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Background: Current treatment and management options for functional dyspepsia FD often fail to alleviate symptoms. Naesohwajung-tang NHT is a herbal formula frequently used to treat functional dyspepsia in traditional Korean medicine. However, few animal and case reports on the use of Naesohwajung-tang for functional dyspepsia treatment exist, and the clinical evidence remains deficient. Objectives: This study aimed to evaluate the efficacy of Naesohwajung-tang in patients with functional dyspepsia. Methods: We enrolled patients with functional dyspepsia at two study sites in this 4 weeks, randomized, double-blind, placebo-controlled trial and randomly assigned them to either the Naesohwajung-tang or placebo group. To evaluate the efficacy of Naesohwajung-tang , the primary endpoint was a score on the total dyspepsia symptom TDS scale after treatment. The overall treatment effect OTE , single dyspepsia symptom SDS scale, food retention questionnaire FRQ , Damum questionnaire DQ , functional dyspepsia-related quality of life FD-QoL questionnaire, and gastric myoelectrical activity measured using electrogastrography were evaluated as secondary outcomes. Laboratory tests were performed to confirm the safety of the intervention. Additionally, the Naesohwajung-tang group showed a greater effect in preventing a decrease in the percentage of normal gastric slow waves after meals than the placebo group. There was no significant difference in the incidence of adverse events between the two groups. Conclusion: This is the first randomized clinical trial to verify that Naesohwajung-tang leads on symptom relief in patients with functional dyspepsia. Patients with functional dyspepsia FD complain of at least one of the following symptoms for more than 6 months prior to diagnosis: postprandial fullness, early satiation, epigastric pain, or epigastric burning. Factors such as dietary habits, sociocultural differences, psychological issues, and gastrointestinal GI infections affect dyspeptic symptoms, resulting in differences in the distribution of prevalence Ghoshal et al. Although the key pathogenesis of FD is not clear, various mechanisms are known to act in combination, including gastric dysmotility, such as gastric emptying and accommodation Park et al. FD extensively affects the health-related quality of life in terms of physical, psychological, and social aspects Aro et al. Moreover, it causes direct and indirect costs owing to its long-lasting and recurrent symptoms, which reduce productivity. Although various treatments including H. FD often shows a chronic course, and its symptoms vary widely over a long period of time Talley and Ford, Herbal medicine, a representative therapy in the realm of complementary and alternative medicine, comprises a diverse array of active ingredients. As a result, it can simultaneously target multiple pathophysiological mechanisms, such as GI motility, secretory function, cellular protection, and psychoactive properties Gwee et al. As these advantages have been highlighted, the potential of herbal medicine as a new treatment for FD, which is complex and involves various etiologies, has been recognized. In a previous study, 4 weeks administration of NHT in children with FD experiencing abdominal pain improved abnormal electrogastrography EGG parameters including the rate of normogastric and dominant power DP in the postprandial phase Kim et al. Based on these results, NHT was expected to ameliorate dysmotility-related FD symptoms by regulating gastric motility. However, no randomized clinical trials RCTs of high methodological quality have been conducted to provide objective evidence for NHT as a treatment option for patients with FD. This is the first randomized placebo-controlled study to evaluate the safety and clinical efficacy of NHT in adult patients with FD. This was a prospective, multi-center, randomized, double-blind, parallel-group, placebo-controlled trial. This clinical trial with a 4 weeks NHT administration aimed to determine whether NHT improves clinical symptoms in patients with FD compared to placebo. The protocol for our recent study described the study information in detail, including sample size calculation, forbidden drugs, criteria for withdrawal, and protocol for EGG recording Ha et al. Before enrollment in the study, all subjects provided written informed consent and were evaluated for eligibility. Additionally, the botanical drugs used in the manufacturing of the trial drugs, preparation procedures, and quality management were rigorously quality