Adverse drug reactions and cost effectiveness of non-steroidal anti-inflammatory drugs, muscle relaxants, and neurotropic drugs in patients with low back pain
Keywords:Adverse drug reactions, Cost effectiveness, Low back ache, Muscle relaxant, Neurotropic drugs, Non-steroidal anti-inflammatory drugs
Background: The objective was to evaluate the adverse drug reactions (ADRs) and cost effectiveness of different classes of drugs in therapy of low back pain.
Methods: A prospective observational study was carried out over a period of 12 months (November 2012 to November 2013) in which a total of 300 patients with low back pain were enrolled and divided equally into three groups – Group 1 (non-steroidal anti-inflammatory drugs [NSAIDs]), Group 2 (NSAIDs ± muscle relaxant), and Group 3 (NSAIDs ± muscle relaxant ± neurotropic drugs). Any ADR developed after the initiation of treatment at 3 weeks and 6 weeks was noted. Prescription cost per day was also calculated.
Results: There was a male predominance in the study population with a mean age of 39.76±9.40 years. A total of 262 ADRs were noted among which most were seen in Group 3 (119 ADRs). Gastritis was the most common ADR in Group 1. Drowsiness was the most common ADR in Group 2 (30%) and 3 (46%). Prescription cost per day was highest in Group 3 (30.28±11.24 Indian Rupee [INR]) followed by Group 2 (25.92±8.66 INR) and Group 1 (12.22±3.38 INR).
Conclusion: Patient on combination of three drugs (NSAIDs, muscle relaxants, and neurotropic agents) had maximum ADRs and their prescription cost per day was highest among the three groups.
Hart LG, Deyo RA, Cherkin DC. Physician office visits for low back pain. Frequency, clinical evaluation, and treatment patterns from a U.S. National survey. Spine. 1995;20(1):11-9.
Deyo RA, Mirza SK, Martin BI. Back pain prevalence and visit rates: estimates from U.S. national surveys, 2002. Spine. 2006;31(23):2724-7.
Luke A, Benjamin Ma C. Sports medicine & outpatient orthopedics. In: Papadakis MA, Mcphee SJ, Rabow MW, editors. 2014 Current Medical Diagnosis & Treatment. 53rd Edition. New York: McGraw-Hill Education; 2014. p. 1626-30.
Engstrom JW, Deyo RA. Back and neck pain. In: Longo DL, Kasper DL, Jameson JL, Fauci AS, Hauser SL, Loscalzo J, editors. Harrison’s Principles of Internal Medicine. 18th Edition. New York: McGraw-Hill Medical Publishing Division; 2011: 129-42.
Maheshwari J, editor. Approach to a patient with back pain. Essential Orthopaedics. 4th Edition. New Delhi: Jaypee Brothers Medical Publishers (P) LTD.; 2011: 250-6.
Freburger JK, Holmes GM, Agans RP, Jackman AM, Darter JD, Wallace AS, et al. The rising prevalence of chronic low back pain. Arch Intern Med. 2009;169(3):251-8.
Koley S, Singh G, Sandhu R. Severity of disability in elderly patients with low back pain in Amritsar, Punjab. Anthropologist. 2008;10(4):265-8.
Mathew AC, Safar RS, Anithadevi TS, Banu MS, Ravi SL, Rai BD, et al. The prevalence and correlates of low back pain in adults: a cross sectional study from Southern India. Int J Med Public Health. 2013;3(4):342-6.
Ningegowda LB, Mekhail NA. Pharmacologic strategies in back pain and radiculopathy. In: Herkowitz HN, Garfin SA, Eismont FJ, Bell GR, Balderston RA, editors. Rothman-Simeone the Spine. 6th Edition. Philadelphia: Elsevier Saunders; 2011: 1895-900.
The use of the WHO-UMC system for standardized case causality assessment. Available at http://www.who-umc.org/Graphics/24734.pdf. Cited 26 September 2014.
Taguchi T. Low back pain in young and middle-aged people. Jpn Med Assoc J. 2003;46(10):417-23.
Hoy D, Bain C, Williams G, March L, Brooks P, Blyth F, et al. A systematic review of the global prevalence of low back pain. Arthritis Rheum. 2012;64(6):2028-37.
Papageorgiou AC, Croft PR, Ferry S, Jayson MI, Silman AJ. Estimating the prevalence of low back pain in the general population. Evidence from the South Manchester Back Pain Survey. Spine. 1995;20(17):1889-94.
Ochsmann E, Rüger H, Kraus T, Drexler H, Letzel S, Münster E. Gender-specific risk factors for acute low back pain: starting points for target-group-specific prevention. Schmerz. 2009;23(4):377-84.
Laine L. The gastrointestinal effects of nonselective NSAIDs and COX-2-selective inhibitors. Semin Arthritis Rheum 2002;32 3 Suppl 1:25-32.
Saper JR, Lake AE 3rd, Cantrell DT, Winner PK, White JR. Chronic daily headache prophylaxis with tizanidine: a double-blind, placebo-controlled, multicenter outcome study. Headache. 2002;42(6):470-82.
Rosenstock J, Tuchman M, LaMoreaux L, Sharma U. Pregabalin for the treatment of painful diabetic peripheral neuropathy: a double-blind, placebo-controlled trial. Pain. 2004;110(3):628-38.
Langley PC, Patkar AD, Boswell KA, Benson CJ, Schein JR. Adverse event profile of tramadol in recent clinical studies of chronic osteoarthritis pain. Curr Med Res Opin. 2010;26(1):239-51.