1,722,709 research outputs found
Pelargonium sidoides extract EPs 7630: a review of its clinical efficacy and safety for treating acute respiratory tract infections in children
No full textDomenico Careddu,1 Andrea Pettenazzo2 1Pediatrics, Italian Health Service, Cameri, Italy; 2Department of Women’s and Children’s Health, University Hospital of Padua, Padova, Italy Background: In numerous randomized controlled trials (RCTs) and systematic reviews such as those published by the Cochrane Collaboration, Pelargonium sidoides extract EPs® 7630 was shown to be effective in acute respiratory tract infections (aRTI) in all investigated age-groups. This narrative review focuses on recently published results from RCTs investigating the clinical efficacy and safety of EPs 7630 in children and adolescents with different manifestations of aRTI, in order to present a broader overview and to provide an update on the state of knowledge regarding the use of EPs 7630 in this age-group.Methods: The Cochrane review on P. sidoides extract for aRTI published by the Cochrane Collaboration was searched for cited RCTs with EPs 7630 in children and adolescents suffering from aRTI. A PubMed and SCOPUS literature search was performed for publications issued before June 13, 2017 (search terms: children, Pelargonium sidoides, EPs 7630, respiratory). Reference lists of publications found were searched for relevant citations. Results: Eight RCTs investigating the application of EPs 7630 in acute bronchitis, acute tonsillopharyngitis, and aRTI in the context of chronic preconditions were identified. Results showed a statistically significant improvement of aRTI symptom severity for EPs 7630 as compared to controls. The investigation of EPs 7630 in asthmatic children and adolescents with aRTI demonstrated a significant symptom-alleviating effect and a possibly associated reduction of asthma attacks. In immunocompromised children with acute upper RTI, an alleviating effect of EPs 7630 was shown. All RCTs reviewed reported good safety and tolerability of EPs 7630.Conclusion: The P. sidoides extract EPs 7630 is effective and safe for those of pediatric age and may be regarded as an alternative option for the management of aRTI. Keywords: Pelargonium sidoides, EPs 7630, children, acute respiratory tract infections, acute bronchitis, asthm
Treatment of hBEC with EP 7630 and RV16 infection.
No full textTreatment of hBEC with EP 7630 and RV16 infection.</p
Treatment of signs and symptoms of the common cold using EPs 7630 - results of a meta-analysis
Get PDF© 2019 The Author(s) The efficacy of Pelargonium sidoides preparation EPs 7630 in the common cold (CC) was assessed by performing meta-analyses of randomized, double-blind, placebo-controlled trials. Mean differences (MD) and risk ratios (RR) with their 95% confidence intervals (CI) were computed. Five trials with a total of 833 patients were included. All trials had a treatment period of ten days with visits at days 3, 5, and 10 after baseline and used a ten-symptom Cold Intensity Score (CIS) as the primary outcome. Significant differences favoring EPs 7630 were observed for total CIS reduction (day 5: MD = -2·30; 95%CI = -4·12,-0·49; day 10: MD = -1·16; 95%CI = -2·22,-0·10), proportion of patients with substantial improvement (day 5: RR = 1·73; day 10: RR = 1·06) and complete remission (day 5: RR = 2·52; day 10: RR = 2·13). Subjects treated with EPs 7630 missed fewer days at work, used less paracetamol and had an improved sleep quality. No serious adverse reactions to EPs 7630 were reported. The results support the efficacy of EPs 7630 in adults with CC
Randomised, double-blind, placebo-controlled trial of EPs 7630 in adults with COPD
No full textSummaryBackgroundPreventing and managing exacerbations is one major component in COPD treatment. We investigated whether EPs 7630, a herbal drug preparation from the roots of Pelargonium sidoides, could prolong time to acute exacerbation in patients with COPD stage II/III.MethodsIn this randomised, double-blind, placebo-controlled clinical trial, patients were randomly allocated to oral 24-week add-on therapy with 3 × 30 drops/day EPs 7630 (n = 99) or placebo (n = 101) to a standardised baseline-treatment. Primary endpoint was time to first exacerbation of COPD. Secondary endpoints were number of exacerbations, consumption of antibiotics, quality of life, patient satisfaction, inability to work, and tolerability.ResultsMedian time to exacerbation was significantly prolonged with EPs 7630 compared to placebo (57 versus 43 days, Kaplan–Maier-estimate; p = 0.005, one-sided centre-stratified log-rank test). The superiority of EPs 7630 was also confirmed in secondary endpoints, e.g., fewer exacerbations, less patients with antibiotic use, improved quality of life, higher patient satisfaction, and less days of inability to work. The incidence of minor gastrointestinal adverse events was higher in the EPs 7630 group.ConclusionsThe results demonstrate a statistically significant and clinically relevant superiority of add-on therapy with EPs 7630 over placebo and a good long-term tolerability in the treatment of moderate to severe COPD. EPs 7630 prolonged time to exacerbations and reduced exacerbation frequency and antibiotic use.Trial Registration No.: ISRCTN01681733
EPs 7630 stimulates human blood immune cells.
