Influencing factors of hospitalization cost of hypertension patients in traditional Chinese medicine hospitals.

Objectives: This study aimed to analyze the influencing factors of hospitalization cost of hypertensive patients in TCM (traditional Chinese medicine, TCM) hospitals, which can provide a scientific basis for hospitals to control the hospitalization cost of hypertension. Methods: In this study, 3,595 hospitalized patients with a primary diagnosis of tertiary hypertension in Tianshui City Hospital of TCM, Gansu Province, China, from January 2017 to June 2022, were used as research subjects. Using univariate analysis to identify the relevant variables of hospitalization cost, followed by incorporating the statistically significant variables of univariate analysis as independent variables in multiple linear regression analysis, and establishing the path model based on the results of the multiple linear regression finally, to explore the factors influencing hospitalization cost comprehensively. Results: The results showed that hospitalization cost of hypertension patients were mainly influenced by length of stay, age, admission pathways, payment methods of medical insurance, and visit times, with length of stay being the most critical factor. Conclusion: The Chinese government should actively exert the characteristics and advantages of TCM in the treatment of chronic diseases such as hypertension, consistently optimize the treatment plans of TCM, effectively reduce the length of stay and steadily improve the health literacy level of patients, to alleviate the illnesses pain and reduce the economic burden of patients.

Analysis of factors influencing hospitalization cost of patients with distal radius fractures: an empirical study based on public traditional Chinese medicine hospitals in two cities, China.

BACKGROUND: Distal radius fractures (DRFs) have become a public health problem for all countries, bringing a heavier economic burden of disease globally, with China's disease economic burden being even more acute due to the trend of an aging population. This study aimed to explore the influencing factors of hospitalization cost of patients with DRFs in traditional Chinese medicine (TCMa) hospitals to provide a scientific basis for controlling hospitalization cost. METHODS: With 1306 cases of DRFs patients hospitalized in 15 public TCMa hospitals in two cities of Gansu Province in China from January 2017 to 2022 as the study object, the influencing factors of hospitalization cost were studied in depth gradually through univariate analysis, multiple linear regression, and path model. RESULTS: Hospitalization cost of patients with DRFs is mainly affected by the length of stay, surgery and operation, hospital levels, payment methods of medical insurance, use of TCMa preparations, complications and comorbidities, and clinical pathways. The length of stay is the most critical factor influencing the hospitalization cost, and the longer the length of stay, the higher the hospitalization cost. CONCLUSIONS: TCMa hospitals should actively take advantage of TCMb diagnostic modalities and therapeutic methods to ensure the efficacy of treatment and effectively reduce the length of stay at the same time, to lower hospitalization cost. It is also necessary to further deepen the reform of the medical insurance payment methods and strengthen the construction of the hierarchical diagnosis and treatment system, to make the patients receive reasonable reimbursement for medical expenses, thus effectively alleviating the economic burden of the disease in the patients with DRFs.

Evaluation of quality of pharmacoeconomic studies involved in traditional Chinese medicine in China.

OBJECTIVES: The pharmacoeconomic studies of traditional Chinese medicine (TCM) are still in its infancy. Assessing the quality of pharmacoeconomic studies of TCM to improve the efficiency of health resource allocation and guide the rational use of medicine. METHODS: Four databases were searched from inception to January 2018. The Consolidated Health Economic Evaluation Reporting Standards statement (CHEERS) and the Quality of Health Economic Studies (QHES) were used to assess the reporting quality and methodological quality. STATA 12.0 and Meta analyst 3.13 were used to analyze the related data. RESULTS: A total of 178 studies were included. The methodological evaluation of the study found that the total score of QHES was 47.85 ± 8.09. The report quality evaluation results found that many studies did not report comprehensive information, such as lack of detailed reports on abstracts, study perspectives, time frames, discount rates, model selection, but the titles, study background and location, and health results, resource and cost estimates, analysis methods, and heterogeneity analysis are reported in more detail. Six of the ten stratification factors have statistically significant differences. CONCLUSION: The overall quality of pharmacoeconomic studies of TCM is low, and further standardization and improvement are needed to obtain reliable study results.

Different impacts of the zero-markup drug policy on county general and traditional Chinese medicine hospitals: evidence from Shandong province, China.

