Opioids for chronic osteoarthritis pain: An updated systematic review and meta-analysis of efficacy, tolerability and safety in randomized placebo-controlled studies of at least 4 weeks double-blind duration.


Journal

European journal of pain (London, England)
ISSN: 1532-2149
Titre abrégé: Eur J Pain
Pays: England
ID NLM: 9801774

Informations de publication

Date de publication:
04 2020
Historique:
received: 11 08 2019
revised: 23 11 2019
accepted: 16 12 2019
pubmed: 27 12 2019
medline: 21 11 2020
entrez: 27 12 2019
Statut: ppublish

Résumé

This updated systematic review evaluated the efficacy and safety of opioids compared with placebo for chronic osteoarthritis pain. Clinicaltrials.gov, CENTRAL, MEDLINE and PsycINFO were searched from October 2013 to July 2019. Randomized controlled trials comparing opioids with placebo and at least 4 weeks double-blinded duration were analysed. Primary outcomes were pain relief of 50% or greater, disability, tolerability and safety. Effects were summarized by a random effects model using risk differences or standardized mean differences with 95% confidence intervals. We added two new studies with 397 participants for a total of 22 studies with 8,942 participants. Study duration ranged between 4 and 24 weeks. Studies with a parallel and cross-over design: Based on very low- to low-quality evidence, opioids provided no clinically relevant pain relief of 50% or greater and no clinically relevant reduction in disability compared with placebo. There was a clinically relevant harm related to the dropout rate due to adverse events. The frequency of serious adverse events did not differ from placebo. Enriched enrolment randomized withdrawal design: Based on very low- to low-quality evidence, opioids provided no clinically relevant pain relief of 50% or greater and no clinically relevant reduction in disability compared with placebo. Dropout rates due to adverse events and frequency of serious adverse events did not differ from placebo. Tolerability of opioids is low and efficacy is not clinically relevant in controlled studies from 4 to 24 weeks for osteoarthritis pain. Within the context of randomized controlled trials (4-24 weeks), opioids provided no clinically relevant pain relief and no clinically relevant reduction in disability compared with placebo in chronic osteoarthritis pain (hip, knee). Number needed to treat for an additional dropout due to side effects was 5 (95% confidence interval 4-7). Two studies found no signals of abuse and addiction. The frequency of serious adverse events including deaths did not differ from placebo.

Sections du résumé

BACKGROUND AND OBJECTIVE
This updated systematic review evaluated the efficacy and safety of opioids compared with placebo for chronic osteoarthritis pain.
DATABASES AND DATA TREATMENT
Clinicaltrials.gov, CENTRAL, MEDLINE and PsycINFO were searched from October 2013 to July 2019. Randomized controlled trials comparing opioids with placebo and at least 4 weeks double-blinded duration were analysed. Primary outcomes were pain relief of 50% or greater, disability, tolerability and safety. Effects were summarized by a random effects model using risk differences or standardized mean differences with 95% confidence intervals. We added two new studies with 397 participants for a total of 22 studies with 8,942 participants. Study duration ranged between 4 and 24 weeks. Studies with a parallel and cross-over design: Based on very low- to low-quality evidence, opioids provided no clinically relevant pain relief of 50% or greater and no clinically relevant reduction in disability compared with placebo. There was a clinically relevant harm related to the dropout rate due to adverse events. The frequency of serious adverse events did not differ from placebo. Enriched enrolment randomized withdrawal design: Based on very low- to low-quality evidence, opioids provided no clinically relevant pain relief of 50% or greater and no clinically relevant reduction in disability compared with placebo. Dropout rates due to adverse events and frequency of serious adverse events did not differ from placebo.
CONCLUSIONS
Tolerability of opioids is low and efficacy is not clinically relevant in controlled studies from 4 to 24 weeks for osteoarthritis pain.
SIGNIFICANCE
Within the context of randomized controlled trials (4-24 weeks), opioids provided no clinically relevant pain relief and no clinically relevant reduction in disability compared with placebo in chronic osteoarthritis pain (hip, knee). Number needed to treat for an additional dropout due to side effects was 5 (95% confidence interval 4-7). Two studies found no signals of abuse and addiction. The frequency of serious adverse events including deaths did not differ from placebo.

