Safety and Dose-Dependent Effects of Echinacea for the Treatment of Acute Cold Episodes in Children: A Multicenter, Randomized, Open-Label Clinical Trial

Weishaupt, Ramon; Bächler, A.; Feldhaus, Simon; Lang, Gabrielle E.; Klein, Peter; Schoop, Roland

doi:10.3390/children7120292

Cited by 12 publications

(17 citation statements)

References 29 publications

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“…The subdomain mean scores were 6.5 days and 6.9 days for the ColdZyme and placebo groups respectively, reflecting a 0.4-day shorter illness with ColdZyme; however, the median times differed by a full day (6.0 vs. 7.0; p=0.05, n=218/218). A 1-2 day reduction in a common cold episode is consistent with other treatments of common colds, [23][24] but also how often subjects were asked to assess the presence of illness in this trial 1 0 (once a day). The return to wellness was also heralded by a significant difference in the proportion of subjects on the preceding day (Day 5) who had recovered as measured by subdomain scores of zero (24.2% vs. 16.0%, p=0.029).…”

Section: Discussionmentioning

confidence: 63%

Early intervention with ColdZyme mouth spray after self-diagnosis of common cold: a randomized, double-blind, placebo-controlled study

Lindberg¹,

Nelson²,

Ranstam

et al. 2022

Preprint

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Background A glycerol throat spray containing cold-adapted cod trypsin creates a protective barrier and is known to deactivate common cold virus in vitro and decrease pharyngeal rhinovirus load after inoculation in humans. Early self-diagnosis and use of the medical device ColdZyme indicate a safe alternative for treatment in naturally occurring common colds. Methods This was a double-blind, randomized, parallel-group, placebo-controlled study conducted at ten German sites to evaluate the efficacy of the medical device ColdZyme, a glycerol mouth spray containing cold-adapted cod trypsin, for naturally occurring common cold, versus placebo. Adults experiencing a minimum of three common colds during the previous year, but otherwise healthy, were enrolled to begin treatment with the mouth spray or placebo six times daily at first sign of a common cold. Jacksons symptom scale and the 9-item Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) quality of life (QoL) domain and sore throat scale were recorded daily by subjects, as well as any use of allowed rescue treatment. The trial is registered at ClinicalTrials.gov, number NCT03794804. Results Between January and April 2019, 701 subjects were enrolled and randomly assigned to the ColdZyme group (n=351) or the placebo group (n=350). Of the 701 subjects, 438 (62.5%) subjects developed symptoms typical of common cold, and all 438 started study treatment (n=220 in the ColdZyme group and n=218 in the placebo group). There were no differences between the groups in primary and major secondary endpoints, however, the assessment using the WURSS-21 QoL domain and Jackson score suggests a slightly faster recovery with ColdZyme, as symptoms and complaints affecting the quality of life were shortened about 1 day. The beneficial effect of ColdZyme was particularly noticeable on the fifth day of the common cold. A positive difference between treatment groups was also seen for the subjects assessments of global efficacy of the investigational product, and a robust safety profile for ColdZyme was demonstrated throughout the study. Conclusion The safety and tolerability of ColdZyme have been confirmed in a larger study population, while establishing evidence of a slightly faster recovery from common cold symptoms. Keywords: glycerol, (cod) trypsin, common cold, quality of life, oral spray, colds viruses

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Section: Discussionmentioning

confidence: 63%

Early intervention with ColdZyme mouth spray after self-diagnosis of common cold: a randomized, double-blind, placebo-controlled study

Lindberg¹,

Nelson²,

Ranstam

et al. 2022

Preprint

View full text Add to dashboard Cite

show abstract

“…The subdomain mean scores were 6.5 days and 6.9 days for the ColdZyme and placebo groups respectively, reflecting a 0.4-day shorter illness with ColdZyme; however, the median times differed by a full day (6.0 vs. 7.0; p = 0.05, n = 218/218). A 1-2 day reduction in a common cold episode is consistent with other treatments of common colds [23,24], but also how often subjects were asked to assess the presence of illness in this trial (once a day). The return to wellness was also heralded by a significant difference in the proportion of subjects on the preceding day (Day 5) who had recovered as measured by subdomain scores of zero (24.2% vs. 16.0%, p = 0.029).…”

Section: Plos Onementioning

confidence: 68%

Early intervention with ColdZyme mouth spray after self-diagnosis of common cold: A randomized, double-blind, placebo-controlled study

