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Background: Current treatment and management options for functional dyspepsia (FD) often fail to alleviate symptoms. Naesohwajung-tang (NHT) is a herbal formula frequently used to treat functional dyspepsia in traditional Korean medicine. However, few animal and case reports on the use of Naesohwajung-tang for functional dyspepsia treatment exist, and the clinical evidence remains deficient.Objectives: This study aimed to evaluate the efficacy of Naesohwajung-tang in patients with functional dyspepsia.Methods: We enrolled 116 patients with functional dyspepsia at two study sites in this 4 weeks, randomized, double-blind, placebo-controlled trial and randomly assigned them to either the Naesohwajung-tang or placebo group. To evaluate the efficacy of Naesohwajung-tang, the primary endpoint was a score on the total dyspepsia symptom (TDS) scale after treatment. The overall treatment effect (OTE), single dyspepsia symptom (SDS) scale, food retention questionnaire (FRQ), Damum questionnaire (DQ), functional dyspepsia-related quality of life (FD-QoL) questionnaire, and gastric myoelectrical activity measured using electrogastrography were evaluated as secondary outcomes. Laboratory tests were performed to confirm the safety of the intervention.Results: The 4 weeks administration of Naesohwajung-tang granules demonstrated a significantly higher reduction in the total dyspepsia symptom (p < 0.05) and a higher degree of improvement in the total dyspepsia symptom (p < 0.01) than the placebo group. Patients who underwent Naesohwajung-tang had a significantly higher overall treatment effect and a greater increase in the degree of improvement in scores such as epigastric burning, postprandial fullness, early satiation, functional dyspepsia-related quality of life, and Damum questionnaire (p < 0.05). Additionally, the Naesohwajung-tang group showed a greater effect in preventing a decrease in the percentage of normal gastric slow waves after meals than the placebo group. As a result of subgroup analyses using the degree of improvement in total dyspepsia symptom, Naesohwajung-tang was found to be more effective than placebo in female, younger patients (Conclusion: This is the first randomized clinical trial to verify that Naesohwajung-tang leads on symptom relief in patients with functional dyspepsia.Clinical Trial Registration:https://cris.nih.go.kr/cris/search/detailSearch.do/17613, identifier KCT0003405

Objective: Although Xiaoyao-san (XYS) is a popular herbal remedy for indigestion, there is insufficient evidence to recommend it as a treatment option for functional dyspepsia (FD). This review aimed to assess the safety and efficacy of XYS in patients with FD, compared to conventional Western medicine (WM).Methods: Two independent reviewers searched for randomized controlled trials (RCTs) using 11 electronic databases, including Medline and Embase, to evaluate therapeutic effects of XYS on FD up to 31 January 2023. The primary outcome was the total clinical efficacy rate (TCE), and secondary outcomes included scores of dyspepsia-related symptoms (DSS) and incidence of adverse events (AEs). The risk of bias was evaluated using the Cochrane collaboration tool, and data synthesis and subgroup analyses were performed using the Review Manager program.Results: Six studies involving 707 participants were included in the meta-analysis. XYS significantly improved TCE compared to WM (RR = 1.15, 95% CI: 1.05, 1.26, p = 0.002) with high heterogeneity (I2 = 59%, p = 0.06). Combination therapy also showed higher TCE than WM alone (RR = 1.22, 95% CI: 1.05, 1.41, p = 0.008), and the heterogeneity was low (I2 = 0%, p = 0.86). The results showed a greater reduction in DSS in the XYS and combination therapy groups than in the WM alone group (SMD = −0.72, 95% CI: −0.90, −0.53, p < 0.00001) with low heterogeneity (I2 = 44%, p = 0.15), especially for abdominal distension and upper abdominal pain. AEs occurred less frequently in the XYS and combination therapy groups than in the WM alone group (RR = 0.20, 95% CI: 0.07, 0.63, p = 0.006), and the heterogeneity was low (I2 = 45%, p = 0.18). The certainty of the evidence for each outcome was rated from “very low” to “high.”Conclusion: This review suggests that XYS is effective and safe for reducing complaints in patients with FD. However, high-quality RCTs should be conducted to establish more convincing therapeutic evidence of XYS for the treatment of FD.Systematic Review Registration:https://www.crd.york.ac.uk/prospero, CRD42020178842

