Efficacy and safety of paracetamol for spinal pain and osteoarthritis: Systematic review and meta-analysis of randomised placebo controlled trials

BMJ (Online)

Volumn 350, Issue , 2015, Pages

  Machado, Gustavo C ^a   Maher, Chris G ^a   Ferreira, Paulo H ^b   Pinheiro, Marina B ^b   Lin, Chung Wei Christine ^a   Day, Richard O ^c   McLachlan, Andrew J ^b,d   Ferreira, Manuela L ^a  

^a UNIVERSITY OF SYDNEY   (Australia)

^b UNIVERSITY OF SYDNEY   (Australia)

^c UNIVERSITY OF NEW SOUTH WALES   (Australia)

^d Department of Microbiology and Infectious Diseases   (Australia)

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; IBUPROFEN; NAPROXEN; PARACETAMOL; PLACEBO; ANALGESIC AGENT;

ALANINE AMINOTRANSFERASE BLOOD LEVEL; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; DISABILITY; DRUG EFFICACY; DRUG SAFETY; DRUG USE; HIP OSTEOARTHRITIS; HUMAN; KNEE OSTEOARTHRITIS; LIVER FUNCTION TEST; LOW BACK PAIN; META ANALYSIS; NECK PAIN; PAIN ASSESSMENT; PAIN INTENSITY; PATIENT COMPLIANCE; PRIORITY JOURNAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; SIDE EFFECT; SINGLE DRUG DOSE; SYSTEMATIC REVIEW; TREATMENT WITHDRAWAL; OSTEOARTHRITIS, HIP; OSTEOARTHRITIS, KNEE; TREATMENT OUTCOME;

ACETAMINOPHEN; ANALGESICS, NON-NARCOTIC; HUMANS; LOW BACK PAIN; NECK PAIN; OSTEOARTHRITIS, HIP; OSTEOARTHRITIS, KNEE; RANDOMIZED CONTROLLED TRIALS AS TOPIC; TREATMENT OUTCOME;

EID: 84926286161     PISSN: 09598146     EISSN: 17561833     Source Type: Journal    
DOI: 10.1136/bmj.h1225     Document Type: Review

References (63)

