Hiroshi Yamaguchi,1 Yasutoshi Kimura,1 Masafumi Imamura,1 Minoru Nagayama,1 Tatsuya Ito,1 Daisuke Kyuno,1 Tsuyoshi Kono,1 Akina Kimura,1 Emi Akizuki,1 Toshihiko Nishidate,1 Kenji Okita,1 Takayuki Nobuoka,1 Toru Mizuguchi,1,2 Koichi Hirata,3 Ichiro Takemasa1 1Department of Surgery, Surgical Oncology and Science, Sapporo Medical University, School of Medicine, Sapporo, Japan; 2Department of Nursing and Surgical Science, Sapporo Medical University School of Health Science, Sapporo, Japan; 3Department of Surgery, JR Sapporo Hospital, Sapporo, JapanCorrespondence: Hiroshi YamaguchiDepartment of Surgery, Surgical Oncology and Science, Sapporo Medical University, South 1, West 16, Sapporo 060-8543, JapanTel +81 11-611-2111 Ext 32810Fax +81 11-613-1678Email hyama@sapmed.ac.jpIntroduction: Delayed gastric emptying (DGE) remains an important problem after pancreaticoduodenectomy (PD). There is a lack of effective treatments for early recovery of oral dietary intake. Rikkunshito (RKT), a Japanese herbal medicine, has been gaining attention as a facilitator of gastric emptying. We evaluated the effects of RKT on DGE after PD.Methods: In this prospective, randomized, open-labeled study, patients were randomly allocated before PD in a 1:1 ratio to the RKT group or the control group that received no additional treatment. The RKT group received 2.5 g of RKT three times daily (7.5 g/day) from postoperative day (POD) 1 to POD 21. The primary endpoint was the incidence of DGE. Secondary endpoints were short-term postoperative outcomes including oral dietary intake volume and perioperative changes in levels of the hormones ghrelin and leptin. Patients were observed until hospital discharge.Results: Twenty-six patients in each group (n = 52) completed the protocol treatment and were included in the analysis set. There were no statistically significant differences in basic characteristics and operative factors. The overall incidence of DGE was not statistically different between the RKT and control groups (30.8% vs 30.8%, p> 0.9999). There were no statistically significant differences in the amount of postoperative oral dietary intake represented by total dietary intake (TDI) up to POD 14 and POD 21, complications, and length of hospital stay. No adverse events related to this study were observed. In the RKT group, total ghrelin and acyl-ghrelin were significantly upregulated and leptin was significantly downregulated earlier than in the control group.Conclusion: RKT treatment from POD 1 to 21 did not reduce the incidence of DGE and had no clinically beneficial effect on short-term postoperative outcomes irrespective of changes in hormone levels.Keywords: delayed gastric emptying, pancreaticoduodenectomy, Rikkunshito, ghrelin, leptin
