Removing the hype from hypertension
Abstract
Symplicity HTN-3 illustrates the importance of randomisation and blinding for exciting new treatments
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Claims the paper makes
Cites
Renal Sympathetic-Nerve Ablation for Uncontrolled Hypertension
Schlaich, M. P., Sobotka, P. A., Krum, H., Lambert, E., & Esler, M. D. (2009) · New England Journal of Medicine · doi:10.1056/nejmc0904179 · Cited by 772 · see citing works
Catheter-Based Renal Sympathetic Denervation for Resistant Hypertension
Symplicity HTN-1 Investigators (2011) · Hypertension · doi:10.1161/hypertensionaha.110.163014 · Cited by 743 · see citing works
Statistics Notes: Blinding in clinical trials and other studies
Day, S. J. (2000) · BMJ · doi:10.1136/bmj.321.7259.504 · Cited by 487 · see citing works
Kandzari, D. E., Bhatt, D. L., Sobotka, P. A., O’Neill, W. W., Esler, M., Flack, J. M., Katzen, B. T., Leon, M. B., Massaro, J. M., Negoita, M., et al. (2012) · Clinical Cardiology · doi:10.1002/clc.22008 · Cited by 304 · see citing works
All trials must be registered and the results published
Chalmers, I., Glasziou, P., & Godlee, F. (2013) · BMJ · doi:10.1136/bmj.f105 · Cited by 131 · see citing works
Howard, J. P., Nowbar, A. N., & Francis, D. P. (2013) · Heart · doi:10.1136/heartjnl-2013-304238 · Cited by 87 · see citing works
Self-citationShun-Shin, M. J., & Francis, D. P. (2013) · PLoS ONE · doi:10.1371/journal.pone.0065323 · Cited by 24 · see citing works
Self-citation
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Al-Lamee, R. K., Thompson, D., Dehbi, H., Sen, S., Tang, K. H., Davies, J., Keeble, T., Mielewczik, M., Kaprielian, R., Malik, I. S., et al. (2017) · The Lancet · doi:10.1016/s0140-6736(17)32714-9 · Cited by 1,030 · see citing works
Self-citationThe Sympathetic Nervous System Alterations in Human Hypertension
Grassi, G., Mark, A., & Esler, M. (2015) · Circulation Research · doi:10.1161/circresaha.116.303604 · Cited by 616 · see citing works
“To many it did—renal denervation does not work!(125) The sham design was lauded.(125) How was it possible to argue against the findings of the SYMPLICITY HTN-3 trial? But the perfection of the trial is an illusion, only apparent if no discrimination is attempted between its form and its substance.”
BackgroundKeene, D., Price, C., Shun-Shin, M. J., & Francis, D. P. (2014) · BMJ · doi:10.1136/bmj.g4379 · Cited by 519 · see citing works
Self-citationEsler, M. (2014) · Journal of the American Society of Hypertension · doi:10.1016/j.jash.2014.06.001 · Cited by 127 · see citing works
de Jong, M. R., Adiyaman, A., Gal, P., Smit, J. J. J., Delnoy, P. P. H. M., Heeg, J., van Hasselt, B. A. A. M., Lau, E., Persu, A., Staessen, J. A., et al. (2016) · Hypertension · doi:10.1161/hypertensionaha.116.07492 · Cited by 92 · see citing works
Translating Stem Cell Research to Cardiac Disease Therapies
Rosen, M. R., Myerburg, R. J., Francis, D. P., Cole, G. D., & Marbán, E. (2014) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2014.06.1175 · Cited by 85 · see citing works
Self-citationde Jong, M. R., Hoogerwaard, A. F., Gal, P., Adiyaman, A., Smit, J. J. J., Delnoy, P. P. H. M., Misier, A. R. R., van Hasselt, B. A. A. M., Heeg, J., de Waroux, J. L. P., et al. (2016) · Hypertension · doi:10.1161/hypertensionaha.115.06604 · Cited by 67 · see citing works
The Sympathetic Nervous System in Hypertension: Back to the Future?
