Abstract
Introduction
The objective of this study was to obtain parameter estimates for the efficacy of duloxetine versus alternative oral therapies for the treatment of chronic low back pain.
Materials and Methods
Electronic databases were searched to identify randomised, double-blind placebo-controlled trials. Studies reporting pain intensity, with parallel-group design of oral treatments with length of treatment of more than 8 weeks were included. A Bayesian approach to indirect comparisons was applied, using standardised mean difference as a measure of relative treatment effect.
Results
Fifteen studies were identified comparing duloxetine with the following oral drug classes: non-scheduled opioids, cyclooxygenase-2 inhibitors, scheduled opioids, selective serotonin reuptake inhibitors, and ‘other’ (i.e. glucosamine). The primary analysis found scheduled opioids to be more effective than duloxetine for the fixed effects model. However, the estimate of the treatment difference reflected a less than small magnitude of effect (|standardised mean difference| <0.2), and there was no difference for the random effects model. No differences were found in sensitivity analyses involving the subset of patients not receiving concomitant non-steroidal anti-inflammatory medication.
Conclusion
The available evidence shows that there does not seem to be any difference in efficacy between duloxetine and other oral pharmacological therapies, providing a valuable alternative for this disabling condition.
This is a preview of subscription content,
to check access.


Similar content being viewed by others
References
Airaksinen O, Brox JI, Cedraschi C, Hildebrandt J, Klaber-Moffett J, Kovacs F, Mannion AF, Reis S, Staal JB, Ursin H, Zanoli G (2006) Chapter 4. European guidelines for the management of chronic nonspecific low back pain. Eur Spine J 15(Suppl 2):S192–S300
Birbara CA, Puopolo AD, Munoz DR, Sheldon EA, Mangione A, Bohidar NR, Geba GP (2003) Treatment of chronic low back pain with etoricoxib, a new cyclo-oxygenase-2 selective inhibitor: improvement in pain and disability––a randomized, placebo-controlled, 3-month trial. J Pain 4:307–315
Buynak R, Shapiro DY, Okamoto A, Van HI, Rauschkolb C, Steup A, Lange B, Lange C, Etropolski M (2010) Efficacy and safety of tapentadol extended release for the management of chronic low back pain: results of a prospective, randomized, double-blind, placebo and active-controlled Phase III study. Expert Opin Pharmacother 11:1787–1804
Chou R, Qaseem A, Snow V, Casey D, Cross JT Jr, Shekelle P, Owens DK (2007) Diagnosis and treatment of low back pain: a joint clinical practice guideline from the american college of physicians and the american pain society. Ann Intern Med 147:478–491
Choy E, Marshall D, Gabriel ZL, Mitchell SA, Gylee E, Dakin HA (2011) A systematic review and mixed treatment comparison of the efficacy of pharmacological treatments for fibromyalgia. Semin Arthritis Rheum 41:335–345
Deyo RA (1996) Drug therapy for back pain. Which drugs help which patients? Spine 21:2840–2849
Dickens CJ (2000) The relationship between pain and depression in a trial using paroxetine in sufferers of chronic low back pain. Psychosomatics 41:2000
Eli Lilly and Company (2009) Effect of duloxetine 60 mg once daily versus placebo in patients with chronic low back pain (F1 J-Mc-HMGC). Internal report: 1–983
Eli Lilly and Company (2008) Duloxetine versus placebo in the treatment of chronic low back pain (F1 J-MC-HMEO). Internal report: 1–1435
Eli Lilly and Company (2008) Effect of duloxetine 60 mg to 120 mg once daily in patients with chronic low back pain (F1 J-MC-HMEN). Internal report: 1–614
Giesecke T, Gracely RH, Grant MA, Nachemson A, Petzke F, Williams DA, Clauw DJ (2004) Evidence of augmented central pain processing in idiopathic chronic low back pain. Arthritis Rheum 50:613–623
Grabois M (2005) Management of chronic low back pain. Am J Phys Med Rehabil 84:S29–S41
Hale M, Khan A, Kutch M, Li S (2010) Once daily OROS hydromorphone ER compared with placebo in opioid-tolerant patients with chronic low back pain. Curr Med Res Opin 26:1505–1518
Hale ME, Ahdieh H, Ma T, Rauck R (2007) Efficacy and safety of OPANA ER (oxymorphone extended release) for relief of moderate to severe chronic low back pain in opioid-experienced patients: a 12-week, randomized, double-blind, placebo-controlled study. J Pain 8:175–184
Hedges LV, Olkin I (1985) Statistical methods for meta-analysis. Academic Press, Orlando
Higgins JPT, Green S (2009) Cochrane handbook for systematic reviews of interventions. version 5.0.2 [updated September 2009]. The cochrane collaboration
