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HOMEONEWS Edición N° 16 Año 2012 2012 Segundo Semestre Director: Farm. Fernando Estevez Castillo DISTRIBUCION GRATUITA PARA PROFESIONALES DE LA SALUD SALUD Homeonews Edición N° 16 – Año 2012 Edición n° 16 Año 2012 Registro de la Propiedad Intelectual n°: 505276 Director: Fernando Oscar Estevez Castillo Propietario: Fernando Oscar Estevez Castillo E.Mail: festevez_castillo@hotmail.com ó festevezcastillo@yahoo.com.ar Director: Fernando Estevez Castillo 2 Homeonews 3 Edición N° 16 – Año 2012 INDICE 1- Editorial, pág. 5. 2- Fitoterapia: Tres hierbas para el tratamiento de la agitación nerviosa en niños; pág. 6. 3- Alopatía: Evaluación de la función sexual masculina en pacientes con síntomas del tracto urinario inferior (LUTS) asociados con hiperplasia prostática benigna (BPH) tratados con un medicamento fitoterápico (Permixon), Tamsulosina o Finasteride, pág. 16. El impacto de las benzodiacepinas sobre la aparición de la pneumonía y la mortalidad por la misma: un estudio de caso y control anidado y análisis de sobrevida en un cohorte de base poblacional, pág. 17. 4- Homeopatía: Efecto de los medicamentos homeopáticos en el estudio polisomnográfico del sueño en adultos jóvenes con antecedentes de insomnio relacionado al consumo de café, pág. 18. 5- Nutrición: Variación de los efectos de tres desayunos diferentes sobre la saciedad subjetiva y la posterior ingesta de energía a través del almuerzo y cena, pág. 33. 6- Notas de interés: -Jornada Internacional de actualización en Medicina Complementaria – Módulo I “Nuevas opciones terapéuticas en enfermedades crónicas, pág. 44. -Conferencia-Debate: Plantas medicinales y alimenticias: ejemplo de neodesarrollo agrícola-productivo con inclusión social, pág 45. -III Jornadas de Farmacia del Sudoeste Bonaerense, pág 50. -Jornada de Medicina Biológica e Integrativa, pág. 54. 7- Novedades: -Programa radial: “Amigos de lo Natural”, pág. 56. -Nuevos productos: AloeGel; pág. 57. -Carrera de Farmacia: Cátedra “Homeopatía”; pág. 58. . 8- Ateneos y Cursos: Director: Fernando Estevez Castillo Homeonews Edición N° 16 – Año 2012 -Ateneos del Departamento de Homeopatía de la Universidad Maimónides pág. 58. -Cursos de la Sociedad Latinoamericana de Fitomedicina, pág. 59. 9- Formulario de suscripción, pág. 60. Foto de tapa: Valeriana officinalis L. (Valerianaceae). Las opiniones vertidas en los artículos firmados son responsabilidad de sus autores. Director: Fernando Estevez Castillo 4 Homeonews 5 Edición N° 16 – Año 2012 EDITORIAL Estimados colegas del equipo de salud: Llegamos al final de este año, y no quería perder oportunidad de reencontrarme con Uds. a través de un nuevo número de Homeonews, muy completo, con trabajos realmente interesantes, y el resumen de muchas actividades realizadas durante el 2012. . En las próximas páginas, podrán encontrar un trabajo de FITOTERAPIA sobre el tratamiento de la agitación nerviosa en niños con una mezclas de tres extractos de hierbas; en ALOPATÍA, los efectos de tres medicamentos utilizados para el tratamiento de la hiperplasia prostática benigna, sobre la función sexual masculina y la relación de las benzodiacepinas con la aparción de pneumonía y la mortalidad por la misma. En el Capítulo de HOMEOPATÍA, una investigación realizada en Estados Unidos, para medir el efecto de algunos medicamentos homeopáticos en el estudio polisomnográfico del sueño en adultos jóvenes con insomnio relacionado al consumo de café. Pasando a NUTRICIÓN, el estudio de tres desayunos diferentes y sus efectos sobre la saciedad y la posterior ingesta de energía a través del almuerzo y cena. En NOTAS DE INTERES, los pormenores y resúmenes de cuatro eventos muy interesantes: “Jornada Internacional de actualización en Medicina Complementaria” (Venezuela), Diálogos del saber: Plantas medicinales y alimenticias, ejemplo de neodesarrollo agrícola-productivo con inclusión social (Buenos Aires); III Jornadas de Farmacia del Sudoeste Bonaerense (Bahía Blanca) y la Jornada de Medicina Biológica e Integrativa (Neuquén). Con respecto a NOVEDADES, Laboratorios Dr. Madaus presentó un nuevo producto, llamado AloeGel; se designó a un nuevo cuerpo docente para la Cátedra de Homeopatía, de la carrera de Farmacia de la Universidad Maimónides; una destacada y prestigiosa incorporación a la conducción del programa radial “Amigos de lo Natural” y en ATENEOS Y CURSOS, distintas alternativas para sumar conocimientos. Seguramente este mes, con la suma de compromisos sociales y familiares, además de los balances laborales del año que se va y los proyectos para el que viene, no va a ser el mejor momento para la lectura completa o en parte de Homeonews, Homeonews, pero se acercan las vacaciones, y quizás podemos aprovechar ese tiempo para intercalar con nuestros momentos de ocio y esparcimiento, tan necesarios y merecidos. Bueno llegó el momento de despedirme, deseándoles que pasen unas muy Felices Fiestas y que el año próximo sea el que Todos deseamos y soñamos!!! Farm. Fernando Estévez Castillo Director: Fernando Estevez Castillo Homeonews 6 Edición N° 16 – Año 2012 FITOTERAPIA TRES HIERBAS PARA EL TRATAMIENTO DE LA AGITACION NERVIOSA EN NIÑOS Trompetter I, Krick B, Weiss Ga a PASCOE pharmazeutische Präparate GmbH, Schiffenberger Weg 55, 35394, Giessen, Germany [Wien Med Wochenschr. 2012 Nov 22] RESUMEN Los problemas emocionales y conductuales en niños y adolescentes no son excepcionales. Emotional and behavioral problems in children and adolescents are no exception. Para poder ver si una combinación de extractos de plantas, puede ayudar a niños que sufren agitación nerviosa por aproximadamente dos años, debido a depresión, entre otras causas, se realizó un estudio observacional prospectivo, multicéntrico (2008), en 115 niños, entre 6 y 12 años. Las evaluaciones de los padres, mostraron una clara mejoría en los niños con problemas de atención, que mostraban aislamiento social y/o eran ansiosos/depresivos. Basado en las evaluaciones de los médicos, al final de la observación, el 81.6-93.9 % de los niños afectados, no tenían síntomas o solo algunos leves, teniendo en cuenta nueve de los trece evaluados, tales como depresión, ansiedad en la escuela, otras ansiedades, problemas para dormir y diferentes problemas físicos. El éxito terapéutico no fue influenciado por medicación adicional u otras terapias. El tratamiento fue bien tolerado. Los extractos de plantas utilizados, se han obtenido a partir St. John's Wort, valeriana raíz, y passiflora. Palabras clave: Agitación nerviosa, ansiedad, depresión, extractos de plantas, niños. ARTICULO ORIGINAL Introduction Especially, young people need a strong mental well-being to cope with all the intricacies of life. However, during the last 16 years, the number of children and adolescents showing psychosomatic symptoms is consistently high. There might be no epidemic [1], but the following numbers are alarming anyway. In any given year, worldwide 20 % of young people experience a mental health problem, most commonly depression or anxiety [2]. In Austria, pupils every day or at least several times a week suffer from sleep disorders (17.2 %), headache Director: Fernando Estevez Castillo Homeonews 7 Edición N° 16 – Año 2012 (14.4 %), petulance (14.2 %), nervousness (11.7 %), and/or backache (11.7 %) [3]. Similar numbers have been measured in other countries, e.g., in Canada, 21–27 % of grade 6 adolescents feel depressed at least once a week, 21 % of children at 2–5 years of age suffer from high levels of emotional problems, anxiety problems, lack of concentration, and/or hyperactivity [4, 5].These numbers are similar in other countries. In Germany, every sixth child or adolescent shows psychiatric disorders [6, 7]. There is a scientific consensus that these children (and their families) have to be supported and treated with adequate therapies [7–9], at least because children with anxieties and depressive episodes are at increased risk for severe emotional problems in adolescence and adulthood [10]. The broad range of interventions for anxieties, nervousness, and depression involve cognitive behavioral therapy as well as mostly chemical antidepressants, anxiolytics, and hypnotics [11–13]. Especially, treatment with traditional allopathic medication is controversially discussed addressing efficacy and safety of psychotropic agents in pediatrics. Due to the potential for side effects and addiction, prolonged treatment with chemical drugs as it is recommended by the WHO is often accompanied by simultaneous impairment of quality of life [7, 9, 12, 14, 15]. As a result, there is a clear increasing demand for complementary and alternative medicine [16] such as a unique combination of extracts from Hypericum perforatum (St. John’s Wort), Passiflora incarnata (Passionflower), and Valeriana officinalis (Valerian). Beyond traditional knowledge about the usage of Hypericum in treatment of mood and sleep disorders, recent studies have shown various effects on central neurotransmitter systems [17, 18] and the ability to act similar to conventional antidepressive drugs [18–20]. The experimentally verified synergistic effect of Passiflora on Hypericum enables application of a small amount of Hypericum with a simultaneous high efficacy. This reduces the probability of side effects [21] and leads to effects more comparable to the impact of Fluoxetine than to the impact of St. John’s Wort extract alone [22]. Passiflora is traditionally used in combination with other herbs as a mild sedative [23, 24]. The third plant, Valerian, is traditionally used in medical conditions of sleep disorders and nervous agitation [25]. The combination of all the three medical plants act on gamma-amino butyric acid (GABA) and serotonin (5-HT) receptors, which are recognized targets of pharmacological antidepressant treatment [26]. The aim of this observational study was the evaluation of safety and effectiveness of the treatment of nervous agitation due to affective disorders in children between 6 and 12 years of age with a fixed herbal combination containing St. John’s Wort, Valerian, and Passionflower. Material and Methods Study objectives After more than 40 years of experience with these plant extracts, we hypothesized that a combination of St. John’s Wort, Valerian, and Director: Fernando Estevez Castillo Homeonews 8 Edición N° 16 – Año 2012 Passionflower has positive impact on children with nervous agitation due to affective disorders. Study duration The duration of the study was from March 2008 to November 2009. Study design This multicenter, prospective observational study was conducted by 17 physicians (15 pediatricians, 1 neurologist, and 1 general practitioner) in Germany. Concept and design of the study as well as its ethical validity and performance are based on the actual recommendations of the Bu ndesinstitut für Arzneimittel und Medizinprodukte (BfArM, German Federal Institute for Drugs and Medical Devices) and referred to the Declaration of Helsinki and Good Clinical Practice. The study was registered on Clinical Trials under the trial registration number NCT 01125579. Furthermore, this study followed the actual strengthening the reporting of observational studies in epidemiology (STROBE) guidelines for items to be included in reports on observational studies [27]. Study setting Before the start of this study, the physicians got a briefing on the observational plan, the ethical and scientific basis of this multicenter, prospective observational study with observational character, the allocation procedure, and the therapy schedule in accordance with the study protocol. Data assessment included a physician-completed questionnaire and a standardized parent-report questionnaire (Child Behavior Checklist (CBCL/4-18)) on three occasions: before the treatment (visit 1, baseline), after approximately 2 weeks of the treatment (visit 2), and after approximately 4 weeks of the treatment (visit 3). The time point of final documentation was set at the physicians’ own discretion. The concomitant diseases were grouped according to the ICD-10 classification. All medications apart from the study medication were classified according to the—to that time current—“Rote Liste 2008”. Study participants The children were chosen by the responsible physician and enrolled after the informed written consent, and a data privacy policy statement had been obtained from their legal guardian. Information of possible unwanted side effects and the possibility to cancel the participation at any time without any negative impact on the treatment of the child were given to the legal guardian. Inclusion criteria were defined as follows: 6–12 years of age, history of nervousness and agitation (including agitated depression) due to affective disorders, informed consent to participate in the prospective cohort study obtained from the legal guardian. Exclusion criteria contained children younger than 6 years or older than 12 years of age, hypersensitivity to any of the Director: Fernando Estevez Castillo Homeonews 9 Edición N° 16 – Año 2012 ingredients, history of skin hypersensitivity to light, receiving phototherapy, or any photodiagnostic procedures. Variables studied Target parameters for effectiveness were the influence of child’s disease on everyday life of the family, the course of common symptoms, and the change in the parent’s questionnaire CBCL (Table 1). Interventions Doses and duration of the treatment with herbal medicine were at the respective physician’s discretion. The combination of three special dry extracts from Hypericum perforatum (St. John’s Wort herb), Valeriana officinalis (Valerian root), and Passiflora incarnata (Passionflower herb; Table 2) has been administrated as tablet via oral route. Study medication was prescribed by a physician and bought by the patient’s legal guardian. Director: Fernando Estevez Castillo Homeonews 10 Edición N° 16 – Año 2012 Results Participants Altogether 31 physicians were invited to collect data and 17 physicians agreed to participate in the study. They gathered correctly and completely filled-out case report forms of 115 children. Therefore, the participant rate was 54.8 %. Descriptive data The patient group involved in this study consisted of 69 boys (60 %) and 45 girls (39.1 %). No statement of sex was made for one child, which explains the missing 0.9 %. In average, the children were 9.4 years old (± 1.6) with an average weight about 35.4 kg (± 9.6). The inclusion diagnosis “nervous agitation” was made on average about 2.3 years ago. So, in the huge majority of the treated children (92.6 %), a subchronic or chronic pattern of symptoms was already present. Period of the treatment enfolded 2 weeks (n = 14), including visit 1 and visit 2 or about 4 weeks (n = 101) including all the three visits (Table 1). The average daily dose was 2–3 tablets in accordance with the recommend dose of 1–3 tablets per day. During the observation period, 16 children (13.9 %) received additional medications related to the inclusion diagnosis, mainly hypnotics/sedatives (64 %) and psychopharmaceuticals/ psychoanaleptics (12 %). Eightyfour percentages of the respective drugs were used as long-term medication. Up to three nonmedical therapies were reported for 61 children (53 %) such as psychological/ psychotherapeutic care (46.6 %) and progressive relaxation (19.2 %). Concomitant diseases were mentioned for 21 children (18.3 %), mainly emotional and behavioral disorders (40.7 %) and diseases of the respiratory system (18.5 %). For 14 children (12.2 %) concomitant medication was reported, mainly broncholytics/antiasthmatics, antiallergics, and dermatologics. Impairment of ordinary family life Behavioral disorders of children and their therapies always affect the everyday family life. At the first visit, parents estimated the impact via a visual analogue scale with 5.95 in the mean. After the treatment, this average value improved to Director: Fernando Estevez Castillo Homeonews 11 Edición N° 16 – Año 2012 3.86. Altogether, a clearly positive development was achieved in 86.7 % of children. Child behavior questionnaire Evaluation of the CBCL displays a detailed picture of the parents’ assessment from the beginning until the end of the observation time. In comparison to children of the same age, most of the children (up to 87.0 %) were assessed as “normal” concerning items of the competency scales at all visits. Some children showed aspects of “borderline abnormal” (up to 11.3 %) or “abnormal” (up to 13.0 %) behavior. Until the end of the observation most children kept their level. According to which the competency scale