A systematic review of the characteristics of data assessment tools to measure medical doctors' work-related quality of life.

PURPOSE: Remarkable progress in healthcare technology has recently been made alongside changes in concepts related to drugs and medical devices. It is speculated that this progress benefits not only patients but also healthcare professionals, such as medical doctors. We performed a systematic review of the characteristics of current data assessment tools to measure medical doctors' work-related quality of life (QOL). METHODS: A literature search was conducted through PubMed and Ichushi-Web in 2020. The related search terms used were 'medical doctor,' 'quality of work life,' and 'questionnaire/interview.' Two reviewers independently screened the studies, and the characteristics of the QOL assessment tools used in the identified studies were qualitatively reviewed and summarized. RESULTS: In total, 5,443 and 760 articles were retrieved from PubMed and Ichushi-Web, respectively, of which 82 studies were included in this review. Sixty-five (79%) studies used structured questionnaires, and 17 (21%) studies used semistructured questionnaires. In terms of the study purpose, the identified studies mainly included four: mental health, the work or labor situation, satisfaction, and QOL. Components used to measure work-related QOL included satisfaction, burnout, QOL, the work environment, stress, mental health, work-life balance, and others. None of the studies used an originally developed QOL questionnaire to assess the work-related benefits of medical doctors. CONCLUSION: This systematic review found that there is a lack of studies directly assessing the work-related QOL of medical doctors and a lack of effective data collection tools to assess all work-related QOL components.

In-Hospital Outcomes of Heart Failure Patients with Valvular Heart Disease: Insights from Real-World Claims Data.

Purpose: Heart failure (HF) is a serious public health burden that is rapidly increasing in the aging population. Valvular heart disease (VHD) is a known etiology of heart failure (HF); however, the impact of VHD on outcomes of patients with HF has not been well-studied in Japan. This study aimed to determine the rates of VHD in Japanese patients admitted for HF and explore associations of VHD with in-hospital outcomes through a claim-based analysis. Patients and methods: We analyzed claims data from 86,763 HF hospitalizations (January 2017 through December 2019) from the Medical Data Vision database. Common etiologies of HF were examined, then hospitalizations were categorized into those with VHD and those without. Covariate-adjusted models were used to explore the association of VHD with in-hospital mortality, length of stay, and medical cost. Results: Of 86,763 hospitalizations for HF, 13,183 had VHD and 73,580 did not. VHD was the second most frequent etiology of HF (15.2%). The most frequent type of VHD was mitral regurgitation (36.4% of all hospitalizations with VHD), followed by aortic stenosis (33.7%) and aortic regurgitation (16.4%). There was no significant difference in in-hospital mortality between hospitalizations with VHD vs those without (9.0% vs 8.9%; odds ratio [95% CI]: 1.01 [0.95-1.08]; p=0.723). Hospitalizations with VHD were associated with significantly longer length of stay (26.1 vs 24.8 days; incident rate ratio [95% CI]: 1.05 [1.03-1.07]; p<0.001) and higher medical costs (1536 vs 1195 thousand yen; rate ratio [95% CI]: 1.29 [1.25-1.32]; p<0.001). Conclusion: VHD was a frequent etiology of HF that was associated with significant medical resource use. Future studies are needed to investigate whether timely VHD treatment could reduce HF progression and its associated healthcare resource utilization.

Valvular heart disease in Japan: Characteristics and treatment of patients in acute care hospitals in 2019.

BACKGROUND: Valvular heart disease (VHD) is one of the commonest causes of cardiovascular morbidity and mortality worldwide, with acquired VHD especially prevalent in countries with aging populations. The scope and pattern of disease are not well understood, as some patients are asymptomatic and available options for invasive treatment vary by affected valve. We sought to understand the burden of VHD in Japan including the distribution of patients by valve disease type and age, using administrative claims data from acute care hospitals. METHODS: This was a retrospective descriptive study of patients with VHD diagnosis and at least one record of echocardiography in 2019 documented in the Medical Data Vision database. Affected valve(s) and type of valve disease were characterized using ICD-10 codes; patients undergoing invasive treatment for VHD at the same facility and during the same year as their diagnosis were assessed using procedure codes. RESULTS: Of 203,398 patients with VHD diagnosis and a record of echocardiography in 2019, 49.0 % had a mitral valve disorder, 44.9 % aortic valve, 22.9 % tricuspid valve, and 2.2 % pulmonic valve (14.9 % of patients had more than one disordered valve). A total of 7201 patients (<4 % of the total diagnosed population) received invasive treatment for VHD in 2019 at the diagnosing hospital. Patients with aortic stenosis (AS) had the highest mean age, at 79 years. Although mitral regurgitation was the most common VHD among diagnosed patients, AS predominated in the cohort of treated patients. A substantial portion of patients undergoing treatment for AS were age 85 years or older (27.2 %). CONCLUSIONS: The cohort of treated patients in 2019 was a small fraction of the total population with a VHD diagnosis in that year. Wide availability of transcatheter treatment for AS in Japan may be allowing more elderly patients to receive intervention than in other types of VHD.

