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Background and Aim Functional dyspepsia (FD) is characterized by chronic and unexplained indigestion at upper abdomen. Because of unsatisfactory effect of conventional treatments, demand is growing for complementary and alternative medicine. Rikkunshito (RKT) is a herbal medicine, which has been widely used for FD in Asia; however, the evidence is lacking. We carried out systematic review and meta‐analysis to evaluate the effect and safety of RKT in the treatment of FD. Methods Electronic databases were searched in April 2019, including PUBMED, EMBASE, and Cochrane Library. All eligible studies should be randomized controlled trials (RCTs) comparing RKT or combination therapy (RKT and western medicine) group to western medicine group. The primary outcome measure was the total clinical efficacy rate (TCE). The secondary outcomes were total dyspepsia symptom scale, gastric emptying rate, gastrin, motilin, recurrence 6 months after treatment, and Hamilton depression rating scale. Results Fifty‐two RCTs with 5475 patients were involved in this systematic review and meta‐analysis. Compared with western medicine, RKT showed significant better result, with higher TCE (relative risk = 1.21, 95% confidence interval 1.17 to 1.25, P

Background: We aimed to critically evaluate the effectiveness and safety of acupuncture as an add-on therapy to conventional Western medication (WM) and assess the quality of evidence (QoE) of these findings.Methods: A total of 12 English, Korean, and Chinese databases were searched on December 18, 2020. Randomized controlled trials (RCTs) assessing the effectiveness of acupuncture as an add-on therapy to conventional WM for functional dyspepsia (FD) were included. The primary outcome was the symptom score of FD. The risk of bias of the included studies and QoE were evaluated using the Cochrane Collaboration's risk of bias tool and Grading of Recommendations, Assessment, Development, and Evaluation method, respectively.Results: A total of 22 RCTs were included. The total and individual FD symptom scores were significantly improved in the acupuncture combined with WM groups compared with the WM alone groups, except for in one study. The Nepean dyspepsia index score and total effective rate mostly improved significantly in the acupuncture group, regardless of the WM used and acupuncture type. FD-related biomarkers, such as ghrelin and gastrin levels, showed mixed results. The acupuncture group showed a significantly lower recurrence rate after 3–6 months of follow-up than the WM alone group. There were no differences in the incidence of adverse events between the two groups. The included studies generally had low methodological quality. The QoE for the main findings was generally very low to moderate.Conclusion: Limited evidence suggests that acupuncture has the potential to improve FD treatment in combination with conventional WM. Furthermore, the methodological quality of the included studies and QoE of the main findings were generally low. Therefore, RCTs with a rigorous methodology, including sham acupuncture and multiethnic subjects, should be performed.Systematic Review Registration: OSF registries [https://osf.io/mxren], PROSPERO [CRD42021226608].

In most cancer patients, chemotherapy-induced oral mucositis (OM) is a frequent side effect, leading to low quality of life and delay in therapy. The aim of this study was to evaluate the effects of Onchung-eum, a well-known herbal prescription in traditional medicine comprising 8 herbs that has long been used for skin diseases, on 5-fluorouracil (5-FU)–induced OM in human pharyngeal cells and golden Syrian hamsters. DPPH (2,2-diphenyl-1-picrylhydrazyl) radical scavenging activity, MTT (3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide) assay, and reactive oxygen species production were measured in vitro. The effects of Onchung-eum on OM of hamster cheek pouches induced by 5-FU were evaluated histologically and using TUNEL assay. In addition, the expression of nuclear factor-κB, caspase-3, and pro-inflammatory cytokines were measured by immunoblotting and immunohistochemistry. Significantly increased cell viability was observed in the Onchung-eum–treated groups compared with the 5-FU–treated control group. In 500 and 1000 mg/kg Onchung-eum–treated groups, the damaged epithelial layers in the cheek pouches of hamsters were significantly recovered. Moreover, at all concentrations, cell death in the cheek pouches of hamsters in the Onchung-eum–treated groups significantly decreased. The expression of pro-inflammatory cytokines, nuclear factor-κB, and caspase-3 also significantly decreased in Onchung-eum–treated groups at 500 and 1000 mg/kg. In conclusion, this study revealed that Onchung-eum can be used to treat chemotherapy-induced OM. However, further studies are required to understand the underlying mechanisms.

