The effect of standard and high dose of rikkunshito on achievement of enteral nutrition target in critically ill patients: a pilot randomized controlled trial

AIM: Rikkunshito is a traditional Japanese medicine used for delayed gastric emptying in intensive care units in Japan. This study aimed to investigate whether standard‐ or high‐dose rikkunshito can improve the achievement of enteral calorie target among critically ill adults. METHODS: This open‐label, single‐center, pilot randomized controlled trial was carried out from March 2018 until December 2018 and enrolled critically ill adult patients requiring enteral nutrition by gastric tube for at least 5 days. Patients were randomized into the control group, the standard‐dose rikkunshito group (2.5 g three times daily), and the high‐dose rikkunshito group (5 g three times daily). Intervention was given for 5 days. The primary outcome measure was the percentage of enteral calorie intake achieved in the target at the fifth day after randomization. RESULTS: The cohort comprised 26 patients; of these, 9, 8, and 9 were included in the control group, the standard‐dose group, and the high‐dose group, respectively. Twenty‐one patients (81%) were included in the primary analysis. The percentage of enteral calorie intake achieved in the target at the fifth day was 59% (interquartile range [IQR], 39–63%), 40% (IQR, 26–61%), and 62% (IQR, 17–83%) in the control, the standard‐dose, and the high‐dose groups, respectively (P = 0.42). The number of adverse events did not differ significantly between the groups (control group, 4 [44%]; standard‐dose group, 3 [38%]; and high‐dose group, 4 [44%], P = 1.00). CONCLUSIONS: Standard‐ or high‐dose rikkunshito did not improve the achievement of enteral calorie target in critically ill adults.