BACKGROUND: As a key part of the new round of health reform, the zero-markup drug policy (ZMDP) removed the profit margins of drug sales at public health care facilities, and had some effects to the operation of these institutions. This study aims to assess whether the ZMDP has different impacts between county general and traditional Chinese medicine (TCM) hospitals. METHODS: We obtained longitudinal data from all county general and TCM hospitals of Shandong province in 2007-2017. We used difference-in-difference (DID) method to identify the overall and dynamic effects of the ZMDP. RESULTS: On average, after the implementation of the ZMDP, the share of revenue from medicine sales reduced by 16.47 and 10.42%, the revenue from medicine sales reduced by 24.04 and 11.58%, in county general and TCM hospitals, respectively. The gross revenue reduced by 5.07% in county general hospitals. The number of annual outpatient visits reduced by 11.22% in county TCM hospitals. Government subsidies increased by 199.22 and 89.3% in county general and TCM hospitals, respectively. The ZMDP reform was not significantly associated with the revenue and expenditure surplus, the number of annual outpatient visits and the number of annual inpatient visits in county general hospitals, the gross revenue, the revenue and expenditure surplus and the number of annual inpatient visits in county TCM hospitals. In terms of dynamic effects, the share of revenue from medicine sales, revenue from medicine sales, and gross revenue decreased by 20.20, 32.58 and 6.08% respectively, and up to 28.53, 63.89 and 17.94% after adoption, while government subsidies increased by around 170 to 200% in county general hospitals. The number of annual outpatient visits decreased by 9.70% and up to 18.84% in county TCM hospitals. CONCLUSION: The ZMDP achieved its some initial goals of removing the profits from western medicines in county hospitals' revenue without disrupting the normal operation, and had different impacts between county general and TCM hospitals. Meanwhile, some unintended consequences were also recognized through the analysis, such as the decline of the utilization of the TCM.

Cost-effectiveness analysis of combining traditional Chinese medicine in the treatment of hypertension: compound Apocynum tablets combined with Nifedipine sustained-release tablets vs Nifedipine sustained-release tablets alone.

BACKGROUND: We evaluated the long-term cost-effectiveness of antihypertensive traditional Chinese medicines (TCMs) and to compare the cost-effectiveness of a combined treatment consisting of compound Apocynum tablets and Nifedipine sustained-release tablets with the cost-effectiveness of treatment with Nifedipine sustained-release tablets alone. METHODS: A Markov model was used to simulate the potential incremental cost-effectiveness per quality-adjusted life year (QALY) to be gained from compound Apocynum tablets and Nifedipine sustained-release tablets compared with Nifedipine sustained-release tablets alone. Model parameter estimates were informed by previously published studies. The direct medical costs of outpatients with hypertension were estimated from the health care provider's perspective. A 5% annual discount rate was applied to both costs and QALYs. RESULTS: TCMs combined with Nifedipine sustained-release tablets group generated a total 20-year cost of 11,517.94 RMB (US $1739.87), whereas Nifedipine sustained-release tablets alone group resulted in a 20-year cost of 7253.71 RMB (US $1095.73). TCMs combined with Nifedipine sustained-release tablets group resulted in a generation of 12.69 QALYs, whereas Nifedipine sustained-release tablets alone group resulted in 12.50. The incremental cost-utility ratio was 22,443.32 RMB (US $3390.23) per QALY. Considering the threshold of 1 GDP per capita in China in 2018 (US $9764.95), the combination of compound Apocynum tablets and Nifedipine sustained-release tablets was a cost-effective strategy. One-way and probabilistic sensitivity analysis showed unchanged results over an acceptable range. CONCLUSIONS: Combining Traditional Chinese Medicines with chemical medicines is more cost-effective strategy in the treatment of hypertension.

Comparative efficacy, safety and cost of oral Chinese patent medicines for rheumatoid arthritis: a Bayesian network meta-analysis.

