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Immunomodulation with Echinacea - A systematic review of controlled clinical trials
Abstract
We performed a systematic review of controlled clinical trials to check the evidence for the immunomodulatory efficacy of preparations containing extracts of Echinacea. Trials were searched by on-line searches in Medline and Embase, a search in the private database Phytodok, contacts with researchers and drug companies, and by checking references in available articles. All available historically and prospectively controlled trials investigating the prophylactic or therapeutic immunomodulatory activity of preparations of Echinacea alone or in combination with other plant extracts or homeopathic dilutions in humans were included. Study characteristics, results, and conclusions of primary authors were analyzed using standardized evaluation forms and methodological quality assessment using a predefined score system. A total of 26 controlled clinical trials (18 randomized, 11 double-blind) were identified; 6 of these involved testing three different mono-extracts, and 20 involved testing three different preparations also containing other ingredients. Nineteen trials studied the efficacy of the prophylactic or curative treatment of infections; 4 trials the reduction of side-effects of antineoplastic therapies and 3 trials the modulation of various laboratory immune parameters. The primary authors claimed that 30 of the 34 treatment strategies showed a superior efficacy to those of the control groups. The methodological quality of most studies was low and only 8 trials scored more than half of the maximum possible score points. Existing controlled clinical trials indicate that preparations containing extracts of Echinacea can be efficacious immunomodulators. However, the evidence is still insufficient for clear therapeutic recommendations as to which preparation to use and which dose to employ for a specific indication. Further methodologically sound, randomized clinical trials should be conducted.
... Interestingly, in addition to antiviral properties, Echinacea possesses notable immunomodulatory, anti-inflammatory, antioxidant, and antibacterial properties [45,46]. Considering the pharmacological effects, molecular mechanisms, and therapeutic potential of Echinacea, we hypothesize that Echinacea could be a potential candidate for COVID-19 treatment. ...
... Echinacea preparations containing either one from different species or a mix of E. angustifolia and E. purpurea are among the top-selling herbal medicines worldwide, including in North America and Europe [48]. Because of their potent antiviral and immunomodulatory properties, they are extensively studied in experimental and clinical studies and reviewed, including in metanalyses that have reported the efficacy and safety of Echinacea preparations in cough, cold, seasonal flu, and upper respiratory infections [46,49,50,51,52,53,54,55]. Clinical studies assessing the effect of Echinacea on the common cold have used various Echinacea preparations and study designs [45,49,50]. Recently, a meta-analysis analyzed 24 double-blind randomized clinical trials with 4631 participants, including comparison of a total of 33 Echinacea preparations and placebo; it indicated that Echinacea preparations exhibit a moderate benefit [49]. ...
... The polysaccharides/glycoproteins in the plant including inulin, arabinogalactans, and heteroxylans, which exhibit immunostimulatory and anti-inflammatory activities [50,60]. The polysaccharide fraction of E. purpurea has been shown to attenuate leukopenia [45] and adjuvant effects on T-cell cytokine responses characterized by enhancing and suppressive effects that are regulated by T-cell density [62]. Phylloxanthobilins present in the leaf extracts of E. purpurea have exhibited free-radical scavenging activity and have restored glutathione levels to counter oxidative stress [63]. ...
Coronavirus disease 2019 (COVID-19) pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is an ongoing public health emergency. The pathogenesis and complications advanced with infection mainly involve immune-inflammatory cascade. Therefore, the therapeutic strategy relies on immune modulation, reducing infectivity and inflammation. Given the interplay of infection and immune-inflammatory axis, the natural products received attention for preventive and therapeutic usage in COVID-19 due to their potent antiviral and anti-immunomodulatory activities. Recently, Echinacea preparations, particularly E. purpurea, have been suggested to be an important antiviral agent to be useful in COVID-19 by modulating virus entry, internalization and replication. In principle, the immune response and the resultant inflammatory process are important for the elimination of the infection, but may have a significant impact on SARS-CoV-2 pathogenesis and may play a role in the clinical spectrum of COVID-19. Considering the pharmacological effects, therapeutic potential, and molecular mechanisms of Echinacea, we hypothesize that it could be a reasonably possible candidate for targeting infection, immunity, and inflammation in COVID-19 with recent recognition of cannabinoid-2 (CB2) receptors and peroxisome proliferator-activated receptor gamma (PPARγ) mediated mechanisms of bioactive components that make them notable immunomodulatory, anti-inflammatory and antiviral agent. The plausible reason for our hypothesis is that the presence of numerous bioactive agents in different parts of plants that may synergistically exert polypharmacological actions in regulating immune-inflammatory axis in COVID-19. Our proposition is to scientifically contemplate the therapeutic perspective and prospect of Echinacea on infection, immunity, and inflammation with a potential in COVID-19 to limit the severity and progression of the disease. Based on the clinical usage for respiratory infections, and relative safety in humans, further studies for the evidence-based approach to COVID-19 are needed. We do hope that Echinacea could be a candidate agent for immunomodulation in the prevention and treatment of COVID-19.
... Previously work carried out by number of investigators with these compounds posses anti-viral activity (16,(19)(20)(21). Melchart, et al. (1994) (22) proved that Echinacea species extracts through oral treatment protects experimentally infected the Influenza-A virus in mice. The immunomodulating action may triggered by antiviral activity compounds (23). ...
... Previously work carried out by number of investigators with these compounds posses anti-viral activity (16,(19)(20)(21). Melchart, et al. (1994) (22) proved that Echinacea species extracts through oral treatment protects experimentally infected the Influenza-A virus in mice. The immunomodulating action may triggered by antiviral activity compounds (23). ...
Partially purified methanolic extract of Cissus quadrangularis (belonging to Vitaceae member, South Indian medicinal plant) have been explored for antiviral activity and their phytochemical characterisation. In vitro antiviral activity against HSV type1 and 2, and Vero cells at non-cytotoxic concentration were determined. HSV1 and HSV2 showed more sensitivity against the partially purified compound. Phytochemical analysis showed the presence of the Steroids and Terpenoids.
... The term "immunomodulatory" is increasingly seen as more appropriate than "immunostimulatory" to describe echinacea's immunological effects, although the latter remains widely used in earlier scientific discussions on the plant [161]. It has been suggested that broadly stimulating the highly complex immune system may not always be beneficial, as some immune responses can be detrimental [162]. ...
Background: Echinacea species, particularly Echinacea purpurea, Echinacea angustifolia, and Echinacea pallida, are renowned for their immunomodulatory, antibacterial, and antiviral properties. Objectives: This review explores the mechanisms by which echinacea herbal extracts modulate immune responses, focusing on their effects on both innate and adaptive immunity in bacterial and viral infections. Results: Key bioactive compounds, such as alkamides, caffeic acid derivatives, flavonoids, and polysaccharides, contribute to these effects. These compounds enhance immune cell activity, including macrophages and natural killer cells, stimulating cytokine production and phagocytosis. The antibacterial activity of echinacea against respiratory pathogens (Streptococcus pneumoniae, Haemophilus influenzae, Legionella pneumophila) and skin pathogens (Staphylococcus aureus, Propionibacterium acnes) is reviewed, as well as its antiviral efficacy against viruses like herpes simplex, influenza, and rhinovirus. Echinacea’s potential as a complementary treatment alongside conventional antibiotics and antivirals is discussed, particularly in the context of antibiotic resistance and emerging viral threats. Conclusions: Challenges associated with variability in phytochemical content and the need for standardized extraction processes are also addressed. This review provides a comprehensive overview of echinacea’s therapeutic potential and outlines future directions for research, including clinical trials and dosage optimization.
... This has been in part due to the lack of uniform standards in preparation, formulation, potency, and actual usage. 10 The dosages necessary to confer therapeutic benefit demonstrated in supportive studies are often much higher than the dosages found in standard products commonly found over the counter in pharmacies and drug stores. A key advantage of the potential use of vitamin, mineral, and herbal preparations as a tool in URI management is the reduced risk of antimicrobial resistance, reduced exposure to the potential side effects of drugs, and the long-term preservation of antibiotic and antimicrobial efficacy for when they are critically needed. ...
Background
Growing antibiotic resistance is among the most serious threats to public health, with antibiotic misuse considered a leading driver of the problem. One of the largest areas of misuse is in outpatient upper respiratory infections (URIs). The purpose of this research is to evaluate the efficacy of EZC Pak, a combination Echinacea-Zinc-Vitamin C dose pack with or without Vitamin D, on the duration of illness and symptom severity of non-specific URIs as an alternative to antibiotics when none are deemed clinically necessary. A secondary analysis was carried out on patient satisfaction.
Methods
A total of 360 patients across the United States were enrolled and randomized in a double-blind manner across two intervention groups, EZC Pak, EZC Pak+Vitamin D, and one placebo group. The study utilized a smartphone-based app to capture data. Once a participant reported the first URI symptom, they were instructed to take the intervention as directed and complete the daily symptom survey score until their symptoms resolved.
Results
The average EZC Pak participant recovered 1.39 days (90% CI 1.05 to 1.73) faster than the average placebo participant (p=0.017). The average EZC Pak participant reported a 17.43% (90% CI 17.1 to 17.8) lower symptom severity score versus placebo (p=0.029). EZC Pak users reported 2.9 times higher patient satisfaction versus placebo users (p=0.012). The addition of Vitamin D neither benefited nor harmed illness duration or symptom severity.
Conclusion
The findings support the potential use of EZC Pak as an alternative to patient request for antibiotics when none are deemed clinically necessary at the time of initial clinical presentation. The decision to replete vitamin D in the acute phase of URI is an individualized decision left to the patient and their clinician. EZC Pak may play a critical role in improving outpatient URI management and antibiotic stewardship (ClinicalTrials.gov number, NCT04943575).
... Its supplements are widely recommended by naturopathic doctors for their immune support function (210). Moreover, it is well known for its various immunomodulatory, antioxidant, anti-inflammatory, and antibacterial properties (211,212). ...
Background
Being “positive” has been one of the most frustrating words anyone could hear since the end of 2019. This word had been overused globally due to the high infectious nature of SARS-CoV-2. All citizens are at risk of being infected with SARS-CoV-2, but a red warning sign has been directed towards cancer and immune-compromised patients in particular. These groups of patients are not only more prone to catch the virus but also more predisposed to its deadly consequences, something that urged the research community to seek other effective and safe solutions that could be used as a protective measurement for cancer and autoimmune patients during the pandemic.
Aim
The authors aimed to turn the spotlight on specific herbal remedies that showed potential anticancer activity, immuno-modulatory roles, and promising anti-SARS-CoV-2 actions.
