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The authors hypothesize that this paradoxical worsening is due to a cytokine imbalance, similar to what is seen with the exacerbation of disease after administration of biological treatments like anti-TNF, which increases interferon (IFN)- release and leukocyte chemotaxis [25]

Combined, these studies involved fewer than 30 human subjects and lacked control groups none used a randomized, placebo-controlled design