Gomez‐Perez 1985.
Methods | Double blind placebo controlled crossover study, 30 days. Two 30 days periods, no washout. No analyses of carry over effect Dose escalation during the first week Randomisation method not stated |
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Participants | Diabetic neuropathy. 24 participants (18 final number). Mean age 55 (range 30 to 73), 9 male and 9 female patients | |
Interventions | Nortriptyline dose escalation from 30 mg to 60 mg and fluphenazine from 1.5 mg to 3 mg daily orally, or placebo daily orally | |
Outcomes | Pain patients reported, pain relief 50% or more, VAS change from baseline Pain relief on active treatment 16/18 , on placebo 1/18 Pain decreased 63.97 % on active treatment, 22.11 % on placebo |
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Notes | Dropouts 6/24 (one ketoacidosis,
2 lack of compliance,
3 lost to follow‐up) No withdrawals due to SE QS = 4 (R1, DB2, W1) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |