Meta-Analysis of the Efficacy of Ectoine Nasal Spray in Patients with Allergic Rhinoconjunctivitis
Table 1
Description of included studies.
Study ID
Indication of study
Comparator
Study design
(Ectoine and control)
Inclusion criteria/exclusion criteria
Duration and dosage
Outcome Parameter
Rating scales
Ectoine versus azelastine, 2010
Allergic rhinitis and conjunctivitis
Azelastine nasal spray and azelastine eye drops
Observational
Ectoine: 21 Control: 21
AR proven by a diagnostic tool or by an allergist Moderate-to-strong nasal symptoms and at least mild eye symptoms at inclusion Signed informed consent Exclusion: allergy to ectoine or azelastine, pregnancy, operation of nose
1 week, ectoine: 4 times daily Azelastine: 2 times daily
Primary: Nasal congestion, rhinorrhoea, sneezing, nasal itching, itching of eyes, itching of palate, teary eyes, conjunctivitis. Secondary: Efficacy, safety.
8-point scale
Ectoine versus cromoglicic acid 2009
Allergic rhinitis
Cromoglicic nasal spray
Observational, cross-over trial
Ectoine: 25 Control: 25
Inclusion: AR proven by skin prick test or by an allergist Moderate-to-strong nasal symptoms at inclusion Signed informed consent Exclusion: allergy to ectoine or cromoglicic acid, pregnancy, operation of nose
1 week, ectoine: 5 times daily Cromoglicic acid: 4 times daily
Primary: Nasal congestion, rhinorrhoea, sneezing. Secondary: Itching of eyes, itching of palate, teary eyes, conjunctivitis, nasal concha hyperplasia, efficacy, safety.
8-point scale
Ectoine versus Livocab, 2011
Seasonal allergic rhinitis
Levocabastine with beclomethasone 0.05% (nasal spray)
Observational
Ectoine: 25 Control: 25
Inclusion: 18–70 years Signed informed consent
2 weeks, intake of medication according to prescribing information
Primary: Total Nasal Symptom Score as sum of nasal congestion, rhinorrhoea, sneezing and nasal itching. Secondary: Itching of palate and ears, efficacy, safety.
4-point scale
Paediatric trial Ectoine versus placebo, 2011
Seasonal allergic rhinitis
Placebo nasal spray and eye drops
RCT
Ectoine: 41 Control: 30
Inclusion: 5–17 years Seasonal AR, general good health status, free of any concomitant conditions that could interfere with conduct of study, sum of TNSS >5, sum of TOSS >3 Signed informed consent (also by parents)
2 weeks Nasal spray: 1 puff per nostril 3 times daily Eye drops: 3 times daily
Primary: Safety Secondary: Efficacy assessment, Total Nasal Symptom Score as sum of runny nose, itchy nose, nasal congestion, sneezing; Total Ocular Symptom Score as sum of itchy eyes, red eyes, watery eyes.
