Open Label Trial of the Efficacy and Safety Profile of Rikkunshito used for the Treatment of Gastrointestinal Symptoms in Patients with Parkinson’s Disease: A Pilot Study

Autor: Koji Yakabi, MD, PhD, Naomi Yamaguchi, MD, PhD, Shino Ono, MD, PhD, Norihito Yoshida, MD, Eriko Hosomi, MD, PhD, Kenjiro Hayashi, MD, PhD, Mitsuko Ochiai, AAT, Kosuke Maezawa, BA, Kyoichi Nomura, MD, PhD
Jazyk: angličtina
Rok vydání: 2017
Předmět:
Zdroj: Current Therapeutic Research, Vol 87, Iss C, Pp 1-8 (2017)
Druh dokumentu: article
ISSN: 0011-393X
1879-0313
DOI: 10.1016/j.curtheres.2017.07.003
Popis: Background: Patients with Parkinson’s disease (PD) usually experience distress related not only to motor dysfunction, but also to nonmotor symptoms, including gastrointestinal dysfunction. Objective: The purpose of this pilot study was to evaluate the efficacy and safety profile of a traditional Japanese medicine, rikkunshito (RKT), used for the treatment of gastrointestinal symptoms, associated with anorexia and dyspepsia, in patients with PD. Methods: Patients were randomly assigned to either Group A (4-week treatment period with 7.5 g/d RKT followed by a 4-week off-treatment period) or Group B (4-week off-treatment period followed by a 4-week treatment period with 7.5 g/d RKT). Appetite, quality of life for gastrointestinal symptoms, and depression were assessed using a visual analog scale, the Gastrointestinal Symptom Rating Scale and the Self-Rating Depression Scale, respectively. The gastric emptying examination and assay of plasma acylated ghrelin level were performed using the 13C-acetate breath test and commercially available assay kits, respectively. Results: RKT treatment produced a significant increase in the appetite score (1.84 [2.34]; P < 0.05), compared to a decrease in the score over the off-treatment period (−1.36 [2.94]). The mean score for abdominal pain, on the Gastrointestinal Symptom Rating Scale, and for self-reported depression, on the Self-Rating Depression Scale, also decreased significantly with RKT treatment (P < 0.05), compared with the off-treatment period scores. No effect of RKT on plasma acylated ghrelin level and rate of gastric emptying was identified. Conclusions: RKT may improve anorexia in patients with PD. The positive effects of RKT on depression and anorexia may improve the overall quality of life of these patients. The benefits of RKT identified in our pilot study will need to be confirmed in a randomized, double-blind, controlled trial. UMIN Clinical Trial Registry identifier: UMIN000009626.
Databáze: Directory of Open Access Journals
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