Assessment of the Efficacy of Cryolipolysis on Abdominal Fat Deposits: A Prospective Study.

BACKGROUND: Cryolipolysis is a non-invasive and efficacious procedure for body contouring. The effectiveness of cryolipolysis has been demonstrated on multiple areas of the body, but on a limited number of subjects. The aim of this study is to demonstrate the effectiveness and the safety of cryolipolysis in the lower abdomen adipose tissue thickness reduction. METHODS: A prospective study on 60 healthy women was carried out using CryoSlim Hybrid device. Each patient underwent two cryolipolysis sessions centered on the abdominal area. The primary endpoint was to decrease the thickness of the abdominal fat deposits. The change in the abdominal circumference and the thickness of the subcutaneous fat layer were assessed. Patient satisfaction and tolerance of the procedure were also taken into account. RESULTS: A significant reduction of the abdominal circumference and subcutaneous fat layer thickness was observed. The mean decrease in abdominal circumference was 2.10 cm (3.1%) 3 months after the procedure and 4.03 cm (5.8%) 6 months after the procedure. The mean decrease in fat layer thickness was 1.25 cm (43.81%) 3 months after the procedure and 1.61 cm (41.73%) 6 months after the procedure. No major adverse events were noted. All patients were very satisfied, and minimal pain was reported. CONCLUSIONS: Cryolipolysis is an effective technique to treat abdominal localized fat deposits. No major adverse events have been described for this procedure. Our promising results should encourage further studies aimed at optimizing the efficacy of the procedure without a considerable increase in the risks. LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors http://www.springer.com/00266 .

Cryothérapie et prévention des neuropathies périphériques induites par l'administration des taxanes / Cryotherapy for the prevention of taxane-induced peripheral neuropathy

