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Year : 2018  |  Volume : 63  |  Issue : 6  |  Page : 524-526
The impact of fixed duration multidrug therapy on the host and the agent: A pilot study using clinical, bacteriological, and quality of life assessment tools

1 Department of Dermatology, IPGMER, Kolkata, West Bengal, India
2 Deparment of Dermatology, Calcutta National Medical College, Kolkata, West Bengal, India
3 Department of Biochemistry, IPGMER, Kolkata, West Bengal, India
4 Department of Dermatology, KPC Medical College, Kolkata, West Bengal, India

Date of Web Publication2-Nov-2018

Correspondence Address:
Dr. Abhishek De
Deparment of Dermatology, Calcutta National Medical College, Kolkata, West Bengal
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/ijd.IJD_116_17

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How to cite this article:
Singhal AK, De A, Reja AH, Aggarwal I, Sharma N, Ansari A, Sarda A. The impact of fixed duration multidrug therapy on the host and the agent: A pilot study using clinical, bacteriological, and quality of life assessment tools. Indian J Dermatol 2018;63:524-6

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Singhal AK, De A, Reja AH, Aggarwal I, Sharma N, Ansari A, Sarda A. The impact of fixed duration multidrug therapy on the host and the agent: A pilot study using clinical, bacteriological, and quality of life assessment tools. Indian J Dermatol [serial online] 2018 [cited 2022 Jul 2];63:524-6. Available from:


World Health Organization (WHO) has introduced multidrug therapy (MDT) for leprosy since 1983 and later made it fixed duration treatment. Still later, the WHO has reduced the duration of multibacillary (MB) MDT regimen from 24 months to 12 months and eliminated the need for follow-up visit and slit-skin smear examination. Although fixed duration treatment has led to massive organizational success and resultant decrease in prevalence and annual case detection rate, follow-up data after completion of WHO MDT are largely lacking particularly from this part of the world.[1] So, we, in a tertiary care center of eastern India, conducted a study among patients who have completed WHO MDT 6 months to 2 years earlier for assessment of clinical, microbiological, and quality of life (QoL). We evaluated the patients for clinical improvement, episodes of reaction, appearance of new lesions, status of slit-skin smear, and overall QoL using Bengali and Hindi versions of Dermatology Life Quality Index (DLQI) scale. We also performed DNA polymerase chain reaction (PCR) for Mycobacterium leprae from the patients' tissues to find PCR positivity in these patients.

A total of 77 patients of Hansen's disease who had completed WHO MDT treatment from 6 months to 2 years earlier at our center were contacted by means of either telephonic or postal communication. These patients were asked to follow-up for evaluation. Only 25 patients turned up with the response rate being 32.4%.

Among the study participants, 21 (84%) participants were male and 4 (16%) were female. Of the 25 patients, 23 had MB and 2 had paucibacillary (PB) leprosy. The age varied from 19 years to 51 years with the mean age being 37.04. Clinically, 22 (88%) patients had borderline leprosy, 2 (8%) had tuberculoid leprosy, and 1 (4%) had lepromatous leprosy. Of these patients, 23 (92%) patients received MB MDT and 2 (8%) PB MDT [Table 1].
Table 1: Demographic data

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Of 25 patients examined clinically, 11 patients showed complete healing, 7 patients had partial healing, and 7 presented with no sign of healing. Changes in the lesions were present in 14 patients in the form of redness, scaling, and pigmentation. Of the 7 patients who had no sign of healing, 5 presented with signs of activity and relapse in the form of appearance of new nerve involvement (2; 8%), appearance of new lesion (5; 20%), and the appearance of new deformity (1; 4%). Type 1 reaction was seen in 8 (32%) patients and Type 2 reaction in 3 (12%).

QoL assessment was done at presentation for all the patients. The mean score was 7. The highest score that was obtained was 18 and the least score was 0. Six patients had a score above 11 indicating very large effect on patients' life and 7 patients showed a score between 6 and 10, which indicated moderate effect. We have used Bengali, Hindi, and English versions of standard DLQI questionnaire.

Of 25 patients, 6 were slit-skin smear positive. PCR by multiplex PCR was done on samples of all the patients, out of which, 23 (92%) were positive showing the presence of bacilli [Table 2].
Table 2: Results of laboratory tests

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The poor turnover (32.4%) of the patients in our study could possibly be attributed to inaccurate entry of address or phone number in records, change of address or phone number, and/or low socioeconomic status and education level in this part of India. On the other hand, it might be that most of the patients had complete healing and they did not respond to follow-up call. This fact was reflected in the high positive and relapsed cases among the respondents.

Epidemiological data in our study correlated well with a similar study done by Vara et al. from India[2] but differ considerably from a study done in Thailand by Dasananjali et al.[3] They found lower number (26.94%) of MB cases compared to 92% in our study. The high number of MB cases found from the two studies done in India could be due to higher bacillary load seen in Indian patients although it would need further validation with a study of larger sample size. Moreover, in our study, there could be a presentation bias also as it was likely that the more severely affected MB cases responded more positively for the follow-up.

