Original Research

Comparison between the Efficacy of Duloxetine and Amitriptyline inthe Management of Painful Diabetic Peripheral Neuropathy: ARandomized Control Trial

DOI https://doi.org/10.70302/jpsim.v6i1.2511
Received: 10 May 2024 Revised: 09 Feb 2025 Accepted: 22 Feb 2025 Published Online: 10 Mar 2025

Abstract

Objective

To compare the efficacy of duloxetine and amitriptyline in reducing pain based on VAS in patients with diabetic distal painful neuropathy and to compare the safety profile in terms of fewer adverse effects.

Methods

This Randomized control trial was done at Mayo Hospital Lahore for a duration of 6 months from June 2023 to December 2023. After obtaining IRB approval and meeting the inclusion criteria, 106 patients were selected and divided into two groups; A and B, and given duloxetine and amitriptyline respectively. Pain assessment was done in both groups using the VAS score system at 3, 6 and 12 weeks and adverse effects were documented based on subjective assessment by the patients.

Results

Duloxetine resulted in a reduced intensity from a mean of 3.91 ± 0.08 to 1.79 ± 0.06 while amitriptyline resulted in decrease in pain from 3.89 ± 0.06 to 2.45 ± 0.06 (p<0.05). Patients taking duloxetine reported fewer side effects as compared to amitriptyline.

Conclusion

Duloxetine has better efficacy in treating painful diabetic peripheral neuropathy both in terms of pain management and fewer side effects.

Keywords
Peripheral neuropathy Duloxetine Amitriptyline Randomized Control Trial Diabetes Mellitus Efficacy Safety Profile.

How to Cite This Article

Murtaza G, Ahmad I, Bano S, Hasnat M, Husnain M. Comparison between the Efficacy of Duloxetine and Amitriptyline inthe Management of Painful Diabetic Peripheral Neuropathy: ARandomized Control Trial. J Pak Soc Intern Med. 2025;6(1):52–55. doi:10.70302/jpsim.v6i1.2511

⭳ Download PDF

Conflict of Interest

All authors declare no competing interests.

Disclosed in accordance with ICMJE and COPE guidelines.

Funding

No specific funding was received for this research.

Funder information follows the Crossref Funder Registry standard.

References

  1. Akram N, Butt A, Waheed K. Peripheral neuropathy in newly diagnosed cases of type II diabetes mellitus. Pak J Neurol Surg. 2019;23(3): 234-8.
  2. Alsaloum M, Estacion M, Almomani R, Gerrits MM, Bönhof GJ, Ziegler D, et al. A gain-of-function sodium channel β 2-subunit mutation in painful diabetic neuropathy. Molecular pain. 2019;15(1):1744806919849802.
  3. Yang CP, Li CI, Liu CS, Lin WY, Hwang KL, Yang SY, et al. Variability of fasting plasma glucose increased risks of diabetic polyneuropathy in T2DM. Neurol. 2017;88(10):944-51.
  4. Snyder MJ, Gibbs LM, Lindsay TJ. Treating painful diabetic peripheral neuropathy: an update. Am Fam physician. 2016;94(3):227-34.
  5. ‌ Alam U, Sloan G, Tesfaye S. Treating pain in diabetic neuropathy: current and developmental drugs. Drugs. 2020;80(4):363-84.
  6. Javeed A, Alam MA, Maqsood A, Azher A, Arif M, Qayyum A. Comparison of efficacy of duloxetine with amitriptyline in terms of reduction in frequency of pain in the patients of diabetic neuropathy. Prof Med J. 2020;27(09):1891-4.
  7. Rosenberger DC, Blechschmidt V, Timmerman H, Wolff A, Treede RD. Challenges of neuropathic pain: focus on diabetic neuropathy. J Neural Transm. 2020;127(4):589-624.
  8. Deli G, Bosnyak E, Pusch G, Komoly S, Feher G. Diabetic neuropathies: diagnosis and management. Neuroendocrinol. 2014;98(4):267-80.
  9. Argoff CE, Cole BE, Fishbain DA, Irving GA. Diabetic peripheral neuropathic pain: clinical and quality-of-life issues. In Mayo Clinic Proceedings. 2006; 81(4):S3-S11.
  10. Goldstein DJ, Lu Y, Detke MJ, Lee TC, Iyengar S. Duloxetine vs. placebo in patients with painful diabetic neuropathy. Pain. 2005;116(1-2):109-18.
  11. Ramirez MA, Borja NL. Epalrestat: an aldose reductase inhibitor for the treatment of diabetic neuropathy. Pharmacother: J Hum Pharmacol Drug Ther. 2008;28(5):646-55.
  12. Kaur H, Hota D, Bhansali A, Dutta P, Bansal D, Chakrabarti A. A comparative evaluation of amitriptyline and duloxetine in painful diabetic neuropathy: a randomized, double-blind, cross-over clinical trial. Diab Care. 2011;34(4):818-22.
  13. Moulik PK, Mtonga R, Gill GV. Amputation and mortality in new-onset diabetic foot ulcers stratified by etiology. Diab Care. 2003;26(2):491-4.
  14. Farias ÁD, Eberle L, Amador TA, Pizzol TD. Comparing the efficacy and safety of duloxetine and amitriptyline in the treatment of fibromyalgia: overview of systematic reviews. Advances in Rheumatology. 2020;60(3):35.

Reference list indexed for Google Scholar and ResearchGate. DOI links resolve via doi.org.

CC BY CC BY 4.0 This article is published under the Creative Commons Attribution 4.0 International License. May be shared and adapted with attribution. © 2025 Journal of Pakistan Society of Internal Medicine.