Methodology
To attain the purpose of the review, the research was conducted at the States National Library of Medicine (PubMed). To search databases, the descriptors used were as follows: “COVID-19”/”SARS-CoV-2”, “Herbal Drugs”, “Autoimmune diseases”, “Rheumatoid Arthritis”, “Asthma”, “Multiple Sclerosis”, “Systemic Lupus Erythematosus” “Nutraceuticals”, “Matcha”, “EGCG”, “Quercetin”, “Cancer”, and key molecular pathways.
Results
This manuscript reviewed most of the herbal drugs that showed a triple action concerning anticancer, immunomodulation, and anti-SARS-CoV-2 activities. Special attention was directed towards “matcha” as a novel potential protective and therapeutic agent for cancer and immunocompromised patients during the SARS-CoV-2 pandemic.
Conclusion
This review sheds light on the pivotal role of “matcha” as a tri-acting herbal tea having a potent antitumorigenic effect, immunomodulatory role, and proven anti-SARS-CoV-2 activity, thus providing a powerful shield for high-risk patients such as cancer and autoimmune patients during the pandemic.
... [16] Studies have found that Echinacea powdered supplements to be effective in aiding immunity if given in 300-500 mg dose, three times daily. However, a combination of Ginger and Echinacea extracts is more effective in decreasing inflammatory mediators than an individual compound, [17] and the length of the side chains determines the level of effectiveness. [18] The aim of this study was to assess the clinical efficacy and safety of oral ginger and Echinacea extracts supplementation in the symptomatic treatment of OA as the growing interest in use of these herbal products in the treatment of OA. ...
Objectives: To evaluate the efficacy and safety of the Echinacea and ginger species extracts supplementation among patients with knee osteoarthritis (OA). Methods: Three hundred female patients with knee OA participated in this randomized study. They had OA of the knee and moderate-to-severe pain and they were divided into two groups. Study group (n=150) and control group (n=150). The study which lasted for 6-week. The study group received Ginger and Echinacea extract supplementations twice daily, with/ without acetaminophen. The study examined the reduction in "knee pain on standing for the study group (Ginger and Echinacea group)" defined by a reduction in pain of > or = 15 mm on a visual analog scale. The study measured other biological values such as BP, ESR, Creatinine and liver enzymes. Results: The supplementation of ginger and Echinacea extracts resulted in improvements in many values. Systolic blood pressure dropped from 120.5 ± 10.4 to 119.7 ± 8.9 mmHg, pain intensity VAS decreased from 6.9 ± 2.1 to 6.6 ± 1.5, ESR17.3 ± 11.9 and 21.0 ± 9.8mm/h, creatinine 0.87 ± 0.19mg/dl and 0.85 ± 0.16 mg/ dl and liver enzymes 21.6 ± 8.5 IU/L and 20.9 ± 4.5 IU/L for ALT and 20.9 ± 4.5 IU/L and 20.3 ± 7.4 IU/L for AST. Conclusion: The use of ginger extract in knee osteoarthritis patients had a moderately statistically significant effect on reducing pain with safe profile and mild GI adverse events.
Key words: Ginger, Echinacea, Knee OA, Osteoarthritis, visual analogue scale (VAS), tumor necrosis factor (TNF)-α.
... A bizonyítékok egyaránt alátámasztják mind a hatékonyságát, mind a hatás hiányát, a készítmények típusától és vizsgálatok felépítésétől függetlenül [3,14,15,16]. A legszélesebb körű alkalmazását, az akut felsőlégúti fertőzések kezelését, a rendelkezésre álló szakirodalom számos publikációval alátámasztja [16,17]. Ennek ellenére a szisztematikus áttekintő közlemények következtetése szerint az Echinacea termékekről nem igazolták egyértelműen, hogy előnyöket nyújtanak a megfázás kezelésére [18,19] és megállapítják, hogy az egyes profilaktikus vizsgálatok eredményei következetesen pozitív (ha nem szignifikáns) tendenciákat mutatnak, bár a lehetséges hatások megkérdőjelezhető klinikai jelentőséggel bírnak [19]. ...
The aim of the study was to explore dietary supplements containing Echinacea on the Romanian market and their qualitative characterization.
The products available on the market were aggregated in 2018, through an electronic search based on the register of the Romanian Medicine Agency (Agenția Națională a Medicamentului şi a Dispozitivelor Medicale din România – ANMDMR) and the list of dietary supplements registered by the Ministry of Agriculture and Rural Development (Institutul Național de Cercetare-Dezvoltare pentru Bioresurse Alimentare – IBA București, Serviciul național pentru plante medicinale, aromatice și produse ale stupului). There are no Echinacea containing medicines registered in Romania. However, there are 58 dietary supplements in the register, 52% of which are mono-components, 29% contain other herbs, plant extract or vitamins, while 19% are registered as tea. The label of 80% of monocomponent products and 76% of multicomponent supplements contains insufficient information: the plant name, its used part and processing methods (grist, extract, quantity) are not clearly identified. Among the listed dietary supplements, the 12 most commonly used formulations in pharmaceutical practice were subjected to phytochemical chromatographic evaluation: TLC and/or HPLC analysis were used. Three of seven monocomponent products showed proper chromatographic fingerprint, by TLC analysis. One monocomponent sample did not have an adequate chromatographic fingerprint. The labelling of multicomponent products was not appropriate. The TLC test suggests that based on the resulting fingerprint they contain E. purpureae herba. However, due to the presence of other components, the TLC does not allow a clear conclusion regarding the exact composition of the products.
The developed HPLC method enables quantification of the concentration of caffeic acid, chicoric acid, echinacoside, chlorogenic and caftaric acids mixture in dietary supplements. None of the tested products contained echinacoside, which is a specific component of E. angustifolia and E. pallida root. In our method, the quantification of caftaric acid is approximate, because it partially overlaps the chlorogenic acid, which is a common component of plant samples, but negligible in Echinacea sp. The tested dietary supplements have a caffeic acid content of 20-140 µg/g, a chicoric acid content of 0.19-2.64 mg/g; the mixture of chlorogenic and caftartic acid is about 0.23-2.07 mg/g.
... [16] Studies have found that Echinacea powdered supplements to be effective in aiding immunity if given in 300-500 mg dose, three times daily. However, a combination of Ginger and Echinacea extracts is more effective in decreasing inflammatory mediators than an individual compound, [17] and the length of the side chains determines the level of effectiveness. [18] The aim of this study was to assess the clinical efficacy and safety of oral ginger and Echinacea extracts supplementation in the symptomatic treatment of OA as the growing interest in use of these herbal products in the treatment of OA. ...
Objectives: To evaluate the efficacy and safety of the Echinacea and ginger species extracts supplementation among patients with knee osteoarthritis (OA). Methods: Three hundred female patients with knee OA participated in this randomized study. They had OA of the knee and moderate-to-severe pain and they were divided into two groups. Study group (n=150) and control group (n=150). The study which lasted for 6-week. The study group received Ginger and Echinacea extract supplementations twice daily, with/ without acetaminophen. The study examined the reduction in "knee pain on standing for the study group (Ginger and Echinacea group)" defined by a reduction in pain of > or = 15 mm on a visual analog scale. The study measured other biological values such as BP, ESR, Creatinine and liver enzymes. Results: The supplementation of ginger and Echinacea extracts resulted in improvements in many values. Systolic blood pressure dropped from 120.5 ± 10.4 to 119.7 ± 8.9 mmHg, pain intensity VAS decreased from 6.9 ± 2.1 to 6.6 ± 1.5, ESR17.3 ± 11.9 and 21.0 ± 9.8mm/h, creatinine 0.87 ± 0.19mg/dl and 0.85 ± 0.16 mg/ dl and liver enzymes 21.6 ± 8.5 IU/L and 20.9 ± 4.5 IU/L for ALT and 20.9 ± 4.5 IU/L and 20.3 ± 7.4 IU/L for AST. Conclusion: The use of ginger extract in knee osteoarthritis patients had a moderately statistically significant effect on reducing pain with safe profile and mild GI adverse events.
Key words: Ginger, Echinacea, Knee OA, Osteoarthritis, visual analogue scale (VAS), tumor necrosis factor (TNF)-α.
... Additionally, Echinacea appears to increase the production of interferon, a group of signal proteins released in response to viruses, speeding up the immune response of viral infections [73]. Several doubleblind, clinical studies have confirmed Echinacea's effectiveness in treating colds and flu [74][75][76][77][78][79]. ...
The pandemic of novel coronavirus caused COVID-19 had resulted in a high number of hospitalizations and deaths and caused a devastating toll on human and society health. The symptoms of the infected patients vary significantly, from life-threatening to mild or even asymptomatic. This clinical observation led to hypothesize on the critical role of host innate immunity in the disease development and progression. As the first defense barrier against microorganisms, the innate immune reaction determines not only the viral infection rate but also immune-mediated response. Therefore, promote healthy behaviors to enhance innate immunity with functional food and nutritional agents may be a rational strategy for minimizing damages caused by viruses to global health.
... ) family should avoid Echinacea as few cases of Echinacea induced anaphylaxis, asthma attack; urticaria and contact dermatitis have been reported. Echinacea can interfere with drugs metabolized by an enzyme family known as the cytochrome p450 system and thus prolong their action.36 When AZT was combined to Echinacea in this study; no interactions reported and efficacy of both drugs were maintained. ...
Purpose
Recurrent tonsillitis in children is a common disease affecting children quality of life and extends to their families. The aim of this study was to assess the effect of combined use of oral Azithromycin (AZT) plus Echinacea compared to exclusive use of AZT in children with recurrent tonsillitis.
Material and methods
A prospective comparative study including three groups of children with recurrent tonsillitis. Group 1: (100 patients) had no prophylactic treatment. Group 2 (100 patients) received [60 mg/kg] prophylactic dose of AZT divided as (10 mg/kg/day) over 6 consecutive days every month for 6 consecutive months. Group 3 (100 patients) received AZT as in group 2 plus commercially available Echinacea in a dose of 5 ml oral suspension; 3 times daily for 10 consecutive days every month for 6 consecutive months. Number of tonsillitis attacks and severity of tonsillitis symptoms were assessed and compared in different groups.
Results
Group 2 and group 3 had significant less number of tonsillitis attacks and severity of assessed symptoms during 6 months of prophylactic treatment with significant better results in group 3 (i.e. AZT plus Echinacea) compared to group 2 (I.e. AZT alone). However; there was no significant difference in patients with any prophylaxis.
Conclusion
The combined use of Echinacea with Azithromycin produced favorable outcome than Azithromycin alone in pediatric patients with recurrent tonsillitis.
... ) family should avoid Echinacea as few cases of Echinacea induced anaphylaxis, asthma attack; urticaria and contact dermatitis have been reported. Echinacea can interfere with drugs metabolized by an enzyme family known as the cytochrome p450 system and thus prolong their action.36 When AZT was combined to Echinacea in this study; no interactions reported and efficacy of both drugs were maintained. ...
