A comparison of ML Flow serology and slit skin smears to assess the bacterial load in newly diagnosed leprosy patients in Brazil

INTRODUCTION: The ML Flow test is an immunochromatographic assay that detects IgM antibodies against M. leprae-specific anti-phenolic glycolipid I (PGL-I). In addition to slit skin smears stained by the Ziehl-Neelsen technique, it can be helpful in the operational classification of leprosy patients for treatment purposes. OBJECTIVE: This work studied the relationship between antibody levels as detected by semi-quantitative ML Flow serologic test and bacterial load as quantified by slit skin smear. PATIENTS AND METHODS: 135 patients with newly detected leprosy at the reference service in Sanitary Dermatology in Brazil had slit skin smears (registered as bacillary index - BI) and an ML Flow test (registered qualitatively and semi-quantitatively) performed at admission. A logistic regression and agreement measures (kappa index) were calculated. RESULTS: Slit skin smears were positive in 35.9% of patients and 57% of patients were seropositive for PGL-1 antibodies. Among the seropositive patients, 416% had five or fewer skin lesions, and 65.8% had more than one peripheral nerve involved. Slit skin smears were positive in only three seronegative patients (5.6%), and negative in 41.9% of seropositive patients. Patients with a BI of 4 + had an OR of 33 for being seropositive in comparison to those with a low BI. CONCLUSIONS: There is a correlation between serologic test and slit skin smear results. Therefore, an ML Flow test may become a useful tool in the clinical classification of leprosy, besides slit skin smears, which require a proper laboratory infrastructure and experienced personnel.     

Comparison of two systems of classification of leprosy based on number of skin lesions and number of body areas involved--a clinicopathological concordance study

BACKGROUND AND AIMS: WHO guidelines classify leprosy patients for therapeutic purposes into paucibacillary (PB) and multibacillary (MB) leprosy based on the number of skin lesions. An alternative system of classification has been in practice in Nepal from 1985 onwards, based on the number of body areas involved in patients of leprosy. We attempted a clinicopathological approach for comparison of these two systems of classification in leprosy patients for their ability to demarcate patients into groups of PB and MB leprosy. MATERIALS AND METHODS: The study included 108 leprosy patients (80 males and 28 females). Complete clinical examination and body charting was carried out in each patient noting the count of skin lesions and the number of body areas involved. Slit skin smears and skin biopsies were taken from an active skin lesion in all patients. RESULTS: On analysis, it was observed that there was good clinicopathological correlation between patients with 5 or < 5 skin lesions and 2 or < 2 body areas involved. (Clinical 95% and histological 96%) A similar correlation was also observed in the other group of patients with > 5 skin lesions and > 2 body areas involved, (Clinical 94% and histological 96%). There were almost identical numbers of patients represented in these two groups of classification. CONCLUSIONS: Our findings suggest that patients with involvement of 2 or less body areas can be classified as PB leprosy and those with more than 2 body areas involved can be classified as MB leprosy for the purposes of therapy. The study of areas of involvement in leprosy patients not only provides additional patient information but also adds another parameter as a basis for the study of leprosy patients.     

The allocation of leprosy patients into paucibacillary and multibacillary groups for multidrug therapy, taking into account the number of body areas affected by skin, or skin and nerve lesions.

In Nepal, the setting up and maintaining of reliable services for slit-skin smears has proven difficult. A clinical classification system for leprosy has therefore been developed to assist in the allocation of patients to either paucibacillary or multibacillary groups for the purpose of multiple drug therapy (MDT), using 9 body areas: head (1), arms (2), legs (2), trunk (4). Patients with more than two areas of the body affected are grouped as multibacillary (MB) and those with only one or two areas affected are paucibacillary (PB). Using a computer simulation model and the data of 53 patients registered at Green Pastures Hospital (GPH) in Pokhara and 703 field patients from the Western Region, different clinical classification systems were evaluated with regard to their sensitivity, specificity, and predictive value for MB or PB classification, as compared with the histological classification for the GPH cases and the bacteriological classification for the field patients. The sensitivity and specificity of the body area system in present use were 93% and 39%, respectively. The low specificity is due to MB overclassification. The sensitivity of the WHO classification system without skin smear facilities is 73% (the difference with the body area system is significant: p < 0.05, McNemar's test). Our histology findings confirm previous publications indicating that, while some borderline-tuberculoid (BT) patients may outwardly have a 'PB appearance' and be skin-smear negative, their nerve biopsy and sometimes skin biopsy may show a 'MB' picture. This is the first publication discussing a 'body area system' for the purpose described, including diagrams of the areas used. In Nepal it has proved easy to use and teach and its use may be justified in other control programmes which implement MDT, particularly if slit-skin smear services are unreliable or nonexistent.     

