Study characteristics |
Methods |
Single‐centre, randomised, double‐blind, placebo‐controlled, 2‐period, cross‐over design for 30 days each period |
Participants |
Pain model: painful diabetic neuropathy. Mean age: 55 years (30 to 73). 24 participants were randomised and 18/24 completed the 2 periods of treatment. 9/18 were women. Medications: information about concomitant analgesia is not stated. |
Interventions |
Nortriptyline 10 mg + fluphenazine 0.5 mg: the starting dose was 1 tablet TID for 2 weeks and it was increased 2 tablets TID for another 15 days. Identical tablets and increasing scheme were applied during the placebo period. |
Outcomes |
The initial level of pain and paraesthesia were given a 100% value and changes were considered positive or negative per cent deviations (mean per cent of change). VAS change from baseline was used in the outcomes assessor’s office as well as a side effects record. |
Notes |
Baseline pain intensity or minimum pain intensity for inclusion in the study was not reported. Small sample size. No carry‐over effect analyses. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
Method of randomisation is not stated |
Allocation concealment (selection bias) |
Unclear risk |
Insufficient information to permit judgement |
Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
"The active drugs, 10 mg of nortriptyline and 0.5 mg of fluphenazine, and the placebo, an inactive substance, were supplied as identical tablets under a code unknown to clinicians" |
Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Insufficient information to permit judgement |
Incomplete outcome data (attrition bias) |
Unclear risk |
Substantial dropout rate |
Selective reporting (reporting bias) |
Low risk |
Not apparent selective outcome reporting. Trial was not registered. |
Other bias |
High risk |
Fewer than 50 participants per period and < 8 weeks duration |