Trial reportPLoS neglected tropical diseases2011
A phase two randomised controlled double blind trial of high dose intravenous methylprednisolone and oral prednisolone versus intravenous normal saline and oral prednisolone in individuals with leprosy type 1 reactions and/or nerve function impairment.
Trial report in PLoS neglected tropical diseases, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
19 citing papers in PubMed, 2 syntheses or guidelines pooled it, 46 citations in OpenAlex.
- A systematic review of adverse effects associated with systemic corticosteroids in the management of leprosy.PLoS neglected tropical diseases · 2026Pooled it
- Corticosteroids for treating nerve damage in leprosy.The Cochrane database of systematic reviews · 2016Pooled it
- AZALEP a randomized controlled trial of azathioprine to treat leprosy nerve damage and Type 1 reactions in India: Main findings.PLoS neglected tropical diseases · 2017Trial
- A Randomized Controlled Double Blind Trial of Ciclosporin versus Prednisolone in the Management of Leprosy Patients with New Type 1 Reaction, in Ethiopia.PLoS neglected tropical diseases · 2016Trial
- Trial
- 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
- Exploring the Neurological Manifestations of Leprosy: Clinical Insights and Implications.Cureus · 2025Review
- Progression of the leprosy reaction and nerve damage: A prospective cohort study in children with leprosy from the Brazilian Amazon.PLoS neglected tropical diseases · 2024Article
- Leprosy.Nature reviews. Disease primers · 2024Review
- Case report: Injected corticosteroids for treating leprosy isolated neuritis.Frontiers in medicine · 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
- Gene Expression Profile ofFrontiers in medicine · 2022Article
- Analysis of therapeutic effectiveness and adverse effects of long-term corticosteroids among leprosy patients with reactions: A retrospective cohort study.SAGE open medicine · 2022Article
- Treatment and Evaluation Advances in Leprosy Neuropathy.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2021Review
- 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
- Viral Co-infection and Leprosy Outcomes: A Cohort Study.PLoS neglected tropical diseases · 2015Article
- Household costs of leprosy reactions (ENL) in rural India.PLoS neglected tropical diseases · 2015Article
- Clofazimine modulates the expression of lipid metabolism proteins in Mycobacterium leprae-infected macrophages.PLoS neglected tropical diseases · 2012Article
- Human beta-defensin 3 is up-regulated in cutaneous leprosy type 1 reactions.PLoS neglected tropical diseases · 2012Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 3 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundLeprosy Type 1 reactions are a major cause of nerve damage and the preventable disability that results. Type 1 reactions are treated with oral corticosteroids and there are few data to support the optimal dose and duration of treatment. Type 1 reactions have a Th1 immune profile: cells in cutaneous and neural lesions expressing interferon-γ and interleukin-12. Methylprednisolone has been used in other Th1 mediated diseases such as rheumatoid arthritis in an attempt to switch off the immune response and so we investigated the efficacy of three days of high dose (1 g) intravenous methylprednisolone at the start of prednisolone therapy in leprosy Type 1 reactions and nerve function impairment.
resultsForty-two individuals were randomised to receive methylprednisolone followed by oral prednisolone (n = 20) or oral prednisolone alone (n = 22). There were no significant differences in the rate of adverse events or clinical improvement at the completion of the study. However individuals treated with methylprednisolone were less likely than those treated with prednisolone alone to experience deterioration in sensory function between day 29 and day 113 of the study. The study also demonstrated that 50% of individuals with Type 1 reactions and/or nerve function impairment required additional prednisolone despite treatment with 16 weeks of corticosteroids.
conclusionsThe study lends further support to the use of more prolonged courses of corticosteroid to treat Type 1 reactions and the investigation of risk factors for the recurrence of Type 1 reaction and nerve function impairment during and after a corticosteroid treatment.
trial registrationControlled-Trials.com ISRCTN31894035.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.