Bromelain and Cardiovascular Risk Factors in Diabetes: An Exploratory Randomized, Placebo Controlled, Double Blind Clinical Trial

Objective: The objective of this trial was to assess whether the dietary supplement (bromelain) had the potential to reduce plasma fibrinogen and other Cardiovascular Disease (CVD) risk factors in patients with diabetes. Methods: This randomized placebo controlled, double blind, parallel design, efficacy study was carried out in China and investigated the effect of 12 weeks of bromelain (1.05g/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, 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. Patients and researcher were blinded and did not know whether they received bromelain or placebo capsules. Plasma fibrinogen, CVD risk factors and anthropometric indicators were determined at baseline and at 12 weeks. Results: The change in the fibrinogen level in the placebo group at the end of the study showed a mean reduction of 0.36g/L (Standard Deviation (SD) 0.96g/L) compared with the mean reduction of 0.13g/L (SD 0.86g/L) for the bromelain 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 0.22g/L), p=0.291). Similarly, the difference in mean change in other CVD risk factors (blood lipids, blood pressure), blood glucose, C - reactive protein (CRP) and anthropometric measures between the bromelain and placebo groups was also not statistically significant. Conclusions: 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.