Background/Aims: Non-cardiac chest pain (NCCP) is defined as recurring angina-like retrosternal chest pain of non-cardiac origin. Information about the epidemiology of NCCP in Japan is lacking. We aim to determine the prevalence and characteristics of NCCP in the Japanese general population. Methods: Two internet-based surveys were conducted among the general population in March 2017. Questions investigated the characteristics of symptoms associated with chest pain and consultation behavior. Quality of life, anxiety, depression, and gastroesophageal reflux disease were analyzed. Results: Five percent of the survey respondents reported chest pain. Subjects with chest pain showed higher frequencies of anxiety and depression and lower quality of life. Among subjects with chest pain, approximately 30% had sought medical attention for their symptoms. Among all consulters, 70% were diagnosed with NCCP. Females were less likely to seek consultations for chest pain than males. Further, severity and frequency of chest pain, lower physical health component summary score, and more frequent gastroesophageal reflux disease were associated with consultation behavior. Subjects with NCCP and cardiac chest pain experienced similar impacts on quality of life, anxiety, and depression. Among subjects with NCCP, 82% visited a primary-care physician and 15% were diagnosed with reflux esophagitis. Conclusions The prevalence of chest pain in this sample of a Japanese general population was 5%. Among all subjects with chest pain, less than one-third consulted physicians, approximately 70% of whom were diagnosed with NCCP. Sex and both the severity and frequency of chest pain were associated with consultation behavior.

Objective: In the instructions for package inserts (PI) of prescription drugs revised in June 2017, the section “persons with reproductive potential” was established under “precautions concerning patients with specific backgrounds.” The description rules associated with contraceptive duration were modified in these. In this study, we investigated descriptions of contraceptive duration in PI that were prepared based on the revised instructions, interview forms (IF), and other proper use materials (PM).Methods: We collected PI, IF, and PM of prescription drugs containing a new active ingredient approved from April 2017 to March 2022 for which the PI were prepared based on the revised instructions and investigated descriptions of PI, contraceptive duration, and its evidence in each information material.Results: Of the 181 drugs studied, 43.1 and 12.7% required females and males to use contraception during the period of drug consumption, respectively. Among these, the ratio of drugs that had descriptions of contraceptive duration were 15.4 and 0% for females and males at PI, respectively; 51.3 and 39.1% for female sand males at IF, respectively. Anticancer drugstended to describe contraceptive duration in the PM rather than PI or IF. For some drugs, there was no description of contraceptive duration in any of the materials. Contraceptive durations ranged from the period of administration of that drug to over a year for females and approximately one week to six months for males. The reasons for these contraceptive durations were diverse.Conclusion: Contraceptive information in the PI based on revised instructions were not sufficient for use by healthcare workers, even when the IF and PM were confirmed. These results suggest that there is a need for standardizing the descriptions, types of materials to be described, and choice of evidence for contraceptive duration.

Background/Aims: Herbal medicine is an important complementary therapy for functional dyspepsia (FD). However, its effect against gastric hypersensitivity in patients with FD has rarely been evaluated. Yokukansan (YKS), a traditional Japanese herbal medicine, is effective against neuropathic and inflammatory pain. This study aims to use a maternal separation (MS) stress-induced FD model to investigate the effects of YKS against gastric hypersensitivity, gastric motility, and duodenal micro-inflammation. Methods: The MS stress model was established by separating newborn Sprague-Dawley rats from their mothers for 2 hours a day from postnatal days 1 to 10. At the age of 7-8 weeks, the rats were treated with YKS at a dose of 5 mL/kg (1 g/kg) for 7 consecutive days. AfterYKS treatment, electromyographic activity in the acromiotrapezius muscle by gastric distention and the gastric-emptying rate were assessed. Immunohistochemical analysis of eosinophils in the duodenum and phosphorylated extracellular signal-regulated kinase(p-ERK) 1/2 in the spinal cord was performed. Results: YKS treatment suppressed MS stress-induced gastric hypersensitivity and decreased the elevated levels of p-ERK1/2 in the spinal cord.In the gastroduodenal tract, YKS inhibited eosinophil-associated micro-inflammation but did not improve gastric dysmotility. Conclusions YKS treatment improved gastric hypersensitivity by alleviating eosinophil-associated micro-inflammation in the gastroduodenal tract.This treatment may be considered an effective therapeutic option for epigastric pain and micro-inflammation in patients with FD.