Purpose
Primary atrophic rhinitis (PAR) is a well-known old disease characterized by a roomy nose and extensive crustations. This study was designed to investigate the effect of topical Mitomycin-C as an adjunct to medical treatment with respect to objective and subjective improvement in patients treated with PAR.
Material and methods
This prospective randomized controlled study was conducted in a tertiary referral hospital in January 2016 and March 2018. Fifty adult patients aged 18 to 45 with PAR were randomly divided into 2 groups. Study group: treatment with Mitomycin-C dissolved in an alkaline wash plus rifampicin and control group: only treated with rifampicin and alkaline nasal wash. Subjective scores for the following symptoms: After 12 weeks of treatment, foul smell, anosmia, crusting, epistaxis, and nasal blockade, an objective score of crusting, the status of nasal mucosa, nature of the secretions and condition of nasal cavity were compared between the two groups.
Results
The degree of crustations (P < 0.0001) and the severity of epistaxis (P < 0.0001) were significantly improved in patients treated with Mitomycin-C dissolved in an alkaline wash (i.e. the study group), and the secretions returned significantly to normal (P < 0.0001). Both groups had significant improvements in both subjective and objective parameters of the assessment.
Conclusions
In patients with primary atrophic rhinitis, the use of Mitomycin-C dissolved in an alkaline nasal wash as an adjunct to oral rifampicin can produce a beneficial result than rifampicin and alkaline nasal wash alone.
... Nineteen trials studied the effectiveness of preventive or therapeutic effects on the body with an associated infection; 4 trials studied the reduction of the risk of adverse effects in the course of an antitumor therapy and 3 trials studies the modulation of various immune parameters. The existing controlled clinical studies show that homeopathic preparations containing Echinacea extracts can be effective immune modulators [31]. Studies of the immunomodulatory activity of homeopathic preparations containing Echinacea extracts were also carried out by another group of researchers on healthy volunteers. ...
Background. Acute respiratory viral infection (ARVI) is accompanied by a general intoxication syndrome and respiratory mucosa predominant damage. A significant number of viral nature pathogens from various nosological groups (influenza viruses, parainfluenza, adenoviruses, respiratory syncytial viruses, coronaviruses, picornaviruses, rhinoviruses, enteroviruses, herpesviruses, etc.) could cause development of ARVI at human respiratory tract. Methods of ethnoscience and non-traditional medicine can be used as part of integrated treatment and prevention of influenza and ARVI. With the help of anti-cold homeopathic remedies, people can be treated from the very beginning of the disease when an elevated temperature is observed and there are all signs of intoxication and inflammation.
Objective. Scientific justification for the safety and efficacy of a complex homeopathic formulation in tablet form (Aconitum napellus D6, Ammonium bromatum D4, Atropa belladonna D6, Bryonia D6, Cinchona pubescens D6, Echinacea D3, Hydrargyrum bicyanatum D8, Rhustoxicodendron D6) intended to enhance the natural immunity in influenza and respiratory diseases, to normalize the functional state of the immune system and upper respiratory tract.
Results. Most patients have acute febrile respiratory syndrome, and some population groups have an increased risk of complications in the form of severe illness or death. These groups include elderly people, very young people, and people with concomitant illnesses. Annually, every third inhabitant of the planet suffers from acute respiratory infections. We have conducted a scientific substantiation of the safety and efficacy of a complex homeopathic tablet formulation (Aconitum napellus D6, Ammonium bromatum D4, Atropa belladonna D6, Bryonia D6, Cinchona pubescens D6, Echinacea D3, Hydrargyrum bicyanatum D8, Rhustoxicodendron D6), which can be used to treat and prevention of these diseases.
Conclusions. Components of developed homeopathic preparation are used in medical practice as anti-cold and immunomodulating mono- and complex homeopathic preparations for more than 100 years. There are no restrictions on the use of the drug in the context of its safety profile, since the active ingredient concentrations used are completely non-toxic. The preparation enhances the body’s protective responses and promotes the relief of symptoms of acute respiratory infections and flu (headache, sneezing, runny nose, sore throat, body aches, fever) and rapid recovery.
... In several studies, the ability of medicinal plants to enhance or reduce the immune response has been reported. The immunomodulatory effect of garlic on cell mediated immunity has been studied [2] Milk thistle has been proven to increase humoral and cellular activity [3] Ginseng enhances production of macrophages, B and T cells [4] Echinacea is being tested as an immune stimulant [5]. Therefore, this study was designed to utilize the plethora of data on the commonly available and traditionally reputed immune enhancer herbs by using a simple in vitro LTA assay. ...
Herbal drugs are believed to enhance the natural immunity of the human body against viral and microbial infection and improve response; their immunomodulatory activities have been reported in numerous plants. In this study, fifty plant alcoholic extracts were screened for their potential immunomodulatory activity using in-vitro human lymphocyte transformation assay (LTA). Among the screened extracts, Aralia victoria, Boswellia carteri, Cyperus rotundus, Ginkgo biloba, Glycyrrhiza glabra, Olea europaea and Rosmarinus officinalis were capable to induce 96.67%, 32.22%, 11.11%, 5.56%, 25.56%, 13.33% and 2.22% respectively of lymphocyte transformation in comparison to Concanavalin-A (20.5%). Subsequently, each extract was further subjected to bio-guided fractionation using LTA. The bio-guided fractionation revealed that Dichloromethane and Petroleum-ether fractions from Glycyrrhiza glabra and Boswellia carteri stimulate the transformation of human lymphocytes by 86% and 28% respectively. This finding stimulated the interest to pursue a comprehensive study on the possible contribution of the commonly known and structurally related triterpens of Glycyrrhiza glabra and Boswellia carteri and their derivatives as potential immunomodulators and their possible use as immune enhancer in many infectious and cancer diseases.
... Data from well-designed clinical trials supporting its efficacy are scarce, yet echinacea is used extensively. Early treatment initiation may decrease the severity and duration of acute respiratory infections [96] but data with standardized dosages and formulations are needed to conclusively recommend it as common cold treatment. Echinacea appears to be generally free of toxic side effects [97] but a theoretical risk of nonspecific stimulation of the immune system excludes its use by people with autoimmune disorders or receiving immunosuppressant drugs, as well as in HIV positive patients, patients with progressive systemic diseases, such as tuberculosis and multiple sclerosis, or with a known allergy to plants of the Asteraceae family. ...
Pharyngitis is primarily a viral infection of the respiratory tract, followed by secondary bacterial invasion due to weakening of local defenses. Influenza A and rhinoviruses are principally involved, the influenza virus having much higher pathogenicity, however, than rhinoviruses which usually cause the common cough and cold without severe damage to the respiratory mucosa. Following initial infection, the virus enters the cells only for multiplication and almost all virulent virus particles subsequently produced are shed onto the throat surface. From the throat surface, the virions infect new healthy cells, damaging the throat mucosa, and creating a favorable ground for secondary bacterial colonization which is the cause of almost all symptoms of throat infection (sore throat, strep throat). The virus' complex structure, its constant mutation, the variety of its surface glycoproteins, as well as the role of topical proteases helping virus entry and virus-bacteria symbiosis must all be taken into account in designing an effective treatment, acting on multiple parameters. As most viruses and all bacteria are present on the throat's outer lining, treatment should be designed to act topically on the surface of the pharynx, which also minimizes side effects. Until 2012, no topical antiviral drugs were available and almost all treatment strategies were directed to relieve only the symptomatic manifestations of throat infections. Anti-influenza vaccination is still considered the best preventive measure, while the use of intracellular virus inhibitors is strictly limited to severe cases as they were not found to be very effective once throat infection is established. The recent development of non-specific topical virus glycoprotein inhibitors, incorporated in a filmogen glycerol solution for an increased duration of action, represents a breakthrough yet relatively simple scientific approach for the treatment of viral throat infections accompanied by secondary bacterial infection. In this review, we analyze the whole process of viral throat infection, virus-bacteria interactions on the throat surface, currently available treatments and their drawbacks, and this innovative therapeutic approach consisting in virus glycoprotein inhibitors in an osmotic solution, destined to totally change the future treatment of throat infections.
... The presence of tannins and other phyto-ingredients may be responsible for the observed antiviral activity of the plant extracts investigated. The immunemodulating activity of phyto-ingredients could also induce the antiviral action [41][42]. In a study it was demonstrated that oral treatment of mice with an extract mixture from Echinacea species, Baptisia tinctoria and Thuja occidentalis protected the animals against influenza A virus infection [43]. ...
... In several studies, the ability of medicinal plants to enhance or reduce the immune response has been reported. The immunomodulatory effect of garlic on cell mediated immunity has been studied [2] Milk thistle has been proven to increase humoral and cellular activity [3] Ginseng enhances production of macrophages, B and T cells [4] Echinacea is being tested as an immune stimulant [5]. Therefore, this study was designed to utilize the plethora of data on the commonly available and traditionally reputed immune enhancer herbs by using a simple in vitro LTA assay. ...
Herbal drugs are believed to enhance the natural immunity of the human body against viral and microbial infection and improve response; their immunomodulatory activities have been reported in numerous plants. In this study, fifty plant alcoholic extracts were screened for their potential immunomodulatory activity using in-vitro human lymphocyte transformation assay (LTA). Among the screened extracts, Aralia victoria, Boswellia carteri, Cyperus rotundus, Ginkgo biloba, Glycyrrhiza glabra, Olea europaea and Rosmarinus officinalis were capable to induce 96.67%, 32.22%, 11.11%, 5.56%, 25.56%, 13.33% and 2.22% respectively of lymphocyte transformation in comparison to Concanavalin-A (20.5%). Subsequently, each extract was further subjected to bio-guided fractionation using LTA. The bio-guided fractionation revealed that Dichloromethane and Petroleum-ether fractions from Glycyrrhiza glabra and Boswellia carteri stimulate the transformation of human lymphocytes by 86% and 28% respectively. This finding stimulated the interest to pursue a comprehensive study on the possible contribution of the commonly known and structurally related triterpens of Glycyrrhiza glabra and Boswellia carteri and their derivatives as potential immunomodulators and their possible use as immune enhancer in many infectious and cancer diseases.
... In various trials with E. purpurea, the start of medication varied from the time of occurrence of first symptoms to several hours afterward; therefore, it is not surprising that the outcome of these studies differed substantially. Unfortunately, such variables within a normal field study of the common cold are difficult to circumvent; thus, this system can result in a critical divergence of results 66,67 . Three rhinovirus inoculation studies investigated the prophylactic effects of well-standardized E. purpurea extracts 68 . ...
