Perfil de eficacia y seguridad de Echinacea purpurea en la prevención de episodios de resfriado común: estudio clínico aleatorizado, doble ciego y controlado con placebo / Safety and efficacy profile of Echinacea purpurea to prevent common cold episodes: a randomized, double-blind, placebo-controlled trial

Objetivo: Investigar la seguridad y la eficacia de un extracto de Echinacea purpurea en la prevención del resfriado común en una amplia población durante un período de 4 meses. Método: 755 sujetos sanos recibieron un extracto etanólico de E. purpurea(95% parte aérea florida y 5% de raíz) fresca o placebo. A los participantes se les solicitó registrar en un diario los acontecimientos adversos y evaluar los síntomas relacionados con el resfriado, durante todo el período del estudio. Se tomaron muestras de las secreciones nasales de los participantes que padecieron resfriados agudos y fueron examinadas en busca de virus. Resultados: Ocurrieron un total de 293 acontecimientos adversos en el grupo al que se le asignó la equinácea y 306 en el grupo placebo. El 9% de los participantes experimentó acontecimientos adversos, que se consideraron al menos posiblemente, relacionados con el extracto (reacciones adversas), frente al 10% en el grupo placebo. Por lo tanto, la seguridad de la equinácea no fue inferior a la del placebo. La equinácea redujo el número total de episodios de resfriados, los días acumulados de resfriado y los episodios comedicados con analgésicos y antiinflamatorios. Asimismo inhibió los resfriados virales confirmados por deteccion del virus y previno especialmente las infecciones de los virus con membrana (p<0,05) La equinácea demostró mayor eficacia en las infecciones recurrentes y los efectos preventivos aumentaron cuando se cumplió estrictamente con el tratamiento y con el protocolo. Conclusión: La toma profiláctica de E. purpurea durante un período de 4 meses proporcionó una relación beneficio/riesgo positiva (AU)

Objective: To investigate the safety (risk) and efficacy (benefit) of Echinacea purpurea extract in the prevention of common cold episodes in a large population over a 4-month period. Methods: 755 healthy subjects were allocated to receive either an alcohol extract from freshly harvested E. purpurea (95% herba and 5% root) or placebo. Participants were required to record adverse events and to rate cold-related issues in a diary throughout the investigation period. Nasal secretions were sampled at acute colds and screened for viruses. Results: A total of 293 adverse events occurred with Echinacea and 306 with placebo treatment. Nine and 10% of participants experienced adverse events, which were at least possibly related to the study drug (adverse drug reactions).Thus, the safety of Echinacea was noninferior to placebo. Echinacea reduced the total number of cold episodes, cumulated episode days within the group, and pain-killer medicated episodes. Echinacea inhibited virally confirmed colds and especially prevented enveloped virus infections (p < 0.05). Echinacea showed maximal effects on recurrent infections, and preventive effects increased with therapy compliance and adherence to the protocol. Conclusions: Compliant prophylactic intake of E. purpurea over a 4-month period appeared to provide a positive risk to benefit ratio (AU)

Interacciones entre agentes antineoplásicos y drogas vegetales de uso común. Revisión sistemática / Interactions between antineoplasic agents and drugs commonly used vegetables. Systematic review

El uso de la raíz o parte aérea de equinácea, así como el té verde debe ser tenido en cuenta cuando se adminsitra cocomitantemente con determinados fármacos quimioterápicos, ya que compraten enzimas metabólicos y proteínas de transporte y por lo tanto pueden interaccionar. Este estudio analiza las posibles interacciones entre estas drogas vegetales y los agentes antineoplásicos, mediante una revisión sistemática. No se encontraron estudios destinados a buscar interacciones en relación con la equinácea, pero sí estudios de metabolismo y transporte in vitro e in vivo que permiten posponer la existencia de posibles interacciones. Las posibles interacciones del té verde han sido estudiadas en relación con bortezomib, 5-fluorounacilo (5-FU), ciclofosfamida, doxorrubicina, erlotinib, sunitinib y irinotecán. Es necesario realizar más investigaciones para conocer sus posibles implicaciones clínicas en la práctica oncológica (AU)

