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

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

doi:10.1186/s12906-017-1978-7

Marilena Anastasaki, Antonios Bertsias + Show 3 more

Open Access

https://doi.org/10.1186/s12906-017-1978-7

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Abstract

BackgroundThe 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.MethodsAn 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.ResultsMean 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.ConclusionsThis pragmatic study added evidence about the potential therapeutic effects of an extract of Cretan herbs on the amelioration of upper respiratory tract infection symptoms.

Highlights

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
Anthropological and laboratory research has explored their antioxidant activity and their effects on the alleviation of common cold symptoms [2, 3]. Such evidence led to the conduction of a double blind, randomized, placebo controlled trial aiming to test the effectiveness of an extract of three Cretan herbs, namely thyme (Coridothymus capitatus (L.) Rchb. f. synonym of Thymbra capitata (L.) Cav.), dictamnus (Origanum dictamnus L.) and sage (Salvia fruticosa Mill., Salvia pomifera L.), on the treatment of upper respiratory tract infections
The results indicated amelioration in the severity of symptoms, with 90% of treated patients being symptom-free at the last day of observation [4]

Summary

Introduction

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. Anthropological and laboratory research has explored their antioxidant activity and their effects on the alleviation of common cold symptoms [2, 3] Such evidence led to the conduction of a double blind, randomized, placebo controlled trial aiming to test the effectiveness of an extract of three Cretan herbs, namely thyme (Coridothymus capitatus (L.) Rchb. The extract was released in the market in 2015, in the form of nutritional supplement (extracts at a dilution of 15 ml/L in extra virgin olive oil, formulated as 0.5 ml soft-gel capsules, for a daily dose of two capsules) The aim of this observational study was to explore the extract’s effectiveness on the treatment of upper respiratory tract infections, after its market release, through a questionnaire-based inquiry of participants. Secondary objectives included the investigation of the extract’s effectiveness on the presence of fever and in cases of supplementary medication intake

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