Identifiants

pubmed: 31876347
doi: 10.1002/ejp.1522
doi:

Substances chimiques

Analgesics, Opioid 0

Types de publication

Journal Article Meta-Analysis Research Support, Non-U.S. Gov't Systematic Review

Langues

eng

Sous-ensembles de citation

IM

Pagination

685-703

Commentaires et corrections

Type : ErratumIn

Informations de copyright

© 2019 European Pain Federation - EFIC®.

Références

Afilalo, M., Etropolski, M. S., Kuperwasser, B., Kelly, K., Okamoto, A., Van Hove, I., … Haeussler, J. (2010). Efficacy and safety of Tapentadol extended release compared with oxycodone controlled release for the management of moderate to severe chronic pain related to osteoarthritis of the knee: A randomized, double-blind, placebo- and active-controlled phase III study. Clin Drug Investig, 30, 489-505. https://doi.org/10.2165/11533440-000000000-00000
Afilalo, M., & Morlion, B. (2013). Efficacy of tapentadol ER for managing moderate to severe chronic pain. Pain Physician, 16, 27-40.
Ashburn, M. A., & Fleisher, L. A. (2018). Editorial: Increasing evidence for the limited role of opioids to treat chronic noncancer pain. JAMA, 320, 2427-2428. https://doi.org/10.1001/jama.2018.19327
Babul, N. D., Novek, R., Chipman, H., Roth, S. H., Gana, T., & Albert, K. (2004). Efficacy and safety of extended-release, once-daily tramadol in chronic pain: A randomized 12-week clinical trial in osteoarthritis of the knee. Journal of Pain and Symptom Management, 28, 59-71. https://doi.org/10.1016/j.jpainsymman.2003.11.006
Bialas, P., Maier, C., Klose, P., & Häuser, W. (2019). Efficacy and harms of long-term opioid therapy in chronic non-cancer pain: Systematic review and meta-analysis of open-label extension trials with a study duration ≥26 weeks. European Journal of Pain. https://doi.org/10.1002/ejp.1496
Breivik, H., Ljosaa, T. M., & Stengaard-Pedersen, K. (2010). A 6-months, randomised, placebo-controlled evaluation of efficacy and tolerability of a low-dose 7-day buprenorphine transdermal patch in osteoarthritis patients naive to potent opioids. Scandinavian Journal of Pain, 1, 122-141.
Busse, J. W., Craigie, S., Juurlink, D. N., Buckley, D. N., Wang, L., Couban, R. J., … Guyatt, G. H. (2017). Guideline for opioid therapy and. chronic noncancer pain. CMAJ, 189, E659-E666.
Caldwell, J. R., Hale, M. E., Boyd, R. E., Hague, J. M., Iwan, T., Shi, M., & Lacouture, P. G. (1999). Treatment of osteoarthritis pain with controlled release oxycodone or fixed combination oxycodone plus acetaminophen added to nonsteroidal antiinflammatory drugs: A double blind, randomized, multicenter, placebo controlled trial. Journal of Rheumatology, 26, 862-869.
Caldwell, J. R., Rapoport, R. J., Davis, J. C., Offenberg, H. L., Marker, H. W., Roth, S. H., … Lynch, P. M. (2002). Efficacy and safety of a once-daily morphine formulation in chronic, moderate-to-severe osteoarthritis pain: Results from a randomized, placebo-controlled, doubleblind trial and an open-label extension trial. Journal of Pain and Symptom Management, 23, 278-291. https://doi.org/10.1016/S0885-3924(02)00383-4
Charlesworth, J., Fitzpatrick, J., Perera, N. K. P., & Orchard, J. (2019). Osteoarthritis- a systematic review of long-term safety implications for osteoarthritis of the knee. BMC Musculoskeletal Disorders, 20, 151. https://doi.org/10.1186/s12891-019-2525-0
Cicero, T. J., Inciardi, J. A., & Muñoz, A. (2005). Trends in abuse of Oxycontin and other opioid analgesics in the United States: 2002-2004. The Journal of Pain, 6, 662-672. https://doi.org/10.1016/j.jpain.2005.05.004