... In a double-blind, placebo-controlled studies enrolling a total of more than 1,000 individuals it was found that various forms and species of Echinacea can reduce cold symptoms and help to get over a cold faster. 30 In another double-blind, placebo-controlled trial, 80 individuals with early cold symptoms were given either an above-ground E. purpurea extract or placebo. 31 The results showed that the people who were given Echinacea recovered significantly more quickly: just 6 days in the Echinacea group versus 9 days in the placebo group. ...
The immune system is one of nature's most fascinating inventions. It is an amazing protection mechanism designed to defend us against millions of bacteria, viruses, fungi, toxins and parasites. The immune system is very complex. It is made up of several types of cells and proteins that have different jobs to do in fighting against foreign invaders. If our immune system is working properly we are protected from dangers caused by microbes. If not, we suffer sickness and disease. It is possible to intervene in this process and make our immune system stronger using immune boosters. Immune boosters work in many ways. They increase the number of white blood cells in the immune system army, train them to fight against microbes causing diseases. This review article gives an overall view about some natural herbs like Echinaceae purpurea [Cone flower], Panex ginseng [Asian ginseng], Astragalus mambraneous [Milk vetch], Uncaria tomentosa [Cat's claw] and Withania somnifera [Aswagandha] that have been proven clinically for their strong immunostimulatory activities.
... Genus Echinacea (Compozitae family) includes more species originating from North America: Echinacea angustifolia, Echinacea pallida, Echinacea purpurea, Echinacea atrorubeus, Echinacea paradoxa, Echinacea stimulata, Echinacea laevigata, Echinacea sanguinea. This special interest of researchers is given by the immunostimulatory properties of this plants [3][4][5][6][7][8][9], antiinflammatory properties [7,10,11], antibacterial properties [12] and antifungical properties [12,13]. Due to these properties, Echinacea is utilised not only in therapeutics but also in cosmetic industry and as an insecticide [7]. ...
The comparative study upon natural compounds with antioxidants properties was focused on two Echinacea species: pallida and purpurea, cultivated in experimental fields at the Research and Development Institute Braşov, species being in different years of vegetation. We studied aerial parts of both species and we observed that both are rich in natural compounds with antioxidant properties, higher values of presence were registered at Echinacea purpurea. It was proved that the antioxidant properties are maintained, in a large extent, for the fifth year of vegetation. We identified for the first time carotenoids in these species.
... Twentyone reviews examined inter-rater reliability and found similar levels of agreement to those discussed previously. In addition, two further reviews 93,129 addressed the validity of their tools. Twelve reviews in the sample (eight of the modified tools and four developed by review authors) did not report the quality items assessed by the authors. ...
... Increase of neutrophil counts was achieved only after the first month and then decreased after the second month on Echinacea treatment group, thereby raising the question as to what other external factors may have contributed to the change. However, Melchart et al. (1995) (Melchart et al., 1994(Melchart et al., , 1995 and O'neill et al. (2002) demonstrated the effect of Echinacea on the capacity of neutrophils to ingest more foreign particles and stimulatory effect on these cells by improving phagocytic function. ...
This study was designed to evaluate the effects of oral administration of Echinacea hydroethanolic extract on the dog's immune system. The study was performed on 14 dogs that were referred to the veterinary clinic. These dogs were randomly allocated to two equal treatment groups. The first group received 1 ml of 5% Echinacea hydroethanolic extract two times a day for 2 months, and the second group received a placebo (water). To do haematology and immunology tests, the dogs were bled on days 0, 30 and 60. Blood tests, including packed cell volume (PCV), haemoglobin (Hb), red blood cell count (RBC), white blood cell count (WBC), counting neutrophils (Nut), lymphocytes (Lym), monocytes (Mon), eosinophils (Eos), basophils (Baso) and B cell, were performed. Furthermore, safety factor IgM and per cent of phagocytosis and phagocyte were measured from the blood sample. The results showed that in the group which received Echinacea PCV, Hb, RBC count, WBC count, Lym, Nut, the per cent of phagocytosis and IgM significantly increased (P < 0.05). Moreover, positive effects of Echinacea plant on the immune system were observed. There was a significant change in HTC, RBC, Hb over time in the group that received Echinacea and the per cent of phagocytosis and IgM (P < 0.05). The study establishes that these extracts might have appreciable immunostimulatory activity. However, further studies are required to confirm these findings.
© 2015 John Wiley & Sons Ltd.
... The botanical genus Echinacea is native to North America, where indigenous peoples used various echinacea preparations for many illnesses (10). However, much of the foundational biomedical research on echinacea was done in Germany, where the plant was introduced in the 1920s and used for various illnesses, including respiratory infection (11,12). Immunoactivity, including macrophage ac-tivation and cytokine expression, has been widely reported (13)(14)(15)(16)(17)(18)(19)(20)(21)(22), but the specific pathways, pharmacokinetics, and mechanism of action of the various phytochemical constituents are incompletely understood (23)(24)(25)(26)(27)(28)(29). ...
Background:
Echinacea is widely used to treat the common cold.
Objective:
To assess the potential benefits of echinacea as a treatment of common cold.
Design:
Randomized, controlled trial. (ClinicalTrials.gov registration number: NCT00065715)
Setting:
Dane County, Wisconsin.
Patients:
719 patients, aged 12 to 80 years, with new-onset common cold.
Intervention:
Patients were assigned to 1 of 4 parallel groups: no pills, placebo pills (blinded), echinacea pills (blinded), or echinacea pills (unblinded, open-label). Echinacea groups received the equivalent of 10.2 g of dried echinacea root during the first 24 hours and 5.1 g during each of the next 4 days. Indistinguishable placebo tablets contained only inert ingredients.
Measurements:
The primary outcome was the area under the curve for global severity, with severity assessed twice daily by self-report using the Wisconsin Upper Respiratory Symptom Survey, short version. Secondary outcomes included interleukin-8 levels and neutrophil counts from nasal wash, assessed at intake and 2 days later.
Results:
Of the 719 patients enrolled, 713 completed the protocol. Mean age was 33.7 years, 64% were female, and 88% were white. Mean global severity was 236 and 258 for the blinded and unblinded echinacea groups, respectively; 264 for the blinded placebo group; and 286 for the no-pill group. A comparison of the 2 blinded groups showed a 28-point trend (95% CI, -69 to 13 points) toward benefit for echinacea (P = 0.089). Mean illness duration in the blinded and unblinded echinacea groups was 6.34 and 6.76 days, respectively, compared with 6.87 days in the blinded placebo group and 7.03 days in the no-pill group. A comparison of the blinded groups showed a nonsignificant 0.53-day (CI, -1.25 to 0.19 days) benefit (P = 0.075). Median change in interleukin-8 levels and neutrophil counts were also not statistically significant (30 ng/L and 1 cell/high-power field [hpf] in the no-pill group, 39 ng/L and 1 cell/hpf in the blinded placebo group, 58 ng/L and 2 cells/hpf in the blinded echinacea group, and 70 ng/L and 1 cell/hpf in the open-label echinacea group).
Limitation:
Higher-than-expected variability limited power to detect small benefits.
Conclusion:
Illness duration and severity were not statistically significant with echinacea compared with placebo. These results do not support the ability of this dose of the echinacea formulation to substantively change the course of the common cold.
Primary funding source:
National Center for Complementary and Alternative Medicine, National Institutes of Health.
... For reviews of clinical studies with Echinacea preparations see [26] and [27] . As a consequence of the activity demonstrated by pharmacological and clinical studies, preparations from the pressed juice of E. purpurea aerial parts (6 -9 ml pressed juice, corresponds to 12-18 g of fresh plants or 200 -400 mg dried juice) have been approved as effective drugs in Germany for the internal adjuvant therapy of relapsing infections of the respiratory and derivative urinary tract, and externally for poorly healing superficial wounds. ...
2) (1)Institut für Pharmazeutische Biologie, Heinri h-Heine-Universität Düsseldo f, Germany (2) R & D Departmen Phytopharm. and Phytochem Products, Flachsmann AG, Zurich c r t The knowledge of pharmacological effects of different preparations of Echinacea purpurea has been used for the medical treatment of several complaints for centuries now. Historical traces are going back to the North-American Indians. Actually, the majority of investigations has been carried through with cold pressed juice of the aerial parts of Echinacea purpurea. Recent studies have proved the stimulation of the non-specific immune system as the main action of this pressed juice. In fact, none of the identified compounds of the polar and lipophilic fraction could have been determined to be solely responsible for this activity. Several compounds as alkamides, polysaccharides and glycoproteins are discussed to be potentially part of the "active principle". Since immunomodulation is a pharmacological effect, most of the clinical studies have focused on treatment and prevention of common cold and infections of the upper respiratory and the urinary tract. Recent clinical studies have provided data on the therapeutic effectiveness of pressed juice of Echinacea purpurea, while other, probably also beneficial Echinacea purpurea preparations are not that well documented.
... The presence of tannins and other phyto-ingredients may be responsible for the observed antiviral activity of the plant extracts investigated. The immunemodulating activity of phyto-ingredients could also induce the antiviral action [41][42]. In a study it was demonstrated that oral treatment of mice with an extract mixture from Echinacea species, Baptisia tinctoria and Thuja occidentalis protected the animals against influenza A virus infection [43]. ...
Background
Immunomodulation is the modification of immune responses to control disease progression. While the synthetic immunomodulators have proven efficacy, they are coupled with toxicity and other adverse effects, and hence, the efforts were to identify natural phytochemicals with immunomodulatory potential.
Objective
The objective of this study is to understand the immunomodulatory properties of various phytochemicals and investigate them in Echinacea species extracts using an in silico approach.
Methodology
Several scientific database repositories were searched using different keywords: “Phytochemicals,” “Alkaloids,” “Polyphenols,” “Flavonoids,” “Lectins,” “Glycosides,” “Tannins,” “Terpenoids,” “Sterols,” “Immunomodulators,” and “Human Immune System” without any language restriction. Additionally, the study specifically investigated the immunomodulatory properties of Echinacea species extracts using gene expression analysis of GSE12259 from NCBI-GEO through the Bioconductor package GEOquery and limma.
Results
A total of 182 studies were comprehensively analyzed to understand immunomodulatory phytochemicals. The in silico analysis highlighted key biological processes (positive regulation of cytokine production, response to tumor necrosis factor) and molecular functions (cytokine receptor binding, receptor-ligand activity, and cytokine activity) among Echinacea species extracts contributing to immune responses. Further, it also indicated the association of various metabolic pathways, i.e., pathways in cancer, cytokine-cytokine receptor interaction, NF-kappa B, PI3K-Akt, TNF, MAPK, and NOD-like receptor signaling pathways, with immune responses. The study revealed various hub targets, including CCL20, CCL4, GCH1, SLC7A11, SOD2, EPB41L3, TNFAIP6, GCLM, EGR1, and FOS.
