Arnold 2014.
Methods | 13‐week multicentre, controlled‐release, double‐blind, placebo‐controlled, EERW trial | |
Participants | Fibromyalgia according to ACR classification and pain diary score ≥ 4 on 11‐point numerical rating scale N = 441 entered titration phase, 121 randomised to double‐blind phase Mean age 50 years, 91% female, 90% white Baseline mean pain score: 6.8/10 |
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Interventions | 4 phases: 1) baseline (1 week), 2) single‐blind (participants were blinded) treatment (6 weeks), 3) double‐blind treatment (13 weeks), and 4) a double‐blind taper period (1 week) Pregabalin controlled release 330 to 495 mg daily, n = 63 Placebo, n = 58 |
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Outcomes | PI on an 11‐point numerical rating scale, using daily pain diary Adverse events Withdrawals |
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Notes | Pfizer sponsored Oxford Quality Score: R2, DB2, W1. Total = 5/5 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described, "randomly assigned" |
Allocation concealment (selection bias) | Low risk | "telephone using the Interactive Voice Recognition System (IVRS)" |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Stated to be double blind. Used a matching placebo |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Stated to be double blind. Used a matching placebo |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants included in analysis |
Selective reporting (reporting bias) | Low risk | All relevant outcomes reported |
Size | Unclear risk | 50 to 199 participants per treatment arm (58, 63) |