Assessment of barium diffusion from therapeutic mud wrapped in micro-perforated polyethylene bags towards the human organism.

Barium is present within the clay-derived therapeutic mud packs deposed on the patient's skin for treating some rheumatologic conditions. We studied in twenty-four young healthy volunteers the diffusion of Ba from mud wrapped in micro-perforated polyethylene bags and soaked in mineral water. No significant systematic increase in plasma or urine Ba levels was evidenced when comparing pre- and post-treatment samples using inductively-coupled plasma mass spectrometry. These levels were markedly inferior to the recommended thresholds in nearly all the participants. Noticeably variability in blood and especially urine Ba concentrations was large and mainly explained by environmental exposure (alimentation). Interestingly, we evidenced an intense Ba accumulation within the therapeutic mud at the end of the regimen. Because we chose a clay with one of the highest Ba content available in France for medical therapy and participants with an optimal transcutaneous diffusion capacity (young individuals with low-fat mass), we conclude unambiguously that there is no risk of Ba overexposure in patients receiving pelotherapy according to the procedure used in French medical spas.

Skin Tolerance of Three Types of Dead Sea Mud on Healthy Skin: A Short-Term Study.

Dead Sea mud (DSM) is commonly used by patients with various skin conditions because of its contents of healing elements. No study was published to show whether DSM application weakens or strengthens skin barrier function. In this study, we investigated the impact of 30-minute single application of various types of DSM ("As Is" mud, mud with extra Dead Sea salt, and over-the-shelf mud) on the barrier function of normal skin. The influence of 30-minute application of various types of DSM was investigated noninvasively on skin barrier properties of healthy female adult volunteers (n = 75) on predetermined circular areas. Skin hydration, transepidermal water loss (TEWL), erythema and melanin levels, and skin pH were measured directly, 30 minutes, and 60 minutes after mud removal. Thirty-minute single application of DSM was well tolerated with short-lived moisturizing effects, which was enhanced by the presence of humectant ingredients, and with no negative impact on barrier integrity, pH, and erythema and melanin levels.

Safety evaluation of traces of nickel and chrome in cosmetics: The case of Dead Sea mud.

BACKGROUND: Metal impurities such as nickel and chrome are present in natural ingredients-containing cosmetic products. These traces are unavoidable due to the ubiquitous nature of these elements. Dead Sea mud is a popular natural ingredient of cosmetic products in which nickel and chrome residues are likely to occur. OBJECTIVE: To analyze the potential systemic and local toxicity of Dead Sea mud taking into consideration Dead Sea muds' natural content of nickel and chrome. METHODS: The following endpoints were evaluated: (Regulation No. 1223/20, 21/12/2009) systemic and (SCCS's Notes of Guidance) local toxicity of topical application of Dead Sea mud; health reports during the last five years of commercial marketing of Dead Sea mud. RESULTS AND CONCLUSIONS: Following exposure to Dead Sea mud, MoS (margin of safety) calculations for nickel and chrome indicate no toxicological concern for systemic toxicity. Skin sensitization is also not to be expected by exposure of normal healthy skin to Dead Sea mud. Topical application, however, is not recommended for already nickel-or chrome-sensitized persons. As risk assessment of impurities present in cosmetics may be a difficult exercise, the case of Dead Sea mud is taken here as an example of a natural material that may contain traces of unavoidable metals.

Can the use of medical muds cause genotoxicity in eukaryotic cells? A trial using comet assay.

Despite the lack of knowledge of their exact effects, peloids (natural muds) are widely applied in clinical treatment and prevention of different diseases, especially in rheumatic and gynecological disorders or skin diseases. Primarily we have information on their inorganic components, but only limited data are available on the organic components and nothing on their mechanism of chemical action. The objective of the present study was to detect the DNA-damaging effects (possible genotoxic effect) of peloid samples using the single-cell comet assay on Long Evans rat lymphocytes, human lymphocytes, and Eisenia fetida coelomocytes. Rat and human lymphocytes were exposed to the in toto peloid samples, in vitro. The Eisenia cells were extracted from the coelom of animals kept in the intact peloid sample. An indicator derived from the DNA fluorescence intensity was used in the statistical evaluation. The predominantly organic (Hévíz) sample showed a significant alteration from the negative control in several cases, while the inorganic (Kolop) applied did not. A higher quantity of organic compounds may have an important role in the emergence of DNA damage. The results revealed that medical muds have not only positive health effects but can also contain substances with potential human toxicity risk. Our research provides essential steps towards the creation of a toxicity profile and the possible safe use of peloids as medicinal therapy.

