Dallocchio 2000.
Methods | Open label parallel design, 12 weeks (four week titration to max tolerated dose then eight week stable dose). Randomisation method not stated. Inclusion criteria: age over 65 years, duration of pain at least six months | |
Participants | Diabetic neuropathy of 8 to 48 months 25 participants (25 final number). Age range 61 to 83 years, 11 male and 14 female patients. Pain score in amitriptyline group 2.8 (0.8), in gabapentin group 2.9 (0.8) Duration of pain significantly longer in gabapentin group than in amitriptyline group |
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Interventions | Amitriptyline dose escalation from 10 mg to 90 mg daily orally, median dose 53 mg (16 mg); or gabapentin dose escalation from 400 mg to 2400 mg daily orally, median dose 1785 mg (351 mg) | |
Outcomes | Pain relief (pain score one or less), VRS (0 to 4) 7/12 on amitriptyline reported pain relief, 8/13 on gabapentin. VRS 1.5 (0.8) on amitriptyline, 1.0 (0.7) on gabapentin |
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Notes | No dropouts SE: 11/12 on amitriptyline, 4/13 on gabapentin; no withdrawals due to SE QS = 2 (R1, DB0, W1) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |