Removing the hype from hypertension

@article{Shunshin2014RemovingTH,
  title={Removing the hype from hypertension},
  author={Matthew J. Shun-shin and J P Howard and D. P. Francis},
  journal={BMJ : British Medical Journal},
  year={2014},
  volume={348}
}
Symplicity HTN-3 illustrates the importance of randomisation and blinding for exciting new treatments 
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Illusions of truths in the Symplicity HTN-3 trial: generic design strengths but neuroscience failings.
  • M. Esler
  • Medicine
  • Journal of the American Society of Hypertension : JASH
  • 2014
TLDR
Criticism applies with special force to the Symplicity HTN-3 trial, where the proceduralists, although expert interventional cardiologists, had no prior experience with the renal denervation technique and their learning curve fell during the trial. Expand
CONSORT and the internal validity of randomized controlled trials in Female Pelvic Medicine
To investigate authors' adherence to the CONSORT reporting guideline for randomized controlled trials (RCTs) in the sub‐specialty Female Pelvic Medicine and to detect any changes in adherence betweenExpand
Renal denervation for treatment of drug-resistant hypertension.
  • M. Esler
  • Medicine
  • Trends in cardiovascular medicine
  • 2015
At the seven-year anniversary of the first catheter-based renal denervation procedure for resistant hypertension, it is timely to reflect on the past, present, and future of the development andExpand
CONSORT and Quality of RCTs in Female Pelvic Medicine 2012- 2013
TLDR
Critical characteristics of RCTs include random allocation, allocation concealment and blinding, and there is evidence that insufficient attention towards these methodological aspects leads to an exaggeration of treatment effects, making a study less reliable and reducing internal validity. Expand
Quantifying the 3 Biases That Lead to Unintentional Overestimation of the Blood Pressure–Lowering Effect of Renal Denervation
TLDR
If differences are caused by trial design and not by some other differences in patients or procedures, which happen to match the trial design, then randomization alone is not enough: blinding is also needed. Expand
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References

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Academics and non-commercial funders are just as guilty as industry of misleading the public about the role of science in society. Expand
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The SYMPLICITY HTN‐3 Trial is a pivotal study designed as a prospective, randomized, masked procedure, single‐blind trial evaluating the safety and effectiveness of catheter‐based bilateral renal denervation for the treatment of uncontrolled hypertension despite compliance with at least 3 antihypertensive medications of different classes at maximal tolerable doses. Expand
Renal sympathetic denervation in patients with treatment-resistant hypertension (The Symplicity HTN-2 Trial): a randomised controlled trial
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Catheter-based renal denervation can safely be used to substantially reduce blood pressure in treatment-resistant hypertensive patients and should be continued, according to the authors. Expand
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The renal sympathetic nerves have been identified as a major contributor to the complex pathophysiology of hypertension in both experimental models and in humans and may be modulated by afferent signaling from renal sensory nerves. Expand
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In patients with resistant hypertension, catheter-based renal sympathetic denervation results in a substantial reduction in BP sustained out to ≥2 years of follow-up, without significant adverse events. Expand
Size of blood pressure reduction from renal denervation: insights from meta-analysis of antihypertensive drug trials of 4121 patients with focus on trial design: the CONVERGE report
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In controlled trials the term blinding, and in particular “double blind,” usually refers to keeping study participants, those involved with their management, and those collecting and analysing clinical data unaware of the assigned treatment, so that they should not be influenced by that knowledge. Expand
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Medtronic announces US renal denervation pivotal trial fails to meet primary efficacy endpoint while meeting primary safety endpoint. Press release
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