Folk pharmaceutical formulations in western Mediterranean: identification and safety of clays used in pelotherapy.

ETHNOPHARMACOLOGICAL RELEVANCE: Clays are naturally occurring ingredients of many natural health products, being included in most of ancient Mediterranean/European medical texts and currently used to prepare therapeutic hot-muds (peloids) in several thermal stations of the Mediterranean region. Clays are included in the formulation of peloids as vehicles of the mineral-medicinal water, to obtain inorganic gels with rheological and thermal properties suitable to be topically applied. Knowledge about formulations and preparation procedures of these traditional medicines has been orally transmitted since ancient times. Increasing recognition of the therapeutic utility of these traditional and natural health care substances make necessary a full ethnopharmaceutic research to ascertain those compositional characters that allow to establish quality attributes and corresponding requirements for these materials and products, including identity, purity, richness and safety. MATERIALS AND METHODS: Five clay samples (A, B, C, D and E) currently used in various spa centers of southern European/Mediterranean countries were studied. X-Ray diffraction (XRD) and X-ray fluorescence (XRF) data were used to asses sample identity and richness. Elemental impurities and microbiological contaminants were also determined and compared to normative limits. Particle size distribution was related to their safety as powder materials. RESULTS: Samples A, C, D and E were identified as "high purity clay", while sample B was identified as a mix of clay minerals and carbonates. The presence of carbonates in this sample could compromise its suitability for pelotherapy. The studied clays meet the main normative limits for metals impurities, with the exception of arsenic in sample A and nickel in sample B. The samples comply with the microbiological limits proposed by European legislation for medicinal products. According to the particle size of the studied samples, prevention and control of dust exposure must be considered. CONCLUSIONS: Despite their demonstrated longevity, the use of clays in traditional medicine formulations as peloids greatly requires comprehension of their identity and safety attributes. Continuity of these mineral substances as recognized health care ingredients oblige to conduct interdisciplinary research to know the features that sustain their traditional use in the preparation of medicines (ethnopharmaceutics).

[Sulphur mineral water and SPA therapy in osteoarthritis]. / Rôle de l'eau minérale sulfurée dans la SPA thérapie de l'arthrose.

OBJECTIVE: Osteoarthritis (OA), the most common degenerative osteoarticular disease, is cause of pain and limitations in physical function with high disability that can conduct to a state of psycological stress, not always considered adequately, with negative impact on the quality of life. The mud and bath therapy can improve this aspect. However, these studies are insufficient. The objective of our research was to evaluate the impact of SPA therapy cycle on safety, efficacy and psychosocial disability in osteoarthritis. MATERIALS AND METHODS: The study was carried out on 99 subjects suffering from OA. The patients has treated for 12 days with applications of sulphurous mud-bath therapy from "Terme di Telese" (Benevento, Italy). At the beginning and at the end of the SPA therapy considered has assessed: 1) the adverse reactions; 2) the efficacy on the pain and functional limitations; c) the impact on the psychosocial function using the VAS scale, the SF-36 questionnaire, the WOMAC index and the SDS-Zung test. Statistical analysis of the data was performed by determining the mean ± SD. The results were compared with the Student "t" test or Wilcoxon test. A p value < 0.05 was considered significant. RESULTS: In comparison to the basal values, this investigation has demonstrated that sulphurous mud and bath therapy has induced a significant (p < 0.01) improvement of overall quality of life with reduction of pain at rest (2.1 ± 1.5 → 1.2 ± 1.3) and during daily activities (2.3 ± 1.3 → 1.4 ± 1.3). This has facilitated the physical function and psychosocial disability as shown by the questionnaires SF-36, WOMAC and SDS Zung. CONCLUSIONS: In conclusion our data suggest that mud-bath therapy with sulphurous mineral water can be considered as an important phase of the therapeutic strategy in OA.

[Application of peloidotherapy at the early stage of rehabilitation after cerebral ischemic stroke].

The objective of the present study was to evaluate clinical efficiency of peloidotherapy in the early reconvalescence period following cerebral ischemic stroke. A rationale for the application of peloidotherapy is presented based on the results of follow-up of 60 patients (26 men and 34 women) aged from 43 to 70 years at the early stage of recovery (within 10 weeks and more after stroke). Special attention was given to clinical dynamics of the post-stroke condition and the influence of peloidotherapy on the mechanisms underlying formation of cerebral hemodynamic effects, adaptive changes in the functional systems of hemostasis and microcirculation, and development of pathophysiological cascade of metabolic processes in the brain. All therapeutic procedures were fairly well tolerated by the patients. Neither allergic reactions nor other adverse effects of the treatment were documented which testifies to the safety of peloidotherapy at the early stage of rehabilitation after cerebral ischemic stroke.

