A randomized pilot study of atractylenolide I on gastric cancer cachexia patients.

We determined the therapeutic efficacy of atractylenolide I (ATR), extracted from largehead atractylodes rhizome, in managing gastric cancer cachexia (GCC), and interpreted its probable pharmacological mechanism via investigating tumor necrosis factor alpha (TNF-alpha), interleukin-1 (IL-1), interleukin-6 (IL-6) and proteolysis-inducing factor (PIF). This was a randomized but not-blinded pilot. The study group (n = 11) received 1.32 g per day of atractylenolide I (ATR) and the control group (n = 11) received 3.6 g per day of fish-oil-enriched nutritional supplementation (FOE) for 7 weeks. Conservative therapy was similar in both groups. Clinical [appetite, body weight, mid-arm muscle circumference (MAMC), Karnofsky performance status (KPS) status], biomarker (TNF-alpha, IL-1, IL-6 and PIF) were evaluated in the basal state, at the third and seventh weeks. To analyze changes of cytokines, an immumohistochemistry technique was adopted. Base line characteristics were similar in both groups. Effects on MAMC and body weight increase, TNF-alpha increase and IL-1 decreases of serum level were significant in both groups (P < 0.05). ATR was significantly more effective than FOE in improving appetite and KPS status, and decreasing PIF positive rate (P < 0.05). Slight nausea (3/11) and dry mouth (1/11) were shown in intervention groups but did not interrupt treatment. These preliminary findings suggest that ATR might be beneficial in alleviating symptoms, in modulating cytokine and in inhibiting PIF proteolysis of gastric cancer cachexia. Further research using a randomized controlled design is necessary to confirm these pilot study findings.