Abstract

Diabetic polyneuropathy (DPNP) is a symmetrical peripheral neuropathy that results from nerve damage after prolonged periods of suboptimal glycemic control. Neuropathy is often associated with significant burning, stabbing or tingling pain and numbness, and can result in sleep interference and severe disability. The aimof this studywas to compare the efficacy and safety of duloxetine (DLX), a balanced and potent dual reuptake inhibitor of serotonin and norepinephrine, with pregabaline (PGB) a calcium Channel blocker in themanagement of diabetic peripheral neuropathic pain. We performed a doubleblind 12-week RCT study of patients with diabetic peripheral neuropathic pain whom have been treated with pregabaline (150 mg/d)(n=55) or doluxetine (60mg/d) (n=50)and had a daily pain score of $4 (VAS)in admission time. The primary objective was a comparison between DLX and PGB on improvement in the weekly mean of the daily pain score. Secondary efficacy measures included sleep interference score, Patient Global Impression of Change (PGIC), and Clinical Global Impression of Change (CGIC).A significant reduction in pain score (VAS), sleep interference score, PGIC, and CGIC was seen in all the two treatment groups across time with no statistically significant difference between the groups. The improvement in pain scores and sleep interference score was faster with PGB compared to DLX. (P<0.05) Adverse drug reactions were mild in 4.5% of all cases. DLX and PGB Produced a clinically and subjectively meaningful pain relief in patients with DPNP with onset of pain relief being faster with PGB.

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