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

Abstract

BackgroundPatients with Parkinson’s disease (PD) usually experience distress related not only to motor dysfunction, but also to nonmotor symptoms, including gastrointestinal dysfunction.ObjectiveThe 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.MethodsPatients 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.ResultsRKT 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.ConclusionsRKT 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.

The gut-brain axis and Parkinson disease: clinical and pathogenetic relevance

“…Administration of dietary herb extract Rikkunshito has been evaluated in two small open-label trials. Contradictory results were found on DGE (improved in one study, no effect in the other), whereas effect on motor fluctuations was not evaluated [ 83 , 84 ].…”

Effects of Parkinson's disease on molar bite force, electromyographic activity and muscle thickness of the masseter, temporal and sternocleidomastoid muscles: A case‐control study

“…Groups Patients with Parkinson's disease present with tremor, stiffness and lack of coordination in agonist and antagonist muscles. 26 These factors may result in recruitment of a greater number of muscle fibres to perform a movement, which leads to alterations in muscular activity. 27 Among the body functions, most affected by Parkinson's disease is the amplitude of the motion of body joints.…”

Risk Factors for Gastrointestinal Injuries in Acute Coronary Syndrome Patients with Double Antiplatelet Therapy in One-Year Follow-Up

“…Some limitations of our research should be considered. First this study didn't provide information about the prevalence of GI injury in ACS patients who did not use DAPT as a contrast.Second, other factors reported by previous surveys may influence the GI injury[30] [31], such as H. pylori infection. However, we didn't evaluate H. pylori infection due to limited funds and H. pylori was not routinely tested for by cardiologists in our hospital.…”