Methods | Randomised, double blind, parallel group, no enriched enrolment. 1-week titration for 300/600 mg (withdrawing those not able to reach target dose) (12 weeks total) | |
Participants | Painful diabetic neuropathy for more than 1 year, and pain at least 40/100 mm. Mean age 59 years, 44% female, 96% white | |
Interventions | Pregabalin 150 mg daily, n = 99 Pregabalin 300 mg daily, n = 99 Pregabalin 600 mg daily, n = 101 Placebo daily, n = 96 |
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Outcomes | Proportion of patients with ≥ 50% decrease in mean pain score between endpoint and baseline, and other outcomes | |
Notes | Oxford quality score: R1, D1, W1 = 3/5 Pfizer sponsored |
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Risk of bias | ||
Item | Authors’ judgement | Description |
Adequate sequence generation? | Unclear | Stated to be randomised |
Allocation concealment? | Unclear | Not described |
Blinding? All outcomes |
Unclear | Stated to be double blind |