An ensemble method based on marginal-effect models (EMM) for estimating usual food intake from single-day dietary data and internal/external two-day dietary data.

BACKGROUND: With collection of repeated 24-hour recalls, there exist challenges in usual intake estimation, including infeasibility of multiple dietary assessments, and shortage of non-zero intakes for episodically consumed foods. OBJECTIVES: We developed an ensemble method based on marginal-effect models (EMM), which estimates usual intake distribution using single-day data with internal or external two-day data. METHODS: The performance of the EMM was evaluated and compared with the National Cancer Institute (NCI) method and NCI 1-d method, via simulations with various scenarios and real data analyses of red meat, fish, and protein from Korea National Health and Nutrition Examination Survey (KNHANES). RESULTS: Simulations indicated the EMM (maximum bias of 1.67, 3.17, 8.57, 11.63 for average, median, 75%-tile, 95%-tile, respectively) provided more accurate estimation than the NCI method (maximum bias of 4.18, 9.43, 7.56, 37.43) across various scenarios on intake probability and within-person variation. The EMM showed robust estimation when an insufficient number of people have positive consumption on two days. In simulations with various external variance ratios, the EMM showed similar or superior performance to the NCI 1-d method. The EMM produced more stable estimates of usual intake distributions for red meat, fish, and protein than the two NCI methods. CONCLUSION: The proposed EMM showed substantial improvement over the NCI methods when data contain a relatively small number of people with positive consumption on two days; is robust when food intake probability is very low or high; and estimates an external variance ratio with relatively low bias.

Association between tongue coating thickness and ultraviolet fluorescence in patients with functional dyspepsia: A prospective observational study.

The aim of this study was to examine the correlation between the tongue coating thickness (TCT) and ultraviolet (UV) fluorescence and propose a new method for the estimation of TCT using a computerized tongue image acquisition system (CTIS).In this prospective and observational single-center study, we acquired tongue images under visible light and near-UV light for 60 patients with functional dyspepsia. Tongue images were acquired twice within a 30-minute interval to assess the reliability of CTIS. Then, the tongue coating was scraped and weighed to derive the wet weight of the tongue coating (WWTC). The percentage of the tongue coating area was calculated from the tongue images acquired under visible light. Mean color values (mCVs) for the UV fluorescence of the dorsal surface of the tongue were also computed.The reliabilities of the derived mCVs and percentage of the tongue coating area were acceptable (intraclass correlation coefficients, 0.907-0.947). The mCVs were more strongly correlated with WWTC than with the area, with mCV of modified lightness showing the strongest association (r = 0.785, P < .01). Finally, we suggested an estimation model for TCT based on the results.The results of this study suggest that both UV fluorescence of the dorsal tongue and the distribution area of tongue coating are useful parameters for the quantitative assessment of tongue coating. We believe that these findings will contribute to the development of a clinically useful CTIS.

An Herbal Medicine, Yukgunja-Tang is more Effective in a Type of Functional Dyspepsia Categorized by Facial Shape Diagnosis: A Placebo-Controlled, Double-Blind, Randomized Trial.

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.

Influence of the patient-practitioner interaction context on acupuncture outcomes in functional dyspepsia: study protocol for a multicenter randomized controlled trial.

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 ).

Comparative Analysis of Tongue Indices between Patients with and without a Self-Reported Yin Deficiency: A Cross-Sectional Study.

We investigated the hypothesis that Yin-deficient patients have a reddened tongue with less coating. We screened 189 participants aged 20 to 49 years, complaining of headache. To classify patients in terms of Yin deficiency, we used two self-reporting Yin-deficiency questionnaires (Yin-Deficiency Questionnaire and Yin-Deficiency Scale) and diagnosis by a doctor. Based on the tests, a total of 33 subjects were assigned to a Yin-deficient group and 33 subjects were assigned to a nondeficient control group. Tongue images were acquired using a computerized tongue diagnostic system, for evaluating tongue indices. The tongue coating percentage and tongue redness were calculated as the mean a⁎ value of both the whole tongue area (WT a⁎) and the tongue body area (TB a⁎). The tongue coating percentage of the Yin-deficient group (34.79 ± 10.76) was lower than that of the nondeficient group (44.13 ± 14.08). The WT a⁎ value of the Yin-deficient group (19.39 ± 1.52) was significantly higher than that of the nondeficient group (18.21 ± 2.06). However, the difference in the TB a⁎ value between the two groups was not significant. In conclusion, we verified that Yin-deficient patients had less tongue coating and tended to have a more reddish tongue than nondeficient patients.

Effects of a Herbal Medicine, Yukgunja-Tang, on Functional Dyspepsia Patients Classified by 3-Dimensional Facial Measurement: A Study Protocol for Placebo-Controlled, Double-Blind, Randomized Trial.

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.

Individualized Acupuncture for Symptom Relief in Functional Dyspepsia: A Randomized Controlled Trial.

OBJECTIVES: This study was implemented to evaluate the effect of individualized acupuncture treatment (AT) on functional dyspepsia (FD). METHODS: 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. RESULTS: 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. CONCLUSION: Individualized AT adequately relieves symptoms in patients with FD, and this effect may persist up to 8 weeks.

Effect of acupuncture and its influence on cerebral activity in functional dyspepsia patients: study protocol for a randomized controlled trial.

BACKGROUND: 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. METHODS/DESIGN: 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. DISCUSSION: 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. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02358486 . Date of Registration: 21 January 2015.

Acupuncture for functional dyspepsia: study protocol for a two-center, randomized controlled trial.