1. Vos T, Flaxman AD, Naghavi M, et al. Years lived with disability (YLDs) for 1160 sequelae of 289 diseases and injuries 1990-2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet 2012;380:2163-96.
2. Cross M, Smith E, Hoy D, et al. The global burden of hip and knee osteoarthritis: estimates from the Global Burden of Disease 2010 study. Ann Rheum Dis 2014;73:1323-30.
3. Hoy D, March L, Brooks P, et al. The global burden of low back pain: estimates from the Global Burden of Disease 2010 study. Ann Rheum Dis 2014;73:968-74.
4. Hoy D, March L, Woolf A, et al. The global burden of neck pain: estimates from the Global Burden of Disease 2010 study. Ann Rheum Dis 2014;73:1309-15.
5. United States Bone and Joint Initiative. The burden of musculoskeletal diseases in the United States. 3rd ed. American Academy of Orthopaedic Surgeons, 2014. www.boneandjointburden.org.
6. Bertin P, Becquemont L, Corruble E, et al. The therapeutic management of chronic pain in ambulatory care patients aged 65 and over in France: the S.AGES Cohort. Baseline data. J Nutr Health Aging 2013;17:681-6.
7. Chou R, Qaseem A, Snow V, et al. 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 2007;147:478-91.
8. Zhang W, Doherty M, Arden N, et al. EULAR evidence based recommendations for the management of hip osteoarthritis: report of a task force of the EULAR Standing Committee for International Clinical Studies Including Therapeutics (ESCISIT). Ann Rheum Dis 2005;64:669-81.
9. Jordan KM, Arden NK, Doherty M, et al. EULAR Recommendations 2003: an evidence based approach to the management of knee osteoarthritis: Report of a Task Force of the Standing Committee for International Clinical Studies Including Therapeutic Trials (ESCISIT). Ann Rheum Dis 2003;62:1145-55.
10. Hochberg MC, Altman RD, April KT, et al. American College of Rheumatology 2012 recommendations for the use of nonpharmacologic and pharmacologic therapies in osteoarthritis of the hand, hip, and knee. Arthritis Care Res 2012;64:465-74.
11. McAlindon TE, Bannuru RR, Sullivan MC, et al. OARSI guidelines for the non-surgical management of knee osteoarthritis. Osteoarthritis Cartilage 2014;22:363-88.
12. Wise J. NICE keeps paracetamol in UK guidelines on osteoarthritis. BMJ 2014;348:g1545.
13. Zhang W, Jones A, Doherty M. Does paracetamol (acetaminophen) reduce the pain of osteoarthritis? A meta-analysis of randomised controlled trials. Ann Rheum Dis 2004;63:901-7.
14. Towheed TE, Maxwell L, Judd MG, et al. Acetaminophen for osteoarthritis. Cochrane Database Syst Rev 2006;1:CD004257.
15. Zhang W, Nuki G, Moskowitz RW, et al. OARSI recommendations for the management of hip and knee osteoarthritis: part III: Changes in evidence following systematic cumulative update of research published through January 2009. Osteoarthritis Cartilage 2010;18:476-99.
16. Tylenol (acetaminophen) professional product information. McNeil Consumer Healthcare, 2010.
17. Jalan R, Williams R, Bernuau J. Paracetamol: are therapeutic doses entirely safe? Lancet 2006;368:2195-6.
18. Graham GG, Davies MJ, Day RO, et al. The modern pharmacology of paracetamol: therapeutic actions, mechanism of action, metabolism, toxicity and recent pharmacological findings. Inflammopharmacology 2013;21:201-32.
19. Graham GG, Day RO, Graudins A, et al. FDA proposals to limit the hepatotoxicity of paracetamol (acetaminophen): are they reasonable? Inflammopharmacology 2010;18:47-55.
20. Laba TL, Brien JA, Fransen M, et al. Patient preferences for adherence to treatment for osteoarthritis: the MEdication Decisions in Osteoarthritis Study (MEDOS). BMC Musculoskelet Disord 2013;14:160.
21. Davies RA, Maher CG, Hancock MJ. A systematic review of paracetamol for non-specific low back pain. Eur Spine J 2008;17:1423-30.
22. Freedman B. Placebo-controlled trials and the logic of clinical purpose. IRB 1990;12:1-6.
23. Liberati A, Altman DG, Tetzlaff J, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: explanation and elaboration. BMJ 2009;339:b2700.
24. Higgins JPT, Green S. Cochrane handbook for systematic reviews of interventions. Version 5.1.0. Cochrane Collaboration, 2009.
25. Higgins JP, Altman DG, Gotzsche PC, et al. The Cochrane Collaboration's tool for assessing risk of bias in randomised trials. BMJ 2011;343:d5928.
26. Guyatt GH, Oxman AD, Vist GE, et al. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ 2008;336:924-6.
27. Guyatt GH, Oxman AD, Kunz R, et al. GRADE guidelines: 2. Framing the question and deciding on important outcomes. J Clin Epidemiol 2011;64:395-400.
28. Guyatt GH, Oxman AD, Kunz R, et al. GRADE guidelines: 8. Rating the quality of evidence-indirectness. J Clin Epidemiol 2011;64:1303-10.
29. Guyatt GH, Oxman AD, Vist G, et al. GRADE guidelines: 4. Rating the quality of evidence-study limitations (risk of bias). J Clin Epidemiol 2011;64:407-15.
30. Guyatt GH, Oxman AD, Kunz R, et al. GRADE guidelines: 7. Rating the quality of evidence-inconsistency. J Clin Epidemiol 2011;64:1294-302.
31. Guyatt GH, Oxman AD, Kunz R, et al. GRADE guidelines 6. Rating the quality of evidence-imprecision. J Clin Epidemiol 2011;64:1283-93.
32. Wandel S, Juni P, Tendal B, et al. Effects of glucosamine, chondroitin, or placebo in patients with osteoarthritis of hip or knee: network meta-analysis. BMJ 2010;341:c4675.
33. Egger M, Davey Smith G, Schneider M, et al. Bias in meta-analysis detected by a simple, graphical test. BMJ 1997;315:629-34.
34. Guyatt GH, Oxman AD, Montori V, et al. GRADE guidelines: 5. Rating the quality of evidence-publication bias. J Clin Epidemiol 2011;64:1277-82.
