Evidence map›Paper›PMID 21819556›Full record

Trial reportBMC neurology2011

A single-blinded trial of methotrexate versus azathioprine as steroid-sparing agents in generalized myasthenia gravis.

Jeannine M Heckmann, Amanullah Rawoot, Kathleen Bateman, Rudi Renison, Motasim Badri

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC neurology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 2 pooled it
4.1field-weighted citation impact, top 6% of its field
1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

32 citing papers in PubMed, 2 syntheses or guidelines pooled it, 117 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Phase II trial of methotrexate in myasthenia gravis.Annals of the New York Academy of Sciences · 2012
    Trial
  7. Article
  8. Guideline for the management of myasthenic syndromes.Therapeutic advances in neurological disorders · 2023
    Review
  9. Review
  10. Review
  11. Article
  12. Review
  13. Adverse Side Effects Associated with Corticosteroid Therapy: A Study in 39 Patients with Generalized Myasthenia Gravis.Medical science monitor : international medical journal of experimental and clinical research · 2021
    Article
  14. Review
  15. Review
  16. Review
  17. Article
  18. Management of Juvenile Myasthenia Gravis.Frontiers in neurology · 2020
    Review
  19. Review
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 1 institution in 2 countries.

Jeannine M HeckmannDepartment of Medicine, Division of Neurology, University of Cape Town, Observatory, Cape Town, 7925, South Africa. Jeanine.heckmann@uct.ac.za
Amanullah Rawoot
Kathleen Bateman
Rudi Renison
Motasim Badri
University of Cape Town · ZA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLong-term immunosuppression is often required in myasthenia gravis (MG). There are no published trials using methotrexate (MTX) in MG. The steroid-sparing efficacy of azathioprine (AZA) has been demonstrated after 18-months of starting therapy. However, AZA is considered expensive in Africa. We evaluated the steroid-sparing efficacy of MTX (17.5 mg weekly) compared with AZA (2.5 mg/kg daily) in subjects recently diagnosed with generalized MG by assessing their average monthly prednisone requirements.

methodsThe primary outcome was the average daily prednisone requirement by month between the two groups. Prednisone was given at the lowest dose to manage MG symptoms and adjusted as required according to protocol. Single-blinded assessments were performed 3-monthly for 2-years to determine the quantitative MG score and the MG activities of daily living score in order to determine those with minimal manifestations of MG.

resultsThirty-one subjects (AZA n = 15; MTX n = 16) satisfied the inclusion criteria but only 24 were randomized. Baseline characteristics were similar. There was no difference between the AZA- and MTX-groups in respect of prednisone dosing (apart from months 10 and 12), in quantitative MG Score improvement, proportions in sustained remission, frequencies of MG relapses, or adverse reactions and/or withdrawals. The MTX-group received lower prednisone doses between month 10 (p = 0.047) and month 12 (p = 0.039). At month 12 the prednisone dose per kilogram bodyweight in the MTX-group (0.15 mg/kg) was half that of the AZA-group (0.31 mg/kg)(p = 0.019).

conclusionsThis study provides evidence that in patients with generalized MG methotrexate is an effective steroid-sparing agent 10 months after treatment initiation. Our data suggests that in generalized MG methotrexate has similar efficacy and tolerability to azathioprine and may be the drug of choice in financially constrained health systems.

trial registrationSANCTR:DOH-27-0411-2436.

Indexed as

AdultAzathioprineFemaleHumansImmunosuppressive AgentsMaleMethotrexateMiddle AgedMyasthenia GravisPrednisoneSingle-Blind MethodAzathioprineImmunosuppressive AgentsMethotrexatePrednisone

Identifiers

PMID21819556
PMCPMC3170595
OpenAlexW2059811371

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.