Methods | Randomised, double blind, parallel group, partial enriched enrolment. No titration (8 weeks in total) | |
Participants | Painful diabetic neuropathy for 1-5 years, and pain at least 40/100 mm. Mean age 60 years, 56% female, 88% white | |
Interventions | Pregabalin 300 mg daily, n = 76 Placebo daily, n = 70 |
|
Outcomes | Proportion of patients with ≥ 50% decrease in mean pain score between endpoint and baseline, and other outcomes | |
Notes | Oxford quality score: R2, D1, W1 = 4/5 Pfizer sponsored |
|
Risk of bias | ||
Item | Authors’ judgement | Description |
Adequate sequence generation? | Yes | “randomisation schedule” |
Allocation concealment? | Unclear | Not described |
Blinding? All outcomes |
Unclear | Not adequately described |