Oxytocin Nasal Spray in the Treatment of Binge Eating Disorder and Obesity: A Pilot, Randomized, Double-Blind Trial
|Roberta Agabio1,2*, Anna Maria Giulia Farci3, Olga Curreli3, Raffaele Deidda4, Silvia Mercuro3, Romina Naitana3, Angelo Restivo5, Elisa Tronci3, Gian Luigi Gessa1,2 and Maria Rosaria Melis1,2|
|1Department of Biomedical Sciences, Section of Neuroscience and Clinical Pharmacology, University of Cagliari, Italy|
|2Center of Excellence on Neurobiology of Dependence, University of Cagliari, Italy|
|3Clinical Nutrition Center, Department of Medical Sciences “M. Aresu”, University of Cagliari, Italy|
|4Pharmaceutical Service, University of Cagliari, Italy|
|5Colorectal Surgery Center, Department of Surgical Sciences, University of Cagliari, Italy|
|*Corresponding Author :||Roberta Agabio
Department of Biomedical Sciences
Section of Neuroscience and Clinical Pharmacology
University of Cagliari, Cittadella Universitaria
Monserrato (CA), Italy
Tel: +39 070 6754325
|Received March 16, 2016; Accepted April 06, 2016; Published April 12, 2016|
|Citation:Agabio R, Farci AMG, Curreli O, Deidda R, Mercuro S, et al. (2016) Oxytocin Nasal Spray in the Treatment of Binge Eating Disorder and Obesity: A Pilot, Randomized, Double-Blind Trial. Clin Pharmacol Biopharm 5:155. doi:10.4172/2167-065X.1000155|
|Copyright: © 2016 Agabio R, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.|
Preclinical studies suggest that the neuropeptide oxytocin reduces food intake and body weight, but only a few clinical studies have investigated the translatability of these findings in humans. The present study investigated the safety and efficacy of oxytocin nasal spray in patients affected by binge eating disorder and obesity.
Seventeen outpatients affected by binge eating disorder and obesity participated in a 8 week double-blind trial and received oxytocin (n=8; 24 IU, four times a day, 20 min before each of three meals and before going to bed) or placebo (n=9) with an energy-restricted diet. Primary outcomes included adverse events and the number of binge eating episodes per week. Secondary measures included body weight, BMI, severity of BED, craving for food, quality of sleep, quality of life, anxiety, and depressive symptoms.
One patient of oxytocin group discontinued prematurely the trial before the first post-randomization efficacy measure. Among the other 16 participants, 13 (81.2%) completed the trial, and 3 (18.8%) discontinued [3 in the oxytocin group; 0 in the placebo group (p=0.0625, Fisher’s exact test)]. No significant difference between groups was found in any outcome evaluated. Patients of the placebo group performed slightly better than patients of the oxytocin group in some secondary outcomes, but these differences were not significant.
Oxytocin nasal spray resulted to be safe, including in women of childbearing age but did not significantly reduce the number of binge eating episodes per week in outpatients affected by binge eating disorder and obesity. These findings are discussed in light of the human oxytocin literature.