Background Abdominal examination (AE), one of the primary diagnostic tools used in traditional Korean medicine (TKM), has a limitation of being subjective due to depending on individual practitioner's experience. Therefore, we devised a novel patient-report pressure algometer (PA) and performed a clinical trial to investigate its validity. Methods In total, 44 participants with functional dyspepsia and 44 healthy participants completed the study. The participants were allocated into one of two groups according to the existence of abdominal stiffness at 5 acupoints or abdominal tenderness at 12 acupoints diagnosed by TKM doctors. The pressure depth and pressure pain threshold (PPT) were evaluated using the PA at the same acupoints. We assessed the validity (sensitivity and specificity) of PA and calculated the area under the curve (AUC) and optimal cutoff value of the test variables (pressure depth and PPT) to criterion standards (abdominal stiffness and tenderness). Results Pressure depth and PPT assessed by PA showed high sensitivity and specificity in diagnosing abdominal stiffness and tenderness. The validity at CV-14 of diagnosing abdominal tenderness with PPT by PA had a sensitivity of 73.1%, specificity of 77.8%, and an AUC of 0.807 with a P value of Conclusion This study may provide evidence of standardization and quantification of AE through PA.

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 Gastroesophageal reflux disease (GERD) is a major cause of chronic cough. GERD-induced chronic cough is difficult to diagnose because some patients do not complain of any gastrointestinal (GI) reflux symptoms. Although chronic cough due to GERD is highly prevalent, no effective treatment is currently available, especially for GERD-related cough without GI symptoms. Because the herbal medicines Ojeok-san and Saengmaek-san can effectively treat GERD and cough, we aim to evaluate the efficacy and safety of a combination of these components for relieving chronic cough due to GERD. Methods/design This is a study protocol of a randomized, double-blind, placebo-controlled, single-center pilot trial. After a 1-week run-in period, a total of 30 patients with GERD-induced chronic cough will be randomly allocated to an intervention group (n = 15) or a placebo group (n = 15). Participants will receive 5.76 g of Ojeok-san plus Saengmaek-san or a placebo three times per day for 6 weeks. The primary outcome measures, which are the frequency and severity of cough, will be recorded using a cough diary. The secondary outcome measures will include a cough visual analogue scale, the Leicester Cough Questionnaire (Korean version), the Gastrointestinal Symptom Rating Scale, the Hull Airway Reflux (hypersensitivity) Questionnaire, the Pattern Identification for Chronic Cough Questionnaire, the Pattern Identification for Gastroesophageal Reflux Disease, and safety testing. Adverse events will also be reported. Discussion This will be the first clinical trial to explore the use of herbal medicines for GERD-related chronic cough, including patients without GI reflux symptoms. This study will provide useful evidence regarding the efficacy and safety of Ojeok-san plus Saengmaek-san treatment. In addition, this trial will offer a scientific basis for the combination of herbal medicines. This study will also provide important data for conducting a larger-scale clinical trial on GERD-induced chronic cough. Trial registration This trial has been registered with Clinical Research Information Service (CRIS) of South Korea (http://cris.nih.go.kr; registration number KCT0003115). Registered August 28, 2018.

