title: Effects of ghrelin administration after total gastrectomy: a prospective, randomized, placebo-controlled phase II study.
abstract: OBJECTIVE
  Body weight (BW) loss and reduction of blood ghrelin level are commonly observed after total gastrectomy (TG). A prospective study was designed to elucidate whether exogenous ghrelin administration prevents postoperative BW loss by improving appetite and oral food intake in patients with gastric cancer after undergoing TG.
  
  
  METHODS
  In this randomized phase II study, 21 patients undergoing TG were assigned to a ghrelin (11 patients) or placebo group (10 patients). They received intravenous infusion of synthetic human ghrelin (3 microg/kg) or saline twice daily for 10 days after starting oral food intake following surgery. Changes in BW, appetite visual analog scale score, food intake calories, body composition, basal metabolic rate, and various blood test results were evaluated.
  
  
  RESULTS
  Excluding one patient who developed profound diaphoresis during ghrelin infusion, 20 patients completed the study. Food intake and appetite were significantly higher with ghrelin compared with placebo (average, 13.8 vs 10.4 kcal/kg/day [P = .030] and 5.7 vs 3.9 cm [P = .032], respectively). BW loss was significantly lower in the ghrelin than in the placebo group (-1.4% vs -3.7%; P = .044). Fat mass, lean body mass, and basal metabolic rate decreased significantly in the placebo group; however, the reductions in lean body mass and basal metabolic rate were not significant in the ghrelin group, although that of fat mass was significant.
  
  
  CONCLUSIONS
  Short-term administration of synthetic ghrelin was safe and successfully lessened postoperative BW loss and improved appetite and food intake after TG.
authors.affiliation: Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Osaka, Japan.
authors.forename: Shinichi
authors.initials: S
authors.lastname: Adachi
authors.forename: Shuji
authors.initials: S
authors.lastname: Takiguchi
authors.forename: Kazuyuki
authors.initials: K
authors.lastname: Okada
authors.forename: Kazuyoshi
authors.initials: K
authors.lastname: Yamamoto
authors.forename: Makoto
authors.initials: M
authors.lastname: Yamasaki
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Miyata
authors.forename: Kiyokazu
authors.initials: K
authors.lastname: Nakajima
authors.forename: Yoshiyuki
authors.initials: Y
authors.lastname: Fujiwara
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Hosoda
authors.forename: Kenji
authors.initials: K
authors.lastname: Kangawa
authors.forename: Masaki
authors.initials: M
authors.lastname: Mori
authors.forename: Yuichiro
authors.initials: Y
authors.lastname: Doki
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001066:Appetite / Q000187:drug effects; D001481:Basal Metabolism / Q000187:drug effects; D001823:Body Composition / Q000187:drug effects; D004435:Eating / Q000187:drug effects; D005260:Female; D005743:Gastrectomy / Q000009:adverse effects*; D054439:Ghrelin / Q000494:pharmacology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D013274:Stomach Neoplasms / Q000601:surgery*; D014628:Vagotomy; D015431:Weight Loss / Q000187:drug effects*
chemical_list: D054439:Ghrelin