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RIKKUNSHITO

Rikkunshito is a traditional Japanese herbal medicine (Kampo) that has been the subject of several clinical trials examining its effectiveness in treating various digestive disorders, particularly functional dyspepsia. This traditional medicine, composed of eight herbal ingredients including Atractylodes lancea Rhizome, Ginseng, and Citrus unshiu Peel, has shown promise in improving gastric function and alleviating symptoms related to digestive discomfort. Recent clinical studies have focused on evaluating Rikkunshito’s efficacy compared to placebo, its mechanisms of action, and its potential benefits for patients suffering from chronic digestive complaints.

Table of Contents

What is Rikkunshito?

Rikkunshito (also known as TJ-43 or Tsumura Rikkunshito) is a traditional Japanese herbal medicine (Kampo medicine) that has been used for centuries to treat various gastrointestinal disorders [1]. This herbal preparation has gained scientific attention in recent years due to its potential benefits in treating functional gastrointestinal disorders, particularly functional dyspepsia.

Composition of Rikkunshito

Rikkunshito is composed of eight herbal medicines, each contributing to its therapeutic effects [3]:

  • Atractylodes lancea Rhizome – helps with digestive function
  • Ginseng – improves energy and overall health
  • Pinellia tuber – reduces nausea
  • Poria sclerotium – has mild diuretic properties
  • Jujube – supports digestive health
  • Citrus unshiu Peel – aids digestion
  • Glycyrrhiza (licorice) – soothes the digestive tract
  • Ginger – helps with nausea and digestion

This combination of herbs works synergistically to provide relief from gastrointestinal symptoms [3].

Medical Uses

Based on clinical trials data, Rikkunshito is primarily used for:

  • Functional Dyspepsia (FD) – especially the subtype called Postprandial Distress Syndrome (PDS), which involves feeling uncomfortably full after meals and early satiation (feeling full after eating only a small amount) [1] [2] [3]
  • Gastrointestinal symptoms – such as nausea, vomiting, and abdominal discomfort [1]
  • Improving gastric motility – the movement of food through the stomach and intestines [2]

Rikkunshito for Functional Dyspepsia

Functional dyspepsia is a chronic disorder affecting up to 15% of the general population, characterized by symptoms in the upper gastrointestinal tract without any identifiable structural or biochemical abnormalities [3]. There are two main subtypes:

  1. Postprandial Distress Syndrome (PDS) – characterized by uncomfortable fullness after meals and early satiation
  2. Epigastric Pain Syndrome (EPS) – characterized by pain or burning in the upper abdomen

Rikkunshito has shown particular promise for treating PDS symptoms. Clinical trials have demonstrated that Rikkunshito can significantly improve symptoms compared to placebo, especially in patients with meal-related symptoms [1] [2].

How Does Rikkunshito Work?

Research suggests Rikkunshito may work through several mechanisms [2] [3]:

  • Improving gastric accommodation – enhancing the stomach’s ability to relax and accept food without causing discomfort
  • Enhancing ghrelin signaling – ghrelin is a hormone that stimulates appetite and improves gastric emptying
  • Improving gastric emptying – helping food move more efficiently through the digestive system
  • Potentially affecting duodenal inflammation and permeability – which may play a role in functional dyspepsia

Studies using specialized techniques such as high-resolution manometry (a method to measure pressure within the digestive tract) have shown that Rikkunshito can affect intragastric pressure, which is an indirect measure of gastric accommodation and motility [2].

Dosage and Administration

Based on clinical trials, the typical dosage and administration of Rikkunshito is [1] [2] [3]:

  • Amount: 2.5 grams
  • Frequency: Three times daily
  • Timing: 30 minutes before meals
  • Method: Dissolved in approximately 30-200 ml of lukewarm water and consumed as a single dose
  • Duration: Treatment periods in clinical trials have typically lasted 4-8 weeks

It’s important to note that dosage should be determined by a healthcare provider based on individual needs and conditions [3].

Clinical Evidence and Research

Several clinical trials have evaluated Rikkunshito’s effectiveness [1] [2] [3]:

  • DREAM Study (Double-blind Trial With Rikkunshito Versus Placebo on Efficacy and Safety in Patients With Functional Dyspepsia): This multi-center study in Japan assessed the efficacy and safety of Rikkunshito compared to placebo in subjects with Functional Dyspepsia (FD) [1].
  • European Studies: Research has begun to evaluate Rikkunshito’s effectiveness in European populations, as most previous studies were conducted in Japan. One study examined the effect of Rikkunshito on gastric accommodation and nutrient volume tolerance using intragastric pressure monitoring [2].
  • Primary Care Study: A trial called PRIMARY CARE DYSPEPSIA RIKKUNSHITO (ACCENT) is evaluating Rikkunshito in functional dyspepsia patients recruited from primary care settings, with a focus on the Postprandial Distress Syndrome subtype [3].