BACKGROUND: Rheumatoid arthritis (RA) is a common inflammatory disease with a substantial burden for society and economic worldwide. Chinese patent medicines (CPMs) have gained attention as alternative remedies due to they can exert the satisfactory therapeutic effects via holistic regulation. Currently, several oral Chinese patent medicines are routinely recommended for managing and treating RA. Therefore, a network meta-analysis (NMA), which tries to synthesize evidences for a decision making by evaluating the comparative effectiveness of multiple interventions against the same disease, was undertaken to identify the optimal intervention according to their efficacy in clinical treatment and symptom remission, safety profile and daily cost. METHODS: Randomized controlled trials (RCTs) regarding CPMs to treat RA were comprehensive retrieved from 3 foreign databases and 4 Chinese databases, and the retrieved results were last updated on January 10, 2019. The bias of the selected trials was assessed by two individuals independently through RoB2. A random-effects model was adopted during the meta-analytic procedures, and outcomes concerning efficacy and safety were evaluated as odds ratios (OR), mean differences (MD) and 95% credible intervals (CI) utilizing Stata 14.1 and WinBUGS 1.4.3 software. Furthermore, the cluster analysis and comprehensive investigation were preformed concerning the comparative efficacy, safety and cost of oral CPMs. RESULTS: One hundred sixteen RCTs involving 10,213 individuals met the inclusion criteria and were enrolled into current NMA. The results from existing evidence indicated that Biqi capsule and Yuxuebi capsule probably had a favorable balance in consideration of benefits, tolerability and daily cost. Furthermore, as the least expensive choice, glucosides of Tripterygium Wilfordii tablet was associated with displaying a trend of relieving joint tenderness, joint swelling, and morning stiffness for patients with RA. CONCLUSION: Biqi capsule, Yuxuebi capsule and glucosides of Tripterygium Wilfordii tablet were recommended for treating RA based on the favorable benefits in both clinical efficacy and symptoms, and they, meanwhile, might be associated with the more tolerable and acceptable therapeutic alternative in terms of safety profile and daily cost. Nevertheless, the additional results from high-quality, multi-center and head-to-head trials would be pivotal for supporting our findings.

[Analysis of projects funded by NSFC in field of pharmacology of traditional Chinese medicine in 2019].

The projects which supported by National Natural Science Foundation of China(NSFC) including General Program, Young Scientist Fund, and Fund for Less Developed Regions, in field of pharmacology of traditional Chinese medicine in 2019 were reviewed. Based on these research items, the main contents and characteristics, as well as the main problems from academic and non-academic point of view, were summarized for reference.

Regional disparities in health care resources in traditional Chinese medicine county hospitals in China.

OBJECTIVE: We aimed to analyze regional disparities of health care resources in traditional Chinese medicine (TCM) county hospitals and their time trends, and to assess the changes of regional disparities before and after 2009 health care reforms. METHODS: We used hospital-based, longitudinal data from all TCM county hospitals in China between 2004 and 2016. To measure the key development features of TCM county hospitals, data were collected on government hospital investment, hospital numbers (the average number of TCM hospitals per county), hospital scale (the number of medical staff and hospital beds) and doctors' workload (the daily visits and inpatient stays per doctor). We used segmented linear regression to test the time trend for outcome variables. We set a breakpoint at 2011, dividing the pre-reform (2004-2011) and post-reform (2012-2016) periods. RESULTS: After the 2009 health reforms, TCM hospitals continued to display large disparities in the number, scale, and doctors' workload across the three regions. In the pre-reform period, yearly government subsidies for TCM hospitals in western area were roughly RMB0.6 million (US$89 thousand) more than those in central and eastern region, which increased under the 2009 reforms to roughly RMB2 million (US$298 thousand) more per yer in post-reform period. These increased subsidies saw an increase in the number of TCM hospitals in the western area, partly addressing regional disparities. But there was no improvement in the regional disparities in terms of scale (number of beds) and the doctors' workload (daily outpatient visits and inpatients per doctor) increased or remained unchanged between the western and other regions. CONCLUSION: Although TCM hospital number, scale, and doctors' workload increased over the past 13 years, substantial regional disparities remained. The 2009 health reforms did not significantly change the regional disparities in health care resources, especially between the eastern and western regions.

There "ain't no mountain high enough"?: The drivers, diversity and sustainability of China's Rhodiola trade.