BACKGROUND: Functional dyspepsia (FD) is a common health problem currently without any optimal treatments. Acupuncture has been traditionally sought as a treatment for FD. The aim of this study is to investigate whether acupuncture treatment helps improve symptoms of FD. METHODS/DESIGN: A two-center, randomized, waitlist-controlled trial will be carried out to evaluate whether acupuncture treatment improves FD symptoms. Seventy six participants aged 18 to 75 years with FD as diagnosed by Rome III criteria will be recruited from August 2013 to January 2014 at two Korean Medicine hospitals. They will be randomly allocated either into eight sessions of partially individualized acupuncture treatment over 4 weeks or a waitlist group. The acupuncture group will then be followed-up for 3 weeks with six telephone visits and a final visit will be paid at 8 weeks. The waitlist group will receive the identical acupuncture treatment after a 4-week waiting period. The primary outcome is the proportion of responders with adequate symptom relief and the secondary outcomes include Nepean dyspepsia index, EQ-5D, FD-related quality of life, Beck's depression inventory, state-trait anxiety inventory questionnaire, and level of ghrelin hormone. The protocol was approved by the participating centers' Institutional Review Boards. DISCUSSION: Results of this trial will help clarify not only whether the acupuncture treatment is beneficial for symptom improvement in FD patients but also to elucidate the related mechanisms of how acupuncture might work. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01921504.

Laminaria japonica combined with probiotics improves intestinal microbiota: a randomized clinical trial.

UNLABELLED: 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. ( TRIAL NUMBER: ClinicalTrials.gov NCT01651741).

Effect of Korean red ginseng on cold hypersensitivity in the hands and feet: study protocol for a randomized controlled trial.

BACKGROUND: Cold hypersensitivity in the hands and feet (CHHF) is one of the most common complaints among Asians, especially in women. Korean red ginseng (KRG), which is a steamed form of Panax ginseng, has vasodilating action in the peripheral vessels and increases blood flow under cold stress. However, few studies have evaluated the effect of KRG on cold hypersensitivity. METHODS/DESIGN: This trial is a randomized, double-blind, placebo-controlled trial in 80 CHHF patients. The trial will be implemented at Kyung Hee University Hospital at Gangdong in Seoul, Korea. The participants will take KRG or a placebo for eight weeks, after which they will be followed-up for four weeks. During the administration period, six capsules of 500 mg KRG or placebo will be provided twice a day. The primary outcome is change of skin temperature in the hands between baseline and after treatment. The secondary outcomes include the visual analogue scale scores of cold hypersensitivity in the hands, change of skin temperature and the VAS scores of cold hypersensitivity in the feet, the recovery rate of the skin temperature by the cold stress test of the hands, the distal-dorsal difference of the hands, power variables of heart rate variability, and the 36-item short form health survey. DISCUSSION: This study is the first trial to evaluate the efficacy of KRG on CHHF by using infrared thermography. Our study will provide basic evidence regarding CHHF. TRIAL REGISTRATION: CliniacalTrials.gov NCT01664156.

Availability of tongue diagnosis system for assessing tongue coating thickness in patients with functional dyspepsia.

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.gov NCT01864837.

Yukmijihwang-tang for the treatment of xerostomia in the elderly: study protocol for a randomized, double-blind, placebo-controlled, two-center trial.

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.

The Effects of Banha-sasim-tang on Dyspeptic Symptoms and Gastric Motility in Cases of Functional Dyspepsia: A Randomized, Double-Blind, Placebo-Controlled, and Two-Center Trial.

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.

Effect of korean herbal medicine combined with a probiotic mixture on diarrhea-dominant irritable bowel syndrome: a double-blind, randomized, placebo-controlled trial.

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.

Development of differential criteria on tongue coating thickness in tongue diagnosis.

OBJECTIVE: 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. METHODS: 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. RESULTS: 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, p<0.01). 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. CONCLUSIONS: 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.

Effect of herbal extract granules combined with probiotic mixture on irritable bowel syndrome with diarrhea: study protocol for a randomized controlled trial.

BACKGROUND: Irritable bowel syndrome (IBS) is a chronic gastrointestinal disorder characterized by abdominal pain and change of bowel habits without organic disease. Many patients seek alternative IBS treatments because of the limitations of conventional treatments. Gwakhyangjeonggisan (GJS), a herbal formula, has long been used for alleviating diarrhea-predominant IBS (D-IBS) in traditional medicine. Duolac7S, which comprises 7 bacterial species as probiotics, has been frequently used for D-IBS. Although GJS and Duolac7S have been administered simultaneously in many D-IBS patients, no study has investigated the effects of GJS and Duolac7S combination therapy on D-IBS. METHODS/DESIGN: The current trial is a randomized, double-blinded, placebo-controlled, 4-arm study. After a 2-week run-in period, 60 patients with D-IBS will be randomly assigned to one of the 4 combination groups consisting of GJS (water extract granules, 3 g/pack, 3 times a day) with Duolac7S (powder form, 1 capsule, 2 times a day) or their placebos and followed up for 2 weeks. The assigned treatments will last for 8 weeks. The primary outcomes are adequate relief of IBS pain and discomfort and the proportion of responders (on a weekly basis). The secondary outcomes are visual analog scale for IBS symptoms (on a daily basis), quality of life (at 0, 8, and 10 weeks), intestinal permeability, and composition of intestinal microbiota (at 0 and 8 weeks). DISCUSSION: The present study is designed to examine the safety and efficacy of GJS and Duolac7S combination therapy on D-IBS. Our study provides the clinical evidence of a new therapeutic strategy for D-IBS.

Banha-sasim-tang as an herbal formula for the treatment of functional dyspepsia: a randomized, double-blind, placebo-controlled, two-center trial.

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.