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- Publisher
- American Journal of Neuroradiology
- ISSN
- 0195-6108
- eISSN
- 1936-959X
- DOI
- 10.3174/ajnr.A5762
- Publisher site
- See Article on Publisher Site
Abstract
LETTERS Vertebroplasty: Expectation or Evidence-Based Interventional Radiology? he review of the latest data concerning vertebroplasty and an integral part of the medical curriculum. Editors must restrain Tkyphoplasty for osteoporotic vertebral fractures seemed a researchers with preliminary observations from “sciensational- 1 8 desperate attempt to cleanse the unconscionable. ism” (sensationalism in science). Terms such as “therapeutic rev- The first vertebroplasty case report appeared in an obscure olution” should be unacceptable. Professional societies must low–Impact Factor (0.8) journal, from a team who subsequently scrutinize their recommendations and grade them according to published dozens of articles but never a trial. Since 1987, al- the evidence. though thousands of articles have been published, it is exceptional Disclosures:SusanBewley—UNRELATED:ChairofHealthWatch,acharitythatstandsfor to find an adequately designed trial (eg, blinded, compared better understanding by the public and the media of the importance of application of with a sham procedure, adequate number of patients, large evidence from robust clinical trials (https://www.healthwatch-uk.org/). patient cohorts, long clinical follow-up using relevant outcomes such as patients’ quality of life). In 2016, the Vertebroplasty for REFERENCES Acute Painful Osteoporotic Fractures (VAPOUR) trial showed 1. Chandra RV, Maingard J, Asadi H, et al. Vertebroplasty and kyphop- improved pain relief but with an absurdly short 14-day follow- lasty for osteoporotic vertebral fractures: what are the latest data? up. The most recent trial on vertebroplasty showed robust evi- AJNR Am J Neuroradiol 2018;39:798–806 CrossRef Medline dence that it did not result in benefit for patients with acute os- 2. Galibert P, Deramond H, Rosat P, et al. Preliminary note on the treat- ment of vertebral angioma by percutaneous acrylic vertebroplasty teoporotic vertebral compression fractures. [in French]. Neurochirurgie 1987;33:166–68 Medline Sadly, health care systems are resistant to learning from error. 3. Clark W, Bird P, Gonski P, et al. Safety and efficacy of vertebroplasty The 2009 Angioplasty and Stenting for Renal Artery Lesions for acute painful osteoporotic fractures (VAPOUR): a multicentre, (ASTRAL) trial showed that dilation and stent placement in renal randomised, double-blind, placebo controlled trial. Lancet 2016;388: arteries provided no benefit over drug treatments but only in- 1408–16 CrossRef Medline 4. Firanescu CE, de Vries J, Lodder P, et al. Vertebroplasty versus sham creased serious harm. However, the procedure had spread like procedure for painful acute osteoporotic vertebral compression wildfire since the 1980s with 45,000 procedures annually in the fractures (VERTOS IV): randomised sham controlled clinical trial. United States. Surgeons and radiologists are not alone because BMJ 2018;361:k1551 CrossRef Medline the issue also concerns medicines. Encainide and flecainide have 5. Wheatley K, Ives N, Gray R, et al; ASTRAL Investigators. Revascular- long been the standard of care after myocardial infarction to sup- ization versus medical therapy for renal-artery stenosis. N Engl J Med 2009;361:1953–62 CrossRef Medline press ventricular premature complexes, until the Cardiac Ar- 6. Greene HL, Roden DM, Katz RJ, et al. The Cardiac Arrhythmia Sup- rhythmia Suppression Trial (CAST) investigators showed it in- pression Trial: first CAST then CAST-II. J Am Coll Cardiol 1992; creased mortality. Presently, most approvals of anticancer 19:894–98 CrossRef Medline medicines are based on flimsy or untested surrogate end points, 7. Kim C, Prasad V. Strength of validation for surrogate end points used and most drugs offer marginal benefits that may be lost in the real in the US Food and Drug Administration’s approval of oncology drugs. Mayo Clin Proc 2016 May 10. [Epub ahead of print] CrossRef world of heterogeneous patients in whom only harms appear. Medline The solution is a challenge. In 1660, Pascal warned, “People al- 8. Braillon A. Sciensationalism. Am J Med 2011;124:e13 CrossRef most invariably arrive at their beliefs not on the basis of proof but on Medline the basis of what they find attractive” (The Art of Persuasion). 9. Braillon A. Direct-acting antiviral drugs and hepatitis C virus: a ther- Pragmatically, Chandra et al should have pledged that all new apeutic revolution? Cancer 2015;121:4268–69 CrossRef Medline patients be included in randomized controlled trials and, if that X A. Braillon were not possible, in registries for monitoring adverse effects. University Hospital Amiens, France At the system level, training in history and humility should be X S. Bewley Women’s Health Academic Centre King’s College London http://dx.doi.org/10.3174/ajnr.A5762 London, UK AJNR Am J Neuroradiol 39:E109 Oct 2018 www.ajnr.org E109
Journal
American Journal of Neuroradiology – American Journal of Neuroradiology
Published: Oct 1, 2018