controlled according to the standards set by the Korean Pharmacopoeia KP and Korean Herbal Pharmacopoeia KHP. Both NHT and placebo were administered in the form of granules. NHT contains the following 19 botanical drugs dosage per serving : the dried ripe fruit of Crataegus pinnatifida Bunge Rosaceae ; Crataegi Fructus 2. Poaceae ; Hordei Fructus Germinatus 2. Wilson Magnoliaceae ; Magnoliae Cortex 1. Alismataceae ; Alismatis Rhizoma 1. Compositae ; Atractylodis Rhizoma 1. Cyperaceae ; Cyperi Rhizoma 1. Rutaceae ; Ponciri Fructus Immaturus 1. Makino Araceae ; Pinelliae Tuber 1. Wolf Polyporaceae ; Poria Sclerotium 1. Ohwi and H. Rosaceae ; Armeniacae Semen , the stem and leaf of Xanthium strumarium L. Compositae ; Xanthii Fructus , the stem and leaf of Artemisia annua L. Poulsen Zingiberaceae ; Amomi Fructus 1. Typhaceae ; Spargarnii Rhizoma 1. Kuntze Lamiaceae ; Agastachis Herba 1. Compositae ; Aucklandiae Radix 0. Leguminosae ; Glycyrrhizae Radix et Rhizoma 0. The extraction yield was The dry extract was then mixed with the excipients of Zea mays corn starch 0. Tests were conducted on raw botanical drugs and dried extracts for identification, purity residual pesticides and heavy metals , and microbiological examination, and the contents and results were found to be suitable. A chemical identification test was conducted in accordance with the procedure of thin-layer chromatography. High-performance liquid chromatography with the diode-array detection method was used for quantitative analysis; the hesperidin content C 28 H 34 O 15 The placebo granules 7. A content test was conducted to confirm that the inclusion of the main ingredients, including hesperidin and glycyrrhizic acid, clearly distinguished the investigational drug from the placebo. Finally, the NHT and placebo granules were packed separately in opaque aluminum bags and were indistinguishable in appearance. The random codes were labeled by an independent manufacturer. The clinical trial pharmacist at each center provided a packaged drug to the subjects based on random allocation. Both drugs were administered to the subjects three times a day at 30 min after each meal for 4 weeks. A total of patients with FD who met the eligible criteria were randomly assigned at a ratio of into either the NHT or placebo group. To maintain the randomization process, random number tables for allocation were concealed using sealed opaque envelopes throughout the study period. The investigational drugs, packaged identically to conceal the intervention allocation for both the participants and investigators, were distributed equally to both study sites with label numbers from 1 to 58 at a ratio of After enrollment, the subjects received the study number in the order of randomization and were assigned to the corresponding groups for 4 weeks and another 4 weeks for follow-up. All investigators and participants were blinded to treatment allocation throughout the study. The total dyspepsia symptom TDS scale was the primary outcome measure to evaluate the severity and degree of improvement of overall dyspeptic symptoms in patients with FD after 4 weeks administration of NHT compared with placebo. The Likert scale ranges from 0 none to 3 severe and is used to rate the intensity of each symptom. The overall score was calculated by adding points for each item, with higher scores indicating more severe indigestion symptoms. It was evaluated throughout the 4 weeks study period, including at follow-up visits. To evaluate the intensity of dyspeptic symptoms, the four main symptoms of FD on the SDS were measured using a 4-point Likert scale. Each symptom was assessed based on the frequency, intensity, and level of discomfort experienced by the patient Zhang et al. The FD-QoL questionnaire consists of 21 items measuring the QoL of patients with FD, grouped into four categories: diet, daily activity, emotion, and social functioning. These items were assessed using a 5-point Likert scale Lee et al. DQ is a diagnostic tool for identifying a phlegm pattern in TKM and is associated with symptoms such as indigestion, dizziness, and headache Park et al. It comprises 14 items rated on a 7-point Likert scale. A higher DQ score indicates a greater probability of a phlegm pattern Park et al. The FRQ is used to diagnose a food retention pattern in TKM, which is characterized by symptoms such as abdominal fullness and pain Zhu et al. It comprises 17 items rated on a 7-point Likert scale. Scores of 1, 2, 3, and 4 were converted to 0 points, whereas scores of 5, 6, and 7 were converted to 1 point. A total score of six or greater indicates that