is viewed two to five children aggravated in their problems, while an improvement was achieved for nine to ten children. Analysis of syndrome scale items also showed that most children behaved “normal” (85.2–64.3 %, depending on the scale). The majority of children were stabilized in a normal behavior under the treatment. Slight aggravation of single participants was detectable in items of a schizoid/compulsive (four children) or dissocial behavior (three children). The highest proportion of “borderline normal” Director: Fernando Estevez Castillo Homeonews 12 Edición N° 16 – Año 2012 or “abnormal”-behaving children were detectable in the two scales “attention problems” (35.7 %) and “anxiety/depression” (29.6 %) (Fig. 1). Figure 1 gives an overview of the number of affected children, and the development they underwent during the therapy. A clear improvement was reported by legal guardians, whose children had attention problems, showed social withdrawal, and/or were anxious/depressive. Between 61.0 and 87.0 % of the affected children developed positively. In the same range was the progress of children with physical and/or social problems. Even children with a schizoid/compulsive behavior improved in their development. A little lower was the percentage of children with a clear progress when the participants showed dissocial (47.1 %) and/or aggressive behavior (50 %) at the beginning of the observation. Altogether, up to 69.6 % of children who were assessed as “borderline abnormal” or “abnormal” reached a “normal” assessment at the end of the observation period. The therapeutic success was not influenced by concomitant medication or therapies due to inclusion diagnosis. Assessment of common symptoms by the physician The statements about the problems of children with nervous agitation given by the CBCL were confirmed by physicians in aspects such as the high number of children affected by attention problems, anxiety/depression, aggressiveness, and/or physical problems. In addition to this, the results of the symptom query presented more details in some aspects. The scale “anxiety/depression” is divided into three symptoms, which showed that the amount of children suffering from examination anxieties (59.1 %) or other anxiety disorders (42.6 %) was much higher than the number of depressive children (29.6 %) in this study. Physical problems are also mentioned for lots of children such as tiredness/fatigue (54.8 %), abdominal/stomach pain (39.1 %), and/or headache (42.6 %). Problems to fall or stay asleep were mentioned in 53.9 and 33.9 % of the children, respectively. After the treatment, 81.6–93.9 % of the affected children had no or just mild symptoms concerning nine of thirteen evaluated symptoms such as depression, school/examination anxieties, further anxieties, sleeping problems, and different physical problems (Fig. 2). The percentage of children suffering from symptoms such as uncoordinated hyperkinesia, aggressiveness/irritability, lack of concentration, and learning disorders was clearly reduced in the end, too. Between 50.8 and 73.0 % of children with these problems had no or just mild symptoms in the end. In general, concomitant therapies or medication due to inclusion diagnosis did not affect the efficacy. At the end of the observation period, the number of children with just slight or no problems tended to be higher in cases without concomitant medication in learning problems/ partial performance problems and problems in falling asleep. A tendency for a better result with concomitant medication was reported for compulsive uncoordinated movements. Director: Fernando Estevez Castillo Homeonews 13 Edición N° 16 – Año 2012 Tolerability A good tolerability was reported for 97.4 % of the children. In seven cases, the tolerability was described as moderate or poor, because of paradox reactions (restlessness, weepiness, increased irritability, or aggressiveness) or other adverse events such as redness in cheekbone region (one case) or stomach pain (one case). All events were considered to have a possible relation to the study treatment. In 53 children (46.1 %), the therapy was continued after the end of the prospective cohort study. Discussion Contrary to various other diseases, nervous agitation due to depressive episodes is not measurable by definite laboratory findings. Each child shows an individual set of few to various symptoms with further variations in intensity. This is also reflected by the assessments of parents, other legal guardians, and physicians taking part in the presented study. Typical symptoms of the examined children were attention problems, anxieties, depression, and psychosomatic problems. However, approximately 40–50 % of children with these disorders do not have a response to medication or behavioral therapy alone [28, 29], and a combination of both is more effective [30]. On the other hand, psychotropic medications are used too early [7] and about 25 % of depressive adolescents develop substance abuse [31]. So, parents prefer nonmedical therapies as initial treatment because of the higher risk of side effects in therapies with chemical medication [30]. For these families, the tested herbal combination of St. John’s Wort, Valerian, and Passionflower offers a good alternative and fulfills the requested aspects. A good tolerability is represented by just a few mild and transient side-effects. The assessments of parents and physicians displayed a good efficacy on a broad spectrum of symptoms linked to inclusion diagnosis. Director: Fernando Estevez Castillo Homeonews 14 Edición N° 16 – Año 2012 Moreover, it is possible to adjust the treatment individually because the good efficacy was independent from concomitant nonmedical and medical therapies—with three exceptions. In situations of learning problems and problems falling asleep, the treatment without concomitant drug therapy due to inclusion diagnosis tended to be more successful. In comparison to that treatment of uncoordinated hyperkinesia seemed to be more effective with concomitant medication. Another advantage for use of the study medication in initial therapies is the fast onset: 3 h after first intake [22]. The experiences collected by long marketing history and supported by the recent results of the presented study showed that the study medication is useful in situations of psychological mood disorders and sleep disorders due to nervousness also in children between 6 and 12 years of age. Limitations Due to the officially required design of a multicenter, prospective observational study some limitations are given. Therefore, it is unavoidable that safety and effectiveness are observed without a placebo group and randomization. Lack of blinding, the subjectivity of assessments, and the potential impact of the relationship between child, parents, and physician on the child’s development may also be limitations. On the other hand, this type of study offered the possibility to prove the medication’s tolerability and effectiveness in everyday life beyond a strictly controlled environment of a clinical study. Acknowledgments We thank all physicians, parents, and children who participated in the study. Conflict of interests Financial support for the analysis was provided by PASCOE pharmazeutische Präparate GmbH, Germany. The sponsor had influence on the conduct of the analysis to the extent that management and evaluation of the data was conducted in the Department of Clinical Research of PASCOE pharmazeutische Präparate GmbH. References 1. Costello EJ, Erkanli A, Angold A. Is there an epidemic of child or adolescent depression? J Child Psychol Psychiatry. 2006;47(12):1263–71. 2. WHO. Adolescent mental health: mapping actions of nongovernmental organizations and other international development organizations. Geneva: WHO; 2012. 3. Bundesministerium für Gesundheit (Österreich). Gesundheit und Gesundheitsverhalten von österreichischen Schülern und Schülerinnen—Ergebnisse des WHO-HBSCSurvey 2010. Geneva: WHO; 2011. 4. Boyce WF, King MA, Roche J. Healthy settings for young people in Canada. Ottawa: Public Health Agency of Canada; 2008. 5. Public Health Agency of Canada. The Chief Public Health Officer’s report on the state of public health in Canada 2009. Ottawa: Public Health Agency of Canada; 2010. Director: Fernando Estevez Castillo Homeonews 15 Edición N° 16 – Año 2012 6. Bundesministerium für Gesundheit (Deutschland). Strategie der Bundesregierung zur Förderung der Kindergesundheit. Berlin: Bundesministerium für Gesundheit; 2008. 7. Correll CU, Kratochvil CJ, March JS. Developments in pediatric psychopharmacology: focus on stimulants, antidepressants, and antipsychotics. J Clin Psychiatry. 2011;72(5):655–70. 8. Taurines R, Gerlach M, Warnke A, et al. Pharmacotherapy in depressed children and adolescents. World J Biol Psychiatry. 2011;12:11–5. 9. Vitiello B. Prevention and treatment of child and adolescent depression: challenges and opportunities. Epidemiol Psychiatr Sci. 2011;20(1):37–43. 10. Costello EJ, Mustillo S, Erkanli A, et al. Prevalence and development of psychiatric disorders in childhood and adolescence. Arch Gen Psychiatry. 2003;60:837–44. 11. Larzelere MM, Wiseman P. Anxiety, depression, and insomnia. Prim Care. 2002;29(2):339–60. 12. Rosenberg RP. Sleep maintenance insomnia: strengths and weaknesses of current pharmacologic therapies. Ann Clin Psychiatry. 2006;18:49–56. 13. Hazell P. Depression in children and adolescents. BMJ Clin Evid. 2009;01:1008–39. 14. Tan KR, Brown M, Labouebe G. Neural bases for addictive properties of benzodiazepines. Nature. 2012;463(7282):769–74. 15. WHO. Pharmacological treatment of mental disorders in primary health care. Geneva: WHO; 2009. 16. Barnes J, Anderson LA, Phillipson JD. Herbal medicines. London: Pharmaceutical Press; 2002. 17. Muller WE, Singer A, Wonnemann M. Mechanism of action of St. Johns wort extract. Schweiz Rundsch Med Prax. 89(50):2111–21. 18. Gambarana C, Tolu PL, Masi F. A study of the antidepressant activity of Hypericum perforatum on animal models.Pharmacopsychiatry. 2001;34:42–4. 19. Chatterjee SS, Noldner M, Koch E, et al. Antidepressant activity of hypericum perforatum and hyperforin: the neglected possibility. Pharmacopsychiatry. 1998;31:7–15. 20. De Vry J, Maurel S, Schreiber R, et al. Comparison of hypericum extracts with imipramine and fluoxetine in animal models of depression and alcoholism. Eur Neuropsychopharmacol. 1999;9(6):461–8. 21. Fiebich BL, Knorle R, Appel K, et al. Pharmacological studies in an herbal drug combination of St. John’s Wort (Hypericum perforatum) and passion flower (Passiflora incarnata): in vitro and in vivo evidence of synergy between Hypericum and Passiflora in antidepressant pharmacological models. Fitoterapia. 2011;82(3):474–80. 22. Dimpfel W, Koch K, Weiss G. Early effect of NEURAPASâ balance on current source density (CSD) of human EEG. BMC Psychiatry. 2011;11:123. 23. Akhondzadeh S, Naghavi HR, Vazirian M. Passionflower in the treatment of generalized anxiety: a pilot double-blind randomized controlled trial with oxazepam. J Clin Pharm Ther. 2001;26(5):363–7. 24. Lakhan SE, Vieira KF. Nutritional and herbal supplements for anxiety and anxiety-related disorders: systematic review. Nutr J. 2010;9:42. 25. Andreatini R, Sartori VA, Seabra M. Effect of valepotriates (valerian extract) in generalized anxiety disorder: a randomized placebo-controlled pilot study. Phytother Res. 2002;16(7):650–4. 26. Gramowski A, Jugelt K, Stuwe S, et al. Functional screening of traditional antidepressants with primary cortical neuronal networks grown on multielectrode neurochips. Eur J Neurosci. 2006 24(2):455–65. 27. Von Elm E, Altman DG, Egger M, et al. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. PLoS Med. 2007;4(10):e296. Director: Fernando Estevez Castillo Homeonews 16 Edición N° 16 – Año 2012 28. James A, Soler A, Weatherall R. Cognitive behavioural therapy for anxiety disorders in children and adolescents. Cochrane Database Syst Rev. 2005;(4):CD004690. 29. Bridge JA, Iyengar S, Salary CB, et al. Clinical response and risk for reported suicidal ideation and suicide attempts in pediatric antidepressant treatment: a meta-analysis of randomized controlled trials. JAMA. 2007;297(15):1683–96. 30. Walkup JT, Albano AM, Piacentini J, et al. Cognitive behavioral therapy, sertraline, or a combination in childhood/anxiety. N Engl J Med. 2008;359(26):2753–66. 31. Birmaher B, Ryan ND, Williamson DE, et al. Childhood and adolescent depression: a review of the past 10 years. Part I. J Am Acad Child Adolesc Psychiatry. 1996;35(11):1427–39. ALOPATIA EVALUACION DE LA FUNCION SEXUAL MASCULINA EN PACIENTES CON SINTOMAS DEL TRACTO URINARIO INFERIOR (LUTS) ASOCIADOS CON HIPERPLASIA PROSTATICA BENIGNA (BPH) TRATADOS CON UN MEDICAMENTO FITOTERAPICO (PERMIXON), TAMSULOSINA O FINASTERIDE Zlotta ARa, Teillac Pb, Raynaud JPc, Schulman CCa. a Department of Urology, Erasme Hospital, University Clinics of Brussels, 808 route de Lennik, B-1070 Brussels, Belgium b Department of Urology, St-Louis Hospital, Paris, France c University Pierre and Marie Curie, Paris, France [European Urology 2005 Aug; 48(2):269-76] RESUMEN Objetivo: La función sexual es uno de los aspectos en el tratamiento de los síntomas del tracto urinario inferior (LUTS) asociados con la hiperplasia prostática benigna (BPH) que ha ganado cada vez más atención. Se compararon la influencia en la sexualidad masculina del Permixon, un extracto lipídico esteroideo de Serenoa repens, con Tamsulosina y Finasteride, utilizando un cuestionario específico validado, explorando las funciones sexuales de los pacientes. Métodos: Fue creada una base de datos que comprende a pacientes de tres estudios principales randomizados a doble ciego - Permixon vs. Finasteride, Permixon vs. Tamsulosin and Permixon 160 mg vs. 320 mg, incluyendo un total de 2511 pacientes. Trecientos cincuenta y cuatro fueron de Tamsulosina, 545 de Finasteride y 1612 de Permixon. LUTS fue evaluado utilizando el cuestionario I-PSS. Se registraron las tasas de flujo máximo y el volumen prostático. Se utilizó el cuestionario MSF-4, que incluye 4 temas que exploran Director: Fernando Estevez Castillo Homeonews 17 Edición N° 16 – Año 2012 el interés del paciente en el sexo, la calidad de la erección, el logro del orgasmo y la eyaculación. Este cuestionario fue mostrado como altamente reproducible y clínicamente válido a través de diferentes culturas. Los coeficientes de correlación fueron dados para evaluar la relación lineal entre las variables contínuas. Resultados: A los 3 meses, no hubo diferencias estadísticamente significativas entre los tres grupos de tratamiento, en términos de I-PSS o Qmax evoluciones (todos valores de p > 0.05). A los 6 meses, cuando se los compara con los datos previos al tratamiento, hubo un ligero incremento en los desórdenes sexuales en los pacientes tratados con Tamsulosina (+0.3) y Finasteride (+0.8), mientras se dio una ligera mejoría en la terapia con Permixon (-0.2). Los efectos adversos más frecuentemente reportados, después de Tamsulosina o Finasteride, fueron los desórdenes en la eyaculación (ambos +0.2 en el específico cuestionario MSF-4 pregunta 4). No hubo correlación entre la evolución de las puntuaciones en el MSF-4 y la evolución en el I-PSS ni en los pacientes tratados con Permixon, Finasteride o Tamsulosina. Sin embargo, hubo una ligera correlación entre la puntuación de MSF-4 al inicio del estudio y el I-PSS en la línea de base (r2 = 0.032). Aunque hubo correlación entre el MSF-4 y la edad, al inicio del estudio (r2 = 0.1452), no hubo correlación entre la evolución en el MSF-4 durante el tratamiento y la edad de los pacientes. Conclusión: El presente estudio demuestra que la terapia con Permixon no tuvo impacto negativo sobre las funciones sexuales masculinas. Tanto el Finasteride como la Tamsulosina, tuvieron un ligero impacto sobre dichas funciones, especialmente en la eyaculación, aunque estos efectos fueron raros y en línea con los reportes previos que existían sobre estas dos drogas. EL IMPACTO DE LAS BENZODIACEPINAS SOBRE LA APARICION DE LA PNEUMONIAY LA MORTALIDAD POR LA MISMA: UN ESTUDIO DE CASO Y CONTROL ANIDADO Y ANALISIS DE SOBREVIDA EN UN COHORTE DE BASE POBLACIONAL Eneanya Obioara1, Richard Hubbard1, Robert D Sanders2,3, Puja R Myles1 1 Division of Epidemiology and Public Health, University of Nottingham, Nottingham, UK Department of Leucocyte Biology and Anaesthetics, Intensive Care and Pain Medicine, Imperial College London, London, UK 3 Wellcome Department of Imaging Neuroscience, University College London, London, UK 2 [Thorax doi:10.1136/thoraxjnl-2012-202374] Resumen