IS ELECTRICAL STIMULATION A DRUG?  IS BIOFEEDBACK A DRUG?

IS ELECTRICAL STIMULATION A BEHAVIORAL THERAPY? 

 

J. D. Perry, Petaluma, California

 

Abstract

 

AHCPR, the federal Agency for Health Care Policy and Research, has assigned electrical stimulation therapy for incontinence to the category “behavioral therapies.”   This gives electrical stimulation the same classification as biofeedback.  The author challenges this classification, and argues for essential differences between behavior therapy, a learning oriented intervention, and electrical stimulation, which actively impacts on a passive patient. In some ways, electrical stimulation is more accurately construed as a type of pharmaceutical, or in a unique fourth category of its own.   He argues that the personal involvement of the teacher and student are critical to education, behavior therapy, and biofeedback, whereas the person of the therapist and patient are irrelevant for electrical stimulation.

 

 

The AHCPR Guideline on Urinary Incontinence in Adults (1992, 1996) assumed that all treatments for incontinence could be divided into just "three major categories": Behavioral, Pharmacologic, and Surgical.  No formal definitions were provided for these categories, but it is clear that AHCPR assumed that Surgical Treatments include all surgical interventions, Pharmacologic Treatments include all medications, and, by default, everything else was classified as a "Behavioral Treatment".  Since electrical stimulation did not involve medication, it was classified in "Other-behavioral therapies". It is our contention, and will be shown, that as a result of this arbitrary classification, considerable confusion has resulted in the analysis of electrical stimulation research and many misleading conclusions have been drawn by well-meaning researchers and practitioners alike.

 

WHAT IS BEHAVIORAL THERAPY?   A leading textbook in the field defines behavioral therapy and behavioral medicine as outgrowths of behavior modification, which taught that "maladaptive behaviors" were "learned" and thus could be "unlearned".  Specifically, "Behavioral medicine focuses on applications of learning theories to medical disorders and other health-related topics."  (Schwartz, 1995, p. 6).  It is central to the concept of behavioral therapy that a person, if willing and motivated, can be taught to modify his or her behavior to enhance physical health.  Common examples include smoking cessation and weight control programs, and it is obvious that a person has to "want to change" or the therapy -- however clever -- will have no effect.

 

WHAT IS PHARMACOLOGY?  All definitions of pharmacologic ingredients are based on the premise that there is an active "agent" (chemical) in the medication itself which produces one or more specific effects in the patient, absolutely without regard to the patient's will or desire to obtain that effect.  In research, trials are controlled so that any patient-related behavior, expectations, or motivations are ascribed to "placebo effects" and are compared, favorably or otherwise, to the action of the "drug itself".  A drug is only approved by the FDA for marketing if it can be shown to produce changes without regard to patient-related variables.  A drug which only works for those patients who "try hard" and "believe in it" can not be sold. 

 

Biofeedback, now some 30 years old, is widely recognized as one of the most technologically sophisticated forms of behavioral therapy.  It involves the monitoring, amplification and display of certain bodily functions in order to permit the patient to learn to have more conscious control over those functions and thus enhance their own health.  EMG Biofeedback has been used in the rehabilitation of pelvic muscles for over 20 years. In classic simplicity, biofeedback involves (1) an electronic device, (2) connecting wires, and (3) sensors attached to the body.  At first glance, there appears to be a superficial similarity between electrical stimulation devices and biofeedback devices -- indeed, many are made by the same manufacturers, and may even include the same external boxes, wires and sensors.

 

But the electronics are quite different, and any similarity is only superficial.  In biofeedback, all electrical currents travel away from the patient into the box.  In electrical stimulation, all electrical currents travel from the box into the patient.  This distinction is as important as the difference between making a deposit into your bank account and writing a check on the account, as many of us have discovered the hard way. 

 

In the early days of electrical stimulation research, subjects were often instructed to "make a Kegel contraction" when they felt the twitch of stimulation.  In this model it became impossible to separate the effects of the stimulator from the effects of the Kegel exercises done by the patient, and the stimulator could not be described as anything more than an over-priced metronome.  More recently, in an effort to provide better "controlled" research, patients have instructed to remain totally passive.  Recent advertisements for a well funded magnetically coupled form of electrical stimulation show a woman seated in a specially equipped chair reading a magazine while the stimulator "fixes" her weak pelvic muscles.  No attention, volition, cooperation, motivation or even activity is required on the patient's part.  Considered at this level, the differences between biofeedback and other behavioral therapies on the one hand, and electrical stimulation on the other, are decisive; electrical stimulation is not a form of behavior therapy.

 

But at a deeper level of analysis, it is well known that the mechanism by which electrical stimulation operates is ultimately, if not initially, very similar to medications.  Many incontinence drugs achieve their effect by enhancing synaptic transmission of electro-chemical impulses to the pelvic muscles.   Stimulators accomplish the same effect by injecting a stronger than natural signal, instead. 