Introduction This study aimed to develop pattern identification scale for Stomach Qi Deficiency (SSQD) and investigated whether this questionnaire satisfied adequate reliability and validity. Methods To develop SSQD, we extracted major symptoms of Stomach Qi Deficiency (SQD) syndrome and requested an expert group to take part in a Delphi survey. The questionnaire was modified by the opinion of the expert group. For the analysis of reliability and validity and investigation of cut-off value, 30 participants who had dyspepsia and diagnosed as SQD and 30 healthy control participants were evaluated. Results Of the 13 questions in the SSQD, 1 question had negative effects on reliability and validity, therefore, it was excluded on further inspection. Overall Cronbach’s α coefficient of SSQD was 0.87. Construct validity was analyzed by factor analysis resulting 3 major factors. Using receiver operating characteristic curve analysis, the optimal cut-off value of SSQD was defined as 14, and its sensitivity and specificity were 93.33% and 86.67%, respectively. There were statistically significant positive correlation between SSQD and other dyspepsia severity scales. Conclusions The newly developed SSQD can provide fundamental reliability and validity as a specific pattern diagnosis questionnaire and can help diagnosing SQD. However, further studies will be needed to further confirm its specificity.

Background: Functional dyspepsia (FD) is the seventh most common disease encountered in Korean medicine (KM) clinics. Despite the large number of FD patients visiting KM clinics, the accumulated medical records have no utility in evidence development, due to being unstructured. This study aimed to construct a standard operating procedure (SOP) with appropriate structured diagnostic methods for FD, and assess the feasibility for use in KM clinics. Methods: Two rounds of professional surveys were conducted by 10 Korean internal medicine professors to select the representative diagnostic methods. A feasibility study was conducted to evaluate compliance and time required for using the structured diagnostic methods by three specialists in two hospitals. Results: As per the results of the professional survey, five questionnaires and one basic diagnostic method were selected. An SOP was constructed based on the survey results, and a feasibility study showed that the SOP compliance score (out of 5) was 3.45 among the subjects, and 3.25 among the practitioners. The SOP was acceptable and was not deemed difficult to execute. The total execution time was 136.5 minutes, out of which the gastric emptying test time was 129 minutes. Conclusion: This feasibility study of the SOP with structured diagnostic methods for FD confirmed it was adequate for use in KM clinics. It is expected that these study findings will be helpful to clinicians who wish to conduct observational studies as well as to generate quantitative medical records to facilitate Big Data research. Keywords: Big Data, Dyspepsia, Korean medicine, Feasibility studies, Observational study

Background Irritable bowel syndrome (IBS) is a common disorder characterized by the recurrence of abdominal pain and changes in bowel habits. Owing to the limitations of conventional treatments, patients with IBS are often dissatisfied with the effect of treatment and have a poor quality of life. Herbal medicines (HMs) are frequently used for the treatment of IBS. This protocol was designed through an overview of systematic reviews (SRs), to investigate the safety and efficacy of HMs for treating IBS. Methods SRs published up to May 2021 will be searched from the following 6 electronic databases: Medline (via PubMed), EMBASE, Cochrane Database of Systematic Reviews, Allied and Complementary Medicine Database, Oriental Medicine Advanced Searching Integrated System, and China National Knowledge Infrastructure database. SRs and/or meta-analyses on the use of HMs for IBS will be included in this overview. The effects of a placebo, no treatment, usual care, or conventional treatment will be compared with those of HMs. Two investigators will independently extract the data and assess the methodological and evidence quality for each main finding. The total clinical effectiveness rate will be measured as the primary outcome. Results This overview is expected to provide data on the use of HMs for the treatment of IBS based on qualitative and quantitative syntheses of the included SR data. Conclusion This overview will evaluate and propose the efficacy and safety of HMs for the treatment of IBS. Registration number DOI 10.17605/OSF.IO/NT6WZ (https://osf.io/nt6wz).

