Restless legs syndrome is a common problem, too often without a satisfactory solution. Because of this, there is plenty of bad advice being given and many different treatments options available; many of which are underpinned by testimonials and anecdotes and with poor or no science or data. When extraordinary claims are made, then extraordinary evidence is needed to support the claims.
Recently a press release was put out for a study on a new product, The Restiffic foot wrap for use in restless legs syndrome. At last count, Google could find the press release carried on 27 websites. One thing all the websites had in common was that they just parroted the press release and demonstrated a total lack of critical thinking skills. I have already raised some issues with the press release elsewhere, but to reiterate:
1. The press release was based on an uncontrolled study in a low impact factor journal. The study did claim to have control group, when it did not. It did have a reference group from unrelated studies on a totally different population that they wrongly did a statistical analysis on. What the study really was is uncontrolled single arm analyzed with a within groups analysis. These types of uncontrolled studies tend to massively overestimate effect sizes and we have no idea if all the effect obtained was not due to placebo or natural history. The claims in the press release and claims made by the company are not supported by the evidence. A properly controlled study is needed to base the claims on.
The reason you need a control group with the same characteristics as the intervention group is that in the statistical analysis of the data you subtract the placebo effect of the control group from the treatment effect in the intervention group to get what is the real effect of the intervention. That is why uncontrolled studies massively overestimate effect sizes (like the above study). I know they claimed to have a “control” group, but they did not. They just used a reference group from a meta-analysis of other studies to compare their outcome to. The placebo effect in restless legs syndrome is strong, so some of the effect, or a large part of it, or all of the effects in this study in question could have been due to placebo. We will not know as they did not have a properly constituted control group.
2. The company behind the product have been claiming that the product is FDA approved, when it is not. The product has simply been cleared as safe by the FDA and to make the claims that it is approved is likely to get them in trouble with the FDA as their guidelines are clear. The company does appear to have backed way from these claims recently.
I have nothing against this product and have full empathy with those who have restless legs syndrome and the lengths they often go to, to get relief. I just do not like seeing them targeted in marketing by products that offer a “cure” based on no science or nonsense.
The Restiffic Foot Wrap may turn out to be an effective product and I hope it does for those who have restless legs syndrome. The company should be applauded for supporting the above study which a lot of restless legs syndrome approaches are not subjected to, but more is needed. I just object to it being marketed implying that it is FDA approved and the strength of the claims as to how effective it is based on an uncontrolled study.
Kuhn, P., Olson, D., & Sullivan, J. (2016). Targeted Pressure on Abductor Hallucis and Flexor Hallucis Brevis Muscles to Manage Moderate to Severe Primary Restless Legs Syndrome The Journal of the American Osteopathic Association, 116 (7) DOI: 10.7556/jaoa.2016.088