The effect of atorvastatin on inflammatory markers in sulfur mustard gas induced bronchitis: a randomized double-blinded, placebo-control clinical trial

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Abstract

Background

This study was performed to evaluate the anti-inflammatory effect of atorvastatin in patients with chronic bronchitis, exposed to sulfur mustard gas.

Methods

In this randomized double-blinded clinical trial we recruited patients with chronic bronchitis after exposure to sulfur mustard gas. Ninety men 45–75 years old diagnosed with chronic bronchitis after exposure to mustard gas during the Iran-Iraq war, were randomly assigned to receive either atorvastatin (40 mg) or placebo once a day for 3 months. The interleukin 6 (IL-6), tumor necrosis factor α (TNF-α), procalcitonin, highly sensitive CRP and COPD assessment test (CAT) score was compared at baseline and after 12 weeks.

Results

After consuming atorvastatin for 12 weeks, IL-6 level (mean difference [95%CI]; 0.2 [− 0.05, 0.5]), TNF-α (mean difference [95%CI]; − 0.07 [− 0.2, 0.07]), high sensitive CRP (mean difference [95%CI] − 0.1 [− 1.2, 0.9]), and procalcitonin (mean difference [95%CI]; 0.003 [− 0.02, 0.03]) did not change significantly. However, in the placebo group, only IL-6 (mean difference [95%CI]; 0.6 [0.2, 1.05]) decreased significantly after 12 weeks, but levels of high sensitive CRP (mean difference [95%CI]; − 0.3 [− 1.4, 0.8]) TNF-α (mean difference [95%CI]; − 0.2 [− 0.34, − 0.06]) and procalcitonin (mean difference [95%CI]; 0.02 [− 0.001, 0.04]) did not change significantly. After 12 weeks, the mean differences in TNF- α, IL-6 level, high sensitive CRP, procalcitonin, and CAT score did not significantly differ between the two groups.

Conclusions

The administration of 40 mg atorvastatin for 3 months did not significantly change the inflammatory markers or the quality of life of patients exposed to mustard gas with chronic bronchitis.

Trial registration: IRCT, IRCT138904144312N1. Registered 16 August 2014, https://en.irct.ir/trial/4577.

Supplementary Information

The online version contains supplementary material available at 10.1186/s12890-021-01481-y.

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Most cited references 32

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Development and first validation of the COPD Assessment Test.

P W Jones, G. Harding, P. Berry … (2009)

There is need for a validated short, simple instrument to quantify chronic obstructive pulmonary disease (COPD) impact in routine practice to aid health status assessment and communication between patient and physician. Current health-related quality of life questionnaires provide valid assessment of COPD, but are complex, which limits routine use. The aim of the present study was to develop a short validated patient-completed questionnaire, the COPD Assessment Test (CAT), assessing the impact of COPD on health status. 21 candidate items identified through qualitative research with COPD patients were used in three prospective international studies (Europe and the USA, n = 1,503). Psychometric and Rasch analyses identified eight items fitting a unidimensional model to form the CAT. Items were tested for differential functioning between countries. Internal consistency was excellent: Cronbach's alpha = 0.88. Test re-test in stable patients (n = 53) was very good (intra-class correlation coefficient 0.8). In the sample from the USA, the correlation with the COPD-specific version of the St George's Respiratory Questionnaire was r = 0.80. The difference between stable (n = 229) and exacerbation patients (n = 67) was five units of the 40-point scale (12%; p<0.0001). The CAT is a short, simple questionnaire for assessing and monitoring COPD. It has good measurement properties, is sensitive to differences in state and should provide a valid, reliable and standardised measure of COPD health status with worldwide relevance.

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Minimum clinically important difference for the COPD Assessment Test: a prospective analysis.

B Haselden, S. Kon, J. C. Dickson … (2014)

