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.

Quantitative assessment of preventive behaviors in France during the Fukushima nuclear crisis.

BACKGROUND: The Fukushima nuclear disaster has generated worldwide concern on the risk of exposure to nuclear radiations. In Europe, health authorities had to issue statements about the lack of usefulness of iodine based preventive treatments within their borders. However a lack of confidence in official messages has developed in various European countries due to recent perceived failures in managing public health crises. The lay population preventive behaviors in this context are largely unknown. Consequently, to examine the effects of public health crisis on lay behaviors leading to pharmaceuticals purchases, we studied the sales of iodine-based products in France before, during and after the crisis. METHODS: We focused our study on 58 iodine-based drugs available with and without a physician prescription. Our data came from a stratified sample of 3004 pharmacies in metropolitan France. Our study period was from January 2010 to April 2012, with a focus on March-April 2011. We differentiated sales of drugs prescribed by physicians from sales of drugs obtained without a prescription. We used a CUSUM method to detect abnormal increases in sales activity and cross-correlations to assess shifts in sales timing. RESULTS: Sales of iodine-based nutritional complements, and later sales of iodine-based homeopathic remedies, substantially increased (up to 3-fold) during a period of 20 days. Their temporal patterns were correlated to specific events during the crisis. Prescriptions for iodine-based homeopathy increased (up to 35% of all sales). Iodine pills, strictly regulated by health authorities, have also been sold but on a very small scale. CONCLUSION: These results indicate uncontrolled preventive behaviors resulting in the potentially unjustifiable consumption of available drugs. They have implications in public policy, and demonstrate the usefulness of drug sales surveillance for instantaneous evaluation of population behavior during a global crisis.