Elsevier

Public Health

Volume 129, Issue 6, June 2015, Pages 777-782
Public Health

Original Research
Duration of treatment in pulmonary tuberculosis: are international guidelines on the management of tuberculosis missing something?

https://doi.org/10.1016/j.puhe.2015.04.010Get rights and content

Abstract

Background

Despite evidence of an association between tuberculosis (TB) treatment outcomes and the performance of national tuberculosis programmes (NTP), no study to date has rigorously documented the duration of treatment among TB patients. As such, this study was conducted to report the durations of the intensive and continuation phases of TB treatment and their predictors among new smear-positive pulmonary tuberculosis (PTB) patients in Malaysia.

Study design

Descriptive, non-experimental, follow-up cohort study.

Methods

This study was conducted at the Chest Clinic of Penang General Hospital between March 2010 and February 2011. The medical records and TB notification forms of all new smear-positive PTB patients, diagnosed during the study period, were reviewed to obtain sociodemographic and clinical data. Based on standard guidelines, the normal benchmarks for the durations of the intensive and continuation phases of PTB treatment were taken as two and four months, respectively. A patient in whom the clinicians decided to extend the intensive phase of treatment by ≥2 weeks was categorized as a case with a prolonged intensive phase. The same criterion applied for the continuation phase. Multiple logistic regression analysis was performed to find independent factors associated with the duration of TB treatment. Data were analyzed using Predictive Analysis Software Version 19.0.

Results

Of the 336 patients included in this study, 261 completed the intensive phase of treatment, and 226 completed the continuation phase of treatment. The mean duration of TB treatment (n = 226) was 8.19 (standard deviation 1.65) months. Half (49.4%, 129/261) of the patients completed the intensive phase of treatment in two months, whereas only 37.6% (85/226) of the patients completed the continuation phase of treatment in four months. On multiple logistic regression analysis, being a smoker, being underweight and having a history of cough for ≥4 weeks at TB diagnosis were found to be predictive of a prolonged intensive phase of treatment. Diabetes mellitus and the presence of lung cavities at the start of treatment were the only predictors found for a prolonged continuation phase of treatment.

Conclusions

The average durations of the intensive and continuation phases of treatment among PTB patients were longer than the targets recommended by the World Health Organization. As there are no internationally agreed criteria, it was not possible to judge how well the Malaysian NTP performed in terms of managing treatment duration among PTB patients.

Introduction

Tuberculosis (TB) is a public health challenge. In 2012, approximately 8.6 million people developed TB. With an estimated 1.3 million deaths every year, TB is the second highest cause of adult mortality from an infectious disease, after human immunodeficiency virus (HIV).1 Malaysia is situated in the Western Pacific region of the World Health Organization (WHO), and is considered to have an intermediate burden of TB.1 According to a recent report, over the past few years, the incidence of TB in Malaysia has been 80–82 cases per 100,000. However, the absolute number of new cases increased from 15,057 in 2000 to 21,851 in 2012.1 These pointers reflect a slowly increasing burden of TB in Malaysia.

Provision of standardized treatment regimens, under supervision, is one of the five components of directly observed therapy (DOT). According to the current TB management guidelines, the treatment regimen for new smear-positive pulmonary tuberculosis (PTB) patients should be six months. Standardized TB treatment is divided into two phases: the intensive phase (IP) and the continuation phase (CP). For the IP of treatment, patients are prescribed isoniazid, rifampicin, pyrazinamide and ethambutol for two months, while during the CP of treatment, isoniazid and rifampicin are prescribed for four months. Patients living in isoniazid-resistant areas or diagnosed with isoniazid-resistant TB are prescribed isoniazid, rifampicin and ethambutol for four months during the CP of treatment.2, 3 In some situations [e.g. if a TB patient is immunocompromised (e.g. HIV, diabetes mellitus), a smoker and/or exhibits extensive lung involvement (e.g. lung cavities) at the start of the treatment], clinicians may decide to treat patients for a longer duration.

In spite of the evidence of an association between TB treatment outcomes and the performance of national tuberculosis programmes (NTP),4, 5, 6 no studies to date have rigorously and extensively documented the durations of the IP and CP of treatment among PTB patients. As such, this study was conducted to determine the duration of TB treatment and its predictors among new smear-positive PTB patients.

Section snippets

Study setting

This study was conducted at the Chest Clinic of Penang General Hospital. In addition to the committed paramedic staff, the Chest Clinic has a minimum of five to six medical officers and three chest consultants. A fully equipped quality assured TB laboratory, situated adjacent to the Chest Clinic, provides routine TB-specific investigation services to patients and suspected TB cases. The Radiology and Pathology Departments of Penang General Hospital also provide routine investigation services to

Results

Three hundred and thirty-six new smear-positive PTB patients were enrolled in the study. The mean age of the patients was 49.1 years [standard deviation (SD) 16.6]. More than 60% of the patients were aged 18–54 years. The Chinese ethnic group constituted the greatest proportion of the patients (53.3%), whilst the Tamils were least represented (9.8%). Table 1 shows the sociodemographic characteristics of the patients.

Only 72 patients exhibited five or more TB-related symptoms at the start of

Discussion

The intricacy and cost of TB treatment have risen in recent years. The emergence of multidrugresistant TB (MDR-TB), longer duration of TB treatment in HIV-seropositive patients, higher treatment failure rates in difficult-to-reach patients (i.e. drug abusers, immigrants, etc.) and increasing demands of DOT programmes contribute to higher costs of TB treatment.12, 13 This has put additional pressure on healthcare budgets. Due to the complexity of treatment regimens, it is difficult to reduce the

Acknowledgements

The authors would like to thank the Director General of Health Malaysia for granting permission to publish this paper.

Ethical approval

This study was registered at National Medical Research Register, Malaysia. The study design and conduct were approved by the National Institute of Health and by the Medical Research Ethics Committee, Ministry of Health, Malaysia (Registration ID: NMRR-10-77-5099; MERC Ref.: dim. KKM/NIHSEC/08/08/04P10-69).

Funding

Institute of Postgraduate Studies at Universiti Sains Malaysia

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