European Journal of Clinical Nutrition

TABLE 1

FROM:

Evidence for a protective (synergistic?) effect of B-vitamins and omega-3 fatty acids on cardiovascular diseases

A de Bree, L I Mennen, S Hercberg and P Galan

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Table 1. Intervention trials evaluating the effect of B-vitamins on the risk of cardiovascular diseases

Reference Subjects Intervention and duration Results Quality score a
de Jong et al (1999)273 M+W with peripheral arterial disease (onset<56 y) Intervention: 5000 mug folic acid/day and 250 mg vitamin B6/dayAfter a median follow-up of 20 months, the adjusted RR for recurrent CVD in the treatment group was 0.76 (95% CI=0.33–1.74) compared to the control group2
  Intervention group: 70 subjects with postmethionine load HHCY Duration: 1–63 months  
  Controls: 162 subjects with no postmethionine load HHCY   
     
Vermeulen et al (2000a)224 M+W with atherothrombotic cerebrovascular disease (onset<56 y) Intervention: 5000 mug folic acid/day and 250 mg vitamin B6/dayAfter a median follow-up of 57 months, the adjusted RR for recurrent CVD in the treatment group was 0.96 (95% CI=0.48–1.92) compared to the control group2
     
  Intervention group: 52 subjects with postmethionine load HHCY Duration: 3–101 months  
  Controls: 151 subjects with no postmethionine load HHCY   
     
Hackam et al (2000)101 M with atherosclerotic vascular disease Intervention: Groups A and B:Until 1996: 5000 mug folic acid/dayAfter 1996: 2500 mug folic acid/day, 25 mg vitamin B6/day and 250 mug vitamin B12/dayMean duration of treatment before vitamin therapy in group A was 2.6 y, vitamin therapy was 1.8 y. Mean duration of treatment before vitamin therapy in group B was 2.7 y, vitamin therapy 1.6 y. Rate of progression of carotid plague before and after vitamin therapy, as determined by ultrasound, was decreased in both groups0
   No risk estimates are given, no adjustments are mentioned 
     
  Group A: 51 subjects with tHcy >14 mumol/lGroup B: 50 subjects with tHcy less than or equal to14 mumol/l Duration: Not indicated when folic acid (only) treatment was started.  
     
Vermeulen et al (2000b)158 M+W, healthy siblings of patients with premature atherothrombotic diseaseRandom double-blind allocation to intervention (n=68) or placebo (n=66) groupIntervention: 5000 mug folic acid/day and 250 mg vitamin B6/dayThe adjusted RR for a decreased rate of abnormal exercise electrography tests (which is a measure of coronary atherosclerosis) in the treatment group was 0.38 (95% CI=0.06–2.27) compared to the control group (unadjusted RR=0.40, 95% CI=0.17–0.93)5
     
   Duration: 2 y  
     
Schnyder et al (2002)553 M+W with a successful angioplastyRandom double-blind allocation to intervention (n=272) or placebo (n=281) groupIntervention: 1000 mug folic acid/day, 400 mug vitamin B12/day, 10 mg vitamin B6/dayAfter a mean follow-up of 11 months (including 6 months of supplementation), the adjusted RR for target lesion revascularization in the treatment group was 0.61 (95% CI=0.41–0.95)5
     
   Duration: 6 months  

a Score between 0 and 5, a score of 5 indicates that the trial complied with all our quality criteria's (see methods section). M=men; W=women; HHCY=hyperhomocysteinemia; CVD=cardiovascular diseases; RR=relative risk; CI=confidence interval; tHcy=total plasma homocysteine concentration.

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