title: Effect of Folic Acid therapy on Homocysteine Level in patients with Atherosclerosis or Buerger's Disease and in Healthy individuals: A clinical trial.
abstract: BACKGROUND
  Hyperhomocysteinemia is considered a risk factor for atherosclerosis and some other vascular diseases such as Buerger's disease.
  
  
  OBJECTIVE
  The aim of this study was to measure the Homocysteine levels in 3 different groups of participants (Buerger's disease, atherosclerosis patients, and healthy cases) and determine the therapeutic effect of folic acid therapy on homocysteine levels for these three groups.
  
  
  METHODS
  This nonrandomized clinical trial study was conducted in the vascular and endovascular surgery research center of Mashhad University of Medical Sciences in Mashhad, Iran. This interventional study consisted of 44 participants of which 22 patients had Buerger's disease and a control group of 22 healthy individuals, all of which were enrolled in this study. All of the study's participants had their serum homocysteine levels measured both before and after 12 weeks of folic acid (5mg/day) therapy. The data analysis used fo data analysis was a Chi square and t-test or their non-parametrical equivalents for data analysis by means of Statistical Package for the Social Sciences (SPSS) version 16.
  
  
  RESULTS
  The homocysteine levels were found to be significantly higher in patients with Buerger's disease as compared to other groups before treatment with folic acid (Buerger = 21.8 ± 8.5 Mm/L, atherosclerosis = 17.3 ± 6.9, healthy = 13.8 ± 3.1; p < 0.001). After treatment with folic acid at 5 mg/daily for 12 weeks, the new plasma homocysteine levels did not show any significant difference (p = 0.38) between the Buerger's disease group (14.6 ± 4.5 Mm/L) and atherosclerosis group (13.9 ± 4.7), but it was found to besignificantly higher in both groups when compared to the healthy group (10.7 ± 3.9, p<0.05). The plasma homocysteine level was reduced significantly when compared to its initial level in all 3 groups. The comparison of differences among three groups was found not to be significant (p=0.41).
  
  
  CONCLUSIONS
  It seems that supplementary therapy with folic acid at a dose of 5 mg daily may reduce the serum homocysteine levels significantly and may have a role in the development of vascular diseases such as Buerger's disease. We suggest that folic acid should be considered as a routine agent in the Buerger's disease therapeutic regime.
  
  
  BACKGROUND
  The trial was registered at the Thai Clinical Trials Registry (http://www.clinicaltrials.in.th) with the ID: TCTR20160601003.
  
  
  BACKGROUND
  This study was not funded by any organization.
authors.affiliation: M.D., Vascular Surgeon, Professor, Department of Vascular Surgery, Vascular and Endovascular Surgery Research Center, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.
authors.forename: Mohammad Hadi Saeed
authors.initials: MH
authors.lastname: Modaghegh
authors.affiliation: M.D., Vascular Surgeon, Associate Professor, Department of Vascular Surgery, Vascular and Endovascular Surgery Research Center, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.
authors.forename: Hassan
authors.initials: H
authors.lastname: Ravari
authors.affiliation: M.D., Plastic Surgeon, Department of Vascular Surgery, Vascular and Endovascular Surgery Research Center, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.
authors.forename: Mohammad Zare
authors.initials: MZ
authors.lastname: Haghighi
authors.affiliation: M.D., Department of Vascular Surgery, Vascular and Endovascular Surgery Research Center, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.
authors.forename: Ata'ollah
authors.initials: A
authors.lastname: Rajabnejad
keywords: Atherosclerosis; Buerger’s disease; Folic acid; Homocysteine