Complementary & Alternative Medicine for Mental Health

 The FDA has grandfathered CES for treatment of depression, anxiety and sleep
disorders
 Brown and Gerbarg cited two early studies of CES that found increased attention and
concentration in normal adults.^7 They add that in clinical practice, they have found that
CES can improve attention, reduce anxiety, and relieve insomnia, all helpful in treating
ADHD.^8
 A 2010 survey of the research on brain-stimulation devices by Edelmuth, Nitsche,
Battistella & Fregni found 16 well-controlled clinical studies of CES, with significant
outcomes reported in 65% of the trials. All of the 16 were controlled trials, and the
majority was double-blinded. Although the majority of trials were for depression, anxiety
disorders, or insomnia (the FDA approved indications), some were for other conditions,
such as recovery from substance use disorders, traumatic brain injury, pain, and
enhancing attention and concentration.^9 See Suggested But Unproven Uses, below.
 Three 2006 meta-analyses by Smith demonstrated significant improvement in anxiety,
depression and insomnia from the use of CES.^10 It should be noted, however, that the
Smith monograph has not been peer-reviewed and that Dr. Smith is a consultant to the
industry. Most studies cited as evidence for the effectiveness of CES failed to report all
data necessary for meta-analysis. And while anxiety effects are well documented by the
studies analyzed by Smith, most depression studies have been small and not double-
blind.^11
 The Smith meta-analyses were summarized as follows by Mischoulon:^12 Each meta-
analysis focuses on a particular treatment indication, as follows:
 Insomnia: 18 studies, 648 subjects, mean improvement 62%
 Depression: 18 studies, 853 subjects, mean improvement 47%
 Anxiety: 38 studies, 1495 subjects, mean improvement 58%
Most of these studies are limited by small samples, heterogeneity of symptoms, and
overlap of conditions, which limits their rigorousness and generalizability to specific
conditions, though these results may be more reflective of “real world” populations in
which co-morbidity tends to be the rule rather than the exception. CES appears to be a
benign intervention with no serious adverse events.