|Year : 2019 | Volume
| Issue : 1 | Page : 56-60
Effectiveness of daily directly observed treatment, short-course regimen among patients registered for treatment at an urban primary health center in Bengaluru
Huluvadi Shivalingaiah Anwith1, Sreerama Reddy Kaushik1, Ramanathan Thenambigai1, M Madhusudan2, Dandiganahalli Shivaram Priyanka1, Nagaraj Deepthi1, PS Karishma1
1 Department of Community Medicine, Kempegowda Institute of Medical Sciences, Bengaluru, Karnataka, India
2 Department of Community Medicine, DM WIMS Medical College, Wayanad, Kerala, India
|Date of Web Publication||4-Jul-2019|
Room No. 202, KIMS Staff Quarters, 17th Cross, Siddanna Layout, Banashankari 2nd Stage, Bengaluru - 560 070, Karnataka
Source of Support: None, Conflict of Interest: None
Background: Tuberculosis (TB) is a major public health problem in India with high morbidity and mortality. As per the World Health Organization guidelines, the Revised National Tuberculosis Control Program introduced daily directly observed treatment, short-course (DOTS) regimen with a fixed-dose combination with weight bands. This study was undertaken to compare the effectiveness of daily DOTS regimen with intermittent regimen and to assess the proportion of adverse drug reactions in both groups.
Materials and Methods: A descriptive study was conducted at a peripheral health institute under one of the TB Units in South Bengaluru. Participants registered for treatment during the third and fourth quarter of 2017 were selected using continuous sampling. Data were collected by case record analysis, structured interviews, and telephonic follow-up.
Results: The study included 81 participants, with the mean age of 40 ± 16.1 years. Majority of the study participants 55 (67.9%) were male, and majority (38 [46.9%]) belonged to the upper-lower class. Forty-two (51.8%) of the study participants were on intermittent regimen, and 39 (48.1%) were on daily DOTS regimen. There was 100% sputum conversion at the end of treatment under both treatment regimens. A total of 36 (85.7%) participants under intermittent regimen and nine (23%) under daily regimen developed one or the other adverse drug reactions. The treatment success for participants under intermittent regimen was 38 (90.47%) and that for daily regimen was 35 (89.74%). However, there was no statistically significant difference between the two groups.
Conclusion: Both daily and intermittent DOTS regimens are equally effective in TB treatment, but adverse drug reactions were more common with the intermittent regimen.
Keywords: Daily regimen, directly observed treatment, intermittent regimen, short-course, treatment outcome
|How to cite this article:|
Anwith HS, Kaushik SR, Thenambigai R, Madhusudan M, Priyanka DS, Deepthi N, Karishma P S. Effectiveness of daily directly observed treatment, short-course regimen among patients registered for treatment at an urban primary health center in Bengaluru. Indian J Community Fam Med 2019;5:56-60
|How to cite this URL:|
Anwith HS, Kaushik SR, Thenambigai R, Madhusudan M, Priyanka DS, Deepthi N, Karishma P S. Effectiveness of daily directly observed treatment, short-course regimen among patients registered for treatment at an urban primary health center in Bengaluru. Indian J Community Fam Med [serial online] 2019 [cited 2019 Dec 6];5:56-60. Available from: http://www.ijcfm.org/text.asp?2019/5/1/56/262123
| Introduction|| |
Tuberculosis (TB) is an ancient disease known to humankind, which continues to cause significant morbidity and mortality despite the availability of highly efficient diagnostic tests and effective treatment. India accounts for one-fourth of the global TB burden with an incidence of 28 lakh and mortality of 4.8 lakh, which amounts for the highest number of TB and multidrug-resistant TB cases in the country according to the global TB report published by the World Health Organization (WHO).,
The National Tuberculosis Program was initiated in India during 1962 which was revised in 1997 as the Revised National Tuberculosis Control Program (RNTCP) that used WHO recommended (directly observed treatment, short-course [DOTS] chemotherapy) strategy. Although DOTS was implemented throughout the country by the year 2006, the number of cases of TB continued to raise simultaneously with increased number of relapses and drug-resistant TB cases.
In this regard, in March 2016, RNTCP introduced daily DOTS regimen with fixed-dose combination in a phased manner for the treatment of TB patients; to make the treatment more effective, reduce the relapses, and the incidence of drug resistance in TB patients.
There are very few studies comparing the effectiveness of intermittent with daily DOTS regimens. In the district where the study site is located, the daily DOTS regimen was started from October 2017. Since it is the transition period between the switch over from intermittent to daily DOTS regimen, this study was taken up to compare the effectiveness of daily and intermittent DOTS regimens and to find out the proportion of adverse drug reactions in both the regimens.
| Materials and Methods|| |
The study design was a descriptive study.