No full text<p>(<b>A, B</b>) PBMCs, isolated from the blood of healthy donors, were treated with EPs 7630 as indicated, TLR3 and TLR4 ligands (T3L, T4L), a cytokine mixture (IL-1β, IL-2, IL-12), or anti-CD3 and anti-CD28 antibodies for 4 h and 24 h. TNF-α (4 h), IL-6 (24 h), and IL-10 (24 h) were quantified in respective culture supernatants by ELISA. Mean (± SEM) data from 6 donors are given as cytokine concentrations (A) or TNF-α/IL-10 ratio (B). (<b>C</b>) Healthy donor PBMCs were cultured in the presence of different concentrations of EPs 7630 as indicated for 48 h, followed by quantification of TNF-α, IL-6, and IL-10 in respective culture supernatants by ELISA. Mean (± SEM) cytokine concentration data from 12 donors are given. (<b>D</b>) Healthy donor PBMCs were stimulated with EPs 7630 and TLR4 ligand as indicated for 4 to 72 h, followed by quantification of TNF-α, IL-6, and IL-10 in respective culture supernatants by ELISA. Mean (± SEM) cytokine concentration data from 4 donors (except TNF-α 48h: n = 3) are given. (<b>A</b>, <b>B</b>) Significant differences compared to control group are indicated (* <i>p</i><0.05, ** <i>p</i><0.01, Wilcoxon matched-pairs signed-rank test).</p
EPs® 7630 Stimulates Tissue Repair Mechanisms and Modifies Tight Junction Protein Expression in Human Airway Epithelial Cells
No full textAirway epithelium repair after infection consists of wound repair, re-synthesis of the extracellular matrix (ECM), and tight junction proteins. In humans, EPs® 7630 obtained from Pelargonium sidoides roots reduces the severity and duration of acute respiratory tract infections. The effect of EPs® 7630 on tissue repair of rhinovirus-16 (RV-16) infected and control human airway epithelial cells was assessed for: (i) epithelial cell proliferation by manual cell counts, (ii) epithelial wound repair by “scratch assay”, (iii) ECM composition by Western-blotting and cell-based ELISA, and (iv) epithelial tight junction proteins by Western-blotting. EPs® 7630 stimulated cell proliferation through cAMP, CREB, and p38 MAPK. EPs® 7630 significantly improved wound repair. Pro-inflammatory collagen type-I expression was reduced by EPs® 7630, while fibronectin was increased. Virus-binding tight junction proteins desmoglein2, desmocollin2, ZO-1, claudin1, and claudin4 were downregulated by EPs® 7630. The RV16-induced shift of the ECM towards the pro-inflammatory type was prevented by EPs® 7630. Most of the effects of EPs® 7630 on tissue repair and regeneration were sensitive to inhibition of cAMP-induced signaling. The data suggest that EPs® 7630-dependent modification of epithelial cell metabolism and function might underlie the faster recovery time from viral infections, as reported by others in clinical studies
Лечение острого бронхита у взрослых экстрактом пеларгонии сидовидной (Pelargonium Sidoides; EPs 7630): рандомизированное двойное слепое плацебо-контролируемое исследование
Get PDFAcute bronchitis is a wide-spread disease. Although it is generally caused by viruses, antibiotics are used for its treatment too much often. So it is very important to evaluate alternative therapy of acute bronchitis. The aim of the trial was to assess efficacy and safety of Pelargonium Sidoides (EPs 7630 is a registered trademark of Dr. Willmar Schwabe GmbH & Co, Karlsruhe, Germany) compared to placebo in patients with acute bronchitis. Study design: randomised, double-blind, placebo controlled trial with planned interim analysis. The trial centres: 6 outpatient medical centres. Patients: 124 adult patients with acute bronchitis, onset of the disease ≤ 48 h, and severity of symptoms ≥ 5 according to BSS scale gave written informed concert. EPs 7630 or placebo were administered in the dose of 30 drops t.i.d. during 7 days. The primary outcome measure was BSS scoring at the 7th day of the treatment. BSS scoring decreased by 7.2 ± 3.1 in the EPs 7630 group (n = 64) vs 4.9 ± 2.7 in the placebo group (n = 60). 