There seems to be a bottomless pit of dubious medical treatments out there, being created faster than we can examine them. That’s why it’s important to understand basic principles of science-based medicine, so you can at least have a sense if something is legitimate. Also, most new claims are variations on a limited number of themes, so once you can categorize a questionable medical practice, you probably have a pretty good idea where it stands.
But still there is no substitute for exploring a specific claim for plausibility and evidence. We were recently asked to take a look at Frequency Specific Microcurrent (FSM – not to be confused with a noodly deity). This treatment is being promoted by the Cleveland Clinic, now infamous (at least in SBM circles) for promoting quackery in the guise of integrative medicine.
FSM has all the hallmarks of pseudoscience, so let’s go through them in detail.
What Is FSM?
According to the FSM website:
FSM was developed by Dr. Carolyn McMakin in 1995 using frequencies passed on from an osteopath in Canada who had a practice that came with a machine made in the 1920’s.
(Dr. McMakin is a chiropractor, her degree is a DC.) That immediately catches my interest- what machine made in the 1920s? This was indeed one of those black boxes from Dr. Abrams, an infamous oscilloclast. This is a story unto itself, but the short version is that Dr. Abrams was making similar claims to diagnose and treat people with energy frequencies, but his devices were found after his death to be frauds. They were just wires and resistors that made the box hum, but didn’t actually do anything else. This is actually now a classic historical medical hoax.
So McMakin is not getting off to a good start, rooting her therapy in a classic hoax. Regardless of origin, what are the current claims?
FSM is applied to the body with a device that delivers a mild current. Microcurrent is an extremely mild electrical current (one millionth of an ampere). The human body actually produces its own current within each cell.
In FSM, depending on the tissue involved, specific frequencies are selected to encourage natural healing of the body and to reduce pain. Frequencies have been identified for nearly every type of tissue in the body.
One of the ways FSM works is by potentially increasing the production of the substance ATP in injured tissues. ATP is the major source of energy for all cellular reactions in the body. Because treatment with FSM can increase ATP production by as much as 500% in damaged tissues, this may help with the recovery process. Depending on the condition, treatment with FSM can “loosen” or soften the muscles, which can help relieve pain and/or stiffness.
This is essentially energy medicine with a hand-waving explanation about ATP. What does it treat? The Cleveland Clinic lists 22 conditions, from asthma to shingles – a typical list of common ailment seemingly devices to maximize marketing.
Let’s look at the published studies. They are pretty thin, starting with the claim that FSM increases ATP. This is based on a single study in vitro with rat heart cells. This is, at best, a preliminary study, with barely significant results. Without independent replication and controlling for possible variables, there is not enough data to conclude what is really going on here, or even if the effect is real.
Also, you cannot extrapolate form a petri dish to a person. There is a lot of potential confounding factors in tissue culture, and directly stimulating cells is not the same thing as stimulating the skin. There is reason to suspect that the tiny microcurrents don’t penetrate significantly through the epidermis.
And that is pretty much it for the basic science. There is no robust literature establishing the basic concepts of FSM, establishing plausibility, that something real and medically exploitable is happening.
What about the clinical evidence? That is also extremely thin. The Cleveland Clinic lists five references, all by McMakin. That is also a huge red flag – when all the research on a treatment involves the same person, that is basically a sign that there has been no independent replication, and there is no interest among serious researchers into the topic. This is the vanity project, apparently, of one chiropractor, not a serious avenue of medical research.
Only one of these references appears to be a clinical study. The others are case reports, commentary, and her textbook. That study, published in 2010, is a typical small pilot study from which no real conclusions can be drawn.
The study looks at FSM for muscle soreness after exercise, and involves 35 subjects. Despite the very small numbers, McMakin did statistical analysis on the results and claims highly significant outcomes. The p-values, in my opinion however, are suspiciously uniform. The baseline comparison between FSM and sham showed no difference, with a p-value of exactly 1.00 (two decimal places). Differences in soreness at 24, 48, and 72 hours were significant, with all three having exactly the same p-value of 0.0005. How nice and tidy.
A small pilot study, without mention of blinding, with a subjective outcome, by the originator of the treatment, with such implausibly uniform results, is not exactly compelling evidence.
I also did a PubMed search on “Frequency Specific Microcurrent” and that was the only actual controlled experimental study that came up.
The claims made for FSM tick many of the familiar boxes of medical pseudoscience. The claims are rooted in demonstrable fraud (Abrams), they are scientifically implausible, there is no body of research establishing the phenomenon, there is no clinical research to establish the clinical claims, the only studies we have are tiny and not compelling, all the publications are being done by the single creator of the treatment, publications are in low-impact journals or those dedicated to alternative medicine, meanwhile there is a long list of implausible applications for this one treatment.
Cleveland Clinic should be ashamed of promoting such rank pseudoscience.