Background/Aims: Gastric acid secretion is suspected to be a pivotal contributor to the pathogenesis of functional dyspepsia. The present study investigates the potential association of the gastric acid secretion estimated by measuring serum pepsinogen with therapeutic responsiveness to the prokinetic drug acotiamide. Methods: Dyspeptic patients consulting participating clinics from October 2017 to March 2019 were prospectively enrolled in the study. The dyspeptic symptoms were classified into postprandial distress syndrome (PDS) and epigastric pain syndrome (EPS). Gastric acid secretion levels were estimated by the Helicobacter pylori infection status and serum pepsinogen using established criteria and classified into hypo-, normo-, and hyper-secretion. Each patient was then administered 100 mg acotiamide thrice daily for 4 weeks, and the response rate to the treatment was evaluated using the overall treatment efficacy scale. Results: Of the 86 enrolled patients, 56 (65.1%) and 26 (30.2%) were classified into PDS and EPS, respectively. The estimated gastric acid secretion was not significantly different between PDS and EPS. The response rates were 66.0% for PDS and 73.1% for EPS, showing no significant difference. While the response rates were stable, ranging from 61.0% to 75.0% regardless of the estimated gastric acid secretion level among subjects with PDF, the rates were significantly lower in hyper-secretors than in non-hyper-secretors among subjects with EPS (42.0% vs 83.0%, P = 0.046). Conclusion Although acotiamide is effective for treating EPS as well as PDS overall, the efficacy is somewhat limited in EPS with gastric acid hypersecretion, with gastric acid suppressants, such as proton pump inhibitors, being more suitable.

Background/Aims: The adenoma detection rate (ADR) of screening colonoscopies performed by trainees is often lower than that of colonoscopies performed by experts. The effcacy of cap-assisted colonoscopy (CAC) in adenoma detection is well documented, especially that of CACs performed by trainees. Endocuff, a new endoscopic cap, is reportedly useful for adenoma detection; however, no trials have compared the effcacy of Endocuff-assisted colonoscopy (EAC) and CAC conducted by trainees. Therefore, the present study retrospectively compared the effcacy between EAC and CAC in trainees. Methods: This was a single-center, retrospective study involving 305 patients who underwent either EAC or CAC performed by three trainees between January and December 2018. We evaluated the ADR, mean number of adenomas detected per patient (MAP), cecal intubation rate, cecal intubation time, and occurrence of complications between the EAC and CAC groups. Results: The ADR was significantly higher in the EAC group than in the CAC group (54.3% vs. 37.3%, p=0.019), as was the MAP (1.36 vs. 0.74, p=0.003). No significant differences were found between the groups with respect to the cecal intubation rate or cecal intubation time. No major complications occurred in either group. Conclusions Our results suggest that EAC exhibits increased ADR and MAP compared to CAC when performed by trainees.

BACKGROUND/AIMS: Magnesium oxide (MgO) has been frequently used as a treatment for chronic constipation (CC) since the 1980s in Japan. The aim of this study is to evaluate its therapeutic effects of MgO in Japanese CC patients. METHODS: We conducted a randomized, double-blind placebo-controlled study. Thirty-four female patients with mild to moderate constipation were randomly assigned to either placebo (n = 17) or MgO group (n = 17) 0.5 g × 3/day for 28 days. Primary endpoint was overall improvement over the 4-week study period. Secondary endpoints were changes from baseline in spontaneous bowel movement (SBM), response rates of complete spontaneous bowel movement (CSBM), stool form, colonic transit time (CTT), abdominal symptom, and quality of life. RESULTS: One patient failed to complete the medication regimen and was omitted from analysis: data from 16 placebo and 17 MgO patients were analyzed. The primary endpoint was met by 25.0% of placebo vs 70.6% of MgO group (P = 0.015). MgO significantly improved SBM changes compared to placebo (P = 0.002). However, MgO did not significantly improved response rates of CSBM compared to placebo (P = 0.76). In addition, MgO significantly improved Bristol stool form scale changes (P < 0.001) and significantly improved CTT compared to the placebo group (P < 0.001). MgO significantly improved the Japanese version of the patient assessment of constipation quality of life (P = 0.003). CONCLUSION: Our placebo-controlled study demonstrated that MgO was effective treatment for improving defecation status and shortened CTT in Japanese CC patients with mild to moderate symptoms.
Asian Continental Ancestry Group ; Colon ; Constipation ; Defecation ; Double-Blind Method ; Female ; Humans ; Japan ; Magnesium Oxide ; Magnesium ; Quality of Life ; Therapeutic Uses

BACKGROUND/AIMS: Gastric motility abnormalities have been considered to be pathophysiological features of functional dyspepsia (FD) that are closely related to dyspepsia symptoms, especially postprandial distress syndrome (PDS). The aims of this study are to (1) investigate the prevalence of gastric motility disorders and (2) evaluate the association between gastric motility abnormalities and dyspeptic symptoms using gastric scintigraphy in the PDS type of FD. METHODS: Forty healthy subjects and 94 PDS type FD patients were enrolled in the study. The volunteers and patients ingested a radiolabeled (technetium-99m) solid test meal, and scintigraphic images were recorded. Gastric accommodation and emptying were assessed by scintigraphic imaging. The patients’ dyspeptic symptoms were also explored using self-completed symptom questionnaires with 10 variables (4 scales, 0–3 points) at the same time. RESULTS: In 94 Japanese FD patients, the prevalence of impaired gastric accommodation and delayed emptying were 14.9% (14/94) and 10.6% (10/94), respectively. Gastric motility abnormalities were seen in 25.5% (24/94) of FD patients. There was no association between gastric motility abnormalities and dyspeptic symptoms. CONCLUSIONS: Gastric motility abnormalities were seen in 25.5% of Japanese PDS type FD patients. However, there was no association between gastric motility abnormalities and dyspeptic symptoms on gastric scintigraphy.
Asian Continental Ancestry Group ; Dyspepsia* ; Healthy Volunteers ; Humans ; Meals ; Prevalence* ; Radionuclide Imaging ; Stomach ; Volunteers ; Weights and Measures