Conclusion
The present study presents a cumulative picture of phytochemicals with therapeutic benefits. Additionally, the study also reported a few novel genes and pathways in Echinacea extracts by re-analyzing GSE 12259, indicating its anti-inflammatory, anti-viral, and immunomodulatory properties.
Background:
Phylloxanthobilins are tetrapyrrolic natural products that arise from the degradation of chlorophyll. Phylloxanthobilins have been discovered roughly 10 years ago in the leaves of deciduous trees, and are now considered a compound class with high and still unexplored potential of bioactivities. To date, however, there are no reports on the occurrence of phylloxanthobilins in parts of a medicinal plant used for pharmaceutical preparations.
Purpose:
The relevance of Echinacea purpurea as medicinal plant is undoubtedly high, and a large variety of pharmaceutical preparations is available on the market, mostly for the treatment of the common cold. Nevertheless, its phytochemical profiling has been limited to analysis for previously characterized substances, and this has not explained all its pharmacological efficacies. We therefore set out to investigate the occurrence of phylloxanthobilins in Echinacea purpurea.
Methods:
Phylloxanthobilins in leaf extracts of Echinacea purpurea were detected using analytical HPLC. Identified phyllobilins were purified from plant material and characterized by UV/Vis, mass spectrometry, MS/MS, and confirmed by co-injections with previously published phyllobilins from different sources. The anti-oxidant activity of selected isolated phylloxanthobilins was assessed by an in vitro ferric reducing antioxidant power (FRAP) assay; in addition, the ability to scavenge ROS in cells caused by hydrogen peroxide stimulation was determined by measuring H2DCF-DA fluorescence and by assessing cellular GSH levels.
Results:
In extracts of Echinacea purpurea leaves, an unprecedented diversity of phylloxanthobilins was detected; surprisingly, not only in senescent yellow leaves, but also in green leaves with no visible chlorophyll degradation. Six phylloxanthobilins were identified and structurally characterized. The uptake of phylloxanthobilins by human endothelial kidney cells was demonstrated. When investigating the anti-oxidative activity of these natural products, a potent in vitro activity was demonstrated; in addition, phylloxanthobilins possess intracellular ROS scavenging ability and can prevent oxidative stress as assessed by total cellular GSH levels.
Conclusion:
Phylloxanthobilins are important constituents of Echinacea purpurea extracts, and our first exploratory studies hint towards promising bioactivities of these natural products, which may be relevant for understanding Echinacea efficacies.
Herbal remedies fit very naturally into the natural and holistic system of medicine. As a result, all physicians and laypersons do not appreciate the kind of compartmentalized, organ-based approach to herbal healing that is followed in this book. Indeed, there are two classes of herbal remedies that do not fit into an anatomically oriented scheme: adaptogens and immune stimulants. Adaptogens are agents that are reputed to increase the body’s resistance to physical, chemical, and biological stressors. Immune stimulants are agents that activate the body’s nonspecific defense mechanisms against infectious organisms, particularly viral and bacterial pathogens.
Medicinal plants are advantageously used in the treatment of respiratory tract diseases. Upper respiratory tract catarrh is one of the diseases associated with seasonal weakening of immunity, and therefore, plant drugs with a non-specific immunomodulation effect are often used. Such plants include, but are not limited to, EChinacea (EChinacea purpurea) and American ginseng (Panax quinquefolius). In combination with medicinal plants having antibacterial and antiseptic effects, such as thyme (Thymus vulgaris) and pelargonium (Pelargonium sidoides), they can constitute efficient help in the treatment of respiratory tract diseases, shorten the duration of the disease and reduce the need of antibiotic therapy. The text presented summarizes the basic information about these plants, their ingredients, mechanisms of action and clinical tests confirming their effect and monitoring eventual adverse effects.
Background Echinacea plant preparations (family Asteraceae) are widely used in Europe and North America for common colds. Most consumers and physicians are not aware that products available under the term Echinacea differ appreciably in their composition, mainly due to the use of variable plant material, extraction methods and the addition of other components. Objectives To assess whether there is evidence that Echinacea preparations are effective and safe compared to placebo in the prevention and treatment of the common cold. Search methods We searched CENTRAL 2013, Issue 5, MEDLINE (1946 to May week 5, 2013), EMBASE (1991 to June 2013), CINAHL (1981 to June 2013), AMED (1985 to February 2012), LILACS (1981 to June 2013), Web of Science (1955 to June 2013), CAMBASE (no time limits), the Centre for Complementary Medicine Research (1988 to September 2007), WHO ICTRP and clinicaltrials.gov (last searched 5 June 2013), screened references and asked experts in the field about published and unpublished studies. Selection criteria Randomized controlled trials (RCTs) comparing mono-preparations of Echinacea with placebo. Data collection and analysis At least two review authors independently assessed eligibility and trial quality and extracted data. The primary efficacy outcome was the number of individuals with at least one cold in prevention trials and the duration of colds in treatment trials. For all included trials the primary safety and acceptability outcome was the number of participants dropping out due to adverse events. We assessed trial quality using the Cochrane 'Risk of bias' tool. Main results Twenty-four double-blind trials with 4631 participants including a total of 33 comparisons of Echinacea preparations and placebo met the inclusion criteria. A variety of different Echinacea preparations based on different species and parts of plant were used. Evidence from seven trials was available for preparations based on the aerial parts of Echinacea purpurea. Ten trials were considered to have a low risk of bias, six to have an unclear risk of bias and eight to have a high risk of bias. Ten trials with 13 comparisons investigated prevention and 15 trials with 20 comparisons investigated treatment of colds (one trial addressed both prevention and treatment). Due to the strong clinical heterogeneity of the studies we refrained from pooling for the main analysis. None of the 12 prevention comparisons reporting the number of patients with at least one cold episode found a statistically significant difference. However a post hoc pooling of their results, suggests a relative risk reduction of 10% to 20%. Of the six treatment trials reporting data on the duration of colds, only two showed a significant effect of Echinacea over placebo. The number of patients dropping out or reporting adverse effects did not differ significantly between treatment and control groups in prevention and treatment trials. However, in prevention trials there was a trend towards a larger number of patients dropping out due to adverse events in the treatment groups. Authors' conclusions Echinacea products have not here been shown to provide benefits for treating colds, although, it is possible there is a weak benefit from some Echinacea products: The results of individual prophylaxis trials consistently show positive (if non-significant) trends, although potential effects are of questionable clinical relevance.
Echinacea has a long history of medical use in the United States. Starting in the 1950s and increasing in recent decades, the immune-stimulating abilities of Echinacea have caught the attention of the medical community. Some Echinacea products have shown in international clinical trials that they are useful for treating and preventing upper respiratory tract infections. There is still much more research that needs to be accomplished to determine which formulation is most efficacious. Overall, Echinacea products appear to be safe and generally they are not the source of allergies or dangerous drug/herb interactions.
Herbal remedies fit very naturally into the natural and holistic system of medicine. As a result, all physicians and laypersons do not appreciate the kind of compartmentalized, organ-based approach to herbal healing that is followed in this book. Indeed, there are two classes of herbal remedies that do not fit into an anatomically oriented scheme: adaptogens and immune stimulants. Adaptogens are agents that are reputed to increase the body’s resistance to physical, chemical, and biological stressors. Immune stimulants are agents that activate the body’s nonspecific defence mechanisms against infectious organisms, particularly viral and bacterial pathogens.
A perennial herb of the COMPOSITAE family that grows up to 45 cm. The leaves are sparse, solitary, lanceolate to linear, opposite or alternate with rough surface, 7.5 to 20 cm long, entire margined on slender petioles. The dried rhizome is grayishbrown, often twisted, longitudinally furrowed, up to about 1 cm in diameter. The transverse section shows a thin bark and a yellowish porous wood flecked with black. The flower heads are large and solitary on terminal peduncles with spreading ray florets. The bracts are in a number of rows. The bracts are dry or leafy, rigid, thorny tipped, and longer than the conical erect disc florets. The reddish or occasionally white florets are conspicuous, usually sterile lingual florets and 3 cm long.
Herbal remedies fit very naturally into the natural and holistic system of medicine. As a result, all physicians and laypersons do not appreciate the kind of compartmentalized, organ-based approach to herbal healing that is followed in this book. Indeed, there are two classes of herbal remedies that do not fit into an anatomically oriented scheme: adaptogens and immune stimulants. Adaptogens are agents that are reputed to increase the body’s resistance to physical, chemical, and biological stressors. Immune stimulants are agents that activate the body’s nonspecific defense mechanisms against infectious organisms, particularly viral and bacterial pathogens.
Pflanzliche Arzneimittel werden gern in Therapiekonzepte im Sinne einer „Natur- und Ganzheitsmedizin“ eingebunden. Die streng organbezogene Zuordnung der einzelnen Phytopharmaka bzw.deren Indikationen, wie sie in diesem Buch vorgenommen worden sind, wird daher nicht von allen Ärzten und Anwendern geteilt. Bei zwei Präparategruppen ist eine solche anatomisch geprägte Zuordnung überhaupt nicht möglich. Es handelt sich dabei um Phytopharmaka, die adaptogen bzw. immunstimulatorisch wirken sollen.Unter Adaptogenen versteht man vorzugsweise Präparate, die einen Organismus gegenüber physikalischen, chemischen und biologischen (nicht infektiösen) „Stressoren“ widerstandsfähiger machen sollen, während die so genannten „Immunstimulanzien“ vor allem die unspezifischen körpereigenen Abwehrmechanismen gegen Krankheitserreger, insbesondere gegen virale und bakterielle Infekte, aktivieren sollen.
Drinking herbal beverages is popular in America for several reasons. Herbal teas provide opportunities to have a low-calorie beverage or a healthy caffeine-free alternative to coffee. Other teas may provide a medicinal effect. These herbal beverages may contain extracts from the bark, roots, seeds, flowers, leaves, or fruits of trees and shrubs. Today, the herbal tea industry has become a multimillion-dollar business. The potential health effect of green and black teas is reviewed in Chapter 10.
Etwa 10% der zugelassenen Arzneimittel entfallen auf Arzneimittel pflanzlicher Herkunft, die heute als Phytopharmaka bezeichnet werden. Sie sind ein wirtschaftlich wichtiger Teil der Pharmakotherapie, sei es in der Versorgung des Patienten in der ärztlichen Praxis oder im Rahmen der Selbstmedikation. Wie Nutzen und Risiken der Anwendung von Phytopharmaka zu beurteilen sind, wird im Lehrgebiet „Pharmakologie für Pharmazeuten“ nicht adäquat angesprochen. Daher kommt es später im Beruf zu einer Fehleinschätzung: teils zu einer unkritischen Überbewertung ihrer therapeutischen Möglichkeiten, teils zur abwertenden Einschätzung als bloße Placebos (zum Placeboeffekt s. Kap. 10.2).
