| Methods | Randomised, double-blind, placebo-controlled, parallel-group, not obviously enriched. No imputation method mentioned Dose adjusted on clinic successive visits, “based on clinical symptoms”, to a maximum of 1200 mg daily (12 weeks total) |
|
| Participants | Painful diabetic neuropathy. N = 32, mean age 54 years, 53% female. Failed conventional treatment. PI ≥ 60/100 at randomisation | |
| Interventions | Gabapentin 1200 mg daily (max), n = 17 Placebo, n = 15 All participants continued with non-opioid analgesia |
|
| Outcomes | ≥ 50% pain reduction | |
| Notes | Oxford Quality Score: R = 1, DB = 1, W = 0, Total = 2 Published as letter, some details confirmed by correspondence |
|
| 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 | 32 randomised |
| Study duration Efficacy |
Yes | 12-week period |
| Outcomes reported | Yes | At least 50% reduction in pain |