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

Abstract

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.

The efficacy and safety of prokinetics in critically ill adults receiving gastric feeding tubes: A systematic review and meta-analysis

“…The effect of prokinetics on hospital length of stay was examined by five studies [ 23 , 25 – 27 , 29 ]. These five studies, which enrolled a total of 250 patients, showed a significant difference in the hospital length of stay between the prokinetic agent-treated group and the control group (MD -3.21, 95% CI -5.35, -1.06; P = 0.003; I 2 = 28%) ( Fig 2 ).…”

“…These five studies, which enrolled a total of 250 patients, showed a significant difference in the hospital length of stay between the prokinetic agent-treated group and the control group (MD -3.21, 95% CI -5.35, -1.06; P = 0.003; I 2 = 28%) ( Fig 2 ). Three studies evaluated the effect of prokinetics on ICU length of stay in the critical care setting [ 23 , 25 , 27 ]. These three studies, enrolling a total of 186 patients, showed that prokinetic agents appeared to have a positive effect on shortening ICU length of stay (MD -2.03, 95% CI -3.96, -0.10; P = 0.04; I 2 = 0%) ( Fig 3 ) .…”

“…Seven studies reported events that met the definition of adverse events in 757 critically ill patients [ 23 – 25 , 27 – 29 , 32 ]. The meta-analysis showed no significant difference in the risk of reported adverse events between the prokinetic agent group and the control group (RR 1.13, 95% CI 0.92, 1.38; P = 0.25; I 2 = 0%) ( S2 Fig ) .…”

“…The effect of prokinetic agents on all-cause mortality was examined by six studies in 691 critically ill patients [ 23 , 25 , 28 , 29 , 31 , 32 ]. There was no significant difference in all-cause mortality between the prokinetic agent group and the control group (RR 0.96, 95% CI 0.81, 1.14; P = 0.64; I 2 = 0%) ( S3 Fig ) .…”

“…The sensitivity analysis, which was performed by excluding the trials with a high risk of bias [ 25 , 28 ], did not show important changes in the pooled effects of hospital length of stay, ICU length of stay, reported adverse events, and all-cause mortality. ( S8 – S11 Figs ).…”