title: Reporting effectiveness of an extract of three traditional Cretan herbs on upper respiratory tract infection: results from a double-blind randomized controlled trial.
abstract: BACKGROUND
  Observations from the island of Crete, Greece suggest that infusions of traditional Cretan aromatic plants, well known for their ethnopharmacological use in Eastern Mediterranean region and Near East, could be effective in the prevention and treatment of upper respiratory tract infections, including viral-induced infections. The aim of this study was to report the effectiveness of an essential-oil extract of three Cretan aromatic plants in the treatment of cases with an upper respiratory tract infection.
  
  
  METHODS
  A double blind randomized controlled trial was implemented between October 2013 and February 2014. An essential-oil extract of Cretan aromatic plants in olive oil (total volume of 15ml of essential oil per litre of olive oil) was administered as 0.5ml soft gel capsules, twice a day, for 7 days. Placebo treatment was 0.5ml olive oil in soft gel capsules. Eligible patients were those presenting for clinical examination in the selected setting with signs and symptoms of upper respiratory tract infection that had begun within the previous 24 hours. Real-Time Polymerase Chain Reaction (PCR) was used for the detection of respiratory viruses. The primary outcome was the severity and duration of symptoms of upper respiratory tract infection, assessed using the Wisconsin Upper Respiratory System Survey (WURSS-21) questionnaire. A secondary outcome of interest was the change in C-reactive protein (CRP) status.
  
  
  RESULTS
  One hundred and five patients completed the study: 51 in the placebo group, and 54 in the intervention (treated) group. Baseline characteristics were similar in the two groups. No statistically significant differences were found in symptom duration or severity between the two groups, although small and clinically favorable effects were observed. When the analysis was restricted to subjects with a laboratory-documented viral infection, the percentage of patients with cessation of symptoms after 6 days of treatment was 91% in the intervention group and 70% in the control group (p=0.089). At baseline, one third of the patients in each group had elevated CRP levels. At follow-up, the respective proportions were 0% in the intervention group and 15% in the placebo group (p=0.121). The data were also in a favorable direction when 50% and 80% symptom reduction points were considered for specific virus types.
  
  
  CONCLUSIONS
  Compared with placebo the essential-oil extract of three Cretan aromatic plants provided no detectable statistically significant benefit or harm in the patients with upper respiratory illness, although descriptive differences were identified in favorable direction mainly in the virus-positive population.
authors: Clinic of Social and Family Medicine, School of Medicine, University of Crete, PO Box 2208, Heraklion 71003, Greece. Electronic address: gduyker@hotmail.com.
authors: G
authors: G
authors: Duijker
authors: Clinic of Social and Family Medicine, School of Medicine, University of Crete, PO Box 2208, Heraklion 71003, Greece. Electronic address: abertsias@med.uoc.gr.
authors: A
authors: A
authors: Bertsias
authors: Clinic of Social and Family Medicine, School of Medicine, University of Crete, PO Box 2208, Heraklion 71003, Greece. Electronic address: symvouman@yahoo.com.
authors: E K
authors: EK
authors: Symvoulakis
authors: Department of Social Medicine, School of Medicine, University of Crete, Heraklion, Greece. Electronic address: j.moschandreas@med.uoc.gr.
authors: J
authors: J
authors: Moschandreas
authors: Department of Clinical Chemistry-Biochemistry, School of Medicine, University of Crete, and University Hospital, Heraklion, Greece. Electronic address: nikimall@me.com.
authors: N
authors: N
authors: Malliaraki
authors: Laboratory of Clinical Virology, School of Medicine, University of Crete, Heraklion, Greece. Electronic address: derdas@med.uoc.gr.
authors: S P
authors: SP
authors: Derdas
authors: Department of Chemistry, School of Sciences and Technology, University of Crete, Heraklion, Greece. Electronic address: gtsikalas@chemistry.uoc.gr.
authors: G K
authors: GK
authors: Tsikalas
authors: Department of Chemistry, School of Sciences and Technology, University of Crete, Heraklion, Greece. Electronic address: kater@chemistry.uoc.gr.
authors: H E
authors: HE
authors: Katerinopoulos
authors: Department of Biology, School of Sciences and Technology, University of Crete, Heraklion, Greece; Botanical Garden, University of Crete, Rethymnon, Greece. Electronic address: pirintsos@biology.uoc.gr.
authors: S A
authors: SA
authors: Pirintsos
authors: Laboratory of Clinical Virology, School of Medicine, University of Crete, Heraklion, Greece. Electronic address: sourvino@med.uoc.gr.
authors: G
authors: G
authors: Sourvinos
authors: Laboratory of Experimental Endocrinology, School of Medicine, University of Crete, Heraklion, Greece. Electronic address: castanas@med.uoc.gr.
authors: E
authors: E
authors: Castanas
authors: Clinic of Social and Family Medicine, School of Medicine, University of Crete, PO Box 2208, Heraklion 71003, Greece. Electronic address: lionis@galinos.med.uoc.gr.
authors: C
authors: C
authors: Lionis
mesh_terms: D000328:Adult; D002097:C-Reactive Protein / Q000032:analysis; D004279:DNA, Viral / Q000032:analysis; D004311:Double-Blind Method; D005260:Female; D006115:Greece; D006801:Humans; D019686:Lamiaceae; D008297:Male; D008875:Middle Aged; D009822:Oils, Volatile / Q000627:therapeutic use*; D008517:Phytotherapy; D010936:Plant Extracts / Q000627:therapeutic use*; D012367:RNA, Viral / Q000032:analysis; D012141:Respiratory Tract Infections / Q000097:blood / Q000188:drug therapy* / Q000821:virology; D016896:Treatment Outcome; D014777:Virus Diseases / Q000097:blood / Q000188:drug therapy* / Q000821:virology
chemical_list: D004279:DNA, Viral; D009822:Oils, Volatile; D010936:Plant Extracts; D012367:RNA, Viral; D002097:C-Reactive Protein
keywords: 2.100: antiviral; 2.172: Clinical trials; 2.641: Traditional medicine Europe; Mediterranean; Near East
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