The Effectiveness of the Bacteria Derived Extremolyte Ectoine for the Treatment of Allergic Rhinitis
Table 3
Studies comparing ectoine nasal spray against other therapy or placebo. AR: allergic rhinitis; AUC: area under the curve; EEC: environmental exposure chamber; EED: ectoine eye drops; ENS: ectoine nasal spray; GC: glucocorticoid; INS: intranasal steroids; LSMD: least square mean difference; QoL: quality of life; RQLQ: rhinitis quality of life questionnaire; TNNSS: total nonnasal symptom score; TNSS: total nasal symptom score; TOSS: total nasal symptom score.
Patients in group 1 had a mean 1.54-fold lower TNSS during posttreatment EEC exposures than placebo patients, though the TNSS decreased not only in group 1 but also in group 2 when compared to baseline. The mean AUC TNSS score was at the EEC screening visit, which was significantly reduced to (-19.7%; ) in group 1 at the posttreatment EEC visits. In group 2, the drop was by 12.2% to . Intergroup comparison showed that the mean change from baseline AUC of TNSS for group 1 was 61.2% greater compared to group 2 (LSMD: -4.92 vs. -3.05). This difference showed clinically meaningful improvement in group 1 in comparison to group 2 but did only approach statistical significance (). Treatment in group 1 resulted in significantly greater relief of the symptom “sneezing” ().
In both treatment groups, the TOSS and TNNSS after EEC exposure in comparison to baseline was reduced, but in group 1, we have seen an improvement in ARC symptoms: the mean change from baseline AUC of TNNSS was also significantly lower in group 1 compared to group 2. Mean cross-sectional areas of the nasal cavity were reduced to a lesser extent in group 1.
According to the patients’ assessment, TNSS values decreased clearly in group 1 (, decrease by -12.86%) and a significant decrease was observed in group 2 (, decrease by 39.69%). In order to study the time of onset of both treatments, TNSS development within the first 12 hours of treatment was analyzed. Both groups showed a significant decrease of TNSS from the first site visit until the first patient assessment at the end of the first day of treatment ( for both groups).
After 14 days of treatment, in the investigator’s assessment, both groups showed a significant reduction in TNSS levels. Single symptom score and ear/palate itching analysis and QoL questionnaire revealed only significant changes for group 2 for sneezing and brushing the nose. In group 1, mean values of (mean values of entire study period) reflected moderate efficacy assessed by patients and a value of showed similar judgment by the physicians. In group 2, the efficacy was judged as good by patients () and as very good by investigators ().
The sum of nasal symptom scores showed a significant decrease from visit 1 to visit 2 (as assessed by physicians): sum scores in group 1 decreased from to () and sum scores in group 2 decreased from to (). According to the patients’ assessment, values decreased by 23.05% in group 1 () and by 33.14% in group 2 (). All single symptoms (nasal obstruction, rhinorrhea, sneezing, nasal itching) decreased significantly in both groups.
As for nasal symptoms, a clear decrease of the symptom palate itching was observed from visit 1 to visit 2: for group 1 and for group 2. Values of the patients’ documentation did only reach statistical significance in group 2 (). The TOSS decreased significantly from visit 1 to visit 2 in both groups ( for group 1, for group 2).
According to the physician’s assessment, TNSS scores decreased significantly for both groups both from visit 1 to visit 2 () and from visit 1 to visit 3 (). Scores assessed by patients showed that decreases in TNSS from day 1 to day 7 were not significant, whereas significant decreases in TNSS scores from day 1 to day 14 were shown for group 1 () as well as group 2 (). Single symptom scores also decreased significantly in both groups.
The development of the sum of TOSS was assessed by the investigator. It could be confirmed that ocular symptoms decreased significantly from visit 1 to visit 2 ( for group 1; for group 2) as well as from visit 1 to visit 3 ( for group 1; for group 2).
At the end of the treatment course, overall improvement was achieved for both groups but was more prominent in group 1 (improvement of the TNSS by 4.6 vs. 4.2; ).
Applying the RQLQ, 81.5% of patients in group 1 scored the treatment results as “good,” 15.8% scored the treatment results as “fair,” and only 2.7% continued to use topical antihistamine products due to polyvalent sensitization and the persistent course of allergic rhinitis. In group 2, a “good” score was achieved for 58% of patients, “fair” score was achieved for 25%, and 17% of pediatric patients had to continue intranasal therapy due to persistent symptoms.