The median time of brain metastasis from the diagnosis of breast cancer is approximately 3 years. In this case report, a 69-year-old woman demonstrated cerebellar ataxia. Brain magnetic resonance imaging revealed enhanced lesions in bilateral cerebellar hemispheres. She had undergone surgery, radiation, and chemotherapy for uterine and breast cancer 24 years prior and 16 years prior, respectively. Although she had not received any anticancer treatment for 10 years, no recurrences were identified using whole body scans. A partial tumor resection was performed and the histological diagnosis was an adenocarcinoma from breast cancer. As no extracranial lesions were found, gamma-knife irradiation was performed, without additional systemic chemotherapy. One month posttreatment, the tumors dramatically reduced in size and the patient completely recovered from cerebellar ataxia. Systemic chemotherapy is not always required for brain metastasis from breast cancer with a long interval period, as long as no evidence of extracranial recurrence is detected.
Adenocarcinoma ; Aged ; Brain* ; Breast Neoplasms* ; Breast* ; Cerebellar Ataxia ; Diagnosis ; Drug Therapy ; Female ; Humans ; Magnetic Resonance Imaging ; Neoplasm Metastasis* ; Neoplasm Recurrence, Local ; Prognosis ; Recurrence* ; Whole Body Imaging

BACKGROUND/AIMS: When a person is experiencing stress, corticotropin-releasing hormone (CRH) can modulate gut physiologies, such as visceral sensation or gastrointestinal motility, and its intravenous administration mimics stress-induced physiological changes. However, the influence of CRH on the esophagus is yet unknown. Accordingly, we investigated whether intravenous CRH administration increases esophageal sensitivity to electrical stimulation in healthy Japanese subjects. METHODS: Twenty healthy subjects were recruited. We quantified the initial perception threshold (IPT) every 15 minutes after CRH injection. Venous blood was collected with a cannula, and both plasma adrenocorticotropic hormone (ACTH) and cortisol were measured at pre-stimulation, 0, 30, 60, 90, and 120 minutes. The results from each time point were compared against a baseline IPT obtained before electrical stimulation was initiated. RESULTS: When compared to the baseline IPT value (16.9 ± 4.5), CRH significantly decreased electrical threshold of the esophagus at 30, 45, 60, 75 minutes (14.1 ± 4.2, 13.1 ± 5.0, 12.1 ± 5.7, 14.0 ± 5.8 minutes, P < 0.01, respectively) after CRH injection, suggesting that CRH increased esophageal sensitivity to the electrical stimulus. CRH also significantly increased plasma ACTH levels at 30 minutes (50.3 ± 17.7, P < 0.01), and cortisol levels at 30 minutes (22.0 ± 6.7 minutes, P < 0.01) and 60 minutes (20.3 ± 6.7 minutes, P < 0.01) after CRH injection, when compared to the pre-stimulation ACTH and cortisol values. CONCLUSION: Intravenous CRH administration increased esophageal electrical sensitivity in normal subjects, emphasizing the important role of stress in esophageal sensitivity.
Administration, Intravenous ; Adrenocorticotropic Hormone ; Asian Continental Ancestry Group ; Catheters ; Corticotropin-Releasing Hormone* ; Electric Stimulation ; Esophagus ; Gastrointestinal Motility ; Healthy Volunteers ; Humans ; Hydrocortisone ; Plasma ; Sensation

Objective: The Japanese risk management plan (RMP) contains the risk minimization action plans for important potential risks of drugs.  One of the basic risk minimization action plans is reminding on package insert; however, we found that some potential risks were not described in package inserts.  In this study, we investigated the description of potential risks on package inserts.
Design: Document analysis.
Methods: We collected all posted RMP documents and the package inserts of corresponding products from the Pharmaceutical and Medical Devices Agency website on January 31, 2015 and investigated the risk minimization action plans of important potential risk items and whether the items had been described in each package insert.
Results: Of 268 important potential risk items in 81 products, 56 items were not described on package insert.  The major reason for not including the risk items on the package insert was “causality was not indicated sufficiently” and some items had no written reason.
Conclusion: About 20% of important potential risks are not described in package inserts.  Because most post-marketing pharmacovigilance plans depend on spontaneous reporting by healthcare personnel, description on package insert, the most frequently referred drug information resource, should be considered.