Association between financial toxicity and health-related quality of life of patients with gynecologic cancer.

OBJECTIVES: Patients often struggle with their financial situation during cancer treatment due to treatment-related costs or loss of income. This resulting negative effect is called financial toxicity, which is a known as a side effect of cancer care. This study aimed to evaluate the association between financial toxicity and health-related quality of life among patients with gynecologic cancer using validated questionnaires. METHODS: In this multicenter study, patients with gynecologic cancer receiving anti-cancer drug treatment for > 2 months were recruited. Patients answered the COmprehensive Score for Financial Toxicity (COST) tool, EORTC-QLQ-C30, disease-specific tools (EORTC-QLQ-OV28/CX24/EN24), and EQ-5D-5L. Spearman's rank correlation coefficient was used to determine associations. RESULTS: Between April 2019 and July 2021, 109 cancer patients completed the COST questionnaire. The mean COST score was 19.82. Strong associations were observed between financial difficulty (r = - 0.616) in the EORTC-QLQ-C30 and body image (r = 0.738) in the EORTC-QLQ-CX24, while weak associations were noted between the global health status/quality of life (r = 0.207), EQ-5D-5L index score (r = 0.252), and several function and symptom scale scores with the COST score. CONCLUSIONS: Greater financial toxicity was associated with worse health-related quality of life scores, such as financial difficulty in gynecologic cancer patients and body image in cervical cancer patients as strong associations, and weakly associated with general health-related quality of life scores and several function/symptom scales.

Use of Anticancer Therapies and Economic Burden Near the End of Life in Japan: Results From Claims Database.

PURPOSE: In patients with cancer, aggressive treatment near the end of life (EOL) may decrease quality of life and increase medical costs. In this study, we examined the use of anticancer therapies near the EOL in Japan. METHODS: We used a commercial database of health insurance claims in Japan, to examine patient data on cancer and death until August 2020. We assessed the proportion of patients using anticancer therapies within 14 days of death, associated factors, and medical costs from the payer's perspective. RESULTS: The database documented 5,759 patients with cancer who died between December 2013 and August 2020. Among them, 4.8% of patients and 3.9% of age-adjusted patients received anticancer therapy within 14 days of death. Patients age < 60 years were associated with a high probability of receiving anticancer therapy near the EOL. The estimated annual anticancer therapy and related costs were Japanese yen 1,296 million (US dollars 12.6 million). CONCLUSION: We found the percentage of patients receiving anticancer therapies within 14 days of death in Japan, its associated factors, and economic burden. Our findings can serve as a benchmark for optimizing EOL care.

Coriolus (Trametes) versicolor mushroom to reduce adverse effects from chemotherapy or radiotherapy in people with colorectal cancer.