ML Flow serological test: complementary tool in leprosy

BackgroundThe evaluation of household contacts of leprosy cases allows the early diagnosis of new cases.ObjectiveTo associate the results of the ML Flow test with the clinical characteristics of leprosy cases and to verify their positivity in household contacts, in addition to describing the epidemiological profile of both.MethodsProspective study with patients diagnosed over the course of one year (n = 26), without prior treatment, and their household contacts (n = 44) in six municipalities in northwestern São Paulo, Brazil.ResultsThere was a predominance of men among the leprosy cases, of 61.5% (16/26); 77% (20/26) were over 35 years old; 86.4% (22/26) were multibacillary; 61.5% (16/26) had a positive bacilloscopy; and 65.4% (17/26) had no physical disability. The ML Flow test was positive in 53.8% (14/26) of the leprosy cases and was associated with those who had a positive bacilloscopy and were diagnosed as multibacillary (p-value <0.05). Among the household contacts, 52.3% (23/44) were women and aged over 35 years; 81.8% (36/44) had been vaccinated with BCG ‒ Bacillus Calmette-Guérin. The ML Flow test was positive in 27.3% (12/44) of household contacts, all of whom lived with multibacillary cases; seven lived with positive bacilloscopy cases and six with consanguineous cases.Study limitationsDifficulty in convincing the contacts to undergo the evaluation and collection of the clinical sample.ConclusionThe ML Flow test, when positive in household contacts, can help the identification of cases that require more attention by the health team, as it indicates a predisposition to disease development, especially when they are household contacts of multibacillary cases, with positive bacilloscopy and consanguineous. The ML Flow test also helps in the correct clinical classification of the leprosy cases.     

MDT-MB therapy in paucibacillary leprosy: a clinicopathological assessment

BACKGROUND: The World Health Organization recommends treatment regimens for paucibacillary (PB) and multibacillary (MB) leprosy, which differ in their duration and components. Hence accurate classification of the disease is required. To overcome difficulties in classification Uniform Multi Drug Therapy (U-MDT) has been recommended. AIM : To evaluate the benefit of adding clofazimine to paucibacillary regimens in leprosy patients by measuring clinical and histological resolution. METHODS: Forty-four paucibacillary patients were included in the study. Twenty-two patients were given MDT-PB regimen and the remaining MDT-MB regimen for six months . Skin biopsies were done before the commencement and at the end of treatment. Clinical and histological resolutions were measured according to the standard criteria a laid down. The results were analyzed using Fishers' test and Crammers' V test. RESULTS: Clinical improvement was observed in 90.9% in the MB group as compared to 27.3% in the PB group. Regression in the nerve swelling was observed in 70% in the MB group and in 37.5% in the PB group while histological resolution was observed in 72.8% and 54.5% respectively. CONCLUSIONS: Addition of clofazimine helps to resolve leprosy lesions both clinically and histologically, thus justifying the concept of Uniform MDT regimen for all patients.     

Evaluation of leprosy patients with 1 to 5 skin lesions with relevance to their grouping into paucibacillary or multibacillary disease