Esler, M. (2015) · Current Hypertension Reports · doi:10.1007/s11906-014-0519-8 · Cited by 60 · see citing works
Renal denervation for treatment of drug-resistant hypertension
Esler, M. (2015) · Trends in Cardiovascular Medicine · doi:10.1016/j.tcm.2014.09.014 · Cited by 55 · see citing works
“The sham design was lauded [47].”
InfluentialHoward, J. P., Shun-Shin, M. J., Hartley, A., Bhatt, D. L., Krum, H., & Francis, D. P. (2016) · Circulation Cardiovascular Quality and Outcomes · doi:10.1161/circoutcomes.115.002533 · Cited by 38 · see citing works
Self-citationRenal Denervation for Treatment of Hypertension: a Second Start and New Challenges
Persu, A., Kjeldsen, S. E., Staessen, J. A., & Azizi, M. (2016) · Current Hypertension Reports · doi:10.1007/s11906-015-0610-9 · Cited by 35 · see citing works
The future of renal denervation
Esler, M., & Guo, L. J. (2016) · Autonomic Neuroscience · doi:10.1016/j.autneu.2016.08.004 · Cited by 24 · see citing works
“The sham design was lauded (Shun-Shun et al., 2014).”
Anatomic Patterns of Renal Arterial Sympathetic Innervation: New Aspects for Renal Denervation
Imnadze, G., Balzer, S., Meyer, B., Neumann, J., Krech, R. H., Thale, J., Franz, N., Warnecke, H., Awad, K., Hayek, S. S., et al. (2016) · Journal of Interventional Cardiology · doi:10.1111/joic.12343 · Cited by 22 · see citing works
Cole, G. D., Nowbar, A. N., Mielewczik, M., Shun-Shin, M. J., & Francis, D. P. (2015) · BMJ · doi:10.1136/bmj.h4708 · Cited by 20 · see citing works
Self-citationElmula, F. E. M. F., Larstorp, A. C. K., Kjeldsen, S. E., Persu, A., Jin, Y., & Staessen, J. A. (2015) · Frontiers in Physiology · doi:10.3389/fphys.2015.00009 · Cited by 15 · see citing works
“In a recent editorial (Shun-Shin et al., 2014), the authors wrote that “measurement of a noisy variable by unblinded optimistic staff is a known recipe for calamitous exaggeration.””
BackgroundA meta-epidemiological study of bias in randomized clinical trials of open and laparoscopic surgery
Amer, M., Herbison, P., Grainger, S., Khoo, C. H., Smith, M. D., & McCall, J. L. (2021) · British journal of surgery · doi:10.1093/bjs/znab035 · Cited by 14 · see citing works
Howard, J. P., & Francis, D. P. (2014) · Trends in Cardiovascular Medicine · doi:10.1016/j.tcm.2014.10.011 · Cited by 14 · see citing works
“Our friend and teacher Prof Murray Esler may have interpreted our BMJ article [11] as saying it “does not work”, but in reality the article’s graphic [11] encapsulated our optimistic guess that the effect size would be between 5 and 10 mmHg (which would have been statistically significant).”
BackgroundMethodInfluentialSelf-citationThe challenge of delivering reliable science and guidelines: opportunities for all to participate.