Objectives: This study was designed to investigate the difference between genuine and pseudo-halitosis in terms of clinical characteristics.Methods: We recruited 51 halitosis patients who visited the halitosis clinic at Kyung Hee University Korean Medicine Hospital from March 2020 to March 2022. We classified the halitosis patients into two groups, genuine and pseudo halitosis, based on oral chroma and evaluated the status of hyposalivation using the drainage method, stress levels using heart rate variability (HRV) parameters, and Ryodoraku.Results: Comparing the genuine halitosis group and the pseudo halitosis group, there was no significant difference in the status of hyposalivation and HRV parameters. However, Ryodoraku was significantly different between genuine and pseudo halitosis. Compared to the genuine halitosis group, the pseudo halitosis group showed a significantly higher value of total average (TA) of Ryodoraku.Conclusion: The results of this study suggest that there is a significant difference in Ryodoraku between genuine halitosis and pseudo halitosis, so when approaching pseudo halitosis patients, we should consider their excitability of the sympathetic nervous system and metabolic function status.

Objective: This case study reports the effects of treating a gastric cancer patient who had undergone gastrectomy with Korean medicine.Methods: After gastrectomy, a 77-year-old female patient received acupuncture, electroacupuncture, herbal medicine (Banhabaekchulchunma-tang, Banhahubak-tang), and moxibustion for one month.Results: After treatment, changes were observed in the patient’s numeric rating scale (from 7 to 2); visual analog scale (from 8.7 to 2.6); Short Form-36 Health Survey scores (physical from 20 to 48 and mental from 14 to 53); Functional Dyspepsia-Related Quality of Life results (from 84 to 41); and Korean Nepean Dyspepsia Index (from 63 to 32).Conclusion: Korean medical treatment for dyspepsia following gastrectomy is worthy of further research.

Objectives: This study aimed to identify the characteristics of the heart rate variability (HRV) index in patients with burning mouth syndrome (BMS) and to evaluate the predictive value of HRV for Korean medical treatment responsiveness to tongue pain in BMS.Methods: Among BMS patients who visited the Oral Diseases Clinic of Kyung Hee University Korean Medicine Hospital from January 1, 2018, to May 31, 2021, we reviewed the clinical records of 217 women aged 50 years and over. HRV and unstimulated saliva flow rate (USFR) measurements were carried out, and all patients were asked to indicate their degree of tongue pain using the visual analog scale (VAS). The subjects were classified into subgroups according to the presence or absence of hyposalivation and VAS improvement, and each subgroup was compared using the HRV index. Logistic regression analysis was conducted to confirm whether cause–effect relationships were present between statistically significant values.Results: BMS patients had lower LF and HF than healthy people. Subgroup analysis demonstrated that there were some statistically significant differences in the HRV index according to salivation rate and degree of pain. In addition, as the LF/HF ratio increased, the pain improvement rate decreased after treatment.Conclusion: The autonomic nerve activity of BMS patients was lower than that of healthy people; however, autonomic balance was not impaired. In addition, tongue pain in BMS patients responded more favorably to Korean medical treatment when patients fell within a normal range of the LF/HF ratio, suggesting that autonomic imbalance could be used as one of the predictable factors in clinical practice.

Purpose: The standard tool for the pattern identification is used for identifying patterns in patients using a questionnaire. The purpose of this study is to reorganize the standard tool for the pattern identification of gastroesophageal reflux disease (GERD) developed in 2017 and to analyze the reliability and validity of the standard tool for pattern identification by applying it to GERD patients.Methods: To reorganize the standard tool for the pattern identification of GERD developed in the previous study, we searched the literature in the main databases, OASIS (Oriental Medicine Advanced Searching Integrated System) and CNKI (China National Knowledge Infrastructure). We added the search results to the data used in the previous study and went through the reorganizing courses, such as evaluating the validity of the translation, the Delphi technique, and a small survey. After reorganization, the patients who visited the Kyunghee University Korean Medicine Center for GERD symptoms were provided the questionnaire, including the reorganized standard tool for pattern identification. We analyzed the survey results to evaluate their reliability and validity.Results: Fifty patients completed the questionnaire. Reliability analysis results showed a pattern identification match rate of 86%, Cronbach’s α coefficient of 0.834, and intraclass correlation coefficient of 0.907. The Mann–Whitney U test and logistic regression were implemented to check the relations between the survey questions and pattern identification results; the Pearson correlation, compared with other scales, showed a moderate score.Conclusion: We reorganized the standard tool for the pattern identification of GERD to be updated on current issues and so that it is easily used. The analysis results of the questionnaire showed that the reorganized standard tool had high reliability and moderate validity.

