Duloxetine for the Treatment of Chronic Low Back Pain: A Systematic Review of Randomized Placebo-Controlled Trials

Takashi Hirase, Jessica Hirase, Jeremiah Ling, Peggy H Kuo, Gilbert A Hernandez, Kayode Giwa, Rex Marco, Takashi Hirase, Jessica Hirase, Jeremiah Ling, Peggy H Kuo, Gilbert A Hernandez, Kayode Giwa, Rex Marco

Abstract

This systematic review determines the efficacy and safety of duloxetine for chronic low back pain (CLBP). We queried the PubMed, SCOPUS, and Ovid MEDLINE databases. All level I and II randomized controlled studies published in the English language investigating the efficacy of duloxetine for chronic low back pain were included. Five studies (832 duloxetine-treated patients, 667 placebo-treated patients, and 41 duloxetine and placebo crossover analysis patients) were analyzed. One study was level I evidence and four studies were level II evidence. All five studies reported statistically significant improvements in more than one back-pain-specific clinical outcome score with duloxetine versus placebo. Four studies found that duloxetine 60 mg daily leads to one or more statistically significant improvements versus placebo in Brief Pain Inventory Severity (BPI-S) scores. All five studies found no significant difference in serious adverse events (AEs) between the duloxetine and placebo groups. One study found a higher rate of total AEs among the duloxetine 120 mg group versus the placebo group; however, the same study did not find a significant difference in total AEs among duloxetine 20 mg and 60 mg groups versus placebo. Duloxetine is a safe and effective first-line option for the treatment of CLBP. Current studies demonstrate that 60 mg taken once daily has the highest efficacy for reducing pain and disability while minimizing minor adverse effects. Further randomized controlled trials with long-term follow-up are necessary to determine its long-term effects.

Keywords: chronic pain; duloxetine; low back pain; lumbar spondylosis; pain management.

Conflict of interest statement

Takashi Hirase was supported by a Burroughs Wellcome Fund Physician-Scientist Award to the Texas A&M University Academy of Physician Scientists.

Copyright © 2021, Hirase et al.

Figures

Figure 1. The Preferred Reporting Items for…
Figure 1. The Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) flowchart showing the application of selection criteria to the studies identified with the search strategy

