KOLs take issue with me and my blog.
As you may know, I recently published a post about a trial that showed an absence of evidence for the benefits of orthodontic vibration. This resulted in a strong response from some of the Propel KOLs. I was also disparaged on social media. This blog is about those comments and my appraisal of the evidence that they put forward.
I have also been listening to a lot of Pink Floyd recently, hence my sub-headings to lighten the mood.
On the turning away
I asked them to let me have some published evidence on the effects of high-frequency vibration. One of them sent me this list of papers. Another KOL for Propel also posted the same list on Facebook.
So, I had a look at this evidence, and this is what I thought.
Animal and ex-vivo studies
These studies were done on rats. While they provided interesting scientific information. Importantly, we need to remember that the medical and dental research is littered with animal studies that do not translate to the clinical situation. We do not treat rats.
Judex, S., & Pongkitwitoon, S. (2018). Differential Efficacy of 2 Vibrating Orthodontic Devices to Alter the Cellular Response in Osteoblasts, Fibroblasts, and Osteoclasts. Dose-Response, 16(3), 155932581879211. doi: 10.1177/1559325818792112
This study was done on samples of cells in containers. As a result, it is not relevant to the human clinical setting.
These papers were not published in any of the major orthodontic journals.
Alansari, S., Atique, M. I., Gomez, J. P., Hamidaddin, M., Thirumoorthy, S. N., Sangsuwon, C., … Nervina, J. M. (2018). The effects of brief daily vibration on clear aligner orthodontic treatment. Journal of the World Federation of Orthodontists, 7(4), 134–140. doi: 10.1016/j.ejwf.2018.10.002
I looked at this paper carefully, and I felt that there were the following significant issues.
- The error of the software measurement was 0.2mm, and random error was 0.1mm. This equalled 0.3mm. As a result, their measurement error was too high.
- They only measured the tipping movement of one lower incisor tooth in the entire mouth. This was not relevant to the typical clinical situation.
- Participants who did not comply with treatment were discontinued.
- The trial was registered with Clinical Trials.Gov. This stated that the study was sponsored by Propel. The authors did not report this conflict in their paper. They also registered the protocol for this study after the completion of the study. This puts the paper at high risk of bias.
- Most of the authors are affiliated to the Consortium for Translational Orthodontic Research. This organisation provides clinical care and promotes MOPs and vibration for increasing the speed of tooth movement. It also holds the patent for the VPro5 device that was evaluated in the study. The authors did not record this conflict.
This was a pilot study of 16 patients.
Propel funded part of this study. The lead author is currently a member of the Clinical Advisory Panel of Propel. These conflicts were declared in the paper.
El-Bialy, T., Farouk, K., & Shipley, T. (2018). Effect of the application of high-frequency mechanical vibration on tooth length concurrent with orthodontic treatment using clear aligners: A retrospective study. Journal of Orthodontic Science, 7(1), 20. doi: 10.4103/jos.jos_53_18
These two papers were from the same sample of patients whose records were collected retrospectively. I could not find any information on the pre-treatment characteristics of the patient’s malocclusion. This is important because we do not know if the two groups were the same at the start of treatment.
Propel funded part of this study. Two of the authors stated that they held lectures for Invisalign:” and one author lectured for Propel.
We don’t need no education
The evidence is a collection of animal/ex vivo studies that may not translate to the clinical situation. Other papers reported unclear retrospective studies and a trial that was significantly flawed. All of the clinical articles were conflicted. I feel that this evidence does not support the selling of an intervention to our patients.
Both of the KOLs attended speciality training programmes that must have included training in appraising the quality of the literature. I am not sure why they felt that this collection of papers provided useful evidence on the effectiveness of vibration?
I have become comfortably numb
In my blog, I address issues that I feel are important to me. As regular readers know, I post and lecture about KOLs and their behaviour. I appreciate that this is a tricky area, and occasionally I have “crossed the line”. Unfortunately, this time there were many comments made about me on social media. Here is a selection.
“I don’t think Kevin is an orthodontist any longer. I have never seen any of his cases”.
“Those who can do, those who can’t post crappy stuff about others who can”. (HSO KOL)
“Funny how he has built his entire reputation on hate and attack”. (HSO KOL).
“I am being slandered for being a KOL by middling orthodontist with malignant penis envy”. (HSO KOL).
I have given these comments considerable thought and evaluated my approach to challenging KOLs. I have decided to continue to highlight unfounded claims made by KOLs on behalf of the companies that pay them. Nevertheless, I will take more care to make sure that I am respectful. I hope that they can do the same. If any KOL wants to post about their point of view on my blog, just send me the post, and I will publish it. We can then all have a civil debate?
Emeritus Professor of Orthodontics, University of Manchester, UK.