Cochrane Pain, Palliative and Supportive Care Group. (2015). PaPaS author and referee guidance. Retrieved from papas.cochrane.org/papas-documents. Accessed June 5, 2015.
Cohen, J. (1988). Statistical power analysis for the behavioral sciences. Hillsdale: Lawrence Erlbaum Associates.
da Costa, B. R., Reichenbach, S., Keller, N., Nartey, L., Wandel, S., Jüni, P., & Trelle, S. (2017). Effectiveness of non-steroidal anti-inflammatory drugs for the treatment of pain in knee and hip osteoarthritis: A network meta-analysis. Lancet, 390, e21-e33. https://doi.org/10.1016/S0140-6736(17)31744-0
Dasgupta, N., Beletsky, L., & Ciccarone, D. (2018). Opioid crisis: No easy fix to its social and economic determinants. American Journal of Public Health, 108, 182-186. https://doi.org/10.2105/AJPH.2017.304187
DeLemos, B. P., Xiang, J., Benson, C., Gana, T. J., Pascual, M. L., Rosanna, R., & Fleming, B. (2011). Tramadol hydrochloride extended-release once-daily in the treatment of osteoarthritis of the knee and/or hip: A double-blind, randomized, dose-ranging trial. American Journal of Therapeutics, 18, 216-226. https://doi.org/10.1097/MJT.0b013e3181cec307
DeMik, D. E., Bedard, N. A., Dowdle, S. B., Burnett, R. A., McHugh, M. A., & Callaghan, J. J. (2017). Are we still prescribing opioids for osteoarthritis? Journal of Arthroplasty, 32, 3578-3582. https://doi.org/10.1016/j.arth.2017.07.030
Dowell, D., Haegerich, T. M., & Chou, R. (2016). CDC guideline for prescribing opioids for chronic pain-United States, 2016. JAMA, 315(15), 1624-1645. https://doi.org/10.1001/jama.2016.1464
European Medicines Agency. (2010). Guideline on clinical investigation of medicinal products used in the treatment of osteoarthritis Accessed April 20, 2019.
European Medicines Agency. (2017). Guideline on the clinical development of medicinal products intended for the treatment of pain. Retrieved from https://www.ema.europa.eu/en/clinical-development-medicinalproducts-intended-treatment-pain Accessed April 20, 2019.
Fayers, P. M., & Hays, R. D. (2014). Don’t middle your MIDs: Regression to the mean shrinks estimates of minimally important differences. Quality of Life Research, 23, 1-4. https://doi.org/10.1007/s11136-013-0443-4
Fishman, R. L., Kistler, C. J., Ellerbusch, M. T., Aparicio, R. T., Swami, S. S., Shirley, M. E., … Bouchard, S. (2007). Efficacy and safety of 12 weeks of osteoarthritic pain therapy with once-daily tramadol (Tramadol Contramid OAD). Journal of Opioid Management, 3, 273-280. https://doi.org/10.5055/jom.2007.0015
Fleischmann, R. M., Caldwell, J. R., Roth, S. H., Tesser, J. R. P., Olson, W., & Kamin, M. (2001). Tramadol for the treatment of joint pain associated with osteoarthritis: A randomized, double-blind, placebo-controlled trial. Current Therapeutic Research, 62, 113-128. https://doi.org/10.1016/S0011-393X(01)80021-7
Friedmann, N., Klutzaritz, V., & Webster, L. (2011). Efficacy and safety of an extended-release oxycodone (Remoxy) formulation in patients with moderate to severe osteoarthritic pain. Journal of Opioid Management, 7, 193-202. https://doi.org/10.5055/jom.2011.0062
Fuggle, N., Curtis, E., Shaw, S., Spooner, L., Bruyère, O., Ntani, G., … Cooper, C. (2019). Safety of opioids in osteoarthritis: Outcomes of a systematic review and meta-analysis. Drugs and Aging, 36, 129-143. https://doi.org/10.1007/s40266-019-00666-9
