Nugteren‐Huying 1990.
Study characteristics | ||
Methods | RCT, active/placebo‐controlled, double‐blind Date of study: not stated Setting: multicentre in the Netherlands |
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Participants |
Randomised: 39 participants (mean age 44 years, 27 male) Inclusion criteria
Exclusion criteria
Dropouts and withdrawals
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Interventions |
Intervention A. Dimethylfumarate (n = 12), orally, 120 mg, gradual increase 1 ‐ 6 tablets, once a day, 16 weeks Control intervention B. Octyl hydrogen fumarate (n = 10), orally, 284 mg, gradual increase 1 ‐ 6 tablets, once a day, 16 weeks C. Placebo (n = 12), orally, once a day, 16 weeks |
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Outcomes | Assessments at 16 weeks Primary outcomes of the trial
Secondary outcomes of the trial
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Notes | Funding source: not stated Declarations of interest: not stated |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote (p 331): "The patients were randomly assigned..." Comment: no description of the method used to guarantee random sequence generation |
Allocation concealment (selection bias) | Unclear risk | Quote (p 331): "The patients were randomly assigned..." Comment: no description of the method used to guarantee allocation concealment |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote (p 331): “The double‐blind treatment lasted 16 weeks for each patients... All tablets (provided by Fumapharm AG, Muri, Switzerland) had the same appearance, size and colour” Comment: probably done |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote (p 331): “The double‐blind treatment lasted 16 weeks for each patients...All tablets (provided by Fumapharm AG, Muri, Switzerland) had the same appearance, size and color” Comment: probably done |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Randomly assigned 39, analysed 34 Comment: no description of the method used to perform analyses of the primary outcome and to manage missing data |
Selective reporting (reporting bias) | Unclear risk | Comment: no protocol was available. The prespecified outcomes mentioned in the Methods section appeared to have been reported |