BACKGROUND: Radiotherapy and chemotherapy are used to improve survival in colorectal cancer but adverse effects can be a problem. Severe adverse effects may result in dose reduction or cessation of treatment, which have an impact on survival. Coriolus versicolor (Trametes versicolor or 'Turkey Tail') mushroom and its extracts have been used by cancer patients to help with adverse effects. OBJECTIVES: To assess the effects of adjunctive Coriolus versicolor (Trametes versicolor) and its extracts on adverse effects and on survival during colorectal cancer treatment (chemotherapy and radiotherapy) compared with no adjunctive treatment. SEARCH METHODS: We searched databases including CENTRAL, MEDLINE, Embase, AMED and CINAHL, Chinese and Japanese databases, and trials registers to 12th April 2022 without restriction of language or publication status. We screened reference lists and attempted to contact researchers in the field to identify additional studies. SELECTION CRITERIA: We included randomised controlled trials (RCTs) investigating the efficacy and safety of Coriolus versicolor and its extracts in adult participants with a confirmed diagnosis of colorectal cancer, in addition to conventional treatment. Interventions included any preparation of Coriolus versicolor (raw, decoction, capsule, tablet, tincture, extract, injection), any part of the fungus (cap, stem, mycelium or whole), in any dose or regimen. Outcomes included adverse events rates, survival, disease progression and recurrence, response rates and quality of life. DATA COLLECTION AND ANALYSIS: Two review authors independently screened and selected studies, extracted outcome data, and assessed risk of bias. We evaluated the overall certainty of evidence using the GRADE approach. MAIN RESULTS: We included seven parallel RCTs (1569 participants). Six studies (1516 participants) were conducted in Japan and one study (53 participants) in China. Studies included both male and female participants with colorectal cancer (five studies), colon cancer (one study) or rectal cancer (one study). Participants were diagnosed with cancer ranging from stage II to stage IV. Coriolus was used in the form of an extract in all seven studies and was generally used after curative resection, although in one study it was used preoperatively. Duration of treatment with the extract varied between four weeks and three years. Chemotherapeutic regimens in six studies consisted of an oral fluoropyrimidine which was preceded by weekly intravenous 5-Fluorouracil (5-FU) in one study, by mitomycin C in two studies, and which was combined with folinic acid (Leucovorin) in two studies and with radiotherapy preoperatively in one study. XELOX (oxaliplatin intravenous infusion and capecitabine) was used in the remaining study. We found very low-certainty evidence of little to no effect of adjunctive treatment with Coriolus (in the form of an extract, polysaccharide-Krestin, PSK) on withdrawal from treatment due to adverse events  (risk ratio (RR) 1.03, 95% confidence interval (CI) 0.45 to 2.34; 703 participants; 3 studies;). We are uncertain whether adjunctive Coriolus versicolor and its extracts compared to usual care alone resulted in a difference in adverse events including neutropenia (RR 0.41, 95% CI 0.24 to 0.71; 133 participants; 3 studies; very low certainty), oral cavity disorders such as oral dryness and mucositis (RR 0.37, 95% CI 0.13 to 1.03; 1022 participants; 5 studies; very low certainty), nausea (RR 0.73, 95% CI 0.44 to 1.22; 969 participants; 4 studies; very low certainty), diarrhoea (RR 0.77, 95% CI 0.32 to 1.86; 1022 participants; 5 studies; very low certainty), and fatigue (RR 0.76; 95% CI 0.33 to 1.78; 133 participants; 3 studies; very low certainty). We found low-certainty evidence of a small effect of adjunctive Coriolus on improved survival at five years compared with no adjunctive care (RR 1.08, 95% CI 1.01 to 1.15; 1094 participants; 3 studies; number needed to benefit (NNTB) = 16 (95% Cl 9 to 70). The effect at earlier time points was unclear. AUTHORS' CONCLUSIONS: Due to the very low certainty of evidence, we were uncertain about the effect of adjunctive Coriolus (in the form of an extract PSK) on adverse events resulting from conventional chemotherapy for colorectal cancer. This includes effects on withdrawal of treatment due to adverse events and on specific adverse outcomes such as neutropenia and nausea. The uncertainty in the evidence also means that it was unclear whether any adverse events were due to the chemotherapy or to the extract itself. While there was low-certainty evidence of a small effect on overall survival at five years, the influence of reduced adverse effects on this could not be determined. In addition, chemotherapy regimens used in assessing this outcome do not reflect current preferred practice.

Cost-Effectiveness Analysis Update of the Adjuvanted Recombinant Zoster Vaccine in Japanese Older Adults.

