Pycnogenol® and Centella Asiatica for asymptomatic atherosclerosis progression.
OBJECTIVE
The aim of the study was to evaluate the effect of the nutritional supplements Pycnogenol and TECA (total triterpenic fraction of Centella Asiatica) on atherosclerosis progression in low-risk asymptomatic subjects with carotid or femoral non-stenosing plaques.


METHODS
This was an observational pilot substudy of the San Valentino epidemiological cardiovascular study. The study included 1363 subjects aged 45-60 without any conventional risk factors who had non stenosing atherosclerotic plaques (<50%) in at least one carotid or common femoral bifurcation, allocated into 6 groups: Group 1 (CONTROLS): management was based on education, exercise, diet and lifestyle changes. This same management plan was used in all groups; Group 2 Pycnogenol 50 mg/day; Group 3 Pycnogenol 100 mg/day; Group 4 Aspirin 100 mg/day or Ticlopidine 250 mg/day if intolerant to aspirin; Group 5 Aspirin 100 mg/day and Pycnogenol 100 mg/day; Group 6 Pycnogenol 100 mg/day plus TECA (total triterpenic fraction of Centella Asiatica) 100 mg/day. There was a six monthly follow-up up to 30 months. Plaque progression was assessed using the ultrasonic arterial score based on the arterial wall morphology and the number of plaques that progressed from the non-stenotic to the stenotic group. A secondary endpoint was to evaluate the changes in oxidative stress at baseline and at 30 months.


RESULTS
The ultrasonic score increased significantly in groups 1, 2 and 4 but not in groups 3, 5 and 6 suggesting a beneficial effect of Pycnogenol 100 mg. The percentage of plaques that progressed from class IV to class V was 8.4% in group 2, 5.3% in group 3, 4% in group 5 and 1.1% in group 6 (P<0.0001) compared with 16.6% in group 4 (aspirin) and 21.3% in the control group suggesting a beneficial effect of Pycnogenol. The lowest rate of progression was in group 6 (Pycnogenol plus TECA). At 30 months, the oxidative stress in all the Pycnogenol groups was less than in the control group. The oxidative stress was lower in the Pycnogenol 100 mg group than the Pycnogenol 50 mg group (P<0.0001). In the combined group of Pycnogenol and TECA the oxidative stress was less than the Pycnogenol alone (P<0.001).


CONCLUSIONS
Pycnogenol and the combination of Pycnogenol+TECA appear to reduce the progression of subclinical arterial lesions in low-risk asymptomatic subjects. The reduction in plaque progression was associated with a reduction in oxidative stress. The results justify a large randomized controlled study to demonstrate the efficacy of the combined Pycnogenol and TECA prophylactic therapy in subclinical atherosclerosis.
Irvine3 Circulation Sciences, Department of Biomedical Sciences, G. D'Annunzio University, Pescara, Italy - cardres@abol.it.
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G
Belcaro
M
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Dugall
M
M
Hosoi
E
E
Ippolito
M
M
Cesarone
R
R
Luzzi
U
U
Cornelli
A
A
Ledda
D058070:Asymptomatic Diseases; D050197:Atherosclerosis / Q000175:diagnosis / Q000188:drug therapy* / Q000378:metabolism; D002317:Cardiovascular Agents / Q000627:therapeutic use*; D002340:Carotid Artery Diseases / Q000175:diagnosis / Q000188:drug therapy* / Q000378:metabolism; D059168:Carotid Intima-Media Thickness; D028041:Centella; D019587:Dietary Supplements; D018450:Disease Progression; D004359:Drug Therapy, Combination; D005260:Female; D005263:Femoral Artery / Q000187:drug effects* / Q000378:metabolism / Q000648:ultrastructure; D005419:Flavonoids / Q000627:therapeutic use*; D006801:Humans; D007558:Italy; D008297:Male; D008875:Middle Aged; D018384:Oxidative Stress / Q000187:drug effects; D008517:Phytotherapy; D010865:Pilot Projects; D010936:Plant Extracts / Q000627:therapeutic use*; D010946:Plants, Medicinal; D058226:Plaque, Atherosclerotic; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D013997:Time Factors; D016896:Treatment Outcome; D014315:Triterpenes / Q000627:therapeutic use*
D002317:Cardiovascular Agents; D005419:Flavonoids; D010936:Plant Extracts; D010975:Platelet Aggregation Inhibitors; C005084:TECA; D014315:Triterpenes; C024070:pycnogenols