Biofeedback is resistant to double-blind drug research – one cannot provide fake real-time feedback of biological processes and expect both the subject and the researcher to remain unaware. However, prevalence of widespread skepticism combined with the preference for evidence-based treatment at some point in time mandated the need for research-based evaluations of treatments.
To meet this need, the Association for Applied Psychophysiology and Biofeedback together with the International Society for Neurofeedback and Research established a “five levels of efficacy” model for judging biofeedback. Each level professes a certain degree of proven effectiveness in clinical trials. The placement of a condition’s treatment on a particular level is not necessarily a statement as to the actual effectiveness of feedback-based treatment of the condition, but is simply a statement as to how well that effectiveness is supported by empirical research. The five levels of efficacy are as follows:
Level 1: Not Empirically Supported
Examples: Eating Disorders, Immune System Functioning
Isolated reports support the efficacy. Controlled research has yet to show results.
Level 2: Possibly Efficacious
At least one study has shown statistically significant results, but without a proper control group.
Level 3: Probably Efficacious
The treatment’s efficacy is supported by multiple studies, but the studies (e.g. observational studies) lack enough scientific rigor to verify that it is the treatment which is producing the results.
Level 4: Efficacious
At least two completely independent researchers have shown valid data supporting the treatments efficacy in comparison with a random control group.
Level 5: Efficacious and Specific
At least two completely independent researchers have shown the treatment to be superior to either a) credible sham therapy, b) pill, or c) alternative bona fide treatment.
*The only condition categorized under Level 5 is female urinary incontinence.
Reference: Wikipedia
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Biofeedback rocks!