INTRODUCTION: Plusieurs tumeurs solides sont traitées par des molécules de chimiothérapie, y compris celles appartenant à la famille des taxanes. Ces molécules peuvent provoquer des effets secondaires non négligeables, particulièrement des symptômes de neuropathie des nerfs périphériques induits par la chimiothérapie (NPIC). Ces symptômes se traduisent par des troubles de la sensibilité et des troubles moteurs ainsi que des douleurs aux membres supérieurs et inférieurs. L'impact est important sur la qualité de vie des patients. L'incidence des symptômes de neuropathie des nerfs périphériques se situe entre 30 et 70 % selon la molécule de chimiothérapie administrée, et aucun traitement médical préventif n'a montré d'efficacité à les prévenir ou à les traiter. Certaines équipes de soins en oncologie recourent à des interventions non pharmacologiques pour prévenir les effets neurotoxiques de la chimiothérapie. La cryothérapie, l'une des méthodes employées, consiste à refroidir les mains et les pieds par l'entremise de mitaines refroidies durant les perfusions de chimiothérapie, notamment de taxanes. Le but de cette intervention est de réduire la quantité du flux sanguin aux extrémités et ainsi de prévenir la neurotoxicité. La Direction adjointe du Programme québécois de cancérologie (PQC) et la Direction générale des affaires universitaires, médicales, infirmières et pharmaceutiques (DGAUMIP) du ministère de la Santé et des Services sociaux (MSSS) ont demandé à l'Institut national d'excellence en santé et en services sociaux (INESSS) de produire un état des connaissances et d'indiquer la position respective des sociétés savantes sur l'efficacité et l'innocuité de la cryothérapie pour prévenir les neuropathies périphériques induites par les taxanes. MÉTHODOLOGIE: Afin de répondre à ce mandat, une recherche de la littérature scientifique et grise a été effectuée en ciblant les revues systématiques, avec ou sans méta-analyse, les études primaires (essais cliniques à répartition aléatoire ou non), les études de cohortes ainsi que les guides de pratique clinique. Les résumés de conférences ainsi que les études narratives ont été exclus. Les constats retenus ont été présentés et discutés avec le Comité d'évolution des pratiques en oncologie (CEPO) du ministère de la Santé et des Services sociaux et ont ensuite été révisés par des lecteurs externes. PRINCIPAUX CONSTATS: En se basant sur la documentation scientifique disponible au moment de la rédaction et sur les consultations menées, les constats suivants sont formulés. Contexte et besoin de santé: La toxicité des nerfs périphériques induite par la chimiothérapie est un phénomène fréquent qui touche de 30 à 70 % des patients qui reçoivent une chimiothérapie. Elle se traduit par des paresthésies et parfois des troubles moteurs (troubles de la dextérité, crampes, faiblesse musculaire) qui peuvent être majeurs chez quelques patients. Certains d'entre eux peuvent avoir des séquelles à long terme. La sévérité de ces symptômes a un impact considérable sur la qualité de vie des personnes traitées par la chimiothérapie, y compris par les taxanes. Elle peut même conduire à la réduction des doses de chimiothérapie requises, au retard ou à l'arrêt du traitement oncologique. Neurotoxicité et cryothérapie: Le paclitaxel et le docétaxel sont deux molécules appartenant à la famille des taxanes qui ont un potentiel neurotoxique élevé. Elles sont fréquemment administrées pour traiter de nombreux types de tumeurs solides. L'utilisation de la cryothérapie pour prévenir la neurotoxicité s'inspire des résultats positifs obtenus par l'usage de casques réfrigérants en prévention de l'alopécie durant l'administration de certaines chimiothérapies et par l'utilisation du froid (mitaines et chaussettes réfrigérantes) pour réduire la toxicité unguéale. Sur ce même principe, des équipes de cliniciens de plusieurs pays utilisent des dispositifs, notamment des gants et des chaussettes réfrigérés, appliqués aux extrémités durant les cycles de traitement oncologique dans le but de prévenir les effets toxiques de la chimiothérapie au niveau des nerfs périphériques. Appréciation du niveau de la preuve Scientifique: Les publications de bonne qualité méthodologique sur le sujet sont peu nombreuses. Onze ont été retenues, dont cinq sont à répartition aléatoire, sans insu et portant sur un faible nombre de patients. Les objectifs visés par la cryothérapie ont été faiblement atteints dans les études recensées, et la significativité clinique de la preuve scientifique est incertaine. Les études rapportées sont entachées de nombreuses limites méthodologiques pouvant mener à un risque de biais très élevé, ce qui rend difficile l'interprétation des résultats : manque de cohérence, de crédibilité et de fiabilité. Efficacité et innocuité: Les données disponibles, provenant d'études de qualité méthodologique faible, ne permettent pas de conclure à propos de: -l'efficacité de la cryothérapie pour prévenir les neuropathies périphériques induites par la chimiothérapie; - l'innocuité de la cryothérapie ainsi que la tolérance des patients à l'égard de ce traitement préventif, lequel exige d'être exposé au froid parfois pendant la durée de l'administration. Par contre, les effets secondaires associés à la cryothérapie semblent peu fréquents et de faible intensité dans les quelques études qui les ont évalués. Bien qu'aucune étude n'ait rapporté de cas d'engelure, l'intolérance au froid a été signalée dans six études sur onze et a causé plusieurs cas d'attrition. Il n'a pas été observé d'arrêt de la cryothérapie dans les autres études. La plupart des auteurs mentionnent qu'il serait important de faire des études méthodologiquement plus robustes pour bien évaluer l'efficacité et l'innocuité de la cryothérapie pour la prévention des neuropathies périphériques (NP) induites par les taxanes. Lignes directrices et études en cours: Le seul guide de pratique clinique repéré indique qu'aucune recommandation ne peut être formulée quant à l'usage de diverses options pharmacologiques et non pharmacologiques de prévention des neuropathies des nerfs périphériques, y compris la cryothérapie, en raison de la faible qualité méthodologique des études retenues. Les auteurs de ce guide ajoutent toutefois que, même si la preuve n'est pas faite, les données disponibles suggèrent que la cryothérapie pourrait en partie prévenir les symptômes de neuropathie et que son usage paraît raisonnablement sécuritaire. Perspective des cliniciens et experts: Les cliniciens et les experts consultés reconnaissent : ­ l'important besoin de prévenir les symptômes de neuropathie induite par les taxanes; ­ l'absence de preuves scientifiques concluantes quant à l'efficacité de la cryothérapie en raison du nombre limité d'études disponibles et de la faible qualité méthodologique de celles-ci; ­ la nécessité de disposer d'études de meilleure qualité avant de pouvoir prendre position sur la question. Bien que les résultats observés soient mitigés, certains experts estiment que la cryothérapie représente tout de même un traitement préventif prometteur, puisqu'elle n'induit que peu ou pas d'effets secondaires et que son arrêt à tout moment est possible sans compromettre l'efficacité du traitement oncologique. MISE À JOUR DE L'ÉTAT DES CONNAISSANCES: La pertinence de mettre à jour le présent état des connaissances sera évaluée et déterminée en fonction des résultats de certains essais cliniques en cours à ce sujet. Les résultats de ces derniers devront paraître à partir de 2023-2024. Une mise à jour pourrait être requise advenant un apport significatif de nouvelles données disponibles à l'une ou l'autre des dimensions examinées dans cet état des connaissances.