BACKGROUND: Patients with 1 to 5 skin lesions are arbitrarily categorized as belonging to the paucibacillary (PB) group for treatment purposes. With the decreasing prevalence of leprosy in India and modifications in leprosy program, the relevance of this grouping needs further study. AIMS: To study a group of leprosy patients with 1 to 5 skin lesions and compare the clinical parameters with histopathological findings and bacteriological status of the skin and nerve to evaluate the relevance of this grouping. METHODS: Seventy seven patients of leprosy with 1 to 5 skin lesions were included in the study. The number of skin lesions was recorded. Slit skin smears (SSS) and skin biopsies were taken in all patients and nerve biopsy was performed in 19 of them. The biopsies were evaluated for the type of pathology and AFB status. RESULTS: In these 77 patients (single skin lesions, 42; two lesions, 18; three lesions, 10; four lesions, 5; and five lesions, 2 patients) the clinical classification was indeterminate leprosy (IL) in 4, tuberculoid leprosy (TT) in 4 patients and borderline tuberculoid leprosy (BT) in 69 patients. Skin smears were positive only in 1 patient. The histological diagnoses in the skin were IL in 13, TT in 3, BT in 48 and borderline lepromatous (BL) in 4 patients. Acid-fast bacilli (AFB) were found in 14 out of 77 skin biopsies. Of the 19 nerve biopsies, 17 showed histological features of BT leprosy; of these, 12 demonstrated AFB on Fite staining. The bacillary index of granuloma (BIG) ranged from 1+ to 2+. The clinico-histopathogical correlation was 63% in the BT group, with 4 patients of this group showing features of BL on histopathology. When the presence of AFB was assessed, the percentage of positivity was 1.3% in SSS, 18% in skin biopsies and 63% in nerve biopsies. CONCLUSION: Our results point to the non-homogeneous nature of this group of leprosy patients with 1 to 5 skin lesions, with varied bacteriological and histopathological features. The significance of MB type findings on histopathology in patients grouped as PB leprosy should be resolved so that these patients may be given the drug therapy and the duration of therapy they warrant.     

Characteristics of known leprosy contact in a high endemic area in Brazil

BACKGROUND AND PURPOSE: The annual number of new cases of leprosy has not declined in Brazil over the last 15 years, indicating that transmission continues at the same level. To study transmission, we interviewed leprosy patients about their known leprosy contact (KLC). METHODS: Clinical and demographic data were collected from 506 leprosy patients in four health units in the Metropolitan Region of Vit?ia, State of Espírito Santo, Brazil. SPSS 9.0 was used as a database and analysis. RESULTS: Two hundred and twenty-six (44.7%) of 506 leprosy patients reported KLC, 136 (60.2%) of 226 were parents. Among 226, the mean of KLC was 1.89 (SD +/- 1.65), and 61.3% had one KLC. KLC as a household contact was reported by 92 (40.7%) out of 226, and 121 (53.5%) had no household contact. KLC were most frequently sisters and brothers in the PB cases, and sons/daughters in MB cases. Mothers occurred more frequently as a KLC than fathers. From the leprosy patients that had reported household contacts, 73% said that at the onset of their skin lesions, the KLCs were either undergoing were not yet released from treatment (RFT), and 23.45% had not begun the treatment yet. Altogether, 62.3% of 226 cases had daily contact with the KLC. CONCLUSION: In Brazil, household contacts, including the family members (mothers, sisters and brothers), as well as the social contact need to be investigated by the control programs.     

Evaluation of polymerase chain reaction-based detection of Mycobacterium leprae for the diagnosis of leprosy

Because Mycobacterium leprae cannot be cultivated in vitro , laboratory diagnosis of leprosy is generally made by microscopic and histopathological examination. The objective of the present study was to evaluate the sensitivity and utility of polymerase chain reaction (PCR) to detect M. leprae in comparison with other conventional methods for diagnosis such as split skin smears, histopathology and serodiagnosis. PCR amplification of the M. leprae -specific 16S ribosomal RNA was compared to other methods. Samples included 37 multibacillary (MB) patients with a positive bacteriological index (BI), 32 newly diagnosed paucibacillary (PB) patients whose BI were negative and 30 plaque psoriasis patients not residing in leprosy endemic areas as controls. The sensitivity of PCR was 30 fg of M. leprae DNA, which is equivalent to the DNA from 8.3 bacilli. The detection rate in MB and PB were 100% and 50%, respectively; the specificity was 100%. Semiquantitative evaluation of PCR correlated well with BI, but not with the morphological index (MI) nor with the serum antibody against phenolic glycolipid-1 (PGL-1). PCR detection of M. leprae targeting 16S ribosomal RNA was specific and more sensitive than conventional methods, and can contribute to early and accurate diagnosis of leprosy.     

