1. Randomized clinical trial: rikkunshito in the treatment of functional dyspepsia-a multicenter, double-blind, randomized, placebo-controlled study.
- Author
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Suzuki, H., Matsuzaki, J., Fukushima, Y., Suzaki, F., Kasugai, K., Nishizawa, T., Naito, Y., Hayakawa, T., Kamiya, T., Andoh, T., Yoshida, H., Tokura, Y., Nagata, H., Kobayakawa, M., Mori, M., Kato, K., Hosoda, H., Takebayashi, T., Miura, S., and Uemura, N.
- Subjects
JAPANESE herbal medicine ,GASTRIC emptying ,INDIGESTION ,HELICOBACTER pylori ,GHRELIN - Abstract
Background Rikkunshito, a standardized Japanese herbal medicine, is thought to accelerate gastric emptying and relieve dyspepsia, although no large-scale, randomized, placebo-controlled trials of rikkunshito have been conducted. This study aimed to determine the efficacy and safety of rikkunshito for treating functional dyspepsia ( FD). Methods FD patients received 2.5 g rikkunshito or placebo three times a day for 8 weeks in this multicenter, randomized, placebo-controlled, parallel-group trial. The primary end point was the proportion of responders at 8 weeks after starting test drug, determined by global patient assessment ( GPA). The improvement in four major dyspepsia symptoms severity scale was also evaluated. In addition, plasma ghrelin levels were investigated before and after treatment. Key Results Two hundred forty-seven patients were randomly assigned. In the eighth week, the rikkunshito group had more GPA responders (33.6%) than the placebo (23.8%), although this did not reach statistical significance ( p = 0.09). Epigastric pain was significantly improved ( p = 0.04) and postprandial fullness tended to improve ( p = 0.06) in the rikkunshito group at week 8. Rikkunshito was relatively more effective among Helicobacter pylori-infected participants (rikkunshito: 40.0% vs placebo: 20.5%, p = 0.07), and seemed less effective among H. pylori-uninfected participants (rikkunshito: 29.3% vs placebo: 25.6%, p = 0.72). Among H. pylori-positive individuals, acyl ghrelin levels were improved just in rikkunshito group. There were no severe adverse events in both groups. Conclusions & Inferences Administration of rikkunshito for 8 weeks reduced dyspepsia, particularly symptoms of epigastric pain and postprandial fullness. ( UMIN Clinical Trials Registry, Number UMIN000003954). [ABSTRACT FROM AUTHOR]
- Published
- 2014
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