95 % confidence interval (CI, 1.21, 3.56) for difference of the effects between two groups demonstrated significant improvement in the EPs 7630 in 7 days of the treatment compared to the placebo group (p < 0.0001). The EPs 7630 patients had parameters of complete recovery for every of 5 individual symptoms reliably higher compared to placebo patients. During the first 4 days of the treatment therapeutic effect was noted in 68.8 % of the EPs 7630 group vs 33.3 % of the placebo group (p < 0.0001). Health-related quality of life improved better in the EPs 7630 patients compared to the placebo group. Adverse events were found in 25 of 124 patients: 15 / 64 in the EPs 7630 group and 10 / 60 in the placebo group. All the adverse events were considered as non-serious. The efficacy of EPs 7630 in treatment of adults with acute bronchitis was higher compared to placebo. It could be an efficient alternative drug in therapy of acute bronchitis at the absence of indications for antibiotics administration.Острый бронхит является широко распространенным заболеванием, и, хотя он главным образом вызывается вирусами, для его лечения все еще излишне часто назначаются антибиотики. Поэтому крайне важно оценить применение альтернативного лечения острого бронхита. Цель исследования – оценить эффективность и безопасность препарата пеларгонии сидовидной (EPs 7630 является зарегистрированной торговой маркой компании Dr. Willmar Schwabe, г. Карлсруэ, Германия) по сравнению с плацебо у пациентов с острым бронхитом. В 6 поликлиниках было проведено рандомизированное двойное слепое плацебо-контролируемое исследование с использованием дизайна с плановым промежуточным анализом. В нем участвовали 124 взрослых пациента с диагнозом острого бронхита, началом заболевания ≤ 48 ч, тяжестью симптомов по шкале оценки тяжести симптомов бронхита (BSS) ≥ 5 баллов; все они подписали информированное согласие. Больные принимали EPs 7630 или плацебо (30 капель 3 раза в день) в течение 7 дней. Первичным критерием являлось изменение показателя BSS на 7-й день. Снижение показателя BSS в сравнении с группой контроля на 7-й день составило 7,2 ± 3,1 балла в группе EPs 7630 (n = 64) и 4,9 ± 2,7 балла в группе плацебо (n = 60). Был рассчитан (1,21; 3,56) 95%-ный доверительный интервал различия эффектов между двумя группами лечения (EPs 7630 – плацебо), показывающий значительное улучшение в группе EPs 7630 по сравнению с плацебо на 7-й день (p < 0,0001). Для каждого из 5 индивидуальных симптомов показатели полного выздоровления были значительно выше в группе EPs 7630. В течение первых 4 дней терапевтический эффект был признан у 68,8 % пациентов в группе EPs 7630 по сравнению с 33,3 % пациентов в группе плацебо (p < 0,0001). Качество жизни значительно улучшилось у больных в группе EPs 7630 по сравнению с группой плацебо. Побочные явления наблюдались у 25 из 124 пациентов (EPs 7630 – 15 из 64 пациентов, плацебо – 10 из 60 пациентов). Все побочные явления были оценены как несерьезные. Эффективность препарата EPs 7630 превосходила таковую плацебо в лечении острого бронхита у взрослых. Поэтому может быть предложена эффективная альтернатива для лечения острого бронхита, если нет четких показаний для применения антибиотиков
The Pelargonium sidoides Extract EPs 7630 Drives the Innate Immune Defense by Activating Selected MAP Kinase Pathways in Human Monocytes.