INTRODUCTION: This study aimed to update cost-effectiveness and public health impact estimates of the two-dose recombinant zoster vaccine (RZV) compared with no vaccination against herpes zoster (HZ) in the Japanese population aged 65 years. List price of the vaccine and latest RZV efficacy and waning estimates were incorporated. METHODS: A multicohort static Markov model with a cycle length of 1 year was used to follow a hypothetical cohort of one million people aged 65 years over their remaining lifetime (base case). Age-stratified vaccine efficacy and waning rates were updated on the basis of the latest clinical trial data (interim ZOE-LTFU; NCT02723773). First-dose coverage was assumed at 40%, and second-dose compliance was assumed at 95%. Costs and outcomes were discounted at 2% annually, and the incremental cost-effectiveness ratio (ICER) was calculated from payer and societal perspectives. The societal perspective considered productivity loss due to suffering HZ, or due to suffering HZ and time required for vaccination. Sensitivity analyses explored the overall uncertainties in the model. Scenario analyses for Japanese adults aged 50, 60, 70, 80, ≥ 50, and ≥ 65 years (main scenario) were conducted. An ICER below ¥5-6 million/quality-adjusted life-year (QALY) was considered cost-effective. RESULTS: RZV was estimated to prevent 71,423 HZ cases and 15,858 post-herpetic neuralgia (PHN) cases per million people aged 65 years compared with no vaccine in Japan. The ICER was ¥4,205,515 from a payer perspective and was most sensitive to assumptions regarding vaccine efficacy waning, proportion of patients with HZ developing PHN, and HZ incidence. From societal perspectives, ICERs were ¥3,854,192 (productivity loss from suffering HZ only) and ¥4,622,212 (productivity loss from suffering HZ and time required for vaccination). Overall, the results were considered robust under extensive sensitivity and scenario analyses. CONCLUSION: Vaccination against HZ with RZV is cost-effective compared with no vaccination in Japanese adults aged 65 years.

Drug Utilization and Medical Cost Study Focusing on Moisturizers in Cancer Patients Treated with Molecular Targeted Therapy: A Retrospective Observational Study Using Data from a Japanese Claims Database.

INTRODUCTION: Molecular targeted therapies (MTTs) cause skin disorders in patients with cancer, and moisturizers are useful treatments; however, their actual use and costs are unknown. Our purpose was to examine the use and costs of moisturizers prescribed for xerosis (asteatosis) in patients with cancer treated with MTTs. METHODS: We used data from a Japanese hospital-based claims database. The index date was the first date of MTT prescription from October 2011 to April 2018 (selection period), and the follow-up period was 1 year from the index date. Patients treated with MTTs during the selection period and who were not prescribed moisturizers in the 6 months before the index date were included as the study cohort. Timing, duration, amount, and costs of the prescribed moisturizers and total medical costs were analyzed. RESULTS: Among the 78,190 patients in the study cohort, 27,906 patients (35.7%) were prescribed moisturizers during follow-up. Moisturizer prescription timing, duration, and volume were inconsistent. The average annual total medical costs for treating patients with MTT who were prescribed moisturizers was JPY 6.165 million (USD 53,797) per patient, and the moisturizer costs were JPY 6033 (USD 53). The number of patients who used moisturizers showed an increasing trend. CONCLUSION: No consistent patterns were observed for the timing or duration of moisturizer use, which suggests various developmental patterns of skin disorders. Furthermore, medical costs for moisturizers accounted for only a small proportion of the total medical costs required for cancer treatment.

Validity of the COmprehensive Score for financial Toxicity (COST) in patients with gynecologic cancer.

OBJECTIVE: Financial toxicity is a financial burden of cancer care itself, which leads to worse quality of life and higher mortality and is considered an adverse effect. The COmprehensive Score for financial Toxicity (COST) tool is a patient-reported outcome measurement used to evaluate financial toxicity. We aimed to validate the internal consistency and reproducibility of the COST tool in patients with gynecologic cancer. METHODS: In this multicenter study covering the period April 2019 to July 2021, using the COST tool in Japan, patients diagnosed with ovarian, cervical, or endometrial cancer receiving systemic anti-cancer drug therapy for more than 2 months were eligible. Patients with no out-of-pocket costs for direct medical costs were excluded. The patients answered the initial test and a retest, which was completed from 2 to 14 days after the initial test. Internal consistency and reproducibility were assessed using Cronbach's alpha and intraclass correlation coefficient (ICC), respectively. Cronbach's alpha ≥0.8 indicates good internal consistency, and ICC ≥0.8 is highly reliable. RESULTS: A total of 112 patients (ovarian: 50, cervical: 26, endometrial: 36) responded to the initial test, and 89 patients answered the retest from 2 to 14 days after the initial test. The median patient age was 58 (range, 28-78) years. The median COST score was 19. Cronbach's alpha showed good internal consistency at 0.83 (95% CI 0.78 to 0.87). The ICC at 0.850 (95% CI 0.777 to 0.900) showed high reliability. CONCLUSIONS: The COST tool has good internal consistency and reliable reproducibility in patients with gynecologic cancer in Japan. The COST tool quantifies financial toxicity in the insurance system, where patients have limited out-of-pocket direct medical costs. The results support the use of the COST tool in patients with gynecologic cancer.