The descriptive study was conducted at the peripheral health institute under one of the TB units in Bengaluru.
The sampling used was continuous sampling.
All cases registered for the treatment during the last quarter of 2017 for daily regimen, and cases registered for the treatment during the third quarter of 2017 for intermittent regimen.
The inclusion criteria are as follows:
- Patients registered for TB treatment during the third and fourth quarter of 2017 at a peripheral health institute attached to a TB unit in Bengaluru
- Patients consenting for the study.
- Seriously ill patients were excluded from the study.
The data collection was started after obtaining permission from the Institutional Ethics Committee of the medical college and the District Tuberculosis Officer, Bengaluru.
The sociodemographic profile of all the participants was collected from the treatment cards and structured interviews. Details regarding the profile of TB, which included the type of TB, the patients were suffering from, prior treatment for TB, test used for diagnosis, and category of DOTS regimen were collected through treatment cards. The socioeconomic status classification was done using the modified Kuppuswamy's classification with updated income ranges for 2018.
Information regarding the comorbidities that patients were suffering from, including HIV status and diabetes, were collected from the treatment cards.
A case record analysis of the participants registered for the treatment from July 2017 to September 2017 was done for assessing the treatment outcome at the end of the intensive phase and at the end of treatment in terms of sputum conversion and weight gain (only for bacteriologically confirmed cases of pulmonary TB).
Similarly, assessment of the cases registered for the treatment from October 2017 to December 2017 was done for the treatment outcome at the end of the intensive phase and at the end of treatment in terms of weight gain, sputum conversion (only for bacteriologically confirmed cases of pulmonary TB), and adverse drug reactions during the treatment were collected by the personal and telephonic follow-up.,
Data were entered in Microsoft Excel 2010 and analyzed using openEpi software (Open Source Epidemiologic Statistics for Public Health). Descriptive statistics such as mean and standard deviation were used. Inferential statistics such as Chi-square test was used to test the association between treatment success and different treatment regimens.
| Results|| |
The present study included 81 participants fulfilling the inclusion and exclusion criteria. The mean age of the study participants was 40 ± 16.1 years. Majority of the study participants were male 55 (67.9%). Sixty-four (79.1%) of the study participants were Hindus and 17 (20.9%) were Muslims by religion. Majority of the participants, 38 (46.9%) belonged to the upper-lower class followed by the lower class 20 (24.7%), lower middle 18 (22.2%), and rest belonged to the upper class. A total of 75 (92.6%) participants were married and 73 (90.1%) of the participants lived in a nuclear family [Table 1].
|Table 1: Distribution of the study participants based on sociodemographic profile|
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The profile of TB was as follows: majority (56 [69.1%]) of the participants were suffering from pulmonary TB and 25 (30.9%) from extrapulmonary TB. Sixty-six (81.5%) were treated with Category I DOTS therapy and 15 (18.5%) on Category II. The number of participants started on treatment during the third quarter of 2017 (i.e., intermittent regimen) was 42 (51.8%), and the number of participants started on treatment during the last quarter (i.e., daily DOTS regimen) was 39 (48.1%). Sixty-two (76.5%) participants were microbiologically confirmed which included sputum microscopy/CBNAAT and 19 (23.4%) were clinically diagnosed [Table 2].
|Table 2: Distribution of the study participants based on the profile of tuberculosis|
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None of the study participants were HIV-positive, and 24 (29.6%) participants were suffering from diabetes. A total of 15 (18.5%) participants were smokers, and 13 (16%) of the participants were alcoholics. The mean weight gain among participants on daily regimen was 2.7 ± 2.2 kg and that among patients on intermittent regimen was 2.4 ± 2.3 kg at the end of the intensive phase. Similarly, the mean weight gain at the end of treatment was 3.2 ± 2.6 Kg for daily regimen and 3.6 ± 2.9 Kg for intermittent regimen. However, on applying t-test, there was no statistically significant difference in the weight gain between the two groups both at the end of the intensive phase and at the end of the treatment.
