Post-market outcome of an extract of traditional Cretan herbs on upper respiratory tract infections: a pragmatic, prospective observational study

Marilena Anastasaki, Antonios Bertsias, Stergios A Pirintsos, Elias Castanas, Christos Lionis, Marilena Anastasaki, Antonios Bertsias, Stergios A Pirintsos, Elias Castanas, Christos Lionis

Abstract

Background: The beneficial effects of traditional herbs of Crete, Greece for the treatment of upper respiratory tract infections have been reported in observational and laboratory studies. Following a published, double blind, randomized, placebo controlled trial, this study aimed to assess the effectiveness of an extract of three Cretan herbs on the treatment of upper respiratory tract infections, upon its market release.

Methods: An observational study was conducted in Heraklion, Crete, Greece. Participants were patients presenting at selected pharmacies with symptoms of upper respiratory tract infection, choosing to receive the extract for their treatment. Patients' symptoms (local, general, total) where recorded at three time points within 1 week, using a questionnaire developed based on the Wisconsin Upper Respiratory System Survey. For each patient, symptoms were scored on a 0-7 Likert scale and three indexes were calculated: the score of local symptoms, the score of general symptoms and the total score of symptoms. Effectiveness was assessed by examining the reduction in these indexes over the 1-week observation period.

Results: Mean score of general symptoms was 19.1 (SE: 0.9) in day 1, dropping to 8.6 (SE: 0.6) and 3.1 (SE: 0.4) in days 4 and 7 respectively. Mean score of local symptoms declined from 7.9 (SE: 0.5) in day 1 to 2.3 (SE: 0.3) in day 4 and to 0.5 (SE: 0.1) in day 7. Total score of symptoms reached 27.0 (SE: 1.2) in day 1, decreasing to 10.9 (SE: 0.8) in day 4 and to 3.5 (SE: 0.5) in day 7. The percentage of participants reporting fever was 82.1% at baseline, 8.0% in day 4 and 2.0% in day 7 (p < 0.0001 for paired differences). Multiple regression models indicated that supplementary medication intake did not seem to affect symptoms' severity or the day patients reported that their symptoms ceased completely.

Conclusions: This pragmatic study added evidence about the potential therapeutic effects of an extract of Cretan herbs on the amelioration of upper respiratory tract infection symptoms.

Keywords: Aromatic plants; Herbal extract; Upper respiratory tract infection.

Conflict of interest statement

Competing interest

CL, EC and SAP are the inventors of the patent describing the compositions of the herbal extract and their use.

Ethics approval and consent to participate

The study was approved by the Bioethics Commission of the University General Hospital of Heraklion (No. 746). All participants provided signed informed consent.

Consent for publication

Not applicable. No individual details, images, videos or audio recordings of any participant are included in this study. All questionnaires were anonymous.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Mean symptoms’ scores and standard errors per day of observation

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Source: PubMed

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