the individual has a food retention pattern Park et al. Participants who had not eaten for more than 8 h and were lying on their backs had three active electrodes with gel applied to their epigastric skin. To evaluate the safety of the intervention, vital signs were checked at each visit, and electrocardiography and laboratory tests, including blood tests and urinalysis, were performed before and after the administration of the investigational drugs. We monitored any negative side effects that occurred throughout the study period. Outcome analysis was performed by an independent statistician using SPSS software version The effectiveness of the NHT was evaluated using the full analysis set FAS , which included all participants who were randomly assigned, received the investigational products, and were subsequently assessed at least once. In instances of missing values for the primary variables, the last observation carried forward method was used as a substitute. The safety of the drug was assessed in randomly assigned participants who took the investigational drugs at least once. The assessment of the therapeutic effects of the drug compared to that at baseline was performed using the paired sample t -test or Wilcoxon signed-rank test and repeated measures analysis. For safety assessment, the frequency of adverse events and clinically significant changes in laboratory measurements were compared between the two groups. From 10 May , to 1 September , patients were recruited to participate in this study. Six participants were excluded as they did not meet the inclusion criteria. During the 4 weeks trial period, seven patients were removed from the efficacy assessment owing to issues with consent and violations of the study protocol that occurred after randomization. By the follow-up period of 4 weeks after the end of drug administration, three patients in the NHT group and one in the placebo group dropped out due to protocol violation. The number of patients who completed the trial in the NHT and placebo groups was 51 and 53, respectively. The detailed research flow and reasons for dropping out are presented in Figure 1 Schulz et al. The demographic characteristics of the patients at baseline were clinically similar between the two groups, including mean age, sex distribution, and mean BMI Table 2. TABLE 2. Baseline clinical characteristics of the patients included in the NHT and placebo groups. The changes in the TDS scores before and after treatment and the degree of improvement are described in Tables 3 , 4 , respectively. Both groups showed significant improvements in dyspeptic symptoms related to TDS at week 4 compared to baseline as well as at the 2 and 8 weeks follow-ups. In addition, the improvement degree of the TDS score were significantly higher in the NHT group than in the placebo group after the 2 and 4 weeks treatments 4. At the 8 weeks follow-up, 4 weeks after taking the medication, the improvement in the TDS score did not differ between the two groups. TABLE 3. TABLE 4. A Comparison of the score of the TDS scale. B Comparison of the improvement degree of the TDS scale score. In both groups, epigastric pain, epigastric burning, postprandial fullness, and early satiation scores, as measured by the SDS scale, significantly decreased after the 2 and 4 weeks treatments, as well as the FD-QoL and DQ scores. However, the 2 weeks score of early satiation in the placebo group did not show any significant changes. When comparing the differences between the two groups at each time point, OTE values measured at weeks 2, 4, and 8 were significantly higher in the NHT group than in the placebo group 2. After the 2 and 4 weeks treatments, there were no significant differences in the other scales between the two groups. A Comparison of the OTE score. C Comparison of the improvement degree in the scores of the DQ. Regarding the OTE score, in the 8 weeks observation time, significant differences were observed between the two groups 0. The NHT group had a greater degree of improvement compared to the placebo group for the scores of epigastric burning 1. Additionally, the NHT group had a greater degree of improvement in postprandial fullness 2. However, no significant differences were observed in the degree of improvement in the epigastric pain scores Figure 4A between the two groups after 2 and 4 weeks of treatment. Comparison of the degree of improvement of the score on the SDS scale. A Epigastric pain. B Epigastric burning. C Postprandial fullness. In both groups, the proportions of FR significantly decreased after the 2 and 4 weeks treatments compared