PMID- 37431675
OWN - NLM
STAT- MEDLINE
DCOM- 20230823
LR  - 20230823
IS  - 1941-9260 (Electronic)
IS  - 0032-5481 (Linking)
VI  - 135
IP  - 6
DP  - 2023 Aug
TI  - Efficacy and effectiveness of the herbal medicinal product BNO 1016 in the 
      management of acute rhinosinusitis in the context of antibiotic stewardship.
PG  - 607-614
LID - 10.1080/00325481.2023.2234274 [doi]
AB  - OBJECTIVES: To substantiate the clinical efficacy and investigate the real-world 
      effectiveness of the herbal medicinal product BNO 1016 in acute rhinosinusitis 
      (ARS) in the context of antibiotic stewardship. METHODS: We performed a 
      meta-analysis of the clinical trials ARhiSi-1 (EudraCT No. 2008-002794-13) and 
      ARhiSi-2 (EudraCT No. 2009-016682-28) comprising 676 patients, analyzing the 
      reduction of the Major Symptom Score (MSS) and improvement of the Sino-Nasal 
      Outcome Test 20 (SNOT-20) by the herbal medicinal product BNO 1016. In addition, 
      we performed a retrospective cohort study including 203,382 patients, comparing 
      the real-life effectiveness of BNO 1016 in reducing ARS-related adverse outcomes 
      in comparison to antibiotics and several other established therapies. RESULTS: 
      Treatment with BNO 1016 ameliorated symptoms of ARS by reducing MSS by 1.9 points 
      (p < 0.0001) and improved quality of life (QoL) for patients by improving SNOT-20 
      by 3.5 points (p = 0.001) in comparison to placebo. In patients with 
      moderate/severe symptoms, the positive effects of BNO 1016 were even more 
      pronounced (MSS: -2.3 points (p < 0.0001); SNOT-20: -4.9 points (p = 0.0158)). In 
      addition, treatment with BNO 1016 was as effective or significantly more 
      effective in reducing the risk for adverse ARS-related outcomes such as follow-up 
      antibiotic prescriptions, sick leave >/=7 days or medical appointments due to ARS, 
      especially when compared to antibiotics. CONCLUSION: BNO 1016 is a safe and 
      effective treatment for ARS that can help reduce the overuse of antibiotics.
FAU - Bittner, Claudia B
AU  - Bittner CB
AUID- ORCID: 0000-0002-7641-0351
AD  - Research & Development, Bionorica SE, Neumarkt i. d. OPf, Germany.
FAU - Steindl, Hubert
AU  - Steindl H
AUID- ORCID: 0000-0002-7195-5061
AD  - Research & Development, Bionorica SE, Neumarkt i. d. OPf, Germany.
FAU - Abramov-Sommariva, Dimitri
AU  - Abramov-Sommariva D
AUID- ORCID: 0000-0002-8293-9403
AD  - Research & Development, Bionorica SE, Neumarkt i. d. OPf, Germany.
FAU - Plach, Michael
AU  - Plach M
AUID- ORCID: 0000-0003-4507-1227
AD  - Research & Development, Bionorica SE, Neumarkt i. d. OPf, Germany.
FAU - Abels, Christoph
AU  - Abels C
AUID- ORCID: 0000-0002-7778-7740
AD  - Research & Development, Bionorica SE, Neumarkt i. d. OPf, Germany.
FAU - Bachert, Claus
AU  - Bachert C
AUID- ORCID: 0000-0003-4742-1665
AD  - Department of Otorhinolaryngology, Head and Neck Surgery, University of Muenster, 
      Muenster, Germany.
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
DEP - 20230725
PL  - England
TA  - Postgrad Med
JT  - Postgraduate medicine
JID - 0401147
RN  - 0 (BNO 1016)
RN  - 0 (Anti-Bacterial Agents)
SB  - IM
MH  - Humans
MH  - Quality of Life
MH  - *Antimicrobial Stewardship
MH  - Retrospective Studies
MH  - *Rhinitis/drug therapy
MH  - *Plants, Medicinal
MH  - *Sinusitis/drug therapy
MH  - Anti-Bacterial Agents/therapeutic use
MH  - Acute Disease
MH  - Chronic Disease
OTO - NOTNLM
OT  - BNO 1016
OT  - antibiotics
OT  - herbal medicine
OT  - phytotherapy
OT  - sinusitis
EDAT- 2023/07/11 06:42
MHDA- 2023/08/23 06:42
CRDT- 2023/07/11 05:27
PHST- 2023/08/23 06:42 [medline]
PHST- 2023/07/11 06:42 [pubmed]
PHST- 2023/07/11 05:27 [entrez]
AID - 10.1080/00325481.2023.2234274 [doi]
PST - ppublish
SO  - Postgrad Med. 2023 Aug;135(6):607-614. doi: 10.1080/00325481.2023.2234274. Epub 
      2023 Jul 25.