A Comparative Evaluation of Amitriptyline and Duloxetine in Painful Diabetic Neuropathy

April 2011
Diabetes Care;Apr2011, Vol. 34 Issue 4, p818
Academic Journal
OBJECTIVE--To 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 bed-time, each for 6 weeks with optional dose uptitration fortnightly. Single-blinded placebo wash-out 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 <25% were considered good, moderate, and mild responses, respectively. RESULTS--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). Although, numerically, more patients preferred duloxetine, overall this was not statistically significant (48 vs. 36%; P = 0.18). CONCLUSIONS--Both duloxetine and amitriptyline demonstrated similar efficacy in PDN. A large, multicentric clinical trial in other populations could possibly demonstrate the superiority of either drug.


Related Articles

  • Amitriptyline vs Duloxetine for Diabetic Peripheral Neuropathic Pain. Kaur, H. // Internal Medicine Alert;5/29/2011 Supplement, p80 

    The article focuses on the double-blind crossover trial performed by H. Kaur and colleagues to compare the efficacy of amitriptyline with duloxetine in the treatment of diabetic peripheral neuropathic pain.

  • A Phase II, Randomized, Double-blind, Placebo-controlled Multicenter Trial of Endostar in Patients With Metastatic Melanoma. Cui, Chuanliang; Mao, Lili; Chi, Zhihong; Si, Lu; Sheng, Xinan; Kong, Yan; Li, Siming; Lian, Bin; Gu, Kangsheng; Tao, Min; Song, Xin; Lin, Tongyu; Ren, Xiubao; Qin, Shukui; Guo, Jun // Molecular Therapy;Jul2013, Vol. 21 Issue 7, p1456 

    Endostatin is a potent endogenous angiogenic inhibitor with implicated antitumor activity. However, efficacy of recombinant human endostatin (rhES) in clinical trials is controversial, and application of rhES in treatment of metastatic melanoma awaits further investigations. This phase II trial...

  • Randomized double blind placebo control studies, the "Gold Standard" in intervention based studies. Misra, Shobha // Indian Journal of Sexually Transmitted Diseases;Jul-Dec2012, Vol. 33 Issue 2, p131 

    Studies follow a hierarchy in terms of the quality of evidence that they can provide. Randomized double blind placebo control (RDBPC) studies are considered the "gold standard" of epidemiologic studies. And the same is discussed at length in this paper taking example of a real journal article...

  • Amitriptyline vs Duloxetine for Diabetic Peripheral Neuropathic Pain.  // OB/GYN Clinical Alert;Jun2011 Clinical Brief, p12 

    The article discusses the double-blind crossover trial of amitriptyline and duloxetine in which these will be used as a treatment for diabetic peripheral neuropathic pain (DPNP).

  • Chinese Medicinal Formula (MHGWT) for Relieving Diabetic Neuropathic Pain: A Randomized, Double-Blind, Placebo-Controlled Trial. Chia-I. Tsai; Tsai-Chung Li; Ming-Hong Chang; Shih-Yi Lin; I.-Te Lee; Cheng-Hung Lee; Tzu-Yuan Wang; Yi-Chang Su // Evidence-based Complementary & Alternative Medicine (eCAM);2013, Vol. 2013, p1 

    Objective. To investigate the effects of modified Hungqi Guizhi Wuwu Tang (MHGWT), a formula that comprises Chinese medicinal herbs, in relieving neuropathic pain in diabetics. Method. Between March 2008 and April 2009, 112 participants were randomly assigned to either the MHGWT group, whose...

  • Incontinence after radical prostatectomy: Anything new in its management? Caremel, Romain; Coreos, Jacques // Canadian Urological Association Journal;May/Jun2014, Vol. 8 Issue 5/6, p202 

    Introduction: With the increasing number of radical prostatectomies (RP) performed, male stress urinary incontinence (SUI) has become common. The artificial urinary sphincter (AUS) is the gold standard to treat SUI post-RP, but new devices have recently been developed. We review the recent...

  • Safety and Tolerability of Duloxetine in the Acute Management of Diabetic Peripheral Neuropathic Pain: Analysis of Pooled Data from Three Placebo-Controlled Clinical Trials. Hall, Jerry; Fujun Wang; Robinson, Michael; Oakes, Tina Myers; Jamal, Hassan; Acharya, Nayan // Diabetes;Jun2007 Supplement 1, Vol. 56, pA574 

    The purpose of this study is to summarize the safety and tolerability of duloxetine in treating diabetic peripheral neuropathic pain (DPNP) using data pooled from 3 double-blind, randomized, placebo-controlled, 12-13 week acute phase therapy studies of duloxetine. Placebo (n=339), duloxetine 20...

  • A randomized trial of memantine as treatment for spasticity in multiple sclerosis. Mehta, Lahar R.; McDermott, Michael P.; Goodman, Andrew D.; Schwid, Steven R. // Multiple Sclerosis (13524585);Feb2010, Vol. 16 Issue 2, p248 

    We report the results of a single center randomized, double-blind, placebo-controlled, parallel group trial of memantine in adults with multiple sclerosis and spasticity conducted over 12 weeks. Eligible MS patients had to have an Ashworth spasticity rating of 2 or higher in at least one lower...

  • Blinding: Who, what, when, why, how? Karanicolas, Paul J.; Farrokhyar, Forough; Bhandari, Mohit // Canadian Journal of Surgery;Oct2010, Vol. 53 Issue 5, p345 

    The article discusses blinding, a methodology in randomized controlled trials (RCTs) to achieve maximum validity of results. It presents several individuals that should be blinded by trialists, including clinicians, data collectors, and data analysts. It discusses how surgical interventions can...


Read the Article


Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics