| Methods |
Randomised, double‐blind, placebo‐controlled cross‐over study |
| Participants |
16 participants with different mitochondrial disorders (3 CPEO, 1 KSS, 3 MELAS, 1 MNGIE, 3 with mitochondrial disorders due to rare point mutations (m.9053T>C, m.4452T>C and m.9035T>C)) |
| Interventions |
Combination of 3 g creatine monohydrate with 2 g of dextrose, 300 mg alpha‐lipoic acid, and 120 mg coenzyme Q10 |
| Outcomes |
Handgrip, ankle dorsiflexion (at 90°) and knee extension, forced vital capacity and forced expiratory volume, free fat mass, percentage body fat and total body water, plasma lactate, urinary 8‐isoprostanes and 8‐hydroxy‐2‐deoxyguanosine |
| Notes |
Across the whole study group, the treatment statistically significantly lowered plasma lactate and urinary 8‐isoprostanes, and there was evidence it attenuated the decline in peak angle dorsiflexion strength |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Method of randomisation not specified |
| Allocation concealment (selection bias) |
Unclear risk |
Method of allocation not specified |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Incomplete outcome data adequately addressed |
| Selective reporting (reporting bias) |
Low risk |
All outcome measures in methods section were reported in results section |
| Other bias |
Low risk |
None identified |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
In this double‐blind study, placebo provided as "identical‐appearing and tasting powder... and gel capsules." |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Participants were randomly assigned to start in either the treatment or placebo arm |