INTRODUCTION: Many solid tumours are treated with chemotherapy drugs, including those in the taxane family. These drugs can have significant adverse effects, especially symptoms of chemotherapy-induced peripheral neuropathy (CIPN). These symptoms manifest as sensory and motor disorders and as pain in the upper and lower limbs. The symptoms are associated with poorer quality of life. The incidence of peripheral neuropathy symptoms ranges from 30% to 70%, depending on the chemotherapy drug administered, and no prophylactic medical treatment has been shown to be effective in preventing or treating them. Some cancer care teams use non-pharmacological measures to prevent the neurotoxic effects of chemotherapy. One of the methods used, cryotherapy, involves cooling the hands and feet with frozen gloves and socks during chemotherapy infusions, particularly taxanes. The goal of this measure is to reduce the amount of blood flow to the extremities and thus prevent neurotoxicity. The assistant director of the Québec Cancer Program (PQC) and the Direction générale des affaires universitaires, médicales, infirmières et pharmaceutiques (DGAUMIP) of the Ministère de la Santé et des Services sociaux (MSSS) asked the Institut national d'excellence en santé et en services sociaux (INESSS) to produce a state-of-knowledge report and to indicate the learned societies' respective positions regarding the efficacy and safety of cryotherapy for the prevention of taxane-induced peripheral neuropathy. METHODOLOGY: For the purpose of this mandate, a search of the scientific and grey literature was conducted, targeting systematic reviews, with or without meta-analysis, primary studies (randomized or non-randomized clinical trials), cohort studies, and clinical practice guidelines. Conference abstracts and narrative studies were excluded. The selected findings were presented and discussed with the Comité d'évolution des pratiques en oncologie (CEPO) and were then reviewed by external reviewers. MAIN FINDINGS: Based on the scientific literature available at the time of writing and on the consultations conducted, the following findings are noted: Context and health need: Chemotherapy-induced peripheral neurotoxicity is a common phenomenon affecting 30% to 70% of patients receiving chemotherapy. It manifests as paresthesia and sometimes motor disorders (manipulative dexterity problems, cramps and muscle weakness), which can be significant. Some patients can experience long-term sequelae. The severity of these symptoms can have a considerable impact on the quality of life of patients receiving chemotherapy, including taxanes. It can even lead to a reduction in the required chemotherapy doses or to a delay in or the discontinuation of cancer treatment. Neurotoxicity and cryotherapy: Paclitaxel and docetaxel are two drugs in the taxane family with a high neurotoxic potential. They are often administered to treat many types of solid tumours. The use of cryotherapy to prevent neurotoxicity is inspired by the positive results obtained with the use of cold caps to prevent alopecia after chemotherapies treatment and with the use of cold (frozen gloves and socks) to reduce nail toxicity. Based on this same principle, teams of clinicians in several countries are using devices, such as frozen gloves and socks, placed on the extremities during cancer treatment cycles to prevent the toxic effects of chemotherapy on the peripheral nerves. Assessment of the level of scientific evidence: There are few publications of good methodological quality on the subject. Eleven were selected, five of which were randomized and unblinded and involved small numbers of patients. The objectives of cryotherapy were poorly achieved in the studies identified, and the clinical significance of the scientific evidence is uncertain. The reported studies have numerous methodological limitations that can lead to a very high risk of bias, which makes it difficult to interpret the results: a lack of consistency, credibility and reliability. Efficacy and safety: The available data, which are from studies of low methodological quality, do not permit any conclusions regarding: The efficacy of cryotherapy in preventing chemotherapy-induced peripheral neuropathy; ­ The safety of cryotherapy or patients' tolerance of this preventive treatment, which requires exposure to cold, sometimes for the entire duration of administration. Otherwise, the adverse effects associated with cryotherapy appear to be infrequent and mild in the few studies that have assessed them. Although no studies reported any cases of frostbite, cold intolerance was reported in six of eleven studies and caused several cases of attrition. No cases of cryotherapy discontinuation were observed in the other studies. Most authors mention that more methodologically robust studies are needed to properly evaluate the efficacy and safety of cryotherapy for the prevention of taxane-induced peripheral neuropathy (PN). Guidelines and ongoing studies: The only clinical practice guideline found states that no recommendation can be made regarding the use of various pharmacological and non-pharmacological options for preventing peripheral neuropathy, including cryotherapy, because of the low methodological quality of the selected studies. However, the authors of the guideline add that, while this has not been proven, the available data do suggest that cryotherapy may partially prevent neuropathy symptoms and that its use appears to be reasonably safe. Perspective of clinicians and experts: The clinicians and experts consulted recognize: The important need to prevent symptoms of taxane-induced neuropathy; The lack of conclusive scientific evidence for the efficacy of cryotherapy due to the limited number of studies available and their low methodological quality; Although the results observed are mixed, some experts feel that cryotherapy is a promising preventive treatment, since it has few or no major adverse effects and can be stopped at any time without compromising the effectiveness of the cancer treatment. The need for better-quality studies before a position can be taken on the matter. UPDATE OF THIS STATE-OF-KNOWLEDGE REPORT: The advisability of updating this state-of-knowledge report will be assessed and determined on the basis of the results of certain ongoing clinical trials on this topic. The results of these trials are expected to be published starting in 2023-2024. An update may be necessary if there is a significant amount of new available data for any of the aspects examined in this state-of-knowledge report.

A Non-Surgical and Cost-Effective Treatment Approach Employing Topical Imiquimod, 5-Fluorouracil, and Tretinoin for Primary Non-Melanoma Skin Cancers.