A 42-year-old patient with functional dyspepsia had suffered from early satiation and postprandial fullness for 1 year despite Western medicine treatment. We treated her with the Spleen Daoyin method, along with acupuncture, moxibustion, and herbal medicine and scored her symptoms using a 4-point Functional Dyspepsia-related Quality of Life (4p-FD-QoL) questionnaire, the Gastrointestinal Symptom Rating Scale (GSRS), and a visual analogue scale (VAS). A 7-day Spleen Daoyin treatment decreased her 4p-FD-QoL score from 61 to 51, with a marked decrease in the emotional part (18 to 10). Her GSRS score did not change, but her bloating score decreased from 3 to 1. Her VAS score decreased from 6.6 to 4.3 for upper abdomen discomfort, but lower abdomen discomfort was unchanged. The patient showed high compliance and satisfaction with exercise therapy and reported no adverse events. Spleen Dayoin may be a useful therapy for functional dyspepsia, especially when accompanied by psychological problems.

Objectives: This study investigated the clinical characteristics of functional dyspepsia (FD) patients with food retention (FR) in regard to the parameters of cutaneous electrogastrography (EGG), Ryodoraku, and heart rate variability (HRV).Methods: This study reviewed the clinical records of 33 FD patients with FR who filled out the FR Questionnaire for FD (FRQ-FD) and underwent EGG for six months from March 1st, 2021. We summarized the clinical characteristics of FD patients with FR and analyzed the correlation between FRQ-FD score and parameters of EGG, Ryodoraku, and HRV.Results: FRQ-FD scores had a positive correlation with percentage of postprandial bradygastria and negative correlation with power ratio, detected on Channel 2, 3 of EGG. The total average (TA) Ryodoraku score was lower, and the high frequency density (HF) of HRV was higher than the normal value.Conclusions: The results of this study suggest that clinicians can use EGG, Ryodoraku, and HRV to increase the accuracy of diagnosing FR in FD patients.

Objectives: The aim of this study was to analyze the correlation between patterns determined by pattern identification of functional dyspepsia (FD) and tongue features, including tongue coating and tooth marks, in FD patients.Methods: We reviewed the clinical records of 68 FD patients who visited the Department of Digestive Diseases of Kyung Hee University Korean Medicine Hospital from September 1, 2020 to August 31, 2021. The subjects were evaluated with a computerized tongue image acquisition system (CTIS) and by pattern identification of FD. Measurement included the percentage of tongue coating, tooth mark levels, and pattern scores.Results: Statistically significant negative correlations were noted between the scores of the pattern of ‘spleen and stomach deficiency and cold' (SSDC) and the percentage of tongue coating in whole, center, and root of the tongue body. However, no other patterns were correlated with any parameter measured by CTIS. No significant difference was noted in the percentage of tongue coating and the tooth mark level between the patterns.Conclusions: This study demonstrated that the pattern of SSDC was significantly associated with the percentage of tongue coating. We suggest that the percentage of tongue coating could be a useful indicator for identifying the degree of patterning of SSDC in patients with FD.

Objectives: This case study examined the effectiveness of Korean medical treatment for pediatric Crohn’s disease.Methods: A 15-year-old female Korean patient with Crohn’s disease received acupuncture, electroacupuncture, herbal medicine, moxibustion, and aromatherapy treatment for 1 month in a hospital.Results: Decreases in the Pediatric Crohn’s Disease Activity Index score (from 22.5 to 7.5) and the size of two abscesses (from 39.97 mm to 33.36 mm, and from 28.14 mm to 18.71 mm) according to an abdominal CT were observed following treatment. Nausea and vomiting disappeared, stool condition improved, and weight increased (from 30 kg to 33 kg) following treatment. Nausea and vomiting disappeared, stool condition improved, and weight increased (from 30 kg to 33 kg) following treatment.Conclusion: It would be worth examining the long-term effectiveness of Korean medical treatment for pediatric Crohn’s disease.

