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The side effects associated with breast cancer treatments often reduce the patients’ quality of life. The effectiveness of acupuncture-related therapies and herbal medicine in managing the side effect is not fully understood. The study included clinical studies published in the 10 years since 2011 and analyzed the effectiveness of the therapies for managing side effects of anticancer treatment. The databases of MEDLINE via PubMed, CENTRAL, EMBASE, OASIS, and NSDL were searched. Thirty studies, including 13 (43.3%) randomized controlled trials (RCTs), 12 (40.0%) before-and-after studies, three (10.0%) case series, one (3.3%) case report, and one (3.3%) non-RCT, were included in this review. The main symptoms identified were aromatase inhibitors-induced arthralgia (AIA), lymphedema, and chemotherapy-induced peripheral neuropathy (CIPN). The types of acupuncture-related therapies applied included manual acupuncture, electro-acupuncture, moxibustion, and electro-moxibustion. In ten studies, eight herbal medications were administered. The Brief Pain Inventory-Short Form (BPI-SF) and Functional Assessment of Cancer Therapy-General (FACT-G) and -Breast (FACT-B) were frequently used to evaluate pain and QoL, respectively. Most studies suggested beneficial effects of acupuncture and herbal medicine on managing pain, daily function, and quality of life in patients going through AIA, CIPN, and/or lymphedema, with mild side effects. The scoping review implies the potential of CAM therapies as promising interventions for managing symptoms which otherwise lack alternative management options, and for improving the quality of life of breast cancer patients.

Objective: This study aimed to ascertain what should be considered in the "Guideline for Clinical Trials with Herbal Medicinal Products for Liver Cancer," by analyzing existing guidelines and clinical trials. Methods: Committee for the development of a guideline, consisting of 6 Korean medicine doctors, reviewed guidelines and clinical trials on using herbal medicine for treating liver cancer. The trials were analyzed in terms of inclusion and exclusion of participants, intervention, comparators, outcomes, and trial design. We then compared the results of our analysis with the guidelines to identify issues we must to consider when following the "Guideline for Clinical Trials with Herbal Medicinal Products for Liver Cancer." Several guidelines for antitumor agents and clinical trials on herbal medicine were obtained from the Ministry of Food and Drug Safety homepage, etc. The search terms were as follows: "liver neoplasms"; "herbal medicine"; "medicine, Korean traditional"; and "medicine, Chinese Traditional.". Results: Ten articles were obtained from pubmed and Embase. There was no guideline for clinical trials on using herbal medicine for treating liver cancer. All the participants in the reviewed articles had primary liver cancer, and the type of intervention varied (e.g., decoction, patches, and capsules. The comparators included placebos and conventional treatments such as chemotherapy. The outcome assessment methods were tumor response, quality of life, survival, and liver function tests. Adverse events occuring during the trial were also evaluated. Conclusion: Findings were derived by reviewing existing guidelines and comparing them with clinical trials on liver cancer and herbal medicinal products. These results will be utilized in the development of the "Guideline for Clinical Trials with Herbal Medicinal Products for Liver Cancer."

Objectives: This study aimed to evaluate the efficacy of Daegunjoong-tang for improvement of gastrointestinal motility after surgery due to gastrointestinal cancer by analyzing the existing clinical research. Methods: Clinical studies about Daegunjoong-tang for improvement of gastrointestinal motili...