The COPD Assessment Test (CAT) is responsive to change in patients with chronic obstructive pulmonary disease (COPD). However, the minimum clinically important difference (MCID) has not been established. We aimed to identify the MCID for the CAT using anchor-based and distribution-based methods. We did three studies at two centres in London (UK) between April 1, 2010, and Dec 31, 2012. Study 1 assessed CAT score before and after 8 weeks of outpatient pulmonary rehabilitation in patients with COPD who were able to walk 5 m, and had no contraindication to exercise. Study 2 assessed change in CAT score at discharge and after 3 months in patients admitted to hospital for more than 24 h for acute exacerbation of COPD. Study 3 assessed change in CAT score at baseline and at 12 months in stable outpatients with COPD. We focused on identifying the minimum clinically important improvement in CAT score. The St George's Respiratory Questionnaire (SGRQ) and Chronic Respiratory Questionnaire (CRQ) were measured concurrently as anchors. We used receiver operating characteristic curves, linear regression, and distribution-based methods (half SD, SE of measurement) to estimate the MCID for the CAT; we included only patients with paired CAT scores in the analysis. In Study 1, 565 of 675 (84%) patients had paired CAT scores. The mean change in CAT score with pulmonary rehabilitation was -2·5 (95% CI -3·0 to -1·9), which correlated significantly with change in SGRQ score (r=0·32; p<0·0001) and CRQ score (r=-0·46; p<0·0001). In Study 2, of 200 patients recruited, 147 (74%) had paired CAT scores. Mean change in CAT score from hospital discharge to 3 months after discharge was -3·0 (95% CI -4·4 to -1·6), which correlated with change in SGRQ score (r=0·47; p<0·0001). In Study 3, of 200 patients recruited, 164 (82%) had paired CAT scores. Although no significant change in CAT score was identified after 12 months (mean 0·6, 95% CI -0·4 to 1·5), change in CAT score correlated significantly with change in SGRQ score (r=0·36; p<0·0001). Linear regression estimated the minimum clinically important improvement for the CAT to range between -1·2 and -2·8 with receiver operating characteristic curves consistently identifying -2 as the MCID. Distribution-based estimates for the MCID ranged from -3·3 to -3·8. The most reliable estimate of the minimum important difference of the CAT is 2 points. This estimate could be useful in the clinical interpretation of CAT data, particularly in response to intervention studies. Medical Research Council and UK National Institute of Health Research. Copyright © 2014 Elsevier Ltd. All rights reserved.

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Author and article information

Contributors

Seyed Masoom Masoompour:

ORCID: http://orcid.org/0000-0002-0129-7155

masoomm@sums.ac.ir

Journal

Journal ID (nlm-ta): BMC Pulm Med

Journal ID (iso-abbrev): BMC Pulm Med

Title: BMC Pulmonary Medicine

Publisher: BioMed Central (London )

ISSN (Electronic): 1471-2466

Publication date (Electronic): 1 April 2021

Publication date PMC-release: 1 April 2021

Publication date Collection: 2021

Volume: 21

Electronic Location Identifier: 112

Affiliations

[1 ]GRID grid.412571.4, ISNI 0000 0000 8819 4698, Department of Internal Medicine, School of Medicine, , Shiraz University of Medical Sciences, ; Shiraz, 7193634154 Iran

[2 ]GRID grid.412571.4, ISNI 0000 0000 8819 4698, Student Research Committee, , Shiraz University of Medical Sciences, ; Shiraz, Iran

[3 ]GRID grid.412571.4, ISNI 0000 0000 8819 4698, Non-Communicable Diseases Research Center, Department of Internal Medicine, School of Medicine, , Shiraz University of Medical Sciences, ; Shiraz, Iran

[4 ]GRID grid.412571.4, ISNI 0000 0000 8819 4698, Transplant Research Center, Department of Pathology, School of Medicine, , Shiraz University of Medical Sciences, ; Shiraz, Iran

[5 ]GRID grid.412571.4, ISNI 0000 0000 8819 4698, Department of Emergency Medicine, School of Medicine, , Shiraz University of Medical Sciences, ; Shiraz, Iran

Author information

Seyed Masoom Masoompour http://orcid.org/0000-0002-0129-7155

Article

Publisher ID: 1481

DOI: 10.1186/s12890-021-01481-y

PMC ID: 8017857

SO-VID: ef1e1341-7dfe-4978-9649-b8209c91453a

License:

Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

History

Date received : 4 June 2020

Date accepted : 25 March 2021

Funding

Funded by: FundRef http://dx.doi.org/10.13039/501100013041, Vice-Chancellor for Research, Shiraz University of Medical Sciences;

Award ID: 7108

Award Recipient : Seyed Masoom Masoompour

Custom metadata

ScienceOpen disciplines: Respiratory medicine

Keywords: chronic bronchitis,statins,atorvastatin,sulfur mustard gas

Data availability:

ScienceOpen disciplines: Respiratory medicine

Keywords: chronic bronchitis, statins, atorvastatin, sulfur mustard gas

The effect of atorvastatin on inflammatory markers in sulfur mustard gas induced bronchitis: a randomized double-blinded, placebo-control clinical trial

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Conclusions

Supplementary Information

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Biomarkers for Inflammatory Lung Disease

Most cited references 32

G*Power 3: A flexible statistical power analysis program for the social, behavioral, and biomedical sciences

Development and first validation of the COPD Assessment Test.

Minimum clinically important difference for the COPD Assessment Test: a prospective analysis.

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