A Randomized Controlled Double Blind Trial of Ciclosporin versus Prednisolone in the Management of Leprosy Patients with New Type 1 Reaction, in Ethiopia.

BACKGROUND: Leprosy Type 1 (T1R) reactions are immune-mediated events leading to nerve damage and preventable disability affecting hands, feet and eyes. Type 1 Reactions are treated with oral corticosteroids. There is little evidence on alternative treatments for patients who do not respond to steroids or experience steroid adverse effects. We report the results of a randomized controlled trial testing the efficacy and adverse effect profile of ciclosporin and prednisolone (CnP) in comparison to prednisolone only (P) in patients with new T1R in Ethiopia. Ciclosporin is a potent immunosuppressant. Outcomes were measured using a clinical severity score, recurrence rate, adverse events and quality of life. RESULTS: Seventy three patients with new T1R were randomized to receive CnP or P for 20 weeks. Recovery rates in skin signs was similar in both groups (91% vs 88%). Improvements in nerve function both, new and old, sensory (66% vs 49%) and motor (75% vs 74%) loss were higher (but not significantly so) in the patients on CnP. Recurrences rates of T1R (85%) were high in both groups, and recurrences occurred significantly earlier (8 weeks) in patients CnP, who needed 10% more additional prednisolone. Serious major and minor adverse events rates were similar in patients in the two treatment arms of the study. Both groups had a significant improvement in their quality of life after the study, measured by the SF-36. CONCLUSIONS: This is the first double-blind RCT assessing ciclosporin, in the management of T1R in Africa. Ciclosporin could be a safe alternative second-line drug for patients with T1R who are not improving with prednisolone or are experiencing adverse events related to prednisolone. This study illustrates the difficulty in switching off leprosy inflammation. Better treatment agents for leprosy patients with reactions and nerve damage are needed.

Performance of general health workers in leprosy control activities at public health facilities in Amhara and Oromia States, Ethiopia.

BACKGROUND: Leprosy is a chronic infectious disease of public health importance and one of the leading causes of permanent physical disability. Nevertheless, the drop in prevalence following multidrug therapy has resulted in the neglect of leprosy. The annual incidence of leprosy has remained the same in Ethiopia since decades with more than 76% of the reported new cases coming from Oromia and Amhara Regional States. This study was aimed to assess the knowledge, attitude and skill of general health workers in leprosy control activities at public health facilities in Oromia and Amhara Regional States. METHODS: A cross-sectional study was conducted from September 2011 to February 2012 at different public health facilities in selected eight zones in Oromia and Amhara Regional States. A multistage sampling method was used to obtain representative samples. High and low endemic zones for leprosy were included in the study in both regional states. Data were collected from general health workers through a structured self-administered questionnaire and at on-site assessment of their performance. Baseline socio-demographic data, health workers' attitude towards leprosy and their knowledge and skill in the management of leprosy were assessed. Bloom's cut off point was used to describe the knowledge and practical skills of the respondents while Likert's scale was used for attitude assessment. RESULT: A total of 601 general health workers responsible for leprosy control activities at public health facilities were included in knowledge and attitude assessment and 83 of them were subjected to practical evaluation, with on-site observation of how they handle leprosy patients. These included medical doctors (4%), health officers and nurses with Bachelor degree in Science (27%), clinical nurses with diploma (66%) and health assistants (2.8%). The median age of the respondents was 26.0 years and females made up of 45%. Generally the knowledge and skills of the respondents were found to be poor while attitude towards leprosy was positive for the majority of the respondents. The result showed that 519 (86.3%) had poor knowledge. Overall 155 (25.8%) of the respondents had positive attitude towards leprosy while 205 (34.1%) had intermediate (mixed) attitude and 241 (40.1%) had negative attitude to the disease. Among 83 respondents assessed for diagnosis of leprosy only 15(18.0%) diagnosed leprosy correctly. Variation in knowledge and attitude indicated a significant difference (p < 0.05) among different health institutions, professions, gender, in-service training and years of experience. CONCLUSION: The current finding underlines that although leprosy control activities are integrated to the general health services in the country, the knowledge and skills of leprosy diagnosis, treatment and management by health workers was unsatisfactory. Hence, attention should be given to develop training strategies that can improve health worker knowledge and promote better leprosy management at public health facilities. This could be achieved through pre-service and in-service training and giving adequate emphasis to leprosy related practical work and continuous follow- up.

Comparison of Efficacy and Safety of Ciclosporin to Prednisolone in the Treatment of Erythema Nodosum Leprosum: Two Randomised, Double Blind, Controlled Pilot Studies in Ethiopia.

