Evidence map›Paper›PMID 25496178›Full record

Trial reportActa oto-laryngologica2015

Herbal drug BNO 1016 is safe and effective in the treatment of acute viral rhinosinusitis.

Rainer Jund, Martin Mondigler, Holger Stammer, Pontus Stierna, Claus Bachert

Abstract readClinical Trial, Phase IIClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in Acta oto-laryngologica, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Guideline
  3. Review
  4. Review
  5. Review
  6. Review
  7. Article
  8. Review
  9. Article
  10. Review
  11. Review
  12. A Herbal Formula in the Therapy of Acute Postviral Rhinosinusitis.Turkish archives of otorhinolaryngology · 2021
    Article
  13. Article
  14. Review
  15. Observational
  16. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Rainer Jund1Department of Oto-Rhino-Laryngology, Ghent University Hospital , Ghent , Belgium.
Martin Mondigler
Holger Stammer
Pontus Stierna
Claus Bachert

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

conclusionDaily intake of 480 mg of BNO 1016 for 15 days is an effective treatment in acute viral rhinosinusitis.

objectivesThe pooled efficacy data of two similar randomized placebo-controlled clinical trials were analyzed. Safety was evaluated on the basis of the individual trials.

methodsThe efficacy analysis was based on 589 patients. Treatment was performed orally with either 3 × 160 mg BNO 1016 (n = 294) or 3 × placebo (n = 295) for 15 days. In both trials patients underwent five visits to the investigational sites. Symptoms were evaluated according to the EPOS 2012 guideline. Ultrasonography was used to confirm the diagnosis at onset of treatment and the remission of symptoms at the last visit. Efficacy was evaluated by the investigator as the mean major symptom score (MSS) at the end of treatment (visit 5, day 14). Patients reported symptoms and social/emotional consequences of rhinosinusitis using a quality of life questionnaire (SNOT-20 GAV).

resultsMSS improved during the treatment period by a mean of 10.02 ± 1.61 score points to 2.47 ± 2.55 for BNO 1016 and of 9.87 ± 1.52 to 3.63 ± 3.63 for placebo. Differences between treatment groups at end of therapy (1.16 ± 3.14 score points; p < 0.0001) and patient-assessed quality of life (p = 0.0015) were statistically significant in favor of BNO 1016.

Indexed as

PhytotherapyAcute DiseaseAdolescentAdultAgedDouble-Blind MethodFemaleHumansMaleMiddle AgedPlant ExtractsProspective StudiesQuality of LifeRhinitisSinusitisSurveys and QuestionnairesBNO 1016Plant ExtractsDry extractEPOS 2012major symptom scoreMSSSino-Nasal Outcome Test (SNOT-20)ultrasonography

Identifiers

PMID25496178
PMCPMC4487568

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.