Cost-saving prediction model of transfer to palliative care for terminal cancer patients in a Japanese general hospital.

Background: Although medical costs need to be controlled, there are no easily applicable cost prediction models of transfer to palliative care (PC) for terminal cancer patients. Objective: Construct a cost-saving prediction model based on terminal cancer patients' data at hospital admission. Study design: Retrospective cohort study. Setting: A Japanese general hospital. Patients: A total of 139 stage IV cancer patients transferred to PC, who died during hospitalization from April 2014 to March 2019. Main outcome measure: Patients were divided into higher (59) and lower (80) total medical costs per day after transfer to PC. We compared demographics, cancer type, medical history, and laboratory results between the groups. Stepwise logistic regression analysis was used for model development and area under the curve (AUC) calculation. Results: A cost-saving prediction model (AUC = 0.78, 95% CI: 0.70, 0.85) with a total score of 13 points was constructed as follows: 2 points each for age ≤ 74 years, creatinine ≥ 0.68 mg/dL, and lactate dehydrogenase ≤ 188 IU/L; 3 points for hemoglobin ≤ 8.8 g/dL; and 4 points for potassium ≤ 3.3 mEq/L. Conclusion: Our model contains five predictors easily available in clinical settings and exhibited good predictive ability.

Real-World Cost-Effectiveness of Palliative Care for Terminal Cancer Patients in a Japanese General Hospital.

Background: The concept of cost-effectiveness is necessary for optimal utilization of limited health care resources. However, few studies have assessed the cost-effectiveness of palliative care using quality-adjusted life years (QALYs), considered common outcomes in health economics. Objective: We aimed to perform a cost-effectiveness analysis of palliative care for terminal cancer patients by using QALYs. Design: A retrospective cohort study was performed. Setting/Patients: We included 401 patients with stage IV cancer, who were hospitalized and died at a Japanese general hospital during the period April 2014 to March 2019. Methods: Using the hospital database, we compared the total admission costs and QALYs based on pain levels of patients admitted to the palliative care (PC) department with those of patients admitted to other usual care (UC) departments. Patients in each group were matched through propensity scores to reduce bias. Bootstrapping estimated the 95% confidence intervals (95% CIs) and the probability that PC was more cost-effective than UC. Results: After matching, 128 patients in each group were selected. Converting 1 U.S. dollar (USD) to 100 Japanese yen, PC reduced mean total admission costs by 1732 USD (95% CI: 1584-1879) and improved mean health benefits by 0.0028 QALYs (95% CI: 0.0025-0.0032) compared with UC. Based on the Japanese cost-effectiveness threshold, there was an 82% probability that PC was more cost-effective than UC. Conclusions: Our results indicated that admission of terminal cancer patients to the PC department was associated with improvement in cost-effectiveness. This finding could support the introduction of palliative care for terminal cancer patients. Our study was approved at St. Luke's International University (receipt number 18-R061 and at the Graduate School of Pharmaceutical Sciences, The Univesity of Tokyo (receipt number 31-29).

Family caregiving in dementia and its impact on quality of life and economic burden in Japan-web based survey.

Background: Dementia has become a growing health-care problem in the rapidly ageing Japanese population. This study assesses the impact of dementia on quality of life, economic burden, and productivity loss. Objective: The objective of this study was to assess the impact of dementia on the Quality of Life (QoL), economic burden, and productivity loss among families living with dementia. Methods: An online survey was conducted among families who lived with relatives with dementia. Demographic data and information about health condition and costs of long-term care and treatment were collected. Participants were asked to answer the EuroQol (EQ-5D-5L) questionnaire, Zarit Burden Interview (ZARIT-8), and Work Productivity and Activity Impairment Questionnaire (WPAI). Multivariate analyses were conducted to assess factors associated with burden by families living with dementia. Results: Six hundred and thirty-five participants completed the survey. Of these participants, 50.5% were primary caregivers. Overall, 78.7% of dementia patients suffered from Alzheimer, and 43.9% needed long-term care. Compared to non-primary caregivers, primary caregivers had lower health utility scores (0.896 vs 0.873; p = 0.02), higher burden of caregiving (ZARIT-8: 21.1 vs 24.5; p < 0.0001), and higher overall work impairment (40.2% vs 20.8%; p < 0.0001), absenteeism (15.3% vs 5.7%; p < 0.0001), and presenteeism-related impairment (33.2% vs 17.3%; p < 0.0001). Conclusion: Families living with dementia caring for a person with dementia experience increased burden. Health policies related to dementia need to be considered not only for patients, but also for their families living with dementia to improve their QoL.