Background: Irritable bowel syndrome (IBS) is a chronic functional bowel disorder characterized by abdominal pain or discomfort, stool irregularities, and bloating. Owing to its atypical symptoms and various mechanisms, there is no standard treatment for IBS. Gwakhyangjeonggi-san (GJS), a traditional Korean herbal medicine, has been used to treat lower intestinal abnormalities in Asia. We will systematically review randomized controlled trials (RCTs) to evaluate the efficacy and safety of GJS as a complementary treatment for IBS. Methods and analysis: Four English databases, namely, Medline (via PubMed), EMBASE, the Cochrane Central Register of Controlled Trials, and the Allied and Complementary Medicine Database, will be searched for entries up to May, 2021. Additional databases will include 5 Korean databases, 1 Chinese database, and 1 Japanese database. RCTs and quasi-RCTs will be searched for to assess the effectiveness and safety of GJS. The primary outcome measure will be the overall efficacy rate, and the secondary outcome will include data such as global symptom scores, IBS Quality of Life measurements, and adverse events. Data analysis will be performed using Review Manager Version 5.3, and the risk of bias will be assessed using the Cochrane Collaboration's risk-of-bias tool. The quality of the results will be evaluated using the Grading of Recommendations Assessment, Development, and Evaluation approach. Conclusion: This systematic review will provide evidence for the efficacy and safety of GJS for IBS. OSF registration number: DOI 10.17605/OSF.IO/V93JN (https://osf.io/v93jn).

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.

The survival rate of patients with hepatocellular carcinoma and extrahepatic metastases is very poor. Sorafenib, a targeted chemotherapy agent, has been shown effective for patients with advanced hepatocellular carcinoma (HCC), but it is associated with serious side effects. In addition, although surgery has been regarded as effective for lung metastases from HCC, its use in these patients is limited. Complementary and alternative medicine, including traditional Korean medicine (TKM), is increasingly used in cancer treatment, as it has been found to improve patient quality of life and maintain tumor size. This report describes a 62-year-old Korean woman with lung metastases from HCC. She first underwent surgery (stage IV) and six cycles of adjuvant chemotherapy. She was subsequently treated with sorafenib, but computed tomography showed progressive disease and she experienced the side effects of sorafenib. The patient started treatment with TKM, including pharmacopuncture and herbal medicine, in addition to sorafenib. After 8 weeks of TKM treatment, the size of the metastatic nodules decreased and the sorafenib-associated side effect symptoms improved. These findings suggest that treatment with a combination of TKM and sorafenib may be a promising method for patients with HCC and extrahepatic metastases.

The aim of this systematic review was to determine how effective acupuncture or electroacupuncture (acupuncture with electrical stimulation) is in treating poststroke patients with spasticity. We searched publications in Medline, EMBASE, and the Cochrane Library in English, 19 accredited journals in Korean, and the China Integrated Knowledge Resources Database in Chinese through to July 30, 2013. We included randomized controlled trials (RCTs) with no language restrictions that compared the effects of acupuncture or electroacupuncture with usual care or placebo acupuncture. The two investigators assessed the risk of bias and statistical analyses were performed. Three RCTs in English, 1 in Korean, and 1 in Chinese were included. Assessments were performed primarily with the Modified Ashworth Scale (MAS). Meta-analysis showed that acupuncture or electroacupuncture significantly decreased spasticity after stroke. A subgroup analysis showed that acupuncture significantly decreased wrist, knee, and elbow spasticity in poststroke patients. Heterogeneity could be explained by the differences in control, acupoints, and the duration after stroke occurrence. In conclusion, acupuncture could be effective in decreasing spasticity after stroke, but long-term studies are needed to determine the longevity of treatment effects.