Evaluation of diagnostic role of in situ PCR on slit-skin smears in pediatric leprosy

A large proportion of early cases of leprosy in children remain AFB negative in skin smears. Such cases required additional techniques to confirm the diagnosis. In situ PCR on slit- skin smears is minimally invasive and less cumbersome as compared to skin biopsies. This study was initiated in our institute with the objective to evaluate the diagnostic value of in situ PCR on slit- skin smears in pediatric leprosy. A total of 25 cases of leprosy below 16 years of age were included in the study. After detailed history and thorough clinical examination, informed consent was obtained from the parents of children for slit- skin smears from lesion sites for AFB staining and for in situ PCR technique. Cases were clinically categorized according to IAL classification into indeterminate (I), tuberculoid tuberculoid (TT), borderline tuberculoid (BT), borderline borderline (BB), borderline lepromatous (BL) and lepromatous (LL). Most of the patients (76%) were between 9-16 years of age and 64% of the cases had history of contact with leprosy patients within the family. Skin smears were positive for AFB in only 20% of the cases. On applying in situ PCR, it was observed that 62.5% cases of I/TT/BT/BB category and 88.8% of BL/LL category gave positive signals. Overall in situ PCR confirmed the diagnosis in 72% cases while by slit smears diagnosis was confirmed in only 20% of cases. Further, out of 20 skin smear negative cases, 13 were positive by in situ PCR. Specificity of the signals of in situ PCR was established by demonstrating the absence of signals in nonleprosy dermatological conditions of vitiligo and P.alba. This study supports the potential usefulness of in situ PCR on slit- skin smears of early pediatric leprosy cases. This strategy will be especially useful in cases where skin smears are negative and in those cases where skin biopsy can not be done either because of unusual locations of lesions or because of sensitive age of the patients.     

Comparison of Bacillary Index on Slit Skin Smear with Bacillary Index of Granuloma in Leprosy and its Relevance to Present Therapeutic Regimens

Background:

As the world moves toward elimination of leprosy, persistence of infective cases in endemic pockets remains a significant problem. The use of clinical criteria to decide the paucibacillary (PB) versus multibacillary (MB) regimens has greatly simplified therapy at the field setting. However, a small but significant risk of under-treatment of so-called “PB” cases which actually have significant bacillary load exists. This study was undertaken to assess this risk and compare two methods of assessment of bacillary load, namely bacillary index on slit skin smear (BIS) versus bacillary index of granuloma (BIG).

Aims:

To compare BIS with BIG on skin biopsy in consecutive untreated cases of leprosy.

Materials and Methods:

This prospective study was conducted over a period of 12 months, wherein new untreated patients with leprosy were consecutively recruited. After a thorough clinical examination, each patient underwent slit skin smear (SSS) where the BIS was calculated. The same patient also underwent a skin biopsy from a clinical lesion where, the BIG was calculated. SSS and skin biopsy for BIS and BIG respectively were repeated for all patients at the end of therapy for comparison. All patients received therapy according to World Health Organization-Multidrug Therapy Guidelines.

Results:

The BIG was positive in all cases where the BIS was positive. Significantly, BIG was positive in three cases of borderline tuberculoid leprosy with <5 lesions who received PB regimen, whereas the BIS was negative in all three cases.

Conclusion:

This study suggests that BIG may be a better indicator of the true bacillary load in leprosy as compared to BIS. Its role in management is significant, at least in tertiary care centers to prevent “under-treatment” of so called PB cases, which may actually warrant MB regimens.     

A study on trend of relapse in leprosy and factors influencing relapse

A retrospective analysis of data pertaining to the rural field operation area of the Central Leprosy Teaching and Research Institute, Chengalpattu, Tamil Nadu, was carried out to determine the magnitude of relapse after MDT and its significance with other variables. The study included 3248 leprosy patients who have successfully completed treatment during 1987-2003, of whom 2892 were PB and 356 MB cases. A total of 58 cases of relapse was reported which gives a crude cumulative relapse rate of 1.78% for the 16-year period of follow-up and the rates for PB and MB were 1.9% and 0.84% respectively. With respect to PB cases, 68% of relapses were reported in the first 3 years of RFT. The person-year relapse rate was highly significant with regard to the number of skin lesions (p<0.0002) and nerve involvement (p<0.0002). The person-year relapse rate did not differ significantly between PB and MB leprosy, male and female, and child and adult cases. RFT year cohort relapse rate reveals that the introduction of MB-MDT regimen for PB leprosy had resulted in the reduction of relapses among PB cases after 1998. The relapse rate with reference to the time gap after RFT reveals that relapse declines with passage of time after RFT. The risk of relapse was very low in both PB and MB leprosy which fact emphasizes that proper counselling about signs and symptoms of relapse during RFT is adequate to combat the problem. A majority of relapses occurred in the first three years after RFT. The number of skin lesions and involvement of nerves were the main risk factors for relapse.     