with those before treatment, with no significant difference between the two groups. Among a total of 84 patients with FD whose GMA was assessed by EGG at baseline 44 in the NHT group and 40 in the placebo group , 47 had some missing data that could not be used for the analysis 21 in the NHT group and 26 in the placebo group ; thus, EGG results of a total of 37 subjects were included in the outcome analysis. At baseline, there were two significant differences of GMA parameters in the postprandial recording between the two groups: percentage of normogastria at Ch1 Comparing the values before and after meals in the NHT group, we observed a significant decrease in the percentage of normogastria in Ch1 and Ch2, a significant increase in the percentage of bradygastria in Ch2 and Ch3, a significant increase in the percentage of tachygastria in all channels, and a significant increase in the percentage of arrhythmia in Ch1 and Ch2. In contrast, in the placebo group, a significant decrease in the percentage of normogastria in Ch2 and Ch3, a significant increase in the percentage of bradygastria in Ch2, and a significant increase in the percentage of tachygastria in all channels were observed Figure 5A. For all channels, the power ratio was found to be 1 or higher, and there was no significant difference between the two groups. Comparison of percentage of normogastria measured by EGG recording. A Baseline. Among the 79 patients with FD 41 in the NHT group and 38 in the placebo group who underwent EGG testing after 4 weeks of treatment, EGG results were analyzed for a total of 50 participants, excluding 29 subjects with detected missing values 17 in the NHT group and 12 in the placebo group. At 4 weeks recoding, the differences in GMA values measured in preprandial were observed in the percentage of normogastria in Ch2 When the preprandial and postprandial values were compared, the NHT group showed a significant decrease in the percentage of normogastria in Ch3, a significant increase in the percentage of bradygastria in all channels, and a significant increase in the percentage of tachygastria in Ch3. In contrast, in the placebo group, a significant decrease in the percentage of normogastria in all channels, a significant increase in the percentage of bradygastria in all channels, an increase in the percentage of tachygastria in Ch1 and Ch2, and a significant increase in the percentage of arrhythmia in Ch1 were observed Figure 5B. Similarly, the power ratio was found to be 1 or higher in all channels, and there was no significant difference between the two groups. The NHT group had a significantly higher degree of improvement in TDS scores for female patients compared to that of the placebo group 6. In patients under 65, the improvement degree of the TDS scores was significantly higher in the NHT group than in the placebo group 6. For the overlap subtype of FD patients, the improvement degree of the TDS scores was significantly higher in the NHT group than in the placebo group 8. TABLE 5. Subgroup analyses of comparing the effect of NHT to placebo on the improvement degree in the TDS scale after 4 weeks treatment. Subgroup analyses of the improvement degree of score on the TDS scale. A Sex. B Age. C BMI. D FD subtype. E FR diagnosis. All adverse events were documented in both groups during the study period. The safety analysis set included participants from both groups. The total number of adverse events was 19 in the NHT group 12 patients and 20 in the placebo group 13 patients. Information regarding the adverse events is shown in Table 6. One serious adverse event SAE occurred in each group, a breast mass in the NHT group and thyroid cancer in the placebo group, but both were judged to be unrelated to the study drugs owing to the onset of the disease. In addition, no clinically significant abnormalities were observed in the vital signs, blood test results, or urinalysis results before and after drug administration. Dyspepsia, characterized by pain or a heavy feeling in the stomach and postprandial discomfort, is a relatively common symptom. However, it is accompanied by a wide range of differential diagnoses and heterogeneous pathological mechanisms Ford et al. As FD has therapeutic limitations as a multifactorial disease in which symptoms are inconsistent and do not individually correspond to the mechanism one by one Miwa, , various FD symptoms must be managed more effectively with multiple drugs for combination therapy than with a single drug Wagner, An advantage of herbal medicines is that they can simultaneously target multiple pathophysiological