A Comparative Trial to Evaluate Amitriptyline and Duloxetine in Painful Diabetic Neuropathy: A randomized, double-blind, cross-over clinical trial

Diabetes Care, 03/10/2011

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).

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