Tolerability of Fenzian ElectrobiofeedbackTreatment for Asthma in a Caribbean Population

1. Tolerability of FenzianElectrobiofeedbackTreatment for Asthma in a Caribbean Population Selvi Jeyaseelan1, Ian Hambleton1, Nkemcho Ojeh1, Noel Archer1, Amy Browne1, Natasha Sobers-Grannum1, Pam Giddings2, James Colthurst2, Gregory B. Diette3 1Faculty of Medical Sciences, The University of the West Indies, Cave Hill, Barbados; 2Fenzian Ltd, Hungerford UK, 3Pulmonary and Critical Care Medicine, Johns Hopkins University, Baltimore, MD, USA • Background: • Asthma is a significant public health problem in Barbados • Side effects and fears about medication use can limit acceptability of available treatment • Non-pharmacologic approaches to asthma, if efficacious, may be desirable • The purpose of this study to determine if a non-pharmacologic treatment (Fenzian) is acceptable for use among people with asthma in the Caribbean. • Methods: • The Fenzian treatment system consists of a trained medical practitioner and an FDA-registered device that provides biofeedback using transcutaneous stimulation with very low dose electrical impulses • Subjects with doctor-diagnosed asthma were recruited from private health care facilities in Barbados for this unmasked, uncontrolled clinical trial. • Subjects received 16 treatments over 4 weeks. Assessments included acceptability of treatment, asthma symptoms, lung function, and QOL • T-tests were performed on post vs. pre-treatment values, with p<0.05 considered significant. • At one-month post treatment, each participant was contacted for three peak flow readings (FEV1, PEFR). • Conclusions: • Tolerability and acceptability of Fenzian are high in patients with asthma in Barbados, pointing to feasibility of conducting a larger, definitive study. • In this uncontrolled study, quality of life and asthma control improved during treatment, while lung function did not • 6 participants were able to be contacted at 1 year post study. At enrollment, they had been using [mean (range), 7 (1-18)] puffs of albuterol per day. At 1 year, only 1 of 6 was using albuterol regularly, while 3 had stopped completely. I used it if he ‘encountered smoke’ once every three months. The other had some albuterol for a chest infection. • Larger, controlled studies of Fenzian are warrented to determine if this treatment is efficacious in asthma.