The use of the root or aerial part of several Echinacea sp., and green tea should be considered when administered concomitantly with certain anticancer drugs because they share some metabolic enzymes and transport proteins and therefore may interact. This study examines possible interaction between these drugs and antineoplastic agents, through a systematic review. No studies aimed to detect interactions related to coneflower were found, but metabolism and transport studies in vitro and in vivo, allowing to suggest possible interactions. In the case of green tea, possible interactions have been studied in relation to bortemozib, 5-fluorouracil (5-FU), cyclophosphamide, doxorubicin, erlotinib, sunitinib and irinotecan. More research is needed in order to know the potential clinical implications in oncology practice (AU)

Estudio del efecto inmunomodulador de la Equinácea purpúrea en pacientes con herpes labial recurrente / Imunomodulatory effects of Echinacea purpurea in patients with recurrent herpes labialis

Introducción: El Herpes Labial Recurrente supone una condición inmunológica alterada, tal como una hiperactividad de células T-reguladoras CD4+CD25+ (Treg). Éstas ejercen control sobre la tolerancia periférica y reducen el riesgo inmunopatológico, suprimiendo otras líneas celulares. Por ende, la supresión ejercida sobre la reacción inmune antiviral podría afectar negativamente el curso de la infección. Este contexto ha impulsado la búsqueda de nuevas alternativas inmunomoduladoras como la Equinácea purpúrea. Dada su propiedad inmunosupresora, se propone en el tratamiento del Herpes Labial Recurrente. Metodología: Estudio clínico prospectivo que analiza las subpoblaciones linfocitarias en 12 pacientes con Herpes Labial Recurrente, antes y después de recibir Equinácea purpúrea (30 gotas tres veces al día durante siete días).Resultados: En comparación con individuos sanos, los pacientes presentan una respuesta aumentada de células Treg. Esta condición se reduce significativamente tras recibir Equinácea purpúrea (515 + 145 y 432 + 113 cel/mm3 antes y después del tratamiento, respectivamente, p < 0,005). Conclusión: La hiperactividad de células Treg podría explicar el estado de inmunosupresión de estos pacientes y favorecería la persistencia viral. Se propone esta fitomedicina como una alternativa inmunoterapéutica beneficiosa.

Background: Recurrent Herpes Labialis patients may suffer from immunological alterations, such as CD4+CD25+Regulatory-T Cell (Treg) hyperactivity. These cells control peripheral tolerance and reduce immunopathology risk by suppressing other immunological cells. Hence, the Treg cell suppression on the antiviral immune reaction may perturb adversely the herpes infection outcome. This scenario has forced physicians to explore new immunomodulatory alternatives in Phytomedicine, such as Echinacea purpurea. Regarding the immunosuppressive property, it has been challenged to be employed in the Recurrent Herpes Labialis management. Methods: Clinical prospective study that analyzed lymphocytic subpopulation profile in twelve patients with Recurrent Herpes Labialis, before and after receiving E. purpurea (30 drops three times a day during seven days). Results: Comparing to healthy subjects, patients presented an enlarged Treg cell response. This condition became significantly reduced after receiving E. purpurea. (515 + 145 and 432 + 113 cel, before and after treatment respectively, p < 0.005). Conclusion: The intensified Treg cell activity may elucidate the immune suppression these patients undergo, aiding the viral persistence and survival. This proposes E. purpurea asa beneficial immunotherapeutic alternative.

Actividad de un extracto de equinácea purpúrea frente a los virus de la influenza H1N1, H5n1 y H7N7 / Activity of an extracto f purple corneflower against the influenza virus H1N1, H5N1 and H7N7

Las infecciones producidas por los virus de la influenza (VI) representan un problema de grandes dimensiones epidemiológicas en todo el mundo. La terapia antiviral incluye vacunas y algunos medicamentos antivirales. Sin embargo no siempre se dispone de las vacunas adecuadas y los virus desarrollan resistencia a los inhibidores de la neuraminidasa como Tamiflu (oseltamivir). Se estudió la actividad antiviral de un extracto comercial estandarizado de Echinacea purpurea (Echinaforce, EF), comprobándose su capacidad para inactivar, en cultivos celulares, los virus de la influenza tipo H1N1, H1N5 y H7N7, inhibiendo la capacidad de unión del virus al receptor y su entrada en la célula. A diferencia del Tamifú, no sólo las incubaciones sucesivas con EF no desarrollan resistencias virales, si no que EF fu activo frente a los virus resistentes al oseltamivir. En conclusión, este preparado de equinácea puede constituir un complemento útil para el control de la replicación y difusión de los virus de la influenza (AU)

