Comparison of dexamethasone regimens in tubercular meningitis (TBM): a randomized open label clinical trial

Introduction: Corticosteroids are used as adjunctive treatment in tuberculous meningitis (TBM). However, there is no universally accepted regimen, type, duration, or route of steroid administration. Methodology: In a randomized open labelled pilot study, TBM patients were divided into overlap ora...

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Published in:Journal of Infection in Developing Countries
Main Authors: Alvee Saluja, Deepti Vibha, Awadh Kishor Pandit, Garima Shukla, Achal Kumar Srivastava, Manjari Tripathi, Madakasira Vasantha Padma Srivastava, Kameshwar Prasad, Sada Nand Dwivedi
Format: Article
Language:English
Published: The Journal of Infection in Developing Countries 2023-12-01
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Online Access:https://jidc.org/index.php/journal/article/view/17563
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author Alvee Saluja
Deepti Vibha
Awadh Kishor Pandit
Garima Shukla
Achal Kumar Srivastava
Manjari Tripathi
Madakasira Vasantha Padma Srivastava
Kameshwar Prasad
Sada Nand Dwivedi
author_facet Alvee Saluja
Deepti Vibha
Awadh Kishor Pandit
Garima Shukla
Achal Kumar Srivastava
Manjari Tripathi
Madakasira Vasantha Padma Srivastava
Kameshwar Prasad
Sada Nand Dwivedi
author_sort Alvee Saluja
collection DOAJ
container_title Journal of Infection in Developing Countries
description Introduction: Corticosteroids are used as adjunctive treatment in tuberculous meningitis (TBM). However, there is no universally accepted regimen, type, duration, or route of steroid administration. Methodology: In a randomized open labelled pilot study, TBM patients were divided into overlap oral dexamethasone (OOD) and direct oral dexamethasone (DOD) arms. The total duration of steroid administration was 8 weeks. The primary outcome was symptomatic resolution at 1 month post randomization. The secondary outcomes were mortality and modified Rankin scale (mRS) at 3 and 6 months after initiation of steroids. Results: Symptomatic resolution after one month of randomization in 53 randomized patients was similar in OOD (71.4% (15/21)) versus DOD ((85.0% (17/20)) arm (p value:0.45). Median mRS was also similar in OOD versus DOD (OOD: 2.5 (IQR: 1.0; 6.0) versus DOD: 1.0 (IQR: (0.0; 4.0); p value: 0.31)) arm at 6 months. The mortality at 6 months was 31.8% (7/22) in the OOD versus 20.0% (4/20) in the DOD arm (p value: 0.49). Conclusions: In this open label pilot study, the outcomes were similar in OOD versus DOD arms in terms of symptomatic resolution at 1 month, and morbidity, and mortality at 3 and 6 months. Patients with stage I to III TBM may be given injectable steroids for 1 week after which they may be switched to oral steroid. This regime cannot be applied to stage IV TBM and patients with complications like optico-chiasmatic or spinal arachnoiditis or vasculitic infarcts.
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spelling doaj-art-e1b679f4d6bd45d39a7ac9151df8e9702025-08-20T03:52:42ZengThe Journal of Infection in Developing CountriesJournal of Infection in Developing Countries1972-26802023-12-01171210.3855/jidc.17563Comparison of dexamethasone regimens in tubercular meningitis (TBM): a randomized open label clinical trialAlvee Saluja0Deepti Vibha1Awadh Kishor Pandit2Garima Shukla3Achal Kumar Srivastava4Manjari Tripathi5Madakasira Vasantha Padma Srivastava6Kameshwar Prasad7Sada Nand Dwivedi8Department of Neurology, All India Institute of Medical Sciences, New Delhi, IndiaDepartment of Neurology, All India Institute of Medical Sciences, New Delhi, IndiaDepartment of Neurology, All India Institute of Medical Sciences, New Delhi, IndiaDepartment of Neurology, All India Institute of Medical Sciences, New Delhi, IndiaDepartment of Neurology, All India Institute of Medical Sciences, New Delhi, IndiaDepartment of Neurology, All India Institute of Medical Sciences, New Delhi, IndiaDepartment of Neurology, All India Institute of Medical Sciences, New Delhi, IndiaDepartment of Neurology, All India Institute of Medical Sciences, New Delhi, IndiaDepartment of Biostatistics, All India Institute of Medical Sciences, New Delhi, India Introduction: Corticosteroids are used as adjunctive treatment in tuberculous meningitis (TBM). However, there is no universally accepted regimen, type, duration, or route of steroid administration. Methodology: In a randomized open labelled pilot study, TBM patients were divided into overlap oral dexamethasone (OOD) and direct oral dexamethasone (DOD) arms. The total duration of steroid administration was 8 weeks. The primary outcome was symptomatic resolution at 1 month post randomization. The secondary outcomes were mortality and modified Rankin scale (mRS) at 3 and 6 months after initiation of steroids. Results: Symptomatic resolution after one month of randomization in 53 randomized patients was similar in OOD (71.4% (15/21)) versus DOD ((85.0% (17/20)) arm (p value:0.45). Median mRS was also similar in OOD versus DOD (OOD: 2.5 (IQR: 1.0; 6.0) versus DOD: 1.0 (IQR: (0.0; 4.0); p value: 0.31)) arm at 6 months. The mortality at 6 months was 31.8% (7/22) in the OOD versus 20.0% (4/20) in the DOD arm (p value: 0.49). Conclusions: In this open label pilot study, the outcomes were similar in OOD versus DOD arms in terms of symptomatic resolution at 1 month, and morbidity, and mortality at 3 and 6 months. Patients with stage I to III TBM may be given injectable steroids for 1 week after which they may be switched to oral steroid. This regime cannot be applied to stage IV TBM and patients with complications like optico-chiasmatic or spinal arachnoiditis or vasculitic infarcts. https://jidc.org/index.php/journal/article/view/17563tuberculous meningitisdexamethasonecorticosteroidcomparison
spellingShingle Alvee Saluja
Deepti Vibha
Awadh Kishor Pandit
Garima Shukla
Achal Kumar Srivastava
Manjari Tripathi
Madakasira Vasantha Padma Srivastava
Kameshwar Prasad
Sada Nand Dwivedi
Comparison of dexamethasone regimens in tubercular meningitis (TBM): a randomized open label clinical trial
tuberculous meningitis
dexamethasone
corticosteroid
comparison
title Comparison of dexamethasone regimens in tubercular meningitis (TBM): a randomized open label clinical trial
title_full Comparison of dexamethasone regimens in tubercular meningitis (TBM): a randomized open label clinical trial
title_fullStr Comparison of dexamethasone regimens in tubercular meningitis (TBM): a randomized open label clinical trial
title_full_unstemmed Comparison of dexamethasone regimens in tubercular meningitis (TBM): a randomized open label clinical trial
title_short Comparison of dexamethasone regimens in tubercular meningitis (TBM): a randomized open label clinical trial
title_sort comparison of dexamethasone regimens in tubercular meningitis tbm a randomized open label clinical trial
topic tuberculous meningitis
dexamethasone
corticosteroid
comparison
url https://jidc.org/index.php/journal/article/view/17563
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