Vibrio vulnificus: an unusual mode of acquisition and novel use of rapid susceptibility testing.

Infection with Vibrio vulnificus is uncommon in Europe but is associated with necrotising wound infections and life-threatening septicaemia. This case is one of infection most likely to have been acquired from a thermal pool in Turkey without preceding exposure to seawater or shellfish. The report also describes how early management was optimised using gradient diffusion antibiotic strips to provide rapid susceptibility data.

Low levels of toxic elements in Dead Sea black mud and mud-derived cosmetic products.

Natural muds used as or in cosmetics may expose consumers to toxic metals and elements via absorption through the skin, inhalation of the dried product, or ingestion (by children). Despite the extensive therapeutic and cosmetic use of the Dead Sea muds, there apparently has been no assessment of the levels of such toxic elements as Pb, As, or Cd in the mud and mud-based products. Inductively coupled plasma mass spectrometry analysis of eight toxic elements in samples collected from three black mud deposits (Lisan Marl, Pleistocene age) on the eastern shore of the Dead Sea in Jordan revealed no special enrichment of toxic elements in the mud. A similar analysis of 16 different commercial Dead Sea mud cosmetics, including packaged mud, likewise revealed no toxic elements at elevated levels of concern. From a toxic element standpoint, the Dead Sea black muds and derivative products appear to be safe for the consumer. Whatever the therapeutic benefits of the mud, our comparison of the elemental fingerprints of the consumer products with those of the field samples revealed one disturbing aspect: Dead Sea black mud should not be a significant component of such items as hand creams, body lotions, shampoo, and moisturizer.

[Skin infection with Fusarium in an immunocompetent patient]. / Infección cutánea por fusarium en paciente inmunocompetente.

Fusarium spp. are fungi found throughout the world and can cause a great variety of skin infections, mainly in immunodepressed individuals. We present a case of skin infection with Fusarium sp. which manifested as painful superficial ulcers on the legs of an immunocompetent female patient, who had applied <> as a <> for leg pain. The condition was cured with oral itraconazole and local treatments.

Final report on the safety assessment of Corylus Avellana (Hazel) Seed Oil, Corylus Americana (Hazel) Seed Oil, Corylus Avellana (Hazel) Seed Extract, Corylus Americana (Hazel) Seed Extract, Corylus Avellana (Hazel) Leaf Extract, Corylus Americana (Hazel) Leaf Extract, and Corylus Rostrata (Hazel) Leaf Extract.

These ingredients are all derived from hazelnut trees. The two seed oils are expressed from the nuts of the hazelnut tree of the particular species identified. Most current reported cosmetic uses are of the seed oils. The seed extracts are the extract of the nuts of the identified species tree. There is one current report of use of seed extract in cosmetics. The leaf extracts are the extract from the leaves of the particular species tree. There are no current reports of use of these extracts in cosmetics. Analysis of seed oil from one species identified Oleic Acid, Palmitoleic Acid, Linoleic Acid, Eicosaenoic Acid, Docosenoic Acid, Eicosanoic Acid, Palmitic Acid, Linolenic Acid, Stearic Acid, and Tetraeicosanoic Acid. Little information is available to characterize the extracts, however. The functions of most of these ingredients in cosmetics are not reported. In studies of hazelnuts from Spain and Egypt, aflatoxin was reported as a possible contaminant. Aflatoxins are considered carcinogenic in humans. Virtually no safety test data are available on these ingredients. Negative results in one comedogenicity study using a seed oil are reported. Cross-sensitivity to proteins in peanuts and those in hazelnuts are reported, but the presence or absence of protein in nut extract and plant extract from hazelnut trees is not known. Additional data were provided regarding concentration of use, method of extraction and contaminants, comedogenicity, and ultraviolet (UV) radiation absorption, but these data related to nut oil from only one species, and were not overall sufficient to resolve questions about irritation, sensitization, and photosensitization. Because of the absence of data, it is concluded that the available data are insufficient to support the safety of these ingredients in cosmetic products. Because of the limited information that characterizes any of these oils or extracts, data are needed on each (except that items 1, 2, and 3 below are not needed for Hazel [Corylus Avellana] Nut Oil). The additonal data needs include: (1) current concentration of use; (2) method of extraction/manufacture and quality control (i.e., chemical analyses); (3) contaminants and methods of extraction (especially pesticides and heavy metals); (4) dermal irritation and sensitization; (5) UV absorption; if there is significant absorption, then a photosensitization study will be needed; (6) 28-day dermal toxicity; (7) reproductive and developmental toxicity; and (8) two genotoxicity assays, one in a mammalian system; if positive, then a 2-year dermal carcinogenesis study using National Toxicology Program (NTP) methods may be needed.