Director: Fernando Estevez Castillo Homeonews 18 Edición N° 16 – Año 2012 Objetivos: Las benzodiacepinas han sido asociadas con un incremento en la incidencia de infecciones, y mortalidad por sepsis, en enfermos críticos. Aquí, nosotros determinamos el efecto del uso de social de las benzodiacepinas en la aparición y la mortalidad por pneumonía. Métodos: A través de un estudio de caso y control anidado, utilizando 29.697 controles y 4964 casos de pneumonía adquirida en la comunidad (CAP) a partir de la Red de Mejoramiento de la Salud, base de datos de Atención Primaria de la Salud, en Reino Unido (2001–2002), investigaron la asociación entre las benzodiacepinas y la aparición de pneumonía mediante regresión logística condicional. El modelo de regresión de Cox, se utilizó para determinar el impacto de las benzodiacepinas en la mortalidad de los 4964 casos de CAP. Los resultados son presentados como OR ajustados, HR ajustados e intervalo de confianza 95% (CI). Resultados: La exposición a las benzodiacepinas fue asociada con un incremento en el riesgo de pneumonía (OR 1.54, 95% CI 1.42 to 1.67). Individualmente, el diazepam, lorazepam y temazepam, pero no el clordiazepóxido, fueron asociados con un incremento en la incidencia de CAP. Como una clase, las benzodiacepinas, se asociaron con un incremento de 30 días (HR 1.22 (95% CI 1.06 to 1.39)) y mortalidad a largo plazo (HR 1.32 (95% CI 1.19 to 1.47)) en pacientes con un diagnóstico previo de CAP. Individualmente, el diazepam, clordiazepóxido, lorazepam y temazepam, afectaron la mortalidad a largo plazo, en estos pacientes. Conclusiones: Las benzodiacepinas fueron asociadas con un incremento del riesgo de contraer y de mortalidad por CAP. Estos datos sugieren una necesidad de más investigaciones en el perfil de seguridad inmunitario de las benzodiacepinas. HOMEOPATIA EFECTO DE LOS MEDICAMENTOS HOMEOPATICOS EN EL ESTUDIO POLISOMNOGRAFICO DEL SUEÑO EN ADULTOS JOVENES CON ANTECEDENTES DE INSOMNIO RELACIONADO AL CONSUMO DE CAFE Iris R. Bell a,b,c,d, Amy Howerter a,e, Nicholas Jackson a,d, Mikel Aickin a, Carol M. Baldwin f, Richard R. Bootzin c a Department of Family and Community Medicine, The University of Arizona College of Medicine, Tucson, AZ, USA b Department of Psychiatry, The University of Arizona College of Medicine, Tucson, AZ, USA c Department of Psychology, The University of Arizona, Tucson, AZ, USA d Mel and Enid Zuckerman College of Public Health, The University of Arizona, Tucson, AZ, USA e Division of Family Studies and Human Development, The University of Arizona, Tucson, AZ, USA f College of Nursing and Health Innovation, Office of World Health Promotion & Disease Prevention, Arizona State University, Tempe, AZ, USA Director: Fernando Estevez Castillo Homeonews 19 Edición N° 16 – Año 2012 [Sleep Medicine 2011 May;12(5):505-11] RESUMEN Antecedentes: La Homeopatía es una medicina alternativa ampliamente distribuida en todo el mundo, basada en los informes subjetivos de los pacientes, para el diagnóstico y tratamiento. La polisomnografía ofrece una metodología moderna para la evaluación objetiva de los efectos de la ingesta de los medicamentos homeopáticos que los médicos indican para mejorar la calidad del sueño en sujetos sensibles. Estudios previos en animales han demostrado algunos cambios en los sueños sin movimientos oculares rápidos, con ciertos medicamentos homeopáticos. Métodos: Participaron del estudio, de un mes de duración, adultos jóvenes de ambos sexos (edades 18–31) con puntuaciones promedio superiores en escalas estandarizadas de personalidad para hostilidad cínica o sensibilidad a la ansiedad (pero no ambas) y una historia de insomnio inducido por el consumo de café. Los registros polisomnográficos fueron obtenidos en sus casas, en dos noches sucesivas por semana, para un total de 8 registros (noches 1, 2, 8, 9, 15, 16, 22, 23). Sujetos: (N = 54) recibieron glóbulos placebo en la noche 8 (ciego simple) y glóbulos verum en la noche 22 (doble ciego) a la 30c de uno de los dos medicamentos homeopáticos, Nux Vomica o Coffea Cruda. Los individuos completaron el índice de calidad de sueño de Pittsburgh, previo al comienzo de la polisomnografía y al final del estudio de cada semana, así como también la escala del perfil del estado de ánimo antes de acostarse en las noches correspondientes al estudio. Resultados: los remedios Verum incrementan significativamente el tiempo total de sueño y NREM (sueño sin movimientos oculares rápidos), así como también los despertamientos y cambios de fases. Los cambios en la actigrafía y en la escala de autoevaluación de los efectos, no fueron significativos. Conclusiones: El estudio demostró la viabilidad del uso, en los hogares, de los registros del sueño de todas las noches, para estudiar los efectos de los medicamentos homeopáticos. Los resultados son simlares, aunque no idénticos, a aquellos reportados en animales con los mismos remedios. Los posibles mecanismos de acción, incluyen la interrupción inicial de la dinámica del los patrones del sueño no linear, por parte de los medicamentos Verum. Palabras clave: Medicina alternativa y complementaria, homeopatía, polisomnografía, café, insomnio, adultos jóvenes, Coffea cruda, Nux vómica. ARTICULO ORIGINAL Director: Fernando Estevez Castillo Homeonews 20 Edición N° 16 – Año 2012 Introduction Previous studies in many different countries have shown that a substantial proportion of the general population, especially individuals with chronic illnesses, use various types of complementary and alternative medicine (CAM) [1–4]. Among CAM users, insomnia and depression/anxiety are common conditions for which they seek alternative therapies [4,5]. Homeopathy, a 200year-old whole system of CAM developed by a German physician, is one of the mostly widely known [6] and controversial modalities [7–9] for which clinicians and consumers worldwide chaim therapeutic benefit in sleep disturbances and fatigue, as well as other medical and psychiatric conditions [10–14]. Homeopathic clinicians often rely on subjective changes in sleep quality and increased mental/physical energy as early indications of the actions of homeopathic medicines (termed ‘‘remedies”) [15]. But the relative lack of objective measures to evaluate homeopathy in human subjects has thus far hindered advances in both clinical care and research. Polysomnography (PSG), which can distinguís divergent findings, if present, between subjective sleep complaints and objective all-night sleep recording assessments in certain types of insomnia [16–18], offers a potentially valuable tool for homeopathic investigations. Multiple studies on healthy animals have shown measurable effects on sleep of three different homeopathic remedies at potencies prepared to a dilution past Avogadro’s number (Histamine, Coffea Cruda, and Nux Vomica) compared with placebo. Each remedy at a 30c potency altered sleep patterns notably with differential effects on electroencephalographic delta frequency (0.5– 2.5 Hz) power during sleep [19–22]. Other investigators have demonstrated effects of Nux Vomica 30c on alcohol-induced sleep time in mice [23,24]. Clinically, homeopaths report that Coffea Cruda patients are mild and timid, but also irritable and oversensitive to all types of sensory stimuli, especially noise, as well as to positive emotions [25,26]. Nux Vomica as a homeopathic remedy is used clinically to treat people with competitive, irritable and impatient Type Alike behavioral patterns and tendencies to abuse alcohol, caffeine, and other substances. Both Coffea Cruda and Nux Vomica patients report insomnia in the middle of the night as a symptom [27]. Taken together with the clinical reports, the animal EEG sleep data provide a basis for selecting Coffea Cruda and Nux Vomica as candidate homeopathic remedies to test in the first homeopathic PSG research on human subjects. The primary purpose of the present within-subjects feasibility study was to examine the PSG effects of one dose of placebo versus either Coffea Cruda 30c or Nux Vomica 30c in relatively healthy young adult human subjects with a past history of coffee-induced insomnia. Because of the importance of personcentered factors in clinical expectations of remedy effects [27,28], inclusion criteria included individual difference traits of increased levels of either anxiety sensitivity or of Type A cynical hostility. Based on the animal studies, the remedy effects were hypothesized to include changes in both quantity and quality (variability in sleep stage changes and in awakenings after sleep onset) Director: Fernando Estevez Castillo Homeonews 21 Edición N° 16 – Año 2012 of NREM sleep, especially slow wave sleep, after controlling for within-subject baseline sleep patterns and placebo effects. 2. Methods 2.1. Subjects Potential subjects were identified by screening young adult male and female college students (age range 18–31) enrolled in the introductory psychology class at the University of Arizona, for scores on the 16-item anxiety sensitivity index (ASI) [29], the 27-item Cook–Medley Cynical Hostility Scale (CMHO) [30], and one 5-point rating item on self-rated physical health [31]. All potential subjects had to score P3 out of 5 on a rating of global health and give a history of coffee-induced insomnia in the past. The anxiety sensitivity and hostility classifications were used to select the study participants, such that individuals were chosen to be high hostile (above CMHO mean, below ASI mean) or high anxiety sensitive (below CMHO mean, above ASI mean). Above- and belowmean cutoffs for inclusion in the high anxiety sensitivity subgroup were P16.8 for males and P19.1 for females on the ASI and <11.0 on the CMHO; for the high hostility subgroup <16.8 for males and <19.1 for females on the ASI andP11.0 on the CMHO. These cutoffs were determined by the study statistician using the mean scores computed from the first 1036 people screened for the study and are comparable to means published with similarly aged samples [32–35]. Subjects were dynamically assigned [36] to one of the two remedies, Nux Vomica or Coffea Cruda, using their CMHO and ASI scores, age, and sex as balancing factors. The study was reviewed and approved by the University of Arizona Institutional Review Board. Research staff contacted eligible individuals and obtained written informed consent for the 4-week homebased PSG study participation. Because of the belief by some homeopaths that beverage coffee (but not caffeine) sometimos antidotes homeopathic remedies, subjects had to be willing to eliminate drinking coffee for the full duration of the study, although they were encouraged to change to and stabilize prior noncoffee caffeinated beverages to maintain their customary daily caffeine intake without interruption, if necessary. Exclusion criteria were pregnancy or planning to become pregnant, major psychiatric or serious chronic medical conditions, chronic use of medications other than contraceptive drugs, and/or a history of anaphylactic shock. Subjects were paid $300 for their month-long participation. Table 1 summarizes descriptive characteristics of the study participants. 2.2. Procedures Participants underwent a total of eight all-night PSG and actigraphic recordings in their own homes, distributed as 4 weekly pairs of consecutive nights (Week 1 baseline; Week 2 single-blind placebo pellets on night 8; Week 3 repeat baseline; Week 4 double- blind verum homeopathic remedy pellets on night 22). Thus, PSGs were performed on nights 1–2, 8–9, 15–16, and 22–23 of study participation. Subjects were instructed not to consume alcohol on the day of the recordings and not to consume caffeinated beverages or tobacco for 6 h prior to Director: Fernando Estevez Castillo Homeonews 22 Edición N° 16 – Año 2012 each PSG, but were otherwise encouraged to maintain their own habitual dietary and sleep–wake patterns in order to obtain naturalistic data. The inclusion of baseline recordings on nights 1, 2, 15, and 16 enabled the establishment of typical sleep characteristics as a control for detecting effects of taking pellets on nights 8 and 22. Although subjects took no pellets on nights 9 or 23, most homeopaths claim to see evolving changes over time in patients for days to weeks and even months after administration of even a single 30c potency dose to patients [37–41]. Basic science and animal studies offer some empirical support for such an assertion [21,42–44]. Therefore, with the clinical prediction of carryover effects from pellet night 22 to no-pellet night 23, the placebo week with recordings on nights 8 and 9 were similarly structured. Because of the claim of persistent effects of homeopathic remedies for variable periods of days to weeks after the last dose [45], the placebo condition was always placed prior to the 2-arm verum condition in time rather than attempting a simultaneous placebo versus remedy or counterbalanced crossover design (see also Walach’s entanglement considerations for homeopathic study designs [46]). Director: Fernando Estevez Castillo Homeonews 23 Edición N° 16 – Año 2012 All subjects completed the Pittsburgh sleep quality index (PSQI) [47,48] five times during the study, at baseline prior to the PSG sessions, and at the end of each study week. Prior to lights out on PSG nights, subjects also completed a profile of mood state (POMS) [49] scale. Bedtimes and sleep periods varied in accord with each individual’s customary bedtime and waking time habits. Nevertheless, subjects were asked to choose the specific consecutive two days of the week when the weekly recordings occurred and to undergo the PSGs on the same two days of the week for each of the 4 weeks. Subjects completed a daily morning sleep quality rating over the 4 weeks of participation. Indistinguishable placebo and verum remedy pellets (Coffea Cruda 30c, Nux Vomica 30c) were purchased from Hahnemann Laboratories, Inc. (San Rafael, CA), an FDA-regulated homeopathic pharmacy experienced in collaborating on research study protocols. The #30 lactose–sucrose dry pellets were certified for purity and lack of contaminants by an independent testing laboratory. All vials of placebo and remedy were number-coded, labeled for blinding, and assigned sequentially by subject number on the basis of a design adaptive allocation procedure appropriate for small sample studies [50,51]. Consistent with clinical practice, subjects were asked to dissolve three pellets from their assigned study vials under the tongue on night 8 (placebo) and night 22 (verum). On verum night 22, half of each personality type group received Coffea Cruda 30c and half received Nux Vomica 30c. 2.3. Polysomnographic and actigraphic recordings Ambulatory PSGs were performed using Cadwell Laboratories Inc. Easy Ambulatory 2 system equipment (Kennewick, WA). Recordings include six unipolar EEG channels (C3, C4, Cz, Pz, O1, and O2 referenced to contralateral mastoids), bilateral electrooculograms (EOG), mental/submental electromyogram, and a two-lead electrocardiogram (bilateral sub-clavicle electrode placement). Electrode impedance levels were kept below 5 kO. Equipment settings for data acquisition included an EEG sampling rate of 200 Hz, a low pass filter set at 35 Hz and a high pass filter set at 0.53 Hz. A 60 cycle notch filter was used to eliminate ambient electrical noise. Actigraphic data were collected using a Mini Mitter Inc., Actiwatch-64 (Bend, OR) worn on the subjects’ left wrist. The Actiwatch was programmed to record in 15-s epochs, with movement sampled at 32 Hz. The actigraphs were analyzed using Actiware-Sleep version 3.4 software (Mini Mitter Inc.), with wake-threshold sensitivity set to medium. Actigraph Bedtime and Uptime were entered as the lights out and lights on time, respectively, as determined by the PSG recording. Technicians performed the hookups in the subjects’ homes prior to customary bedtimes and departed until the next day when they picked up the equipment for data downloading. Data were scored in 30-s epochs in accord with standard Rechtschaffen–Kales criteria [52] by a sleep technician certified to 94% interrater reliability criteria by a registered PSG technician and blinded to the remedy Director: Fernando Estevez Castillo Homeonews 24 Edición N° 16 – Año 2012 received. Arousal scoring was performed in accordance with the American Academy of Sleep Medicine guidelines [53]. Subjects initiated a marker for lights out by a button press on the Cadwell Easy Ambulatory 2 unit. Nights on which subjects had less than 4 h of scorable sleep were not used in the analyses as previous sleep studies have done [54,55]. Setting