Herbal remedies are booming worldwide, This article briefly reviews our present knowledge regarding three of the most popular herbal drugs: echinacea, ginkgo biloba and hypericum. With all three, several open questions persist. It is concluded that herbal treatments can represent promising therapeutic options worthy of more research, particularly randomized clinical trials and systematic reviews.
Otita la câine este o afectiune cu o incidență ridicată, care uneori întâmpină dificultăți sau erori de diagnostic şi de tratament. Aceste erori pot fi asociate cu o mare diversitate de manifestări clinice, diferite de la un animal la altul. Pseudomonas aeruginosa este frecvent implicată în cazul otitelor medii și externe însoțite de eroziuni, ulcerații și de cantități apreciabile de exsudat galben-deschis, de obicei cu evotuție cronică și recidivantă.
Lotul de studiu a inclus 26 de tulpini Pseudomonas aeruginosa, izolate în perioada 2013-2014 în laboratorul de microbiologie al Centrului Universitar de Cercetări Medical- Veterinare Iași din cadrul FMV –IAȘI.
Am folosit recomandările recente (Magiorakos et al., 2012) pentru a defini tulpinile multidrog rezistente, MDR.
Cele 7 clase de antibiotice cercetate au fost: cefalosporine, combinații penicilină anti-Pseudomonas+inhibitor de β-lactamază, cefalosporine cu spectru extins, monobactame, carbapeneme, fluorochinolone, aminoglicozide și polimixine.
Prezentul studiu a evidențiat 16 tulpini MDR, în consecință în Medicina Veterinară din cauza paletei restrânse de antibiotice de elecție din sfera ORL, concomitent cu capacitatea de rezistență multidrog a tulpinilor de Pseudomonas aeruginosa se impune un protocol de diagnostic etiologic diferit.
Background: Echinacea spp. have been used in traditional medicine for many years. Recently, many investigations have been done on this plant and they showed that the plant is an immunostimulant agent. The plant contains different components such as flavonoids, phenolic compounds and isobutylamides. Phenolics are one of the most important agents in immunostimulant effects of the plant; therefore, determination of a method for the best extraction of these compounds from the plant is important. Objective: In this research, the effects of solvent, extraction procedure, plant particle size and plant:solvent ratio on extraction of phenolic compounds of Echinacea purpurea (L.) Moench have been investigated. Methods: Different polar and non-polar solvents from hexane to acidic water were used in order to determine the best solvent for phenolics extraction. Moreover, the methods of maceration, sonification, perculation, digestion and continuous extraction (by use of soxhelet apparatus), different particle sizes of the plant powder and various plant:solvent ratios were examined as well. Results: The results showed that the best method for extraction of phenolics is methanol:water 80:20 as solvent, method of digestion (2h, 50 °C), particle size of 300 μm for the plant powder and plant: solvent ratio of 1:200. Conclusion: It can be concluded that in order to efficient extraction of phenolic compounds from Echinacea purpurea aerial parts, special condition should be considered.
Systematische Übersichtsarbeiten klinischer Studien spielen bei der Beurteilung der Wirksamkeit prophylaktischer und therapeutischer Interventionen eine zentrale Rolle. Übersichtsarbeiten (im folgenden synonym mit der Bezeichnung Review gebraucht) werden dann als systematisch bezeichnet, wenn sie vordefinierte und transparente Methoden bzgl. Literatursuche, Studienselektion und Studienbewertung verwenden. Systematische Übersichtsarbeiten, bei denen die einbezogenen Studien (Primärstudien) in einer integrierenden statistischen Analyse wie eine einzige große Studie ausgewertet (gepoolt) werden, bezeichnet man als Meta-Analysen. Die vorliegende Monographie präsentiert 1. zwei größere eigene systematische Übersichtsarbeiten als Anwendungsbeispiele (Kapitel 2), 2. drei empirisch-methodische Untersuchungen zum Thema Studienqualität und deren Auswirkung auf das Ergebnis (Kapitel 3) und 3. eine Analyse der vorliegenden systematischen Übersichtsarbeiten in den Bereichen Akupunktur, Phytotherapie und Homöopathie (Kapitel 4). Sie versteht sich als Beitrag zur methodischen Diskussion und Entwicklung von systematischen Übersichtsarbeiten. Im ersten Anwendungsbeispiel wurde untersucht, ob Propranolol, Metoprolol und Flunarizin bei der prophylaktischen Behandlung der Migräne wirksamer sind als Placebo, ob die einzelnen Substanzen ähnlich wirksam sind bzw. wie wirksam sie im Vergleich zu anderen Medikamenten sind. Eingeschlossen wurden randomisierte klinische Studien an erwachsenen Migränepatienten mit mindestens 4 Wochen Dauer, in denen eine oder mehrere der genannten Substanzen mit Placebo oder einem anderen Medikament verglichen wurden. Die Literatursuche erfolgte in Medline und der Cochrane Library sowie über das Durchsuchen von Literaturverzeichnissen. Informationen zu Patienten, Interventionen und Ergebnissen wurden mit Hilfe eines vorgetesteten Formulars extrahiert. Die Qualität der Studien wurde mit drei Skalen beurteilt. Soweit möglich erfolgten Effektstärkeberechnungen für Therapieerfolg, Attackenhäufigkeit und Zahl der Patienten mit Nebenwirkungen. Eine quantitative Meta-Analyse wurde aufgrund der inkonsistenten und häufig inadäquaten Ergebnispräsentation in den Primärstudien nicht durchgeführt. Insgesamt entsprachen 57 Studien zu Propranolol (mit 25 Vergleichen vs. Placebo und 46 Vergleichen mit anderen Medikamenten), 16 zu Metoprolol (mit 4 Vergleichen vs. Placebo und 17 vs. andere) und 40 zu Flunarizin (mit 10 Vergleichen vs. Placebo und 36 vs. andere) den Einschlusskriterien. Die Qualität der Studien war in vielen Fällen unbefriedigend. Hauptproblem war die unzureichende Beschreibung von Studienabbrüchen und -ausschlüssen bzw. deren Berücksichtigung in der Analyse. Alle drei Substanzen waren in Bezug auf Therapieerfolg und Attackenzahl Placebo überlegen. Langzeiteffekte über 6 Monate hinaus und nach Absetzen können nicht sicher beurteilt werden. Mit wenigen Ausnahmen ergaben sich in Vergleichen mit anderen Substanzen keine signifikanten Unterschiede; die meisten Studien hatten jedoch zu geringe Fallzahlen, um potenziell relevante Unterschiede ausschließen zu können. Insgesamt kann die Wirksamkeit von Propranolol, Metoprolol und Flunarizin in der Migräneprophylaxe aufgrund der Konsistenz der Ergebnisse trotz der häufig unbefriedigenden Studienqualität als belegt angesehen werden. Im zweiten Anwendungsbeispiel wurde untersucht, ob Hypericumextrakte (Hypericum perforatum, Johanniskraut) bei der Behandlung von Depressionen (a) wirksamer sind als Placebo, (b) ähnlich wirksam sind wie synthetische Antidepressiva und (c) nebenwirkungsärmer sind als synthetische Antidepressiva. Eingeschlossen wurden randomisierte Studien an depressiven Patienten mit einer Therapiedauer von mindestens 4 Wochen, in denen ein Hypericummonoextrakt mit Placebo oder einem anderen Antidepressivum verglichen wurde. Die Literatursuche erfolgte in verschiedenen Datenbanken, über das Prüfen von Literaturverzeichnissen und über Kontakte mit Experten und Herstellern. Hauptzielkriterium für die Beurteilung der Wirksamkeit war der Responderanteil (meist definiert als ein Rückgang um 50% oder auf einen Wert von max. 10 auf der Hamilton Rating Scale for Depression). 33 Studien (23 Vergleiche mit Placebo, 12 mit anderen Antidepressiva) entsprachen den Einschlusskriterien. Im Vergleich zu Placebo erwiesen sich die Hypericumextrakte als deutlich überlegen, allerdings war der Effekt in neueren Studien und in Studien mit schwerer depressiven Patienten geringer ausgeprägt. Im Vergleich zu älteren und neueren Antidepressiva waren Hypericumextrakte ähnlich effektiv; Nebenwirkungen waren jedoch signifikant seltener. Aufgrund der vorliegenden Daten kann die Wirksamkeit von Hypericumextrakten bei leichten bis mittleren Depressionen als nachgewiesen gelten. Die Heterogenität in den Ergebnissen der einzelnen Studien deutet jedoch darauf hin, dass verschiedene Faktoren (möglicherweise Extraktwahl, Dosierung, Patientenklientel) die Effektivität beeinflussen. Die erste der drei empirisch-methodischen Analysen in Kapitel 3 untersucht die methodische Qualität randomisierter Studien zu Akupunktur, Phytotherapie und Homöopathie. Insgesamt 207 randomisierte Studien wurden einbezogen; diese waren im Rahmen von 5 systematischen Übersichtsarbeiten gesammelt und bewertet worden. Die Beurteilung der methodischen Qualität erfolgte mithilfe einer validierten Skala (Jadadscore) und Einzelitems. Die methodische Qualität der bewerteten Studien war in hohem Maße variabel, die Mehrzahl der Studien hatte relevante Schwächen. Hauptprobleme waren die Beschreibung der Verblindung der Gruppenzuteilung sowie von Studienabbrüchen und -ausschlüssen. Phytotherapiestudien hatten im Mittel bessere Qualität als Homöopathie- und Akupunkturstudien. Publikationen in einer Medline-gelisteten Zeitschrift, in jüngerer Vergangenheit und in englischer Sprache hatten im Mittel bessere Qualität als ältere, nicht in gelisteten Zeitschriften und in anderen Sprachen veröffentlichte Arbeiten. Die Qualitätsscores der komplementärmedizinischen Studien waren im Schnitt ähnlich wie diejenigen von Studien zu konventionellen Interventionen, die in ähnlichen Analysen bewertet worden waren. In der zweiten empirisch-methodischen Untersuchung wurde geprüft, ob ein Zusammenhang zwischen methodischer Qualität und Studienergebnis in 89 placebokontrollierten Studien zur Homöopathie besteht. Die Beurteilung der methodischen Qualität erfolgte mit zwei Skalen und Einzelkriterien. Ein potenzieller Zusammenhang zwischen methodischer Qualität wurde mit drei Methoden untersucht: Prüfung eines Zusammenhangs zwischen einzelnen Qualitätskomponenten und Studienergebnis (Komponentenanalyse), Vergleich von Studien, die eine bestimmte Minimumpunktzahl auf den Qualitätsskalen erreichten bzw. nicht erreichten (Mindestscoreanalyse), und konsekutiver Einschluss von Studien in die Meta-Analyse entsprechend den erreichten Qualitätsscores (kumulative Meta-Analyse). Mit allen drei Methoden ergab sich, dass bessere Studien weniger optimistische Ergebnisse erbracht hatten. In der dritten empirisch-methodischen Untersuchung wurde am Beispiel der klinischen Studien zu Akupunktur bei Kopfschmerzen die zuletzt angesprochene Thematik auch auf nichtkontrollierte Studien ausgeweitet. Es wurde geprüft, inwieweit sich randomisierte und nichtrandomisierte Studien in Bezug auf Patienten, Interventionen, design-unabhängige Qualitätsaspekte und Ergebnisse unterscheiden. 59 Studien (24 randomisierte und 35 nichtrandomisierte) konnten in die Analyse einbezogen werden. Randomisierte und nichtrandomisierte Studien unterschieden sich bzgl. Patienten und Interventionen zum Teil deutlich. Nichtrandomisierte Studien hatten im Schnitt schlechtere Qualität, jedoch gab es unter den randomisierten Studien sehr schlechte und unter den nichtrandomisierten auch gute Studien. Ein Randomisationsdesign und bessere Qualität waren mit weniger positiven Ergebnissen assoziiert. Die nichtrandomisierten Studien nutzten potenzielle Vorteile (bzgl. Fallzahl, Langzeitbeobachtung, Repräsentativität und Untersuchung prognostischer Faktoren) kaum. Der Einbezug nichtrandomisierter Studien in einen systematischen Review zur Evidenz für die Wirksamkeit der Akupunktur bei Kopfschmerzen hätte daher die Schlussfolgerungen kaum beeinflusst. In Kapitel 4 wurden die bis Frühjahr 2001 verfügbaren systematischen Übersichtsarbeiten zu Akupunktur, Phytotherapie und Homöopathie zusammengestellt. Die Suche erfolgte primär über die Datenbank des Bereichs Komplementärmedizin der Cochrane Collaboration und in Medline. Um als systematisch klassifiziert zu werden, mußte ein Review mindestens eines der folgenden drei Kriterien erfüllen: explizite Beschreibung von Literatursuche und Einschlusskriterien und/oder formale Beurteilung der methodischen Qualität der eingeschlossenen Studien und/oder Beschreibung und Durchführung einer quantitativen Meta-Analyse. 