Invited Editorial

The Eects of VitalStim on Clinical and Research Thinking

in Dysphagia
Jeri A. Logemann, PhD, CCC-SLP, BRS-S
1,2
1
The Roxelyn and Richard Pepper Department of Communication Sciences and Disorders, Northwestern University, Evanston, Illinois; and
2
Departments of Head and Neck Surgery Otolaryngology and Neurology, Feinberg School of Medicine, Northwestern University, Chicago,
Illinois
When VitalStim was rst reported [1] and the man-
ufacturer began selling products, many clinical
investigators and clinicians began to question the true
ecacy of the procedure in the treatment of oro-
pharyngeal dysphagia. The data presented in the
initial publication [1] were unconvincing because of
the poor description of the procedure itself, the mixed
use of standard therapy with the VitalStim procedure,
and the use of cricopharyngeal myotomy or cri-
copharyngeal dilatation in many patients without any
clear description of how, why, and when they were
performed. In addition, the underlying neurophysio-
logic basis for using the procedure that involves
surface electrode placement on the external lateral
neck was poorly dened.
The second reaction to VitalStim was from
clinicians eager to oer a uniform treatment proce-
dure to their oropharyngeal dysphagic patients
without the need for careful assessment of the pa-
tients swallow physiology to dene the specic
swallow problems from which the patient was suf-
fering. VitalStim gave some clinicians an easy out
from understanding each patients underlying swal-
low physiology, if they so desired. Unfortunately, this
led to a large market for VitalStim among clinicians
and desperate patients willing to try anything
whether or not it had a rm scientic base and known
ecacy. This response was similar to the rush in the
1970s to use Laetrile by cancer patients, who went to
Mexico to get the magic cure. Interestingly, there
was an unwillingness initially by the National Insti-
tutes of Health (NIH) to fund studies of Laetrile to
dene its true ecacy. In the end, Congress needed
to instruct NIH-National Cancer Institute (NCI) to
conduct such studies to protect patients. Those
studies found that the use of Laetrile had no clinical
ecacy [2].
To date, there are very few studies of surface
electrical stimulation to the neck for swallowing that
support the ecacy of VitalStim. In fact, there are
now several studies indicating that the procedure is
not eective. This includes the study featured in an
article in this issue of Dysphagia that was conducted
by a group of clinicians and was designed to eval-
uate the actual eectiveness of VitalStim. The fact
that the procedure has sparked a great deal of
clinical interest and, more importantly, research
interest by clinical investigators to systematically
evaluate the eectiveness of the procedure is a po-
sitive outcome of the attention the procedure has
received. Over the years many clinicians have ex-
pressed interest in conducting research in various
aspects of dysphagia treatment. Often the diculty
of conducting research has discouraged these novice
clinical investigators and caused them to abandon
their research interests. However, the article in this
issue of Dysphagia shows clinicians who succeed in
pursuing their research until they are able to collect
meaningful data for all of us. They are to be con-
gratulated. This article presents some interesting,
negative data about VitalStim.
Correspondence to: J.A. Logemann, PhD, Northwestern Univer-
sity, Communication Sciences and Disorders, 2240 Campus Drive,
Evanston, IL 60208, USA; E-mail: j-logemann@northwestern.edu
Dysphagia 22:1112 (2007)
DOI: 10.1007/s00455-006-9039-2
A second study published in this issue of
Dysphagia and that was presented at the Medical
University of South Carolina - Charleston Swallow-
ing Conference (2005) [3] examined the eect of
electrical stimulation on the external lateral neck
relative to hyolaryngeal elevation during swallow.
Results found that electrical stimulation on the neck
surface in fact caused downward movement of the
hyoid during swallow, probably the result of stimu-
lating the sternohyoid muscle rather than the thyro-
hyoid muscle, which was the goal of the procedure.
Here we nd a physiologic study that increases our
understanding of the eects of VitalStim on oro-
pharyngeal swallow.
One positive eect of VitalStim is that it
stimulated our thinking with respect to clinical e-
cacy studies. Are negative studies of ecacy truly
helpful? I believe they are, if adequate numbers of
subjects are included, because they provide us with
important information that indicates that the proce-
dure under study, in this case VitalStim, has a nega-
tive eect on oropharyngeal swallow. Just as the
study of Laetrile in cancer patients proved it did not
really cure cancer, so do negative studies of VitalStim
assist patients and clinicians in determining that the
use of VitalStim may not be an ecacious treatment
for oropharyngeal dysphagia.
The manner in which VitalStim was conceived
by its producers and evaluated in publication also has
made many clinical investigators and clinicians think
carefully about how a new procedure should be de-
signed, evaluated, and introduced for commercial
gain. Generally, there should be a strong neuro-
physiologic rationale for the procedures application
to a particular patient group or groups, followed by
studies that dene the ecacy of the procedure in a
small group of patients, preferably a homogeneous
group, then study of a larger group of patients,
preferably several groups representing dierent
diagnoses; and then a clinical trial should be devel-
oped if the procedure is found to have strong ecacy
in smaller-group studies. None of these steps had
been done by the producers of VitalStim.
In summary, VitalStim has provided us with
helpful food for thought about the methods used
for introducing new therapy procedures. The pro-
ducers of VitalStim have not faced their responsibility
to the clinical research world and patients with dys-
phagia who are desperate for additional treatment
procedures. Clearly, much more research is needed to
determine whether VitalStim or other methods of
neuromuscular electrical stimulation have any role to
play in the management of oropharyngeal swallowing
diculties in any specic patient group. In the
meantime, the best advice is Clinician and patient,
beware.
References
1. Freed ML, Freed L, Chatburn RL, Christian M: Electrical
stimulation for swallowing disorders caused by stroke.
Respiratory Care 46(5):466471, 2001
2. Milazzo S, Ernst E, Lejeune S, Schmidt, K: Cochrane Data-
base Syst Rev 2006 Apr 19;(2):CD005476 [review]
3. Ludlow C: Physiological eects of surface electrical stimula-
tion vs. intramuscular stimulation on swallowing in chronic
pharyngeal dysphagia. Presented at the Charleston Swallow-
ing Conference, Charleston, SC, October 6, 2005
12 J.A. Logemann: Eects of VitalStim in Dysphagia