Infections caused by influenza virases represent a large epidemiological problema Worl wide. Antiviral therapy includes vaccines and few antiviral drugs. However vaccines are not always available in time and viruses develop resistance to neuraminidase inhibitors such as Tamiflu (oseltamivir). We studied the antiviral activity of a commercial standardized extract of Echinacea purpurea (Echinaforce, EF), that demonstrated its ability to inactivate, in cell culture, the influenza viruses H1N1, H5N1 and H7N7, inhibiting the virus binding capacity to the cell receptor and its entry into the cell. Unlike Tamiflu, not only successive incubations with EF did not develop viral resistance, but EF was active against oseltamivir-viruses. In conclusion, this preparation of Echinacea could be a useful addition for the control of replication and spread on influenza virus (AU)

Evaluación de la eficacia y seguridad de un preparado a base de lúpulo, equinácea, bardana y vitamina Een el tratamiento oral del acné leve a moderado / Evaluation of the efficacy and safety of a preparation based on hops, echinacea, burdock and vitamin E in the oral treatment of mild to moderate acne

Se realizó un estudio abierto, prospectivo y longitudinal que evaluó la eficacia y seguridad de un preparado a base de extractos de estróbilo de lúpulo, raíz de equinácea, raíz de bardana y vitamina E (Asepxia®), administrado por vía oral durante 8 semanas, en el tratamiento del acné leve o moderado. Completaron el estudio 548 pacientes, observándose una disminución promedio de 17 lesiones (media de 30,3 lesiones iniciales frente a 13 lesiones finales). La disminución media de lesiones inflamatorias fue de 20,9% para las pápulas y 35,7% para las pústulas; en lesiones no inflamatorias, fue de 41% en comedones abiertos y 43,4% en comedones cerrados. El 1,8% de los pacientes presentó alguna reacción adversa durante el estudio, aunque solamente 1,3% se consideraron relacionadas con el preparado. Todas las reacciones adversas fueron clasificadas como leves. El porcentaje de casos evaluados como respuesta positiva fue del 92% por parte de los médicos y del 91% por parte de los pacientes (AU)

A longitudinal, prospective, open-label study was performed in order to evaluate the efficacy and safety of a preparation of extracts of hop strobile, echinacea root, burdock root and vitamin E (AsepxiaTM) in the oral treatment (8 weeks) of mild to moderate acne. 548 patients completed the study, showing a reduction average of 17 acne lesions (mean: 30,3 initial lesions versus 13 final lesions). The reduction of inflammatory lesions was, in average, 20,9% for papules and 35,7% for pustules, while the reduction of non-inflammatory lesions was 41% for open comedones and 43,4% for closed comedones. Adverse reactions during the study were shown by 1,8% of the patients, but only 1,3% were considered related to the preparation. All of them were mild reactions. The response to the treatment was evaluated as positive in the 92% of the cases by physicians and in 91% by patients (AU)

Colutorios de Eschinacea angustifolia 2D en el tratamiento de gingivitis simple en niños de 8 a 13 años / Eschinacea angustifolia 2D mouthrinses in the treatment of simple gingivitis in 8- to 13-year-old children

Se llevó a cabo un estudio cuasi experimental, doble ciego, paralelo, controlado con placebo (agua destilada, alcohol 87° y colorante vegetal), sobre la acción de colutorios de Echinacea angustifolia 2D (1 mL = 20 gotas, diluidas en 10 mL de agua) en gingivitis simple, en 61 escolares; 30 mujeres y 31 hombres entre 8 y 13 años. Realizaron colutorios tres veces al día durante 14 días después de su cepillado dental, se indicó mantener esta solución en la boca por 60 segundos, no ingerir alimentos o bebidas 30 minutos posterior a su aplicación. Se logró una mejoría estadísticamente significativa en los grados de gingivitis y en el porcentaje de placa dentobacteriana (PDB). En comparación con el placebo la Echinacea angustifolia exhibió una superioridad, eliminó en 19 de 31 casos la gingivitis simple y disminuyó el grado de gingivitis en los 12 casos restantes, el grupo placebo no mostró cambios. Con respecto al porcentaje de PDB en el grupo experimental, disminuyó en un 47 por ciento, pasó del 80 al 33 por ciento, en el grupo placebo disminuyó en 11 por ciento, pasó de 78 por ciento inicial a 67 por ciento.

