Methotrexate to treat hand osteoarthritis with synovitis (METHODS): an Australian, multisite, parallel-group, double-blind, randomised, placebo-controlled trial
Authors' conclusion
Treatment of hand osteoarthritis and synovitis with 20 mg methotrexate for 6 months had a moderate but potentially clinically meaningful effect on reducing pain
Study context
- Population
- Participants aged 40–75 years with hand OA (Kellgren and Lawrence grade ≥2 in at least one joint) and MRI-detected synovitis grade 1 or more, recruited from the community in Melbourne, Hobart, Adelaide and Perth, Australiarandomly assigned
- Participants
- 97 participants
- Comparison
- Methotrexate 20 mg orally once weekly for 6 months vs identical placebo
- Methotrexaten = 50
- Placebon = 47reference
- Primary endpoint
- Pain reduction in the study hand (100 mm VAS), ITT population
- Follow-up
- 6 months
Methodological detailsmultisite, parallel-group, double-blind, placebo-controlled, block randomisation stratified by site and sex, Nov 22, 2017 to Nov 8, 2021
- Multisite
- Parallel-group
- Double-blind
- Placebo-controlled
- Block randomisation stratified by site and sex
- Nov 22, 2017 to Nov 8, 2021
Primary result
As reported in the abstract
Mean change in VAS pain
Methotrexate
−15.2
mean · SD 24.0 · mm
Placebo
−7.7
mean · SD 25.3 · mm
Each group vs placeboMean between-group difference (95% CI)P value
Methotrexate
−9.9(−19.3 to −0.6)
P = 0.037- Methotrexate
- effect size (SMD) 0.45 (95% CI 0.03–0.87)
Safety
Adverse events · all randomly assigned participants
Original publication
Methotrexate to treat hand osteoarthritis with synovitis (METHODS): an Australian, multisite, parallel-group, double-blind, randomised, placebo-controlled trial. Lancet. Published 12 October 2023. doi:10.
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