Purpose: Functional dyspepsia (FD) is a chronic syndrome accompanied by repetitive digestive symptoms that appear in the upper gastrointestinal tract and are not caused by specific diseases. Psychological symptoms like anxiety, depression, insomnia, and somatization are frequently observed in FD. The purpose of this study was to review the effect of herbal medicine on the psychological symptoms that accompany FD.Methods: Database search (PubMed, EMBASE, KISS, Kmbase, KoreanMed, NDSL, OASIS, CNKI) was performed on February 24, 2021; a total of 1825 studies were searched. After the screening, 22 studies were included.Results: The studies were assessed by Cochrane RoB 2 and sorted into a table according to psychological symptoms. Meta-analysis was performed to estimate the effect of herbal medicine. Twenty of the twenty-two studies reported that herbal medicine was significantly more effective than the control group. Only three of the studies did not have a high risk of bias.Conclusion: Herbal medicine was significantly effective with or without Western medicine and had fewer adverse effects. Severe adverse effect was not reported. Psychological symptoms in FD affect onset and duration of FD, and some FD patients want to be treated for their anxiety before other symptoms. Reliable information about treatment for the psychological symptoms of FD is lacking. We reviewed the effect of herbal medicine treatment in this study, the results of which could be selected for primary or secondary treatment for FD.

The herbal medicine Yukgunja-tang has been widely used for the treatment of functional dyspepsia (FD) in the clinical setting of East Asian traditional medicine. This paper presents a protocol for a randomized, assessor-blind, controlled, multicenter, three-arm parallel clinical trial comparing the effectiveness, safety, and cost-effectiveness of Yukgunja-tang with Pyeongwi-san and usual care. A total of 140 participants with Rome IV-diagnosed FD will be randomly assigned to either the Yukgunja-tang (n = 56), Pyeongwi-san (n = 56), or usual care (n = 28) groups. All participants will be educated on dietary guidelines for FD patients. Participants in the Yukgunja-tang and Pyeongwi-san groups will take investigational products for 6 weeks. All participants will be assessed for clinical parameters at weeks 0, 3, 6, 9, and 24. The primary outcome will be measured on the total dyspepsia symptom scale, and the secondary outcome will include the single dyspepsia symptom scale, overall treatment effect, the visual analog scale for dyspepsia, FD-related quality of life, hospital anxiety and depression scale, EuroQol-5 dimension, pattern identification, and serum levels of acyl-ghrelin and deacyl-ghrelin. Adverse events and laboratory tests will be monitored for safety assessment. The results will provide evidence of the effectiveness, safety, and cost-effectiveness of Yukgunja-tang in the treatment of FD.

Functional dyspepsia (FD) is a functional gastrointestinal disease that occurs without any explanatory organic disease, involving discomforts in upper abdomen such as bloating or pain after eating food. Although there is a standard treatment for FD, the disease often recurs or develops into a chronic condition, resulting in poor quality of life for the patients and high socioeconomic burden. Chuna therapy is a manual treatment commonly used in traditional Korean medicine (TKM) for musculoskeletal diseases such as intervertebral disc disorders and spinal stenosis. Recent studies have shown that Chuna therapy can be applied for the treatment of FD and is helpful in symptom improvement; however, high-quality evidence is still lacking. Therefore, this systematic review protocol intends to analyze the efficacy and safety of Chuna manual therapy for FD.We will search 11 electronic databases, including the Embase and MEDLINE, from their inception to June 2022. Two reviewers will independently screen the relevant studies and determine their compatibility with the search eligibility of this review. The primary outcome is the total clinical effective rate, and other variables such as dyspepsia-related symptom score, quality of life score, and adverse events will be analyzed. We will evaluate the quality of the evidence and interpret the overall findings using the Cochrane risk-of-bias tool for randomized trials and the Grading of Recommendations Assessment, Development, and Evaluation tool. To reduce the heterogeneity of the included studies, subgroup analysis according to the subdivisions of FD will be conducted and operational methods of Chuna therapy will be recorded in detail.This protocol describes the systematic review to establish scientific evidence of Chuna manual therapy in FD patients.We will categorize various types of Chuna therapy for providing guidelines that can be applied reproducibly in clinical practice.