These studies measure outcomes including [1]:

  • Overall Treatment Efficacy (OTE) – patients’ evaluation of their symptomatic improvement
  • Modified Frequency Scale for Symptoms of Gastroesophageal Reflux Disease (FSSG) – assessing both GERD and dyspeptic symptoms
  • Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM) – evaluating various gastrointestinal symptoms
  • Quality of life measures – using questionnaires such as SF-8 (Short-form Health Survey-8)
  • Anxiety and depression scales – using tools like the Hospital Anxiety and Depression Scale (HAD)

Safety and Side Effects

Clinical trials have included safety assessments of Rikkunshito through [1] [2]:

  • Monitoring of adverse events
  • Blood pressure, heart rate, and weight assessment
  • Electrocardiogram (ECG)
  • Physical examination
  • Blood tests to check liver and kidney function

Overall, Rikkunshito appears to be well-tolerated in clinical trials, though as with any medication or supplement, individual responses may vary. Always consult with a healthcare provider before starting any new treatment [2].

Similar Herbal Formulations

Several other traditional herbal formulations share some similarities with Rikkunshito in terms of ingredients or uses [4] [5] [6]:

  • Xiang-Sha-Liu-Jun-Zi-Tang (XSLJZT) – a traditional Chinese herbal medicine used for gastrointestinal disorders including irritable bowel syndrome (IBS) [4]
  • Liu-Jun-Zi-Tang – used in combination with other herbal medicines for conditions such as childhood asthma [5]
  • Combination formulas – such as Shin-yi-san + Xiao-qing-long-tang + Xiang-sha-liu-jun-zi-tang, which have been studied for conditions like allergic rhinitis [6]

While these formulations may share some ingredients or therapeutic principles with Rikkunshito, they are used for different conditions and should not be considered interchangeable without medical guidance [4] [5] [6].

Aspect Details
Drug Composition Rikkunshito (also known as TJ-43) is composed of eight herbal medicines: Atractylodes lancea Rhizome, Ginseng, Pinellia tuber, Poria sclerotium, Jujube, Citrus unshiu Peel, Glycyrrhiza, and Ginger.
Primary Conditions Studied Functional Dyspepsia (FD), particularly Postprandial Distress Syndrome (PDS) with symptoms including meal-related fullness and early satiation.
Dosage in Clinical Trials Typically 2.5g dissolved in lukewarm water, taken three times daily, 30 minutes before meals.
Administration Method Oral administration; powder dissolved in 30-200ml of lukewarm water.
Treatment Duration Clinical trials ranged from 4 to 12 weeks of treatment.
Study Designs Primarily randomized, double-blind, placebo-controlled trials with crossover designs in some studies.
Primary Outcome Measures Symptom improvement measured by validated questionnaires (FSSG, PAGI-SYM, GOS), overall treatment efficacy, and quality of life assessments.
Secondary Measures Gastric accommodation, intragastric pressure during meal intake, gastric emptying rate, and various biological markers.
Proposed Mechanisms Improvement of gastric accommodation, enhancement of food intake, increasing circulating ghrelin levels, and potential effects on duodenal mucosal integrity and immune activation.
Geographic Scope Studies conducted in Japan, Belgium, and other European countries, investigating efficacy across different populations.
Related Herbal Formulations Other traditional formulations studied in gastrointestinal disorders include Xiang-Sha-Liu-Jun-Zi-Tang for Irritable Bowel Syndrome and Liu-Jun-Zi-Tang in combination with other herbs for various conditions.