Fitoterapia y SIDA / Phytotherapy and AIDS

El uso de tratamientos complementarios derivados de hierbas medicinales es bastante común entre las personas infectadas por VIH. Diversos estudios señalan que, en USA, hasta el 80% de la población seropositiva ha recurrido alguna vez a la medicina complementaria. Los objetivos que se buscan en este tipo de terapias son reforzar el sistema inmunológico, evitar las neoplasias, tratar problemas asociados al SIDA, como las infecciones, las alteraciones de la piel, la depresión o paliar los efectos adversos de los antirretrovirales, como las náuseas, la diarrea o la pérdida de peso. La falta de eficacia de estos tratamientos y, sobre todo las potenciales interacciones de los remedios herbales utilizados en estos casos con los fármacos antirretrovirales hacen necesaria su revisión

The use of complementary treatments derived from medicinal herbs is quite common among HIV-infected individuals. Several studies show that up to 80% of the seropositive population in the USA has resorted at one time or another to the use of complementary medicine. The objective that these types of therapies seek is to reinforce the immunological system, to avoid neoplasias, to treat AIDS-associated problems, infections, skin disorders, depression, and to palliate the side effects of antiretroviral agents, such as nausea, diarrhoea, or weight loss. The lack of efficacy of these treatments and, mainly, the potential interactions of herbal remedies with antiretroviral agents used in these cases, call for their urgent review

[Palliative immunotherapy of cancer]. / Palliative Immuntherapien bei Krebs.

In addition to surgery, chemotherapy and radiation, immunotherapy of cancer resembles a potential treatment strategy for patients with cancer. To strengthen the immune system might help to control or even to eradicate malignant tumors. Immunoaugmentative strategies include biological response modifiers as interferons and interleukins. Recently, monoclonal antibodies directed against tumor associated antigens and coupled with radioisotopes or cytotoxic agents have become available. Adoptive immunotherapy uses immune effector cells, i.e. T-cells or natural-killer cells that are activated in-vitro by appropriate cytokines. Dendritic cells, either unstimulated or pulsed with tumor derived molecules have shown promising anticancer activity in selected tumors. Immunonutrition, that is the manipulation of immune phenomenons through edibles is a new and interesting topic. Immunologic strategies for the treatment of malignant diseases are currently under intensive preclinical and clinical investigation. Further insights into the mechanisms of host-defense against cancer cells and the modification of immune-effector cells might pave the way to efficient treatment strategies, even in the palliative setting.

Efficacy of Echinacea purpurea in patients with a common cold. A placebo-controlled, randomised, double-blind clinical trial.

Common colds are one of the most frequent acute illnesses with major economical impact. Echinaceae purpureae herba (Echinacin, EC31J0) has shown promising results in the relief of common cold symptoms and the time taken to improvement compared to placebo. This study was aimed to confirm these findings by performing a randomised, double-blind, placebo-controlled clinical trial. A total of 80 adult male or female patients with first signs of a cold were recruited. The number of days of illness with a complete picture of the common cold (defined by the modified Jackson score of at least 5 points and experience of rhinorrhea and/or a subjective sensation of having a cold) was the primary end-point. In the verum group the median time of illness was 6.0 days compared to 9.0 days in the placebo group, assigning zero time for patients without a complete picture (one-sided p = 0.0112). EC31J0 was well tolerated and clinically effective in alleviating symptoms more rapidly than placebo in patients with a common cold.

The use of dietary supplements in pediatrics: a study of echinacea.

Alternative medical therapies are commonly used and have increased in popularity. Although patients may not always disclose the use of alternative therapies, they may seek advice regarding their use, especially for children. Regulation and standardization of these modalities, especially botanicals, is incomplete. The University of Arizona has initiated a study of the use of echinacea in the prevention of recurrent otitis media. A review of echinacea preparations was undertaken, and this report discusses the complexities surrounding the use of this dietary supplement. The number and diversity of echinacea preparations are detailed; the role of the physician as "botanical" advisor to patients and families is examined.

Does the extract of the plant Echinacea purpurea influence the clinical course of recurrent genital herpes?