ETHNOPHARMACOLOGICAL RELEVANCE: Across Asia, Rhodiola species have been used in Bhutanese, Mongolian, Nepalese, Kazakh, Kyrgyz and Uzbek traditional medical systems. China is globally significant in terms of Rhodiola species diversity, with over 60% (55 species) of the world's 90 Rhodiola species, including 16 species found nowhere else in the world. Since the late 1980's there has been a shift from relatively low demand for infusions using chopped dried Rhodiola roots, to high 21st century demand for a wide variety of processed products. China's trade in Rhodiola products is now very diverse, with use in cosmetics and foods in addition to herbal products. Rhodiola crenulata (Hook.f. & Thomson) H.Ohba is the most widely traded species in China. In addition to R. crenulata and Rhodiola rosea L., 19 Rhodiola other species are used. AIMS OF THE STUDY: These were to: (i) better understand why adulteration occurs in Rhodiola products; (ii) become more aware of what drives the growing market demand for Rhodiola products in China; (iii) find out whether increased demand is reflected in wholesale prices for Rhodiola raw materials traditional medicine markets; (iv) to examine Rhodiola supply chains and (v) given that wild populations are the primary supply source, to review the implications of growing demand for conservation and sustainable use. MATERIALS AND METHODS: Firstly, we assessed growth in the diversity of Rhodiola products using three approaches: (i) by assessing patent applications for Rhodiola products in China (1990-2019); (ii) in 2018, through on-line searches of CFDA (China Food and Drug Administration) records for medicines and dietary supplements that had Rhodiola as an ingredient and (iii) by visiting retail stores in 2018 and 2019 to assess the diversity of commercial Rhodiola based products in trade. Secondly, we visited traditional medicine markets in Yunnan, Sichuan, and Qinghai provinces to investigate the trade in Rhodiola (folk taxonomy, trade names, prices, source areas, levels of processing and grading). Thirdly, we analysed the wholesale price data for Rhodiola raw materials in trade over a 16-year period (2002-2018). Fourthly, as most products come from wild collected Rhodiola species, we documented the extent of Rhodiola cultivation in China. RESULTS: International exports of Rhodiola products from China, particularly extracts, is a major driver of commercial trade. One proxy indicator of Rhodiola product diversification in China has been the rapid rise in patent applications from single applications in 1990 and 1991, to a peak of 1017 patent applications in 2015. Wholesale price data from 2002 to 2018 shows a steady increase in wholesale prices. As the growing market for Rhodiola products in China is currently supplied entirely from wild collection, there are justifiable concerns about sustainability. Commercial cultivation needs to expand to meet future demand. CONCLUSIONS: In contrast to Europe and North America, where R. rosea is the focal species in commerce, the trade in Rhodiola products in China is much more diverse. In the face of growing demand, both effective conservation of wild populations and cultivation are needed.

Analysis of projects funded by NSFC in field of pharmacology of traditional Chinese medicine in 2019 / 中国中药杂志

The projects which supported by National Natural Science Foundation of China(NSFC) including General Program, Young Scientist Fund, and Fund for Less Developed Regions, in field of pharmacology of traditional Chinese medicine in 2019 were reviewed. Based on these research items, the main contents and characteristics, as well as the main problems from academic and non-academic point of view, were summarized for reference.

Saiga horn user characteristics, motivations, and purchasing behaviour in Singapore.

Unsustainable wildlife trade is a pervasive issue affecting wildlife globally. To address this issue, a plethora of demand reduction efforts have been carried out. These necessitate consumer research which provides crucial knowledge for designing and evaluating targeted interventions. We implemented a rigorous consumer survey on saiga (Saiga tatarica) horn use in Singapore, where usage is legal and widely sold. Saiga are Critically Endangered antelopes from Central Asia with horns (often marketed as ling yang) used in traditional Chinese medicine (TCM). Few past studies have assessed saiga horn consumers. This work is the most extensive consumer research to date specifically characterising saiga horn consumers and usage. We conducted 2294 in-person surveys on saiga horn use with Chinese Singaporeans, employing neutral questioning approaches. We found 19% of individuals reported saiga horn as a product they choose most often for themselves and/or others when treating fever and/or heatiness (a TCM state of illness), indicating a minimum estimate of high-frequency usage, not including possible low-frequency users. Overall saiga users were most characterised as middle-aged Buddhists and Taoists. However, saiga users were found in a range of demographic groups. Women preferred saiga shavings (the more traditional form), while men preferred saiga cooling water (the more modern form). About 53% of individuals who used saiga horn themselves also bought it for someone else. Buyers for others were most likely to be female middle-aged Buddhists or Taoists. Key motivating reasons for usage were "it works" and "someone recommended it to me." The top two reported recommenders were family and TCM shopkeepers. Saiga users were more likely than non-saiga users to perceive saiga as a common species in the wild. This research holds significance for interventions targeting saiga horn consumption within Singapore and throughout Asia, by identifying potential target audiences, product types, non-desirable alternatives, and motivations for use.

"The biggest reform to China's health system": did the zero-markup drug policy achieve its goal at traditional Chinese medicines county hospitals?