a minimum threshold for time in bed (TIB) is a common control in ambulatory sleep studies [55] to prevent skewed values of variables dependent on TIB, such as sleep efficiency which is computed as total sleep time (TST) divided by TIB. 2.4. Statistics Based on the clinical literature and animal studies, primary outcome variables of interest were total sleep time, slow wave sleep, stage changes, and awakenings after sleep onset, as a function of verum remedy versus placebo across all subjects. Given the exploratory and early research phase nature of the current study on human subjects, however, PSG sleep onset and rapid eye movement (REM) latencies, REM and other NREM stages, as well as actigraphic measures of TST, sleep onset latency, sleep efficiency, and fragmentation index, were examined secondarily for possible effects. The focus of the current paper is the effects of remedies themselves. Subsequent papers will report on the interactions between remedy effects and personality types for POMS and individual night effects on spectral EEG. To facilitate use of personality as a covariate in regression models, a net personality score (CMASI) was computed as a unitary continuous variable, using the values from the ASI and CMHO, where a higher value signified greater hostility and less anxiety sensitivity. CMASI scores are a linear combination of the CMHO and ASI which varied from 0 to 1, with large values denoting high CMHO and low ASI and small values denoting low CMHO and high ASI. Due to the design of the study, CMHO and ASI scores are inversely related. Using the sleep outcome variables listed above as dependent variables, we tested whether the outcome variable for the verum week (nights 22, 23) differed from means for the placebo week (nights 8, 9) after adjusting for the mean for the four baseline nights (1, 2, 15, 16). Averaging all four baseline nights helped lessen any confounds from first-night effects in the home setting on study night 1 by providing multiple assessments of the subjects’ usual sleep patterns without study medications in both Weeks 1 and 3 of the protocol. We utilized a random effect regression model for analysis, with person as the random effect. The regression equations each controlled for sex, the CMASI net personality score, the baseline value of the outcome variable, and total time in bed. For example, we tested whether a subject’s Week 4 (verum) stage changes differed from their Week 2 (placebo) stage changes, after adjusting for their own baseline stage changes, sex, CMASI and total time in bed. Director: Fernando Estevez Castillo Homeonews 25 Edición N° 16 – Año 2012 Descriptive statistics, t-tests, and v2 analyses were used to assess demographic variables. STATA 10.0 was used for all data reduction and analyses. 3. Results A total of 4279 people were screened for the study. Seventy people met all eligibility criteria, volunteered and enrolled in the study. But 5 participants who started the study were administratively withdrawn due to early protocol violations making them ineligible for study participation (e.g., beginning medication on the exclusion list, an undisclosed health problem on the exclusion list). Three subjects opted out of the study (e.g., schedule conflicts, catching the flu) prior to treatment allocation and 3 subjects were not within the targeted age range for the present study, leaving a total of 59 participants who received the homeopathic treatment and completed the study. Five subjects from the remaining 59 enrolled participants did not meet the criterion for the minimum 4 h of sleep per night and/or did not have enough data on their baseline recordings for analysis. The results reported reflect the findings from the remaining 54 participants (allocated to Coffea Cruda [n = 26] or Nux Vomica [n = 28] on night 22). In-home recordings pose unique challenges for data quality. Portions of different nights and unavailability for some subjects on certain nights contributed to difficulties obtaining complete data. Individual electrodes or, rarely, the main battery pack cables detached during the sleep period on various nights in different subjects, resulting in partial data loss. On average, out of the 4 possible baseline nights (nights 1, 2, 15, 16) subjects contributed 2.96 ± 1.00 baseline nights. There were two possible nights of data on both placebo and remedy weeks. Subjects on average contributed 1.39 ± 0.74 and 1.33 ± 0.67 days, respectively, on placebo and remedy week. Outcome data on missing nights (due to the absence of data or failure to meet the sleep quality standard) were imputed as follows: any values that had valid data on any preceding or following night in the study design were determined by linear interpolation. Then, any remaining missing values were filled in by carrying the last value forward. The final sample of young adults (N = 54) in the current report had a mean age of 20 SD 2 years (50% female). Table 1 shows that the subsets of subjects who received Coffea Cruda (n = 26) versus Nux Vomica (n = 28) did not differ in age, gender distribution, CMASI, PSQI, baseline PSG and sleep diary parameters. Table 2 gives the verum effects in comparison with placebo and significance levels for the effects of the remedies together and separately. These effects are reported using unstandardized coefficients with standard errors to interpret the variables in their unit of measurement. When data from the two remedies were combined, overall PSG for the remedy week showed significantly longer TST, increased NREM sleep including more minutes in stage 2 and increased slow wave sleep (SWS), with a trend toward increased minutes of stage 4 sleep (b = 5.8, P < 0.10) compared with placebo. Remedies also led to more sleep disruptions after sleep onset, with significantly increased awakenings, number Director: Fernando Estevez Castillo Homeonews 26 Edición N° 16 – Año 2012 of stage changes, and more type 2 arousals compared to placebo. In the remedy-specific within-subject analyses, Coffea Cruda and Nux Vomica recipients both showed similar significant effects of increasing TST and NREM on verum as compared with placebo nights. But only Nux Vomica effects were significant for increases in type 2 arousals and on the Arousal Index on verum versus placebo nights. Differences between Nux Vomica and Coffea Cruda treatment groups for remedy week nights 22 and 23 were compared. The only variable with a significant difference was a lower arousal index for the Coffea Cruda recipients (b = 1.24, 95% confidence interval 2.5 to 0.01, t = 2.1, P = 0.049). Nux Vomica and Coffea Cruda recipients did not significantly differ on the remaining variables listed in Table 2. Within-subject analyses of the actigraphic measures, which depend on indications of gross motor activity of the wrist rather than EEG, showed no significant treatment effects on TST, sleep onset latency, sleep efficiency, or fragmentation index. For the subjective measures, individuals receiving Coffea Cruda showed a trend toward a decrease in POMS fatigue on the post-verum night compared with the post-placebo night (Table 2). Overall, remedy (verum) week was not different from placebo week on the subjective ratings of global sleep quality on the weekly PSQI, after controlling for baseline values. On the daily morning sleep diary ratings (3 possible categories: fatigued, somewhat refreshed, refreshed), the only finding was a trend toward poorer subjective sleep for Nux Vomica compared with placebo in a logistic regression, controlling for personality and sex (OR 0.29, CI 0.08–1.11, P = 0.07). 4. Discussion The current study demonstrates the feasibility of using in-home all-night sleep recordings with ambulatory PSG equipment in young adults to assess the effects of homeopathic remedies. Both remedies led to an increase in TST reflected mainly in increased NREM sleep. The increased NREM time is similar to observations from previous animal sleep studies with Coffea Cruda 30c [19– 21]. Director: Fernando Estevez Castillo Homeonews 27 Edición N° 16 – Año 2012 In addition, consistent with the animal data showing increased variability of EEG sleep after Nux Vomica 30c [56], the human subjects in the present study had a significant increase in stage changes on remedy nights compared to those on placebo nights. The Nux Vomica group also demonstrated a higher arousal index than did the Coffea Cruda subjects. Despite an increase in sleep disruption after sleep onset, manifested by more awakenings on remedy week nights versus placebo nights, POMS fatigue ratings were lower for the remedy nights. Notably, during open-ended exit interviews while still blinded, many subjects reported their perceptions of greater sleep disruption following placebo, compared to remedy nights. The POMS fatigue subscale findings are consistent with the latter qualitative observations. One possible interpretation of the data could be that the seeming changes in sleep during the remedy week resulted from the passage of time and general adaptation of subjects to the study protocol and equipment, rather than that of remedy effects. The objective findings, however, are not fully consistent with a time effect by itself. The regression analyses were controlled for PSG sleep variable findings not only on nights 1–2, but also on nights 15–16. If subjects were simply sleeping better as time passed in the study without a role for the remedies themselves, then awakenings and other measures of transient sleep disturbances during the night should have decreased by the remedy week (study Week 4). Instead, even though TST increased, the number of awakenings, sleep stage changes, and arousal index increased, especially with Nux Vomica 30c. Moreover, personality type interacted with the specific remedy received to produce differential changes in the POMS; effects are reported elsewhere [57]. Thus, even if the passage of time contributes to some of the apparent differences between theWeek2 placebo and Week 4 remedy findings, the data suggest remedy effects beyond those from the simple passage of time. Individual susceptibility to unique remedy-specific, as opposed to non-specific placebo, symptoms in healthy human subjects appears characteristic of other widely-used homeopathic remedies in 30c potency as well [58]. The use of objective markers of remedy effects such as PSG recordings offers an innovative approach to advancing work in a controversial area such as homeopathy, where most contested clinical studies rely on subjective assessments alone. Waking EEG also has shown promise in documenting the effects of individualized homeopathic remedies on patient populations [59,60]. In the present study, it is notable that the PSG but not the actigraphic measures showed remedy effects above those attributable to placebo. The ability of homeopathic remedies to cause subtle and unique subjective symptoms that conventional standardized questionnaires can miss [58] and the current observation of significant remedy effects on sleep EEG, but not actigraphy, suggest caution in relying solely on actigraphy for future sleep studies of homeopathic remedies. Because of the dependence on muscle movement, actigraphy can underestimate sleep latency, waking periods, and Director: Fernando Estevez Castillo Homeonews 28 Edición N° 16 – Año 2012 total sleep time as compared with PSG recordings whenever subjects are awake, but physically inactive [61]. The study design was deliberately structured with single-blind placebo preceding allocation to one or the other of the two double-blind remedies in order to address a different potential methodological and theoretical concern, i.e., the reported risk of non-local or entanglement confounds of placebo and remedy effects, when treatment arms are administered double-blind in a closed system of a homeopathic study. Keeping the experimental system open with single-blind placebo may have provided a strategy to reduce the risk of entanglement between placebo and remedy effects [62–65]. The mixed directionality of the sleep changes on remedy nights, i.e., some improvements and some disruptions in PSG variables, is consistent with the clinical literature and practice theory [15,66,67]. That is, homeopaths claim bidirectional and mixed direction effects for their remedies under several common circumstances dependent on (a) initial state of the host; and/or (b) differential direction of global versus local effects (improved global with worsened local changes). Nonlinear, bidirectional effects of homeopathic remedies, especially early in the course of the response, are consistent with state dependency. That is, the same remedy at the same potency (e.g., 30c) can cause a set of transient symptoms in a healthy person, but alleviate similar symptoms in a sick person or animal [66]. Given previous data on evolving nonlinear changes over time after administration of homeopathic remedies [22,68], further examination of the dynamics of the physiological and self-report measures over time will be essential [69]. The brief time period in which the PSG recordings were obtained following remedy administration (2 nights) would reflect only an initial, destabilized transitional phase in the dynamic response to the remedies [70]. In summary, the current findings on human sleep are similar but not identical to previously-reported, objectively-measurable effects of the same two homeopathic remedies on animals. Future studies are needed to evaluate longitudinal changes in EEG dynamics and to examine evolution of sleep patterns over a much longer period of time after remedy administration in persons with primary insomnia and in healthy individuals. Overall, the sleep literature on various forms of alternative medicine, including homeopathy, is very limited, requiring more rigor and more study [71–73]. Moreover, the present findings do not address the question of whether or not either of the homeopathic remedies tested here would be therapeutic for certain people with insomnia. Rather, the data provide initial evidence for feasibility of the PSG methodological approach and the ability of homeopathic remedies to alter objective sleep in human subjects. New basic science evidence begins to address some of the major concerns of skeptics about the plausibility of biological activity in homeopathic remedies [43,44,74–78]. Several different laboratories have reported measurable physicochemical changes in the solvent during the succussion (vigorous shaking) Director: Fernando Estevez Castillo Homeonews 29 Edición N° 16 – Año 2012 procedure in homeopathic remedy preparation, even when the dilution process takes the original source material past Avogadro’s number of molecules. Thus, the data open the door to reconsidering the biological as well as psychological effects of adjunctive use of homeopathic remedies in human subjects [79]. Acknowledgments This study was supported by National Center for Complementary and Alternative Medicine Grants R21 AT000388 and K24 AT000057 to IRB. The authors would like to thank Keith Fridel, PhD RPSGT for training and supervising the sleep scoring, and Elizabeth Acker, Michael Biuso, Erica Morey, Molly Taylor, and Alivia Wieseler for their technical assistance in data collection and quality assurance procedures. Dr. Bell serves as a consultant to Standard Homeopathic Co./Hyland’s Inc., a homeopathic manufacturer whose products were not used in the current study. Standard Homeopathic Co./Hyland’s Inc. did not provide any funding for the current study. References [1] Menniti-Ippolito FGL, Bologna E, Forcella E, Raschetti R. Use of unconventional medicine in Italy: a nation-wide survey. Eur J Clin Pharmacol 2002;58:61–4. [2] Becker-Witt C, Lüdtke R, Weisshuhn TE, Willich SN. Diagnoses and treatment in homeopathic medical practice. 