A Comparative Trial to Evaluate Amitriptyline and Duloxetine in Painful Diabetic Neuropathy: A randomized, double-blind, cross-over clinical trial
Diabetes Care, 03/09/2011
Kaur H et al. - Both duloxetine and amitriptyline demonstrated similar efficacy in painful diabetic neuropathy (PDN).
This was a randomized, double-blind, cross-over, active-control trial.
58 patients were included.
They received amitriptyline and duloxetine orally once daily at bedtime, each for 6 weeks with optional dose uptitration fortnightly.
Single-blinded placebo washout was given for 2 weeks between the two treatments
Single-blinded placebo run-out phase of 4 weeks was given at the end of the treatment period.
Pain relief was measured by the patient’s global assessment of efficacy, using a visual analog scale (0–100) as a primary end point.
Overall improvement and adverse events were assessed as secondary outcome measures.
Median pain score reductions of >50%, 25–50%, and <25% were considered good, moderate, and mild responses, respectively.
There was a significant improvement in pain with both treatments compared with their baseline values (P < 0.001 for both).
Good, moderate, and mild pain relief was achieved in 55, 24, and 15% of patients, respectively, on amitriptyline and 59, 21, and 9% of patients, respectively, on duloxetine.
There were no significant differences in various other outcome measures between the groups.
Of the reported adverse events, dry mouth was significantly more common with amitriptyline than duloxetine (55 vs. 24%; P < 0.01).
Numerically, more patients preferred duloxetine, (48 vs. 36%; P = 0.18).