 

Because of the many differences between stimulation and biofeedback, and the basic similarities between stimulation and medication, it is proposed that stimulation devices be classified, for purposes of this discussion, as pharmaceuticals, rather than behavioral therapies.  And as a consequence of this reclassification, stimulators should be subject to the same rigid experimental controls and research requirements as other drugs that rely on the presence of an "active agent" in the treatment.

 

One result of moving electrical stimulation out of the behavioral category is that it leaves behind a much more consistent and coherent group of therapies.  In the words of the 1992 Guideline, "All behavioral techniques involve educating the patient and providing positive reinforcement for effort and progress (p. 27)."   In addition, the Guideline states that "These techniques . . . require personal (and caregiver) involvement and continued practice.  If motivated, most people . . . show improvement . . .(p. 28)."  [Note that none of these requirements applied to electrical stimulation, anyway.] 

 

The Guideline also discusses various limitations "that determine the effectiveness of behavioral interventions".  But given the emphasis on "learning" and "motivation", it is noteworthy that when actually reviewing research there is absolutely no discussion about the skill, experience or expertise of the person who teaches these techniques and attempts to encourage high levels of motivation in the patient.  Is it not likely that some teachers are better than others?  That some methods are better than others?  That some trainers are more "motivating" than others?  If behavioral therapies were a sub-category of pharmaceuticals, these questions would be considered inappropriate.  The effectiveness of a medication must be entirely independent of the personal characteristics, including expertise and experience, of the medication dispenser.  But that is not true of teachers.  Almost everyone remembers with fondness and appreciation certain teachers who, by virtue of personal characteristics, stand out as having made a difference in our lives.

 

It is important to notice that the personal characteristics of the dispenser were considered important in the third treatment category, Surgery.   The Guideline states quite clearly that "Success of any surgical procedure depends on operator expertise…Prospective comparisons often include different surgeons with different degrees of experience and expertise."  (1992, p. 48).  Why, we may ask, is "operator expertise" considered a valid question for surgeons but not for teachers?  It does not make sense to allow for surgeon's skills and not to consider teacher's skills. 

 

Surgeons have specialized training, and must demonstrate specific skills to practice at all. And in every state in the Union, public school teachers must be certified to meet minimum state requirements for teaching skills.  Why should we assume that skill level is not important in behavioral therapies?  The Biofeedback Certification Institute of America has been certifying competence in biofeedback for nearly two decades, and many nurses and physical therapists are certified and use the initials "BCIA-C" after their names. 

 

Yet unlike surgeons, the competence of teachers of behavioral therapies is seldom examined.  In published research the personality and motivational capacity of the teacher has often been overlook or downgraded.  Berghmans et al (1996) actually boasts that biofeedback patients were treated the same as controls: "The physiotherapist gives the treatments in such a way that no difference is noticeable in the approach of the two interventions (p. 40)."  Burns (1993) also reported extensive efforts to provide exactly equivalent therapist contact to both experimental and control group subjects.  While appropriate in drug research designs, such depersonalization of teaching can hardly be justified by any theory of education or motivation. 

 

CONCLUSION:  Electrical stimulation may be considered a variant of pharmacology for research purposes, and personal qualities of the dispensing staff are necessarily irrelevant.  In contrast, for incontinence research involving either surgeons or teachers, issues of training, experience, and expertise are of major significance and should be fully disclosed and discussed. 

 

 

 

 

References

 

Berghmans LCM, Frederiks CMA, de Bie RA, Weil EHJ, Smetts LWH, Janknegt RA (1996) Efficacy of biofeedback, when included with standard pelvic floor training, for genuine stress incontinence.  Neurology and Urodynamics, 15:37-52.

 

Burns PA, Pranikoff K, Nochajski TH, Hadley EL, Levy KJ, Ory MG (1993): A comparison of effectiveness of biofeedback and pelvic muscle exercise treatment of stress incontinence in older community-dwelling women. J Gerontol Medical Sciences 48: 167-174.

 

Fantl, JA, Newman, DK, & Colling, J (1996).  Urinary Incontinence in Adults:  Acute and Chronic Management:  Clinical Practice Guideline.  Rockville:  U.S. Department of Health and Human Services. Public Health Service, Agency for Health Care Policy and Research. AHCPR Publication No. 96-0682.

 

Schwartz M. (Ed.)  Biofeedback: A Practitioner's Guide, Second Edition.  New York, London:  Guilford Press.

Urinary Incontinence Guideline Panel  (1992). Urinary Incontinence in Adults: Clinical Practice Guideline.  Rockville, MD: Agency for Health Care Policy and Research, Public Health Service, U.S. Department of Health and Human Services.  AHCPR Pub. No. 92-0038.