Final report on the safety assessment of Malic Acid and Sodium Malate.

Malic Acid functions in cosmetic formulations as a pH adjuster, and Sodium Malate functions as a skin conditioning agent-humectant. Malic Acid is reportedly used in almost 50 cosmetic formulations across a range of product types at low concentrations, whereas Sodium Malate is used in only one. As a pH adjuster, Malic Acid is used at low concentrations. One commercial method of preparing Malic Acid is hydration of fumaric acid or maleic acid, and then purified to limit the amount of the starting material present. Because Malic Acid is a component of the Kreb's cycle, another method is fermentation. Malic Acid was relatively nontoxic in acute toxicity studies using animals. In a chronic oral study, feeding Malic Acid to rats resulted only in weight gain changes and changes in feed consumption. Malic Acid did not cause reproductive toxicity in mice, rats, or rabbits. Malic Acid was a moderate to strong skin irritatant in animal tests, and was a strong ocular irritant. Malic Acid was not mutagenic across a range of genotoxicity tests. Malic Acid was irritating in clinical tests, with less irritation seen as pH of the applied material increased. Patients patch tested with Malic Acid, placed on a diet that avoided foods containing Malic or citric acid, and then challenged with a diet high in Malic and citric acid had both immediate urticarial and delayed contact dermatitis reactions. These data were considered sufficient to determine that Malic Acid and Sodium Malate would be safe at the low concentrations at which these ingredients would be used to adjust pH (even though Sodium Malate is not currently used for that purpose). The data, however, were insufficient to determine the safety of these ingredients when used in cosmetics as other than pH adjusters and specifically, the data are insufficient to determine the safety of Sodium Malate when used as a skin conditioning agent-humectant. The types of data required for the Expert Panel to determine the safety of Sodium Malate as a skin-conditioning agent are: concentration of use data; dermal irritation and sensitization data; and ocular irritation data, if available. The data needed to assess the safety of Malic Acid or Sodium Malate for some function other than as a skin-conditioning agent cannot be specified without knowing the intended function. Were these ingredients to be used as exfoliants, for example, data similar to that included in the Cosmetic Ingredient Review safety assessment of Glycolic Acid would be needed. Until these data are available, it is concluded that the available data are insufficient to support the safety of these ingredients in cosmetic formulations for functions other than use as a pH adjuster.

Aplicación de la medicina natural y tradicional / Application of the natural and traditional medicine

Se realizó un estudio en el hospital rural "Julio Ortiz Pascua", Sopimpa en 1999 para el cual se utilizó la Medicina Natural y Tradicional, con los datos obtenidos del registro de pacientes atendidos por el departamento. Se realizó mediante la técnica de acupuntura, digitopuntura y fangoterapia y el personal de Enfermería tuvo una participación directa en la aplicación de estos. Su evolución fue favorable, ya que en el mayor porcentaje se pudo erradicar la mayoría de los síntomas. En todos los casos se utilizó el método porcentual. Con este trabajo se motivó al personal médico y de Enfermería a continuar aplicando activamente la Medicina Natural y Tradicional en nuestro centro(AU)

A study was conducted in 1999 at "Julio Ortiz Pascua" Rural Hospital, Sopimpa by using natural and traditional medicine, according to the data obtained from the register of patients that received attention at the department. The techniques of acupuncture, pressure acupuncture and mud therapy were used. The nursing personnel had a direct participation in their application. It was observed a favorable evolution, since most of the symptoms were erradicated in a high number of patients. The percentage method was used in all cases. With this paper it was possibe to encourage the medical and nursing personnel to continue the active application of natural and traditional medicine in our center(AU)

[The evolution of lumbar myalgia under the influence of the product Pelnicol administered in suppositories]. / Evolutia mialgiilor lombare secundare sub influenta produsului "Pelnicol" administrat în supozitoare.

After having done a wide study in vitro and in vivo reported in several publications, we applied the lyophylized extract "Pelnicol" under the form of suppositories, in 36 cases of secondary back diseases. The improvement with "Pelnicol" suppositories is observed, by mean, the 6th day of treatment. It can be seen that etiopathological factors are determining the diseases evolution, which has to be, in first rang, considered causally. It is realised with the "Pelnicol" suppositories.