PMID- 16618018
OWN - NLM
STAT- MEDLINE
DCOM- 20060620
LR  - 20220310
IS  - 0004-4172 (Print)
IS  - 0004-4172 (Linking)
VI  - 56
IP  - 3
DP  - 2006
TI  - [Efficacy and safety profile of a herbal drug containing nasturtium herb and 
      horseradish root in acute sinusitis, acute bronchitis and acute urinary tract 
      infection in comparison with other treatments in the daily practice/results of a 
      prospective cohort study].
PG  - 249-57
AB  - PATIENTS AND METHODS: In a prospective cohort study from 251 centers in Germany 
      patients with age of 4 years or above who were treated due to acute sinusitis, 
      bronchitis or urinary tract infections (UTI) in the period from 1st March 2004 - 
      30th July 2005, were elected. They were included in the study analysis, if they 
      had no exclusion criteria (severe diseases, need for antibiotic therapy, 
      participation in another trial) and came to the final investigation. The patients 
      were treated either with the nasturtium herb and horseradish root containing 
      herbal drug Angocin Anti-Infekt N (test group, n = 1223) or with standard 
      antibiotic therapy (control group, n = 426). Treatment, dosage and treatment 
      duration were determined by the physician in accordance with the patient. 536 
      subjects (408 test, 128 control patients) suffered from acute sinusitis, 634 
      subjects (469 test, 165 control patients) from acute bronchitis and 479 subjects 
      (346 test, 133 control patients) from UTI. At study start and end the severity of 
      the symptoms were judged by the investigator and quantified with 4 scores (0 = no 
      symptom, 3 severe symptom). During the treatment information on use of 
      medication, concomitant procedures and adverse events (AEs) in a patient diary. 
      At the end of the study (disease free or after 7-14 days) the patient returned to 
      the investigator, who recorded the vital parameters, finally judged the treatment 
      efficacy and potential persisting symptoms on the basis of score values. Primary 
      efficacy criterion was the change of the complaints quantified by the change of 
      the relative symptom score averaged over all symptoms and related to the baseline 
      value. RESULTS: In patients with acute sinusitis the mean relative reduction of 
      the averaged symptom score was 81.3% for the test group and 84.6% for the control 
      group, in patients with acute bronchitis the mean reduction was 78.3% for the 
      test group and 80.3% for the control group, in patients with UTI 81.2% for the 
      test group and 87.9% for the control group. The 95% confidence interval for the 
      difference of the expected reductions between test and control group was -8.5% to 
      1.8% for acute sinusitis, 7.6% to 3.6% for acute bronchitis and -13.1% to -0.1% 
      for UTI. Non-inferiority of the test treatment, i.e. if the lower limit of the 
      95% confidence interval is greater than 10%, could be stated for acute sinusitis 
      and bronchitis. In UTI the non-inferiority level was exceeded only by 3%. 
      Complementary procedures were less in the test group than in the control group. 
      For 1.5 % of test patients and 6.8% of control patients AEs were observed 
      CONCLUSION: Therapy with the herbal drug in the indications acute sinusitis, 
      acute bronchitis und acute urinary tract infection is - with regard to its 
      efficacy comparable to the treatment with standard antibiotics. The application 
      of supportive procedures and the administration of concurrent medication were 
      less expressed in the group treated with the herbal drug. In the above mentioned 
      indications the group treated with the herbal drug displayed a clear advantageous 
      safety profile compared to the group treated with standard antibiotics.
FAU - Goos, Karl-Heinz
AU  - Goos KH
AD  - Repha GmbH, Biologische Arzneimittel, Langenhagen.
FAU - Albrecht, Uwe
AU  - Albrecht U
FAU - Schneider, Berthold
AU  - Schneider B
LA  - ger
PT  - Comparative Study
PT  - English Abstract
PT  - Journal Article
PT  - Multicenter Study
TT  - Wirksamkeit und Vertraglichkeit eines pflanzlichen Arzneimittels mit 
      Kapuzinerkressenkraut und Meerrettich bei akuter Sinusitis, akuter Bronchitis und 
      akuter Blasenentzundung im Vergleich zu anderen Therapien unter den Bedingungen 
      der taglichen Praxis. Ergebnisse einer prospektiven Kohortenstudie.
PL  - Germany
TA  - Arzneimittelforschung
JT  - Arzneimittel-Forschung
JID - 0372660
RN  - 0 (Anti-Bacterial Agents)
RN  - 0 (Plant Extracts)
RN  - 0 (angocin Anti-Infekt N)
SB  - IM
MH  - Adult
MH  - Anti-Bacterial Agents/therapeutic use
MH  - Armoracia/adverse effects/*chemistry
MH  - Bronchitis/*drug therapy
MH  - Cohort Studies
MH  - Female
MH  - Humans
MH  - Male
MH  - Nasturtium/adverse effects/*chemistry
MH  - *Phytotherapy/adverse effects
MH  - Plant Extracts
MH  - Plant Roots/adverse effects/chemistry
MH  - Prospective Studies
MH  - Sinusitis/*drug therapy
MH  - Treatment Outcome
MH  - Urinary Tract Infections/*drug therapy
EDAT- 2006/04/19 09:00
MHDA- 2006/06/21 09:00
CRDT- 2006/04/19 09:00
PHST- 2006/04/19 09:00 [pubmed]
PHST- 2006/06/21 09:00 [medline]
PHST- 2006/04/19 09:00 [entrez]
AID - 10.1055/s-0031-1296717 [doi]
PST - ppublish
SO  - Arzneimittelforschung. 2006;56(3):249-57. doi: 10.1055/s-0031-1296717.