The zero-markup drug policy (ZMDP) was heralded as the biggest reform to China's modern health system. However, there have been a very limited number of investigations of the ZMDP at county hospital level, and those limited county hospital studies have several limitations in terms of sample representativeness and study design. We investigated the overall and dynamic effects of ZMDP at traditional Chinese medicine (TCM) county hospitals. We obtained longitudinal data from all TCM county hospitals in 2004-16 and the implementation year of ZMDP for each hospital. We used differences-in-difference methods to identify the overall and dynamic effects of ZMDP. On average, the ZMDP reform was associated with the reduction in the share of revenue from drug sales (3.1%), revenue from western medicines sales (12.7%), revenue from medical care services (3.6%) and gross hospital revenue (3.4%), as well as increased government subsidies (24.4%). The ZMDP reform was not significantly associated with the number of annual outpatient and inpatient visits. In terms of dynamic effects, the share of revenue from drug sales decreased by 2.5% in the implementation year and by about 5% in the subsequent years. Revenue from western medicine sales fell substantially in the short term and continued to drop in the long term. Government subsidies went up strikingly in the short term and long term, and revenue from medical care services and gross revenue decreased only in the implementation year. The ZMDP achieved its stated goal through reducing the share of revenue from drug sales without disrupting the availability of healthcare services at TCM county hospitals. The success of ZMDP was mainly due to the huge growth in the government's financial investment in TCM hospitals.

Single-Center Analysis of the Potential Inappropriate Use of Intravenous Medications in Hospitalized Patients in China.

This study categorizes the types of inappropriate intravenous prescriptions in hospitalized patients in China. Prescription data from 2016 were retrospectively analyzed based on predefined categories of inappropriateness. Of the 123,521 patients included, 89.2% received intravenous medications, contributing to 80% of the patients' hospital medication costs. Of significant concern, antibiotics and traditional Chinese medicines were administered to 44.3% and 14.5% of hospitalized patients, respectively. Overall, 11.4% of all intravenous prescriptions were classified as inappropriate, with improper diluent and diluent volumes being the primary cause. A team-based collaborative approach is necessary to address this widespread issue in China.

[Research on competitiveness of traditional Chinese medicine industry's international trade based on diamond theory].

China has a long history of the international trade of traditional Chinese medicine(TCM).And the export products mainly composed of Chinese herbal medicine and its extracts with Chinese patent herbal medicine and health care products as complementary items.The international trade of TCM faces problems of structural disequilibrium in export products and trade barriers.In this study,we used Michael Porter's diamond model to analyze the international competitiveness of TCM industry.We found that TCM industry in China was rich in production factors and broad in market demands,but lack of the related and supporting industries.In addition,compared with the herbal medicine manufacturers in European,American and Japanese,enterprises in China were weaker in the strategy making,market positioning and industry competing.The development of the international market of herbal medicine,the arrival of the aging society,and the introduced policies of the TCM,provide great opportunities for TCM industry' s development.In order to improve the competitiveness of the TCM industry,we propose to increase the international recognition of TCM by developing clinical study,cope with international trade barrier by strengthen international standardization research,and improve the competitiveness of TCM industry by economies of scale formed by the accumulation of the pharmaceutical industry.

Traditional Chinese medicine (TCM) collaborative care for patients with axial spondyloarthritis (AcuSpA): protocol for a pragmatic randomized controlled trial.

BACKGROUND: Axial spondyloarthritis (AxSpA) is a chronic disease which results in fatigue, pain, and reduced quality of life (QoL). Traditional Chinese medicine (TCM), especially acupuncture, has shown promise in managing pain. Although a TCM collaborative model of care (TCMCMC) has been studied in cancer, there are no randomized controlled trials investigating TCM in AxSpA. Therefore, we will conduct a pragmatic trial to determine the clinical effectiveness, safety, and cost-effectiveness of TCMCMC for patients with AxSpA. We define TCMCMC as standard TCM history taking and physical examination, acupuncture, and TCM non-pharmacological advice and communications with rheumatologists in addition to usual rheumatologic care. The purpose of this paper is to describe the rationale for and methodology of this trial. METHODS/DESIGN: This pragmatic randomized controlled trial will recruit 160 patients who are diagnosed with AxSpA and have inadequate response to non-steroidal anti-inflammatory drugs (NSAIDs). Simple randomization to usual rheumatologic care or the intervention (TCMCMC) with a 1:1 allocation ratio will be used. Ten 30-min acupuncture sessions will be provided to patients assigned to the TCMCMC arm. All participants will continue to receive usual rheumatologic care. The primary endpoint - spinal pain - will be evaluated at week 6. Secondary endpoints include clinical, quality of life, and economic outcome measures. Patients will be followed up for up to 52 weeks, and adverse events will be documented. DISCUSSION: This trial may provide evidence regarding the clinical effectiveness, safety, and cost-effectiveness of a TCMCMC for patients with AxSpA. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03420404 . Registered on 14 February 2018.

