Trial reportPLoS neglected tropical diseases2016
A Randomized Controlled Double Blind Trial of Ciclosporin versus Prednisolone in the Management of Leprosy Patients with New Type 1 Reaction, in Ethiopia.
Trial report in PLoS neglected tropical diseases, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 3 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
14 citing papers in PubMed, 3 syntheses or guidelines pooled it, 39 citations in OpenAlex.
- A systematic review of adverse effects associated with systemic corticosteroids in the management of leprosy.PLoS neglected tropical diseases · 2026Pooled it
- Descriptions of the natural history of erythema nodosum leprosum to inform clinical classification - A semi-systematic review.PLoS neglected tropical diseases · 2026Pooled it
- Revised estimates of leprosy disability weights for assessing the global burden of disease: A systematic review and individual patient data meta-analysis.PLoS neglected tropical diseases · 2021Pooled it
- Effectiveness of 32 versus 20 weeks of prednisolone in leprosy patients with recent nerve function impairment: A randomized controlled trial.PLoS neglected tropical diseases · 2017Trial
- Involvement of African patient populations in clinical trials on leprosy: a scoping review.Tropical medicine and health · 2026Review
- Pattern of treatment outcome and safety of prednisolone in the treatment of leprosy reactions among leprosy patients in ALERT hospital: a retrospective cohort study.BMC infectious diseases · 2026Article
- Leprosy.Nature reviews. Disease primers · 2024Review
- Methotrexate as a corticosteroid-sparing agent in leprosy reactions: A French multicenter retrospective study.PLoS neglected tropical diseases · 2023Article
- Metformin as adjunctive therapy in combination with multidrug treatment for multibacillary leprosy: A protocol for a randomized double-blind, controlled Phase 2 trial in Indonesia (MetLep Trial).Wellcome open research · 2023Article
- Treatment and Evaluation Advances in Leprosy Neuropathy.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2021Review
- Management of leprosy patients in the era of COVID-19.Dermatologic therapy · 2020Article
- Clinico-pathological features of erythema nodosum leprosum: A case-control study at ALERT hospital, Ethiopia.PLoS neglected tropical diseases · 2017Article
- A leprosy clinical severity scale for erythema nodosum leprosum: An international, multicentre validation study of the ENLIST ENL Severity Scale.PLoS neglected tropical diseases · 2017Article
- Risk Factors for Disability Upgrading Among Leprosy Patients During Treatment: Multilevel Modeling Analysis.SAGE open nursingArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundLeprosy 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.
resultsSeventy 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.
conclusionsThis 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.
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