Lindberg¹,

Nelson²,

Ranstam³

et al. 2023

PLoS ONE

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Background Previous clinical and in vitro investigations have supported the efficacy of a glycerol throat spray containing cold-adapted cod trypsin (ColdZyme) against respiratory viruses causing the common cold bycreating a protective mucosal barrier shown to deactivate common cold virus in vitro and decrease pharyngeal rhinovirus load. Methods and findings This was a double-blind, randomized, parallel-group, placebo-controlled study conducted at 10 German sites to evaluate the efficacy of the medical device ColdZyme, a glycerol mouth spray containing cold-adapted cod trypsin for a naturally occurring common cold versus placebo spray. Adults experiencing a minimum of three common colds during the previous year, but otherwise healthy, were enrolled to begin treatment with the mouth spray or placebo six times daily at first sign of a common cold. Jackson’s symptom scale and the 9-item Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) quality of life (QoL) domain and a sore throat scale were recorded daily by subjects, as well as any use of allowed rescue treatment. Between January and April 2019, 701 subjects were enrolled and randomly assigned to the ColdZyme group (n = 351) or the placebo group (n = 350). Of the 701 subjects, 438 (62.5%) subjects developed symptoms typical of common cold, and all 438 started study treatment (n = 220 in the ColdZyme group and n = 218 in the placebo group). The demographic profile of the treatment groups were comparable with 68.1% female and almost all subjects being Caucasian (98.4%). The age ranged between 18 and 70 years with a mean age of 41.3 (±14.4) years. There were no differences between the groups in primary and major secondary endpoints, however, the assessment using the WURSS-21 QoL domain and Jackson score suggests a slightly faster recovery with ColdZyme as symptoms and complaints affecting the quality of life were shortened by about 1 day. The beneficial effect of ColdZyme was particularly noticeable on the fifth day of the common cold. A positive difference between treatment groups was also seen for the subjects’ assessments of global efficacy of the investigational product A robust safety profile for ColdZyme was demonstrated throughout the study. Conclusion The safety and tolerability of ColdZyme have been confirmed in a large study population and further establishes evidence of a faster recovery from common cold symptoms. Early self-diagnosis and early use of ColdZyme mouth spray is a safe alternative for treatment of naturally occurring colds.

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“…The mean difference of the extrapolated recovery times was 1.8 days (p <0 .001; Figure 3). For analyses of recovery to absent or mild symptoms, as used in previous publications (19,20), there was a non-significant trend to faster recovery with new formulations (median 6d vs. 7d, p = 0.36 and median: 5d vs. 7d, p = 0.08, respectively; Supplementary Figure S1) when evaluating first and all treated episodes, respectively.…”

Section: Secondary Endpointsmentioning

confidence: 83%

Novel Echinacea formulations for the treatment of acute respiratory tract infections in adults—A randomized blinded controlled trial

et al. 2023

Self Cite

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BackgroundEchinacea purpurea has clinical antiviral activity against respiratory viruses and modulates immune functions. In this study, we compared higher doses of new Echinacea formulations with conventional formulations at lower, preventive doses for therapy of respiratory tract infections (RTIs).MethodsIn this randomized, blinded, controlled trial, healthy adults (n = 409) were randomized between November 2018 and January 2019 to one of four Echinacea formulations, which were taken in case of an RTI for up to 10 days. New formulations A (lozenges) and B (spray) delivered an increased dose of 16,800 mg/d Echinacea extract during days 1–3 and 2,240–3,360 mg/d afterward; as controls, conventional formulations C (tablets) and D (drops) delivered a lower daily dose of 2,400 mg, usually taken for prevention. The primary endpoint was time to clinical remission of first RTI episodes based on the Kaplan–Meier analysis of patient-reported, investigator-confirmed, respiratory symptoms assessed for up to 10 days. In a sensitivity analysis, the mean time to remission beyond day 10 was calculated by extrapolating the treatment effects observed on days 7 to 10.ResultsA total of 246 participants (median age 32 years, 78% female participants) were treated for at least one RTI. Recovery by day 10 (complete absence of symptoms) was achieved in 56 and 44% of patients with the new and conventional formulations, respectively, showing a median time to recovery of 10 and 11 days, respectively (p = 0.10 in intention-to-treat analysis, p = 0.07 in per-protocol analysis). In the extrapolated sensitivity analysis, new formulations resulted in a significantly shorter mean time to remission (9.6 vs. 11.0 days, p < 0.001). Among those with an identified respiratory virus, viral clearance until day 10 based on real-time PCR from nasopharyngeal swabs was more frequent with new formulations (70 vs. 53%, p = 0.046). Tolerability and safety (adverse events: 12 vs. 6%, p = 0.19) were good and similar between formulations. There was one severe adverse event with a potential hypersensitivity reaction in a recipient of the novel spray formulation.ConclusionIn adults with acute RTI, new Echinacea formulations with higher doses resulted in faster viral clearance than conventional formulations in prophylactic dosages. The trend for faster clinical recovery was not significant by day 10 but became so upon extrapolation. A dose increase during acute respiratory symptoms might improve the clinical benefits of orally administered Echinacea formulations.Trial registrationThe study was registered in the Swiss National Clinical Trials Portal (SNCTP000003069) and on ClinicalTrials.gov (NTC03812900; URL https://clinicaltrials.gov/ct2/show/NCT03812900?cond=echinacea&draw=3&rank=14).

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Safety and Dose-Dependent Effects of Echinacea for the Treatment of Acute Cold Episodes in Children: A Multicenter, Randomized, Open-Label Clinical Trial

Cited by 12 publications

References 29 publications

Early intervention with ColdZyme mouth spray after self-diagnosis of common cold: a randomized, double-blind, placebo-controlled study

Early intervention with ColdZyme mouth spray after self-diagnosis of common cold: a randomized, double-blind, placebo-controlled study

Early intervention with ColdZyme mouth spray after self-diagnosis of common cold: A randomized, double-blind, placebo-controlled study

Novel Echinacea formulations for the treatment of acute respiratory tract infections in adults—A randomized blinded controlled trial

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