Methods | Randomised, double blind, parallel group, partial enriched enrolment. Initial dose titration before fixed dose for 450 mg only (8 weeks in total) | |
Participants | Fibromyalgia according to ACR classification and pain of at least 40/100 mm in week before randomisation. Mean age 49 years, 92% female, 93% white | |
Interventions | Pregabalin 150 mg daily, n = 132 Pregabalin 300 mg daily, n = 134 Pregabalin 450 mg daily, n = 132 Placebo daily, n = 131 |
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Outcomes | Proportion of patients with ≥ 30% or ≥ 50% decrease in mean pain score between endpoint and baseline, and other outcomes | |
Notes | Oxford quality score: R2, D1, W1 = 4/5 Pfizer sponsored |
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Risk of bias | ||
Item | Authors’ judgement | Description |
Adequate sequence generation? | Yes | “computer generated code” |
Allocation concealment? | Unclear | Not described |
Blinding? All outcomes |
Unclear | Stated to be double blind |