mechanisms. Herbal medicines used to treat FD exert combined pharmacological effects related to motility and secretory activity in the GI tract Gwee et al. According to the Asian guidelines Miwa et al. A recent network meta-analysis of 12 different herbal medicines in 15 RCTs showed that Xiao Yao Pill and Modified Ban Xia Xie Xin Decoction were significantly more effective than the placebo in improving dyspepsia-related symptoms Ho et al. Researchers have conducted several experiments using animal and cellular models to elucidate its therapeutic effects and mechanisms of action. NSS comprises 11 botanical drugs that promote gastric emptying through the cholinergic pathway in antral-dilated mice Kim and Yoon, Anti-inflammatory effects have also been observed in experiments on rats with indomethacin-induced gastroinflammation Park and Baik, DHJ, composed of seven botanical drugs, inhibits smooth muscle contractions induced by acetylcholine chloride and barium chloride in isolated ileum, colon, and fundus strips of rats. In addition, it has been shown to prevent pyloric ulcers induced by indomethacin and hydrochloride ethanol in rats Yang et al. These studies indicate that NHT, combined with the efficacy of the above two prescriptions, can treat FD by promoting GI motility to improve gastric dysmotility and adaptive relaxation disorders, and prevent inflammation against gastric mucosal injury. To the best of our knowledge, this is the first randomized, double-blind, placebo-controlled clinical trial to show that NHT alleviates dyspeptic symptoms in patients with FD. Moreover, compared to placebo, not only did the TDS score show a significant change at both 2 and 4 weeks, but also significant improvements were demonstrated in the symptoms of epigastric burning, postprandial fullness, early satiation, and FD-QoL scale after 4 weeks of NHT administration. The improvement degree of the DQ score in the NHT group was significantly greater than that in the placebo group after 4 weeks. Among the symptoms of FD, there was no significant difference in the degree of improvement of epigastric pain between the two groups. Similarly, it is necessary to consider different applications of herbal medicines for different patterns and symptoms in patients with FD. In addition to subjective symptoms, this objective evaluation provides a quantitative analysis of the clinical characteristics of patients with FD. The results showed that group administered NHT for 4 weeks had a less significant decrease in the percentage of normogastria after meals than the placebo group. There was a greater increase in the postprandial percentages of bradygastria, tachygastria, and arrhythmia in the placebo group than in the NHT group. However, the analysis of the results was based on only a few remaining clean data because a large number of subjects with missing values were excluded from the analysis. Bias in the results owing to missing information makes it difficult to generalize the outcomes. In addition, although a decreasing pattern in the percentage of normogastria was observed in the fed state compared to that in the fasted state in both groups, all the values satisfied the normal ranges of dominant frequency 2. For more consistent data collection in the future, it is necessary to completely test and retest measurements to minimize recording errors for a larger number of subjects and to determine significant values for each channel. FR Park et al. This indicates that multiple prescriptions can be suggested depending on the type and pattern of the disease, even for similar symptoms. This differentiated therapeutic approach can help increase the effectiveness of herbal medicines in patients with FD who experience limitations with conventional treatments. In future studies, a detailed analysis will be required to evaluate the characteristics of patients with FD who show a positive response to the NHT. In terms of safety, NHT had no noticeable adverse events compared with the placebo. The NHT and placebo groups had similar numbers and types of adverse events; their severity was mild and resolved without worsening. Although there was one SAE in each group, there was no definite connection to the study drug, thus confirming the safety of NHT. Based on a systematic review of 26 RCTs aimed at determining the extent and underlying factors of the placebo response in FD, we found that the overall placebo response rate in pharmacological trials for FD was approximately The placebo effect is thought to be influenced by psychological, neurobiological, and natural mechanisms Jones and Holtmann, As lower