Methods |
Randomised, double‐blind, placebo‐controlled cross‐over trial |
Participants |
15 participants with mitochondrial cytopathies (mean age 49 ± 9 years) |
Interventions |
Creatine 0.15 g/kg daily versus placebo
Each treatment phase lasted 6 weeks
4‐week washout period |
Outcomes |
Isometric maximum voluntary contraction of the calf muscles
Tensiometric hand grip test
P‐31 MRS during calf muscle ergometric test (aerobic and ischaemic exercise at 30% of MVC)
Skeletal muscle function assessed by modified Boston score
Subjective endurance performance and general physical condition using individual rating scales
Creatine and creatinine plasma levels |
Notes |
|
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
A computer random number generator was used |
Allocation concealment (selection bias) |
Low risk |
Central allocation by hospital pharmacy |
Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Blinding of participants and study personnel. Capsules used for administration of creatine and placebo were identical in appearance |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Reasons for missing outcome data unlikely to be related to true outcome |
Selective reporting (reporting bias) |
Low risk |
All of the study's pre‐specified outcomes that are of interest in the review have been reported |
Other bias |
Low risk |
The study appears to be free of other sources of bias |