All the 28 (66.7%) participants under intermittent regimen with smear-positive status at the beginning of treatment had sputum conversion at the end of the intensive phase, i.e., no TB bacilli was detected at the end of the intensive phase; hence, it was 100% conversion. However, of the 28 (71.8%) participants under daily regimen having initial sputum-positive status, four (14.3%) participants continued to have the sputum-positive status even at the end of the intensive phase; hence, the conversion rate was 85.7% for the daily regimen. At the end of the treatment, the sputum conversion was 100% for both the regimens; however, on applying the Chi-square test, there was no statistically significant association between the groups [Table 3].
|Table 3: Distribution of study participants based on treatment outcome at the end of the intensive phase|
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On assessing the final treatment outcome of the 39 participants under daily DOTS regimen, 26 (66.7%) participants were labeled cured, 9 (23%) treatment completed, 3 (7.7%) participants died during the treatment, and 1 (2.6%) participant was diagnosed with extensively drug-resistant TB [Table 4]. Similarly, of the 42 participants on intermittent DOTS regimen, 26 (61.9%) were labeled cured, 12 (28.6%) treatment completed, and 4 (9.5%) participants died during the course of treatment. No participants were lost to follow-up during the course of treatment [Table 4] and [Graph 1].
|Table 4: Distribution of study participants based on treatment outcome at treatment completion|
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Just 9 (23%) participants on daily regimen developed some sort of adverse drug reactions with the most common one being generalized itching, and 36 (85.7%) participants on intermittent regimen had one or the other adverse drug reactions with fatigue being most common [Table 5].
|Table 5: Distribution of study participants based on adverse reactions following treatment|
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Thirty-five (89.7%) participants had overall treatment success (participants with treatment outcome as cured and treatment completed) under daily DOTS regimen and 38 (90.4%) participants under intermittent regimen. However, there was no statistically significant difference between the two treatment regimens in terms of treatment success [Table 6].
|Table 6: Comparison of treatment success of daily and intermittent regimens|
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| Discussion|| |
The Government of India has made tremendous efforts to control TB and ultimately eliminate TB by 2025. A strong commitment toward TB control is seen since the inception of National Tuberculosis Control Program in 1962, and subsequently, RNTCP was implemented as pilot project from 1993 and implemented throughout India by the year 2006. Accordingly, the treatment regimens were more standardized and adequate treatment supply was ensured. Despite efforts, even after the pan India implementation of RNTCP, the burden of the disease continued to be high, and hence, the government revised the treatment and operational guidelines in 2016 based on the revised guidelines published by the WHO, and accordingly, daily regimen was one of the strategies.,,,
Majority of the study participants in the present study were in the age group of 30–40 years, but in a study conducted in Kolkata in 2011 revealed that majority of the study participants were in the age group of 21–40 years.
At the end of the intensive phase, the sputum conversion rate was 100% for participants taking intermittent regimen and 85.7% for participants taking daily regimen. However, in a clinical trial conducted at the National Institute of Research in Tuberculosis, Chennai, it was observed that daily treatment was better than the intermittent regimen which may be attributed to different study settings.
The cure rate in the current study was 61.9% for participants under intermittent regimen and 66.7% for those under daily regimen, but according to a study done in South India, the cure rate for participants taking intermittent regimen was 84% which may be attributed to the differences in the sociodemographic characteristics of the participants. Similarly, a study conducted by us at a TB unit, Bengaluru, the treatment success rate was 80.9% which is again less than the objective of 85% set by RNTCP. Similarly, a study done at a tertiary hospital in Kolkata concluded that sputum conversion rate and treatment success rate at the end of intensive phase were almost similar in both regimens.,,,
On assessing the adverse drug reactions, the intermittent regimen had more adverse reactions compared to daily regimen, which may be attributed to the lack of weight bands in the participants receiving intermittent regimen. However, a study done at a tertiary hospital in Kolkata, India, observed that the incidence of adverse drug reactions was more among the patients taking treatment under daily DOTS regimen.
| Conclusion|| |
The treatment success rates for the daily and intermittent regimens were almost the same with no statistically significant difference between them. The weight gain in participants under both the regimens was also the same. The participants under intermittent regimen had better sputum conversion at the end of the intensive phase compared to those taking daily regimen, but the sputum conversion rate was the same at the end of treatment for both the regimens. The adverse drug reactions were more among the participants who took treatment under intermittent regimen compared to daily DOTS regimen; this can be attributed to treatment under daily DOTS regimen based on weight bands. There is a need for similar studies with a larger sample size to confirm the results of the study.
Limitation of the study
The study is done on a small sample size in only one peripheral health institute, hence the study findings cannot be generalized.
Similar studies at multiple sites in different geographical areas and different clinical settings have to be conducted with a larger sample size to arrive at a better conclusion and to generalize the results.
We would like to thank all the staff and postgraduates of the department and RNTCP staff for their cooperation.
Financial support and sponsorship
The present study is an ICMR Short Term Studentship project.
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6]