baseline symptom scores are significantly related to higher placebo responses, proper entry criteria based on symptom severity should be established Bosman et al. The SDS scale, which consists of four cardinal dyspeptic symptoms, was used as a secondary outcome measure. Additionally, we established a 4 week follow-up evaluation period after the administration of the investigational products to assess the sustained treatment effect in the absence of interventions. Previous studies on the use of NHT for the treatment of FD have not compared its efficacy with that of a placebo in a clinical setting. Studies in animals, cells, and patients have shown that NHT can relieve dyspeptic symptoms and treat FD related to gastric dysmotility. This recent clinical trial confirmed that NHT administration could improve dyspepsia symptoms, quality of life, and GMA values; however, the reliability of the NHT findings in this study needs to be merged with further clinical and experimental evidence to verify other underlying mechanisms. This study has several limitations. First, the study duration was limited to 4 weeks, and there was a lack of long-term follow-up. According to the FD guidelines for conducting clinical trials, considering the prognosis of FD and the pharmacological functions of drugs, at least 4 weeks of treatment is recommended to assess short-term therapeutic effects Lee et al. This 4 weeks treatment period is common in previous studies on FD using PPIs, prokinetics, and other herbal therapies Jee et al. However, as FD is prone to developing into a chronic disease in which symptoms change over time and recur periodically, further research is needed on the long-term safety and efficacy of NHT. Second, in addition to GMA measurement through EGG, other objective parameters related to GI motility, such as plasma levels of ghrelin and motilin, must also be analyzed. Furthermore, establishing a correlation between objective and other subjective evaluations in a sufficient number of participants with FD would enhance the credibility and clinical applicability of these findings. In the future, it will be important to elucidate the pathogenesis by which the active components of NHT relieve FD symptoms. Finally, this trial was conducted only in Korea, and further assessment of its external validity is required. In this RCT, the results showed that after a 4 weeks treatment with NHT in patients with FD, symptom severity and quality of life significantly improved compared with placebo. There were no clinically significant differences in the incidence of adverse events between the two groups. This evidence can be used to develop clinical practice guidelines for the effective treatment and management of FD, which can help promote public health. In conclusion, our study showed that the herbal formula of NHT could be used as an effective and safe alternative therapy for FD. Further large-scale multinational clinical trials of NHT as an effective herbal medicine for FD or in combination with other therapies are needed. JK supervised the study and reviewed the manuscript. All authors contributed to the article and approved the submitted version. The funding source did not influence the interpretation of the findings and the writing and publication of the manuscript. The authors would like to thank the Ministry of Health and Welfare of the Republic of Korea for their support in sponsoring this study. The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher. Aro, P. Functional dyspepsia impairs quality of life in the adult population. Berle, C. A novel approach to evaluate traditional Chinese medicine treatment outcomes using pattern identification. Bosman, M. Placebo response in pharmacological trials in patients with functional dyspepsia—A systematic review and meta-analysis. Carbone, F. Chen, J. Gastric slow wave abnormalities in patients with gastroparesis. PubMed Abstract Google Scholar. Ford, A. Functional dyspepsia. Lancet , — Ghoshal, U. Epidemiology of uninvestigated and functional dyspepsia in Asia: Facts and fiction. Gwee, K. Herbal medicines in functional dyspepsia—untapped opportunities not without risks. Ha, N. Google Scholar. A clinical study on safety and efficacy of Naesohwajung-tang on functional dyspepsia. Ho, L. Herbal medicine for functional dyspepsia: Network meta-analysis of placebo-controlled randomised trials. Jackson, J. Treatment of functional gastrointestinal disorders with antidepressant medications: A meta-analysis. Jee, S. Guidelines for the treatment of functional dyspepsia. Korean J. Jones, M. Placebo effects in functional dyspepsia: Causes and implications for clinical trials. Kim, J. Effect of naeso-san on gastric motility between normal intact and antral dilatated rats. Korean Med. Effect of Naesowhajung-tang on Electrogastrography in children with functional dyspepsia. Ko, S. 