Analysis of Hepatobiliary Disorder Reports Associated With the Use of Herbal Medicines in the Global Suspected ADR Database Vigibase.

Introduction: Use of herbal medicines (HMs) is widespread across the world, with many people relying on HMs for their primary healthcare or using HMs in the context of a healthy life style. HMs originate from plant material and, as such, are often seen as "natural" and believed to be (relatively) safe by patients. Hepatobiliary disorders have been associated with numerous HMs. Aim: This paper aims to analyze reporting patterns for hepatobiliary disorders associated with HMs use from reports submitted to the WHO global database of individual case safety reports (ICSRs) VigiBase. Methods: A data extraction in VigiBase, the WHO international database of ICSR reports, was performed by the Uppsala Monitoring Centre on 2019-01-16. The dataset contained all ICSRs where an HM was identified with the UMC-assigned ATC code "V90: unspecified herbal and traditional medicine" and where the HM was classified as being either the suspected drug or an interacting drug, and containing at least one adverse reaction in the MedDRA® System Organ Class (SOC) Hepatobiliary Disorders (HBD). Descriptive analyses in Excel 2013® were used to determine general characteristics of the reports in the broad data set, including total number of reports, reporting country and patient characteristics. For single suspect herbal reports, reports categorized as "serious" according to CIOMS criteria (CIOMS), 2001) were extracted. Results: In total, 2,483 reports describing with at least one ADR in the SOC HBD were extracted from VigiBase. In total, 780 (31.4%) reports concern only one suspect HM. However, for 188 reports of these reports (24.1%), the single suspect herbal preparation contains more than one herbal ingredient. The 592 reports for single suspect herbal preparations described a total of 764 ADRs in the SOC HBD. Jaundice was the most reported ADR for these reports. Conclusion: Almost 2,500 reports for HMs and with at least one ADR coded to the MedDRA® SOC HBD were retrieved from VigiBase. Of the HBD SOC HM reports, around 25% concerned a single herbal species as the suspect "drug." Substantial issues with coding of the suspect herbal drugs were found. In-depth causality assessment of the cases is needed to draw conclusions on the strength of the relationships.

Systematic review with network meta-analysis: indirect comparison of the efficacy of vonoprazan and proton-pump inhibitors for maintenance treatment of gastroesophageal reflux disease.

BACKGROUND: Long-term maintenance treatment of gastroesophageal reflux disease (GERD) is important to prevent relapse. Proton-pump inhibitors (PPIs) are used for both treatment and maintenance therapy of GERD. Recently, a potassium-competitive acid blocker vonoprazan was launched in Japan. We evaluated the comparative efficacy of vonoprazan and other PPIs for GERD maintenance. METHODS: A systematic literature search was performed using MEDLINE and Cochrane Central Register of Controlled Trials. Double-blind randomized controlled trials (RCTs) of PPIs, vonoprazan, and placebo for GERD maintenance published in English or Japanese were selected. Among them, studies conducted at the recommended dose and for the recommended use, and containing information on maintenance rate based on endoscopic assessment, were included. The comparative efficacies of treatments were estimated by performing a Bayesian network meta-analysis, which assessed the consistency assumption. Outcomes were number or rate of patients who maintained remission. RESULTS: Of 4001 articles identified, 22 RCTs were eligible for analysis. One study published as an abstract was hand-searched and added. The consistency hypothesis was not rejected for the analysis. The odds ratio of vonoprazan 10 mg to each PPI was 13.92 (95% credible interval [CI] 1.70-114.21) to esomeprazole 10 mg; 5.75 (95% CI 0.59-51.57) to rabeprazole 10 mg; 3.74 (95% CI 0.70-19.99) to lansoprazole 15 mg; and 9.23 (95% CI 1.17-68.72) to omeprazole 10 mg. CONCLUSIONS: The efficacy of vonoprazan in GERD maintenance treatment may be higher than that of some PPIs. However, a direct comparison of vonoprazan and PPIs is required to confirm these effects.

Vonoprazan versus proton-pump inhibitors for healing gastroesophageal reflux disease: A systematic review.

