A Comparative Trial to Evaluate Amitriptyline and Duloxetine in Painful Diabetic Neur

Sysop · February 26th, 2011, 12:32 AM

OBJECTIVETo compare the efficacy and safety of duloxetine and amitriptyline in painful diabetic neuropathy (PDN).
RESEARCH DESIGN AND METHODS
In this randomized, double-blind, cross-over, active-control trial, 58 patients 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 and a 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, and overall improvement and adverse events were assessed as secondary outcome measures. Median pain score reductions of >50%, 25–50%, and

February 26th, 2011, 12:32 AM	#1
Sysop Administrator Join Date: Apr 2008 Posts: 83	A Comparative Trial to Evaluate Amitriptyline and Duloxetine in Painful Diabetic Neur OBJECTIVETo compare the efficacy and safety of duloxetine and amitriptyline in painful diabetic neuropathy (PDN). RESEARCH DESIGN AND METHODS In this randomized, double-blind, cross-over, active-control trial, 58 patients 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 and a 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, and overall improvement and adverse events were assessed as secondary outcome measures. Median pain score reductions of >50%, 25–50%, and