Gana, T. J., Pascual, M. L. G., Fleming, R. R. B., Schein, J. R., Janagap, C. C., Xiang, J., & Vorsanger, G. J. (2006). Extended-release tramadol in the treatment of osteoarthritis: A multicenter, randomized, double-blind, placebo-controlled clinical trial. Current Medical Research and Opinion, 22, 1391-1401. https://doi.org/10.1185/030079906X115595
Gregori, D., Giacovelli, G., Minto, C., Barbetta, B., Gualtieri, F., Azzolina, D., … Rovati, L. C. (2018). Association of pharmacological treatments with long-term pain control in patients with knee osteoarthritis: A systematic review and meta-analysis. JAMA, 320, 2564-2579. https://doi.org/10.1001/jama.2018.19319
Häuser, W., Bock, F., Engeser, P., Tölle, T., Willweber-Strumpf, A., & Petzke, F. (2014). Long-term opioid use in non-cancer pain. Dtsch Arztebl Int, 24, 732-740. https://doi.org/10.3238/arztebl.2014.0732
Häuser, W., Schmutzer, G., Hilbert, A., Brähler, E., & Henningsen, P. (2015). Prevalence of chronic disabling noncancer pain and associated demographic and medical variables: A cross-sectional survey in the general German population. Clinical Journal of Pain, 15, 886-892.
Häuser, W., Schubert, T., Scherbaum, N., & Tölle, T. (2018). Guideline-recommended vs high-dose long-term opioid therapy for chronic noncancer pain is associated with better health outcomes: data from a representative sample of the German population. Pain, 159, 85-91.
Higgins, J. P. T., Churchill, R., Chandler, J., & Cumpston, M. S. (editors) (2017). Cochrane handbook for systematic reviews of interventions version 5.2.0 (updated February 2017), Cochrane, 2017. Retrieved from https://training.cochrane.org/handbook.
Hunter, D. J., McDougall, J. J., & Keefe, F. J. (2008). The symptoms of osteoarthritis and the genesis of pain. Rheumatic Diseases Clinics of North America, 34, 623-643. https://doi.org/10.1016/j.rdc.2008.05.004
Katz, N., Hale, M., Morris, D., & Stauffer, J. (2010). Morphine sulfate and naltrexone hydrochloride extended release capsules in patients with chronic osteoarthritis pain. Postgraduate Medicine, 122, 112-118. https://doi.org/10.3810/pgm.2010.07.2179
Kean, W. F., Bouchard, S., & Roderich, G. E. (2009). Women with pain due to osteoarthritis: The efficacy and safety of a once-daily formulation of tramadol. Pain Medicine, 10, 1001-1011. https://doi.org/10.1111/j.1526-4637.2009.00677.x
Krebs, E. E., Gravely, A., Nugent, S., Jensen, A. C., DeRonne, B., Goldsmith, E. S., … Noorbaloochi, S. (2018). Effect of opioid vs nonopioid medications on pain-related function in patients with chronic back pain or hip or knee osteoarthritis pain: The SPACE randomized clinical trial. JAMA, 319, 872-882. https://doi.org/10.1001/jama.2018.0899
Langford, R., McKenna, F., Ratcliffe, S., Vojtassak, J., & Richarz, U. (2006). Transdermal fentanyl for improvement of pain and functioning in osteoarthritis: A randomized, placebocontrolled trial. Arthritis and Rheumatism, 54, 1829-1837. https://doi.org/10.1002/art.21884
Markenson, J. A., Croft, J., Zhang, P. G., & Richards, P. (2005). Treatment of persistent pain associated with osteoarthritis with controlled-release oxycodone tablets in a randomized controlled clinical trial. Clinical Journal of Pain, 21, 524-535. https://doi.org/10.1097/01.ajp.0000146215.86038.38
Matsumoto, A. K., Babul, N., & Ahdieh, H. (2005). Oxymorphone extended-release tablets relieve moderate to severe pain and improve physical function in osteoarthritis: Results of a randomized, double-blind, placebo- and active-controlled phase III trial. Pain Medicine, 6, 357-366. https://doi.org/10.1111/j.1526-4637.2005.00057.x