BACKGROUND AND AIM: Gastroesophageal reflux disease (GERD) is a common disease caused by reflux of gastric contents to the esophagus. Proton-pump inhibitors (PPIs) are recommended as a first-line therapy to treat GERD. Recently, a new potassium-competitive acid blocker, vonoprazan, was launched in Japan. We aimed to evaluate the comparative efficacy of vonoprazan and other PPIs in healing GERD. METHODS: We used MEDLINE and the Cochrane Central Register of Controlled Trials to search the literature. Double-blind randomized controlled trials for PPIs and/or vonoprazan that were published in English or Japanese and assessed healing effects in adult GERD patients were included. To estimate the comparative efficacy of treatments, we performed a Bayesian network meta-analysis to assess the consistency assumption. RESULTS: Of 4001 articles identified in the database, 42 studies were eligible. One study was hand-searched and added to the analysis. For the main analysis of healing effects at 8 weeks, odds ratios (ORs) of vonoprazan (20 mg daily) to esomeprazole (20 mg), rabeprazole (20 mg), lansoprazole (30 mg), and omeprazole (20 mg) were 2.29 (95% credible interval, 0.79-7.06), 3.94 (1.15-14.03), 2.40 (0.90-6.77), and 2.71 (0.98-7.90), respectively. Subgroup analysis for patients with severe esophagitis at baseline showed significantly higher ORs for vonoprazan versus most of the comparator PPIs. CONCLUSIONS: This analysis shows that the GERD healing effect of vonoprazan is higher than that of rabeprazole (20 mg) but not higher than other PPIs. Subgroup analysis indicated that vonoprazan is more effective than most PPIs for patients with severe erosive esophagitis.

Phytotherapy as an alternative to conventional antimicrobials: combating microbial resistance.

INTRODUCTION: In the modern antimicrobial era, the rapid spread of resistance to antibiotics and introduction of new and mutating viruses is a global concern. Combating antimicrobial resistant microbes (AMR) requires coordinated international efforts that incorporate new conventional antibiotic development as well as development of alternative drugs with antimicrobial activity, management of existing antimicrobials, and rapid detection of AMR pathogens. Areas covered: This manuscript discusses some conventional strategies to control microbial resistance. The main purpose of the manuscript is to present information on specific herbal medicines that may serve as good treatment alternatives to conventional antimicrobials for infections sensitive to conventional as well as resistant strains of microorganisms. Expert commentary: Identification of potential new antimicrobials is challenging; however, one source for potential structurally diverse and complex antimicrobials are natural products. Natural products may have advantages over other post-germ theory antimicrobials. Many antimicrobial herbal medicines possess simultaneous antibacterial, antifungal, antiprotozoal and/or antiviral properties. Herbal products have the potential to boost host resistance to infections, particularly in immunocompromised patients. Antimicrobial broad-spectrum activity in conjunction with immunostimulatory properties may help to prevent microbial resistance to herbal medicine. As part of the efforts to broaden use of herbal medicines to treat microbial infections, pre-clinical and clinical testing guidelines of these compounds as a whole should be implemented to ensure consistency in formulation, efficacy and safety.

Herbal medicines: challenges in the modern world. Part 3. China and Japan.

INTRODUCTION: Medicinal plants, and formulations prepared from them, have been used in China and Japan for thousands of years. Nowadays, ancient formulations of Traditional Chinese and Kampo (Japanese) Medicines coexist with Western herbal medicines (HMs) and complement each other. HMs are used for the treatment of mild and chronic diseases, as an adjunct therapy, to improve wellbeing and delay aging, or as healthy (functional) foods. AREAS COVERED: This article, a third part in a series of reviews, is focusing on history, use and regulation of the traditional and modern HMs in Japan and China. Materials available from legislative and governmental websites, PubMed and news media were used. Expert commentary: HMs are heavily regulated in both countries, often in a similar manner as conventional pharmaceutical drugs. The majority of herbal formulations are sold as over-the-counter medications supplied with leaflets describing indications and appropriate dosages for patients of different ages. Medical practitioners prescribe herbal formulations that are tailored to the needs of particular patients. Both countries had problems with adverse drug reactions and toxicity of single herbs and herbal formulations that have been investigated by authorities, and some drugs have been removed from the market.

Characteristics and practices of Traditional Chinese Medicine retail shops in London, UK: A cross-sectional study using an observational approach.

