| Methods | Randomised, double-blind, placebo-controlled, cross-over, not enriched. No imputation method mentioned Titration over 3 days to 900 mg, then fixed dose for remainder of 6-week period; 3 week washout, then cross-over |
|
| Participants | Painful diabetic neuropathy 1 to 5 years, pain ≥ moderate for over 3 months. N = 40, mean age 62 years, 23% women. Pain intensity at randomisation ≥ 40/100, initial pain intensity not reported | |
| Interventions | Gabapentin 900 mg, n = 19 (first phase) Placebo, n = 21 (first phase) Medication for diabetes control remained stable during study. Stable doses of NSAID or narcotics allowed |
|
| Outcomes | Pain relief at end of treatment (4-point global score) moderate or excellent Adverse events |
|
| Notes | Oxford Quality Score: R = 1, DB = 1, W = 0, Total = 3 Sponsored by Warner Lambert/Parke-Davis Note: no separate data for first period, small group sizes, non standard global scale |
|
| Risk of bias | ||
| Item | Authors’ judgement | Description |
| Allocation concealment? | Unclear | Not reported |
| Blinding? All outcomes |
Unclear | Not reported |
| Incomplete outcome data addressed? Efficacy |
Unclear | Imputation not mentioned |
| Size Efficacy |
No | 40 randomised |
| Study duration Efficacy |
Unclear | 6-week period |
| Outcomes reported | Unclear | Moderate or excellent pain relief |