Mayorga, A. J., Wang, S., Kelly, K. M., & Thipphawong, J. (2016). Efficacy and safety of fulranumab as monotherapy in patients with moderate to severe, chronic knee pain of primary osteoarthritis: A randomised, placebo- and active-controlled trial. International Journal of Clinical Practice, 70, 493-505. https://doi.org/10.1111/ijcp.12807
Moher, D., Liberati, A., Teztlaff, J., & Altman, G.; The PRISMA Group (2009). Preferred reporting items for systematic reviews and meta-analyses: The PRISMA statement. Annals of Internal Medicine, 51, 1-7.
Moisset, X., & Martinez, V. (2016). Opioid use for the management of chronic non-cancer pain: French guidelines. Revue Neurologique, 172, 337-338. https://doi.org/10.1016/j.neurol.2016.05.004
Moore, A. R., Eccleston, C., Derry, S., Wiffen, P., Bell, R. F., Straube, S., & McQuay, H. (2010). "Evidence" in chronic pain-establishing best practice in the reporting of systematic reviews. Pain, 150, 386-389. https://doi.org/10.1016/j.pain.2010.05.011
Moore, R. A., Barden, J., Derry, S., & McQuay, H. J. (2008). Systematic Reviews in Pain Research: Methodology Refined. (1st ed.). Washington: IASP Press.
Munera, C., Drehobl, M., Sessler, N. E., & Landau, C. (2010). A randomized, placebo-controlled, double-blinded, parallel-group, 5-week study of buprenorphine transdermal system in adults with osteoarthritis. Journal of Opioid Management, 6, 193-202. https://doi.org/10.5055/jom.2010.0017
NCT00979953 (2015). Efficacy and Safety Study Evaluating ADL5859 and ADL5747 in Participants With Pain Due to Osteoarthritis of the Knee. Retrieved from https://www.clinicaltrials.gov/ct2/show/NCT00979953?term=NCT00979953&rank=1. Accessed June 23, 2019.
Nelson, A. E., Allen, K. D., Golightly, Y. M., Goode, A. P., & Jordan, J. M. (2014). A systematic review of recommendations and guidelines for the management of osteoarthritis: The chronic osteoarthritis management initiative of the U.S. bone and joint initiative. Seminars in Arthritis and Rheumatism, 43, 701-712. https://doi.org/10.1016/j.semarthrit.2013.11.012
Neogi, T., & Zhang, Y. (2013). Epidemiology of osteoarthritis. Rheumatic Diseases Clinics of North America, 39, 1-19. https://doi.org/10.1016/j.rdc.2012.10.004
Noble, M., Treadwell, J. R., Tregear, S. J., Coates, V. H., Wiffen, P. J., Akafomo, C., … Chou, R. (2010). Long-term opioid management for chronic noncancer pain. Cochrane Database Systematic Review, 1, CD006605. https://doi.org/10.1002/14651858.CD006605.pub2
O'Brien, T., Christrup, L. L., Drewes, A. M., Fallon, M. T., Kress, H. G., McQuay, H. J., … Wells, J. C. (2017). European Pain Federation position paper on appropriate opioid use in chronic pain management. European Journal of Pain, 21, 3-19. https://doi.org/10.1002/ejp.970
Peloso, P. M., Bellamy, N., Bensen, W., Thomson, G. T. D., Harsanyi, Z., & Darke, A. C. (2000). Double blind randomized placebo control trial of controlled release codeine in the treatment of osteoarthritis of the hip or knee. Journal of Rheumatology, 27, 764-771.
Persson, M. S. M., Stocks, J., Walsh, D. A., Doherty, M., & Zhang, W. (2018). The relative efficacy of topical non-steroidal anti-inflammatory drugs and capsaicin in osteoarthritis: A network meta-analysis of randomised controlled trials. Osteoarthritis Cartilage, 26, 1575-1582. https://doi.org/10.1016/j.joca.2018.08.008
Rauck, R., Rapoport, R., & Thipphawong, J. (2013). Results of a double-blind, placebo-controlled, fixed-dose assessment of once-daily OROS® hydromorphone ER in patients with moderate to severe pain associated with chronic osteoarthritis. Pain Practice, 13, 18-29.