Background: Functional dyspepsia (FD) has a high prevalence rate. The dyspeptic symptoms are not easily cured despite the availability of various conventional Western medical treatments. Banha-sasim-tang (BST) is a traditional herbal medicine that has long been used for treating FD. Methods: The following databases will be searched from inception to January 2019: Medline via PubMed, the Cochrane Central Register of Controlled Trials, EMBASE, Allied and Complementary Medicine Database, National Digital Science Library, Korean Medical Database (KoreaMed), Oriental Medicine Advanced Searching Integrated System, Korean Studies Information Service System, China National Knowledge Infrastructure Database, and Citation Information by Nii. Randomized controlled trials (RCTs) that used BST or herbs-added BST for treating FD will be included in the systematic review. Control groups in these RCTs will be the placebo, no-treatment, and conventional Western medicine groups. RCTs that compared BST and Western medicine combination therapy with the conventional Western medicine will also be included in the systematic review to investigate the synergistic effect of BST and Western medicine. Data extraction and evaluation of risk of bias will be performed by 2 independent investigators. The primary outcome will be the total clinical effective rate and secondary outcomes will include gastrointestinal symptom scale, visual analog scale, FD-related quality of life, electrogastrography, plasma motilin, dyspepsia-related symptom score, gastric emptying, and adverse events. RevMan version 5.3 will be used for data integration and analysis. Results: This systematic review will provide a high-quality integration of current evidence of BST for treating FD from several aspects including total clinical effective rate, dyspepsia-related symptoms, quality of life, and adverse events. Conclusions: This systematic review will provide evidence of the effectiveness and safety of BST on FD. Ethics and dissemination: Identifying information of the participants will not be revealed; hence, this protocol does not need ethical approval. The systematic review will be published in a peer-reviewed journal and disseminated electronically. Trial registration number: PROSPERO CRD42019123285.

Ethnopharmacological relevance Yukmijihwang-tang (YMJ) is a typical herbal formula to treat Yin-deficiency (YD) syndrome by enriching the fluid-humor of the body. YMJ has been used to treat dry mouth symptoms for hundreds of years in traditional East Asian medicine. Xerostomia, a subjective oral dryness, is common in the elderly and results in impaired quality of life. Many conventional treatments for xerostomia provide only temporary symptom relief, and have side effects. The aim of this study is to investigate the efficacy and safety of YMJ for the treatment of xerostomia in the elderly. Methods This study was designed as a randomized, placebo-controlled, double-blinded, two center trial. Ninety-six subjects aged 60–80 years who had experienced xerostomia for at least 3 months and presented with score>40 on the visual analog scale (VAS) for subjective oral dryness were recruited and randomly allocated to YMJ and placebo groups. YMJ or placebo was administered to each group for 8 weeks (3 g of YMJ or placebo, three times per day). The primary outcome was change of VAS for xerostomia from 0 to 8 weeks. Results VAS for xerostomia was decreased by 22.04±22.76 in the YMJ group and 23.58±23.04 in the placebo group. YMJ had no effect on xerostomia. However, participants with BMIs lower than 29.37 kg/m2 showed improvement of xerostomia after 8 weeks of treatment with YMJ compared to placebo. In addition, YMJ improved oral moisture, which is associated with subjective oral dryness in the YMJ group, and the relationship between VAS for xerostomia and YD was significant. Conclusion A trend was observed in which YMJ improved oral moisture status and subjective oral dryness in elderly subjects with lower BMI and greater tendency toward YD.

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.