Fine needle aspiration cytology (FNAC) of nerves in leprosy

Leprosy is primarily a disease of the peripheral nerves and a technique that is simpler than nerve biopsy is required to evaluate nerve involvement, especially in pure neuritic (PN) leprosy. This study was designed to evaluate the role of FNAC of the nerve in the diagnosis and classification of leprosy. A prospective study was carried out on 25 patients with clinically active leprosy and at least one thickened peripheral sensory nerve. Nerve aspirates were evaluated by May-Grunwald-Giemsa and Fite's staining. Lepromin test, slit skin smears (SSS), skin biopsies (except PN cases) and nerve biopsies were performed and compared with FNAC. FNAC of nerve from 23 cases (92%) yielded diagnostic aspirates. Acid fast bacilli were observed in six cases by FNAC. FNAC and nerve pathology were equally comparable with the other parameters evaluated. Based on the results, cytological criteria were developed for interpreting nerve aspirates and the cases were classified as paucibacillary (18), BB (2), BL (2), LL (1) and non-diagnostic (2). All PN cases showed diagnostic paucibacillary type cytology. FNAC of the nerve yields diagnostic aspirates in leprosy comparable with nerve pathology and the proposed cytological criteria may be useful in classification of nerve aspirates.     

A study on the impact of FD-MDT on 200 leprosy patients

A study was carried out from June 1999 to June 2001 to assess the impact of fixed duration multidrug therapy (FD-MDT) in newly detected cases of leprosy in terms of clinical and neurological improvement and changes in the bacillary index of skin smear for AFB. 200 new leprosy cases (both PB & MB) were started on FD-MDT. Of these 200 cases, 16 were of pure neuritic leprosy. After treatment, out of 184 cases with typical skin lesions of leprosy, all 26 PB cases showed inactivity of skin lesions, and, of the remaining 158 MB cases, 40.5% showed inactivity and 59.5% showed complete resolution of skin lesions. Out of 68 skin smear-positive cases, 42 cases with a BI of < or = 3 became smear-negative, while others showed gradual fall in the BI. Such heavily bacilliferous cases were continued with treatment for 1 more year to prevent relapse. As FD-MDT alone does not cure established sensory and motor impairment, it did not show any change in 19% of the patients presented with permanent sensory motor disturbance. FD-MDT prevents progression of sensory/motor disturbance.     

Patterns of erythropoiesis and anaemia in leprosy

A total of 128 leprosy patients were investigated for the morphological type of anaemia, the underlying disturbances in iron metabolism and patterns of erythropoiesis and other cytomorphological changes in the bone marrow. The anaemia was a mild to moderate degree in paucibacillary (PB) leprosy, while in multibacillary (MB) leprosy it was of a severe degree. Iron deficiency was observed in only a few patients. Impaired iron utilization as observed in a anaemia of a chronic disorder was a common finding in MB leprosy (41.7%) and more so in new cases (50%). Megaloblastic erythropoiesis was also more frequent in MB leprosy (45.2%) as compared to PB leprosy (16%), accounting for the severe degree of anaemia in the former type. In 17.2% of the total patients (MB, 21.4%; PB, 9%) both megaloblastic erythropoiesis and features of impaired iron utilization were observed in bone marrow. Disturbances in iron metabolism and erythropoiesis were also observed but to a lesser degree in patients receiving specific antileprosy treatment. Irrespective of the type of disease and duration of treatment, increasing frequency of acid-fast bacillia (AFB) positivity and granulomas was observed in the bone marrow with an increasing severity of anaemia.     

Relapses after multidrug therapy for leprosy: a preliminary report of 22 cases in west Nepal

The WHO recommended multidrug therapy regimens for leprosy patients were implemented in Nepal from 1982. Therefore a considerable number of both paucibacillary (PB) and multibacillary (MB) patients have been on observation after release from MDT, for as long as 4-5 years. A retrospective study was done considering the patients who relapsed during this period and who were registered at the Out-patients Department of Green Pastures Hospital in Pokhara, Nepal. A total of 22 patients relapsed out of 927 who were released from MDT.     