Ranapurwala, S. I., Naumann, R. B., Austin, A. E., Dasgupta, N., & Marshall, S. W. (2019). Methodologic limitations of prescription opioid safety research and recommendations for improving the evidence base. Pharmacoepidemiology and Drug Safety, 28, 4-12.
Review Manager (RevMan) [Computer program]. (2014). The Nordic Center. Version Version 5.3. Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration.
Santos, J., Alarcão, J., Fareleira, F., Vaz-Carneiro, A., & Costa, J. (2015). Tapentadol for chronic musculoskeletal pain in adults. Cochrane Database Systematic Review, 5, CD009923. https://doi.org/10.1002/14651858.CD009923.pub2
Schaefert, R., Welsch, P., Klose, P., Sommer, C., Petzke, F., & Häuser, W. (2015). Opioids in chronic osteoarthritis pain. A systematic review and meta-analysis of efficacy, tolerability and safety in randomized placebo-controlled studies of at least 4 weeks duration. Schmerz, 29, 47-59.
Serrie, A., Lange, B., & Steup, A. (2017). Tapentadol prolonged-release for moderate-to-severe chronic osteoarthritis knee pain: A double-blind, randomized, placebo- and oxycodone controlled release-controlled study. Current Medical Research and Opinion, 33, 1423-1432. https://doi.org/10.1080/03007995.2017.1335189
Smith, S. R., Deshpande, B. R., Collins, J. E., Katz, J. N., & Losina, E. (2016). Comparative pain reduction of oral non-steroidal anti-inflammatory drugs and opioids for knee osteoarthritis: Systematic analytic review. Osteoarthritis Cartilage, 24, 962-972. https://doi.org/10.1016/j.joca.2016.01.135
Spierings, E. L., Fidelholtz, J., Wolfram, G., Smith, M. D., Brown, M. T., & West, C. R. (2013). A phase III placebo- and oxycodone-controlled study of tanezumab in adults with osteoarthritis pain of the hip or knee. Pain, 154, 1603-1612. https://doi.org/10.1016/j.pain.2013.04.035
Thorne, C., Beaulieu, A. D., Callaghan, D. J., O'Mahony, W. F., Bartlett, J. M., Knight, R., … Darke, A. C. (2008). A randomized, double-blind, crossover comparison of the efficacy and safety of oral controlled-release tramadol and placebo in patients with painful osteoarthritis. Pain Research and Management, 13, 93-102. https://doi.org/10.1155/2008/165421
Toupin April, K., Bisaillon, J., Welch, V., Maxwell, L. J., Jüni, P., Rutjes, A. W., … Tugwell, P. (2019). Tramadol for osteoarthritis. Cochrane Database Systematic Review, 5, CD005522.
Vojtaššák, J., Vojtaššák, J., Jacobs, A., Rynn, L., Waechter, S., & Richarz, U. (2011). A phase IIIb, multicentre, randomised, parallel-group, placebo-controlled, double-blind study to investigate the efficacy and safety of OROS hydromorphone in subjects with moderate-to-severe chronic pain induced by osteoarthritis of the hip or the knee. Pain Research and Treatment, 2011, 239501. https://doi.org/10.1155/2011/239501
Zeng, C., Dubreuil, M., LaRochelle, M. R., Lu, N., Wei, J., Choi, H. K., Lei, G., & Zhang, Y. (2019). Association of tramadol with all-cause mortality among patients with osteoarthritis. JAMA, 321, 969-982.

Auteurs

Patrick Welsch (P)

Health Care Center for Pain Medicine and Mental Health, Saarbrücken, Germany.

Frank Petzke (F)

Pain Medicine, Department of Anesthesiology, University Medical Center Göttingen, Göttingen, Germany.

Petra Klose (P)

Department Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen, Essen, Germany.

Winfried Häuser (W)

Health Care Center for Pain Medicine and Mental Health, Saarbrücken, Germany.
Department Psychosomatic Medicine and Psychotherapy, Technische Universität München, Munich, Germany.

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