Linking resource supplies and price drivers: Lessons from Traditional Chinese Medicine (TCM) price volatility and change, 2002-2017.

ETHNOPHARMACOLOGICAL RELEVANCE: Worldwide, one of the drivers of substitution and adulteration is the cost of the natural resources (plants, animals, fungi) that are ingredients of traditional medicines. Relatively few studies have been done that link prices of traditional medicine ingredients to what drives changes in price, yet this is an important topic. Theoretically, prices have been widely considered as an economic indicator of resource scarcity. Rare, slow growing medicinal plants sell for high prices and common, less popular species for low prices. Price levels also influence the viability of farming vs. wild harvest (and incentives to overharvest high value species when tenure is weak). Prices can also influence the harvesting or buying behaviour of harvesters, traders or manufacturers. When prices are high, then there is a greater incentive to use cheaper substitute species or adulterants. As previous studies on herbal medicine ingredients have shown, adulteration applies in a wide variety of cases, including to some Traditional Chinese Medicine (TCM) species. AIM OF THE STUDY: The aim of this study was to gain a better understanding of which factors influenced changes in the market prices of document prices for four popular, but very different traditional Chinese medicine (TCM) species (2002 - 2017). MATERIALS AND METHODS: Fluctuations in market prices were followed over a 15-year period (2002-2017) for four very different TCM ingredients: two plant species (one wild harvested for fruits (Schisandra sphenanthera Rehder & E.H. Wilson) the other in a transition from wild harvest to cultivation (Paris polyphylla Smith), an animal species (the Tokay gecko (Gekko gecko L.)) and the entomophagous "caterpillar fungus" (Ophiocordyceps sinensis (Berk). G.H. Sung, J.M. Sung, Hywel-Jones & Spatafora). RESULTS: High prices of medicinal plants are widely considered to reflect resource scarcity. Real-time market prices for three of the four very different TCM species we studied all showed major price fluctuations. The exception was P. polyphylla, whose wild populations are widely known to be increasingly scarce, where there was a steady increase in price, with few fluctuations in the upward price trend. The three other species showed significant price fluctuations. These were driven by multiple factors. Ecological and biogeographic factors that influence abundance or scarcity of supply certainly played a role. But other factors were also influential. These included both national and global economic factors (the influence of the Global Financial Crisis (GFC)), national policy changes that in turn influenced businessmen giving expensive gifts (that included O. sinensis)), climate change (influencing fruiting success of S. sphenanthera), price speculation by traders and lack of information (e.g: reduction in G. gecko prices due to traders incorrectly believing that domestication would increase supplies). CONCLUSIONS: Price fluctuations in the four TCM species we examined are influenced by many factors and not just resource scarcity. And the situation is more complex than the trajectory based on Homma's (1992) model, where he predicted that higher prices would result in a shift to cultivation, thus replacing wild harvest. In case of both O. sinensis and P. polyphylla, Homma (1992, 1996) was right in terms of scarcity and high prices stimulating a major investment in cultivation (P. polyphylla) and artificial production (O. sinensis). But in both cases, intensive production through cultivation or artificial propagation do not yet occur on a large enough scale to reduce harvest of wild stocks. Substitution and adulteration occur with all four species. Improving information to medicinal plant traders on the supply status of TCM stocks, whether from wild harvest or from cultivation could benefit product quality, cultivation initiatives and conservation efforts.

Improve the ethical review of clinical trials on traditional medicine: A cross-sectional study of clinical trial registration, ethical review, and informed consent in clinical trials of Traditional Chinese Medicine.