Tongue diagnosis is a significant procedure to examine the physiological and pathological changes of the human body in oriental medicine. However, the conventional method of tongue diagnosis including direct observation of tongue has limitations because of various external factors and subjective factors. Therefore, the current study investigated the usefulness of the tongue diagnosis system (TDS) as a diagnostic tool for evaluating tongue coating thickness (TCT) by assessing the agreement between the TDS and a gold standard established by assessors using the conventional method.The present study was designed as a prospective clinical trial including 60 patients with functional dyspepsia. The TDS was used to capture tongue images twice within a 30-min interval to assess its reproducibility. Tongue coating percentage was measured by the TDS, and TCT was classified as either no coating, thin coating, or thick coating according to the existing diagnostic criteria. After both TDS examinations, the weight of tongue coating was quantitatively measured, and the correlation between the actual quantity of tongue coating and the percentage of the coating measured by the TDS was analyzed using Pearson׳s correlation. After collecting tongue images in all 60 patients, tongue coating was evaluated using a conventional method by 5 well-trained assessors to establish the gold standard for evaluating TCT, which allowed us to assess the diagnostic agreement between the TDS and the gold standard. After 2 weeks, TCT evaluation was repeated by the same assessors using the same images but in a random order.The agreement between the TDS and the gold standard for evaluating TCT was almost perfect (weighted kappa, 0.840), as was the reproducibility of the TDS (weighted kappa, 0.851). The percentage of tongue coating measured by the TDS was significantly correlated with the weight of tongue coating (r=0.442, p0.001). The levels of intra-rater reliability ranged from substantial to almost perfect (range of weighted kappa, 0.777-0.923). The inter-rater reliability of 5 assessors was moderate (weighted kappa, 0.563).The present study demonstrated that the TDS can be used as a diagnostic tool for the objective and standardized evaluation of TCT in actual clinical practice.

Laminaria japonica--a widely used ingredient in seaweed kimchi--and lactic acid bacteria (LAB)--a main component of traditional fermented Korean food--may alter human intestinal microbiota composition and have a positive effect on various digestive problems. However, few clinical trials have investigated the potential benefits of L. japonica when combined with LAB for human intestinal microbiota. Therefore, this study was designed to evaluate the effects of L. japonica and representative LAB on the human intestine. Forty participants with no known digestive diseases were randomly assigned to one of the two combination groups: (1) L. japonica with LAB and (2) L. japonica with placebo LAB. The study agents were administered for 4 weeks with a 2-week follow-up period. The primary outcome measure was the number of each of the seven LAB species in the human intestine, and the secondary outcome measures included the Korean version of the Gastrointestinal Symptom Rating Scale, the World Health Organization Quality of Life, and bowel functions. The primary outcome was evaluated before and after administration of the study agents (0 and 4 weeks), and the secondary outcomes were evaluated at 0, 4, and 6 weeks. Four of the seven LAB species were found to be significantly increased in the L. japonica with the LAB group and five species were significantly different from those of the placebo group. The secondary outcome measures did not change significantly. In conclusion, L. japonica with LAB facilitated the proliferation of beneficial human intestinal microbiota. (ClinicalTrials.gov NCT01651741).

Nutmeg (seed of Myristica fragrans [MF]) is one of the most commonly used spices in the world and also a well-known herb for the treatment of various intestinal diseases, including colitis in traditional Korean medicine. The purpose of the current study was to investigate whether water extract of MF (MFE) can protect against dextran sulfate sodium (DSS) induced colitis in a mouse model. Colitis was induced by 5% DSS in balb/c mice. MFE (100, 300 or 1000 mg/kg) was orally administered to the mice twice a day for 7 days. Body weight, colon length, clinical score, and histological score were assessed to determine the effects on colitis. Proinflammatory cytokines (interferon-γ, tumor necrosis factor-α, interleukin [IL]-1β, and IL-6) were measured to investigate the mechanisms of action. MFE dose dependently inhibited the colon shortening and histological damage to the colon. However, it did not prevent weight loss. MFE also inhibited proinflammatory cytokines. The current results suggest that MFE ameliorates DSS-induced colitis in mice by inhibiting inflammatory cytokines. Further investigation, including the exact mechanisms is needed.

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.