BACKGROUND: Minimally invasive alternative approaches to treat non-melanoma skin cancers remain limited and unproven. OBJECTIVE: We aim to assess the efficacy of varying combinations of anti-tumor agents—imiquimod 5% cream, 5-fluorouracil 2% solution, and tretinoin 0.1% cream—with brief cryotherapy in treating non-melanoma skin cancers. METHODS: This retrospective study included 690 cases of non-melanoma skin cancers in 480 patients who received a diagnosis of a basal cell carcinoma or squamous cell carcinoma during a ten-year period. During treatment period, patients applied 30 applications of one of three combinations (imiquimod/tretinoin, 5-fluorouracil/tretinoin, or imiquimod/5-fluorouracil/tretinoin) and had cryotherapy every 2 weeks. Each patient had a clinical examination at least three years post-treatment or documented treatment failure. Clearance was defined by a lack of persistence or recurrence for 3 years following the completion of treatment. The likelihood of lesion clearance was evaluated using multivariable logistic regression analysis. RESULTS: A total of 186 cases (97; basal cell carcinoma and 89; squamous cell carcinoma) in 133 patients [37% women and 63% men; median (interquartile range) age, 77 (69, 83) years] met the inclusion criteria. Multivariable logistic regression analysis adjusting for clinical and lesion variables demonstrated that, relative to the imiquimod/5-fluorouracil/tretinoin treatment approach, imiquimod/ tretinoin (odds ratio, 0.05; 95% confidence interval, 0.00-0.99) and 5-fluorouracil/tretinoin (0.02; 0.00–0.45) were associated with lower likelihoods of lesion clearance. Likewise, morpheaform basal cell carcinoma had a lower probability of clearance (0.05; 0.00–0.72). CONCLUSIONS: The combination of imiquimod/5-fluorouracil/tretinoin with cryotherapy had high clearance rates and was the most effective treatment regimen. J Drugs Dermatol. 2021;20(3):260-267. doi:10.36849/JDD.5427.

Energy Expenditure and Macronutrient Oxidation in Response to an Individualized Nonshivering Cooling Protocol.

OBJECTIVE: This study aimed to describe the energy expenditure (EE) and macronutrient oxidation response to an individualized nonshivering cold exposure in young healthy adults. METHODS: Two different groups of 44 (study 1: 22.1 [SD 2.1] years old, 25.6 [SD 5.2] kg/m2 , 34% men) and 13 young healthy adults (study 2: 25.6 [SD 3.0] years old, 23.6 [SD 2.4] kg/m2 , 54% men) participated in this study. Resting metabolic rate (RMR) and macronutrient oxidation rates were measured by indirect calorimetry under fasting conditions in a warm environment (for 30 minutes) and in mild cold conditions (for 65 minutes, with the individual wearing a water-perfused cooling vest set at an individualized temperature adjusted to the individual's shivering threshold). RESULTS: In study 1, EE increased in the initial stage of cold exposure and remained stable for the whole cold exposure (P < 0.001). Mean cold-induced thermogenesis (9.56 ± 7.9 kcal/h) was 13.9% ± 11.6% of the RMR (range: -14.8% to 39.9% of the RMR). Carbohydrate oxidation decreased during the first 30 minutes of the cold exposure and later recovered up to the baseline values (P < 0.01) in parallel to opposite changes in fat oxidation (P < 0.01). Results were replicated in study 2. CONCLUSIONS: A 1-hour mild cold exposure individually adjusted to elicit maximum nonshivering thermogenesis induces a very modest increase in EE and a shift of macronutrient oxidation that may underlie a shift in thermogenic tissue activity.

Assessment of the Influence Systemic Cryotherapy Exerts on Chosen Skin Scores of Patients with Atopic Dermatitis: Pilot Study.

BACKGROUND: One of the most important tasks in the treatment of atopic dermatitis (AD) is alleviation of racking skin dryness and persistent pruritus, because these factors exert a significant influence on worsening patients' quality of life. Cryotherapy being a new form of rehabilitation in AD may supplement and support a long-term process of AD treatment, because it has anti-inflammatory and antipruritic effects and exerts a positive influence on the nervous system. METHODS: 14 adults (mean age 32 ± 10.8) with mild to moderate AD were enrolled. WBC (15 treatments in total) took place in winter 2018/2019. Patient skin parameters (hydration of the epidermis, sebum level, and skin pH level) were measured with probes produced by Courage + Khazaka Electronic GmbH. RESULTS: Changes were observed in the hydration level of the epidermis. The SCORAD index evaluating the AD intensity level also changed (decreased). CONCLUSION: Due to these properties, hypothesis has been put forward that WBC can be an effective, supporting method in the treatment of AD.

Experimental study for evaluation of a low-cost spray cryotherapy system.