Introduction. Functional dyspepsia (FD) is a functional gastrointestinal disorder characterized by persistent upper dyspeptic symptoms without organic lesions. There is no standard therapy for FD. Yukgunja-tang (YGJT) is an herbal medicine used for treating upper gastrointestinal symptoms in Asia. Studies on the effect of YGJT on FD have been conducted. However, the results were inconsistent. In Hyungsang medicine, traditional Korean medicine, FD patients are classified into bladder body (BB) or gallbladder body (GB) subtypes by the shape and angle of their faces. Each subtype may have different characteristics, physiology, and pathology of the same disease. YGJT is more effective for patients with BB subtype. The three-dimensional facial shape diagnostic system (3-FSDS) was shown to be effective in diagnosing BB or GB subtypes. This study aimed to investigate the effect of YGJT on FD patients classified using the 3-FSDS. Materials and Methods. The current study was a placebo-controlled, double-blinded, randomized, two-center trial. Eligible patients were diagnosed with either BB or GB FD subtype using the 3-FSDS. Ninety-six participants (48 BB and 48 GB subtypes) were randomly allocated to treatment or control groups in a 2:1 ratio. YGJT or placebo was administered for eight weeks. The primary outcome was assessed using the total dyspepsia symptom scale (TDS), while the secondary outcomes were assessed using the single dyspepsia symptom scale (SDS), proportion of responders, visual analog scale, Nepean dyspepsia index, functional dyspepsia-related quality of life, and spleen qi deficiency questionnaire. Results and Discussion. The result of TDS showed the superior effect of YGJT on BB over GB subtype. The subgroup analysis of TDS and SDS scores showed the superior effect of YGJT over placebo. Other outcome variables did not show any significant differences between groups. Conclusion. YGJT may be considered for FD patients diagnosed with BB subtype using 3-FSDS.

Background In the treatment of functional dyspepsia, the placebo effect has been reported to be high, and the influence of the patient-practitioner relationship may be a major component of this effect. The specific and non-specific effects of acupuncture cannot be easily distinguished, and the patient-practitioner relationship may influence the total therapeutic effect in clinical practice. There have been no studies that investigate the influence of patient-practitioner relationship on acupuncture treatment for patients with functional dyspepsia. Methods Patients with postprandial distress syndrome, a functional dyspepsia subtype, will be recruited at three hospitals (two in Korea and one in USA) for an international, multi-center, randomized, patient/assessor-blinded, clinical trial. The total anticipated sample size is 88. The participants will be randomly allocated into two groups: an augmented interaction group and a limited interaction group. Acupuncture, with total 12 acupoints, will be performed twice weekly for 4 weeks in both groups. Trained practitioners will provide an “augmented” or “limited” interaction context, as determined by random allocation. The primary outcome measure is the proportion of responders, the proportion of participants who answer “yes” to more than half of the adequate relief questions during the study. Secondary outcome measures include questionnaires for quality of life and symptoms of dyspepsia, and maximum tolerable volume of nutrient drink test. Data will be collected at baseline and following 4 weeks of acupuncture. Discussion This study will evaluate the influence of the patient-practitioner interaction on clinical effects of acupuncture in patients with functional dyspepsia. Trial registration CRIS Identifier: ( KCT0002229 ).

Introduction. Functional dyspepsia (FD), a common upper gastrointestinal disease, is difficult to manage because of the limitations of current conventional treatments. Yukgunja-tang (YGJT) is widely used to treat FD in clinical practice in Korea, Japan, and China. However, YGJT significantly improves few symptoms of FD. In Korean medicine, FD is a well-known functional gastric disease that shows difference in the effect of herbal medicine depending on constitution or type of Korean medicine diagnosis. This study aims to investigate the efficacy of YGJT on FD patients classified by 3-dimensional facial measurement using a 3-dimensional facial shape diagnostic system (3-FSDS).Methods. A placebo-controlled, double-blind, randomized, two-center trial will be performed to evaluate the efficacy of YGJT on FD patients. Eligible subjects will be initially classified as two types by 3-dimensional facial measurement using the 3-FSDS. Ninety-six subjects (48 subjects per each type) will be enrolled. These subjects will be randomly allocated into treatment or control groups in a 2 : 1 ratio. YGJT or placebo will be administered to each group during the 8-week treatment period. The primary outcome is total dyspepsia symptom scale, and the secondary outcomes include single dyspepsia symptom scale, proportion of responders with adequate symptom relief, visual analog scale, Nepean dyspepsia index-Korean version, functional dyspepsia-related quality of life, and spleen qi deficiency questionnaire.Discussion. This is the first randomized controlled trial to assess the efficacy of the YGJT on FD patients classified by 3-dimensional facial measurement. We will compare the treatment effect of the YGJT on FD patients classified as two types using the 3-FSDS. The results of this trial will help the FD patients improve the symptoms and quality of life effectively and provide objective evidence for prescribing the YGJT to FD patients in clinical practice.Trial Registration. This trial is registered with Clinical Research Information Service Identifier:KCT0001920, 15 May, 2016.