FAQ

  • What is Rikkunshito and what is it used for? Rikkunshito is a traditional Japanese herbal medicine (Kampo) composed of eight herbal ingredients including Atractylodes lancea Rhizome, Ginseng, Pinellia tuber, Poria sclerotium, Jujube, Citrus unshiu Peel, Glycyrrhiza, and Ginger. In clinical trials, it's primarily being studied for treating functional dyspepsia, which involves chronic upper gastrointestinal symptoms like postprandial fullness, early satiation, and epigastric pain or burning that occur without an identifiable cause after routine investigation.
  • How is Rikkunshito administered in clinical trials? In most clinical trials, Rikkunshito is administered orally as a powder that needs to be dissolved in lukewarm water. The typical dosage is 2.5 grams taken three times daily, usually 30 minutes before meals. Patients are instructed to dissolve the powder in approximately 30-200 ml of lukewarm water and consume it as a single dose.
  • What symptoms does Rikkunshito help with? Clinical trials are investigating Rikkunshito's effects on various digestive symptoms including postprandial fullness (feeling overly full after eating), early satiation (feeling full before finishing a normal-sized meal), epigastric pain or burning, bloating, and nausea. It's also being studied for its effects on gastric accommodation (the stomach's ability to relax and expand upon food intake) and gastric emptying rate.
  • How does Rikkunshito work in the body? While the exact mechanisms are still being investigated, research suggests that Rikkunshito may work by improving gastric accommodation (the stomach's ability to relax and expand upon food intake), enhancing gastric emptying, and increasing levels of ghrelin, a hormone that stimulates appetite. Some studies also examine whether Rikkunshito affects duodenal mucosal integrity and immune activation, which may be related to symptoms of functional dyspepsia.
  • What outcomes are measured in Rikkunshito clinical trials? Clinical trials measuring Rikkunshito's effectiveness typically assess changes in symptom severity using validated questionnaires (like the PAGI-SYM, FSSG, or GOS scales), changes in quality of life, gastric function measurements (such as intragastric pressure and gastric emptying rate), and sometimes biological markers. Researchers also track symptom improvement through patient-reported outcomes, frequency of symptom occurrences, and overall treatment efficacy compared to placebo.

Ongoing Clinical Trials on RIKKUNSHITO

  • Study on the Effects of Rikkunshito on Functional Dyspepsia in Primary Care Patients

    Recruiting

    1 1
    Investigated drugs:
    Belgium

Glossary

  • Functional Dyspepsia (FD): A chronic digestive disorder characterized by recurring symptoms of upper abdominal pain, discomfort, early satiation, fullness, bloating, or nausea without identifiable structural or biochemical abnormalities during routine clinical investigations, including upper GI endoscopy.
  • Postprandial Distress Syndrome (PDS): A subtype of functional dyspepsia characterized primarily by meal-related symptoms including early satiation (feeling full shortly after starting to eat) and postprandial fullness (uncomfortable fullness after meals).
  • Epigastric Pain Syndrome (EPS): A subtype of functional dyspepsia characterized by epigastric pain or burning that is not exclusively related to meals.
  • Kampo Medicine: A traditional Japanese herbal medicine system adapted from Traditional Chinese Medicine, characterized by standardized herbal formulations used to treat various conditions.
  • Gastric Accommodation: The natural relaxation and expansion of the stomach upon food intake, allowing the stomach to hold larger volumes without increasing pressure.
  • Intragastric Pressure (IGP): The pressure inside the stomach, which can be measured using specialized equipment. It serves as an indirect measure of gastric accommodation and motility.
  • High-Resolution Manometry (HRM): A diagnostic procedure that measures pressure within the gastrointestinal tract using multiple pressure sensors, helping to evaluate gastrointestinal motility disorders.
  • Modified FSSG: Modified Frequency Scale for the Symptoms of Gastroesophageal Reflux Disease, a questionnaire used to assess symptoms related to GERD and dyspepsia.
  • PAGI-SYM: Patient Assessment of Upper Gastrointestinal Symptom Severity Index, a questionnaire designed to measure the severity of upper gastrointestinal symptoms.
  • GOS: Global Overall Symptom scale, a measurement tool used to assess the overall severity of gastrointestinal symptoms.
  • Quality of Life (QOL): A measure of an individual's perception of their position in life in relation to their goals, expectations, standards, and concerns, often assessed in clinical trials to determine how a treatment affects overall wellbeing.
  • Double-blind Study: A research study in which neither the participants nor the researchers know which participants are receiving the experimental treatment and which are receiving a placebo or standard treatment.
  • Placebo: An inactive substance or treatment that looks identical to the active treatment being tested but has no therapeutic effect, used as a control in clinical trials.
  • Duodenal Mucosal Integrity: The structural and functional soundness of the lining of the duodenum (first part of the small intestine), which can be compromised in some gastrointestinal disorders.
  • Ghrelin: A hormone produced primarily in the stomach that stimulates appetite and is involved in regulating food intake and energy homeostasis.

References

  1. https://clinicaltrials.gov/study/NCT02037776
  2. https://clinicaltrials.gov/study/NCT03856294
  3. https://clinicaltrials.eu/trial/study-on-the-effects-of-rikkunshito-on-functional-dyspepsia-in-primary-care-patients/
  4. https://clinicaltrials.gov/study/NCT02179580
  5. https://clinicaltrials.gov/study/NCT05066841
  6. https://clinicaltrials.gov/study/NCT04388358