ABSTRACT
<p><b>OBJECTIVE</b>To assess whether the dietary supplement (bromelain) has the potential to reduce plasma fibrinogen and other cardiovascular disease (CVD) risk factors in patients with diabetes.</p><p><b>METHODS</b>This randomized placebo controlled, double blind, parallel design, efficacy study was carried out in China and investigated the effect of 12 weeks of bromelain (1,050 mg/day) on plasma fibrinogen. This randomized controlled trial (RCT) recruited 68 Chinese diabetic patients [32 males and 36 females; Han origin, mean age of 61.26 years (standard deviation (SD), 12.62 years)] with at least one CVD risk factor. Patients were randomized into either bromelain or placebo group. While bromelain group received bromelain capsule, the placebo group received placebo capsule which consisted inert ingredient and has no treatment effect. Subjects were required to take 1,050 mg (3×350 mg) of either bromelain or starch-filled placebo capsules, two to be taken (2×350 mg) after breakfast and another (350 mg) after dinner, daily for 12 weeks. Plasma fibrinogen, CVD risk factors and anthropometric indicators were determined at baseline and at 12 weeks.</p><p><b>RESULTS</b>The change in the fibrinogen level in the bromelain group at the end of the study showed a mean reduction of 0.13 g/L (standard deviation (SD) 0.86g/L) compared with the mean reduction of 0.36 g/L (SD 0.96 g/L) for the placebo group. However, there was no significant difference in the mean change in fibrinogen between the placebo and bromelain groups (mean difference=0.23g/L (SD 0.22 g/L), =0.291). Similarly, the difference in mean change in other CVD risk factors (blood lipids, blood pressure), blood glucose, C-reactive protein and anthropometric measures between the bromelain and placebo groups was also not statistically significant. Statistical differences in fibrinogen between bromelain and placebo groups before the trial despite randomization may have influenced the results of this study.</p><p><b>CONCLUSION</b>This RCT failed to show a beneficial effect in reducing fibrinogen or influencing other selected CVD risk factors but suggests other avenues for subsequent research on bromelain.</p>
Subject(s)
Female , Humans , Male , Middle Aged , Blood Glucose , Bromelains , Pharmacology , Therapeutic Uses , C-Reactive Protein , Metabolism , Cardiovascular Diseases , Blood , Drug Therapy , Demography , Diabetes Mellitus, Type 2 , Blood , Drug Therapy , Double-Blind Method , Fibrinogen , Metabolism , Lipids , Blood , Placebos , Risk Factors , Treatment OutcomeABSTRACT
<p><b>OBJECTIVE</b>To observe the changes of vascular endothelial functions and general neuro-endocrine-immunity (NEI) network under the state of qi-deficiency syndrome induced by excessive idleness and to approach their internal relevance and illuminate initially the pathophysiological mechanism of vascular lesion induced by excessive idleness.</p><p><b>METHODS</b>A total of 100 male Wistar rats were randomly divided into the control group and the qi-deficiency syndrome model group, 50 rats in each group. The qi-deficiency syndrome model was established by feeding the animals with hyper-alimentation diet in combination with restricting movement for 10 weeks. Changes of common chemical signal molecules related to NEI and vascular endothelial functions were measured by the end of the experiment. Furthermore, their internal relevance was analyzed by the method of canonical correlation analysis.</p><p><b>RESULTS</b>The vascular endothelial structure and function were obviously injured in the model group. Compared with the control group, the chemical signal molecules, such as 5-hydroxytryptamine (5-HT), corticosterone (CORT), triiodothyronine (T3), tetraiodothyronine (T4), angiotensin II (Ang II), interleukin-1 (IL-1), and tumor necrosis factor-alpha (TNF-alpha) in peripheral blood of the model group (n=43) were changed significantly (P<0.05 or P<0.01). Canonical correlation analysis showed that vascular endothelial dysfunction was correlated to the changes of these signal molecules in the NEI network.</p><p><b>CONCLUSIONS</b>Comfort-based lifestyle induced not only vascular endothelial dysfunction but also an imbalance of the NEI network. Vascular endothelial dysfunction and the imbalanced NEI network interacted with each other, and an imbalance of the NEI network may be the pathophysiologic basis for the genesis and development of vascular endothelial dysfunction, even diseases of the blood vessel.</p>
Subject(s)
Animals , Male , Rats , Aorta , Metabolism , Pathology , Biomarkers , Metabolism , Cardiovascular Diseases , Metabolism , Pathology , Disease Models, Animal , Endothelins , Metabolism , Endothelium, Vascular , Metabolism , Pathology , Immune System , Metabolism , Pathology , Physiology , Neuroimmunomodulation , Physiology , Neurosecretory Systems , Metabolism , Pathology , Physiology , Nitric Oxide , Metabolism , Qi , Rats, Wistar , Sedentary Behavior , Syndrome , Yin Deficiency , Metabolism , PathologyABSTRACT
Objective: To investigate the application of entropy partition method (EPM) for studying the diagnostic criteria of Traditional Chinese Medicine (TCM) syndrome. Methods: A clinical epidemiological survey was conducted in 400 patients with vascular endothelial dysfunction and the EPM was adopted to extract the TCM syndrome elements of "stagnancy of collateral-Qi in a deficiency condition", the correlation degree between each symptom of "stagnancy of collateral-Qi in a deficiency condition" was calculated and the diagnostic threshold of vascular endothelial dysfunction was established. The sensitivity, specificity and accuracy of the EPM-associated diagnostic criteria were assessed by comparing with those of clinical epidemiology. Results: The diagnostic criteria of "stagnancy of collateral-Qi in a deficiency condition" in vascular endothelial dysfunction established with EPM had a satisfactory diagnostic efficiency. Conclusion: EPM for complex system is suitable for studying the diagnostic criteria of TCM syndrome. EPM is a scientific and strict method and has great value in clinical practice.