OBJECTIVE: To evaluate the feasibility and applicability of a low-cost cryotherapy system. METHODS: Experimental study with 25kg Landrace pigs submitted to a longitudinal cervico-thoraco-abdominal incision for exposure of the trachea, thorax and abdomen. The tissues were frozen by continuous spray application at different periods of time (5, 10 and 15 seconds). Spray cryotherapy was performed using a fluorinated gas (tetrafluorethane) delivered at - 47°C temperature (DermaFreeze®, Emdutos; ANVISA registration 80409950001; price R$ 394,00). via an adapted, disposable 1.8mm cholangiography catheter (Olympus; price R$ 280,00). The specimens were resected for histopathological analysis. RESULTS: Thirty samples were obtained from ten different organs and divided according to spray cryotherapy application time. System activation for 5, 10 or 15 seconds led to consumption of 14g, 27g and 40g of gas respectively (average gas consumption, 2.7g/s using a 1.8mm catheter). The system comprising a spray tube and catheter proved user-friendly and effective, with constant gas dispersion and adequate tissue freezing. In spite of effective freezing, microscopy failed to reveal tissue changes. This may have reflected methodological constraints precluding evaluation at tissue damage peak time (48 hours). CONCLUSION: The low-cost spray cryotherapy system proved feasible and safe.

Anatomic, Visual, and Financial Outcomes for Traditional and Nontraditional Primary Pneumatic Retinopexy for Retinal Detachment.

PURPOSE: To determine factors predictive of anatomic, visual, and financial outcomes after traditional and nontraditional primary pneumatic retinopexy (PR) for rhegmatogenous retinal detachment (RD). DESIGN: Retrospective interventional case series and cost comparison. METHODS: Participants: Total of 178 eyes (156 patients) with PR-repaired primary RD by a single surgeon at a clinical practice from January 2001 to December 2013 and followed for ≥1 year. The cohort had 2 subgroups: traditional (TPR) and nontraditional (NTPR) PR. MAIN OUTCOME MEASURES: Characteristics associated with best-corrected visual acuity (BCVA) and anatomic outcomes. Cost analysis and potential cost savings comparing PR to scleral buckle and vitrectomy. RESULTS: One hundred thirty-one of 178 eyes (73.5%) were successfully treated at 1 year (postoperative year 1): 72.8% (75/103) in TPR and 74.6% (56/75) in NTPR. Macula-off detachment (-0.44 logMAR, P < .001) and clock hours of RD (-0.84 logMAR, P < .001) correlated with improved BCVA; pseudophakia (0.26 logMAR, P = .002) and inferior retinal tears (0.62 logMAR, P = .009) correlated with worsening BCVA. Pseudophakia (-0.15, P = .03), inferior quadrant RD (-0.27, P < .001), and proliferative vitreoretinopathy (-0.68, P < .001) correlated with anatomic failure. Total average cost for TPR and NTPR was $1248.37 ± $882.11 and $1471.91 ± $942.84, respectively (P = .10). PR had a potential cost savings of 62% and 60.8% when compared to scleral buckle and vitrectomy, respectively. CONCLUSIONS: PR results in successful anatomic and visual outcomes in both TPR and NTPR repair of primary RD. Preoperative pseudophakia is associated with worse visual outcomes and less anatomic success. The cost of primary PR and subsequent procedures to achieve final anatomic success was not significantly different between TPR and NTPR, and supports the possible cost-effectiveness of expanded indications for PR.

Experimental study for evaluation of a low-cost spray cryotherapy system / Estudo experimental para avaliação de um sistema de baixo custo para crioterapia em spray

ABSTRACT Objective To evaluate the feasibility and applicability of a low-cost cryotherapy system. Methods Experimental study with 25kg Landrace pigs submitted to a longitudinal cervico-thoraco-abdominal incision for exposure of the trachea, thorax and abdomen. The tissues were frozen by continuous spray application at different periods of time (5, 10 and 15 seconds). Spray cryotherapy was performed using a fluorinated gas (tetrafluorethane) delivered at - 47°C temperature (DermaFreeze®, Emdutos; ANVISA registration 80409950001; price R$ 394,00). via an adapted, disposable 1.8mm cholangiography catheter (Olympus; price R$ 280,00). The specimens were resected for histopathological analysis. Results Thirty samples were obtained from ten different organs and divided according to spray cryotherapy application time. System activation for 5, 10 or 15 seconds led to consumption of 14g, 27g and 40g of gas respectively (average gas consumption, 2.7g/s using a 1.8mm catheter). The system comprising a spray tube and catheter proved user-friendly and effective, with constant gas dispersion and adequate tissue freezing. In spite of effective freezing, microscopy failed to reveal tissue changes. This may have reflected methodological constraints precluding evaluation at tissue damage peak time (48 hours). Conclusion The low-cost spray cryotherapy system proved feasible and safe.