Supplemental Digital Content is available in the text, Background: Functional dyspepsia (FD) is a chronic gastrointestinal disorder diagnosed with dyspeptic symptoms, such as recurrent or persistent postprandial fullness, epigastric pain, burning, and early satiety without any evidence of structural abnormality. In traditional Korean medicine, herbal remedies are one of the preferred treatments for gastrointestinal symptoms. Among them, Naesohwajung-tang (NHT) has been frequently prescribed to improve dyspeptic symptoms for a long time. However, the safety and efficacy of NHT still remain unclear. Therefore, this study aims to evaluate the safety and efficacy of NHT in patients with FD using a randomized controlled trial. Methods: This is a protocol for a multi-center, randomized, double-blind, placebo-controlled trial. Total 116 participants aged between 19 and 75 years diagnosed with FD according to the Rome IV diagnosis criteria will be recruited at two Korean medicine hospitals. Eligible participants will be randomly assigned to either a NHT group or a placebo group in a 1:1 ratio. Each participant will be instructed to take NHT or placebo granules three times a day for 4 weeks. The primary outcome is the change in the total dyspepsia symptom score to confirm the efficacy of NHT. The secondary outcomes include overall total effect, single dyspepsia symptom scale, food retention questionnaire, Damum questionnaire, FD-related quality of life, electrogastrography, and safety assessments. Adverse events will be evaluated at every visit. The primary endpoint will be measured at week 4, and then re-evaluated at week 8 through a follow-up phone visit. Discussion: This trial will evaluate the safety and efficacy of NHT as a treatment of FD. The results of this trial will not only verify whether NHT improves FD symptoms and gastric myoelectrical activity, but also clarify those correlations. Trial registration number: CRIS KCT0003405.

Background Functional dyspepsia (FD) is characterized by persistent and recurrent dyspeptic symptoms, such as postprandial fullness and epigastric pain. Although it is rarely severe or life-threatening, it can degrade the quality of life and cause social and economic issues. As symptoms often persist despite the treatment with conventional Western medicine, herbal medicine can be considered as an alternative for treating FD. Siho-sogan-san (SHS) is a traditional herbal formula prescribed for dyspepsia for hundreds of years. This protocol for a systematic review was designed to evaluate the safety and efficacy of SHS for the treatment of FD through a meta-analysis. Methods Studies will be searched from the following electronic databases up to March 2020: Embase, MEDLINE (via PubMED), Cochrane Central Register of Controlled Trials, Allied and Complementary Medicine Database, Korean Medical Database, KoreaMed, Korean Studies Information Service System, National Digital Science Library, Oriental Medicine Advanced Searching Integrated System, China National Knowledge Infrastructure Database, and Citation Information by Nii. Randomized controlled trials of SHS and herb-added SHS for treating FD will be selected in this review. The control groups of no-treatment, placebo, and conventional Western medicine will be compared with SHS for its efficacy. The synergetic effect of SHS with Western medicine will also be analyzed in comparison with conventional Western medicine alone. Two independent reviewers will collect the data and assess the risk of bias in individual studies. The total clinical effectiveness rate will be synthesized and evaluated as primary outcome. Results This systematic review will present an adequate clinical evidence of SHS for the treatment of FD based on specific parameters, including dyspepsia-related symptoms, gastric emptying, and adverse events. Conclusion This study will provide evidence for the safety and efficacy of SHS for the treatment of patients with FD. REVIEW REGISTRY UNIQUE IDENTIFYING NUMBER:: reviewregistry952.

Background Functional dyspepsia (FD) is a common condition characterized by gastrointestinal symptoms, such as abdominal fullness and epigastric pain. With the limitations of conventional Western medical treatments, symptoms often recur and lead to poor quality of life. Soyo-san (SYS) is a traditional herbal medicine that has been frequently used to treat indigestion. This protocol was designed to investigate the safety and efficacy of SYS for treating FD through a systematic review and meta-analysis. Methods Trials will be searched from the following 11 electronic databases, up to March 2020: EMBASE, Medline (via PubMED), the Cochrane Central Register of Controlled Trials (CENTRAL), Allied and Complementary Medicine Database (AMED), Korean Medical Database (KMbase), KoreaMed, Korean Studies Information Service System (KISS), National Digital Science Library (NDSL), Oriental Medicine Advanced Searching Integrated System (OASIS), China National Knowledge Infrastructure Database (CNKI), and Citation Information by Nii (CiNii). Randomized controlled trials (RCTs) of SYS or modified SYS for FD will be included in this systematic review. The effects of control interventions such as placebo, no-treatment, and conventional Western medicine will be compared with those of SYS. RCTs investigating the synergetic effect of SYS and Western medicine compared with conventional Western medicine alone will also be evaluated. Two investigators will independently extract the data and assess the risk of bias in the included studies. The total clinical effective rate will be measured as the main outcome. Results This systematic review will provide data on the use of SYS in the treatment of FD, based on indicators such as dyspepsia-related symptom score, recurrence rate, and adverse events. Conclusion This study will determine the safety and efficacy of SYS for the treatment of FD. REVIEW REGISTRY UNIQUE IDENTIFYING NUMBER:: reviewregistry969.