medwireNews: The use of concomitant medications that may influence outcomes is “poorly reported” in rheumatology trials, say researchers.
Michele Iudici (University Hospitals of Geneva, Switzerland) and study co-authors analyzed data from 109 randomized controlled trials (RCTs) published in the five rheumatology and five general medical journals with the highest impact factors. Most (81%) of the trials were industry-funded and they most commonly focused on patient populations with rheumatoid arthritis (47%).
As reported in Seminars in Arthritis and Rheumatism, the permitted dosage of concomitant medications was missing in 38% of trials studied, and incompletely reported in 23%. Information on the range of doses permitted was missing in 95% of cases for nonsteroidal anti-inflammatory drugs, 85% of cases for analgesics, and 40% for oral glucocorticoids. Moreover, the baseline number of patients taking concomitant medications per arm was lacking in 18% of trials.
These results demonstrate that “the description of the use of concomitant medications in rheumatology RCTs is poor and can represent a threat to study conclusion validity,” say Iudici and team.
“[W]e believe that this issue would deserve more attention in rheumatology where the management of inflammatory or systemic autoimmune diseases very often requires the use of treatment strategies based on a combination of drugs,” they conclude.
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Semin Arthritis Rheum 2019; doi:10.1016/j.semarthrit.2019.03.009