35. Hjermstad MJ, Fayers PM, Haugen DF, et al. Studies comparing numerical rating scales, verbal rating scales, and visual analogue scales for assessment of pain intensity in adults: a systematic literature review. J Pain Symptom Manage 2011;41:1073-93.
36. Kersten P, White PJ, Tennant A. The visual analogue WOMAC 3.0 scale-internal validity and responsiveness of the VAS version. BMC Musculoskelet Disord 2010;11:80.
37. Pincus T, Yazici Y, Bergman M. Development of a multi-dimensional health assessment questionnaire (MDHAQ) for the infrastructure of standard clinical care. Clin Exp Rheumatol 2005;23:S19-28.
38. Bellamy N. WOMAC osteoarthritis index user guide IV. University of Queensland, 2000.
39. Higgins JP, Thompson SG. Quantifying heterogeneity in a metaanalysis. Stat Med 2002;21:1539-58.
40. Nuesch E, Trelle S, Reichenbach S, et al. Small study effects in meta-analyses of osteoarthritis trials: meta-epidemiological study. BMJ 2010;341:241.
41. Langan D, Higgins JP, Gregory W, et al. Graphical augmentations to the funnel plot assess the impact of additional evidence on a meta-analysis. J Clin Epidemiol 2012;65:511-9.
42. Ferreira ML, Herbert RD, Crowther MJ, et al. When is a further clinical trial justified? BMJ 2012;345:e5913.
43. Amadio P Jr, Cummings DM. Evaluation of acetaminophen in the management of osteoarthritis of the knee. Curr Ther Res Clin Exp 1983;34:59-66.
44. Zoppi M, Peretti G, Boccard E. Placebo-controlled study of the analgesic efficacy of an effervescent formulation of 500?mg paracetamol in arthritis of the knee or the hip. Eur J Pain 1995;16:42-48.
45. Nadler SF, Steiner DJ, Erasala GN, et al. Continuous low-level heat wrap therapy provides more efficacy than Ibuprofen and acetaminophen for acute low back pain. Spine 2002;27:1012-7.
46. Case JP, Baliunas AJ, Block JA. Lack of efficacy of acetaminophen in treating symptomatic knee osteoarthritis: a randomized, doubleblind, placebo-controlled comparison trial with diclofenac sodium. Arch Intern Med 2003;163:169-78.
47. Golden HE, Moskowitz RW, Minic M. Analgesic efficacy and safety of nonprescription doses of naproxen sodium compared with acetaminophen in the treatment of osteoarthritis of the knee. Am J Ther 2004;11:85-94.
48. Miceli-Richard C, Le Bars M, Schmidely N, et al. Paracetamol in osteoarthritis of the knee. Ann Rheum Dis 2004;63:923-30.
49. Pincus T, Koch G, Lei H, et al. Patient preference for placebo, acetaminophen (paracetamol) or celecoxib efficacy studies (PACES): two randomised, double blind, placedo controlled, crossover clinical trials in patients with knee or hip osteoarthritis. Ann Rheum Dis 2004;63:931-39.
50. Altman RD, Zinsenheim JR, Temple AR, et al. Three-month efficacy and safety of acetaminophen extended-release for osteoarthritis pain of the hip or knee: a randomized, double-blind, placebo-controlled study. Osteoarthritis Cartilage 2007;15:454-61.
51. Herrero-Beaumont G, Ivorra JA, Del Carmen Trabado M, et al. Glucosamine sulfate in the treatment of knee osteoarthritis symptoms: a randomized, double-blind, placebo-controlled study using acetaminophen as a side comparator. Arthritis Rheum 2007;56:555-67.
52. Wetzel L, Zadrazil M, Paternostro-Sluga T, et al. Intravenous nonopioid analgesic drugs in chronic low back pain patients on chronic opioid treatment: a crossover, randomised, double-blinded, placebocontrolled study. Eur J Anaesthesiol 2014;31:35-40.
53. Williams C, Maher C, Latimer J, et al. Efficacy of paracetamol for acute low-back pain: a double-blind, randomised controlled trial. Lancet 2014;384:1586-96.
54. Prior MJ, Harrison DD, Frustaci ME. A randomized, double-blind, placebo-controlled 12 week trial of acetaminophen extended release for the treatment of signs and symptoms of osteoarthritis. Curr Med Res Opin 2014;30:2377-87.
55. Glimet TJ, Lermusiaux JL, Masse C, et al. Etude controlee de l'action antalgique du paracetamol effervescent dans la gonarthrose. Rev Rhum 1989;56:269.
56. Altman RD. Ibuprofen, acetaminophen and placebo in osteoarthritis of the knee: a six-day double-blind study. Arthritis Rheum 1999;42:S403.
57. Amar PJ, Schiff ER. Acetaminophen safety and hepatotoxicity-where do we go from here? Expert Opin Drug Saf 2007;6:341-55.
58. Watkins PB, Kaplowitz N, Slattery JT, et al. Aminotransferase elevations in healthy adults receiving 4 grams of acetaminophen daily-a randomized controlled trial. JAMA 2006;296:87-93.
59. Barthel HR, Peniston JH, Clark MB, et al. Correlation of pain relief with physical function in hand osteoarthritis: randomized controlled trial post hoc analysis. Arthritis Res Ther 2010;12:R7.
60. Schein JR, Kosinski MR, Janagap-Benson C, et al. Functionality and health-status benefits associated with reduction of osteoarthritis pain. Curr Med Res Opin 2008;24:1255-65.
61. Gronblad M, Hupli M, Wennerstrand P, et al. Intercorrelation and test-retest reliability of the pain disability index (PDI) and the Oswestry disability questionnaire (ODQ) and their correlation with pain intensity in low back pain patients. Clin J Pain 1993;9:189-95.
62. Sheldon EA, Bird SR, Smugar SS, et al. Correlation of measures of pain, function, and overall response: results pooled from two identical studies of etoricoxib in chronic low back pain. Spine 2008;33:533-8.
63. Uthman OA, van der Windt DA, Jordan JL, et al. Exercise for lower limb osteoarthritis: systematic review incorporating trial sequential analysis and network meta-analysis. BMJ 2013;347:f5555.