RESUMO Objetivo Avaliar a exequibilidade e a aplicação de um sistema de baixo custo de crioterapia. Métodos Estudo experimental realizado com um suíno da raça Landrace, 25kg, submetido à cervicotoracolaparotomia longitudinal, com exposição de traqueia, tórax e abdome. Procedemos ao congelamento das estruturas em tempos diferentes (5, 10 e 15 segundos) com jato contínuo. A crioterapia foi realizada com gás fluoretado (tetrafluoretano), na forma de spray em tubo, que atinge a temperatura de -47°C (DermaFreeze®, Emdutos; registro ANVISA 80409950001; preço R$ 394,00). A este tubo, adaptamos um cateter descartável de colangiografia de 1,8mm (Olympus; preço R$ 280,00). As peças foram ressecadas para análise histopatológica. Resultados Foram obtidas 30 amostras em 10 órgãos diferentes, divididos em três intervalos de tempo distintos. Quando o sistema foi acionado por 5 segundos, gastaram-se 14g de gás; por 10 segundos, 27g; e por 15 segundos, 40g; o gasto médio foi de 2,7g/s pelo cateter de 1,8mm. O sistema confeccionado com tubo de gás e cateter proporcionou resultado efetivo, com dispersão adequada e constante do gás, congelamento adequado e de fácil execução. Apesar da técnica evidenciar congelamento efetivo, na microscopia não houve alteração tecidual. Isso ocorreu porque o pico de lesão tecidual por congelamento ocorre após 48 horas, o que não foi possível avaliar por este método proposto. Conclusão O sistema de crioterapia em spray de baixo custo foi exequível e seguro.

Costs and cost-effectiveness of LEEP versus cryotherapy for treating cervical dysplasia among HIV-positive women in Johannesburg, South Africa.

BACKGROUND: Cervical cancer incidence is significant in countries, such as South Africa, with high burdens of both HIV and human papillomavirus (HPV). Cervical cancer is largely preventable if dysplasia is diagnosed and treated early, but there is debate regarding the best approaches for screening and treatment, especially for low-resource settings. Currently South Africa provides Pap smears followed by colposcopic biopsy and LEEP if needed in its public health facilities. We estimated the costs and cost-effectiveness of two approaches for treating cervical intraepithelial neoplasia grade 2 or higher (CIN2+) among HIV-infected women, most of whom were taking antiretroviral treatment, at a public HIV treatment facility in Johannesburg, South Africa. METHODS: Method effectiveness was derived from an intention-to-treat analysis of data gathered in a clinical trial completed previously at the study facility. In the trial, women who were diagnosed with CIN2+ and eligible for cryotherapy were randomized to cryotherapy or LEEP. If women were CIN2+ at six months as determined via Pap smear and colposcopic biopsy, all women-regardless of their original treatment assignment-received LEEP. "Cure" was then defined as the absence of disease at 12 months based on Pap smear and colposcopic biopsy. Health service costs were estimated using micro-costing between June 2013 and April 2014. Capital costs were annualized using a discount rate of 3%. Two different service volume scenarios were considered, and results from an as-treated analysis were considered in sensitivity analysis. RESULTS: In total, 166 women with CIN2+ were enrolled (86 had LEEP; 80 had cryotherapy). At 12 months, cumulative loss to follow-up was 12.8% (11/86) for the LEEP group and 13.8% (11/80) for cryotherapy. Based on the unadjusted intention-to-treat analysis conducted for this economic evaluation, there was no significant difference in efficacy. At 12 months, 83.8% (95% CI 73.8-91.1) of women with CIN2+ at baseline and randomized to cryotherapy were free of CIN2+ disease. In contrast, 76.7% (95% CI 66.4-85.2) of women assigned to LEEP were free from disease. On average, women initially treated with cryotherapy were less costly per patient randomized at US$ 118.00 (113.91-122.10), and per case "cured" at US$ 140.90 (136.01-145.79). Women in the LEEP group cost US$ 162.56 (157.90-167.22) per patient randomized and US$ 205.59 (199.70-211.49) per case cured. In the as-treated analysis, which was based on trial data, LEEP was more efficacious than cryotherapy; however, the difference was not significant. Cryotherapy remained more cost-effective than LEEP in all sensitivity and scenario analyses. CONCLUSIONS: For this cost-effectiveness analysis, using an intention-to-treat approach and taking into consideration uncertainty in the clinical and cost outcomes, a strategy involving cryotherapy plus LEEP if needed at six months was dominant to LEEP plus LEEP again at six months if needed for retreatment. However, compared to other studies comparing LEEP and cryotherapy, the efficacy results were low in both treatment groups-possibly due to the HIV-positivity of the participants. Further research is needed, but at present choosing the "right" treatment option may be less important than ensuring access to treatment and providing careful monitoring of treatment outcomes.

Effects of Thermomechanical Stimulation during Vaccination on Anxiety, Pain, and Satisfaction in Pediatric Patients: A Randomized Controlled Trial.

