Repeated administration of ghrelin to patients with functional dyspepsia: its effects on food intake and appetite

Background: Ghrelin plays a major role in the regulation of food intake (FI), which makes it a strong candidate for the treatment of anorexia. Objective: We attempted to evaluate the clinical response to repeated ghrelin administration in patients with anorexia caused by functional disorders, such as functional dyspepsia (FD). Subjects and methods: Subjects included in this study were those who 1) were diagnosed with functional anorexia, including FD and other eating disorders with the exception of anorexia nervosa; 2) were lean (body mass index (BMI) < 22 kg/m(2)); and 3) exhibited decreased FI. Subjects received an i.v. infusion of ghrelin (3 mu g/kg) for 30 min twice a day (before breakfast and dinner) for 2 weeks. We investigated the effects of ghrelin administration on FI, appetite, hormones, and metabolic parameters. Results: Six patients with FD were enrolled in this study. Ghrelin administration tended to increase daily FI in comparison with levels before and after completion of treatment, but this difference that was the primary endpoint of this study did not reach statistical significance (P=0.084). Hunger sensation was significantly elevated at the end of drip infusion (P < 0.0001). No severe adverse effects were observed. Conclusions: These results suggest that ghrelin administration is safe and that this treatment has stimulatory effects on appetite in patients with FD. Further studies are necessary to confirm the efficacy of ghrelin treatment for anorexia-related disorders.