Desnuelle 2001.
| Methods | Randomized, placebo controlled, double‐blind study Duration: 12 months | |
| Participants | Country: France Multicentre: 28 sites Diagnosis: probable or definite ALS by El Escorial criteria Number of participants: 288 (144 treated, 144 placebo, 55% male) Age: mean 64 years Inclusion criteria: to have been treated with riluzole for at least 3 months without side effects Exclusion criteria: dementia and/or major psychiatric disorders, or other serious disease or handicap, forced vital capacity less than 60%, monoclonal gammopathy, conduction blocks, abnormal liver function tests as defined, taking vitamin E or hepatotoxic drugs | |
| Interventions | 1. a‐tocopherol (500 mg capsules twice daily, Toco 500) plus riluzole 50 mg twice daily 2. placebo twice daily (identically‐appearing capsules) plus riluzole 50 mg twice daily | |
| Outcomes | Primary: the change in functional status of each patient using the modified Norris limb scale Secondary: included survival, bulbar function assessed with the Norris bulbar scale, manual muscle testing Fatigue, limb stiffness, cramps and fasciculations were assessed using visual analogue scales. Respiratory function, quality of life using the Sickness Impact Profile, the ALS Health State scale. Biological markers of oxidative stress ‐ plasma thiobarbituric acid, erythrocyte superoxide dismutase, erythrocyte glutathione peroxidase ‐ in a subgroup of 122 patients | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "patients were randomly assigned to one of the two treatment groups according to a randomization schedule prepared by Labaratoire Rhone‐Poulenc Rorer (now trading under the name Laboratoire Aventis" Comment: probably adequate |
| Allocation concealment (selection bias) | Unclear risk | Comment: probably adequate |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | "double blind, placebo controlled". "identically appearing capsules, bid, Rhone‐Poulenc Rorer" Comment: probably adequate |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | "Intent to treat population which included all randomized patients who had received at least one treatment dose" |
| Selective reporting (reporting bias) | Low risk | Appears adequate |
| Other bias | Low risk | Appears adequate |