Cole, G. D., & Francis, D. P. (2014) · PubMed · Cited by 8 · see citing works
Self-citationKjeldsen, S. E., Elmula, F. E. M. F., Os, I., Persu, A., Jin, Y., & Staessen, J. A. (2015) · European Heart Journal - Cardiovascular Pharmacotherapy · doi:10.1093/ehjcvp/pvu009 · Cited by 8 · see citing works
Kim, M. S., & Prasad, V. K. (2019) · JAMA Network Open · doi:10.1001/jamanetworkopen.2019.3981 · Cited by 8 · see citing works
CONSORT and the internal validity of randomized controlled trials in Female Pelvic Medicine
Koch, M., RISS, P. A., Umek, W. H., & Hanzal, E. (2015) · Neurourology and Urodynamics · doi:10.1002/nau.22811 · Cited by 7 · see citing works
“Randomized Controlled Trials (RCTs) are considered the gold standard for scientific methods to compare two (or more) clinical interventions.(1,2) Critical characteristics of RCTs include Randomization, Allocation and Blinding, as well as a detailed description of the participants’ flow, including dropouts and withdraw…”
MethodRenal sympathetic denervation in the aftermath of Symplicity HTN-3
Kjeldsen, S. E., Elmula, F. E. M. F., Persu, A., Jin, Y., & Staessen, J. A. (2014) · Blood Pressure · doi:10.3109/08037051.2014.953861 · Cited by 6 · see citing works
Impact of number of prescribed medications on visit-to-visit variability of blood pressure
Howard, J. P., Patel, H. C., Shun-Shin, M. J., Mourad, J., Blacher, J., Mahfoud, F., Zeller, T., Weber, M. A., & Francis, D. P. (2015) · Journal of Hypertension · doi:10.1097/hjh.0000000000000708 · Cited by 6 · see citing works
“While early trials reported large falls in blood pressure (BP) of the order of 20–30mmHg [2], later trials [3,4], which calculated the effect [5] by blinded comparison against patients undergoing a placebo procedure, reported smaller effects [6].”
BackgroundSelf-citationRenal Denervation After Symplicity HTN-3 – Back to Basics. Review of the Evidence
Persu, A., Elmula, F. E. M. F., Jin, Y., Os, I., Kjeldsen, S. E., & Staessen, J. A. (2014) · European Cardiology Review · doi:10.15420/ecr.2014.9.2.110 · Cited by 4 · see citing works
Tofield, A. (2014) · European Heart Journal · doi:10.1093/eurheartj/ehu287 · Cited by 3 · see citing works
Renal denervation for severe hypertension: Past, present and future
Esler, M. (2015) · Dialnet (Universidad de la Rioja) · doi:10.7775/ajc.83.2.4582
“The sham design was lauded; purist trial ideology was unrestrained (29).”
BackgroundDénervation artérielle rénale : l’histoire se répéterait-elle ?
Blacher, J. (2014) · Journal des Maladies Vasculaires · doi:10.1016/j.jmv.2014.04.005
Townsend, R. R. (2019) · Mayo Clinic Proceedings · doi:10.1016/j.mayocp.2019.07.006
Renal sympathetic denervation: renal nerve stimulation
de Jong, M. (2019) · doi:10.33612/diss.99857558
Advanced Meta-analysis in Surgical Research
Amer, M. (2019) · Otago University Research Archive (University of Otago)
- Authors
- Shun-Shin, M. J., Howard, J. P., & Francis, D. P.
- Affiliations
- Imperial College London (GB)
- Venue
- BMJ
- Publisher
- BMJ
- Published
- 2014-03-06
- Volume
- 348
- Issue
- mar06 2
- Pages
- g1937-g1937
- ISSN
- 1756-1833 (ISSN-L)
- OpenAlex
- W1987472439
- Cited by
- 30
- References
- 8
- Citations by year
- 2021: 1 · 2019: 4 · 2017: 1 · 2016: 6 · 2015: 8 · 2014: 10
- Type
- journal article
- Language
- en
- Update notices
- correction (2014-03-11)
- Open access
- closed
- Locations
- BMJ (publishedVersion)
- PubMed (publishedVersion)
- HighWire Press Open Archive (submittedVersion)
- Funders
- National Institute for Health and Care Research (ACF-2011-21-003)
- British Heart Foundation (FS/14/27/30752, FS/10/38/28268)
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Blood Pressure and Hypertension Studies
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Clinical practice guidelines implementation
- Keywords
- hypertension, SYMPLICITY HTN-3, renal denervation, randomized controlled trials, blinding, treatment efficacy
- MeSH terms
- Humans, Hypertension, Kidney, Sympathectomy, Bias, Randomized Controlled Trials as Topic, Treatment Outcome
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