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.

A cost-effectiveness analysis of calcipotriol plus betamethasone dipropionate aerosol foam versus gel for the topical treatment of plaque psoriasis.

BACKGROUND: Calcipotriol 50 µg/g and betamethasone 0.5 mg/g dipropionate (Cal/BD) aerosol foam formulation provides greater effectiveness and improved patient preference compared with traditional Cal/BD formulations for the topical treatment of plaque psoriasis. OBJECTIVE: To determine the cost-effectiveness of Cal/BD foam compared with Cal/BD gel from the Australian perspective. METHODS: A Markov model was developed to evaluate the cost-effectiveness of topical Cal/BD foam and gel for the treatment of people with plaque psoriasis. Treatment effectiveness, safety, and utilities were based on a randomized control trial, resource use was informed by expert opinion, and unit costs were obtained from public sources. Outcomes were reported in terms of 1-year costs, quality-adjusted life years, and incremental cost-effectiveness ratios. All costs were reported in 2017 Australian Dollars. RESULTS: The model showed that patients using Cal/BD foam had more QALYs and higher costs over 1 year compared with patients using Cal/BD gel, resulting in a cost of $13,609 per QALY gained at 4-weeks. When 4 weeks of Cal/BD foam was compared with 8 weeks of Cal/BD gel treatment, Cal/BD foam was $8 less expensive and resulted in 0.006 more QALYs gained. Sensitivity analyses showed that, compared with Cal/BD ointment, Cal/BD foam was associated with an incremental cost of $15,091 per QALY gained. CONCLUSION: Cal/BD foam is the most cost-effective Cal/BD formulation for the topical treatment of patients with plaque psoriasis.

Cost effectiveness of adding clostridial collagenase ointment to selective debridement in individuals with stage IV pressure ulcers.

OBJECTIVE: The purpose of this study was to determine the cost effectiveness (from a payer's perspective) of adding clostridial collagenase ointment (CCO) to selective debridement compared with selective debridement alone (non-CCO) in the treatment of stage IV pressure ulcers among patients identified from the US Wound Registry. METHODS: A 3-state Markov model was developed to determine costs and outcomes between the CCO and non-CCO groups over a 2-year time horizon. Outcome data were derived from a retrospective clinical study and included the proportion of pressure ulcers that were closed (epithelialized) over 2 years and the time to wound closure. Transition probabilities for the Markov states were estimated from the clinical study. In the Markov model, the clinical outcome is presented as ulcer-free weeks, which represents the time the wound is in the epithelialized state. Costs for each 4-week cycle were based on frequencies of clinic visits, debridement, and CCO application rates from the clinical study. The final model outputs were cumulative costs (in US dollars), clinical outcome (ulcer-free weeks), and incremental cost-effectiveness ratio (ICER) at 2 years. RESULTS: Compared with the non-CCO group, the CCO group incurred lower costs ($11,151 vs $17,596) and greater benefits (33.9 vs 16.8 ulcer-free weeks), resulting in an economically dominant ICER of -$375 per ulcer. Thus, for each additional ulcer-free week that can be gained, there is a concurrent cost savings of $375 if CCO treatment is selected. Over a 2-year period, an additional 17.2 ulcer-free weeks can be gained with concurrent cost savings of $6,445 for each patient. CONCLUSIONS: In this Markov model based on real-world data from the US Wound Registry, the addition of CCO to selective debridement in the treatment of pressure ulcers was economically dominant over selective debridement alone, resulting in greater benefit to the patient at lower cost.

Topical therapy for scalp psoriasis in adults.

An estimated 2% of the UK population has psoriasis. For many patients this affects the scalp. Particular challenges in managing scalp psoriasis include choosing an appropriate treatment option, difficulties of applying topical treatments and deciding how to treat severe disease. Moreover, there is a lack of good-quality evidence on which to base treatment decisions. Here, we offer some practical advice, taking into account the available evidence.

Benefit-cost analysis of moist exposed burn ointment.