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Electroencephalographic alpha sensitization in individualized homeopathic treatment of fibromyalgia. Int J Neurosci 2004;114:1195–220. [61] Morgenthaler T, Alessi C, Friedman L, Owens J, Kapur V, Boehlecke B, et al. Practice parameters for the use of actigraphy in the assessment of sleep and sleep disorders: an update for 2007. Sleep 2007;30:519–29. [62] Walach H. Entanglement model of homeopathy as an example of generalized entanglement predicted by weak quantum theory. Forschende Komplementarmedizin und Klassische Naturheilkunde 2003;10:192–200. [63] Mollinger H, Schneider R, Loffel M, Walach H. A double-blind, randomized, homeopathic pathogenetic trial with healthy persons: comparing two high potencies. Forschende Komplementarmedizin und Klassische Naturheilkunde 2004;11:274–80. [64] Walach H. Generalized entanglement: a new theoretical model for understanding the effects of complementary and alternative medicine. J Altern Complement Med 2005;11:549–59. [65] Walach H, Mollinger H, Sherr J, Schneider R. Homeopathic pathogenetic trials produce more specific than non-specific symptoms: results from two doubleblind placebo controlled trials. J Psychopharmacol 2008;22:543–52. [66] Bertani S, Lussignoli S, Andrioli G, Bellavite P, Conforti A. Dual effects of a homeopathic mineral complex on carrageenan-induced oedema in rats. Br Homoeopathic J 1999;88:101–5. [67] Bellavite P. Complexity science and homeopathy: a synthetic overview. Homeopathy 2003;92:203–12. [68] Hyland ME, Lewith GT. Oscillatory effects in a homeopathic clinical trial: an explanation using complexity theory, and implications for clinical practice. Homeopathy 2002;91:145–9. [69] Bell IR, Koithan M. Models for the study of whole systems. Integr Cancer Ther 2006;5:293–307. [70] Hollenstein T. State space grids: analyzing dynamics across development. Int J Behav Dev 2007;31:384–96. [71] Stevinson C, Ernst E. Valerian for insomnia: a systematic review of randomized clinical trials. Sleep Med 2000;1:91–9. [72] Freire AO, Sugai GC, Chrispin FS, Togeiro SM, Yamamura Y, Mello LE, et al. Treatment of moderate obstructive sleep apnea syndrome with acupuncture: a randomised, placebo-controlled pilot trial. Sleep Med 2007;8:43–50. [73] Yeh GY, Mietus JE, Peng CK, Phillips RS, Davis RB, Wayne PM, et al. Enhancement of sleep stability with Tai Chi exercise in chronic heart failure: preliminary findings using an ECG-based spectrogram method. Sleep Med 2008;9:527–36. [74] Rey L. Thermoluminescence of ultra-high dilutions of lithium chloride and sodium chloride. Physica A 2003;323:67–74. Director: Fernando Estevez Castillo Homeonews 33 Edición N° 16 – Año 2012 [75] Rey L. Can low-temperature thermoluminescence cast light on the nature of ultra-high dilutions? Homeopathy 2007;96:170–4. [76] Roy R, Tiller W, Bell IR, Hoover MR. The structure of liquid water: novel insights from materials research and potential relevance to homeopathy. Mater Res Innov 2005;9:557–608. [77] Rao ML, Roy R, Bell IR, Hoover R. The defining role of structure (including epitaxy) in the plausibility of homeopathy. Homeopathy 2007;96:175–82. [78] Rao M, Roy R, Bell IR. Characterization of the structure of ultra dilute sols with remarkable biological properties. Mater Lett 2008;62:1487–90. [79] Witt C, Albrecht H, editors. New directions in homeopathy research. Essen, Germany: KVC Verlag; 2009. NUTRICION VARIACION DE LOS EFECTOS DE TRES DESAYUNOS DIFERENTES SOBRE LA SACIEDAD SUBJETIVA Y LA POSTERIOR INGESTA DE ENERGIA A TRAVES DEL ALMUERZO Y LA CENA Rosalind Fallaize, Louise Wilson, Juliet Gray, Linda M. Morgan, Bruce A. Griffin. Department of Nutrition and Metabolism, Faculty of Health and Medical Sciences, University of Surrey, Guildford, Surrey GU2 7XH, UK [Eur J Nutr. 2012 Sep 5] RESUMEN Objetivo: Determinar el impacto relativo de tres desayunos isocalóricos, de composición variable, sobre la saciedad, el hambre y la posterior ingesta de energía. Métodos: En un diseño triple cruzado, 30 hombres sanos (edad de 21.7 ± 1.2 años; BMI, 23.1 ± 2.7 kg/m2) fueron randomizados a uno de tres desayunos de ensayo, en 3 ocasiones diferentes, separadas por una semana. Los desayunos consistieron en, huevos con tostadas, cereales (copos de maíz) con leche y tostadas, o una medialuna y jugo de naranja. Se registraron, a intervalos de 30 minutos, la saciedad por calificación subjetiva, el hambre, la plenitud y el deseo de comer, mediante escalas analógicas visuales electrónicas (VAS). La ingesta de energía fue evaluada por el peso de la comida ingerida en el almuerzo y cena, ad libitum. Resultados: Los participantes mostraron un incremento de la saciedad, menos hambre y un menor deseo de comer, después del desayuno que contenía huevos con respecto al de cereales (p\0.02), y el basado en medialunas Director: Fernando Estevez Castillo Homeonews 34 Edición N° 16 – Año 2012 (p\0.0001). El desayuno con huevos, fue también acompañado por una baja significativa de la ingesta de energía con respecto a los otros dos, en el almuerzo y cena, respectivamente, 1,284 ± 464 (huevos) versus 1,442 ± 426 kcal (medialuna), p = 0.03, 1,407 ± 379 (cereales) en el almuerzo y 1,899 ± 729 (huevo) versus 2,214 ± 620 kcal (cereales), p = 0.02, 2,047 ± 712 (medialuna) en la cena. El desayuno con el mayor efecto sobre la saciedad y sus consecuencias sobre la posterior ingesta de energía, fue el que tuvo el mayor contenido de proteinas y el más bajo de carbohidratos con respecto a los otros dos. Conclusión: Estos hallazgos produjeron evidencia para sustentar la importancia de la elección de los alimentos para el desayuno para incrementar la saciedad por la mañana y reducir la ingesta de energía en el almuerzo. Palabras clave: Saciedad – Proteína dietaria – Desayuno – Huevos ARTICULO ORIGINAL Introduction The passive overconsumption of energy is recognised as a major causative factor in the development of obesity [1]. This has fuelled interest in the identification of foods that can increase satiety as a means of limiting energy intake and promoting weight loss. While there is an evidence to suggest that foods can promote effects on satiety that are independent of their macronutrient content or energy density, dietary protein has been implicated as the macronutrient with the greatest impact in increasing satiety, most notably when consumed at breakfast rather than later in the day [2–7]. This finding has focused attention on foods that are high in protein and commonly consumed at breakfast. Intervention studies with eggs have provided some of the strongest evidence to support a positive effect of dietary protein in increasing satiety and decreasing subsequent energy intake [8–11]. However, of these two effects, data on measures of satiety have always been weaker and less convincing, possibly because of the subjective nature of the measurements, aspects of study design, inappropriate choice of comparative foods or subjects and/or the timing of meals. One study that compared the consumption of three iso-caloric lunches of baked potato, eggs or a chicken sandwich showed significant effects on satiety, but not on the subsequent intake of energy [8]. Two other studies that showed significant effects on both satiety, subsequent energy intake and weight loss compared eggs against a bagel [9, 10], a food that is less commonly consumed at breakfast in Europe than in North America. The aim of the present study was to determine the relative effects of three iso-caloric breakfasts on subjective measures of satiety and subsequent energy intake at an ad libitum lunch and evening meal in young, healthy men. Director: Fernando Estevez Castillo Homeonews 35 Edición N° 16 – Año 2012 Methods Participants Participants were recruited from the male student population at the University of Surrey via e-mails, posters and personal communications. Previously published [12] and unpublished studies using VAS scoring and ad libitum intake of food at buffet meals have established that a minimum sample size of 30 participants is required to achieve statistically significant differences between test meals. All participants underwent an initial screening visit in the Clinical Investigation Unit (CIU) at the University of Surrey prior to taking part in the study. Before this visit, participants were sent a ‘Participant Information Sheet’, which explained all aspects of the study. Height, weight and BMI were measured at this initial screening visit. Participants completed a general health questionnaire, a Dutch Eating Behaviour Questionnaire (DEBQ) [14] and ‘SCOFF’ questionnaire [15] to assess their general health, tendency for restrained eating and eating disorders, respectively. They were also given full instruction and a demonstration on how to use the PRO-Diary VAS scoring watches. All participants had to be habitual breakfast eaters and accustomed to eating three meals a day. They also had to meet the entry criteria that included being a healthy male (as determined by health questionnaire), aged between 18 and 35 years with a BMI C 18.5 B 30 kg/m2 and a weekly alcohol consumption of \28 units. Exclusion criteria included smoking, a dislike, intolerance or allergy to the test foods (eggs, wheat and dairy), any eating disorder or restrained eating behaviour, as determined by the ‘SCOFF’ and DEBQs, and participation in any other research study within 1 month of this study. Those meeting the entry criteria were invited to take part and asked to provide written and witnessed consent of participation. Experimental protocol The study had a randomised, three way, crossover design with three iso-caloric breakfast options, to which participants were assigned in a randomised order, as determined by block randomisation. This was achieved by placing a random order of treatment options, for example, ABC or BCA, into identical sealed envelopes. The envelopes were marked with sequential numbers and distributed to the volunteers in the order of their arrival. This method ensured allocation concealment and reduced selection bias. Participants were instructed to maintain their normal lifestyles on the day before each study day, but to refrain from alcohol, caffeine and physical exercise, other than walking, and to record anything they ate or drank between 18:00 and 20:00 h. They were asked to consume their evening meal no later than 20:00 h, and then fast for 12 h; that is, they were allowed water, but no foodstuffs or energy-containing drinks until breakfast the next morning. On each study day, participants arrived at the CIU at 08:30 h. The first VAS score was completed immediately before breakfast at 08:45 h. All study meals were consumed within 30 min, in silence, in individually isolated, curtained-off, booths. Each breakfast meal was served with water (180 ml). Post-breakfast VAS scores were completed at 09:30 h and at 30-min intervals thereafter, until lunch at 12:30 h. During the morning, participants were allowed free access to water and to engage in such activities as reading, working on a PC or watching films, none of which contained any references to Director: Fernando Estevez Castillo Homeonews 36 Edición N° 16 – Año 2012 food or eating. Diet: Test breakfasts, buffet lunch and evening meal The three test breakfasts were iso-caloric (*330 kcal/ 1,386 kJ), but differed in macronutrient content (Table 1). The egg breakfast consisted of two poached eggs on a slice of white toast and water (180 ml), the cereal and toast breakfast, a bowl of cornflakes with semiskimmed milk, a slice of white toast and water (180 ml), and the croissant and orange juice breakfast, a croissant with butter and jam and orange juice (180 ml). The two main outcome measures were subjective ratings of satiety, as assessed throughout the day by the response to three questions using VAS, and subsequent energy intake at lunch and evening meal as measured by weighed food intakes. All meals were prepared fresh on the day of the study, using products bought from local supermarkets. Lunch consisted of an ad libitum intake of food from a buffet of cheese sandwiches, plain crisps and water (180 ml). Participants were instructed to eat until ‘comfortably full’. Post-lunch VAS scores commenced at 13:30 h and at 30-min intervals thereafter, until the evening meal at 17:45 h. After lunch, participants were free to leave the CIU. While the participants were instructed to avoid eating or drinking anything other than water, to which they were given free access, they were asked to record in a diary any food or drink that was consumed during the afternoon. Participants returned at 17:30 h for the evening meal, which consisted of pasta with a tomato-based sauce and cheese (Table 2) and water (180 ml). Participants were once again instructed to eat until ‘comfortably full’. The end of the evening meal marked the end of the study day. Director: Fernando Estevez Castillo Homeonews 37 Edición N° 16 – Año 2012 Subjective ratings of satiety Ratings of satiety were determined using electronic VAS on a PRO-Diary watch (Camtech, UK). Electronic instrumentation was used to increase reliability of data capture and decrease investigator workload. Similar electronic systems have been previously validated against traditional paper VAS scales [13]. The PRO-Diary watches had the capacity for up to eight questions, but only three questions were used to measure satiety in this study, the delivery order of which was randomised during each study day. Each individual was allocated a PRODiary watch at the start of each study day, and VAS scores were measured at 8:45am immediately prior to breakfast, and then every 30 min from 09:30 to 17:30, with a 1-h break between 12:30 and 13:30 h. Energy consumption by weighed food intake Foods were weighed at both lunch and dinner on each study day. Both the lunch and dinner meals were offered ad libitum. Each participant was presented with a preweighed meal in a quantity far exceeding their usual portion size and was asked to eat until they were ‘comfortably full’, after which the remains of the meal were re-weighed to determine food intake. Statistical analysis Data from the PRO-Diary watches were downloaded at the end of each study day via PRO-Diary software into an excel spreadsheet. Missing VAS scores (in total less than 1 %) were interpolated to provide an average value. The area under the curve (AUC) for the VAS score profile for each question was calculated in the morning, before lunch (short-term inhibition of food intake), and in the afternoon, between lunch and evening meal (long-term inhibition of food intake), and for the whole day, using the trapezoidal rule [16]. VAS scores (AUCs) and energy intake data were checked for normality using the Shapiro– Wilk test. Variance between the three test breakfasts, for normally distributed data, was determined by a one-way analysis of variance (ANOVA) and post hoc Bonferroni test for pairwise differences. Asymmetric data were log transformed and, if still asymmetric, examined by a Friedman’s ANOVA and post hoc Wilcoxon signed rank test. Baseline VAS results, including product-liking scores (palatability) for the three test breakfasts, were tested in the same way. Differences were considered significant at p B 0.05, except for the post hoc Wilcoxon signed ranks test, in which significance was set at p B 0.02 (i.e. p\0.05/3). Differences in VAS scores over time were assessed by a general linear model (VAS scores as the response variable, time and breakfast meal as interactive terms in the model) and a post hoc Tukey–Kramer test for the pairwise comparison of individual time points. All statistical analyses were performed using SPSS software (version 18.0, SPSS Inc., Chicago, IL). The mean score at each time point for each meal was calculated and represented graphically. The energy and composition of the test meals (including lunch and evening meal) were calculated using data from the food manufacturer, Director: Fernando Estevez Castillo Homeonews 38 Edición N° 16 – Año 2012 McCance and Widdowson’s Composition of Foods [17], and the UK Food Standards Agency. Food Portion Sizes [18]. The energy conversion factors used to determine the percentage contribution of macronutrients were 3.75 kcal (15.75 kJ)/gram for carbohydrate, 4 kcal (16.8 kJ)/gram for protein and 9 kcal (37.8 kJ)/gram for fat. Ad libitum food intake at lunch was combined with that of the evening meal and any other recorded intake to provide total energy intake for the day. The study was granted a favourable ethical opinion from the University of Surrey’s Advisory Committee on Ethics. Results Of the 33 male subjects screened, 31 met the inclusion criteria and were randomised into the study. One participant was unable to attend study days, leaving 30 participants to complete all three arms of the intervention study. The characteristics of the 30 male participants including the mean ± SD age and body mass index (range, median) were 21.7 ± 1.15 (19–24, 22) years and 23.1 ± 2.65 (18.5–29.7, 22.9) kg/m2, respectively. Subjective measures of satiety, prospective consumption and hunger (VAS scores) were variably distributed, even after log transformation, and were thus subjected to parametric and nonparametric tests. Less than 15 VAS scores were incomplete in a total of 1,530 responses (\1 %). Energy intake data were normally distributed and analysed by parametric tests. There was no significant difference in response to the questions: ‘How hungry do you feel?’ (Q1), ‘How much do you think you could eat?’ (prospective consumption) (Q2) or ‘How full do you feel?’ (Q3), at baseline. There was also no significant difference in the product-liking and palatability between the egg-, cereal- or croissantbased breakfasts as assessed by questionnaire (data not shown). Following the test breakfasts, and prior to the ad libitum lunch, participants were consistently the most full, had less desire to eat (prospective consumption) and were less hungry after consumption of the egg breakfast compared to the cereal- and croissant-based breakfasts (Fig. 1). There were significant differences for all three questions between the egg- and croissantbased breakfasts from 30 to 150 min after the breakfast. This showed the cereal- and the croissant-based breakfasts to be the second and third most satiating meals, respectively. This pattern of differential responses was not maintained in the afternoon after the ad libitum lunch and before the evening meal, when there was no clear difference in satiety ratings between the breakfast meals (Fig. 1). When VAS scores were analysed as AUCs, the results were consistent in showing the same significant differences in satiety ratings between the egg-, cereal- and croissant-based breakfasts before, but not after lunch (Table 3). No food or drink, other than water, which was unrestricted and unrecorded, was consumed before lunch and between the lunch and evening meal. Director: Fernando Estevez Castillo Homeonews 39 Edición N° 16 – Año 2012 There was significant variation in the intake of energy at the ad libitum lunch and evening meal after the three breakfast meals. The egg-based breakfast was followed by a significantly lower intake of energy at lunch relative to the croissant-based breakfast (p = 0.030). The egg-based breakfast was also associated with a significantly lower intake of energy at the evening meal relative to the cerealbased breakfast (p = 0.023) (Fig. 2). The combined energy intakes for lunch and evening meal produced a significantly lower intake after the egg-based breakfast relative to the cereal-based breakfast (p = 0.007). There was no difference in energy intake between the cereal and croissantbased breakfast at either the lunch or evening meal. Discussion This study showed that an egg-based breakfast had a greater effect on subjective feelings of satiety (increased fullness, hunger and decreased desire to eat) and reduced the subsequent intake of energy, in comparison with two other iso-caloric breakfasts. Obese and overweight subjects have been previously shown to consume less energy, protein, fat and carbohydrate at an ad libitum lunch and up to 36 h after the isocaloric consumption of eggs versus a bagel breakfast [8–11]. Ratliff et al. [11] found that the same type of subjects consumed less energy over 24 h in Director: Fernando Estevez Castillo Homeonews 40 Edición N° 16 – Año 2012 response to an egg breakfast compared to a bagel breakfast. While these studies were formative in establishing the satiating properties of high-protein foods such as eggs, both compared eggs against a bagel, a food that is less commonly consumed at breakfast in Europe as compared to North America. These studies also used food diaries to estimate energy intake after an ad libitum lunch, a method prone to the underreporting of energy and fat intake, and thus less reliable than weighing food intake directly [19, 20]. The three test breakfast meals in the present study contained foods that are commonly consumed at breakfast in Europe, extending the applicability and thus relevance of the results. The study design was also extended to allow the direct assessment of ad libitum intake of energy by weighed food intake at two subsequent meals (lunch and evening meal). A significantly reduced intake of energy at lunch was observed between the two breakfasts with the greatest difference in satiety. This suggests that the ability of the egg-based breakfast to reduce energy intake at lunch may have depended upon the magnitude of the satiety response and duration over which this response was maintained. Increased feelings of satiety have not always been followed by a reduced intake of energy at the next meal [21, 22]. In studies that have reported a reduced energy intake, this effect was apparent 3 h after an egg-based breakfast [9, 11], but not after 4 h when eggs were consumed at lunch rather than breakfast [8]. In accordance with the present findings, these earlier studies showed that as the time period between the two meals increased, the impact of the test meal in reducing subsequent energy intake was decreased. Since in reality, the period of time between breakfast and lunch may be greater than 4 h, this may limit the effects of breakfast on satiety, to Director: Fernando Estevez Castillo Homeonews 41 Edición N° 16 – Año 2012 reducing the urge to snack between meals, rather than reducing food consumption at the lunch. The egg-based breakfast contained a significantly higher proportion of energy from protein than either the cereal or croissant (22 vs. 12 and 6 %, respectively), and fat (57 vs. 27 and 50 %, respectively), and a lower proportion of energy from carbohydrates (21 vs. 61 and 44 %, respectively). While most studies have shown that protein is the most satiating of all the macronutrients [2–5], particularly at breakfast [6], some others have not [23, 24]. High-protein foods have been repeatedly shown to have a greater effect on satiety than foods high in fat or carbohydrate [25]. There is also evidence to suggest that a minimum of 50 g of protein is required to elicit a measurable effect on satiety [26]. However, if the protein content of the egg-based breakfast contributed to the effect on satiety in the present study, this would provide evidence to refute the existence of a critical threshold for protein intake, given that this breakfast contained only 18 g of protein. The rate of food consumption, and more specifically, slowing bite rate, has been shown to reduce energy intake, possibly through increased satiety [27]. In the present study, the participants were given 30 min to consume the breakfast meals. However, the exact time and rate of consumption was not recorded and could potentially have influenced subsequent satiety ratings. The unrestricted intake of water between meals could also have influenced the outcome. There was no difference in palatability between the three test breakfasts, as assessed in the ‘product-liking’ questionnaire, thus removing the possibility of liking or preference for foods, which has been previously shown to stimulate the drive to eat more frequently [28]. However, there was still potential for confounding influences produced by the orosensory stimulation of satiety. This could include differences in the sensory quality of the foods, such as texture and temperature, and differences in familiarity and expectancy of the meals in relation to the habitual intake of the participants [29, 30]. In the last respect, many of the participants overate at the ad libitum meals. The mean intake of energy at lunch and dinner was 3,431 (±915) kcal (14,410 (±3,843) kJ (range, 1,313 kcal (5,515 kJ)–5,934 kcal (24,923 kJ)). This raises the possibility that the breakfast meals provided less energy than the habitual breakfasts of the participants. Since none of our participants were obese, and few could be classed as extremely physically active, the energy consumed at lunch and dinner was in excess of their nutritional requirements (energy requirements for males aged 19–50 years = 2,550 kcal/day, COMA, 1991 [31]; or aged 18–50 years = 2,450 kcal, DoH [18]). This might suggest that the normal mechanisms of satiety that control the intake of food were overridden by environmental and psychological factors [32]. While the participants, who were all male university students, were instructed to eat until ‘comfortably full’, younger males have been previously shown to display an opportunistic response and overconsume in lunchtime appetite studies [33]. It is conceivable that this finding invalidates the interdependency between the two ad libitum meals, and any conclusions relating to the influence of the breakfasts on energy intake at the evening meal. Director: Fernando Estevez Castillo Homeonews 42 Edición N° 16 – Año 2012 Conclusion An egg-based breakfast was accompanied by unequivocally greater effects on subjective measures of satiety and reduced subsequent energy intake relative to two other breakfast meals. These findings provide evidence to highlight the importance of food choice at breakfast to help in promoting morning satiety and in reducing energy intake at lunch. Acknowledgments This work was supported by a small undergraduate student project grant from the University of Surrey. Foods for the breakfasts, lunches and evening meals were purchased with the support from the British Egg Industry Council. Conflict of interest Juliet Gray and Bruce Griffin have acted as scientific advisors to the British Egg Information Service. The study was originally conceived and conducted at the University of Surrey as an independent undergraduate research project. The authors did not receive any payment, or external input into the study design, interpretation of results or conclusions, or any financial support, other than that described above. References 1. Kopelman PG (2000) Obesity as a medical problem. Nature 404:635–643 2. Hill A, Blundell JE (1986) Macronutrients and satiety: the effects of a high-protein or high-carbohydrate meal on subjective motivation to eat and food preferences. Nutr Behav 3:133–144 3. de Graaf C, Hulshof T, Weststrate JA, Jas P (1992) Short-term effects of different amounts of protein, fats and carbohydrates on satiety. Am J Clin Nutr 55:33–38 4. Lang V, Bellisle F, Oppert J, Craplet C, Bornet FRJ, Slama G, Guy-Grand B (1998) Satiating effect of proteins in healthy subjects: a comparison of egg albumin, casein, gelatin, soy protein, pea protein, and wheat gluten. Am J Clin Nutr 67:1197–1204 5. 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Raben A, Agerholm-Larsen L, Flint A, Holst JJ, Astrup A (2003) Meals with similar energy densities but rich in protein, fat, carbohydrate, or alcohol have different effects on energy expenditure and substrate metabolism but not on appetite and energy intake. Am J Clin Nutr 77:91–100 25. Stubbs RJ, O’Reilly LM, Johnstone AM, Harrison CL, Clark H, Franklin MF, Reid CA, Mazlan N (1999) Description and evaluation of an experimental model to examine changes in selection between highprotein, high-carbohydrate and high-fat foods in humans. Eur J Clin Nutr 53:13–21 26. Anderson GH, Moore SE (2004) Dietary proteins in the regulation of food intake and body weight in humans. J Nutr 134:974S– 979S 27. Scisco JL, Muth ER, Dong Y, Hoover AW (2011) Slowing bite rate reduces energy intake: an application of the bite counter device. J Am Diet Assoc 111:1231–1235 28. Berthoud H (2007) Interactions between the ‘‘cognitive’’ and ‘‘metabolic’’ brain in the control of food intake. Physiol Behav 91:486–498 29. Stubbs JR (1999) Peripheral signals affecting food intake. Nutrition 15:614–625 30. Yeomans MR, Chambers L (2011) Satiety-relevant sensory qualities enhance the satiating effects of mixed carbohydrateprotein pre-loads. Am J Clin Nutr 94:1410–1417 Director: Fernando Estevez Castillo Homeonews 44 Edición N° 16 – Año 2012 31. Dietary reference values for food energy and nutrients for the United Kingdom. Report of the panel on dietary reference values of the committee on medical aspects of food policy (1991) Rep Health Soc Subj (Lond) 41:1–210 32. Blundell J (2010) Making claims: functional foods for managing appetite and weight. Nat Rev Endocrinol 6:53–56 33. Livingstone BE, Robson PJ, Welch RW, Burns AA, Burrow MS, McCormack C (2000) Methodological issues in the assessment of satiety. Scand J Nutr 44:98–103 NOTAS DE INTERES JORNADA INTERNACIONAL DE ACTUALIZACION EN MEDICINA COMPLEMENTARIA – MODULO I “NUEVAS OPCIONES TERAPEUTICAS EN ENFERMEDADES CRONICAS” MARACAIBO - VENEZUELA El sábado 23 de junio del corriente año, tuvo lugar en el Auditorio del Hotel Kristoff de la Ciudad de Maracaibo, Venezuela, la Jornada Internacional de Actualización en Medicina Complementaria, Módulo I, cuyo título fue: “Nuevas opciones terapéuticas en enfermedades crónicas”, auspiciada por la Sociedad Latinoamericana de Fitomedicina. Los disertantes invitados para el desarrollo del Módulo I, fueron, el Dr. Jorge Alonso (Arg.) y el Farm. Fernando Estevez Castillo (Arg.). Al finalizar la Jornada, los disertantes, Dr. Jorge Alonso y el Farm. Fernando Estevez Castillo, junto a los organizadores del evento y funcionarios del Ministerio del Poder Popular para la Salud y del Instituto Nacional de Higiene “Rafael Rangel” Director: Fernando Estevez Castillo Homeonews 45 Edición N° 16 – Año 2012 La actividad contó con la asistencia de un gran número de médicos, no solo del lugar de la sede del evento, sino también de otros Estados del país, así como también con la presencia de un grupo de funcionarios del Ministerio del Poder Popular para la Salud (Productos Naturales) y del Instituto Nacional de Higiene “Rafael Rangel”, quienes intercambiaron experiencias, opiniones y comentarios, con los disertantes, reafirmando de esta manera, la importancia de los Medicamentos Homeopáticos y Fitoterápicos para el abordaje de enfermedades crónicas, así como también la necesidad de contar con Legislaciones adecuadas para estos tipos de productos, profesionales capacitados en la temática y laboratorios en condiciones óptimas para producir los mismos. Para el próximo año, se tiene proyectado el desarrollo del Módulo II, con otra temática, y en otra Ciudad de Venezuela. Conferencia – Debate Plantas Medicinales y Alimenticias: Ejemplo de neodesarrollo agrícola-productivo con inclusión social Honorable Senado de la Nación – Buenos Aires La Dirección General de Relaciones Institucionales del Honorable Senado de la Nación, a través del programa de transdisciplinariedad "Diálogo de Saberes", realizó el pasado 19 de Octubre, un encuentro cuyo título fue: “Plantas Medicinales y Alimenticias: ejemplo de neodesarrollo agrícolaproductivo con inclusión social”. Este Ciclo de Conferencias, tiene como propósito generar un ámbito propicio para la difusión e intercambio de conocimientos y modos de pensar sobre distintas cuestiones que plantea nuestra sociedad actual, vinculadas con aspectos económicos, culturales, científicos y tecnológicos que estimamos de particular interés por su incidencia en el progreso material y espiritual de la humanidad. En esta oportunidad, la actividad se desarrolló en el Salón Auditorio del Edificio Alfredo Palacios del Honorable Senado de la Nación sito en la Ciudad Autónoma de Buenos Aires, bajo la coordinación del Dr. Ricardo Machiavelli, y su apertura estuvo a cargo de la Dra. Lía Mendez, Directora General de la Dirección General de Relaciones Institucionales de la Presidencia del Honorable Senado de la Nación. Luego siguieron tres conferencias, que plantearon la temática propuesta desde diferentes puntos de vista, y finalmente se permitieron las Director: Fernando Estevez Castillo Homeonews 46 Edición N° 16 – Año 2012 preguntas de los asistentes y el intercambio de opiniones y debate con los disertantes. CONFERENCIAS 1- “Aprovechamiento de los recursos vegetales del país para el desarrollo de medicamentos fitoterápicos y nutracéuticos”, Dr. Cristian Desmachelier (Presidente de Neotrópico Consultants. Asesor del Ministerio de CyT de la Nación) 2- “Plantas medicinales: su inclusión en el Sistema Público de Salud de Argentina y Latinoamérica”, Dr. Jorge Alonso (Presidente de la Sociedad Latinoamericana de Fitomedicina) 3- “Chía (Salvia hispánica): ejemplo de desarrollo de neocultivos en Argentina”, Farm. Fernando O. Estevez Castillo (Director del Curso de Posgrado de Farmacia Homeopática, FFyB – UBA, Director Científico de Laboratorios Dr. Madaus & Farmacia+Natural) RESUMENES “Aprovechamiento de los recursos vegetales del país para el desarrollo de medicamentos fitoterápicos y nutracéuticos” Dr. Cristian Desmachelier De acuerdo a las cifras que maneja actualmente el Ministerio de Salud de la Nación, las provincias correspondientes al noreste argentino, son las más afectadas por la falta de medicamentos para su atención primaria de la salud, existiendo focos epidémicos y sectores altamente vulnerables que debido a su precariedad económica, no cuenta con un acceso legítimo a sus necesidades primordiales. Por otra parte, se ha comprobado un déficit