In this month’s issue of the Scandinavian Journal of Gastroenterology John E. Eaton et al., reports on the results of a 12-week open-label pilot study to examine whether curcumin, a naturally occurring compound, could reduce the markers of cholestasis in patients with PSC. Curcumin is the principal curcuminoid of the rhizome turmeric (Curcuma longa) and is believed to have anti-inflammatory and anti-oxidant effects. Curcumin may function as a free radical scavenger and reduce oxidative damage through several proposed mechanisms. In two separate rodent models of cholestasis curcumin was associated with a reduction in liver enzymes and improvement in hepatic histology.
In this pilot study by John E. Eaton et al., patients with PSC and a serum alkaline phosphatase (SAP) greater than 1.5 x the upper limit of normal (ULN) received curcumin 750 mg orally twice daily for 12 weeks. The primary study endpoint was the proportion of subjects who had a reduction of SAP to less than 1.5 x ULN or a 40% reduction in SAP between baseline and week 12. Secondary study endpoints included changes in serum aspartate aminotransferase, total bilirubin, Mayo PSC risk score and self-reported health questionnaires. The authors screened 258 patients with PSC in order to enroll 15 subjects. The most common reason for subject exclusion was SAP < 1.5 x ULN (n = 98 or 38%). Curcumin did not result in a significant median (interquartile range) change in SAP x ULN [3.43 (2.10–4.32) to 2.46 (1.89–4.41), p = .36] and only 20% (3/15) of subjects achieved the primary study endpoint. There was no significant change in the secondary study endpoints. The authors did not report any serious adverse events among the enrolled patients. In summary, curcumin was well tolerated by the study participants but it was not associated with significant improvement of cholestasis or symptoms.
In this first clinical trial of curcumin among patients with PSC only 20% of the subjects, rather the target of 30%, met the primary study endpoint. Moreover, the study emphasizes that a SAP of <1.5 x ULN is common among patients with PSC. This observation, which highlights the known fluctuation of SAP during the course of PSC, makes this biomarker suboptimal as a tool to predict the progression of disease. Thus, there is an urgent need to discover more reliable biomarkers of PSC in order to better understand the disease progression and ultimately to improve its therapy.
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