title: A comparative evaluation of amitriptyline and duloxetine in painful diabetic neuropathy: a randomized, double-blind, cross-over clinical trial.
abstract: OBJECTIVE
  To compare the efficacy and safety of duloxetine and amitriptyline in painful diabetic neuropathy (PDN).
  
  
  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 <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.
authors.affiliation: Department of Pharmacology, Postgraduate Institute of Medical Education and Research, Chandigarh.
authors.forename: Harjot
authors.initials: H
authors.lastname: Kaur
authors.forename: Debasish
authors.initials: D
authors.lastname: Hota
authors.forename: Anil
authors.initials: A
authors.lastname: Bhansali
authors.forename: Pinaki
authors.initials: P
authors.lastname: Dutta
authors.forename: Dipika
authors.initials: D
authors.lastname: Bansal
authors.forename: Amitava
authors.initials: A
authors.lastname: Chakrabarti
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000639:Amitriptyline / Q000627:therapeutic use*; D018592:Cross-Over Studies; D003929:Diabetic Neuropathies / Q000188:drug therapy*; D004311:Double-Blind Method; D000068736:Duloxetine Hydrochloride; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D013876:Thiophenes / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D013876:Thiophenes; D000639:Amitriptyline; D000068736:Duloxetine Hydrochloride