Effectiveness, safety, and economic evaluation of topical application of a herbal ointment, Jaungo, for radiation dermatitis after breast conserving surgery in patients with breast cancer (GREEN study): Study protocol for a randomized controlled trial.

INTRODUCTION: This is a prospective, open-label, parallel-group, randomized controlled trial that evaluates the effectiveness and safety of adjuvant application of Jaungo (JUG) for radiation-induced dermatitis (RD) in breast cancer patients undergoing radiation therapy, in comparison with general supportive care (GSC). METHODS/DESIGN: Eighty female patients, who have been diagnosed with unilateral breast cancer, will be allocated to either the JUG or GSC group with an allocation ratio of 1:1 after breast conservation surgery, in the Kyung Hee University Korean Medicine Hospital, Seoul, Republic of Korea. Both the groups will be subjected to GSC, but only the JUG group participants will apply adjuvant JUG ointment on the irradiated skin for 6 weeks, twice a day. The primary outcome of this study is the assessment of incidence rate of RD using the Radiation Therapy Oncology Group (RTOG) for toxicity gradation of 2 or more. Maximum pain level, quality of life, adverse reactions, and pharmacoeconomic evaluations will also be included. DISCUSSION: The primary outcome will be statistically compared using the logrank test after estimating the survival curve using the Kaplan-Meier method. Continuous variables will be tested using independent t test or Mann-Whitney U test. The adverse events will be evaluated with Chi-square or Fisher exact test. All the data will be analyzed at a significance level of 0.05 (two-sided) with R software (The R Foundation). TRIAL REGISTRATION: CRIS (Clinical Research Information Service), KCT0003506, 14 February 2019.

The prevalence, characteristics, and factors associated with purchasing Chinese herbal medicine among adults in Taiwan.

BACKGROUND: The objective of this study was to investigate the prevalence and factors associated with purchasing Chinese herbal medicine (CHM) without a physician's prescription among adults. METHODS: Using data from the 2005 National Health Interview Survey and National Health Insurance, we identified 16,756 individuals aged 20 years and older. Socio-demographic factors, lifestyle, medical services utilization and health behaviors were compared between people with and without a history of purchasing CHM by calculating adjusted odds ratios (ORs) and 95% confidence intervals (CIs) in a multiple logistic regression analysis. RESULTS: The one-month prevalence of purchasing CHM without a physician' prescription was 5.2% in Taiwan. People more likely to purchase CHM included people aged ≥70 years (OR 2.84, 95% CI 2.03-3.99), women (OR 1.28, 95% CI 1.11-1.48), non-indigenous people (OR 2.61, 95% CI 1.29-5.30), and people with an illness not receiving medical care (OR 2.69, 95% CI 2.19-3.31). CONCLUSION: The prevalence of purchasing CHM without a physician's prescription is high in Taiwan and is correlated with factors such as socio-demographics, disease history, and behaviors surrounding the utilization of medical care.

Individualized perfusion of sargent gloryvine decoction for clinical severe acute pancreatitis treatment.

BACKGROUND/AIMS: To observe the effects of Sargent gloryvine decoction (SGD) on severe acute pancreatitis (SAP) treatment and to evaluate its clinical value. METHODOLOGY: 112 patients of SAP in our hospital from January, 2005 to December, 2012 were recruited for retrospective analysis. They were divided into two groups, SGD group (62 patients) and control group without treated with SGD (50 patients). Inflammation factor, CT grade and Ranson grade were used to estimate the severity of SAP, and were compared in these two groups. In addition, peripancreatic infection, incidence of pseudo pancreatic cyst, time of anal exsufflation and duration of fever were used to evaluate the effect of SGD treatment. After perfusion of SGD for different time, hospitalization days and cost were recorded to evaluate clinical value of SGD. RESULTS: After perfusion, many indexes in SGD were remarkably superior to those of control group, such as duration of fever, incidence of pseudo pancreatic cyst, peripancreatic infection and Ranson grade. Meanwhile, SGD can sharply down-regulate inflammation reaction levels of SAP patients, so that the hospitalization days and costs can be obviously saved. CONCLUSION: According to comparison, perfusion of SGD is a potential candidate for SAP treatment and is valuable in clinical application.

Use of Chinese medicine correlates negatively with the consumption of conventional medicine and medical cost in patients with uterine fibroids: a population-based retrospective cohort study in Taiwan.

