This is the second installment of a multi-part story about the Flex Belt System Abs belt.
In the first installment I reviewed claims made by the Flex Belt System Abs folks and provided some excerpts from the Federal Trade Commission’s (FTC) position on electrical muscle stimulator (EMS) belts. At the end of the last piece I mentioned that the Flex Belt marketing pitch includes a mention of a “clinical study” that found 100% success for subjects in the study using a device that used the same technology as the Flex Belt. Curiously, the Flex Belt people do not provide any details of this groundbreaking study on their web site.
I did some digging and think I may have come up with a reason why the Slendertone people don’t include any details about the study that they say was conducted in Ireland.
Perhaps, the reason for the lack of detail on the Flex Belt “study” can be found in the application of Bio-Medical Research, Ltd. of Galway Ireland to the Food and Drug Administration (FDA), to market their Slendertone Flex Bottom and Thigh Toning System in 2003, and their subsequent application that included the System Abs device in 2007.
Back in 2003 Bio-Medical Research included a controlled, single blind study (those conducting the study knew which subjects were receiving the treatment and which group was getting the placebo) in their application that involved 60 female volunteers and their response to EMS on their buttock and thigh muscles. The study was conducted by BMR at their research center in Ireland.
As is stated in BMR’s application, psychometric tests determined that “the treated group in the study reported a marked improvement in firmness compared to the control group over the period of the study.” Psychometrics is the study of psychological measurements, not physiological measurements. So these subjects felt they had improved “firmness.”
Since firmness is not an objective physiological measurement, this claim is an extremely thin reed from which to hang credibility and proof of efficacy. The BMR people stated the EMS group reported improvements in self-image and well being. There is also some question as to the reliability of single blind studies, as this kind of study can result in bias by those conducting the study.
Given that the BMR study conducted psychometric testing, it’s possible to see how researcher bias could be considered responsible for the reported 100% success rate, and also why the Slendertone people haven’t been more forthcoming with the details about this study. On a related note, if anyone can come up with a valid piece of research that resulted in a 100% success rate I’d like to know about it.
On top of this, there were no details with regard to whether or not either group engaged in any exercise during this study and the conclusions reached by BMR offered little in the way of significant, objective details. However, based on the safety of the device and that the subjects felt better, BMR concluded that their device resulted in “significant improvement in firmness, strength and muscle tone.”
Firmness and muscle tone are not measurable. Despite this under whelming study the FDA approved BMR’s application to market their butt and thigh EMS device. Fast forward to 2007 when BMR applied for – and received – FDA approval for their System Abs device, and did so without submitting any new research, relying on the data that was part of the 2003 butt and thigh application.
Given the total lack of detail on the Flex Belt site with regard to the study cited to prove the devices efficacy, it’s pretty apparent the 2003 “application study” done at the BMR labs in Ireland is this mystery study. What’s troubling about this whole scenario is that the Flex Belt received approval from the FDA without providing any apparent, valid scientific data to show exactly how this device is any different than any other device that has not received approval.
Check back next week for the final installment of this story.