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Comment & Response |

What Constitutes an Adequate Evaluation of Device-Guided Breathing?—Reply

Gijs W. D. Landman, MD, PhD1; Kornelis J. J. van Hateren, MD1; Nanne Kleefstra, MD, PhD1,2,3
[+] Author Affiliations
1Diabetes Centre, Isala Clinics, Zwolle, the Netherlands
2Department of Internal Medicine, University Medical Center Groningen, Groningen, the Netherlands
3Langerhans Medical Research Group, Zwolle, the Netherlands
JAMA Intern Med. 2014;174(4):638. doi:10.1001/jamainternmed.2013.13790.
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In Reply We want to thank Huang and Subak for their interest in our study.1 They state that we should not have made strong conclusions concerning nonefficacy based on results extending outside the present study and that we performed an underpowered study with methodological limitations and unsuccessful randomization. We respectfully disagree with all their statements.

We do agree with their last sentence “broad conclusions about nonefficacy of device-guided breathing are not supported by this study alone.” Nonefficacy was also the result of 2 other trials performed by our research group.2,3 A recent meta-analysis, specifically in studies with sufficient methodological quality, confirmed that there is no evidence for short-term effects on blood pressure.4 Furthermore, there is absence of evidence for long-term blood pressure effects.4 The absence of short-term and long-term effects, let alone cardiovascular end points, justifies our conclusion. Consistent short-term benefits should first be established. It is not up to us to prove nonefficacy, there should be evidence for efficacy, not the other way around.


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April 1, 2014
Alison J. Huang, MD, MAS; Leslee L. Subak, MD
1Department of Medicine, University of California, San Francisco
2Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco
JAMA Intern Med. 2014;174(4):637. doi:10.1001/jamainternmed.2013.13791.
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