References

    1. Global low back pain prevalence and years lived with disability from 1990 to 2017: estimates from the Global Burden of Disease Study 2017. Wu A, March L, Zheng X, et al. Ann Transl Med. 2020;8:299.
    1. Epidemiology of low back pain. Manchikanti L. Pain Physician. 2014;3:167–192.
    1. Prevalence of low back pain, seeking medical care, and lost time due to low back pain among manual material handling workers in the United States. Ferguson SA, Merryweather A, Thiese MS, Hegmann KT, Lu ML, Kapellusch JM, Marras WS. BMC Musculoskelet Disord. 2019;20:243.
    1. Lumbar disc disorders and low-back pain: socioeconomic factors and consequences. Katz JN. J Bone Joint Surg Am. 2006;88 Suppl 2:21–24.
    1. The rising prevalence of chronic low back pain. Freburger JK, Holmes GM, Agans RP, et al. Arch Intern Med. 2009;169:251–258.
    1. Trends and variations in the use of spine surgery. Deyo RA, Mirza SK. Clin Orthop Relat Res. 2006;443:139–146.
    1. Patterns and trends in opioid use among individuals with back pain in the United States. Luo X, Pietrobon R, Hey L. Spine (Phila Pa 1976) 2004;29:884–890.
    1. Peripheral and central hyperexcitability: differential signs and symptoms in persistent pain. Coderre TJ, Katz J. Behav Brain Sci. 1997;20:404–419.
    1. Low back pain. Deyo RA, Weinstein JN. N Engl J Med. 2001;344:363–370.
    1. Clinical practice guidelines for the management of non-specific low back pain in primary care: an updated overview. Oliveira CB, Maher CG, Pinto RZ, et al. Eur Spine J. 2018;27:2791–2803.
    1. Nonsteroidal anti-inflammatory drugs for low back pain. A systematic review within the framework of the Cochrane Collaboration Back Review Group. van Tulder MW, Scholten RJ, Koes BW, Deyo RA. Spine (Phila Pa 1976) 2000;25:2501–2513.
    1. Adverse drug reactions of nonsteroidal anti-inflammatory drugs in orthopedic patients. Gor AP, Saksena M. J Pharmacol Pharmacother. 2011;2:26–29.
    1. Practice guidelines for the management of low back pain. Consensus Group of Practice Parameters to Manage Low Back Pain. Guevara-López U, Covarrubias-Gómez A, Elías-Dib J, Reyes-Sánchez A, Rodríguez-Reyna TS. Cir Cir. 2011;79:264-79, 286-302.
    1. Comparison of stratified primary care management for low back pain with current best practice (STarT Back): a randomised controlled trial. Hill JC, Whitehurst DG, Lewis M, et al. Lancet. 2011;378:1560–1571.
    1. Epidural corticosteroid injection in the conservative management of sciatica. Buchner M, Zeifang F, Brocai DR, Schiltenwolf M. Clin Orthop Relat Res. 2000:149–156.
    1. Duloxetine, 60 mg once daily, for major depressive disorder: a randomized double-blind placebo-controlled trial. Detke MJ, Lu Y, Goldstein DJ, Hayes JR, Demitrack MA. J Clin Psychiatry. 2002;63:308–315.
    1. Pharmacotherapy of generalized anxiety disorder: results of duloxetine treatment from a pooled analysis of three clinical trials. Allgulander C, Hartford J, Russell J, Ball S, Erickson J, Raskin J, Rynn M. Curr Med Res Opin. 2007;23:1245–1252.
    1. A double-blind, randomized multicenter trial comparing duloxetine with placebo in the management of diabetic peripheral neuropathic pain. Raskin J, Pritchett YL, Wang F, D'Souza DN, Waninger AL, Iyengar S, Wernicke JF. Pain Med. 2005;6:346–356.
    1. A double-blind, multicenter trial comparing duloxetine with placebo in the treatment of fibromyalgia patients with or without major depressive disorder. Arnold LM, Lu Y, Crofford LJ, Wohlreich M, Detke MJ, Iyengar S, Goldstein DJ. Arthritis Rheum. 2004;50:2974–2984.
    1. A double-blind, randomized trial of duloxetine versus placebo in the management of chronic low back pain. Skljarevski V, Ossanna M, Liu-Seifert H, et al. Eur J Neurol. 2009;16:1041–1048.
    1. Efficacy and safety of duloxetine in patients with chronic low back pain. Skljarevski V, Desaiah D, Liu-Seifert H, et al. Spine (Phila Pa 1976) 2010;35:0–85.
    1. Duloxetine versus placebo in patients with chronic low back pain: a 12-week, fixed-dose, randomized, double-blind trial. Skljarevski V, Zhang S, Desaiah D, Alaka KJ, Palacios S, Miazgowski T, Patrick K. J Pain. 2010;11:1282–1290.
    1. Randomized, double-blind, placebo-controlled phase III trial of duloxetine monotherapy in Japanese patients with chronic low back pain. Konno S, Oda N, Ochiai T, Alev L. Spine (Phila Pa 1976) 2016;41:1709–1717.
    1. Efficacy of duloxetine in chronic low back pain with a neuropathic component: A randomized, double-blind, placebo-controlled crossover trial. Schukro RP, Oehmke MJ, Geroldinger A, Heinze G, Kress HG, Pramhas S. Anesthesiology. 2016;124:150–158.
    1. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. Moher D, Liberati A, Tetzlaff J, Altman DG. PLoS Med. 2009;6:0.
    1. CEBM. Levels of evidence: an introduction. [Dec;2020 ];CEBM CEBM. 2020
    1. How to write a systematic review. Harris JD, Quatman CE, Manring MM, Siston RA, Flanigan DC. . Am J Sports Med. 2014;42:2761–2768.
    1. Studies of surgical outcome after patellar tendinopathy: clinical significance of methodological deficiencies and guidelines for future studies. Coleman BD, Khan KM, Maffulli N, Cook JL, Wark JD. Scand J Med Sci Sports. 2000;10:2–11.
    1. Strength of recommendation taxonomy (SORT): a patient-centered approach to grading evidence in the medical literature. Ebell MH, Siwek J, Weiss BD, Woolf SH, Susman J, Ewigman B, Bowman M. Am Fam Physician. 2004;69:548–556.
    1. GRADE working group. [Dec;2020 ]; 2004
    1. Estimating data from figures with a web-based program: considerations for a systematic review. Burda BU, O'Connor EA, Webber EM, Redmond N, Perdue LA. Res Synth Methods. 2017;8:258–262.
    1. Intercoder reliability and validity of WebPlotDigitizer in extracting graphed data. Drevon D, Fursa SR, Malcolm AL. Behav Modif. 2017;41:323–339.
    1. RoB 2: a revised tool for assessing risk of bias in randomised trials. Sterne JAC, Savović J, Page MJ, et al. BMJ. 2019;366:0.
    1. Estimation of minimum clinically important difference for pain in fibromyalgia. Mease PJ, Spaeth M, Clauw DJ, et al. Arthritis Care Res (Hoboken) 2011;63:821–826.
    1. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole MR. Pain. 2001;94:149–158.
    1. Pain assessment: global use of the Brief Pain Inventory. Cleeland CS, Ryan KM. Ann Acad Med Singap. 1994;23:129–138.
    1. Clinically important outcomes in low back pain. Ostelo RW, de Vet HC. Best Pract Res Clin Rheumatol. 2005;19:593–607.
    1. Clinically significant changes in pain along the Pain Intensity Numerical Rating Scale in patients with chronic low back pain. Suzuki H, Aono S, Inoue S, et al. PLoS One. 2020;15:0.
    1. Non-steroidal anti-inflammatory drugs for chronic low back pain. Enthoven WT, Roelofs PD, Deyo RA, van Tulder MW, Koes BW. Cochrane Database Syst Rev. 2016;2:0.
    1. Individual NSAIDs and upper gastrointestinal complications: a systematic review and meta-analysis of observational studies (the SOS project) Castellsague J, Riera-Guardia N, Calingaert B, et al. Drug Saf. 2012;35:1127–1146.
    1. Treatment modalities for hip and knee osteoarthritis: a systematic review of safety. Aweid O, Haider Z, Saed A, Kalairajah Y. J Orthop Surg (Hong Kong) 2018;26:2309499018808669.
    1. Opioids for chronic low back pain: an updated systematic review and meta-analysis of efficacy, tolerability and safety in randomized placebo-controlled studies of at least 4 weeks of double-blind duration. Petzke F, Klose P, Welsch P, Sommer C, Häuser W. Eur J Pain. 2020;24:497–451.
    1. Rates of opioid misuse, abuse, and addiction in chronic pain: a systematic review and data synthesis. Vowles KE, McEntee ML, Julnes PS, Frohe T, Ney JP, van der Goes DN. Pain. 2015;156:569–576.

Source: PubMed

Patrocinadores e Colaboradores

Condições médicas

Intervenções de drogas

3
Se inscrever