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There is a weight of evidence behind the use of plant stanols and sterols in the effective lowering of cholesterol. In this section we aim to highlight the studies and research that have been conducted in the past.

Clinical trials

Plant Stanol Esters, the cholesterol lowering ingredient in all Benecol® foods, have been clinically proven to lower cholesterol in over 70 independent studies.

A report from the British Nutrition Foundation suggested that studies investigating intakes of around 2-3g per day of plant stanols, provided as their esters, have demonstrated an average control-adjusted reduction in serum LDL concentration of 10%. Findings from these studies indicate that the beneficial effect of plant stanols on LDL concentration is established within a few weeks, and remains stable over the duration of plant stanol ester consumption.8

Furthermore, studies have shown that consuming plant stanol esters in addition to a low-fat cholesterol-reducing diet leads to an even greater effect on LDL than consuming a low-fat cholesterol reducing diet alone.9,10

Plant stanol esters and statins

Consuming plant stanol esters in addition to statins has a greater effect on lowering cholesterol than with statins alone. A study including 176 patients, all of whom were taking statins, found a combination of 3 servings per day of plant stanol ester enriched spread (providing them with 3g of plant stanols) with statins resulted in a 10% greater reduction in cholesterol concentrations than the effect seen with the control spread.11

Consuming plant stanol esters in combination with statins appears to be a more effective method of reducing cholesterol than simply doubling the statin dose, which usually only results in an additional reduction in LDL cholesterol concentrations of approximately 6%.12

European Atherosclerosis Society (EAS)

The European Atherosclerosis Society (EAS) published a new Consensus Statement on Plant Stanols and Sterols in the Management of Dyslipidaemia and Prevention of Cardiovascular Disesase13 on 3rd February, 2014. The statement is the first concerning diet, and highlights the use of functional foods with added plant stanols (2 g/d) as an aid to other beneficial lifestyle changes, also in conjunction with cholesterol-lowering medication. The daily use of plant stanols reduces blood levels of LDL-cholesterol by an average of 10 %.

According to the Consensus Statement, plant stanols may specially benefit individuals who have elevated levels of LDL-cholesterol but whose global cardiovascular risk is, at most, moderately increased (10 year risk of cardiovascular death < 5%). In these individuals, the prevention of cardiovascular diseases is based on lifestyle changes. The use of plant stanols may also be considered in individuals with an increased cardiovascular risk who are already on cholesterol–lowering medication but who have not reached their LDL-cholesterol target with medication alone.

Plant Sterols and Plant Stanols in the Management of Dyslipidaemia and Prevention of Cardiovascular Disease is the fourth Consensus Statement published by the EAS but is the first one on diet. An independent Consensus Panel consisting of top experts in the field reviewed all the scientific data on the safety and efficacy of plant stanols and sterols, and prepared the Consensus Statement based on this evidence. The Consensus Statement was published in the renowned scientific journal Atherosclerosis.

European Food Safety Authority (EFSA) and European Commission (EC)

Following a rigorous 30-trial review of clinical evidence and a positive opinion on the efficacy of Plant Stanol Ester by the European Food Safety Authority (EFSA), the European Commission (EC) authorised the claim that Plant Stanol Esters ‘have been shown to lower blood cholesterol’, also acknowledging that 'high cholesterol is a risk factor in the development of heart disease'. Plant Stanol Esters are amongst only 6 foods to be granted an approved health claim by the European Commission.

Joint British Society 3 (JBS3)

The positive benefits of stanols and sterols were referenced within the new JBS3 guidelines, published in March, 2014. The guidelines stated that “Stanols and sterols appear to offer a degree of LDL-c reduction (approximately 10%),14 even with concomitant statin use.15 Although there is no CVD outcome data for such products (and never likely to be), it is reasonable to assume a beneficial effect on CVD outcomes based on the LDL lowering hypothesis.”16

This statement reinforces the substantial evidence base that exists to support the role of plant stanols and sterols in lowering cholesterol.

National Institute for Health and Care Excellence (NICE) – CG181 Lipid modification

Recent guidance from the National Institute for Health and Care Excellence (NICE) on Lipid Modification (CG181) states that plant stanols and sterols should not be recommended for certain patients in the prevention of CVD.17

This is in direct contrast to other authoritive medical groups that conclude foods with plant stanols and sterols may be considered in individuals with high cholesterol at intermediate or global risk of CVD or as an adjunct to pharmacologic therapy.

These guidelines are provided on the basis that no benefit of plant stanols and sterols can be found in relation to CVD outcomes, but does not take into consideration efficacy of lowering cholesterol in reducing the risk of CHD.