Acute onset/exacerbation of dermatomyositis and Sjogrens Syndrome following ingestion of IsaLean® herbal supplement: Clinical and immunostimulatory findings

Summary: The use of complementary and alternative medicine has gained popularity in the US over the last few decades. However, herbal supplements are known to have adverse medical effects. We observed two patients with acute onset/flare of their classic dermatomyositis (DM) and one patient with acute onset of Sjogren's syndrome (SS) after the ingestion of IsaLean®, an herb-based weight-loss product. The purpose of this study was to investigate and characterize the immunostimulatory properties of the herbal and dietary supplement IsaLean®. Peripheral blood mononuclear cells were isolated from five DM patients and five control subjects stimulated with increasing concentrations of IsaLean®: 0, 0.05, 0.5, and 5 µg/ml to evaluate the cellular production of tumor necrosis factor alpha (TNFα), interferon alpha (IFN-α), and interferon beta (IFN-β), which are key pathogenic cytokines in DM and SS. The cells were also incubated with IsaLean® and lipopolysaccharide (LPS), and the effect of neutralizing anti-TLR4, quinacrine (QC), and hydroxychloroquine (HCQ) on the cellular production of TNFα was examined. Cytokine production was measured by enzyme-linked immunosorbent assay. The one-way analysis of variance with Dunnett's multiple comparison test was used to compare the level of TNF-α, IFN-α, and IFN-β after stimulation with Isalean and treatment with anti-TLR4, QC, and HCQ. IsaLean® increased cellular secretion of TNFα at 0.5 µg/ml (p<0.01) and 5 µg/ml (p<0.001). Anti-TLR4 suppressed cellular secretion of TNFα from IsaLean® (p<0.001) and LPS-stimulated cells (p<0.01). QC significantly reduced the production of TNFα from IsaLean® (p<0.001) and LPS-stimulated cells (p<0.05) compared to HCQ. Ultimately, IsaLean® induced secretion of key immunostimulatory cytokines (TNFα, IFN-α, and IFN-β) from immune cells of DM patients in vitro. Further, the results suggest the pro-stimulatory effects of IsaLean® are mediated through TLR4.