Clinically, evidence of relapse was presence of any of the followings, i.e., occurrence of new skin lesions, extension of previous lesions, and new nerve involvement. Five out of 25 (20%) patients showed clinical signs of relapse. This finding was similar to the finding of Vara et al.[2] who found evidence of relapse in 26 out of 100 (26%) patients they followed up. However, in some other studies, where follow-up was done for a longer period of time, clinical evidence of relapse was found to be much lower (2/163; 1.2%).[3],[4],[5] The higher rate of relapse in our study and in the one done by Vara et al. raised questions toward efficacy of WHO MDT to efficiently kill M. leprae in our scenario. There could be many causes for this higher rate of relapse, like, persisters, poor compliance of patients, and inaccurate record keeping. Earlier, the authors have shown that genomic reduction can be a survival strategy in leprosy bacilli at least in the context of pure neural Hansen disease.[6],[7] Furthermore, what we must borne in mind while interpreting these findings was that it was possible that people suffering from relapse were more keen to attend the follow-up visit in our study, which might have led to such a high number of relapses.

Type 1 reaction was seen in 8 (32%) patients and Type 2 reaction was seen in 3 (12%) patients. These results were similar to results obtained by Balagon et al.[8] who found that 38/139 (27%) patients experienced one or more reversal reactions, while 7/139 (5%) had erythema nodosum leprosum (ENL) after completion of 1 year of MDT. They highlighted the fact that reactional states and thereof the ensuing morbidity to patients were common even 1 year after completion of MDT, especially so in MB patients.

Microbiological evaluation was done in our study using the slit-skin smear and PCR to identify M. leprae DNA. Of 25 patients, 6 (24%) were slit-skin smear positive. A study done in northeastern Thailand by Dasananjali et al.[3] showed that at the end of follow-up period of 10 years, they still had 32 positive slit-skin smears out of 188 patients (12.23%).

The PCR positivity for M. leprae was seen in 23 (92%) out of 25 patients. This high level of positive result could be because of the fact that the time elapsed between cessation of MDT and follow-up in our study was less, and it might not be enough for dead bacteria and its DNA to be cleared by body.

We had also performed QoL assessment of our patients using the DLQI which has been validated for leprosy. A good number (6; 24%) of the patients were found to be largely affected by leprosy even after completing MDT. Of these 6 patients, 2 had a relapse, while 5 had reaction episodes. It was evident that both relapse and reactions affected the patient's life poorly. Furthermore, there were 7 patients (28%) who had their lives moderately affected.

We have made huge strides over the past decades in achieving leprosy elimination, and the vision is to achieve leprosy eradication. Although we have examined a very small number of patients due to limited time and resources, our study points towards a possible good number of reaction and relapses in the patients who have already completed MDT. It is also important to note that even after the completion of treatment and apparent cure of the disease; leprosy affects QoL of these patients.

The study was limited by low sample size, inability to do histopathology for confirmation of the disease due to limited ethical permission, and lack of longitudinal analysis. We understand the need to conduct a longitudinal study with larger cohort for more comprehensive analysis of the disease status after completion of WHO MDT.


This study was partially supported with research grant from IADVL, West Bengal.

Financial support and sponsorship


Conflicts of interest

There are no conflicts of interest.

   References Top

Dogra S, Kumaran MS, Narang T, Radotra BD, Kumar B. Clinical characteristics and outcome in multibacillary (MB) leprosy patients treated with 12 months WHO MDT-MBR: A retrospective analysis of 730 patients from a leprosy clinic at a tertiary care hospital of Northern India. Lepr Rev 2013;84:65-75.  Back to cited text no. 1
Vara N, Agrawal M, Marfatia Y. Leprosy beyond MDT: Study of follow-up of 100 released from treatment cases. Indian J Lepr 2010;82:189-94.  Back to cited text no. 2
Dasananjali K, Schreuder PA, Pirayavaraporn C. A study on the effectiveness and safety of the WHO/MDT regimen in the Northeast of Thailand; a prospective study, 1984-1996. Int J Lepr Other Mycobact Dis 1997;65:28-36.  Back to cited text no. 3
Kumar A, Girdhar A, Girdhar BK. Twelve months fixed duration WHO multidrug therapy for multibacillary leprosy: Incidence of relapses in Agra field based cohort study. Indian J Med Res 2013;138:536-40.  Back to cited text no. 4
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Chen XS, Li WZ, Jiang C, Ye GY. Studies on risk of leprosy relapses in China: Relapses after treatment with multidrug therapy. Int J Lepr Other Mycobact Dis 1999;67:379-87.  Back to cited text no. 5
Reja AH, De A, Biswas S, Chattopadhyay A, Chatterjee G, Bhattacharya B, et al. Use of fine needle aspirate from peripheral nerves of pure-neural leprosy for cytology and PCR to confirm the diagnosis: A pilot study. Indian J Dermatol Venereol Leprol 2013;79:789-94.  Back to cited text no. 6
[PUBMED]  [Full text]  
De A, Reja AH, Biswas S, Bhattacharya B, Chatterjee G, Basu K, et al. Unique TTC repeat base pair loss mutation in cases of pure neural leprosy: A Survival strategy of Mycobacterium leprae? Indian J Dermatol 2015;60:351-5.  Back to cited text no. 7
[PUBMED]  [Full text]  
Balagon MF, Cellona RV, Cruz ED, Burgos JA, Abalos RM, Walsh GP, et al. Long-term relapse risk of multibacillary leprosy after completion of 2 years of multiple drug therapy (WHO-MDT) in Cebu, Philippines. Am J Trop Med Hyg 2009;81:895-9.  Back to cited text no. 8


  [Table 1], [Table 2]


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