An increasing proportion of the population perceive complementary medicine as a safer alternative for non-life threatening conditions such as genital herpes. The extract of the plant Echinacea purpurea (Echinaforce) has been shown to have immunomodulating properties and has been advocated in the lay press for the treatment of genital herpes. This study, a single centre, prospective, double blind, placebo-controlled cross-over trial set out to assess whether an extract of the plant and root of E. purpurea can prevent or decrease the frequency and severity of genital herpes recurrences. These were assessed using a detailed history and clinical review of symptoms. Visual analogue scales were used for documentation and haematological and immunological parameters were measured. Over a one-year period, 50 patients took part in the study receiving 6 months' placebo and 6 months' Echinaforce each. No statistically significant benefit could be detected in this study comparing placebo versus Echinaforce in the treatment of frequently recurrent genital herpes.

Recurrent erythema nodosum associated with Echinacea herbal therapy.

We report a case of recurrent erythema nodosum that is temporally and perhaps causally associated with use of echinacea herbal therapy. The genus Echinacea is traditionally used as an immunostimulant in the prophylaxis and treatment of upper respiratory tract infections. In vitro and in vivo studies of echinacea administration in animal and human-derived models suggest a definite stimulatory effect on the cellular immune system, although the clinical impact of echinacea is still unknown. The public's increasing use of alternative and complementary therapies necessitates that dermatologists be familiar with the cutaneous adverse effects of these agents.

The treatment of rhinovirus infections: progress and potential.

The common cold is an important illness both as a result of the economic impact of this common disease and because of the morbidity associated with the complications of the illness. Recent attempts to develop antiviral treatments for the common cold represent a substantial advance over previous efforts. Formidable barriers remain to be overcome, however, before any of these new products will be proven to be clinically useful. Recent advances in our understanding of the pathogenesis of common cold symptoms have provided insights into potential new targets for the treatment of this illness.

The efficacy of echinacea compound herbal tea preparation on the severity and duration of upper respiratory and flu symptoms: a randomized, double-blind placebo-controlled study.

OBJECTIVES: The aim of this study was to determine the efficacy of an echinacea compound herbal tea preparation (Echinacea Plus) given at early onset of cold or flu symptoms in a random assignment double-blind placebo-controlled study. DESIGN AND SUBJECTS: A total of 95 subjects with early symptoms of cold or flu (runny nose, scratchy throat, fever) were randomly assigned to receive Echinacea Plus tea five to six cups per day titrating to 1 over 5 days or placebo in a double-blind situation. Each participant completed a questionnaire 14 days after beginning the program. The efficacy, number of days the symptoms lasted, and number of days for change were measured with a self scoring questionnaire. RESULTS: The study period was 90 days (January 1, 1999 to March 30, 1999). There was a significant difference between the experimental group (Echinacea Plus) and control group (placebo) for all 3 questions measured: p < 0.001. There were no negative effects reported by any of the subjects in either group. CONCLUSIONS: Treatment with Echinacea Plus tea at early onset of cold or flu symptoms was effective for relieving these symptoms in a shorter period of time than a placebo.

Evaluation of echinacea for treatment of the common cold.

Considered to have immunostimulating activity, echinacea is a widely used phytomedicinal for treatment of the common cold and upper respiratory tract infections (URTIs). We reviewed the literature from the MEDLINE database (January 1966-July 1999), International Pharmaceutical Abstracts (IPA) online database, Cambridge Scientific Abstracts Biological Sciences online database, Alt-Health Watch online database, EMBase CD-ROM database, and references from published articles, reviews, and letters to evaluate evidence from clinical trials of echinacea's purported efficacy for treating or preventing URTIs. Twelve clinical studies published from 1961-1997 concluded that echinacea was efficacious for treating the common cold, but the results are unclear due to inherent flaws in study design. Five trials were published since 1997; two showed that echinacea lacked efficacy for treating and preventing URTI symptoms, and three concluded that it was effective in reducing the frequency, duration, and severity of common cold symptoms. Again, these results are unclear because of methodologic uncertainties, such as small populations and use of noncommercially available, nonstandardized dosage forms. Although evidence for echinacea's efficacy is inconclusive, it appears to be safe. Patients without contraindications to it may not be dissuaded from using an appropriate preparation to treat the common cold.

Ineffectiveness of echinacea for prevention of experimental rhinovirus colds.

The purpose of this study was to assess the effectiveness of echinacea for the prevention of experimental rhinovirus colds. Infection occurred in 44 and 57% and illness occurred in 36 and 43% of the echinacea- and placebo-treated subjects, respectively. This preparation of echinacea had no significant effect on either the occurrence of infection or the severity of illness.