Evidence-Based Complementary and Alternative Medicine Table 1: Baseline characteristics of experimental and control groups. Characteristic Male/female Mean age (years) Body mass index (kg/m2) Smokers Mean no. standard alcoholic drinks/week DP group (n = 20) 8/12 53.3 ± 10.7 26.0 ± 4.4 0a 3.6 ± 2.6a Placebo group (n = 20) 7/13 51.6 ± 14.4 25.2 ± 3.6a 4 4.7 ± 4.1 a n = 19 (data not shown for one subject). San Diego, CA, USA) for 1 h, protected from light, then washed in 0.5 mL HBSS to remove residual antibody and analyzed using the FACS scanning ﬂow cytometer and CellQuest software (Becton Dickinson, Franklin Lakes, NJ, USA). Assays for other serum markers were conducted in the Pathology Department of the Alfred Hospital using estab- lished techniques. These included total serum cholesterol, triglycerides, HDL-cholesterol and C-reactive protein (Roche method for ﬁrst 3 months then Abbott method for remainder of study, cross-calibrated for consistency of values), LDL cholesterol (Abbott, Illinois, USA), homocysteine (Abbott AxSym), ﬁbrinogen (Von Claus method on Diagnostica Astago STAR), Von Willebrand Factor (ELISA manual method). 2.5. Statistical Analysis. The study was designed to be able to identify a 10% change in total serum cholesterol and LDL- cholesterol with a Type 1 error of 0.05 with a power of 0.8. Within-groups analyses were conducted on all deﬁned outcome variables. Where data were normal, the paired Student t-test was used. Where tests for normality of data were violated the Wilcoxon Signed Ranks Test was used. A two-sided P-value of .05 was considered as statistically signiﬁcant. 3. Results A total of 40 subjects, 20 in each medication group, completed the study protocol. The characteristics of par- ticipants in each group are set out in Table 1. There was no signiﬁcant diﬀerence between the two groups in terms of mean age of participants, alcohol use, physical activity, dietary content or body mass index. Physical activity did not change signiﬁcantly in either group over the study period, as measured by the Baecke Physical Activity Questionnaire [17]. 3.1. CAM. Circulating levels of ICAM-1 and E-selectin decreased signiﬁcantly in the DP group (by 9 and 15%, resp.). In the Placebo group there were no signiﬁcant changes in any of the CAMs tested. There was no signiﬁcant change in VCAM-1 levels in either group (Table 2). 3 3.2. Adverse Eﬀects. There was no diﬀerence in reported adverse eﬀects between the two groups. Five participants in the Placebo group and three in the DP group reported various symptoms, predominantly gastrointestinal in nature, such as bloating, alteration of stools, mild nausea, belching and gastric reﬂux. One participant in the Placebo group discontinued the study 6 weeks after randomization due to indigestion. 3.3. Biochemical and Hematological Analyses. There were no clinically or statistically signiﬁcant changes in urea and electrolytes, blood glucose, lipids, hemoglobin, platelet count, white cell count or C-reactive protein in either group (data not shown). There were minor changes in derived hematological parameters and bilirubin within the reference range for normal adults in both groups, which were not diﬀerent between the two groups. The liver enzyme alanine transferase declined signiﬁcantly within the reference range in the DP group (P = .02) but did not change in the Placebo group. 4. Discussion This study has shown that 12 weeks administration of the Chinese herbal mixture DP to men and women with mild-to-moderate elevation in lipid levels is associated with reduced expression of the CAMs ICAM-1 and E-selectin. The study has also shown that in this setting the preparation is well tolerated and free from signiﬁcant biochemical adverse eﬀects. CAMs have emerged as a risk factor for CVD. They are believed to play important roles in the initiation of the atherosclerotic process by mediating various steps in leukocyte recruitment. Upregulation of adhesion molecule expression in the development of atherogenesis has been observed in both animal models and humans [18, 19]. Leukocyte recruitment to atherosclerosis sites is mediated by CAM expressed on the surface of endothelial cells, which bind circulating leukocytes to the vascular endothelium in the early phase of atherosclerosis [6]. CAM gene expression is upregulated in inﬂammatory states through cytokine release by various cells including endothelial cells, smooth muscle cells and leukocytes [1]. Hemodynamic shear stress is also able to increase ICAM-1 expression in addition to cytokine stimulation [20]. ICAM-1 and VCAM-1 mediate stronger attachment of leukocytes to the endothelium whilst the selectins (E-selectin, P-selectin) mediate transient leukocyte rolling on the endothelial surface [7, 20]. Raised levels of ICAM-1 have been found to be predictive of increased risk of cardiovascular events [2–4]. In patients with stable coronary artery disease plasma levels of E- selectin is synthesized and exported on the endothelial cell surface in inﬂammatory situations [21] and appears to reﬂect the severity of systemic atherosclerosis [6]. P-selectin levels predict CVD risk in healthy women [5]. VCAM-1 may be a speciﬁc marker for advanced atherosclerosis, since it is usually expressed on atherosclerotic plaques [7] and VCAM- 1 levels correlated with extent of atherosclerosis [22]. In view