PATIENTS AND METHODS: In this study which was carried out in the period between 1st May until 4th October 2006 in 65 study sites as a prospective cohort study in 858 children, adolescents and juveniles in the age between 4 and 18 years who consulted the physician due to an acute sinusitis, acute bronchitis or acute urinary tract infection (UTI). Data of in total 858 patients were recorded. The patients were treated either with the herbal drug preparation Angocin Anti-Infekt N (test group, n = 523, 61%) or with a standard antibiotic (control group, n = 335, 39%) according to the decision of the physician. The duration of treatment as well as the dosage was determined by the physician. 297 patients suffering from acute sinusitis (197 test group 66%, 100 control patients 34%), 290 patients suffering from acute bronchitis (178 test group 61%, 112 control patients 39%) and 271 patients with acute urinary tract infection (148 test group 55%, 123 control patients 45 %) were included. The patients recorded in a diary the utilization of the medication, concomitant procedures and adverse events (AEs). The physician recorded at study start and at the end of the study the compliance in a standardised form. Single symptoms were recorded according to their intensity with a score ranging from 0 = no symptom to 3 = severe symptoms. At the end of the study (disease free or after 7-14 days) the physicians finally judged on the course of the treatment as well on the efficacy as observed. The patients recorded their satisfaction with the treatment. Primary efficacy criterion was the change of the complaints quantified by the change of the relative symptom score average over all symptoms between result at study start and study end related to the baseline value. RESULTS: The two therapy groups differ in their basis data with regard to the mean age (test group 12.2 years, control group 13.5 years; p > 0.001) and the frequency of concomitant diseases (test group 6.3%, control group 2.4%; p = 0.008). At start of treatment the complaints in the test group were significantly less severe (mean of the complaint score 1.67) compared to the control group (mean 2.00; p > 0.001). At the end of treatment there were no significant differences in the mean complaint score between the groups (test group 0.41, control group 0.49; p = 0.722). The mean reduction of the complaint score expressed in percentages was for the indication acute sinusitis in the test group 84.8% and in the control group 85.5%, for the indication acute bronchitis in the test group 82.1% and in the control group 77.7% and for the indication acute urinary tract infection in the test group 89.9% and in the control group 93.1%. In total the mean reduction of the complaint score for the test group was 85.3% and in the test group 85.7% (p = 0.828). The 95% confidence interval for difference of the expected reductions between test group and control group ranged from -3.87% up to 3.10%. With a border of +/- 10% the mean reduction for both groups is equivalent, and more importantly non-inferior for the test group compared with the control group. Adverse events were recorded for 3 patients (0.6%) of the test group and for 14 patients (3.9%) of the control group (p = 0.001). In conclusion it was demonstrated that therapy with the herbal drug preparation in the indications acute sinusitis, acute bronchitis and acute urinary tract infection is--with regard to efficacy--comparable to a treatment with standard antibiotics. The test preparation displayed in all indications a significantly lower potential for adverse events compared to a treatment with standard antibiotics and, therefore, a better safety profile could be concluded.
PATIENTS AND METHODS: In this study which was carried out in the period between 1st May until 4th October 2006 in 65 study sites as a prospective cohort study in 858 children, adolescents and juveniles in the age between 4 and 18 years who consulted the physician due to an acute sinusitis, acute bronchitis or acute urinary tract infection (UTI). Data of in total 858 patients were recorded. The patients were treated either with the herbal drug preparation Angocin Anti-Infekt N (test group, n = 523, 61%) or with a standard antibiotic (control group, n = 335, 39%) according to the decision of the physician. The duration of treatment as well as the dosage was determined by the physician. 297 patients suffering from acute sinusitis (197 test group 66%, 100 control patients 34%), 290 patients suffering from acute bronchitis (178 test group 61%, 112 control patients 39%) and 271 patients with acute urinary tract infection (148 test group 55%, 123 control patients 45 %) were included. The patients recorded in a diary the utilization of the medication, concomitant procedures and adverse events (AEs). The physician recorded at study start and at the end of the study the compliance in a standardised form. Single symptoms were recorded according to their intensity with a score ranging from 0 = no symptom to 3 = severe symptoms. At the end of the study (disease free or after 7-14 days) the physicians finally judged on the course of the treatment as well on the efficacy as observed. The patients recorded their satisfaction with the treatment. Primary efficacy criterion was the change of the complaints quantified by the change of the relative symptom score average over all symptoms between result at study start and study end related to the baseline value. RESULTS: The two therapy groups differ in their basis data with regard to the mean age (test group 12.2 years, control group 13.5 years; p > 0.001) and the frequency of concomitant diseases (test group 6.3%, control group 2.4%; p = 0.008). At start of treatment the complaints in the test group were significantly less severe (mean of the complaint score 1.67) compared to the control group (mean 2.00; p > 0.001). At the end of treatment there were no significant differences in the mean complaint score between the groups (test group 0.41, control group 0.49; p = 0.722). The mean reduction of the complaint score expressed in percentages was for the indication acute sinusitis in the test group 84.8% and in the control group 85.5%, for the indication acute bronchitis in the test group 82.1% and in the control group 77.7% and for the indication acute urinary tract infection in the test group 89.9% and in the control group 93.1%. In total the mean reduction of the complaint score for the test group was 85.3% and in the test group 85.7% (p = 0.828). The 95% confidence interval for difference of the expected reductions between test group and control group ranged from -3.87% up to 3.10%. With a border of +/- 10% the mean reduction for both groups is equivalent, and more importantly non-inferior for the test group compared with the control group. Adverse events were recorded for 3 patients (0.6%) of the test group and for 14 patients (3.9%) of the control group (p = 0.001). In conclusion it was demonstrated that therapy with the herbal drug preparation in the indications acute sinusitis, acute bronchitis and acute urinary tract infection is--with regard to efficacy--comparable to a treatment with standard antibiotics. The test preparation displayed in all indications a significantly lower potential for adverse events compared to a treatment with standard antibiotics and, therefore, a better safety profile could be concluded.