Comparative study of safety and efficacy of pregabalin, gabapentin and amitriptyline in management of neuropathic pain

Nagaraju Kancherla, G. Chitti Babu, Hukum Singh, Mayank Khandelwal, Nitika Sharma, Masuram Bharath Kuma


Background: Neuropathic pain has a significant negative impact on the patients’ quality of life. Now a day’s anticonvulsants and antidepressants drugs are often used as first-line drugs for the treatment of neuropathic pain. The present study aims to evaluate the safety and efficacy of gabapentin, amitriptyline, and pregabalin in patients of severe neuropathic pain not controlled by simple analgesics.

Methods: A total of 360 patients diagnosed with cases of chronic lumbar radiculopathy based on symptoms, clinical examination, X-ray, and magnetic resonance imagining (MRI) scan of the lumbosacral spine, were randomized into three groups. Group A patients received pregabalin 75 mg, Group B patients received gabapentin 300 mg, and Group C patients received amitriptyline 10 mg, respectively. Pain intensity was measured at the baseline, after 1 month and after 2 months with the Numeric pain rating scale (NPRS). Adverse drug reaction reported by the patient or observed by the clinician during the study was reported using the adverse drug reaction (ADR) reporting form.

Results: At baseline, the mean±SD of NPRS score in Group A was 8.42±1.48, in Group B and Group C were 8.53±1.94 and 8.33±1.26 respectively with an F-value of 0.843 and p value of 0.584, which was not statistically significant. At 1 month, the mean±SD of NPRS score in Group A was 7.23±1.58, in Group B and Group C were 7.43±2.03 and 7.99±2.10 respectively with F-value of 1.58 and p value of 0.085 which was not statistically significant. At 2 months, the mean±SD of NPRS score in Group A was 4.38±2.72, in Group B and Group C were 4.74±2.86 and 6.32±2.31 respectively with F-value of 5.53 and p value of 0.002 which was statistically significant.

Conclusions: Pregabalin has the advantages in terms of the NPRS score over gabapentin and amitriptyline. Gabapentin has fewer reported adverse effects and hence better patient compliance on long term use. Amitriptyline is more cost effective than pregabalin which is an important factor to keep in mind while treating patients.


Gabapentin, Amitriptyline, Pregabalin, Neuropathic pain

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Costigan M, Scholz J, Woolf CJ. Neuropathic Pain. A Maladaptive Response of the Nervous System to Damage. Annu Rev Neurosci. 2009;32:1-32.

Attal N, Gruccu G, Baron R, et al. EFNS guidelines on the pharmacological treatment of neuropathic pain: 2010 revision. Eur J Neurol. 2010;17(9):1113-23.

Finnerup NB, Attal N, Haroutounian S, et al. Pharmacotherapy for neuropathic pain in adults: a systematic review and meta-analysis. Lancet Neurol. 2015;14(2):162-73.

Arnold L., Russell I., Diri E., Duan W., Young J., Jr, Sharma U., et al. . (2008) A 14-week, randomized, double-blinded, placebo-controlled monotherapy trial of pregabalin in patients with fibromyalgia. J Pain 9: 792–805.

Campbell JN, Meyer RA. Mechanisms of neuropathic pain. Neuron. 2006;52:77-92.

Nascimento OJ, Pessoa BL, Orsini M, Ribeiro P, Davidovich E, Pupe C, et al. Neuropathic pain treatment: still a challenge. Neurol Int. 2016;8:6322.

Liu Y, Qian C, Yang M. Treatment patterns associated with ACR-recommended medications in the management of Fibromyalgia in the United States. J Manag Care Spec Pharm. 2016;22:263-71.

Park HJ, Moon DE. Pharmacologic management of chronic pain. Korean J Pain. 2010;23:99-108.

Kamble SV, Motlekar SA, D'souza LL, Kudrigikar VN, Rao SE. Low doses of amitriptyline, pregabalin, and gabapentin are preferred for management of neuropathic pain in India: is there a need for revisiting dosing recommendations?. Korean J Pain. 2017;30(3):183-91.

Apfel SC, Asbury AK, Bril V, Burns TM, Campbell JN, Chalk CH, et al. Positive neuropathic sensory symptoms as endpoints in diabetic neuropathy trials. J Neurol Sci. 2001;189:3-5.

Abbott CA, Malik RA, van Ross ER, Kulkarni J, Boulton AJ. Prevalence and characteristics of painful diabetic neuropathy in a large community-based diabetic population in the U.K. Diabetes Care. 2011;34:2220-4.

Veves A, Backonja M, Malik RA. Painful diabetic neuropathy: Epidemiology, natural history, early diagnosis, and treatment options. Pain Med. 2008;9:660-74.

Bansal D, Bhansali A, Hota D, Chakrabarti A, Dutta P. Amitriptyline versus. pregabalin Pregabalin in painful diabetic neuropathy: A randomized double blind clinical trial. Diabet Med. 2019;26:1019-26.

Daousi C, MacFarlane IA, Woodward A, Nurmikko TJ, Bundred PE, Benbow SJ. Chronic painful peripheral neuropathy in an urban community: A controlled comparison of people with and without diabetes. Diabet Med. 2004;21:976-82.

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, crossover clinical trial. Diabetes Care. 2011;34:818-22.

Gore M, Brandenburg NA, Dukes E, Hoffman DL, Tai KS, Stacey B. Pain severity in diabetic peripheral neuropathy is associated with patient functioning, symptom levels of anxiety and depression, and sleep. J Pain Symptom Manage. 2005;30:374-85.

Schmader KE. Epidemiology and impact on quality of life of postherpetic neuralgia and painful diabetic neuropathy. Clin J Pain. 2002;18:350-4.

Ghosh AK, Ghosh A, Kundu A, Das AK, Bhattacharya KB. Comparative study of efficacy and safety of pregabalin and gabapentin in neuropathic pain. Asian J Pharm Life Sci. 2012;2:64-71.

Franklin GM, Shetterly SM, Cohen JA, Baxter J, Hamman RF. Risk factors for distal symmetric neuropathy in NIDDM. The San Luis Valley Diabetes Study. Diabetes Care. 1994;17:1172-7.

Vinik AI, Tuchman M, Safirstein B, Corder C, Kirby L, Wilks K et al. Lamotrigine for treatment of pain associated with diabetic neuropathy: Results of two randomized, double-blind, placebo-controlled studies. Pain. 2007;128:169-79.

Collins SL, Moore RA, McQuay HJ, Wiffen P. Antidepressants and anticonvulsants for diabetic neuropathy and postherpetic neuralgia: A quantitative systematic review. J Pain Symptom Manage. 2000;20:449-58.

Dongre YU, Swami OC. Sustained-release pregabalin with methylcobalamin in neuropathic pain: an Indian real-life experience. Int J Gen Med. 2013;6:413-7.

Patel R, Dickenson AH. Mechanisms of the gabapentinoids and alpha 2 delta-1 calcium channel subunit in neuropathic pain. Pharmacol Res Perspect. 2016;4(2):1-13.

Kumar K, Taylor RS, Jacques L, Eldabe S, Meglio M, Molet J et al. Spinal cord stimulation versus conventional medical management for neuropathic pain: a multicentre randomised controlled trial in patients with failed back surgery syndrome. Pain. 2007;132:179-88.