Treatment outcome and impact of leprosy elimination campaign in Sokoto and Zamfara states, Nigeria

A Leprosy Elimination Campaign (LEC) was implemented in 37 districts of Sokoto and Zamfara states, Nigeria from 13 August to 30 November 1998. The campaign utilized intensive community mobilization and training of local health personnel to detect hidden leprosy cases. During 8 weeks of case finding, 160,127 persons were screened; 353 new cases of leprosy were detected and placed on MDT; 236 (67%) of new cases detected were classified as MB, 64 cases (18%) suffered visible deformities and 24 patients (6.8%) were children. Follow-up in December 1999 of patients placed on MDT revealed 97% PB and 96% MB cure rates, respectively. Detection of cases in communities led some community leaders to ask for repeat surveys in their communities. Repeat surveys continue to yield new cases. The authors recommend that LECs be maintained for 3 years to accelerate leprosy elimination in the region. The cost effectiveness and impact of LEC in Sokoto-Zamfara are discussed.     

1990-2018年云南省新发麻风患者畸残情况分析

目的：分析云南省1990-2018年新发麻风患者2级畸残情况。方法：对1990-2018年11010例新发麻风患者资料进行分析。结果：新发病例中2级畸残2647例,2级畸残率24.04%。4006例少菌型患者中2级畸残者1294例（32.3%）, 7004例多菌型患者中畸残者1353例(19.3%)。对其中的2202例畸残者进一步分析,单侧和双侧眼部畸残分别为138例和184例,手部单双侧畸残分别为742例和430例,足部单双侧畸残分别为384例和144例。结论：少菌型（PB）比多菌型（MB）麻风患者畸残比例更高,手部畸残明显高于眼部和足部,手部和足部畸残常呈不对称性。     

Bacillaemia and bone marrow involvement in leprosy

Fifty patients (24 new and 26 receiving specific treatment) of leprosy were investigated to study the concentration and morphological index (MI) of the lepra bacilli in skin, peripheral blood and bone marrow. The organisms were detected in 28 cases on skin slit smear examination, in 38 cases on bone marrow examination and in 38 cases on examination of smears made from buffy coat of peripheral blood. Out of 22 cases negative for the bacilli on skin slit smears, 15 had the organisms either in buffy coat or bone marrow or both. Acid fast bacilli in peripheral blood and bone marrow with skin smear negativity were mainly observed in patients with paucibacillary type of the disease and in those who were receiving treatment. Examination of buffy coat and bone marrow for presence of lepra bacilli is suggested to establish the diagnosis in doubtful cases.     

Clinical trial for uniform multidrug therapy for leprosy patients in Brazil (U-MDT/CT-BR): adverse effects approach

Background:The Clinical Trial for Uniform Multidrug Therapy for Leprosy Patients in Brazil (U-MDT/CT-BR), designed to evaluate the effectiveness of a six-months regimen, assessed the adverse effects caused by the drugs.Objective:Describe adverse effects due to MDT in U-MDT/CT-BR, comparing the uniform regimen (U-MDT) to the current WHO regimen (R-MDT). Patients and methods: After operational classification, patients were randomly allocated to the study groups. U-MDT PB and U-MDT MB groups, received the U-MDT regimen, six doses of MB-MDT (rifampicin, dapsone and clofazimine). R-MDT PB and R-MDT MB groups, received the WHO regimens: six doses (rifampicin and dapsone) for PB and 12 doses (rifampicin, dapsone and clofazimine) for MB. During treatment, patients returned monthly for clinical and laboratorial evaluation. Patients with single lesion were not included in this trial.Results:Skin pigmentation (21.7%) and xerosis (16.9%) were the most frequent complaints among 753 patients. Laboratory exams showed hemoglobin concentration lower than 10g/dL in 23.3% of the patients, glutamic oxaloacetic transaminase (GOT) above 40U/L in 29.5% and glutamic pyruvic transaminase (GPT) above 40U/L in 28.5%. Twenty-four patients (3.2%) stopped dapsone intake due to adverse effects, of whom 16.6% due to severe anemia. One case of sulfone syndrome was reported.Study limitations:Loss of some monthly laboratory sample collection.Conclusions:There was no statistical difference regarding adverse effects in the R-MDT and U-MDT groups but anemia was greater in patients from R-MDT/MB group, therefore adverse effects do not represent a constraint to recommend the six-month uniform regimen of treatment for all leprosy patients.