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.
References
- Saxena, A. K., S. Nath, and R. Kapoor. "Diabetic Peripheral Neuropathy: Current Concepts and Future Perspectives." Journal of Endocrinology and Diabetes 5 (2015): 1-8.
- Baron, Ralf, et al. "Peripheral neuropathic pain: a mechanism-related organizing principle based on sensory profiles." Pain 2 (2017): 261.
- Park, Si Young, et al. "Neuropathic pain components in patients with lumbar spinal stenosis."Yonsei medical journal 4 (2015): 1044-1050.
- Elders, Leo AM, and Alex Burdorf. "Prevalence, incidence, and recurrence of low back pain in scaffolders during a 3-year follow-up study."Spine 6 (2004): E101-E106.
- Urquhart, Donna M., et al. "Is low-dose amitriptyline effective in the management of chronic low back pain? Study protocol for a randomised controlled trial." Trials1 (2016): 514.
- Alexander, Christopher, and Scott Dulebohn. "Lumbosacral Radiculopathy." (2017).
- Saldaña, María Teresa, et al. "Patient-reported-outcomes in subjects with painful lumbar or cervical radiculopathy treated with pregabalin: evidence from medical practice in primary care settings." Rheumatology international 8 (2010): 1005-1015.
- Micó, Juan A., et al. "Antidepressants and pain."Trends in pharmacological sciences 7 (2006): 348-354.
- Goldenberg, Don L. "Pharmacological treatment of fibromyalgia and other chronic musculoskeletal pain."Best Practice & Research Clinical Rheumatology 3 (2007): 499-511.
- McQuay, H. J., et al. "A systematic review of antidepressants in neuropathic pain."Pain 2-3 (1996): 217-227.
- Atkinson, J. Hampton, et al. "Efficacy of noradrenergic and serotonergic antidepressants in chronic back pain: a preliminary concentration-controlled trial." Journal of clinical psychopharmacology 2 (2007): 135-142.
- Davis, Jonathan L., et al. "Peripheral diabetic neuropathy treated with amitriptyline and fluphenazine." Jama 21 (1977): 2291-2292.
- Moore, R. Andrew, et al. "Amitriptyline for neuropathic pain and fibromyalgia in adults."Cochrane Database Syst Rev 12 (2012).
- Bryson, Harriet M., and Michelle I. Wilde. "Amitriptyline."Drugs & aging 6 (1996): 459-476.
- Yaqub, Basim A., Abdulaziz Siddique, and Riad Sulimani. "Effects of methylcob-alamin on diabetic neuropathy." Clin Neurol Neurosurg2 (1992): 105-111.
- Thanon, Imad A. J., Ashraf H. Ahmed, and Bashar S. Mahmood. "Efficacy of mecobalamin (Methylcobalamin) in the treatment of diabetic peripheral neuropathy "Medical Journal of Babylon3 (2005): 330-335.
- Zhang, Ming, et al. "Methylcobalamin: a potential vitamin of pain killer."Neural plasticity 2013 (2013).
- Kalita, J., et al. "An open labeled randomized controlled trial of pregabalin versus amitriptyline in chronic low backache."Journal of the neurological sciences 1 (2014): 127-132.
- Dongre, Yasmin U., and Onkar C. Swami. "sustained-release pregabalin with methylcobalamin in neuropathic pain: an Indian real-life experience." International journal of general medicine 6 (2013): 413.
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.
DOI: https://dx.doi.org/10.18535/jmscr/v7i1.135
