A Randomized Clinical Trial of Intravenous Methylprednisolone With 2 Protocols in Patients With Graves Orbitopathy
Authors' conclusion
The efficacy and safety of the 2 protocols are comparable; the monthly protocol could be used as an alternative to the weekly protocol.
Study context
- Population
- Patients aged 18–60 years with active, moderate to severe Graves orbitopathy (GO), previously untreated; third affiliated hospital of Southern Medical University
- Participants
- 58 patients
- Comparison
- Weekly vs monthly IV methylprednisolone protocol
- Primary endpoint
- Overall effective rate
Methodological detailsprospective, observer-masked, single-centre, Follow-up to week 24
- Prospective
- Observer-masked
- Single-centre
- Follow-up to week 24
Primary result
As reported in the abstract
Effective rate · week 12
- Between Weekly protocol and Monthly protocol: P = 0.195
Further findings
| Outcome | P value |
|---|---|
| Effective rate · up to week 24No significant difference | P = 0.441 |
Clinical activity score, exophthalmos, soft tissue involvement, diplopia and quality of life (QOL) improvement
- No significant difference between the 2 groups
Mean and maximum signal intensity ratio (SIR) · up to week 24
- Lower than before treatment in both groups; no statistically significant difference between groups
Safety
| Outcome | P value |
|---|---|
| Adverse eventsNo significant difference in incidence | P = 0.773 |
Original publication
A Randomized Clinical Trial of Intravenous Methylprednisolone With 2 Protocols in Patients With Graves Orbitopathy. J Clin Endocrinol Metab. Published 14 August 2023. doi:10.
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