No full textPelargonium sidoides is a medical herb and respective extracts are used very frequently for the treatment of respiratory tract infections. However, the effects of Pelargonium sidoides and a special extract prepared from its roots (EPs 7630) on human immune cells are not fully understood. Here we demonstrate that EPs 7630 induced a rapid and dose-dependent production of TNF-α, IL-6, and IL-10 by human blood immune cells. This EPs 7630-induced cytokine profile was more pro-inflammatory in comparison with the profile induced by viral or bacterial infection-mimicking agents. The search for EPs 7630 target cells revealed that T-cells did not respond to EPs 7630 stimulation by production of TNF-α, IL-6, or IL-10. Furthermore, pretreatment of T-cells with EPs 7630 did not modulate their TNF-α, IL-6, and IL-10 secretion during subsequent activation. In contrast to lymphocytes, monocytes showed clear intracellular TNF-α staining after EPs 7630 treatment. Accordingly, EPs 7630 predominantly provoked activation of MAP kinases and inhibition of p38 strongly reduced the monocyte TNF-α production. The pretreatment of blood immune cells with EPs 7630 lowered their secretion of TNF-α and IL-10 and caused an IL-6 dominant response during second stimulation with viral or bacterial infection-mimicking agents. In summary, we demonstrate that EPs 7630 activates human monocytes, induces MAP kinase-dependent pro-inflammatory cytokines in these cells, and specifically modulates their production capacity of mediators known to lead to an increase of acute phase protein production in the liver, neutrophil generation in the bone marrow, and the generation of adaptive Th17 and Th22 cells
TLR3- and TLR4-induced responses in immune cells are modulated by EPs 7630 pretreatment.
No full text<p>Healthy donor PBMCs were treated with different concentrations of EPs 7630 as indicated for 24 h. Afterwards, TLR3 or TLR4 ligands (T3L, T4L) were added for additional 24 h, followed by quantification of TNF-α, IL-6, and IL-10 in respective culture supernatants by ELISA. Mean (± SEM) cytokine concentration data from 12 donors are given as percent of 0 μg/ml EPs 7630 group (control). Cytokine concentrations in the absence of EPs 7630 in TL3L and TL4L groups were: 1267±414 and 1534±324 pg/ml (TNF-α), 1278±369 and 2135±650 pg/ml (IL-6), 1011±127 and 1430±140 pg/ml (IL-10), respectively. Significant differences compared to 0 μg/ml EPs 7630 group are indicated (* <i>p</i><0.05, ** p<0.01, Wilcoxon matched-pairs signed-rank test).</p
Faster recovery and reduced paracetamol use – a meta-analysis of EPs 7630 in children with acute respiratory tract infections
No full textAbstract Objective Fever is a very common adaptive immune response in acute respiratory tract disorders during infancy. Antipyretic / analgesic drugs such as paracetamol (acetaminophen) are widely used to improve the comfort of the child but may cause medically unneeded antipyresis and rare but potentially serious side effects. We assess whether treatment with Pelargonium sidoides extract EPs 7630 reduces the administration of paracetamol in children with acute tonsillopharyngitis (ATP) or acute bronchitis (AB). Design Meta-analysis of randomised, placebo-controlled clinical trials. Methods We searched clinical trial registries (ISRCTN, ClinicalTrials.gov) and medical literature (MEDLINE, EMBASE), for randomised, placebo-controlled trials investigating the administration of EPs 7630 to children with ATP or AB and reporting the co-administration of paracetamol. Based on the individual participant data of the eligible trials, study populations were characterized according to sex and age, and meta-analyses were performed for cumulative paracetamol use and ability to attend school at treatment end. Results Six trials including a total of 523 children aged 6–10 years (EPs 7630: 265; placebo: 258) and suffering from non-β-hemolytic streptococcal ATP (3 trials) or from AB (3 trials) were identified and eligible. Children received EPs 7630 or placebo for 6 (ATP) or 7 days (AB). Compared to placebo, EPs 7630 reduced the cumulative dose of paracetamol in 5 out of the 6 trials, by an average of 244 mg (Hedges’ g; − 0.28; 95% confidence interval: [− 0.53; − 0.02]; p < 0.03). At treatment end, 30.2% (EPs 7630) and 74.4% (placebo) of the children were still unable to attend school (risk ratio: 0.43; 95% confidence interval: [0.29; 0.65]; p < 0.001). Conclusions In children aged 6–10 years with AB or ATP, EPs 7630 alleviated the symptom burden and accelerated recovery. Although EPs 7630 has no known antipyretic effect, concomitant use of paracetamol was reduced
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