BACKGROUND: Chinese medicine is commonly used and covered by health insurance to treat symptoms of uterine fibroids in Taiwan. This retrospective cohort study compared the consumption of conventional western medicine and medical cost between Chinese medicine (CM) users and nonusers among patients with uterine fibroids. METHODS: We extracted 44,122 patients diagnosed with uterine fibrosis between 1996 and 2010 from the National Health Insurance reimbursement database, which is a population-based database released by a government-run health insurance system. Multivariate linear regression models were used to find association between using Chinese medicine and the consumption of conventional medicine, and between using Chinese medicine and medical cost. RESULTS: The total fibroid-related conventional western medicine consumed by CM users was less than that by nonusers (ß = -10.49, P < 0.0001). Three categories of conventional medicines, including antianemics (-3.50 days/year/patient, P < 0.0001), hemostatics (- 1.89 days/year/patient, P < 0.0001), and hormone-related agents (-3.13 days/year/patient, P < 0.0001), were used less in patients who were CM users. Moreover, although using CM increased 16.9 USD per patient in CM users annually (P < 0.0001), the total annual medical cost for treating fibroid was 5610 USD less in CM users than in nonusers (P < 0.0001). CONCLUSIONS: Our results suggested that CM reduced the consumption of conventional medicine, and might be a potential therapeutic substitute for conventional western medicines to treat uterine fibroids with low cost.

Post-marketing safety monitoring of shenqifuzheng injection: a solution made of dangshen (Radix Codonopsis) and huangqi (Radix Astragali Mongolici).

OBJECTIVE: To identify the potential risk factors associated with Shenqifuzheng injection (SFI), a solution made of Dangshen (Radix Codonopsis) and Huangqi (Radix Astragali Mongolici), for the timely provision of information to regulatory authorities. METHODS: A comprehensive analysis of the production process, quality standards, pharmacology, post-marketing clinical studies, and safety evaluation using the primary literature of adverse reactions (ADR), case analyses, and systematic reviews, intensive hospital safety monitoring of post-marketing drugs, and data provided by the hospital information system (HIS). RESULTS: Sub-acute toxicity tests suggesting that a dose of 15 mL/kg (concentrated solution) had specific biological effects, whereas a smaller dose engendered no observable effects. Long-term toxicity testing in domestic rabbits showed that after SFI was administered for 90 days, the animals in each dosing group showed no chronic toxic reactions. Among 20 100 cases observed, the incidence of an ADR was 1.85 per thousand. From March to November 2013, of the leading institutions and 22 sub-centers involved in the post-marketing clinical safety intensive hospital monitoring, 21 units completed 8484 cases of monitoring, and reported 23 cases of adverse reactions. No damage to renal function was found using SFI at a dosage and a treatment course larger and longer than that recommended for the adjuvant treatment of tumors. This could reduce the mortality rate of admitted patients based on the analysis of the data provided by the HIS. A total of 16 clinical case reports of adverse reactions related to SFI in 1999-2012 were obtained through literature retrieval. These reports contained information concerning 17 cases, with adverse reaction symptoms including thrombocytopenia, rash, chills, feeling cold, palpitation, dyspnea, edema of a lower extremity, palpebral edema, and superficial vein inflammation, among others. CONCLUSION: This study introduces "get full access" to the flow of information on medicines regarding their ADR incidence rate and characteristics and factors. It supports the safety of SFI for clinical, research,and production uses based on objective, reliable, and scientific information to provide safe medication.

Co-administration of Wuzhi capsules and tacrolimus in patients with idiopathic membranous nephropathy: clinical efficacy and pharmacoeconomics.

PURPOSE: Tacrolimus is an effective (but relatively expensive) immunosuppressant that is used widely in patients with membranous nephropathy. To reduce the tacrolimus dose while maintaining an equivalent therapeutic effect, we studied the clinical efficacy and pharmacoeconomic impact of co-administration of Wuzhi capsules (WZC that protects against damage to liver cells) and tacrolimus. METHODS: Sixty patients with membranous nephropathy were divided randomly into two groups: experimental (tacrolimus + WZC + corticosteroids) and control (tacrolimus + corticosteroids). Each group received treatments continuously for >6 months. Liver function; renal function; and whole-blood concentrations of tacrolimus, sugars, lipids, as well as 24-h urinary protein levels were used in the clinical evaluation. The cost of drugs was calculated, and the pharmacoeconomic cost-effectiveness analyses were carried out to compare indices between the two groups. RESULTS: Doses and costs of tacrolimus differed significantly between experimental and control groups (p < 0.01 or p < 0.05). Costs in the experimental group were 13,702.62 ± 1,458.6 CNY (2,194.10 ± 233.56 USD) and those in the control group were 17,796.87 ± 2,469.27 CNY (2,849.69 ± 395.39 USD), with clinical efficacy of 93.3 and 90.0 %, respectively. The cost-effectiveness ratios were 146.86 ± 15.63 and 197.73 ± 27.44, respectively. Compared with the experimental group, the control group showed an incremental cost-effectiveness ratio of 1,240.68 ± 306.25 CNY (198.66 ± 49.04 USD), whereas remission between the two groups was similar. CONCLUSION: Co-administration of WZCs and tacrolimus can reduce the dose of tacrolimus and decrease the costs incurred by patients within the same therapeutic window to that seen for treatment with tacrolimus alone.