BACKGROUND: Erythema Nodosum Leprosum (ENL) is a serious complication of leprosy. It is normally treated with high dose steroids, but its recurrent nature leads to prolonged steroid usage and associated side effects. There is little evidence on the efficacy of alternative treatments for ENL, especially for patients who have become steroid resistant or have steroid side effects. These two pilot studies compare the efficacy and side effect profile of ciclosporin plus prednisolone against prednisolone alone in the treatment of patients with either new ENL or chronic and recurrent ENL. METHODS AND RESULTS: Thirteen patients with new ENL and twenty patients with chronic ENL were recruited into two double-blinded randomised controlled trials. Patients were randomised to receive ciclosporin and prednisolone or prednisolone treatment only. Patients with acute ENL had a delay of 16 weeks in the occurrence of ENL flare-up episode, with less severe flare-ups and decreased requirements for additional prednisolone. Patients with chronic ENL on ciclosporin had the first episode of ENL flare-up 4 weeks earlier than those on prednisolone, as well as more severe ENL flare-ups requiring 2.5 times more additional prednisolone. Adverse events attributable to prednisolone were more common that those attributable to ciclosporin. CONCLUSIONS: This is the first clinical trial on ENL management set in the African context, and also the first trial in leprosy to use patients' assessment of outcomes. Patients on ciclosporin showed promising results in the management of acute ENL in this small pilot study. But ciclosporin, did not appear to have a significant steroid-sparing effects in patients with chronic ENL, which may have been due to the prolonged use of steroids in these patients in combination with a too rapid decrease of steroids in patients given ciclosporin. Further research is needed to determine whether the promising results of ciclosporin in acute ENL can be reproduced on a larger scale.

The pattern of bacterial isolates and drug sensitivities of infected ulcers in patients with leprosy in ALERT, Kuyera and Gambo hospitals, Ethiopia.

INTRODUCTION: Leprosy remains a public health problem, mainly in Africa, Asia and Latin America. Leprosy has many complications that include leprosy reactions, development of plantar and hand ulcerations, lagophthalomus and corneal anesthesia. OBJECTIVES: In Ethiopia there is scarce information on the pattern of bacterial isolates and drug sensitivities of infected ulcers in patients with leprosy. This study was undertaken to identify the bacteriology of infected ulcers and to determine their antimicrobial susceptibility pattern. STUDY DESIGN: A descriptive cross-sectional study was conducted in 245 informed and consented leprosy patients with infected ulcers visiting ALERT, Kuyera and Gambo hospitals during the period August 2006 to May 2007. MATERIAL AND METHODS: Wound aspirate specimens were collected from ulcers of each patient aseptically and inoculated into standard bacteriological media. Antimicrobial susceptibility testing was performed for all isolates according to the criteria of the National Committee for Clinical Laboratory Standards (NCCLS) by disk diffusion method. RESULTS: Of the 245 patients investigated, 64.1% were males and 35.9% females (P < 0.05). The average age of the patients was 50 years (age range 13 to 92 years). According to Ridley-Jopling classifications, patients presented with TT (3.7%), BT, (31.4%), BL (44.5%) and LL (15.9%) types of leprosy. Plantar and hand ulcers were observed in 92.2% and 7.8% of patients, respectively. According the patients, the commonest cause of their ulcers was 'spontaneous' (56.7%). There were 44% Gram-positive and 56% Gram negative bacteria (P > 0.05). Proteus spp. accounted for 29.5% of the total isolates followed by Staphylococcus spp. (28.8%), beta-hemolytic streptococci (15.1%) and different types of Gram-negative bacteria (26.2%). Multiple organisms (two or three) were isolated from 19.6% patients. Of the 212 wound samples cultured anaerobically, 5.2% were positive for anaerobic culture. In this study both Gram-positive and Gram negative bacteria showed decreased sensitivity to most antimicrobial agents tested. CONCLUSION: Proteus spp. was the most common isolate from infected ulcers. Ciprofloxacin, norfloxacin and gentamicin were the most effective drugs against the tested bacteria mainly for Gram-negative bacteria. This refers to the in vitro-sensitivity during the study period. The results of this study may help inform clinicians about the selection of an antibiotic in situations where use of an antibiotic may be indicated.

Outbreak of cutaneous leishmaniasis in Silti woreda, Ethiopia: risk factor assessment and causative agent identification.

An outbreak of skin lesions was reported in June 2005 in the district of Silti woreda, 150 km south of Addis Ababa, by the Christian Children's Fund (CCF) and confirmed to be cutaneous leishmaniasis (CL) by our group from the Armauer Hansen Research Institute in July 2005. A house-to-house survey of 1907 residents in three kebeles of Silti woreda conducted in April 2006 showed a prevalence of 4.8%. RFLP analysis of the internal transcribed spacer RNA (ITS1) showed that Leishmania aethiopica was the causative agent. In the survey, it was found that the age group 11-20 years was the most affected. Environmental factors such as proximity of the house to the gorge where hyraxes reside, presence of the plants Adhatoda schimperiana and Acacia spp. in the compound and sharing the same room with domestic animals were significantly associated with developing CL. The prevalence of active disease was higher in Kibet town (10.4%) compared to the rural kebeles. The identified risk factors of CL in the area need further study. The appearance of leishmaniasis in Silti, which was not known to be endemic for the disease, underlines the need to initiate a leishmaniasis control program in Ethiopia to limit its expansion.