Hoaglin DC, Hawkins N, Jansen JP, Scott DA, Itzler R, Cappelleri JC, Boersma C, Thompson D, Larholt KM, Diaz M, Barrett A (2011) Conducting indirect-treatment comparison and network-meta-analysis studies: report of the ISPOR task force on indirect treatment comparisons good research practices: part 2. Value Health 14:429–437
Hoy D, Brooks P, Blyth F, Buchbinder R (2010) The epidemiology of low back pain. Best Pract Res Clin Rheumatol 24:769–781
Katz N, Rauck R, Ahdieh H, Ma T, Gerritsen vdH, Kerwin R, Podolsky G (2007) A 12-week, randomized, placebo-controlled trial assessing the safety and efficacy of oxymorphone extended release for opioid-naive patients with chronic low back pain. Curr Med Res Opin 23:117–128
Machado LA, Kamper SJ, Herbert RD, Maher CG, McAuley JH (2009) Analgesic effects of treatments for non-specific low back pain: a meta-analysis of placebo-controlled randomized trials. Rheumatology 48:520–527
Moore RA, Straube S, Derry S, McQuay HJ (2010) Chronic low back pain analgesic studies––a methodological minefield. Pain 149:431–434
Pallay RM, Seger W, Adler JL, Ettlinger RE, Quaidoo EA, Lipetz R, O’Brien K, Mucciola L, Skalky CS, Petruschke RA, Bohidar NR, Geba GP (2004) Etoricoxib reduced pain and disability and improved quality of life in patients with chronic low back pain: a 3 month, randomized, controlled trial. Scand J Rheumatol 33:257–266
Peloso PM, Fortin L, Beaulieu A, Kamin M, Rosenthal N (2004) Analgesic efficacy and safety of tramadol/acetaminophen combination tablets (Ultracet) in treatment of chronic low back pain: a multicenter, outpatient, randomized, double blind, placebo controlled trial. J Rheumatol 31:2454–2463
Quilici S, Chancellor J, Lothgren M, Simon D, Said G, Le TK, Garcia-Cebrian A, Monz B (2009) Meta-analysis of duloxetine versus pregabalin and gabapentin in the treatment of diabetic peripheral neuropathic pain. BMC Neurol 9:6
Ruoff GE, Rosenthal N, Jordan D, Karim R, Kamin M (2003) Tramadol/acetaminophen combination tablets for the treatment of chronic lower back pain: a multicenter, randomized, double-blind, placebo-controlled outpatient study. Clin Ther 25:1123–1141
Shekelle PG, Markovich M, Louie R (1995) An epidemiologic study of episodes of back pain care. Spine (Phila Pa 1976) 20:1668–1673
Shekelle PG, Markovich M, Louie R (1995) Comparing the costs between provider types of episodes of back pain care. Spine (Phila Pa 1976) 20:221–226
Skljarevski V, Desaiah D, Liu-Seifert H, Zhang Q, Chappell AS, Detke MJ, Iyengar S, Atkinson JH, Backonja M (2010) Efficacy and safety of duloxetine in patients with chronic low back pain. Spine (Phila Pa 1976) 35:E578–E585
Skljarevski V, Ossanna M, Liu-Seifert H, Zhang Q, Chappell A, Iyengar S, Detke M, Backonja M (2009) A double-blind, randomized trial of duloxetine versus placebo in the management of chronic low back pain. Eur J Neurol 16:1041–1048
Skljarevski V, Zhang S, Desaiah D, Alaka KJ, Palacios S, Miazgowski T, Patrick K (2010) Duloxetine versus placebo in patients with chronic low back pain: a 12 week, fixed-dose, randomized, double-blind trial. J Pain 11:1282–1290
Spiegelhalter D, Abrams K, Myles J (2004) Bayesian approaches to clinical trials and health-care evaluation. Statistics in Practice. Wiley, New York
Straube S, Derry S, McQuay HJ, Moore RA (2008) Enriched enrollment: definition and effects of enrichment and dose in trials of pregabalin and gabapentin in neuropathic pain. A systematic review. Br J Clin Pharmacol 66:266–275
Tacconelli E (2010) Systematic reviews: CRD's guidance for undertaking reviews in health care. Lancet Infect Dis 10(4):226
Vorsanger GJ, Xiang J, Gana TJ, Pascual ML, Fleming RR (2008) Extended-release tramadol (tramadol ER) in the treatment of chronic low back pain. J Opioid Manag 4:87–97
Webster LR, Butera PG, Moran LV, Wu N, Burns LH, Friedmann N (2006) Oxytrex minimizes physical dependence while providing effective analgesia: a randomized controlled trial in low back pain. J Pain 7:937–946
Wilkens P, Scheel IB, Grundnes O, Hellum C, Storheim K (2010) Effect of glucosamine on pain-related disability in patients with chronic low back pain and degenerative lumbar osteoarthritis: a randomized controlled trial. JAMA 304:45–52
Conflict of interest
This study was funded by Eli Lilly and Company.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Cawston, H., Davie, A., Paget, MA. et al. Efficacy of duloxetine versus alternative oral therapies: an indirect comparison of randomised clinical trials in chronic low back pain. Eur Spine J 22, 1996–2009 (2013). https://doi.org/10.1007/s00586-013-2804-7
Received:
Revised:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s00586-013-2804-7