Oxytocin Nasal Spray in the Treatment of Binge Eating Disorder and Obesity: A Pilot, Randomized, Double-Blind Trial

Abstract

BackgroundPreclinical 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. MethodsSeventeen 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. ResultsOne 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. ConclusionOxytocin 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.

Relationship between dietary intake and behaviors with oxytocin: a systematic review of studies in adults

“…The studies varied in the particular dietary characteristics examined (Table 2 [42][43][44][45][52][53][54][55][56][57][58][59][60][61][62][63][64][65][66][67][68][69][70][71] ). Endogenous oxytocin concentrations were examined in relation to the following dietary exposures, intakes, and behaviors, in descending order: alcohol (n ¼ 6), eating disorders (AN and BN; n ¼ 3), caffeine (n ¼ 1), dietary and supplemental calcium (n ¼ 1), fat-rich meal (n ¼ 1), low-and high-sodium diets (n ¼ 1), short-term fasting (n ¼ 1), and food addiction (n ¼ 1).…”

“…Eleven of the 26 studies included female participants exclusively, 56,58,60-64,66,68,70,71 7 included only male participants, 43-45,52,55,57,69 and 8 included both male and female participants. 42,53,54,59,65,67 Fourteen of the studies included participants with clinical characteristics: diabetes mellitus [T1DM] (n ¼ 2), 53,62 gastroparesis (n ¼ 1), 53 functional dyspepsia (n ¼ 1), 53 chronic normal-transit constipation (n ¼ 1), 68 AN (n ¼ 5), 58,60,61,63,66 bulimia nervosa (BN; n ¼ 3), 58,62,66 binge-eating disorder (BED; n ¼ 1), 71 and food addiction (n ¼ 1). 42 Participants were recruited from 7 countries: United States (n ¼ 7 studies), 44,52,55,58,[62][63][64][65] Germany (n¼ 4), 43,45,59,70 Italy (n ¼ 3), 56,57,71 Sweden (n ¼ 4), 53,54,67,68 South Korea (n ¼ 2), 60,61 Denmark (n ¼ 1), 69 and Canada (n ¼ 1). 42 Participants ranged in age from 16 to 65 years (mean, 31.1 6 9.0).…”

“…The average age of participants was < 45 years for all but 2 studies. 53,71 Across all of the included studies, the most common secondary measures examined, in descending order, were appetite hormones and blood parameters (n ¼ 8), mood states (n ¼ 5), gastric emptying rates (n ¼ 3), energy expenditure (n ¼ 3), anxiety and depression (n ¼ 3), temperament traits (n ¼ 2), emotional recognition (n ¼ 2), and autism spectrum traits (n ¼ 1).…”

“…Thirteen studies (Table 2 [42][43][44][45][52][53][54][55][56][57][58][59][60][61][62][63][64][65][66][67][68][69][70][71] ), which were published between 2006 and 2016, examined the effect of exogenous oxytocin on dietary intake and behaviors in healthy individuals (n ¼ 8) [43][44][45]54,65,67,70 and individuals with clinical characteristics (n ¼ 5; functional dyspepsia, gastroparesis, AN, BN, and BED). 53,60,61,71 Sample sizes ranged from 10 to 102 (median, 20). Four of the studies included female participantss exclusively, 60,61,70,71 3 included only male participants, [43][44][45] and 5 included both male and female participants.…”

“…53,60,61,71 Sample sizes ranged from 10 to 102 (median, 20). Four of the studies included female participantss exclusively, 60,61,70,71 3 included only male participants, [43][44][45] and 5 included both male and female participants. 53,54,65,67 Participants ranged in age from 16 to 62 years (mean, 34.1 6 11.1).…”