39 Reviews zur Akupunktur, 58 zur Phytotherapie und 18 zur Homöopathie entsprachen den Einschlusskriterien. Positive Schlussfolgerungen waren im Bereich Phytotherapie am häufigsten, bei der Akupunktur am seltensten. Die Qualität der Reviews war variabel, viele hatten jedoch relevante methodische Schwächen. Siebzehn Fragestellungen wurden von mehr als einer systematischen Übersicht bearbeitet. Die Zahl der eingeschlossenen Primärstudien variierte bei 10 von 17 Vergleichen um mehr als 50%. Unterschiede in den Einschlusskriterien und der Literatursuche erschienen als wahrscheinlichste Ursache für die Diskrepanzen, Unterschiede in der methodischen Qualität der Reviews schienen dagegen eine geringe Rolle zu spielen. Die Schlussfolgerungen waren trotz der Diskrepanzen häufig ähnlich. Die vorgelegten Anwendungsbeispiele, empirisch-methodischen Untersuchungen und die Zusammenstellung zu Akupunktur, Phytotherapie und Homöopathie demonstrieren Stärken und Schwächen von systematischen Reviews. Trotz der zu erwartenden methodischen Weiterentwicklungen werden derartige Übersichtsarbeiten auch in Zukunft mit Sorgfalt und Zurückhaltung interpretiert werden müssen.
It is the position of The American Dietetic Association that functional foods, including whole foods and fortified, enriched, or enhanced foods, have a potentially beneficial effect on health when consumed as part of a varied diet on a regular basis, at effective levels. The Association supports research to further define the health benefits and risks of individual functional foods and their physiologically active components. Dietetics professionals will continue to work with the food industry, government, the scientific community, and the media to ensure that the public has accurate information regarding this emerging area of food and nutrition science. Knowledge of the role of physiologically active food components, both from phytochemicals and zoochemicals, has changed the role of diet in health. Functional foods have evolved as food and nutrition science has advanced beyond the treatment of deficiency syndromes to reduction of disease risk. This position reviews the definition of functional foods, their regulation, and the scientific evidence supporting this emerging area of food and nutrition. Foods can no longer evaluated only in terms of macronutrient and micronutrient intake. Analyzing the content of other physiologically active components will be necessary. The availability of health-promoting functional foods in the US diet has the potential to help ensure a healthier population. However, each functional food should be evaluated on the basis of scientific evidence to ensure appropriate integration into a varied diet.
Quantification of the equine lentivirus equine infectious anemia virus (EIAV) infection effects on the cellular immunity of 96 equids were tested in vitro. The phagocytic function represents one of the important aspects of the innate immunity, while the blast transformation is a measure of the specific cell-mediated reactivity. Carbon particle inclusion test was used to monitor spontaneous innate phagocytosis, with 3 variants (control, alcohol and nettle extract). In vitro blast transformation test was performed with 8 experimental variants (control, Phytohemagglutinin-M, alcohol and plant extracts from Calendula officinalis, Echinacea angustifolia, Echinacea purpurea, Urtica dioica and Aloe vera). A possible rapid carbon particle ingestion, followed by cell membrane fragility could explain the stimulating effects of nettle extract on the phagocytosis in young, recently EIAV infected horses, while as a consequence of a lack of antigenic stimulation in vivo, the value of stimulation indexes were decreases in healthy animals. Duration of disease evolution emphasizes the incapacity of response to PHA M as opposed to the trend encountered in young animals, probably due to reduction in immune responsiveness with aging. Generally, the immunoreactivity and the immune recovery effects of the used plant extracts are more obvious in young, newly infected animals suggesting that viral infection has an increasingly negative effect on the immunity of older horses.
An Introduction Our health is directly influenced by our immune system. A balanced and healthy immune system is central to the body's ability to defend against infections. "It is our ability to create a healthy immune system that represents the greatest potential for gains in human health." 1 Today, however, many factors contribute to the general weakening of the body's defenses. Antibiotics have begun to fail as the resistance of many infectious strains multiplies. Due to the failure of government control of health codes, deterioration of water quality, and frequent international travel diseases now spread more easily than ever before. Fortunately, recent research has uncovered a natural agent that can increase our ability to fight disease and improve the quality of life for many people. Transfer factor is the name given to this relatively new agent. It is found in colostrum and other sources and is a natural way of strengthening our immune systems against disease. What is Transfer Factor? Transfer factor is the most exciting health discovery in recent decades. Transfer factors are small immune messenger molecules that are produced by higher organisms. 2 Their role is to transfer immune recognition signals between immune cells and thereby assist in educating naive immune cells about a present or potential danger. In the harsh and hostile environment in which a baby suddenly finds itself, invading microorganisms could rapidly overcome and destroy the new life. Nature has provided a procedure to rapidly educate the infant's naive immune system. Prior to delivering a baby, the expectant mother prepares a natural immunizing cocktail that she includes in the first milk (colostrum) she provides to her new baby.Transfer factor is a key part of this process. Dr. C. H. Kirkpatrick determined that transfer factors were small peptides of about eight amino acid residues. 7 Eighteen different amino acids have been represented which may combine to create billions of different transfer factors. These very small transfer factor molecules contain the essence of the immunological message.
Ethanolic extracts of Echinacea purpurea, E. pallida and E. angustifolia roots were examined for immunological activity in the carbon clearance test with mice and in the granulocyte test. In the in vivo experiment all extracts, administered orally, were found to enhance phagocytosis significantly. These results correlate with the stimulation of phagocytosis in the in vitro granulocyte test. The lipophilic fractions of the extracts appeared to be more active than the polar fractions. All extracts were analyzed by HPLC in order to correlate the chemical constituents with the immunological activities.
In about one third of cases the duration of pertussis may be reduced to five days by giving three repeated injections of echinacine (2 ml/day in children, 1 ml/day in infants) on three consecutive days; this procedure is particularly successful in an early stage of the disease. A combination of echinacine and antibiotic is not equally effective but may be superior to treatment with an antibiotic alone. Moreover, it must not be overlooked that the latter is only required in high risk children, although it is often claimed to be necessary with regard to 'elimination of bacteria' and 'prevention of complications'. Injections of echinacine are tolerated well; temperature rises up to 39° C on the day of treatment were only seen in isolated cases. Erythema and localized pain at the injection site were occasionally reported. The question as to whether the 'reduction' in the efficacy of echinacine during concurrent therapy with antibiotic is to be attributed to epithelial lesions by B. pertussis, cellular changes in the bronchial tract or inhibition of opsonification or phagocytosis due to antibiotics remains to be clarified and should be discussed further.
Zusammenfassung In einer randomisierten Studie wurde an 70 Patientinnen mit fortgeschrittenem Mammakarzinom untersucht, ob eine Zusatzbehandlung mit Esberitox N die Nebenwirkungen einer kombinierten Chemo-Strahlentherapie verhindern oder mindern kann. Da nicht auszuschließen war, daß die Wirkung von Esberitox N in Abhängígkeit von einer Vorbelastung durch eine hämatotoxische Therapie unterschiedlich ausfällt, erfolgte die Untersuchung an verschiedenen Risikogruppen. Beurteilungsparameter waren das periphere Blutbild und das Auftreten von Infekten. Es zeigte sich, daß eine Esberitox-N-Wirkung nachweisbar war, wenn nur eine geringe Vorschädigung des Knochenmarks vorlag. Der Effekt scheint in der Förderung der Regeneration des hämatopoetischen Systems zu liegen. Die Häufigkeit von Infekten wurde durch die zusätzliche Esberitox-N-Behandlung nicht signifikant, jedoch im Trend günstig beeinflußt.Copyright © 1989 S. Karger AG, Basel
Publication bias occurs if the results from studies which have not been published are different from the published ones. From a Bayesian viewpoint, it also concerns non-publication of studies with similar results as the published ones because the strength of the evidence will be influenced. Publication bias complicates the interpretation of reviews and meta-analyses. If favourable results are published more often there will be an overestimation of the effects of a treatment. There have been several attempts to assess the magnitude of publication bias. Unpublished trials could be identified by means of a survey among researchers, and the results could subsequently be compared with the outcomes of published trials. Also, the results from published trials could be compared with trials from a registry. Furthermore, the results from registered but unpublished trials could be compared with those of registered and subsequently published trials. Studies addressing publication bias have shown that it is a serious problem which complicates the interpretation of reviews. In assessments of publication bias other factors must be taken into account. These include the mode of publication: refereed journals, other journals, books, etc. Differences could also be related to the quality of trials. Finally, the source of funding may influence both the results and subsequent publication. Publication bias can only be avoided by registration of all trials before data collection is started; several of such registries have already been installed. Perhaps, if more of such registries exist, reviewers could only use registered trials for their main conclusions. All other information could then be considered sensitive to publication bias.