SPIRIT 2013 Checklist. Completed SPIRIT checklist. (PDF 57 kb)

Although various placebo acupuncture devices have been developed and used in acupuncture research, there is controversy concerning whether these devices really serve as appropriate placebos for control groups. The proposed study is a single-center prospective random sequence participant- and assessor-blinded trial with two parallel arms. A total of 76 participants will be randomly assigned to Group 1 or Group 2 in a 1:1 ratio. Group 1 will consist of Sham Streitberger’s needle, Real Streitberger’s needle, and Phantom acupuncture session. Group 2 will consist of Park Sham device with real needle, Park Sham device with sham needle, and no treatment session. Participants will have a total of three acupuncture sessions in a day. The primary endpoint is blinding test questionnaire 1. Secondary endpoints are the Bang’s blinding index, the Massachusetts General Hospital Acupuncture Sensation Scale index, and physiological data including heart rate, heart rate variability, and skin conductance response. This trial will evaluate the relevance of using placebo acupuncture devices as controls using a validation test procedure. Clinical Research Information Service: KCT0001347 .

To develop differential criteria on the tongue coating thickness (TCT), and especially propose the standard for judgment on thin and thick coating in tongue diagnosis.Sixty oriental medical doctors evaluated the TCT (none, thin, and thick coating) in 50 realistic tongue photographs revealing from tip-to-root. The photographs were obtained with a digital tongue imaging system (DTIS) which measured the percentages of tongue coating on the tongue surface. We calculated the match rate which is the ratio in which the assessor's judgment is consistent with the decision standard on the tongue coating, and then 24 assessors (≥80% match rate) were selected to improve the reliability of the decision. The agreement level among 24 assessors was examined to assess the inter-rater reliability. The correlation between TCT judgments and DTIS-measured values was examined to ascertain the reliability of DTIS measurements. Finally, the assumption probability for the analysis of quantified characteristics of the tongue coating was calculated with a proportional odds model.The inter-rater reliability was assessed as moderate (κ=0.56) among 24 assessors, the level of correlation between TCT judgments and DTIS measurements in 24 assessors was relatively high (0.76, p0.01). As the analysis of the proportional odds model, 29.06% was a cut-off point to separate no coating and thin coating, 63.51% was a cut-off point to separate thin and thick coating.The differential criteria for TCT in tongue diagnosis were suggested, and particularly thick coating is defined as one that tongue coating which tongue body is invisible, occupy approximately more than two third areas on the tongue surface.

Surgical colorectal resection including regional lymph node dissection is routinely performed in the management of colorectal cancer (Ohigashi et al. 2011). However, mild to severe postoperative pain has been reported in about 86 % of patients after abdominal surgery and this type of pain tends to be more severe after discharge (Apfelbaum et al. 2003). Moreover, postoperative pain distinctly decreases health-related quality of life (QoL) of patients (d’Amours and Ferrante 1996). Therefore, intensive pain control is necessary for most of postoperative colorectal cancer patients. There are several methods to manage postoperative pain such as conventional analgesics, hot or ice pack application, relaxation therapy and other conservative treatments (Meissner 2009; Hong 2011). Clinically, opioid analgesics remain the mainstay for postoperative pain control (Sun et al. 2008). However, opioid analgesics can induce undesirable side effects like nausea, vomiting, pruritus, sedation, dizziness, and bowel dysfunction which can lead to delayed postoperative recovery (Sun et al. 2008). Therefore, adjuvant treatment for postoperative pain that provides opioid-sparing effects and decreases the incidence of opioid-related side effects is necessary. There have been increasing numbers of clinical evidences on acupuncture and related techniques as adjuvant methods for postoperative analgesia (Sun et al. 2008). On the other hand, there are few reports evaluating the effects of herbal medicines on postoperative pain. In the current case, postoperative pain has been managed effectively using the traditional Korean medicine treatment, particularly herbal medicines. Therefore, we would like to report the effect of the traditional Korean medicine therapy for postoperative pain as adjuvant treatment.

