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. 2017 Jun 9;2017(6):CD007938. doi: 10.1002/14651858.CD007938.pub4

Cohen 2015.

Methods Multicentre, randomised, double‐blind (double‐dummy), active‐controlled, parallel groups, partial enrichment. Titration to maximum tolerated dose (1800 mg to 3600 mg daily) over 15‐24 days (3 months total)
Participants Radicular leg pain for ≥ 6 weeks and < 4 years, PI ≥ 4/10 or ≥ 3/10 if leg pain ≥ back pain, symptoms of lumbosacral radicular pain. Findings of herniated disc or spinal stenosis on MRI concordant with presentation. Age ≥ 17 years
 Excluded: neuropathic pain > 4 years, previous failed trial with gabapentin or pregabalin, steroid injections ≤ 3 years, cauda equina syndrome, planned surgery
N = 145
Mean age 43 years, 26% women
 18% had pain ≤ 3 months, 25% taking opioids
 Initial PI: worst leg 7.8/10; average leg 5.4/10
Interventions Gabapentin capsule + saline injection, n = 72
Depomethylprednisolone 60 mg injection + 1 ml 0.25% bupivacaine + placebo capsule, n = 73
Gabapentin titrated to 1800 mg to 3600 mg/day (3 divided doses) over 15‐24 days, but ≥ 5 days before follow‐up
Steroid injected into epidural space (interlaminar or transforaminal), saline injected into posterior ligaments
 Tramadol and NSAIDs "as needed" for rescue medication, or opioids increased by ≥ 20% for those taking them. No other co‐interventions
Outcomes Mean PI, for average and worst leg and back pain
Global evaluation (non‐standard scales)
Adverse events
Withdrawals
Notes Oxford Quality Score: R = 2, DB = 2, W = 1, Total = 5
Congressional grant from the Center for Rehabilitation Sciences Research, Bethesda
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated randomisation tables, stratified by site. Central pharmacy
Allocation concealment (selection bias) Low risk "sequentially numbered opaque sealed envelope"
Blinding (performance bias and detection bias) 
 All outcomes Low risk "A central research pharmacy over‐capsulated 300 mg gabapentin and placebo capsules to appear identical". Participants "visually shielded from the image screen" during injections", had no further contact with physician
Incomplete outcome data (attrition bias) 
 Efficacy Unclear risk LOCF imputation
Size 
 Efficacy Unclear risk 50‐200 participants per treatment arm