Groeneveld 2003.
| Methods | Randomized, double‐blind, placebo‐controlled | |
| Participants | The Netherlands N = 175 (creatine ‐ 88, placebo ‐ 87) Mean age: 57.1 (creatine), 58.4 (placebo) Gender distribution, male (%): 56% (creatine), 62% (placebo) Family history of ALS: 1.1% (creatine), 6.9% (placebo) |
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| Interventions | Creatine or placebo (Polycose, an odorless glucose polymer) 5 g twice daily |
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| Outcomes | Primary: event‐free survival, where 'events' included death from any cause, tracheostomy and persistent assisted ventilation Secondary: rate of decline of MVCI strength of 8 muscle groups in the arms (bilateral shoulder and elbow, flexion and extension), rate of decline of vital capacity, rate of decline of ALSFRS‐R, physical and mental summary scores of the Short Form‐36 (SF‐36) |
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| Notes | Support from the Dammers Fonds, the ALS Onderzoeksfonds and the Royal Netherlands Academy of Arts and Sciences | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Adequate sequence generation? | Low risk | Randomization was performed by an independent physician according to the minimization method of Pocock and Zelen |
| Allocation concealment? | Low risk | After having allocated a trial participant to 1 of 2 treatment groups, Groups A or B, the independent physician, ignorant to whether A or B was creatine, would instruct the research pharmacist to prepare trial medication A or B. The research pharmacist was the only person who knew the trial code of A or B |
| Blinding? All outcomes | Low risk | "... to receive creatine monohydrate ... or the same dose of Polycose, an odorless glucose polymer resembling creatine monohydrate in color and form" Trial medication was packed in blank containers and handed out at the coordinating site to the trial nurse, who delivered the trial medication to the participants |
| Incomplete outcome data addressed? All outcomes | Low risk | The final analysis included the results of all 175 participants |
| Free of selective reporting? | Low risk | Results for all primary and secondary outcome measures reported |
| Free of other bias? | High risk | Small number of familial ALS participants |