (‐0.01 to 0.45) | 0.08 |
| Somatropin | Placebo | Risk Ratio (95% CI) | P value | |
| Number of adverse events | 14 | 9 | — | — |
| Number of participants with adverse events | 11 | 7 | 1.57 (0.78 to 3.17) | 0.34 |
| Number (%) of participants discontinued intervention | 3 (15%) | 0 (0%) | — | — |
CI: confidence interval; FVC: forced vital capacity; HFMSE: Hammersmith Functional Motor Scale Expanded; MRC: Medical Research Council; SD: standard deviation.