Evidence map›Paper›PMID 33841955›Full record

ArticleJournal of thoracic disease2021

Effect of OM-85 BV on reducing bronchiectasis exacerbation in Chinese patients: the iPROBE study.

Jinming Gao, Lun Li, Nan Jiang, Ying Liao, Lingfei Kong, Yuanlin Song, Jinfu Xu, Jie Cao, Yuping Li, Chengli Que and 1 more

Open access · diamondAbstract read
In one paragraph

Article in Journal of thoracic disease, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
1.4field-weighted citation impact, top 20% 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

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 5 citations in OpenAlex.

  1. A systematic literature review of the clinical and socioeconomic burden of bronchiectasis.European respiratory review : an official journal of the European Respiratory Society · 2024
    Pooled it
  2. Article
  3. 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

11 authors at 8 institutions in 2 countries.

Jinming GaoDepartment of Pulmonary and Critical Care Medicine, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences, Beijing, China.
Lun LiDepartment of Pulmonary and Critical Care Medicine, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences, Beijing, China.
Nan JiangDepartment of Medicine, Peking Union Medical College & Chinese Academy of Medical Sciences, Beijing, China.
Ying LiaoDepartment of Medicine, Peking Union Medical College & Chinese Academy of Medical Sciences, Beijing, China.
Lingfei KongDepartment of Pulmonary and Critical Care Medicine, First Affiliated Hospital of China Medical University, Shenyang, China.
Yuanlin SongDepartment of Pulmonary and Critical Care Medicine, Zhongshan Hospital, Fudan University, Shanghai, China.
Jinfu XuDepartment of Pulmonary and Critical Care Medicine, Shanghai Pulmonary Hospital, Tongji University, Shanghai, China.
Jie CaoDepartment of Pulmonary and Critical Care Medicine, Tianjin Medical University General Hospital, Tianjin, China.
Yuping LiDepartment of Pulmonary and Critical Care Medicine, First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China.
Chengli QueDepartment of Pulmonary and Critical Care Medicine, First Hospital of Peking University, Beijing, China.
Roy A PleasantsDivision of Pulmonary Medicine and Critical Care, Chapel Hill, NC, USA.
Chinese Academy of Medical Sciences & Peking Union Medical College · CNChina Medical University · CNFirst Affiliated Hospital of Wenzhou Medical University · CNPeking University · CNPulmonary and Critical Care Associates · USTianjin Medical University General Hospital · CNTongji University · CNZhongshan Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBronchiectasis is characterized by recurrent infectious exacerbations. No existing data inform preventive strategy for exacerbations beyond chronic macrolides. OM-85 BV, an immunostimulant, has been shown to prevent recurrent respiratory infections. We initiated this 1-year, multi-centered, double-blind, and controlled trial to investigate the PReventive effect of OM-85 BV on Bronchiectasis Exacerbations in Chinese patients (iPROBE).

methodsPatients with bronchiectasis aged 18 to 75 years, having at least one exacerbation in the past year, were randomized to receive, in addition to any respiratory medications, two courses of 7 mg of OM-85 BV or matching placebo (one capsule orally per day for 10 days a month) for 3 consecutive months, followed by 3 months without treatment. The primary outcomes included the number of acute infectious exacerbations and the time to first exacerbation. Secondary endpoints included patient-reported respiratory outcomes. Safety measures were also assessed.

resultsAmong the 196 participants, 99 were in the OM-85 BV group and 97 in the placebo group. At week 52, the mean number of acute exacerbations per patient was equal to 0.98 and 0.75, respectively, in the two groups (P=0.14). Difference in the time to first pulmonary exacerbation was not statistically significant (P=0.11). There was no statistically significant difference in any secondary end-points. The safety profile in the two arms was good and the majority of adverse events were mild.

conclusionsOM-85 BV did not demonstrate protection in decreasing pulmonary exacerbations of bronchiectasis in this trial performed in Chinese patients. It had good safety profile.

Indexed as

bronchiectasisimmunostimulationinfectionOM-85 BVpulmonary exacerbation

Identifiers

PMID33841955
PMCPMC8024857
OpenAlexW3135501072

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.