PURPOSE: Vaccination can be a significant source of pain for pediatric patients, which could result in fear of medical procedures and future reluctance to seek medical care. It is important for nurses to provide pain prevention during these procedures. This study sought to measure the impact of an intervention combining cold and vibration on pain scores during routine pediatric immunization. DESIGN AND METHODS: A prospective, open-label, randomized controlled trial to examine the effectiveness of the Buzzy device (thermomechanical stimulation) compared to no intervention (control group) in reducing child-reported pain during routine immunization. The Wong Baker Faces scale was used to collect child, parent, and observer reported anxiety and pain. Parents reported satisfaction with the procedure and overall office visit. RESULTS: Fifty children between the ages of 3 and 18 were included in the present analysis. Mean child-reported pain scores were significantly lower in the group receiving thermomechanical stimulation compared to control (3.56 vs 5.92, p=0.015). Buzzy did not impact child-reported anxiety or how much pain the child expected. Parent-reported satisfaction did not vary significantly between groups, but was strongly associated with parent-reported pain scores. CONCLUSIONS: Thermomechanical stimulation with the Buzzy device significantly reduced pain during pediatric immunization over a wide range of ages compared to control, but did not impact pre-procedure anxiety. PRACTICE IMPLICATIONS: The Buzzy device is an easy to implement intervention to reduce pediatric pain during vaccination. It may have the greatest impact in younger children but could be offered during all immunizations.

A Network Meta-Analysis of Non-Melanoma Skin Cancer (NMSC) Treatments: Efficacy and Safety Assessment.

The mainstream treatments for non-melanoma skin cancer (NMSC) include photodynamic therapy (PDT), surgery excision (SE), cryotherapy (CT), imiquimod (IM), radiotherapy (RT), 5-fluorouracil (FU), and vehicle (VE). Our network meta-analysis (NMA) was aimed at evaluating the efficacy and safety of these seven treatments and providing superior ones. After searching the trials from Embase and PubMed and screening with our criteria, we conducted the NMA with software R 3.2.3 and STATA 13.0. Complete lesion response (CLR), complete lesion clearance (CLC), cumulative recurrence probabilities (CRP), and adverse effects (AEs) were considered as outcomes and displayed as odds ratios (ORs) and 95% credible intervals (CrI). The surface under the cumulative ranking curve (SUCRA) was calculated to rank each treatment on each index. The consistency of direct and indirect evidence was also assessed by node-splitting and heat plot methods. Data from 18 trials with 3706 patients were included. Both IM and SE were demonstrated significantly higher CLR rate than VE (OR = 9.12, 95% CrI = 1.92-47.5; OR = 26.1, 95% CrI = 1.92-347; respectively), while only IM was proved to be statistically better than VE in CLC rate (OR = 7.03, 95% CrI = 1.51-32.8). No significant difference was observed concerning CRP, and IM was more likely to induce AEs than VE (OR = 4.44, 95% CrI = 1.58-13.9). The SUCRA results indicated that SE was the treatment with best ranking in the entire three efficacy indexes and a relatively high safety. Taking efficacy and safety into account, our study recommended SE as the optimal regimen for NMSC with high efficacy considering CLR, CLC, and CRP and moderate AEs when compared with other interventions. J. Cell. Biochem. 118: 3686-3695, 2017. © 2017 Wiley Periodicals, Inc.

Tolerability of 2.5% Lidocaine/Prilocaine Hydrogel in Children Undergoing Cryotherapy for Molluscum Contagiosum.

The tolerability of a 2.5% lidocaine/prilocaine hydrogel (Nanorap, Biolab Indústria Farmacêutica Ltd., Sao Paulo, Brazil) was evaluated in 20 children ages 2 to 11 years undergoing cryotherapy for molluscum contagiosum (MC). The product was well tolerated, with only two children presenting with eczema at the application site. These adverse reactions were considered unlikely to be related to the test product, because a patch test was negative in one of the individuals and the other event occurred in only one of the two treated areas. Nanorap is an efficacious and well-tolerated option for topical anesthesia in children undergoing cryotherapy for MC.

Técnicas de crioterapia para el tratamiento de la neoplasia intraepitelial en el instituto hondureño de seguridad social durante el período de enero 2011 a junio del 2012 / Cryotherapy techniques for the treatment of intraepithelial neoplasia in the honduran institute of social security during the period January 2011 to June 2012

Ojetivo: Describir las técnicas de crioterapia de simple y doble congelación, determinar la eficacia complicaciones del tratamiento en las mujeres que asisten a la consulta externa. Métodos: estudio descriptivo transversal, seleccionando 120 mujeres a conveniencia que asistieron a la consulta externa del Instituto Hondureño de Seguridad Social con diagnóstico de neoplasia intraepitelial de bajo grado. Resultados: de las 120 pacientes tratadas con crioterapia, 25 pacientes persistieron con NIC 7 de ellas tratadas con doble congelación y 16 con una sola congelación. 4 pacientes presentaron complicaciones las cuales fueron tratadas con la técnica doble...

Objective: Describe cryotherapy techniques and double freezing, determine the efficacy of treatment complications in women attending outpatient. Methods: cross-sectional study, 120 women choosing to convenience attending the outpatient Social Security Institute diagnosed with low-grade intraepithelial neoplasica. Results: Of the 120 patients treated with cryotherapy, 25 patients persisted with CIN 7 were treated with double freeze and 16 with a single freeze. 4 patients had complications which were treated with the technique with double freeze...