Burn injury is one of the most devastating injuries that may affect a patient. Even in economically deprived areas, burn care is largely driven by relatively plentiful resources equating quality of care with generous monitoring and clinical attention with little concern to management cost. Burn care costs have been the subject of very few investigations and are among the least studied by health services researchers. Nevertheless, it can be stated that local care of burn wounds accounts for a large proportion of the cost per day for treating patients. As economic times are changing and as market penetration of managed care contracts and stiff competition in the health care industry gains momentum, ways to reduce expenditures without adversely affecting the quality of care have become of primary importance. We report a randomized prospective comparative study analyzing the benefit-cost value of moist exposed burn ointment (MEBO) application, an exposed method for burn wound care without the need for a secondary covering dressing, as compared to conventional closed methods.

Randomised controlled trial of short bursts of a potent topical corticosteroid versus prolonged use of a mild preparation for children with mild or moderate atopic eczema.

OBJECTIVE: To determine whether a three day burst of a potent corticosteroid is more effective than a mild preparation used for seven days in children with mild or moderate atopic eczema. DESIGN: Randomised, double blind, parallel group study of 18 weeks' duration. SETTING: 13 general practices and a teaching hospital in the Nottingham area. PARTICIPANTS: 174 children with mild or moderate atopic eczema recruited from general practices and 33 from a hospital outpatient clinic. INTERVENTIONS: 0.1% betamethasone valerate applied for three days followed by the base ointment for four days versus 1% hydrocortisone applied for seven days. MAIN OUTCOME MEASURES: Primary outcomes were total number of scratch-free days and number of relapses. Secondary outcomes were median duration of relapses, number of undisturbed nights, disease severity (six area, six sign atopic dermatitis severity scale), scores on two quality of life measures (children's life quality index and dermatitis family impact questionnaire), and number of patients in whom treatment failed in each arm. RESULTS: No differences were found between the two groups. This was consistent for all outcomes. The median number of scratch-free days was 118.0 for the mild group and 117.5 for the potent group (difference 0.5, 95% confidence interval -2.0 to 4.0, P=0.53). The median number of relapses for both groups was 1.0. Both groups showed clinically important improvements in disease severity and quality of life compared with baseline. CONCLUSION: A short burst of a potent topical corticosteroid is just as effective as prolonged use of a milder preparation for controlling mild or moderate atopic eczema in children.

Evaluating the role of alternative therapy in burn wound management: randomized trial comparing moist exposed burn ointment with conventional methods in the management of patients with second-degree burns.

CONTEXT: Moist exposed burn ointment (MEBO), from China, has been said to revolutionize burn management. OBJECTIVE: Our study was conducted to compare MEBO with conventional management (C) with respect to the rate of wound healing, antibacterial and analgesic effect, and hospital costs. DESIGN: This is a prospective, randomized, controlled clinical trial conducted between 1 March 1997 and 24 October 1998. SETTING: The trial was conducted in a specialized burn facility located in a tertiary referral hospital in a developed and industrialized island-state in Southeast Asia. PATIENTS: We randomly assigned 115 consecutive patients between the ages of 12 and 80 who had partial-thickness thermal burns covering less than 40% of body surface area (BSA) to receive either MEBO or C. Fifty-seven patients were assigned to MEBO and 58 patients to C. The latter group received twice-daily dressing changes; MEBO patients received MEBO every 4 hours. MAIN OUTCOME MEASURES: Patients were hospitalized until 75% BSA had healed. BSA was determined by visual inspection and charted on Lund and Browder charts regularly. Wound healing rate, bacterial infection rate, pain score, and hospitalization costs were recorded. RESULTS: The median time to 75% healing was 17.0 and 20.0 days with MEBO and C, respectively (HR = 0.67, 95% CI = 0.41-1.11, P =.11), suggesting similar efficacy between the 2 modalities. Bacterial infection rates were similar between the 2 groups (HR = 1.10, 95% CI = 0.59-2.03, P =.76). MEBO imparted a greater analgesic effect in the first 5 days of therapy and reduced hospital costs by 8%. CONCLUSIONS: MEBO is as effective as conventional management but is not the panacea for all burn wounds. The use of MEBO eases the management of face and neck burns and facilitates early institution of occupational therapy in hand burns. It confers better pain relief such that fewer opiates are used during the first 5 days after burn injury.