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Category: Volume 07 Issue 01 January 2019
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Title: A Multi-Centered Study to Evaluate the Efficacy and Safety of Amitriptyline and Mecobalamine in the Management of Low Back Pain and Lumbar Radiculopathy

Authors: Dr Mayuresh Dilip Kiran, Shaheen Naseem Sheikh, Lalit Jeeevan Pawaskar

 DOI: https://dx.doi.org/10.18535/jmscr/v7i1.135

Abstract

 

Introduction: Low Back Pain (LBP) is a pain and disability comfort localized below costal margins and above the inferior gluteal folds with or without referred pain in legs. Lumbar Radiculopathy (LR) is a term used to describe pain caused by compression or irritation of nerve root in the low back. An FDC of Amitriptyline a neuroanalgesia and Mecobalamine (Vitamin B12) a damage nerve rejuvenator have an important role in management of LBP and LR caused by Neuropathic pain. 

Methodology: Of 400 registered, 339 patients completed the study. Efficacy assessment was made by reduction in mean VAS score and percentage of patients with ≥50% reduction in LBP and LR was calculated at conclusion visit and used to determine the corresponding NNT. Safety assessment was made by investigating the adverse events during the study.

Results: Reduction in mean VAS score, in LBP patients was from 8.01 (baseline) to 4.18 (day 30) and 1.74 (day 45) and in LR patients reduction was from 7.24 (baseline) to 4.80 (day 30) and 3.20 (day 45). Nearly all the patients had experience ≥50% reduction in LBP and LR. NNT score was calculated by using risk reduction parameter at conclusion visit. Overall 116 patients experience adverse events and were of mild to moderate intensity.

Conclusion: The combination of Amitriptyline and Mecobalamine was safe, efficacious and well-tolerated in management of Low back pain (LBP) and Lumbar Radiculopathy (LR).

Keywords: Low back pain, Lumbar radiculopathy, Neuropathic pain, Amitriptyline, Mecobalamine, VAS score and NNT score.

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Corresponding Author

Dr Mayuresh Dilip Kiran

Vice-President, Medical Services and Pharmacovigilance., Centaur Pharmaceuticals Pvt. Ltd. Mumbai, India

Mobile No. +91-9820068567, Email: This email address is being protected from spambots. You need JavaScript enabled to view it.