Evidence map›Paper›PMID 21802026›Full record

Trial reportAnnals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology2011

A randomized, double-blind, parallel trial comparing capsaicin nasal spray with placebo in subjects with a significant component of nonallergic rhinitis.

Jonathan A Bernstein, Benjamin P Davis, Jillian K Picard, Jennifer P Cooper, Shu Zheng, Linda S Levin

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
2.2field-weighted citation impact, top 14% of its field
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

13 citing papers in PubMed, 1 synthesis or guideline pooled it, 72 citations in OpenAlex.

  1. Capsaicin for non-allergic rhinitis.The Cochrane database of systematic reviews · 2015
    Pooled it
  2. Review
  3. Article
  4. Article
  5. Article
  6. Review
  7. Article
  8. Capsaicin for Rhinitis.Current allergy and asthma reports · 2016
    Review
  9. Review
  10. Article
  11. Neural Abnormalities in Nonallergic Rhinitis.Current allergy and asthma reports · 2015
    Review
  12. Nonallergic rhinitis.Current allergy and asthma reports · 2014
    Review
  13. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors at 2 institutions in 1 country.

Jonathan A BernsteinDepartment of Internal Medicine, Division of Immunology/Allergy Section, University of Cincinnati College of Medicine, Cincinnati, Ohio 45267-0563, USA. jonathan.bernstein@uc.edu
Benjamin P Davis
Jillian K Picard
Jennifer P Cooper
Shu Zheng
Linda S Levin
University of Cincinnati Medical Center · USMedical Diagnostic Laboratories (United States) · US

Funding

Immunology/Allergy Fellowship Training GrantT32AI060515 · NIAID · UNIVERSITY OF CINCINNATI · PI BERNSTEIN, DAVID I., ROTHENBERG, MARC E. · 2004 to 2018
$2.8M
NIAID NIH HHS T32 AI060515
6 · The paper itself

Abstract

objectiveTo investigate the efficacy and safety of ICX72 or Sinus Buster, a proprietary homeopathic preparation of Capsicum annum and Eucalyptol, versus placebo administered continuously over 2 weeks in subjects with a significant component of nonallergic rhinitis (NAR).

methodsForty-two consented subjects meeting inclusion/exclusion criteria were randomized to ICX72 (n = 20) or control (n = 22) administered twice daily over 2 weeks. The primary endpoint was change in total nasal symptom scores (TNSS) from baseline to end of study. Secondary endpoints included changes in individual symptom scores (ISS) over 2 weeks and average time to first relief. Mean TNSS and ISS were recorded after single dosing at different intervals over 60 minutes. Rhinitis quality-of-life, rescue medication, and safety endpoints were analyzed.

resultsICX72 versus placebo subjects exhibited significant differences in changes from baseline to end of study for TNSS and each ISS (P < .01), had an average time to first relief of 52.6 seconds (P < .01), and improvement in nasal congestion, sinus pain, sinus pressure, and headache at 5, 10, 15, and 30 minutes, persisting at 60 minutes for nasal congestion and sinus pain (P < .05). No difference between groups in adverse events or rescue medication was observed. ICX72 versus placebo subjects experienced no rebound congestion or impaired olfaction at the end of the study.

conclusionThis is the first controlled trial demonstrating intranasal capsaicin, when used continuously over 2 weeks, rapidly and safely improves symptoms in rhinitis subjects with a significant NAR component.

Indexed as

Surveys and QuestionnairesAdolescentAdultCapsaicinDouble-Blind MethodFemaleHeadacheHumansMaleMiddle AgedNasal ObstructionNasal SpraysPlacebosQuality of LifeRhinitisCapsaicinNasal SpraysPlacebos

Identifiers

PMID21802026
PMCPMC8209653
OpenAlexW2112708526

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.