This study was implemented to evaluate the effect of individualized acupuncture treatment (AT) on functional dyspepsia (FD).A randomized, waitlist-controlled, two-center trial was performed. Seventy-six patients with FD were enrolled in the trial with partially individualized AT in a more realistic clinical setting performed twice a week for 15 minutes a session over 4 weeks. The participants were randomly allocated to a group receiving 8 sessions of AT for 4 weeks or a waitlist control group. After 4 consecutive weeks, the AT group was followed up without AT and the control group received the identical AT. The proportion of responders with adequate symptom relief, Nepean Dyspepsia Index (NDI), FD-related quality of life, Beck Depression Inventory, State-Trait Anxiety Inventory, Acupuncture Belief Scale, and acupuncture credibility test were assessed.After the first 4 weeks, the proportion of responders significantly improved (59% in AT group [n = 37] versus 3% in control group [n = 39]; p 0.001). The difference was no longer significant at 8 weeks, at which point the waitlist control group showed similar improvement after receiving AT (68% in the AT group versus 79% in the control group). Total NDI scores were significantly reduced in the AT group compared with the waitlist group (p = 0.03). Among NDI items, discomfort (p = 0.01), burning (p = 0.02), fullness after eating (p = 0.02), and burping (p = 0.02) were significantly improved in the AT group compared with the control group. No significant differences were observed between groups in other secondary variables.Individualized AT adequately relieves symptoms in patients with FD, and this effect may persist up to 8 weeks.

Background: Functional dyspepsia (FD) is a common functional gastrointestinal disorder characterized by recurrent dyspeptic symptoms. Yukgunja-tang (YGT) is a traditional herbal formula that has been used for treating FD. This systematic review protocol aims to provide a guideline for investigating the efficacy and safety of YGT in the treatment of FD. Methods: The following databases will be searched from their inception until July 2018: Medline (via PubMed), EMBASE, the Cochrane Central Register of Controlled Trials (CENTRAL), Allied and Complementary Medicine Database (AMED), KoreaMed, National Digital Science Library (NDSL), Korean Medical Database (KMbase), Oriental Medicine Advanced Searching Integrated System (OASIS), Korean Studies information Service System (KISS), China National Knowledge Infrastructure Database (CNKI), and Citation Information by Nii (CiNii). Randomized controlled trials (RCTs) that used YGT or modified YGT for treating FD will be included. The control groups in these RCTs will include placebo, no-treatment waiting, and conventional western medicine groups. Trials testing YGT as an adjunct to western medicine for synergistic effect will also be included. The main outcome will be the total clinical efficacy rate. Data extraction and risk of bias assessment will be performed by two independent assessors. RevMan V.5.3 will be used for data analysis. Results: This study will provide a high-quality synthesis of current evidence of YGT for FD from several aspects including dyspepsia-related symptoms, quality of life and adverse events. Conclusion: The conclusion of our systematic review will provide evidence to judge whether YGT is an effective intervention for patient with FD. Ethics and dissemination: The protocol does not need ethics approval because identifying information of the participants will not be revealed. The systematic review will be published in a peer-reviewed journal and disseminated electronically and in print. Trial registration number: PROSPERO CRD42018090139.