Recently, there is an increasing number of clinical trials on Traditional Chinese medicine (TCM) published, but the implementation of Clinical Trial Registration (CTR), Ethical Review (ER), and Informed Consent (IC) in clinical trials of TCM is unclear. This study aims to investigate the status of CTR, ER, and IC in clinical trials of TCM.Clinical trials of TCM published in 10 high-quality Chinese journals in 2016 were selected as a sample. Information of clinical trial registration, ethical review, and informed consent of clinical trials was extracted for analysis. Two authors independently screened the literature and extracted the relevant information.A total of 659 clinical trials met the criteria and were included for analysis. Only 9 clinical trials reported information of clinical trial registration (1.4%). The number for ethical review and informed consent were 156 (23.7%) and 502 (76.2%).Trial registration, protocol approval, and informed consent were not well executed. Especially registration and ethical review of clinical trials in TCM should be carefully concerned by researchers, clinicians, and journal editors. Training on methodology of clinical trial should be strengthened.

Efficacy, Safety, and Cost of Therapy of the Traditional Chinese Medicine, Catalpol, in Patients Following Surgical Resection for Locally Advanced Colon Cancer.

BACKGROUND The aim of this study was to evaluate the efficacy, safety, and cost of treatment of the traditional Chinese herbal medicine, catalpol, in patients following surgical resection for locally advanced colon cancer. MATERIAL AND METHODS The 345 patients who had undergone surgical resection for locally advanced colon adenocarcinoma, were divided into three groups: a placebo-treated group (n=115); patients treated with an intraperitoneal injection of 10 mg/kg catalpol twice a day for 12 weeks (treatment group) (n=115); patients treated with 5 mg/kg intravenous bevacizumab twice a week for 12 weeks (control group) (n=115). Serum levels of carbohydrate antigen 19-9 (CA 19-9), carcinoembryonic antigen (CEA), matrix metalloproteinases-2 (MMP-2), and matrix metalloproteinases-9 (MMP-9) were measured. Patient overall survival (OS), cancer-free survival (CFS), adverse effects, and cost of therapy were evaluated. Statistical analysis included the Wilcoxon rank sum test and Tukey's test for clinicopathological response at 95% confidence interval (CI). RESULTS Patients in the catalpol-treated group had significantly reduced serum levels of CA 19-9 (p=0.0002, q=3.202), CEA (p=0.0002, q=3.007), MMP-2 (p£0.0001, q=6.883), and MMP-9 (p<0.0001, q=3.347). Only non-fatal adverse effects occurred in the catalpol treatment group (p<0.0001, q=5.375). OS and CFS were significantly increased in the catalpol treatment group compared with the placebo group (p<0.0001 q=7.586). The cost of catalpol treatment compared favorably with other treatments (p<0.0001, q=207.17). CONCLUSIONS In this preliminary study, treatment with the Chinese herbal medicine, catalpol, showed benefits in clinical outcome, at low cost, and with no serious complications.

Treatment patterns and healthcare resource utilization and costs in heavy menstrual bleeding: a Japanese claims database analysis.

AIMS: Heavy menstrual bleeding (HMB) is a highly prevalent condition, characterized by excessive menstrual blood loss and cramping, that interferes with activities of daily life. The aim of this study was to investigate treatment patterns in HMB in Japan, and to assess healthcare resource utilization and costs among women newly-diagnosed with the condition. MATERIALS AND METHODS: This study retrospectively analyzed health insurance data available in the Japan Medical Data Center (JMDC) database on women aged 18-49 years who were newly-diagnosed with primary or secondary HMB. Treatment patterns were analyzed, and healthcare utilization and costs were evaluated and compared to matched controls. RESULTS: The study included a total of 635 patients, 210 with primary HMB and 425 with secondary HMB. In the primary HMB cohort, 60.0% of patients received one or more pharmacological or surgical treatments, compared with 76.2% in the secondary HMB cohort. The most commonly prescribed medications in all patients were hemostatic agents (28.7%), traditional Chinese medicine (TCM) (12.1%), and low-dose estrogen progestins (LEPs) (10.1%). After adjustment for patient baseline characteristics, healthcare costs were 1.93-times higher in primary HMB cases (p < .0001) and 4.44-times higher in secondary HMB cases (p < .0001) vs healthy controls. Outpatient care was the main cost driver. LIMITATIONS: The main limitations of this study are related to its retrospective nature, and the fact that only reimbursed medications were captured in the source database. CONCLUSIONS: A substantial proportion of HMB patients did not receive the recommended treatments. Healthcare costs were considerably increased in the presence of an HMB diagnosis.