2. Oral creatine versus placebo outcomes (Wong 2007).
Creatine | Placebo | Difference (95% CI) | P value | |
All ages | ||||
Number of participants randomised | 27 | 28 | — | — |
Number (%) of participants evaluable for analysis disability | 18 (67%) | 22 (79%) | — | — |
Median change in disability score (GMFM) | 0 | ‐1 | 1 (‐1 to 2) | 0.19 |
Number (%) of participants evaluable for analysis QoL | 17 (63%) | 21 (75%) | — | — |
Median change in quality of life (PedsQL, neuromuscular module) | ‐5 | 2 | ‐7 (‐11 to 3) | 0.31 |
Age 2 to 5 years | ||||
Number of participants randomised | 8 | 12 | — | — |
Number (%) of participants evaluable for analysis disability | 7 (88%) | 10 (83%) | — | — |
Median change in disability score (GMFM) | 1 | ‐2 | 1.5 (‐4 to 9) | 0.18 |
Number (%) of participants evaluable for analysis QoL | 6 (75%) | 9 (75%) | — | — |
Median change in QoL (PedsQL, neuromuscular module) | 4.5 | 3 | 2 (‐8 to 13) | 0.71 |
Age 5 to 18 years | ||||
Number of participants randomised | 19 | 16 | — | — |
Number (%) of participants evaluable for analysis disability and QoL | 11 (58%) | 12 (75%) | — | — |
Median change in disability score (GMFM) | ‐1 | ‐0.5 | 0 (‐2 to 2) | 0.77 |
Number (%) of participants evaluable for analysis QoL | 11 (58%) | 12 (75%) | — | — |
Median change in quality of life (PedsQL, neuromuscular module) | ‐6 | 0 | ‐6 (‐15 to 2) | 0.11 |
Number (%) of participants evaluable for analysis of muscle strength | 11 (58%) | 11 (69%) | — | — |
Mean (SD) change in arms muscle strength (QMT) | ‐0.34 (6.98) | 1.49 (8.50) | ‐1.83 (‐8.75 to 5.09) | 0.59 |
Mean (SD) change in legs muscle strength (QMT) | 1.51 (4.21) | 0.93 (3.06) | 0.58 (‐2.70 to 3.85) | 0.72 |
Mean (SD) change in total muscle strength (QMT) | 1.17 (9.67) | 2.42 (10.3) | ‐1.25 (‐10.1 to 7.6) | 0.77 |
Number (%) of participants evaluable for analysis pulmonary function | 11 (58%) | 12 (75%) | — | — |
Mean (SD) change in pulmonary function (FVC % of predicted value in litres) | ‐0.27 (14.5) | ‐0.83 (11.5) | 0.56 (‐10.75 to 11.87) | 0.92 |
Creatine | Placebo | Risk ratio (95% CI) | P value | |
All ages | ||||
Number of adverse events | 55 | 43 | — | — |
Number of participants with adverse events | 13/27 | 16/28 | 0.84 (0.51 to 1.40) | 0.59 |
Number of severe adverse events | NA | NA | — | — |
Number of participants with severe adverse events | NA | 1 (death by respiratory failure) | — | — |
CI: confidence interval; FVC: forced vital capacity; GMFM: Gross Motor Function Measure; NA: not available; PedsQL: Pediatric Quality of Life Inventory; QMT: quantitative muscle test; QoL: quality of life; SD: standard deviation.