There had
been an article on methotrexate (MTX) in knee osteoarthritis (OA), which had
been published in 2014. As it had been a double-blind, randomized controlled
trial, I had had a closer look at the article back then (1). Abou-Raya and colleagues submitted and published: "Methotrexate
in the treatment of symptomatic knee osteoarthritis: randomised
placebo-controlled trial". I had been critical about the article and the
results of the study. Today I revisited the article, as I wanted to know more
on subsequent trials.
I was quite surprised
that the article had been retracted. The Annals of Rheumatic diseases discussed
the decision (2). They listed eight points of “great concern”. And the
Investigation Committee’s report concluded: “There is an unintentional mistake
in the statistical process, with errors in collection of data in some groups”.
Let’s hope that Sarah R. Kingsbury and colleagues fare better with their
study: “Pain reduction with oral methotrexate in knee
osteoarthritis, a pragmatic phase III trial of treatment effectiveness
(PROMOTE): study protocol for a randomized controlled trial”. (3) Discussion: “The PROMOTE trial is designed to examine whether MTX is an effective
analgesic treatment for OA. The MRI substudy will address the relationship
between synovitis and symptom change. This will potentially provide a much
needed new treatment for knee OA.” The follow-up should have been completed by
December 2016, so we should get results during 2017. Allow me already to voice some
doubts. MTX is an immunosuppressant and any reduction of pain is due to this
mode of action (4). Chronic
low-grade inflammation is thought as a major driver of joint degradation in osteoarthritis
(5); and it's unclear if MTX suppresses this kind of inflammation. “Despite the clear role of inflammation in OA, recent trials of potent
anti-inflammatory therapies, including use of systemic and intra-articular
biologic agents to inhibit TNFα and IL-1β, proved disappointing [Hunter,
2008].”
But let’s wait for the publication
of the PROMOTE study, which I’ve just misspelled as PRO MORTE.
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