en la llegada de medicamentos básicos a través del plan de emergencia medicamentosa conocido como “Plan Remediar”, el cual incluso carece de algunos fármacos que resulten eficaces para las necesidades epidemiológicas de la región. Ante esta delicada situación, las posibilidades de poder adquirir un medicamento en farmacias por parte de estos sectores vulnerables se hace difícil dada la precariedad económica en la Director: Fernando Estevez Castillo Homeonews 47 Edición N° 16 – Año 2012 que están sumergidos, ya sea por falta de trabajo o sueldos que apenas alcanzan a cubrir necesidades básicas. A ello se suma la pérdida de identidad cultural, el desarraigo y la falta de educación de estos sectores, en donde las nuevas generaciones prácticamente desconocen sus raíces y los saberes ancestrales delegados por sus antecesores. Precisamente una parte importante del acervo cultural está dado por las plantas medicinales, cuyo correcto manejo y uso ha sido un bastión generacional que como huella digital, ha permitido una identidad propia para estas culturas. Poder devolver parte de este conocimiento a la comunidad, y darle un justo reconocimiento como patrimonio cultural de la región, son una de las premisas que basan esta propuesta, además de incorporar a la propia comunidad como nueva mano de obra aprovechando los conocimientos de domesticación que tienen sobre diferentes especies de la región, pasibles de ser incorporadas en los proyectos sanitarios que den respuesta a las necesidades epidemiológicas locales, con costos mucho menores a los que normalmente el Estado está acostumbrado a gastar. Antecedentes: Los países de Latinoamérica cuentan con la mayor biodiversidad vegetal de todo el mundo, lo cual se erige en un patrimonio único e irreemplazable, y que puede ser el punto de partida de nuevos polos de desarrollos productivos regionales. Esta situación ha sido contemplada por varios países de la región, que sin dudar, han incorporado las plantas medicinales en los sistemas de salud, con óptimos resultados según surgen de las propias auditorías efectuadas por la propia Organización Mundial de la Salud. Precisamente este máximo organismo de referencia sanitaria mundial, es el que propicia e insta a los diferentes gobiernos, a que apliquen en sus políticas sanitarias, la incorporación de plantas medicinales. A raíz de ello, el gobierno de Brasil por medio de un decreto del año 2006 firmado por el presidente Lula da Silva, ha incorporado de manera obligatoria a las plantas medicinales en el SUS (Sistema Único de Salud). De manera similar, México ha incorporado la medicina indigenista en los propios hospitales de varios Estados de ese país, a efectos de atender las necesidades culturales que a diario reclamaban las diferentes comunidades indígenas. Chile, Bolivia y Perú cuentan con Departamentos de Medicina Tradicional en sus propios Ministerios de Salud, lo cual es una muestra de la importancia que para esos países representa la temática. “Plantas medicinales: su inclusión en el Sistema Público de Salud de Argentina y Latinoamérica” Dr. Jorge Alonso Desde tiempos inmemoriables, el hombre ha hecho uso de las plantas con diferentes fines, ya sea para alimentarse, vestirse, curarse o construir su propia vivienda. De hecho, las plantas medicinales han constituido la herramienta por excelencia del arte de curar a través de miles de años. Sin embargo, con la llegada de la síntesis química, se propone un nuevo estereotipo de abordaje terapéutico en los últimos 70 años, sostenido por la posibilidad de patentamiento de Director: Fernando Estevez Castillo Homeonews 48 Edición N° 16 – Año 2012 las nuevas moléculas que se sinteticen. Este modelo hegemónico ha permitido sin lugar a dudas desarrollar una industria farmacéutica floreciente, con hallazgos novedosos e importantes para la salud, prevaleciendo la seguridad, eficacia y calidad de cada producto por encima de todas las cosas, pero que debido a sus altos costos, ha hecho perder la ACCESIBILIDAD de este recurso a vastos sectores de la población mundial. En la reunión de Alma-Ata realizada por la OMS a mediados de la década del ’70, se propone a los diferentes gobiernos, revalidar y reconsiderar las prácticas terapéuticas tradicionales de cada país, para así poder satisfacer la demanda de medicamentos que por razones económicas, muchos países se veían privados en su acceso. Es así que comienza a revalidarse la Medicina Tradicional China, la Homeopatía, la Fitoterapia y la Medicina Ayurvédica, como las disciplinas más importantes del ámbito alternativo de la salud. Su incorporación en la enseñanza oficial universitaria, también constituyó un importante hito para su jerarquización académica, y su puesta en práctica en los sistemas de atención primaria de la salud. En los diferentes países de América se han llevado a cabo diferentes tareas para revalidar estos conocimientos ancestrales y ponerlos en la práctica en los servicios de salud. En cuanto al panorama de la República Argentina, a mediados de la década del ‘90 el país contaba con un sistema de cobertura sanitaria bastante aceptable, en donde los remedios sintéticos llegaban a muy bajos costos a los sectores carenciados, no planteándose en ningún momento otro tipo de abordaje de los problemas sanitarios, que no sea el oficial. Sin embargo, la política neoliberal imperante a fines de esa década, produjo un desempleo creciente, el cierre de muchas fábricas nacionales y el comienzo de una desvalorización de los ingresos salariales. Esto produjo que en el año 2001 el sistema colapsara totalmente, produciéndose una devaluación muy importante de la moneda, sumado a la retención de los ahorros de los ciudadanos, lo cual derivó en 40% de desocupación y en un 55% de indigentes, sin acceso a medicamentos básicos y a los sistemas de salud primarios. Fue por ello menester realizar acciones conjuntas entre los diferentes sectores de la comunidad, a fin de crear un marco propicio que pueda asegurar la correcta provisión de medicamentos a la población. En ese sentido, la Asociación Argentina de Fitomedicina elevó a las autoridades de la Cooperación Italiana (COE) y Región Lombardía, una propuesta que contempló la fabricación de fitomedicamentos con altos estándares de calidad, a ser elaborados por laboratorios provinciales (aprobados por ANMAT = Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) a partir de materias primas provenientes de cultivos realizados en áreas cedidas por diferentes intendencias provinciales, y en la cual trabajarían sectores de la población desocupados o jefes de familia con recursos económicos restringidos. En los controles de calidad actuaron Universidades provinciales, y en la correcta identificación botánica, así como en la selección de terrenos, tanto botánicos como ingenieros agrónomos calificados, lo cual nos da una idea de la interacción entre las distintas disciplinas que conforman la Fitomedicina. Se efectuaron estudios epidemiológicos en las regiones seleccionadas, a efectos de conocer índices de prevalencia de enfermedades y el grado de conocimiento de las personas sobre el empleo de plantas medicinales. Este tipo de modelo se ha planteado como un proyecto perfectamente autosustentable, en la medida que todos los actores interactúen entre sí. Asimismo, fueron llevadas a cabo actividades docentes hacia la población como hacia el cuerpo profesional de APS. Por otra parte, fue elaborado un libro sobre Plantas Autóctonas de Argentina y APS, de distribución gratuita a Universidades y Centros de APS de Argentina. Las plantas medicinales seleccionadas que constituyeron fitomedicamentos fueron: - Ambay (Cecropia pachystachia) Congorosa (Maytenus ilicifolia) Caléndula (Calendula officinalis) Carqueja (Baccharis trimera) Director: Fernando Estevez Castillo Homeonews 49 Edición N° 16 – Año 2012 En cuanto a la revaloración de otras especies, se rescató un cultivo ancestral propio de los países andinos, que es el Amaranto (Amaranthus mantegazzianus), con un contenido en nutrientes muy importante, pudiendo satisfacer carencias alimenticias entre niños de escasos recursos y desnutridos. Sobre las plantas que comenzaron a cultivarse en el proyecto (Caléndula y Amaranto), se han realizado manuales de cultivo que se constituyen en un documento y una herramienta indispensables para lograr estos objetivos, de los cuales no habían antecedentes en el país. De las otras especies autorizadas, se están elaborando nuevos manuales. Un hecho importante del proyecto fue el de revalorizar el conocimiento ancestral de las culturas originarias de nuestro país, lo cual pudo cristalizarse en diciembre del 2005 en un encuentro llevado a cabo en Posadas (Misiones) denominado “Encuentro de Culturas para la Salud”, y que conglutinó exposiciones orales sobre temas de salud de los integrantes de las culturas Mapuche, Toba y Guaraní, entre otras. El evento fue inaugurado musicalmente por el coro de indígenas Tobas y contó con la participación de autoridades de salud provinciales. Es importante señalar que los fitomedicamentos elaborados en el proyecto son distribuidos gratuitamente en los Centros de Atención Primaria de la Salud seleccionados a tal fin, y que todas estas acciones son reconocidas y propuestas por la propia Organización Mundial de la 1-2 Salud en sus programas de Atención Primaria de la Salud . Gracias al aporte económico del Gobierno Italiano se pudo cristalizar este proyecto, denominado “Cultivando la Salud”, el cual pretende generar polos productivos provinciales aprovechando los propios recursos florísticos regionales, y que a futuro permitan propiciar modelos de gestión autosustentables, con la significativa reducción en los gastos en salud (compra de medicamentos costosos, menores efectos iatrogénicos, etc ). Como corolario de este proyecto, el 10 de agosto de 2006 se llevó a cabo la Jornada Nacional de Medicamentos Fitoterápicos en el propio auditorio del Senado de la Nación, y el cual contó con más de 300 inscriptos entre investigadores universitarios, cámaras de laboratorios nacionales y extranjeros, diputados, senadores, la OPS/OMS, profesionales de la salud, un representante de la Embajada de Italia y autoridades sanitarias no solo de Argentina, sino también de países vecinos: Uruguay, Chile, Brasil y Perú. Esta Jornada contó, a su vez, con la participación de disertantes de EE.UU y Guatemala. La Jornada fue una muestra del gran interés que despertó el proyecto “Cultivando la Salud”, como modelo para ser ejecutado en todo el país. Actualmente estamos planificando junto a los presidentes de las Comisiones de Salud de las Cámaras de Senadores y Diputados, las tareas organizativas para llevar adelante un proyecto similar a nivel de la Nación. “Chía (Salvia hispánica): ejemplo de desarrollo de neocultivos en Argentina” Farm. Fernando O. Estevez Castillo Director: Fernando Estevez Castillo Homeonews 50 Edición N° 16 – Año 2012 Hay evidencia científica que muestra que la semilla de chía (Salvia hispánica L.) comenzó a usarse en la alimentación humana unos 3500 años antes de Cristo y se convirtió en un cultivo básico en el Centro de México entre 1500 y 900 años A.C. La conquista española reprimió a los nativos, suprimiendo sus tradiciones y destruyendo la mayoría de la producción agrícola intensiva y el sistema de comercialización existente. Muchos cultivos que mantuvieron una posición preponderante en las dietas de la América precolombina, entre ellos la chía, fueron destruidos por los españoles debido a la estrecha asociación con la religión y fueron reemplazados por otras especies extranjeras (trigo, cebada, zanahorias, etc.) que tenían una gran demanda entre los conquistadores. La chía sobrevivió sólo en pequeños parches en áreas montañosas escarpadas del sur de México y Guatemala hasta que un programa de investigación y desarrollo se inició en 1991, a partir de un grupo de productores, entidades comerciales y personal técnico y científico de Argentina, Bolivia, Colombia, Perú y los Estados Unidos, seleccionando nuevas áreas de producción y prácticas de desarrollo, con el fin de poner a la chía en el mercado como un nuevo producto. Esta semilla ofrece el mayor contenido de ácidos grasos omega-3 disponible en el reino vegetal (tiene el mayor porcentaje conocido de ácido alfa-linolénico); contiene más proteínas, lípidos, energía y fibra (pero menos carbohidratos) que el arroz, la cebada, la avena, el trigo o el maíz; es una excelente fuente de calcio, fósforo, magnesio, potasio, hierro, zinc y cobre; es pobre en sodio (78 veces menos que el salmón, 237 veces menos que el atún) y a diferencia de otras fuentes de ácidos grasos omega-3, no tiene "sabor a pescado". La ciencia actual explica por qué las antiguas civilizaciones consideraban a la chía un componente básico de su dieta. La composición química de misma y su valor nutricional, le confiere un gran potencial para usarla dentro de los mercados alimenticios e industriales. Así, la información tecnológica ha dado una excelente oportunidad para crear una industria agrícola, totalmente capaz de ofrecer al mundo un “cultivo nuevo y antiguo a la vez”. III JORNADAS DE FARMACIA DEL SUDOESTE BONAERENSE Del 9 al 10 de Noviembre pasado, tuvo lugar en el Salón de Actos del Rectorado de la Universidad Nacional del Sur, sito en la Ciudad de Bahía Blanca, las III Jornadas de Farmacia del Sudoeste Bonaerense, organizadas por el Departamento de Biología, Bioquímica y Farmacia de la mencionada Casa de Estudios. Estas Jornadas fueron declaradas de interés municipal, fueron gratuitas y contaron con el auspicio del citado Departamento, la Secretaría General de Ciencia y Tecnología de la UNS, el Colegio de Farmacéuticos de la Provincia de Buenos Aires y el Ente Coordinador de Unidades Académicas de Farmacia y Bioquímica (ECUAFyB), y cuyo objetivo fundamental es promover la Director: Fernando Estevez Castillo Homeonews 51 Edición N° 16 – Año 2012 integración profesional y el conocimiento científico en las diferentes áreas de las Ciencias Farmacéuticas. Se desarrollaron de 9 a 19 hs, con la disertación de especialistas locales y nacionales, y fueron dirigidas a Farmacéuticos y alumnos de quinto año de la carrera de Farmacia. El Farm. Fernando Estevez Castillo durante sus dos disertaciones. Las actividades se desarrollaron a través de Conferencias plenarias a cargo de especialistas en cada materia, quienes expusieron los siguientes temas: -“Presentación líneas de investigación del área farmacéutica de la Universidad Nacional del Sur”, Dra. Noelia Gonzalez Vidal y Dra. Verónica Ramirez Rigo (UNS) -“Homeopatía: de la receta al medicamento”, Farm. Fernando Estevez Castillo (Fac. de Farmacia y Bioquímica, UBA) -“Avances en nanotecnologia farmacéutica”, Dr. Carlos Bregni (Fac. de Farmacia y Bioquímica, UBA) -“Relevancia de las evaluaciones económicas den el sector salud en contextos inflacionarios”, Dra. Nebel Moscoso (UNS) -“Farmacoterapia oncológica”, Dr. Eduardo Lagomarsino (Fac. de Farmacia y Bioquímica, UBA) -“El antiinflamatorio natural: Árnica montana”, Farm. Fernando Estevez Castillo (Laboratorios Dr. Madaus) -“Medicamentos producidos en el Laboratorio de Hemoderivados de la Universidad Nacional de Córdoba”, Dra. Cecilia Sobrero (Laboratorio de Hemoderivados, UNC) -“PVC de calidad médica en soluciones parenterales y biomédicos”, Farm. Marcelo Atempiz (Laboratorios Rivero) Director: Fernando Estevez Castillo Homeonews 52 Edición N° 16 – Año 2012 -“Sentirnos bien, vernos bien. La importancia de la hidratación cutánea”, Esp. en Producción de Cosméticos Andrea Spagnuoli (Fac. de Farmacia y Bioquímica, UBA - ANMAT) -“Normalización en el área farmacéutica”, Farm. Mariana Funes (IRAM). -“Ejercicio Profesional Farmacéutico: Herramientas Institucionales”, Farm. Isabel Reinoso y Farm. Nicolás Troffe (Colegio de Farmacéuticos de la Prov. de Bs. As.) Todas las actividades se caracterizaron por la presencia de gran cantidad de asistentes, tanto de alumnos de la carrera de Farmacia como Farmacéuticos, quienes además pudieron participar a través de preguntas a los Conferencistas. Organizadores de las Jornadas Por último quisiera felicitar a los organizadores, a través de la D Drraa.. N Nooeelliiaa G o n z á l e z V i d a l González Vidal, por el éxito alcanzado en estas III Jornadas, y por seguir siendo excelentes anfitriones, además de progresar año tras año, en la organización de esta actividad, como por ejemplo, con la incorporación de un importante número de posters, con trabajos de investigación de la Universidad Nacional del Sur. RESUMENES DE ALGUNAS CONFERENCIAS El antiinflamatorio natural: Arnica montana Farm. Fernando Estévez Castillo Arnica montana es una planta