RESUMO
Purpose: In Germany, there are several microcurrent medical devices that are certified for the treatment of patients suffering from one of the indications chronic back pain, skeletal system pain, fibromyalgia, migraine or depression. While certification is based on controlled, randomized clinical trials, evidence of efficacy and safety under real-world conditions is limited to very few observational studies. To fill this gap, this study was conducted. Patients and Methods: Fifty patients per indication already using the investigational device before study entry were included and followed for a total 6 months. Each participant used the Healy in an individualized schedule to optimize the treatment of his/her special indication. This means that each participant performed on average 1-2 microcurrent applications per day for 20 to 30 minutes each. In all indications, the improvement of health-related quality of life was assessed by the SF-36 questionnaire and other validated indication specific surveys. Results: In all indications, the improvement of health-related quality of life as assessed by the SF-36 questionnaire was statistically highly significant and clinically relevant. These findings were supported by more specific outcome measures applied in each indication. Only four adverse events related to the application of microcurrent occurred during the trial. Conclusion: Microcurrent therapy has been demonstrated to be efficient and safe under real-world conditions for the treatment of each of the conditions for which the device is certified.
RESUMO
BACKGROUND: Bioenergy treatment devices for self-treatment with the aim to improve well-being are widely available, have become popular, and are used by a rather large number of persons. Yet, a systematic analysis of the assumed effect of these devices has not yet been conducted. We meta-analyzed eight very similar studies of the Healy device to assess the joint effect size. METHOD: Eight studies with similar designs, some active controlled and some wait-list controlled, testing the Healy bioenergy device, were meta-analyzed. They were conducted by the producer of the device for quality assurance and further development of the application. An additional literature search revealed no additional, independent studies. RESULT: The overall effect size across studies, combining all active arms and averaging outcome measures, is Hedge's g = 0.757 (random effects model, I2 = 85.8; z = 6.57; p < 0.0001). The stronger active intervention against control yields a heterogeneous g = 0.825 (random effects, I2 = 82.5; z = 7.77; p < 0.0001). Active treatments against each other result in a significant g = 0.29 (fixed effects, I2 = 0.0; z = 8.34; p < 0.0001). DISCUSSION: The highest effect sizes are produced by a measure of coherence, followed by the WHO5 well-being questionnaire, the Perceived Stress Scale, with the Measure Your Own Medical Outcome Profile, resulting in the smallest effect size. Heterogeneity can be partially explained by the type of control, with active control producing smaller and wait-list control producing larger outcomes. Another source of heterogeneity is the sequencing of studies. Effect sizes grew for three studies, which were similar, and then fell and remained very similar for the rest of the studies. A limitation of this analysis is the fact that all studies were conducted by the R and D Department of the producer of the device. CONCLUSION: In this meta-analysis, the Healy device showed considerable effects, improving general well-being in healthy individuals. Nonetheless, an independent confirmation of these findings would be desirable. Moreover, the potential mechanisms of effect of the bioenergy device remain unclear, and further studies addressing this research question are warranted.