Efficacy
Yucha and Montgomery's (2008) ratings are listed for the five levels of efficacy recommended by a joint Task Force and adopted by the Boards of Directors of the Association for Applied Psychophysiology (AAPB) and the International Society for Neuronal Regulation (ISNR). From weakest to strongest, these levels include: not empirically supported, possibly efficacious, probably efficacious, efficacious, and efficacious and specific.
Level 1: Not empirically supported. This designation includes applications supported by anecdotal reports and/or case studies in non-peer reviewed venues. Yucha and Montgomery (2008) assigned eating disorders, immune function, spinal cord injury, and syncope to this category.
Level 2: Possibly efficacious. This designation requires at least one study of sufficient statistical power with well identified outcome measures but lacking randomized assignment to a control condition internal to the study. Yucha and Montgomery (2008) assigned asthma, autism, Bell palsy, cerebral palsy, COPD, coronary artery disease, cystic fibrosis, depression, erectile dysfunction, fibromyalgia, hand dystonia, irritable bowel syndrome, PTSD, repetitive strain injury, respiratory failure, stroke, tinnitus, and urinary incontinence in children to this category.
Level 3: Probably efficacious. This designation requires multiple observational studies, clinical studies, wait list controlled studies, and within subject and intrasubject replication studies that demonstrate efficacy. Yucha and Montgomery (2008) assigned alcoholism and substance abuse, arthritis, diabetes mellitus, fecal disorders in children, fecal incontinence in adults, insomnia, pediatric headache, traumatic brain injury, urinary incontinence in males, and vulvar vestibulitis (vulvodynia) to this category.
Level 4: Efficacious. This designation requires the satisfaction of six criteria:
(a) In a comparison with a no-treatment control group, alternative treatment group, or sham (placebo) control using randomized assignment, the investigational treatment is shown to be statistically significantly superior to the control condition or the investigational treatment is equivalent to a treatment of established efficacy in a study with sufficient power to detect moderate differences.
(b) The studies have been conducted with a population treated for a specific problem, for whom inclusion criteria are delineated in a reliable, operationally defined manner.
(c) The study used valid and clearly specified outcome measures related to the problem being treated.
(d) The data are subjected to appropriate data analysis.
(e) The diagnostic and treatment variables and procedures are clearly defined in a manner that permits replication of the study by independent researchers.
(f) The superiority or equivalence of the investigational treatment has been shown in at least two independent research settings.
Yucha and Montgomery (2008) assigned anxiety, chronic pain, epilepsy, constipation (adult), headache (adult), hypertension, motion sickness, Raynaud's disease, and temporomandibular disorder to this category.
Level 5: Efficacious and specific. The investigational treatment must be shown to be statistically superior to credible sham therapy, pill, or alternative bona fide treatment in at least two independent research settings. Yucha and Montgomery (2008) assigned urinary incontinence (females) to this category.
Read more about this topic: Biofeedback, Clinical Effectiveness
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