title: Bromelain and cardiovascular risk factors in diabetes: An exploratory randomized, placebo controlled, double blind clinical trial.
abstract: OBJECTIVE
  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.
  
  
  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 (1,050 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.
  
  
  RESULTS
  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.
  
  
  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.
authors.affiliation: School of Health and Social Care, London South Bank University, SE1 0AA, London, UK. leykara@yahoo.com.my.
authors.forename: Chit Moy
authors.initials: CM
authors.lastname: Ley
authors.affiliation: Department of Endocrinology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100730, China.
authors.forename: Qing
authors.initials: Q
authors.lastname: Ni
authors.affiliation: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, 100700, China.
authors.forename: Xing
authors.initials: X
authors.lastname: Liao
authors.affiliation: Department of Endocrinology, Yiling Hospital Affiliated to Hebei Medical University, Shijingzhuang (050091), Hebei Province, China.
authors.forename: Huai-Lin
authors.initials: HL
authors.lastname: Gao
authors.affiliation: School of Health and Social Care, London South Bank University, SE1 0AA, London, UK.
authors.forename: Nicola
authors.initials: N
authors.lastname: Robinson
mesh_terms: D001786:Blood Glucose; D001963:Bromelains / Q000494:pharmacology / Q000627:therapeutic use*; D002097:C-Reactive Protein / Q000378:metabolism; D002318:Cardiovascular Diseases / Q000097:blood / Q000150:complications* / Q000188:drug therapy*; D003710:Demography; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000150:complications* / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D005340:Fibrinogen / Q000378:metabolism; D006801:Humans; D008055:Lipids / Q000097:blood; D008297:Male; D008875:Middle Aged; D010919:Placebos; D012307:Risk Factors; D016896:Treatment Outcome
chemical_list: D001786:Blood Glucose; D008055:Lipids; D010919:Placebos; D001963:Bromelains; D005340:Fibrinogen; D002097:C-Reactive Protein
keywords: bromelain; cardiovascular disease; diabetes; fibrinogen; randomized control trial