A cost-utility analysis of ingenol mebutate gel for the treatment of actinic keratosis: a Scottish perspective.

BACKGROUND: Actinic keratosis (AK) is a UV-induced, pre-malignant skin condition that is common in adults over 60 years of age with fair skin in Scotland. The most commonly prescribed first-line treatment for AK in Scotland is currently diclofenac gel (3 %). Ingenol mebutate gel is a recently developed topical therapy available in two strengths for the treatment of AK lesions on the face and scalp (150 mcg/g once daily for 3 consecutive days) or trunk and extremities (500 mcg/g once daily for 2 consecutive days). OBJECTIVE: To compare the cost-effectiveness of two strengths of ingenol mebutate gel developed to treat AK lesions on the face and scalp (150 mcg/g once daily for 3 consecutive days) or trunk and extremities (500 mcg/g once daily for 2 consecutive days) with other first-line AK therapies including diclofenac gel, 5-FU, 5-FU/salicylic acid, and cryotherapy for the first-line treatment of AK in adult patients, from the perspective of the National Health Service (NHS) in Scotland. METHODS: A cost-utility analysis was conducted using a decision-tree approach to calculate the costs and benefits of different treatment strategies for AK on the face and scalp or trunk and limbs over a 12-month time horizon. Data on the relative efficacy of treatments were obtained from a systematic literature review and meta-analysis. Utility scores and resource-use data were obtained from published sources. RESULTS: Over 12 months, ingenol mebutate 150 mcg/g gel and 500 mcg/g gel were cost-effective compared with the most commonly used topical therapy in Scotland, diclofenac (3 %) gel, at a willingness-to-pay threshold of £20,000 per QALY, with a minimal additional cost of £43 and £105, respectively per QALY gained. CONCLUSIONS: Ingenol mebutate gel is a cost-effective therapy for the first-line treatment of AK from a Scottish NHS perspective.

Effectiveness of erbium:YAG laser and cryosurgery in seborrheic keratoses: Randomized, prospective intraindividual comparison study.

BACKGROUND AND OBJECTIVE: Seborrheic keratoses (SK) are benign cutaneous lesions frequently seen in old age. The aim of the study is to compare the efficiency of Er:YAG lasers with cryotherapy in the treatment of SK. PATIENTS AND METHODS: The study was carried out on 42 patients with SK sized 0.5-3 cm, located on the back, chest, face and neck. Lesions with a similar size and location on the same patient were matched. In the same session, half of the lesions were treated with cryotherapy, while the other half were treated with Er:YAG lasers. All of the patients were clinically evaluated in two recalls with a one-month interval between appointments. The efficiency of the treatments was clinically evaluated. RESULTS: Following the first treatment, complete healing was detected in all of the lesions (100%) treated with Er:YAG lasers, while the healing rate was 68% in the cryotherapy group (p < 0.01). In the Er:YAG laser-treated group, hyperpigmentation was significantly lower and more erythema developed than in the cryotherapy group. CONCLUSION: Er:YAG lasers offer a one-step procedure which is a very simple and economic treatment and provides an alternative treatment method with better cosmetic results compared to cryotherapy.

Cost-effectiveness analysis of 5-fluorouracil 0.5%/salicylic acid 10% in the treatment of actinic keratosis in Spain.

OBJECTIVE: The aim of this study is to conduct a cost-effectiveness analysis of 5-fluorouracil 0.5%/salicylic acid 10% (5-FU/SA) in the treatment of isolated hyperkeratotic actinic keratosis lesions in Spain. METHODS: An analytical decision-making model was constructed to compare whether 5-FU/SA was a cost-effective option compared with cryotherapy from the perspective of the Spanish National Health System with a time horizon of 6 months. Costs were expressed in 2014 euros. RESULTS: The cost of patients with hyperkeratotic actinic keratosis treated with 5-FU/SA or cryotherapy was €266 and €285, respectively. 5-FU/SA was associated with higher rates of treatment success and, consequently, more quality-adjusted life years, than cryotherapy. Therefore, 5-FU/SA was the dominant treatment, as it was associated with a lower treatment cost and greater effectiveness than cryotherapy. CONCLUSIONS: Economically, 5-FU/SA was a dominant option compared with cryotherapy in the treatment of isolated hyperkeratotic actinic keratosis lesions in Spain.

Health technology assessment in evolution - focal therapy in localised prostate cancer.

Focal therapy in prostate cancer aims to treat only the part of the gland harboring clinically significant disease while preserving the rest of the tissue. This approach may substantially reduce treatment-related toxicity without compromising disease control outcomes. Short- to medium-term functional and oncological results in prospective interventional studies are promising, but comparative effectiveness research against standard of care is required to incorporate focal therapy among standard options. In this review, we discuss the actual stage of assessment and results of sources of energy commonly used to deliver focal therapy. We also provide our viewpoint on how the field will evolve in the near future.