Investigation of targeted pyrrolizidine alkaloids in traditional Chinese medicines and selected herbal teas sourced in Ireland using LC-ESI-MS/MS.

Publications linking hepatotoxicity to the use of herbal preparations are escalating. Herbal teas, traditional Chinese medicines (TCMs) and dietary supplements have been shown to contain pyrrolizidine alkaloids (PAs). Acute PA toxicosis of the liver can result in sinusoidal-obstruction syndrome, also known as veno-occlusive disease (VOD). This paper describes a sensitive and robust method for the detection of targeted PAs and their N-oxides (PANOs) in herbal products (selected herbal teas and TCMs) sourced within Ireland. The sample preparation includes a simple acidic extraction with clean-up via solid-phase extraction (SPE). Sample extracts were accurately analysed by using LC-ESI-MS/MS applying for the first time a pentafluorophenyl (PFP) core-shell column to the chromatographic separation of PAs and PANOs. The method was validated for selectivity, taking into consideration matrix effects, specificity, linearity, precision and trueness. Limits of detection (LOD) and limits of quantitation (LOQ) were quantified for all PAs and PANOs ranging from 0.4 to 1.9 µg kg⁻¹ and from 1.3 to 6.3 µg kg⁻¹, respectively. In this study 10 PAs and four PANOs were targeted because they are commercially available as reference standards. Therefore, this study can only report the levels of these PAs and PANOs analysed in the herbal teas and TCMs. The results reported represent the minimum levels of PAs and PANOs present in the samples analysed; commercially available herbal teas (n = 18) and TCMs (n = 54). A total of 50% herbal teas and 78% Chinese medicines tested positive for one or more PAs and/or PANOs included within this study, ranging from 10 to 1733 and from 13 to 3668 µg kg⁻¹, respectively.

Quantification of aristolochic acids I and II in herbal dietary supplements by ultra-high-performance liquid chromatography-multistage fragmentation mass spectrometry.

A rapid, selective and sensitive ultra-high-performance liquid chromatography-multistage fragmentation mass spectrometry (UHPLC-MS³) method was developed and evaluated for the determination of aristolochic acids I and II (AA I and II) in herbal dietary supplements. A hybrid triple quadrupole/linear ion-trap mass spectrometry was used to monitor MS³ ion transitions m/z 359.2 > 298.1 > 268.0 and m/z 329.2 > 268.2 > 238.0 to detect AA I and II, respectively. The extraction and clean-up of target analytes from dry powdered samples was performed using the quick, easy, cheap, effective, rugged and safe (QuEChERS) procedure. Herbal liquid extracts were analysed directly. Average recoveries ranged from 89% to 112%, with relative standard deviations (RSDs) ranging from 3% to 16%. Limits of quantification (LOQs) estimated for three selected matrices were as follows (AA I/II): 5/10 ng g⁻¹ (tablets); 25/50 ng g⁻¹ (capsules); and 2.5/5.0 ng ml⁻¹ (liquid herbal extract). The method was applied in a limited survey of 30 herbal products marketed in the United States via the Internet. AA I and II were detected in 20% and 7%, respectively, of tested samples.

[Dynamic monitoring risk of anti-hepatoma new drug development].

Risk monitoring of new Chinese patent anti-hepatoma drugs is tracking recognized risks and residual risks, identifying emerging risk and ensure the implementation of the plan, estimating the process of reducing effectiveness. The paper is mainly through understanding the status of Chinese patent anti-hepatoma drugs, the content, characteristic and analysis method of dynamic risk monitoring, and then select the risk control indicators, collect risk information. Finally, puts forward the thought of anti-hepatoma drugs listed evaluation in our country, and try to establish the model of dynamic risk management of anti-hepatoma drugs.

[Cost analysis of Shenqi Fuzheng injection on reducing adverse effects during chemotherapy].

OBJECTIVE: The goals of this work was to analyse the cost of Shenqi Fuzheng injection-an extraction of a Chinese traditional herbs on reducing adverse effects in lung cancer patients during chemotherapy. METHODS: In a randomized cross-over trial, each patient completed two identical cisplatin-based chemotherapy cycles, one with Shenqi Fuzheng injection, another without Shenqi Fuzheng injection. Adverse effects and change scores of quality of life (QOL) during chemotherapy were compared in tow cycles. The direct cost dealing with adverse effect and cost-effectiveness analysis were taken. RESULTS: One hundred and thirty were enrolled with 123 of whom were evaluable. The patient characteristics were well balanced between the two groups. The chemotherapy cycles with Shenqi Fuzheng injection spent 220.5 more Chinese yuan, but the adverse effect of leukopenia, thrombocytopenia and vomiting were slight different and the change of score of several QOL domains showed significant better as compared to those in another cycle. CONCLUSION: Shenqi Fuzheng injection could reduce the severity of toxicity related to chemotherapy and improve the QOL of patients and had some benefits in terms of cost-effectiveness.