The purpose of this study is to evaluate the efficacy and safety of myofascial-meridian release acupuncture (MMRA) in the treatment of chronic neck pain compared with sham acupuncture. A protocol for a randomized, patient- and assessor-blinded, sham controlled parallel trial is presented. Seventy-four participants with a ≥3 month history of neck pain and a score of ≥4 on the 11-point pain intensity numerical rating scale (PI-NRS) will be randomly assigned to the MMRA group (n = 37) or sham acupuncture group (n = 37). The participants will receive the MMRA treatment or sham acupuncture treatment twice per week for 4 weeks. The primary outcome is the mean change in the PI-NRS (0 = no pain and 10 = worst possible pain, 11-point Likert scale) from baseline to 4 weeks. The secondary outcomes are the mean change from baseline on the clinical relevance of the pain (ratio of changes greater than 1.5 or with percentiles greater than 30 % and 50 % in the PI-NRS), function (Neck Disability Index and Cervical Range of Motion), autonomic and psychometric measurements (Heart Rate Variability and Perceived Stress Scale), quality of life (EuroQol), global assessment (Patient Global Impression of Change), semi-objective outcomes (pressure pain threshold, consumption of rescue medicine and days of restricted activity) and immunologic/stress biomarkers. Adverse events will be evaluated at every visit. The results of this trial will provide evidence to confirm the efficacy and safety of acupuncture for chronic neck pain. The trial is registered with the Clinical Research Information Service (CRiS), Republic of Korea: KCT0001573 .

Idiopathic chronic fatigue (ICF), defined as medically unexplained chronic fatigue, is common these days. To date, there is no definite cure for ICF, and alternative therapies are being investigated. Oriental medicine music therapy (OMMT), a novel music therapy that occurs through an active behavioral process, has been applied to various chronic diseases, including ICF. In the present study, we aimed to evaluate the effect of OMMT on ICF.Randomized controlled trial of OMMT compared with the waitlist control (6 sessions each) during a 2-week period.Thirty participants who had had ICF for at least 6 months before the experiments were recruited.We evaluated fatigue severity scale (FSS), visual analog scale (VAS) for overall fatigue, revised Chalder fatigue scale (RCFS), World Health Organization quality of life scale abbreviated version (WHOQOL-BREF), Buzhongyiqi-Tang questionnaire (BZTQ), and salivary cortisol level at baseline (week 0) and at the end of the study (week 2) in the two groups.FSS, VAS, and RCFS scores were significantly lower, and WHOQOL-BREF scores were significantly higher in the OMMT group than in the waitlist group (p=0.006, p=0.004, p=0.002, and p=0.002, respectively). In contrast, salivary cortisol level and BZTQ scores were not significantly different between the OMMT group and the waitlist group.The present study suggests that OMMT may be an alternative treatment for ICF. Based on this result, further studies including possible mechanisms are needed.

Jungtae Leem1, Jimin Park2, Gajin Han4, Seulgi Eun3, Meena Makary3, Seung Won Shin4, Kwanil Kim4, Kyungmo Park3, Sanghoon Lee2, Junhee Lee4 1 Kyunghee Univ Korean Medicine Hospital Korean Medicine Clinical Trial Center 2 Department of Acupuncture and Moxibustion, College of Korean Medicine, Kyung Hee University 3 Department of Biomedical Engineering, Kyung Hee University 4 Korean Medicine Clinical Trial Center, Kyung Hee University Korean Medicine Hospital

The aim of this systematic review was to determine how effective acupuncture or electroacupuncture (acupuncture with electrical stimulation) is in treating poststroke patients with spasticity. We searched publications in Medline, EMBASE, and the Cochrane Library in English, 19 accredited journals in Korean, and the China Integrated Knowledge Resources Database in Chinese through to July 30, 2013. We included randomized controlled trials (RCTs) with no language restrictions that compared the effects of acupuncture or electroacupuncture with usual care or placebo acupuncture. The two investigators assessed the risk of bias and statistical analyses were performed. Three RCTs in English, 1 in Korean, and 1 in Chinese were included. Assessments were performed primarily with the Modified Ashworth Scale (MAS). Meta-analysis showed that acupuncture or electroacupuncture significantly decreased spasticity after stroke. A subgroup analysis showed that acupuncture significantly decreased wrist, knee, and elbow spasticity in poststroke patients. Heterogeneity could be explained by the differences in control, acupoints, and the duration after stroke occurrence. In conclusion, acupuncture could be effective in decreasing spasticity after stroke, but long-term studies are needed to determine the longevity of treatment effects.