de la familia de las Asteraceae, originaria del centro y sur de Europa, que crece principalmente en las praderas de las montañas (entre los 700 y 2500 msnm). Su recolección silvestre intensiva, la ha puesto en peligro de extinción en varios países, por lo cual fue incluida en los listados de la Convención de Washington (1981)sobre la protección de especies y la Unión Europea ha establecido medidas de control para la Director: Fernando Estevez Castillo Homeonews 53 Edición N° 16 – Año 2012 conservación de la misma. Se cultiva en Alemania, España, Hungría y Reino Unido, aunque buena parte de la materia prima sigue proviniendo de la recolección silvestre en España y Rumania. Contrariamente a lo esperado, el Árnica era desconocido para los médicos greco-romanos y tampoco se mencionó en los textos de la Alta Edad Media. Fue introducida en 1533, por el editor de la obra Physica de Santa Hildegarda de Bingen, para referirse a una planta con propiedades medicinales, mágicas y fabulosas. La especie Árnica montana L., fue descripta por Linneo en 1753, alcanzando gran éxito en el siglo XVIII, para el tratamiento de golpes e inflamaciones y se popularizó a lo largo de los siglos XIX y XX. La parte utilizada de la planta, varía de acuerdo al tipo de medicamento elaborado; los capítulos florales para los fitomedicamentos, y la planta entera, incluyendo la raíz, para los homeopáticos. Actualmente el Árnica es utilizada en formas farmacéuticas de uso externo, excepto en el caso de los medicamentos homeopáticos (uso interno), para reducir el dolor e inflamación resultante de lesiones, accidentes y/o traumas quirúrgicos, incluyendo hematomas, esguinces, torceduras, contusiones y edemas por fracturas, así como también como adyuvante en tratamientos de enfermedades crónicas, tales como: artritis, artrosis, gota y otras enfermedades inflamatorias de articulaciones y músculos. Los principales compuestos activos que contiene la planta, son lactonas sesquiterpénicas (ésteres de helenalina y 11,13– dihidrohelenalina), que inhiben la activación del factor de transcripción NF-κB (factor de transcripción nuclear kappa B), interfiriendo de esta manera con la regulación de los genes que codifican muchos mediadores inflamatorios. Entre otros componentes, los polisacáridos, estimulan la fagocitosis y reducen las hematomas. Existen un número importante de investigaciones con Árnica montana (in vivo e in vitro) que confirman la eficacia de las preparaciones que la contienen, como antiinflamatorio. Como medicamento fitoterápico, el Arnica montana, se presenta en formas de uso externo, tales como, tinturas, geles, cremas y pomadas. El uso interno, solo es permitido en las formas homeopáticas (glóbulos, gotas, tabletas), donde la dilución respectiva de la tintura madre inicial, elimina su acción tóxica por esta vía, ya que las lactonas sesquiterpénicas pueden causar irritación de la mucosa gástrica, náuseas, vómitos y diarreas. HOMEOPATIA: “De la receta al medicamento” Farm. Fernando Estévez Castillo La HOMEOPATIA es un sistema terapéutico, creado por un médico alemán, el Dr. CHRISTIAN FEDERICO SAMUEL HAHNEMANN (1755-1843), y que se caracteriza por aplicar la Ley de los Similares y utilizar los medicamentos en dosis infinitesimales para lograr la curación de los pacientes. En nuestro país y en el mundo podemos destacar tres Escuelas Médicas Homeopáticas: 1) UNICISTA: es la Escuela Hahnemanniana Clásica u Ortodoxa, que sigue los lineamientos dados por el Creador de éste Sistema Terapéutico, y que utiliza un solo medicamento, en alta potencia (en dinamización muy alta) para cada paciente, de acuerdo a su totalidad sintomática, para lograr la curación. Ej.: el médico, luego de la consulta le prescribe Lycopodium 1000C 1 Papel. 2) PLURALISTA: siguen los mismos lineamientos que la escuela anterior, pero utilizan más de un medicamento, en alta potencia, para cada paciente, pero administrándolos en forma única y alternada, debido a que su concepción es que con un solo medicamento no pueden cubrir la totalidad sintomática del individuo. Ej.: el médico, luego de la consulta le prescribe: 1º día: Lycopodium 1000C 1 Papel, 2º día Sulphur 1000C 1 Papel, 3º día Nux vómica 1000C 1 Papel y al 4º día vuelve al primer medicamento, y así sucesivamente. 3) COMPLEJISTA: tienen un enfoque diferente al de las dos Escuelas anteriores, ya que no tienen en cuenta la totalidad sintomática, sino los síntomas de la enfermedad local, utilizando un medicamento compuesto por más de una droga, en bajas potencias (en dinamizaciones bajas). Ej.: Chelidonium 3X, Taraxacum 3X, Cynara 4X Gotas. Director: Fernando Estevez Castillo Homeonews 54 Edición N° 16 – Año 2012 Todas los medicamentos homeopáticos, independientemente la orientación del médico prescriptor, se preparan de acuerdo a lo especificado en las principales Farmacopeas Homeopáticas, teniendo en cuenta las monografías de las materias primas (drogas y vehículos), los métodos de preparación de los productos intermedios (tinturas madre, soluciones madre y dinamizaciones) y de las distintas formas farmacéuticas, aplicando como condición indispensable, las Buenas Prácticas de Manufactura de Medicamentos Homeopáticos. En Argentina, existe Legislación a nivel Nacional y también en algunas Provincias, que regulan la elaboración del Medicamento Homeopático en la oficina de Farmacia, como medicamento magistral, con excepción de La Rioja, donde también existe la posibilidad de elaboración industrial, aunque todavía sin reglamentar. Con respecto a la Formación del profesional Farmacéutico, existen algunas Facultades que han incorporado la Materia Homeopatía, como optativa u obligatoria, durante el grado, así como Cursos de Posgrado para los egresados. La aplicación de la atención farmacéutica en la Farmacia Homeopática requiere una capacitación específica en esta materia (ver párrafo anterior), para poder asesorar a los pacientes, con respecto a la posología, formas de administración, interacciones, contraindicaciones y conservación de este tipo de medicamento. Para poder comprender correctamente los distintos pasos que se siguen en una Farmacia Homeopática, desde la Receta al Medicamento, trabajaremos durante esta Conferencia, sobre recetas médicas reales, contemplando y explicando cada una de las diferentes etapas que comprenden la interpretación de la receta, la elaboración y dispensación del medicamento homeopático. JORNADA DE MEDICINA BIOLOGICA E INTEGRATIVA Neuquén 2012 El sábado 17 de Noviembre, se realizó en la Ciudad de Neuquén, una Jornada de Medicina Biológica e Integrativa, organizada por la Farmacia Farmacéuticos Asociados de dicha ciudad y por Farmacia+Natural de Buenos Aires, y auspiciada por Powerfarm® y Laboratorios Dr. Madaus. La actividad se desarrolló en el Auditorio del Consejo Provincial de Educación, y tuvo como disertantes a la Dra. Ana María Soerensen1 y al Farm. Fernando O. Estevez Castillo. La apertura de la Jornada estuvo a cargo del Farm. Federico Arrigoni, Director Técnico de Farmacia Farmacéuticos Asociados, empresa con destacada trayectoria en la Ciudad de Neuquén, y organizadora de otros eventos relacionados con la Medicina Natural, tales como la I Jornada de Homeopatía del Comahue, realizada en el año 2007, cuyo principal disertante fue el prestigioso y recordado Dr. Ricardo Alvarez. Director: Fernando Estevez Castillo Homeonews 55 Edición N° 16 – Año 2012 Los temas abordados por la Dra. Ana María Soerensen fueron: Actualización en Medicina Naturista, Medicina Biológica o Integrativa. Modelo de paciente, diagnóstico y tratamiento. Educación para la salud. Concepto de sistema en biología. Terapia complementaria por sistemas. Semiología de la mano. Oculoanálisis. Alcances y limitaciones. Reflexoterapias. Orofaringe: lengua hepática, saburral, en constipación y diarrea, reumática, en terreno cancerígeno, en parasitosis, etc. Diagnóstico y tratamiento. La Dra. Ana María Soerensen durante la parte práctica (izq.) y su disertación (der.) A la presentación teórica de los temas, la Dra. Ana María Soerensen le sumó también la parte práctica, lo cual facilitó el entendimiento y despertó gran interés en todos los presentes. Por su parte, el Farm. Fernando O. Estevez Castillo, desarrolló el siguiente temario: Escuelas Homeopáticas (Unicista, Pluralista y Complejista). Similitudes y diferencias. Características del medicamento. Su aplicación en el sistema de Salud Público y Privado. Evaluación de resultados. Compendio de orientación terapéutica basado en la tradición popular homeopática CentroEuropea. Antecedentes y evolución en Argentina. Investigaciones nacionales e internacionales. De izq. a der: Farm. Fernando Estevez Castillo, Dra. Ana M. Soerensen, y organizadores de la Jornada: Farm. Federico Arrigoni, Farm. Patricia Hirsch y Farm. Pedro Alfieri Director: Fernando Estevez Castillo Homeonews 56 Edición N° 16 – Año 2012 Por último, todos los asistentes recibieron en un CD, el material de la Jornada, y el cierre estuvo a cargo del Farm. Federico Arrigoni, quien se comprometió a realizar el próximo año, otras actividades de similares características, para fomentar estas disciplinas no convencionales, colaborando de esta manera con la formación de los profesionales de la salud que las practican. 1 Médica egresada de la Facultad de Medicina de la Universidad de Buenos Aires. Master en Psiconeuroinmunoendocrinología-Univ. Favaloro. Posgrados en formación intensiva en Cardiología. Docente de Cursos de Medicina Naturista, Oculoanálisis, Terapia Biológica y Quiropraxia, en Argentina y el exterior. Docente de la Diplomatura anual en Medicinas no convencionales y Terapias Complementarias, Módulos sobre Medicina Naturista y Homotoxicología (Universidad de Belgrano). Docente del Curso intensivo en Medicina Integrativa, Asociación Médica Argentina. Co-Autora de los libros, Rumbo a la salud y Vivir en plenitud y autora de numerosos trabajos presentados en Congresos Nacionales e Internacionales NOVEDADES PROGRAMA RADIAL “AMIGOS DE LO NATURAL” Alimentación – Salud – Ecología – Hábitos saludables FM 94.7 (RADIO PALERMO) TODOS LOS MIERCOLES DE 15 A 16 HS CONDUCEN DR. JORGE ALONSO FARM. FERNANDO ESTEVEZ CASTILLO PRODUCCION También podés escucharlo a través de la web: www.radiopalermo.com.ar Director: Fernando Estevez Castillo Homeonews 57 Edición N° 16 – Año 2012 NUEVOS PRODUCTOS ALOEGEL Laboratorios Dr. Madaus & Co., ha presentado un nuevo producto llamado ALOEGEL, de uso externo, de alto poder descongestivo a base de Aloe vera, rico en cualidades emolientes, hidratantes y antisépticas, procurando alivio en el caso de irritaciones cutáneas. Presentación: Gel uso externo por 75 gramos. Para más información: Av. Luis María Campos 585 – Buenos Aires – Argentina (C1426BOD) Tel.: (54) (11) 4771-1734 / 4772-2428 Fax: (54) (11) 4775-4380 e.mail: info@drmadaus.com.ar Director: Fernando Estevez Castillo Homeonews 58 Edición N° 16 – Año 2012 CARRERA DE FARMACIA : CATEDRA “HOMEOPATIA” En Argentina existen hasta el momento, solo tres Facultades de Farmacia que dictan una materia relacionada a la Homeopatía, dentro del Plan de Estudios de la carrera de Farmacia. Dos de ellas, la tienen como materia optativa o electiva: la Facultad de Bioquímica, Química y Farmacia de la Universidad Nacional de Tucumán (“Introducción a la Farmacia Homeopática”); y la Facultad de Bioquímica, Quimica y Farmacia de la Universidad Nacional de San Luis (“Homeopatía”). La Facultad de Ciencias de la Salud de la Universidad Maimónides, es la única en el país, que dicta de forma obligatoria, la materia ”Homeopatía”, a los alumnos del cuarto año de la carrera de Farmacia. A partir de Julio del presente año, fue designado como Profesor Titular de la Cátedra de “Homeopatía”, el Farm. Fernando Oscar Estevez Castillo, acompañado por la Farm. Miriam Bruno como Profesora Adjunta, ambos profesionales con una dilatada trayectoria en la práctica y enseñanza de la Farmacotecnia Homeopática, quienes brindarán una información teórica completa y actualizada, con trabajos prácticos incluidos, para lograr que el alumno pueda interpretar, elaborar y dispensar medicamentos homeopáticos. ATENEOS Y CURSOS ATENEOS Ateneos del Departamento de Homeopatía Universidad Maimónides. Hidalgo 775, Buenos Aires. Aula 307. Entrada libre para Médicos y Estudiantes de Medicina. Para más información: Departamento de Homeopatía - Universidad Maimónides Hidalgo 775, Buenos Aires - Argentina Tel. (54-11) 4905-1142 homeopatia@maimonides.edu www.homeos.org ; www.maimonides.edu Director: Fernando Estevez Castillo Homeonews 59 Edición N° 16 – Año 2012 CURSOS Sociedad Latinoamericana de Fitomedicina Cursos a distancia para profesionales de la Salud Curso de Fitomedicina: Son 40 módulos en formato PDF totalmente ilustrados. Se entregan de a 4 módulos por semana. Se abordan las principales patologías humanas de acuerdo a los diferentes sistemas o aparatos. Se incluyen formulaciones para todos los casos con aval de las principales farmacopeas de todo el mundo. El examen consiste en un multiple choice de 30 preguntas o el cursista puede optar por la redacción de una monografía con tema a determinar oportunamente. Curso de Fitodermatología y Fitoestética: Se trata de 16 módulos en formato PDF totalmente ilustrados. Se abordan las principales patologías dermatológicas (acné, psoriasis, vitiligo, alopecía, celulitis, rosácea, legislación, etc). Se incluyen formulaciones para todos los casos con aval de las principales farmacopeas de todo el mundo. El examen consiste en un multiple choice de 30 preguntas o el cursista puede optar por la redacción de una monografía con tema a determinar oportunamente. Curso de Alimentos Funcionales y Nutracéuticos: Este curso consta de 30 módulos en formato PDF totalmente ilustrados, donde el alumno podrá tener acceso a toda una gama de información moderna relacionada con la actividad científicamente demostrada por aquellos principios activos comprendidos en nuestros alimentos y en productos nutracéuticos. El rol preventivo que cumplen en muchas enfermedades, así como el mejoramiento de procesos crónicos tras su consumo, hace de esta temática una materia obligada para todo profesional de la salud. El examen consiste en un multiple choice de 30 preguntas o la redacción de una monografía. Curso de Medicina Indigenista Americana: Se trata de un curso en formato PDF totalmente ilustrado, distribuido en 20 módulos, a enviarse cada fin de semana. El curso se acompaña de trabajos científicos referidos a tópicos tratados en el temario. Se verán la organización política y social, los aspectos religiosos y las cosmovisiones sobre salud y enfermedad de las principales etnias y civilizaciones americanas: Sioux, Apaches, Mayas, Aztecas, Caribes, Kunas, Jíbaros, Guaraníes, Incas, Aymarás, Mapuches, Onas, y muchos más. La evaluación consistirá en una monografía o realizar un multiple choice. Inscripción, programa e informes: fitomedic@gmail.com Director: Fernando Estevez Castillo Homeonews 60 Edición N° 16 – Año 2012 SUSCRIPCIÓN GRATUITA A HOMEONEWS Nombre y Apellido:........................................................................................................... Profesión:............................................................................................................................ Domicilio particular: Calle:........................................................... Nº:................................................................. Localidad:....................................................Prov.:............................................................ C.P.:……………..Tel.:.…..............................………….Fax:........................................... E.Mail:…………………………………………………………………………………… Domicilio laboral: Calle:........................................................... Nº:................................................................. Localidad:....................................................Prov.:............................................................ C.P.:……………..Tel.:.…..............................………….Fax:........................................... E.Mail:…………………………………………………………………………………… Temas de interés: ............................................................................................................................................. ............................................................................................................................................. ............................................................................................................................................. Director: Fernando Estevez Castillo
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