Immune responses induced by Pelargonium sidoides extract in serum and nasal mucosa of athletes after exhaustive exercise: Modulation of secretory IgA, IL-6 and IL-15

Luna, Luiz; Bachi, André Luís Lacerda; Brito, Rosineide Santana de; Eid, Roland; Suguri, Vinícius Magalhães; Oliveira, Priscila; Gregório, Luiz Carlos; Vaisberg, Mauro

doi:10.1016/j.phymed.2010.08.003

Cited by 27 publications

(22 citation statements)

References 20 publications

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“…The results are also consistent with recently published studies involving the administration of EPs 7630 but not included in our review [53][54][55][56] for which no adverse effects on the hepatobiliary system were reported. Current evidence therefore does not provide any evidence that EPs 7630 could have a hepatotoxic effect.…”

Section: Discussionsupporting

confidence: 93%

Safety and Tolerability of EPs 7630 in Clinical Trials

Kamin¹

2013

Adv Pharmacoepidem Drug Safety

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Herbal medicines play an increasingly important role in the perception of physicians and patients looking for equally effective, albeit safer approaches to conventional management of certain diseases. The controversy surrounding effective management regimes for respiratory tract infections (RTI) has made many healthcare providers reconsider current therapeutic strategies.This review presenting the available evidence from clinical trials and non-interventional studies on the safety and tolerability profile of EPs 7630 is based on publications and study reports of 29 clinical trials and post-marketing surveillance studies completed by February 2010. It includes study data from 10,026 adults and children suffering from acute or chronic RTI such as acute tonsillopharyngitis, rhinopharyngitis, sinusitis, bronchitis, or COPD and from 31 healthy subjects.In 19 double-blind, placebo-controlled trials, the type and incidence rate of adverse events under EPs 7630 were similar to those in patients treated with placebo. For gastrointestinal complaints and epistaxis, event rate differences of 2.9% and of 0.6% against EPs 7630 were determined; hypersensitivity reactions and all other system groups showed rate differences <0.5%. For liver associated events, rate differences of 0.0% for all events and of 0.1% for potentially related events were observed. Patients treated with EPs 7630 did not exhibit increased liver enzyme or bilirubin values -neither in terms of a shift in the mean, nor according to individual deviations from the reference ranges. These findings were fully supported by the data from the post-marketing surveillance studies reviewed.EPs 7630 appears to be a well-tolerated herbal medicine in the management of RTI in adults and children alike. Evidence for hepatotoxic effects in humans during routine administration was neither provided in the literature, nor by our own analyses. its isolated constituents have demonstrated pharmacological activities including moderate direct antibacterial and antiviral action and notable immune-modulatory capabilities: immune-modulatory activities are mediated mainly by the release of tumour necrosis factor α and nitric oxides, the stimulation of interferon β, and an increase in natural killer cell activity [5][6][7][8]; further biological activities in vitro are improved phagocytosis, oxidative burst and intracellular killing by human peripheral blood phagocytes, and inhibition of interaction between group-A-streptococci and host epithelia [9,10]. Safety and Tolerability of EPs 7630 in Clinical TrialsSeveral open-label and randomised double-blind clinical studies have been published over the last years in the indications of tonsillopharyngitis, bronchitis and sinusitis [11][12][13][14][15][16][17][18][19][20][21][22][23][24][25][26][27][28][29][30]. While systematic reviews and meta-analyses of EPs 7630 for acute bronchitis and RTI [31,32] This review adds to these findings by providing the first overview of safety and tolerability of EPs 7630 based on publications and st...