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. Lacy, B. Functional dyspepsia: The economic impact to patients. Lee, E. Lee, H. Guideline recommendation for endpoints used in clinical trials for functional dyspepsia. Mahadeva, S. Clinical and epidemiological differences in functional dyspepsia between the East and the West. Epidemiology of functional dyspepsia: A global perspective. World J. Mak, A. Dyspepsia is strongly associated with major depression and generalised anxiety disorder-a community study. Masuy, I. Review article: Treatment options for functional dyspepsia. Mazzoleni, L. Miwa, H. Asian consensus report on functional dyspepsia. Why dyspepsia can occur without organic disease: Pathogenesis and management of functional dyspepsia. Moayyedi, P. Pharmacological interventions for non-ulcer dyspepsia. Cochrane Database Syst. Eradication of Helicobacter pylori for non-ulcer dyspepsia. Park, J. A comparative study of eejin-tang, hyangsaeejin-tang and naeso-san extracts on indomethacin-induced gastric mucosal lesions in mice. Development of questionnaire for Damum patternization. Korean Inst. Park, S. Gastric motor dysfunction in patients with functional gastroduodenal symptoms. Park, Y. Development of a valid and reliable food retention questionnaire. Development of a valid and reliable phlegm pattern questionnaire. Pinto-Sanchez, M. Proton pump inhibitors for functional dyspepsia. Pittayanon, R. Prokinetics for functional dyspepsia: A systematic review and meta-analysis of randomized control trials. Qin, F. Chinese herbal medicine modified xiaoyao san for functional dyspepsia: Meta-analysis of randomized controlled trials. Schulz, K. Stanghellini, V. Gastroduodenal disorders. Gastroenterology 6 , — Talley, N. Van Zanten, S. Validation of a 7-point Global Overall Symptom scale to measure the severity of dyspepsia symptoms in clinical trials. Vanheel, H. Pathophysiological abnormalities in functional dyspepsia subgroups according to the Rome III criteria. Therapeutic options for functional dyspepsia. Wagner, H. Multitarget therapy—the future of treatment for more than just functional dyspepsia. Phytomedicine 13, — World Health Organization. World Health Organization : Geneva, Switzerland. Xiao, Y. Chinese herbal medicine Liu jun zi tang and Xiang sha Liu jun zi tang for functional dyspepsia: meta-analysis of randomized controlled trials. Based Complement. Yang, S. Yin, J. Electrogastrography: Methodology, validation and applications. Yoon, J. An experimental study on the component variation of naesowhajung-tang by the three types of extraction method and the effects of each type on the gastrointestinal tract. Zhang, S. Efficacy of modified LiuJunZi decoction on functional dyspepsia of spleen-deficiency and qi-stagnation syndrome: A randomized controlled trial. BMC Complement. Zhao, L. Efficacy of modified ban xia xie xin decoction on functional dyspepsia of cold and heat in complexity syndrome: A randomized controlled trial. Zhu, W. Textbook of traditional Chinese medical diagnosis: Etiological factors and Qi-Blood-Fluid pattern identifying method. Beijing: Ren min wei sheng chu ban she , — Keywords: functional dyspepsia, randomized controlled trial, Naesohwajung-tang , electrogastrography, pattern identification, herbal medicine. The use, distribution or reproduction in other forums is permitted, provided the original author s and the copyright owner s are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher. Top bar navigation. About us About us. Sections Sections. About journal About journal. Article types Author guidelines Editor guidelines Publishing fees Submission checklist Contact editorial office. Efficacy and safety of the herbal formula Naesohwajung-tang for functional dyspepsia: a randomized, double-blind, placebo-controlled, multi-center trial. TABLE 1. Composition and dosage of NHT. Flow chart of the trial; NHT, Naesohwajung-tang. TABLE 6. Adverse events in the NHT and placebo groups. Keywords: functional dyspepsia, randomized controlled trial, Naesohwajung-tang , electrogastrography, pattern identification, herbal medicine Citation: Ha N-Y, Ko S-J, Park J-W and Kim J Efficacy and safety of the herbal formula Naesohwajung-tang for functional dyspepsia: a randomized, double-blind, placebo-controlled, multi-center trial.

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