Background Xerostomia, a subjective sense of dry mouth, is not generally regarded a disease despite its high prevalence among the elderly, and therefore continues to impair affected patients’ quality of life. In traditional Korean medicine, ‘Yin-Deficiency’ has been implicated in the pathogenesis of xerostomia among the elderly. Yukmijihwang-tang is a famous herbal prescription used to relieve ‘Yin-Deficiency’, and reportedly has antioxidant effects; therefore, it is postulated that Yukmijihwang-tang can be used to treat xerostomia in the elderly. However, to our knowledge, no clinical trial has been conducted on the effects of Yukmijihwang-tang on xerostomia. Thus, we designed a randomized clinical trial to investigate the effects and safety of Yukmijihwang-tang on xerostomia in the elderly. In addition, we will clarify the aforementioned assumption that ‘Yin-Deficiency’ is the major cause of xerostomia in the elderly by identifying a correlation between xerostomia and ‘Yin-Deficiency’. Methods/Design This randomized, double-blind, placebo-controlled trial will be carried out at two centers: Kyung Hee University Korean Medicine Hospital and Kyung Hee University Hospital at Gangdong. We will recruit 96 subjects aged 60-80 years who have experienced xerostomia for 3 months prior to participation. Subjects who present with score >40 on the visual analogue scale for xerostomia and unstimulated salivary flow rate under 0.3mL/min will be included and the randomization will be carried out by an independent statistician by using a random number creation program. The subjects and all researchers except the statistician will be blinded to the group assignment. Yukmijihwang-tang or placebo will be administered to each group for 8 weeks. The primary outcome is change in the scores for the visual analogue scale for xerostomia and the dry mouth symptom questionnaire from 0 to 8 weeks. Discussion It will be assessed whether Yukmijihwang-tang can be used as a new herbal treatment for xerostomia in the elderly by demonstrating its therapeutic effects in a well-designed clinical trial. Trial registration ClinicalTrials.gov Identifier:NCT01579877

Introduction. Functional dyspepsia (FD) is highly prevalent, and no standard treatments exist for this condition. Herbal prescriptions are widely used to treat FD. In traditional Korean medicine,Banha-sasim-tang(BST) is a famous herbal prescription for dyspepsia. This study aimed to evaluate the efficacy of BST and to examine the relationship between gastric slow waves and dyspeptic symptoms.Materials and Methods. In total, 100 FD patients were recruited; BST or placebo was administered for 6 weeks. The gastrointestinal symptom scale, FD-related quality of life scale, and frequency or power variables regarding gastric slow waves were measured at 0, 6, and 14 weeks.Results. There were no significant differences in the overall dyspeptic symptoms or quality of life between the BST and placebo groups. However, early satiety was significantly improved in the BST group (P=0.009, at 6 weeks by intention-to-treat analysis). Abnormal gastric dysrhythmias and power ratios were also significantly improved by BST.Conclusion. BST had no significant effects on FD. However, early satiety appeared to improve after BST administration. Electrogastrography may be a useful technique for assessing changes in gastric motility dysfunction after interventions for FD. Further investigation focused on specific symptoms or subtypes of FD is required.