Meta-analysis is a method of synthesizing evidence from multiple sources. It has been increasingly applied to combine results from randomized trials of therapeutic strategies. Unfortunately there is often variation in the quality of the trials that are included in meta-analyses, limiting the value of combining the results in an overview. This variation in quality can lead to both bias and reduction in precision of the estimate of the therapy's effectiveness. There are a number of methods for quantifying the quality of trials including the detailed Chalmers system and simple scales. The nature of the relationship between these quality scores and the true estimate of effectiveness is unknown at this time. We discuss four methods of incorporating quality into meta-analysis: threshold score as inclusion/exclusion criterion, use of quality score as a weight in statistical pooling, visual plot of effect size against quality score and sequential combination of trial results based on quality score. The last method permits an examination of the relation between quality and both bias and precision on the pooled estimates. We conclude that while it is possible to incorporate the effect of variation of quality of individual trials into overviews, this issue requires more study.
Meta-analytic investigations sometimes use assessments of research quality according to a formal protocol as a tool for improving research synthesis. We asked whether a particular quality scoring system could have a direct use in adjusting the summary estimates of a treatment difference. In an empirical study of the relation of quality scores to treatment differences in published meta-analyses of 7 groups of controlled randomized clinical trials comprising 107 primary studies, we found no relation between treatment difference and overall quality score. We also found no relation between quality score and variation in treatment difference. The level of quality scores has increased at a rate of 9% per decade for three decades, averaging 0.51 on a scale of 0 to 1 for the 1980s, and leaving much room for improvement. Nevertheless, attention to quality of studies by editors, reviewers, and authors may be raising both the level of research done and quality of the reports.
A new type of research, termed meta-analysis, attempts to analyze and combine the results of previous reports. We found 86 meta-analyses of reports of randomized controlled trials in the English-language literature. We evaluated the quality of these meta-analyses, using a scoring method that considered 23 items in six major areas--study design, combinability, control of bias, statistical analysis, sensitivity analysis, and application of results. Only 24 meta-analyses (28 percent) addressed all six areas, 31 (36 percent) addressed five, 25 (29 percent) addressed four, 5 (6 percent) addressed three, and 1 (1 percent) addressed two. Of the 23 individual items, between 1 and 14 were addressed satisfactorily (mean +/- SD, 7.7 +/- 2.7). We conclude that an urgent need exists for improved methods in literature searching, quality evaluation of trials, and synthesizing of the results.
A clinical trial cannot be adequately interpreted without information about the methods used in the design of the study and the analysis of the results. To determine the frequency of reporting what we consider 11 important aspects of design and analysis, we surveyed all 67 clinical trials published in the New England Journal of Medicine, the Lancet, and the British Medical Journal from July through December 1979 and in the Journal of the American Medical Association from July 1979 through June 1980. Of all 11 items in the 67 trials published in all four journals, 56 per cent were clearly reported, 10 per cent were ambiguously mentioned, and 34 per cent were not reported at all. At least 80 per cent of the 67 trials reported information about statistical analyses, statistical methods used, and random allocation of subjects, yet only 19 per cent reported the method of randomization. Loss to follow-up was discussed in 79 per cent of the articles, treatment complications in 64 per cent, and admission of subjects before allocation in 57 per cent, but eligibility criteria for admission to the trial appeared in only 37 per cent. Although information about whether patients were blind to treatment was given in 55 per cent, information about whether there was blind assessment of outcome was reported in only 30 per cent. The statistical power of the trial to detect treatment effects was discussed in only 12 per cent of the articles. The clinical trials published in The New England Journal of Medicine reported 71 per cent of the 11 items, those in the Journal of the American Medical Association 63 per cent, those in the British Medical Journal 52 per cent, and those in the Lancet 46 per cent. These rates are significantly different (P less than 0.001). We recommend that editors improve the reporting of clinical trials by giving authors a list of the important items to be reported.
A system has been constructed to evaluate the design, implementation, and analysis of randomized control trials (RCT). The degree of quadruple blinding (the randomization process, the physicians and patients as to therapy, and the physicians as to ongoing results) is considered to be the most important aspect of any trial. The analytic techniques are scored with the same emphasis as is placed on the control of bias in the planning and implementation of the studies. Description of the patient and treatment materials and the measurement of various controls of quality have less weight. An index of quality of a RCT is proposed with its pros and cons. If published papers were to approximate these principles, there would be a marked improvement in the quality of randomized control trials. Finally, a reasonable standard design and conduct of trials will facilitate the interpretation of those with conflicting results and help in making valid combinations of undersized trials.
Zusatzbehandlung mit Esberi-tox bei Patientinnen mit kurativer adjuvanter Bestrahlung nach Mammakarzinom [Additional treatment with Esberitox in pati-ents with curative adjuvant radiotherapy after breast cancer]
- R Bendel
- K Renner
- K Stolze
Bendel, R., Renner, K., Stolze, K.: Zusatzbehandlung mit Esberi-tox bei Patientinnen mit kurativer adjuvanter Bestrahlung nach Mammakarzinom [Additional treatment with Esberitox in pati-ents with curative adjuvant radiotherapy after breast cancer]. Strahlentherapie und Onkologie 164: 278-283,1988.
Milderung grippaler Infekte durch ein pflanzliches Im-munstimulans [Treatment of influenza-like syndroms with a phytotherapeutic immunostimulatory preparation
- M Dorn
Dorn, M.: Milderung grippaler Infekte durch ein pflanzliches Im-munstimulans [Treatment of influenza-like syndroms with a phytotherapeutic immunostimulatory preparation]. Natur-und Ganzheitsmedizin 2: 314-319,1990.
Beeinflussung der Haufigkeit banaler Er-kaltungsinfekte durch Esberitox [Influence of Esberitox on the frequency of the common cold
- H Forth
- N Beuscher
Forth, H., Beuscher, N.: Beeinflussung der Haufigkeit banaler Er-kaltungsinfekte durch Esberitox [Influence of Esberitox on the frequency of the common cold]. Zeitschrift fur Allgemeinmedi-zin 57: 2272-2275, 1981.
Reduzierte Krankheitsdauer bei Per-tussis durch unspezifisches Immunstimulans [Decreased durati-on of pertussis by treatment with an unspecific immunostimula-tor]
- U Freitag
- U Stammwitz
Freitag, U., Stammwitz, U.: Reduzierte Krankheitsdauer bei Per-tussis durch unspezifisches Immunstimulans [Decreased durati-on of pertussis by treatment with an unspecific immunostimula-tor]. Kinderarzt 15: 1068-1071, 1984.
Haufigkeit banaler Infekte im Kindesalter und Mog-lichkeiten der Prophylaxe [Frequency of common cold in child-ren and possibilities for prophylaxis]
- H U Freyer
Freyer, H. U.: Haufigkeit banaler Infekte im Kindesalter und Mog-lichkeiten der Prophylaxe [Frequency of common cold in child-ren and possibilities for prophylaxis]. Fortschritte der Medizin 92: 165 -168, 1974.
Ways to en-hance the quality and acceptance of clinical and laboratory stu-dies in homoeopathy Erste Phase-I-Untersuchung von Echinacea-Polysaccharid (EPO VIla/EPS) bei i. v. application [First phase-I-investigation on polysaccharides of Echinacea applied i.v
- H Kleinschmidt
- K Linde
- D Melchart
- W D Jonas
- J Hornung
- D Melchart
- E Worku
- K Linde
- Flesche
- R Eife
- H Wagner
Kleinschmidt, H.: Versuche zur Herabsetzung der Infektneigung bei Kleinkindern mit Esberitox [Trials to decrease the frequency of infects in infants with Esberitox]. Therapie der Gegenwart 104:1258-1262,1965. Linde, K, Melchart, D., Jonas, W.D., Hornung, J.: Ways to en-hance the quality and acceptance of clinical and laboratory stu-dies in homoeopathy, Br. Hom.]. 83: 3-7, 1994. Melchart, D., Worku, E, Linde, K, Flesche, c., Eife, R., Wagner, H.: Erste Phase-I-Untersuchung von Echinacea-Polysaccharid (EPO VIla/EPS) bei i. v. application [First phase-I-investigation on polysaccharides of Echinacea applied i.v. (EPO VIla/EPS)]. Erfahrungsheilkunde 42: 318-323,1993. Melchart, D., Linde, K., Worku, E, Sarkady, L., Holzmann, M., Jurcic, K, Wagner, H.: Immunomodulatory activity and safety of preparations of Echinacea -results of 5 randomized placebo-controlled studies in healthy volunteers. Submitted for publica-tion.
Zur Therapie der strahlenbedingten Leukopenie mit Esbe-ritox [Therapy of radiation-induced leucopenia with Esberitox]
- P Pohl
Pohl, P.: Zur Therapie der strahlenbedingten Leukopenie mit Esbe-ritox [Therapy of radiation-induced leucopenia with Esberitox]. Tberapie der Gegenwart 109: 902-906,1970.
Die Beeinflussung der Phagozytosefahigkeit von Granulozyten durch homoopathische Arzneipraparate -in-vitro-Tests und kontrollierte Einfachblindstudien [Influence of homoeopathic drug preparations on phagocytic activity of human granulocytes -in vitro tests and controlled single-blind studies]
- H Wagner
- K Jurcic
- A Doenicke
- E Rosenhuber
- N Behrens
Wagner, H., Jurcic, K., Doenicke, A., Rosenhuber, E., Behrens, N.: Die Beeinflussung der Phagozytosefahigkeit von Granulozyten durch homoopathische Arzneipraparate -in-vitro-Tests und kontrollierte Einfachblindstudien [Influence of homoeopathic drug preparations on phagocytic activity of human granulocytes -in vitro tests and controlled single-blind studies]. Arzneim.-Forsch.lDrug Research 36,II: 1421-1425, 1986.
Immunologische Untersuchungen von pflanzlichen Kombinationspraparaten [Immunological investi-gation of phytotherapeutic combination preparations]. Arz-neim.-Forsch
- H Wagner
- K Jurcic
Wagner, H., Jurcic, K.: Immunologische Untersuchungen von pflanzlichen Kombinationspraparaten [Immunological investi-gation of phytotherapeutic combination preparations]. Arz-neim.-Forsch.lDrug Research 41,II: 1072-1076, 1991.
The quality of medical literature: an analysis ofvalidation assessments
- J W Williamson
- P G Goldschmidt
- T Colton
Williamson, J. W., Goldschmidt, P.G., Colton, T.: The quality of medical literature: an analysis ofvalidation assessments. In: Bai-lar, J. c., Mosteller, E: Medical uses of statistics, NEJM Books, Waltham, Massachusetts (1986) pp. 370-391.