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Section: Discussionsupporting

confidence: 93%

Safety and Tolerability of EPs 7630 in Clinical Trials

Kamin¹

2013

Adv Pharmacoepidem Drug Safety

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“…Collected data included characteristics of participants and study, intervention type and dose, study description/ overview/setting, study recruitment, risk of bias, and outcomes. Unsuccessful attempts were made to contact 2 investigators for additional statistics (29,30).…”

Section: Methodsmentioning

confidence: 99%

Section: Study Characteristicsmentioning

confidence: 99%

“…In summary, all of the studies were RCTs, 3 used a crossover design (38,39,47) and 11 used a parallel design (30,(35)(36)(37)(40)(41)(42)(43)(44)(45)(46). The studies were conducted in a range of countries, including 9 in the United States (36, 38-43, 45, 46), 3 in Germany (37,44,47), 1 in the United Kingdom (35), and 1 in Brazil (30). A total of 4 studies used individual flavonoid supplements, either anthocyanidins (35) or quercetin (36,42,43), whereas the remaining used a combination of flavonoids (30,(37)(38)(39)(40)(41)(44)(45)(46)(47).…”

Section: Study Characteristicsmentioning

confidence: 99%

“…The studies were conducted in a range of countries, including 9 in the United States (36, 38-43, 45, 46), 3 in Germany (37,44,47), 1 in the United Kingdom (35), and 1 in Brazil (30). A total of 4 studies used individual flavonoid supplements, either anthocyanidins (35) or quercetin (36,42,43), whereas the remaining used a combination of flavonoids (30,(37)(38)(39)(40)(41)(44)(45)(46)(47). In 5 trials, the specific flavonoid and/or amount were not reported (30,37,40,44,45).…”

Section: Study Characteristicsmentioning

confidence: 99%

See 2 more Smart Citations

Effect of Flavonoids on Upper Respiratory Tract Infections and Immune Function: A Systematic Review and Meta-Analysis

Somerville

Braakhuis

Hopkins

2016

Advances in Nutrition

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Previous research on animals indicates flavonoid compounds have immunomodulatory properties; however, human research remains inconclusive. The aim of this systematic review was to assess the efficacy of dietary flavonoids on upper respiratory tract infections (URTIs) and immune function in healthy adults. A created search strategy was run against Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE and EMBASE classic, CINAHL, and AMED. The returned studies were initially screened, and 2 reviewers independently assessed the remaining studies for eligibility against prespecified criteria. Fourteen studies, of 387 initially identified, were included in this review, and the primary outcome measure was the effect of flavonoids on URTI incidence, duration, and severity. Of the included studies, flavonoid supplementation ranged from 0.2 to 1.2 g/d. Overall, flavonoid supplementation decreased URTI incidence by 33% (95% CI: 31%, 36%) compared with control, with no apparent adverse effects. Sick-day count was decreased by 40% with flavonoid supplementation, although unclear. Differences in bio-immune markers (e.g., interleukin-6, tumor necrosis factor-α, interferon-γ, neutrophils) were trivial between the intervention and control groups during the intervention and after exercise when a postintervention exercise bout was included. These findings suggest that flavonoids are a viable supplement to decrease URTI incidence in an otherwise healthy population.

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Pelargonium sidoides extract for treating acute respiratory tract infections

Timmer

Günther²,

Motschall

et al. 2013

Cochrane Database of Systematic Reviews

104

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P. sidoides may be effective in alleviating symptoms of acute rhinosinusitis and the common cold in adults, but doubt exists. It may be effective in relieving symptoms in acute bronchitis in adults and children, and sinusitis in adults. The overall quality of the evidence was considered low for main outcomes in acute bronchitis in children and adults, and very low for acute sinusitis and the common cold. Reliable data on treatment for other ARIs were not identified.

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Immune responses induced by Pelargonium sidoides extract in serum and nasal mucosa of athletes after exhaustive exercise: Modulation of secretory IgA, IL-6 and IL-15

Cited by 27 publications

References 20 publications

Safety and Tolerability of EPs 7630 in Clinical Trials

Safety and Tolerability of EPs 7630 in Clinical Trials

Effect of Flavonoids on Upper Respiratory Tract Infections and Immune Function: A Systematic Review and Meta-Analysis

Pelargonium sidoides extract for treating acute respiratory tract infections

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