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Year : 2012  |  Volume : 135  |  Issue : 1  |  Page : 140-141

Treatment of tuberculosis guidelines, 4 th ed.

Department of Medicine, All India Institute of Medical Sciences, New Delhi 110 029, India

Date of Web Publication1-Mar-2012

Correspondence Address:
S K Sharma
Department of Medicine, All India Institute of Medical Sciences, New Delhi 110 029
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Source of Support: None, Conflict of Interest: None

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How to cite this article:
Sharma S K. Treatment of tuberculosis guidelines, 4 th ed. Indian J Med Res 2012;135:140-1

How to cite this URL:
Sharma S K. Treatment of tuberculosis guidelines, 4 th ed. Indian J Med Res [serial online] 2012 [cited 2021 Sep 29];135:140-1. Available from:

Treatment of tuberculosis guidelines, 4 th ed. (World Health Organization, Geneva, Switzerland), 2010. 157 pages. Price: CHF/US$ 25.00, in developing countries: CHF/US$ 17.50

ISBN 978-92-4-154783-3

Tuberculosis (TB) is one of the most common causes of preventable deaths in the world. The millennium development goal is to halt and begin the reversal of incidence by 2015. In the quest to achieve the same, World Health Organization (WHO) has come up with the fourth edition of guidelines on treatment of tuberculosis. It focuses on management of TB in adults, covering various aspects including emerging problems such as multidrug resistant-tuberculosis (MDR-TB) and HIV-TB co-infection. On one hand, there is continued emphasis on conventional short-course chemotherapy, and on the other application of newer modalities such as line probe assay and liquid culture has been strongly advocated. The guidelines are written in concise and comprehensible manner, thereby greatly enhancing the reading and understanding of the document. Seven key questions have been listed to deal with various issues pertaining to TB management and recommendations are mentioned as part of their answers. Nevertheless, lack of sound evidence and inadequate data prevent unanimous acceptance of many recommendations and thus it is entirely up to individual nations to implement these guidelines after carefully considering the suitability, risk-benefit ratio, cost-effectiveness and usefulness of each recommendation in respective settings.

Some of the major highlights of these guidelines include abandoning the use of categories to classify patients; exclusion of severity of disease as a feature of the case definition, thereby abolishing subjectivities in therapeutic decisions; recommendation for universal application of regimen containing at least 6 months of rifampicin (already being followed in the Indian national programme) and phasing out of isoniazid (INH) and ethambutol (EMB) combination in the continuation phase (CP). However, in more than one area, the document requires further scrutiny. South East Asian region currently accounts for staggering proportion of cases, yet has small representation in the guidelines group. More participation from this part of the world would have helped to handle areas of conflicts as well as aided in sufficiently addressing the logistics of implementing the recommendations in the resource constrained settings.

Daily therapy in both HIV negative as well as positive populations with TB has been promoted over currently practiced alternate day therapy. This may be a welcome proposal for HIV-TB co-infected patients, where small clinical trials and studies have consistently shown better cure rates, lower frequencies of relapse and treatment failure with daily treatment. However, there is a paucity of trials with adequate power to sufficiently warrant its application on a programmatic scale. Extension of this recommendation to include HIV negative population merits much more attention and detailed analysis. Thrice weekly intermittent regimen of anti-tuberculosis drugs forms backbone of ongoing programmes all over the world and has shown astounding results as far as treatment adherence and cure rates are concerned. Switching to daily therapy under programmatic set up may have operational logistic problems and will not only require high degree of motivation on part of treatment providers as well as patients but may also increase risk of certain side-effects (e.g. hepatotoxicity), and thus may adversely affect the programme performance. Overall, tolerability, feasibility and unequivocal evidence of efficacy of intermittent therapy make it a preferred choice for management of TB in a programmatic set up.

Discontinuation of extension of intensive phase (IP) for patients having positive sputum smear at the end of second month of treatment has been recommended but lacks adequate data to provide support to the guidelines. IP extension is a cost-effective, operationally feasible practice that has consistently shown to decrease relapse rate and, therefore, must be continued without hesitation.

Empirical treatment for MDR-TB in patients with treatment failure and other subgroups with high likelihood of MDR-TB has been advocated. This recommendation is not only impractical for resource-poor countries but simultaneously encourages management practices, which do not have sound basis for treatment initiation. This will result in wasteful consumption of resources, acquired resistance to second-line drugs due to over usage, amplification of MDR-TB to extensively drug resistant tuberculosis (XDR-TB), unnecessary pill burden and exposure to adverse events, far worse than the first-line drugs.

Certain other recommendations are reasonably favourable proposals but require generation of more evidence before implementation in a programmatic set up. Addition of ethambutol in continuation phase in areas of high level of INH resistance is one of these, but many uncertainties prevent its implementation in the national programmes. Foremost of these, is lack of data to determine threshold of community INH resistance, justifying basis of inclusion of ethambutol in the regimen. This, coupled with disadvantages of amplified pill count, development of acquired resistance to ethambutol adversely affecting treatment options for MDR-TB, along with dose and duration dependent irreversible ocular side-effects create a need for careful consideration for this recommendation. Likewise, recommendation to use high dose of INH for the treatment of MDR-TB in a programmatic set up also requires generation of more data on efficacy and safety.

A few other recommendations may be a welcome addition to existing treatment practices but need to be executed with caution. The number of specimens for screening of TB suspects has been reduced from 3 to 2 due to low additional yield of third sputum smear. This approach decreases burden on laboratories, helps in early initiation of treatment and at the same time, reduces number of visits for collection of sample. However, it only applies to settings with well functioning external quality assurance (EQA) with blind rechecking as well as good internal quality control. Therefore, countries should implement this recommendation only after carefully assessing their resources and ensuring feasibility of quality control; otherwise potential cases may be missed in turn leading to transmission of disease and propagation of drug resistance especially in HIV-TB co-infected patients, where cases with paucibacillary sputum samples are common.

Though the guidelines adequately focus on majority of areas of concerns and uncertainties in TB management, some important issues should have been dealt with greater emphasis. Extrapulmonary tuberculosis (EPTB), especially in HIV-TB co-infected patients is one such neglected topic. There is a lack of clarity regarding diagnosis, treatment duration, follow up, and clear-cut endpoints to declare cure/successful treatment in such patients. Paucity of research as well as lack of consensus among experts interfere with making proper recommendations to sufficiently address these problems. Similarly, duration of treatment in HIV-TB co-infected patients, management strategies for patients found to have pre-treatment INH resistance, drugs other than INH for tuberculosis prophylaxis are some other areas of conundrum, which merit more attention.

To summarise, WHO guidelines 2010 for treatment of tuberculosis is an informative, easy to understand document but suffers from lack of adequate evidence to put forth arguments in favour of many recommendations. In the absence of firm evidence, implementing the recommendations just becomes like a game of gambling, where the tilt could be on either side. There is an urgent requirement for guidelines based on good quality research to address areas of conflicts and in better decision making. It is hoped that for the next edition, there will be wider representation from high burden countries, data based on sound evidence and recommendations to take care of existing controversies in TB management. Hopefully, the next edition will incorporate changes based on accumulating evidence and contribute to much awaited renaissance of tuberculosis management.


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