Impact of Proven Viral Load on Common Cold Patients Treated with Pelargonium sidoides Preparation EPs 7630

Abstract

The Common Cold (CC) is an acute respiratory tract disorder with viral etiology in at least 90% of the cases. Nevertheless, molecular diagnostic testing often confirms the presence of viral Nucleic Acids (NA) in only about half of the patients. Based on the results of a non-comparative, interventional multicenter study we compare the course of CC between patients with and without proof of viral NA, who were treated with Pelargonium sidoides extract preparation EPs 7630. 120 adults with CC and at least 2 out of 10 common cold symptoms received 3×1 film-coated 20 mg tablet EPs 7630 daily for 10 days. At baseline, tests for viral NA were performed. CC-associated symptoms and treatment satisfaction were evaluated after 5 days and at treatment end. Out of 119 patients with molecular nucleic acid based assessments, 61 (61.3%) were tested positive for viral NA. Patients with and without proof of viral NA showed a similar time course of recovery from CC associated symptoms and had a comparable global outcome. In both subsets, less than 20% of the patients received concomitant paracetamol for antipyresis and only 2 required antibiotic treatment. Independently of whether or not viral NA was confirmed at baseline the course of CC treated with EPs 7630 was comparable. The results do not support the necessity to measure the viral load in order to treat CC patients effectively.

Pelargonium Extract EPs 7630 in the Treatment of Human Corona Virus-Associated Acute Respiratory Tract Infections – A Secondary Subgroup-Analysis of an Open-Label, Uncontrolled Clinical Trial

“…The results of our subset analyses are in line with the results obtained for the whole population of the underlying trial (Keck et al, 2015;Keck et al, 2018). Therefore, it is not surprising that patients who tested positive for HCoV NA showed a comparable course of disease under EPs 7630 treatment as patients infected with other viruses.…”

“…Additionally, the number of days off work or school and the use of paracetamol were documented. Further methodological details on the outcomes of this clinical trial are described elsewhere (Keck et al, 2015;Keck et al, 2018).…”

“…Details on the methodology and the main results for the total population of the underlying clinical trial are described elsewhere (Keck et al, 2015;Keck et al, 2018). In the following, only the methodological details and results for the subset analysis are given.…”

“…Moreover, most patients showed a favourable course of recovery from the disease. In a secondary subgroup-analysis of trial data (Keck et al, 2018), the association between the detection of viral nucleic acids at the start of treatment and the subsequent course of the disease specific symptoms was further investigated. This analysis revealed that the most frequently detected viruses by molecular testing at baseline were enterovirus/rhinovirus followed by HCoV-HKU1 and HCoV-OC43 (Keck et al, 2018).…”

Pelargonium Extract EPs 7630 in the Treatment of Human Corona Virus-Associated Acute Respiratory Tract Infections – A Secondary Subgroup-Analysis of an Open-Label, Uncontrolled Clinical Trial

“…The results of our subset analyses are in line with the results obtained for the whole population of the underlying trial (Keck et al, 2015;Keck et al, 2018). Therefore, it is not surprising that patients who tested positive for HCoV NA showed a comparable course of disease under EPs 7630 treatment as patients infected with other viruses.…”

“…Additionally, the number of days off work or school and the use of paracetamol were documented. Further methodological details on the outcomes of this clinical trial are described elsewhere (Keck et al, 2015;Keck et al, 2018).…”

“…Details on the methodology and the main results for the total population of the underlying clinical trial are described elsewhere (Keck et al, 2015;Keck et al, 2018). In the following, only the methodological details and results for the subset analysis are given.…”

“…Moreover, most patients showed a favourable course of recovery from the disease. In a secondary subgroup-analysis of trial data (Keck et al, 2018), the association between the detection of viral nucleic acids at the start of treatment and the subsequent course of the disease specific symptoms was further investigated. This analysis revealed that the most frequently detected viruses by molecular testing at baseline were enterovirus/rhinovirus followed by HCoV-HKU1 and HCoV-OC43 (Keck et al, 2018).…”

Pelargonium Extract EPs 7630 in the Treatment of Human Corona Virus-Associated Acute Respiratory Tract Infections – A Secondary Subgroup-Analysis of an Open-Label, Uncontrolled Clinical Trial

“…The results of our subset analyses are in line with the results obtained for the whole population of the underlying trial (Keck et al, 2015;Keck et al, 2018). Therefore, it is not surprising that patients who tested positive for HCoV NA showed a comparable course of disease under EPs 7630 treatment as patients infected with other viruses.…”

“…Additionally, the number of days off work or school and the use of paracetamol were documented. Further methodological details on the outcomes of this clinical trial are described elsewhere (Keck et al, 2015;Keck et al, 2018).…”

“…Details on the methodology and the main results for the total population of the underlying clinical trial are described elsewhere (Keck et al, 2015;Keck et al, 2018). In the following, only the methodological details and results for the subset analysis are given.…”

“…Moreover, most patients showed a favourable course of recovery from the disease. In a secondary subgroup-analysis of trial data (Keck et al, 2018), the association between the detection of viral nucleic acids at the start of treatment and the subsequent course of the disease specific symptoms was further investigated. This analysis revealed that the most frequently detected viruses by molecular testing at baseline were enterovirus/rhinovirus followed by HCoV-HKU1 and HCoV-OC43 (Keck et al, 2018).…”

Pelargonium Extract EPs 7630 in the Treatment of Human Corona Virus-Associated Acute Respiratory Tract Infections – A Secondary Subgroup-Analysis of an Open-Label, Uncontrolled Clinical Trial

“…The results of our subset analyses are in line with the results obtained for the whole population of the underlying trial (Keck et al, 2015;Keck et al, 2018). Therefore, it is not surprising that patients who tested positive for HCoV NA showed a comparable course of disease under EPs 7630 treatment as patients infected with other viruses.…”

“…Additionally, the number of days off work or school and the use of paracetamol were documented. Further methodological details on the outcomes of this clinical trial are described elsewhere (Keck et al, 2015;Keck et al, 2018).…”

“…Details on the methodology and the main results for the total population of the underlying clinical trial are described elsewhere (Keck et al, 2015;Keck et al, 2018). In the following, only the methodological details and results for the subset analysis are given.…”

“…Moreover, most patients showed a favourable course of recovery from the disease. In a secondary subgroup-analysis of trial data (Keck et al, 2018), the association between the detection of viral nucleic acids at the start of treatment and the subsequent course of the disease specific symptoms was further investigated. This analysis revealed that the most frequently detected viruses by molecular testing at baseline were enterovirus/rhinovirus followed by HCoV-HKU1 and HCoV-OC43 (Keck et al, 2018).…”