ETHNOPHARMACOLOGICAL RELEVANCE: Traditional Chinese Medicine (TCM) is a popular form of ethnomedicine in the UK, and is accessed by Western, Chinese and other ethnic groups. The current regulatory regime does not effectively protect the public against poor-quality and unsafe TCMs. Understanding ethnopharmacological information on how TCM is promoted and practiced may help to inform initiatives aimed at ensuring the safe use of TCMs in the UK, and put laboratory-based ethnopharmacological investigations of TCMs in a broader context. AIM OF THE STUDY: This study aimed to examine the characteristics and practices of TCM retail outlets in London, UK, and to identify factors relevant to the safe use of TCM in the UK. MATERIALS AND METHODS: TCM retail outlets ('shops') in London, UK, were identified using a systematic approach. A structured questionnaire including questions on shop business type was used to recruit participant shops. Shops consenting to participate were visited within six weeks of providing consent. A piloted semi-structured questionnaire on shop characteristics was used for data collection following observation. The British National Formulary 53 was used to classify medical conditions/uses for TCMs promoted in the shops. Data were stored and analysed using MS Access 2003, MS Excel 2003 and SPSS 13. RESULTS: In total, 54 TCM shops in London were identified, of which 94% offered TCM consultations with a TCM practitioner. Detailed characteristics were described within 35/50 shops that gave consent to observing their premises. Most shops labelled and displayed over 150 Chinese Materia Medica (CMMs; crude materials, particularly herbs) for dispensing after consultations with a TCM practitioner. Medical conditions/uses and Patent Chinese Medicines (PCMs) were commonly promoted. In total, 794 occurrences of 205 different medical conditions/uses (median=32, QL=19, QU=48) were identified. These conditions/uses most commonly related to the following therapeutic systems: central nervous system (160/794, 20.2%); musculoskeletal and joint disease (133/794, 16.8%); obstetrics, gynaecology, and urinary-tract disorders (122/794, 15.4%); skin (102/794, 12.9%); gastrointestinal system (62/794, 7.8%). Specific conditions/uses that were frequently promoted included eczema (19/23 shops, 82.6%), arthritis (18/23, 78.3%), acne (17/23, 73.9%), obesity/weight loss/slimming (17/23, 73.9%) and psoriasis (17/23, 73.9%). Claimed conditions/uses included some serious medical conditions (e.g. diabetes, cancer and hypertension) and those focusing on vulnerable groups (e.g. children's diseases and pregnancy treatments). CONCLUSIONS: TCM shops in London, UK, typically displayed names of a wide range of medical conditions/uses for TCMs using readily understandable medical terms, implying TCM can be used to prevent or treat these conditions. However, many of these advertisements did not comply with UK regulations on medical claims for herbal medicines. Future studies should explore how these advertisements influence consumers' decisions to access TCM in the UK, practices of TCM shop staff towards the supply of TCMs in the UK, and what are the health implications at the individual and population levels.

Review of the use of defined daily dose concept in drug utilisation research in China.

PURPOSE: This study aimed to understand the characteristics of drug utilisation researches (DURs) using concepts of defined daily dose in China and to provide further suggestion for future DURs in China. METHODS: DURs using concepts of defined daily dose published in China were identified from China Journal Full-text Database, and in-depth data analysis was conducted for DURs published in every even-numbered year. RESULTS: In total, 2,911 DURs published between 1989 and 2009 were identified, of which 1,268 were included for further data analysis. All studies were hospital-based. Types of drugs commonly assessed in DURs were Anti-infectives for systemic use (34.1%), drugs for Nervous system (25.5%) and drugs for Alimentary tract and metabolism (14.3%). In addition, 63 DURs published in even-numbered year focusing on Chinese Herbal Medicine (CHM) were identified. Commonly used sources of defined dose were Xin Bian Yao Wu Xue/New Materia Medica (83.9%), drug information leaflets (66.8%) and Chinese Pharmacopoeia (52.0%). Common indicators used in DURs include defined daily doses (DDDs), drug utilisation index (DUI) and daily dose cost (DDC). CONCLUSION: DUR is a popular method to explore the use of both pharmaceutical drugs and CHM in China. The definition of defined daily dose and its related indicators presented in the DURs were highly varied. From this, it follows that DURs with more consistent methodology are highly needed for a thorough understanding of drug utilisation in China. Apart from DURs focusing on the hospital setting, more DURs from other health settings are needed.