Functional dyspepsia (FD) is a prevalent gastric disorder that is difficult to manage due to lack of satisfactory treatments. Acupuncture has been studied with regard to the rising need for treating FD, but the mechanism verifying its efficacy has not yet been fully revealed. The aim of this study is to explore the efficacy and mechanism of acupuncture for FD compared with a sham group. We describe a proposal for a randomized, assessor-blind, sham-controlled trial with 70 eligible participants who will be randomly allocated either into an acupuncture or a sham group. Participants in the acupuncture group will receive 10 sessions of real acupuncture treatment and those in the sham group will be treated with identical sessions using a Streitberger needle. Functional magnetic resonance imaging (fMRI) and metabolomics studies will be implemented before and after 4 weeks of treatment to investigate the mechanism of acupuncture. The primary outcome is a proportion of responders with adequate symptom relief and the secondary outcomes include the Nepean Dyspepsia Index - Korean version, Functional Dyspepsia-Related Quality of Life questionnaire, Ways of Coping Questionnaire, Coping Strategies Questionnaire, perception of bodily sensation questionnaire, State-Trait Anxiety Inventory, and the Center for Epidemiological Studies - Depression Scale. The outcomes will be evaluated before and after the treatment. This is the first large-scale trial evaluating the efficacy and mechanism of acupuncture with fMRI and metabolomic methods. We will compare real acupuncture with the Streitberger sham needle to verify the specific effect of acupuncture. The results of this trial are expected to be relevant evidences affecting policy and decision-makers associated with routine healthcare. ClinicalTrials.gov Identifier: NCT02358486 . Date of Registration: 21 January 2015.

Objective. Abdominal examination (AE) is one of the essential diagnostic methods in traditional Korean medicine that has been widely used for deciding treatment, cause, and prognosis of the disease. AE majorly depends on the experience of practitioners; therefore, standardization and quantification of AE are desperately needed. However, few studies have tried to objectify AE and established its standard. We assessed the reliability and validity of newly developed diagnostic device for AE called modified algometer (MA).Methods. Thirty-six subjects with functional dyspepsia were allocated into one of 2 groups according to gold standard of AE: epigastric discomfort without tenderness (n=23) group or epigastric discomfort with tenderness (n=13) group. Pressure pain threshold was evaluated at participants’ epigastric region with algometer and MA. We assessed reliability and validity (sensitivity and specificity) and calculated optimal cutoff value.Results. MA showed high intertrial reliability (ICC 0.849; 0.703–0.923;P<0.000) and validity (sensitivity: 76.92%; specificity: 60.87%), and cutoff value was 330.0 mmHg. Algometer and MA showed moderate correlation (r=0.583,P≤0.000).Conclusion. MA can be reliable and valid diagnostic device for AE and has the possibility of practical use for quantification and standardization of AE.

Inflammatory bowel diseases (IBD) are chronically relapsing inflammatory disorders of the intestine. Although some therapeutic agents, including steroids, are available for the treatment of IBD, these agents have limited use. Therefore, dietary supplements have emerged as possible interventions for IBD. Japanese honeysuckle flower, the flower of Lonicera japonica, is a well-known dietary supplement and has been used to prevent or treat various inflammatory diseases. In the present study, we investigated the effects of L. japonica on experimental murine colitis. Colitis was induced by 5 % dextran sulphate sodium (DSS) in Balb/c mice. The water extract of L. japonica (LJE) at doses of 20, 100 or 500 mg/kg was orally administered to mice twice per day for 7 d. Body weight, colon length and a histological damage score were assessed to determine the effects on colitis. Cytokine profiles were assessed to examine the effects on helper T (Th) cell-related immunological responses. In addition, CD4 þ CD25 þ Foxp3 þ T cells were analysed in vivo and in vitro for investigating the effects on regulatory T (Treg) cells. LJE showed dose-dependent inhibitory effects against colon shortening, weight loss and histological damage. LJE down-regulated IL-1b, TNF-a, interferon-g, IL-6, IL-12 and IL-17. However, LJE did not show any significant effects on IL-10, IL-23, transforming growth factor-b1 and Treg cell populations. In conclusion, LJE showed protective effects against DSS-induced colitis via the Th1/Th17 pathway and not via Treg cell-related mechanisms.