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Benefits and Harms of Cranial Electrical Stimulation

IN RESPONSE: We disagree with Dr. Marksberry that our search strategy and review were biased. We searched multiple electronic databases without language restrictions, ClinicalTrials.gov, previous systematic reviews, the reference lists of included studies, studies cited on manufacturers' Web sites, an 11-page document provided by the makers of Alpha-Stim entitled Clinical Evaluation Report that included many citations of studies using the Alpha-Stim device, and a U.S. Food and Drug Administration executive summary (prepared 10 February 2012) in response to a petition to request a change in classification for cranial electrical stimulators. We restricted eligibility to studies measuring clinical outcomes for patients with our target conditions (chronic painful conditions, depression, anxiety, and insomnia) and that were randomized controlled trials, the least-biased study design for assessing effectiveness of interventions for chronic conditions that can have a fluctuating course and variable natural history. We doubt that including additional study designs in our review would have changed our conclusion. Of note, despite the U.S. Food and Drug Administration's inclusion of observational studies in their review, their conclusion was similar: [The U.S. Food and Drug Administration] has consistently stated that the effectiveness of [cranial electrical stimulation] has not been established by adequate scientific evidence (1). Lande and Gragnani's article (2) states, The study's primary outcome variables were the time to sleep onset, total time slept, and number of awakenings and that differences between groups were not statistically significant. No result in Table 2 of their article on change in hours in sleep timeincluding measurements on days 2, 3, 4, and 5 of treatment and 3 and 10 days after treatmentis reported as having a statistically significant difference between the treatment and control groups. We agree with Dr. Marksberry that additional nonaddictive, safe, and effective treatments for anxiety, insomnia, depression, and pain are needed. We look forward to well-designed and well-conducted studies of cranial electrical stimulation to evaluate its effectiveness.