Evidence map›Paper›PMID 27390702›Full record

ArticleMedical journal of the Islamic Republic of Iran2016

The safety and effectiveness of the current treatment regimen with or without roflumilast in advanced COPD patients: A systematic review and meta-analysis of randomized controlled trials.

Saeideh Jafari Andarian, Alireza Olyaeemanesh, Seyed Alireza Hosseini, Ali Akbari Sari, Shahram Firoozbakhsh, Mojtaba Nouhi Jadesi, Mohammadreza Mobinizadeh

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In one paragraph

Article in Medical journal of the Islamic Republic of Iran, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact, top 90% 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

0 citing papers in PubMed, 2 citations in OpenAlex.

No citing paper in PubMed yet.

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

7 authors at 4 institutions in 1 country.

Saeideh Jafari AndarianMSc Student, HTA, Tehran University of Medical Sciences, Tehran, Iran. ja.saeideh@gmail.com.
Alireza OlyaeemaneshAssistant Professor, National Institute of Health Research, Tehran University of Medical Sciences, Tehran, Iran. arolyaee@yahoo.com.
Seyed Alireza HosseiniPhD, Office for Clinical Trials, Food and Drug Organization, Tehran, Iran. hosseini.reza7@gmail.com.
Ali Akbari SariAssociate Professor, Department of Health Management and Economics, and Knowledge Utilization Research Center, Tehran University of Medical Sciences, Tehran, Iran. akbarisari@tums.ac.ir.
Shahram FiroozbakhshAssociate Professor, Department of Pulmonary Medicine, Tehran University of Medical Sciences, Tehran, Iran. shafirus@yahoo.com.
Mojtaba Nouhi JadesiPhD Student in Health Economics, Department of Health Economics, School of Management and Information Sciences, Iran University of Medical Sciences, Tehran, Iran. mojtabanouhi@gmail.com.
Mohammadreza MobinizadehYoung Researchers and Elites Club, Science and Research Branch, Islamic Azad University, Tehran, Iran. mobinreza@yahoo.com.
Tehran University of Medical Sciences · IRIran University of Medical Sciences · IRIran Nanohealth Committee Food and Drug Organization · IRIslamic Azad University, Science and Research Branch · IR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundChronic obstructive pulmonary disease (COPD) is a chronic respiratory disease, which reduces the lung function and causes respiratory symptoms over time, and it is primarily associated with shortness of breath, cough and sputum production. Roflumilast, which is a long-acting selective inhibitor, reduces the anti-inflammatory effect of the main symptoms of COPD. The aim of this study was to compare the clinical effectiveness of adding roflumilast to the current treatment regimen of patients with severe COPD.

methodsTo retrieve the marker studies, medical databases were searched up to February 2014. We included studies, which compared the clinical effectiveness and safety of roflumilast as concomitant to Long-acting ß2-agonist/Long-acting muscarinic antagonist (LABA/LAMA) regimen, in adult patients with severe COPD. The number of exacerbations, changes in the lung function FEV1, FEV1/FVC and quality of life were the major predefined outcomes. Meta-analysis of outcomes was performed by the RevMan software, with I(2)> 50%, representing considerable heterogeneity.

resultsSeven randomized controlled trials and two systematic reviews were included. In terms of safety, participants were likely to experience more side effects from roflumilast compared to placebo, particularly gastrointestinal effects (diarrhea, nausea, vomiting), headache and weight loss. There was no significant difference in the risk of cardiac complications or flu-like symptoms or upper respiratory tract infection in the two groups. In terms of effectiveness, only a small improvement was observed in SGRQ (St George's Respiratory Questionnaire) index. Roflumilast reduced moderate to severe attacks, and caused significant improvements in the lung function regardless of the severity of the disease and the concurrent use of other standard COPD therapies.

conclusionRoflumilast anti-inflammatory therapy reduces the chronic bronchitis symptoms in patients with moderate to severe COPD, and it can be safely used with other drugs simultaneously.

Indexed as

COPDEffectivenessRoflumilastSafety

Identifiers

PMID27390702
PMCPMC4898851
OpenAlexW2468422607

What OpenQuestion holds

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Registered trials

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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.