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Review
. 2016 Sep 1;9(9):CD012091.
doi: 10.1002/14651858.CD012091.pub2.

Six months therapy for tuberculous meningitis

Sophie Jullien  1 , Hannah Ryan, Manish Modi, Rohit Bhatia
Affiliations
Review

Six months therapy for tuberculous meningitis

Sophie Jullien et al. Cochrane Database Syst Rev. .

Abstract

Background: Tuberculous meningitis (TBM) is the main form of tuberculosis that affects the central nervous system and is associated with high rates of death and disability. Most international guidelines recommend longer antituberculous treatment (ATT) regimens for TBM than for pulmonary tuberculosis disease to prevent relapse. However, longer regimens are associated with poor adherence, which could contribute to increased relapse, development of drug resistance, and increased costs to patients and healthcare systems.

Objectives: To compare the effects of short-course (six months) regimens versus prolonged-course regimens for people with tuberculous meningitis (TBM).

Search methods: We searched the following databases up to 31 March 2016: the Cochrane Infectious Diseases Group Specialized Register; the Cochrane Central Register of Controlled Trials (CENTRAL), published in the Cochrane Library; MEDLINE; EMBASE; LILACS; INDMED; and the South Asian Database of Controlled Clinical Trials. We searched the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) and ClinicalTrials.gov for ongoing trials. We also checked article reference lists and contacted researchers in the field.

Selection criteria: We included randomized controlled trials (RCTs) and prospective cohort studies of adults and children with TBM treated with antituberculous regimens that included rifampicin for six months or longer than six months. The primary outcome was relapse, and included studies required a minimum of six months follow-up after completion of treatment.

Data collection and analysis: Two review authors (SJ and HR) independently assessed the literature search results for eligibility, and performed data extraction and 'Risk of bias' assessments of the included studies. We contacted study authors for additional information when necessary. Most data came from single arm cohort studies without a direct comparison so we pooled the findings for each group of cohorts and presented them separately using a complete-case analysis. We assessed the quality of the evidence narratively, as using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was inappropriate with no direct comparisons between short- and prolonged-course regimens.

Main results: Four RCTs and 12 prospective cohort studies met our inclusion criteria, and included a total of 1881 participants with TBM. None of the included RCTs directly compared six months versus longer regimens, so we analysed all data as individual cohorts to obtain relapse rates in each set of cohorts.We included seven cohorts of participants treated for six months, with a total of 458 participants. Three studies were conducted in Thailand, two in South Africa, and one each in Ecuador and Papua New Guinea between the 1980s and 2009. We included 12 cohorts of participants treated for longer than six months (ranging from eight to 16 months), with a total of 1423 participants. Four studies were conducted in India, three in Thailand and one each in China, South Africa, Romania, Turkey and Vietnam, between the late 1970s and 2011.The proportion of participants classified as having stage III disease (severe) was higher in the cohorts treated for six months (33.2% versus 16.9%), but the proportion with known concurrent HIV was higher in the cohorts treated for longer (0/458 versus 122/1423). Although there were variations in the treatment regimens, most cohorts received isoniazid, rifampicin, and pyrazinamide during the intensive phase.Investigators achieved follow-up beyond 18 months after completing treatment in three out of the seven cohorts treated for six months, and five out of the 12 cohorts treated for eight to 16 months. All studies had potential sources of bias in their estimation of the relapse rate, and comparisons between the cohorts could be confounded.Relapse was an uncommon event across both groups of cohorts (3/369 (0.8%) with six months treatment versus 7/915 (0.8%) with longer), with only one death attributed to relapse in each group.Overall, the proportion of participants who died was higher in the cohorts treated for longer than six months (447/1423 (31.4%) versus 58/458 (12.7%)). However, most deaths occurred during the first six months in both treatment cohorts, which suggested that the difference in death rate was not directly related to duration of ATT but was due to confounding. Clinical cure was higher in the group of cohorts treated for six months (408/458 (89.1%) versus longer than six months (984/1336 (73.7%)), consistent with the observations for deaths.Few participants defaulted from treatment with six months treatment (4/370 (1.1%)) versus longer treatment (8/355 (2.3%)), and adherence was not well reported.

Authors' conclusions: In all cohorts most deaths occurred in the first six months; and relapse was uncommon in all participants irrespective of the regimen. Further inferences are probably inappropriate given this is observational data and confounding is likely. These data are almost all from participants who are HIV-negative, and thus the inferences will not apply to the efficacy and safety of the six months regimens in HIV-positive people. Well-designed RCTs, or large prospective cohort studies, comparing six months with longer treatment regimens with long follow-up periods established at initiation of ATT are needed to resolve the uncertainty regarding the safety and efficacy of six months regimens for TBM.

PubMed Disclaimer

Conflict of interest statement

SJ and HR are employed by the CIDG, which is funded by a grant from the UK Government DFID.

SJ and HR conducted the preliminary work that contributed to the conception and design of this Cochrane Review as part of the evidence review process for the Indian Extra‐Pulmonary TB (INDEX‐TB) Guidelines, a guideline for extrapulmonary TB commissioned by the Ministry of Health and Family Welfare, Government of India. Global Health Advocates funded this guideline, and the All India Institute of Medical Sciences, New Delhi convened it.

RB and MM were part of the technical advisory group on central nervous system TB and took part in discussions that led to the recommendations in the INDEX‐TB Guidelines.

Figures

1
1
Possible disadvantages of prolonged and short‐course antituberculous regimens for treating people with TBM.
2
2
Study flow diagram.
3
3
'Risk of bias' summary for the cohorts treated for six months (left) and the cohorts treated for longer than six months.
4
4
'Summary of findings' table.
See this image and copyright information in PMC

Update of

  • doi: 10.1002/14651858.CD012091

References

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Raut 2013 {published data only}
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Rojas‐Echeverri 1996 {published data only}
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Ruslami 2013 {published data only}
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Saleem 2011 {published data only}
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Saleem 2015 {published data only}
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Salekeen 2013 {published data only}
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Schoeman 1990 {published data only}
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Schoeman 1991 {published data only}
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Schoeman 1997a {published data only}
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Schoeman 1997b {published data only}
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Schoeman 2000a {published data only}
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Schoeman 2000b {published data only}
    1. Schoeman JF, Springer P, Ravenscroft A, Donald PR, Bekker LG, Rensburg AJ, et al. Adjunctive thalidomide therapy of childhood tuberculous meningitis: possible anti‐inflammatory role. Journal of Child Neurology 2000;15(8):497‐503. - PubMed
Schoeman 2002 {published data only}
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Schoeman 2004 {published data only}
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Schoeman 2011 {published data only}
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Shah 2014 {published data only}
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Shahbaz 2011 {published data only}
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Sharma 2013b {published data only}
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Thwaites 2003a {published data only}
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Thwaites 2005c {published data only}
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References to studies awaiting assessment

Caliman‐Sturdza 2010 {published data only}
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References to ongoing studies

NCT02454569 {unpublished data only}
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