Introduction. Although combination therapy with herbal medicine and probiotics is gaining popularity for controlling diarrhea-dominant irritable bowel syndrome (D-IBS) symptoms, few studies have investigated its clinical effects.Materials and Methods. Fifty-three patients with D-IBS were randomly allocated into 1 of the following 4 groups: herbal medicine (Gwakhyangjeonggisan; GJS) plus probiotics (Duolac7S; DUO), GJS plus placebo DUO, placebo GJS plus DUO, and placebo GJS plus placebo DUO. The study period consisted of a 2-week run-in, 8 weeks of administration, and 2 weeks of follow-up. The primary outcomes were weekly adequate relief (AR) of overall IBS symptoms and the proportion of responders (PR) during the administration period. The secondary outcomes included individual IBS symptoms, stool assessment, and quality of life. Changes of intestinal microbiota and intestinal permeability were also analyzed.Results and Discussion. Weekly AR was not different among the 4 groups throughout the treatment period. However, the 3 treatment groups exhibited significant improvements in PR compared to the findings in the placebo group. In the intestinal microbiota assessment, herbal medicine and probiotics synergistically increased beneficial bacteria counts.Conclusion. Combination therapy with herbal medicine and probiotics appears to relieve overall IBS symptoms by synergistically increasing beneficial intestinal microbe counts.

Tongue diagnosis is an important procedure in traditional Korean medicine (TKM). In particular, tongue coating thickness (TCT) is deemed to show the progression of the disease. However, conventional tongue diagnosis has limitations because of various external factors. Therefore, it is necessary to investigate the availability of tongue diagnosis system (TDS) in the assessment of TCT. This study has been designed as a prospective clinical trial involving 60 patients with functional dyspepsia. Tongue images will be obtained by TDS twice with a 30 min interval. The system will measure the percentage of TCT and classify it as either no coating, thin coating, or thick coating according to the existing diagnostic criteria. After finishing the collection of 60 patients' tongue images, TCT on the images will be simultaneously evaluated by the conventional method to establish the gold standard for assessing TCT by 5 well-trained clinicians. The evaluation will be repeated by the same clinicians after 2 weeks, but the order of the images will be changed. This trial is expected to provide clinical evidence for the availability of TDS as a diagnostic tool and to contribute to the standardization of the diagnosis system used in TKM. This trial is registered with ClinicalTrials.govNCT01864837.

Background Functional dyspepsia (FD) is characterized by a high prevalence rate and no standard conventional treatments. Alternative therapies, such as herbal formulas, are widely used to treat FD. However, there are inadequate evidences regarding the safety and efficacy of these formulas. Moreover, the mechanisms by which herbal formulas act in the gastrointestinal tract are controversial. In traditional Korean medicine, Banha-sasim-tang has long been one of the most frequently prescribed herbal formulas for treating dyspepsia. The current study is designed to evaluate the efficacy and safety of Banha-sasim-tang for FD patients and to examine whether there will be a significant correlation between cutaneous electrogastrography recordings and dyspeptic symptoms in FD patients, and between changes in gastric myoelectrical activity and improvement in dyspeptic symptoms during Banha-sasim-tang administration. Methods This randomized, double-blind, placebo-controlled trial will be performed at two centers and will include a Banha-sasim-tang group and placebo group. Each group will consist of 50 FD patients. Six weeks of administration of Banha-sasim-tang or placebo will be conducted. During the subsequent 2 months, follow-up observations of primary and secondary outcomes will be performed. The primary outcomes are differences as measured on the gastrointestinal symptom scale, and the secondary outcomes are differences as measured on the visual analogue scale for dyspepsia and on the questionnaire for FD-related quality of life. All outcomes will be measured at baseline, at 2, 4, and 6 weeks of treatment, and at the 1 and 2 month follow-up. Cutaneous electrogastrography will be performed and assessed at baseline and at 6 weeks. Discussion This trial will provide evidence of the safety and efficacy of Banha-sasim-tang for the treatment for FD. Furthermore, based on the assessment of the relationship between cutaneous electrogastrography recordings and dyspeptic symptoms in this trial, the possibility of clinical applications of cutaneous electrogastrography in the treatment of FD will be elucidated. Trial Registration Current Controlled Trials (ISRCTN 51910678); Clinical Trials.gov Identifier: NCT00987805