Levels of LDL-cholesterol were reduced by 42.4 per cent following consumption of the fish oil and red yeast rice combination, compared to reductions of 39.6 per cent in the statin group, according to results of a randomised trial published in the Mayo Clinic Proceedings.
"These results are intriguing and show a potential benefit of an alternative, or naturopathic, approach to a common medical condition," said David Becker, MD, from the University of Pennsylvania Health System.
High cholesterol levels, hypercholesterolaemia, have a long association with many diseases, particularly cardiovascular disease.
CVD causes almost 50 per cent of deaths in Europe, and is reported to cost the EU economy an estimated €169bn ($202bn) per year.
According to the American Heart Association, 34.2 per cent of Americans (70.1m people) suffered from some form of cardiovascular disease (CVD) in 2002.
Study details Becker and co-workers recruited 74 people with hypercholesterolaemia and randomly assigned them to receive a daily statin dose of simvastatin (40 mg/d) or the fish oil (EPA 2106 mg/d, DHA 1680 mg/d, N3 Oceanic) and red yeast rice (N3 Oceanic).
The red yeast rice contained a total monacolin content of 5.3 mg, with 2.53 mg in the form of monacolin K (lovastatin).
Red yeast rice is the product of yeast grown on rice.
It is a dietary staple in some Asian countries, and reportedly contains several compounds that inhibit cholesterol production.
After 12 weeks of intervention, the researchers found statistically significant LDL reductions in both groups, but no difference between the groups.
In addition to the LDL cuts, the fish oil/ red yeast rice combination also produced significant reductions in triglyceride levels of 29 per cent, compared to a non-significant nine per cent reduction in the statin group.
"Lifestyle changes combined with ingestion of red yeast rice and fish oil reduced LDL-C in proportions similar to standard therapy with simvastatin," wrote the researchers.
"Pending confirmation in larger trials, this multifactorial, alternative approach to lipid lowering has promise for a subset of patients unwilling or unable to take statins," they added.
Mechanisms "Red yeast rice contains naturally occurring lovastatin and nine different substances called monacolins that could inhibit 3-hydroxy-3-methylglutaryl coenzyme A reductase," wrote Becker and co-workers.
"The dose of RYR in our study (2.4-3.6 g/d) was equivalent to a daily lovastatin dose of 10 to 15 mg, less than the established therapeutic dose (20-40 mg)."
The reductions in triglyceride levels observed in the study were put down to the fish oil part of the combination.
"The triglyceride -lowering effects of fish oil have been established and could be responsible for the results observed in the current study," they added.
Further study The researchers called for a large, long-term multi-centre trial to further evaluate the effects on cardiovascular outcomes.
"Our small, short-term study did not and could not evaluate reduction in cardiovascular morbidity and mortality, which is clearly the most important outcome," they wrote.
Source : Mayo Clinic Proceedings 2008, Volume 83, Issue 7, Pages 758-764 "Simvastatin vs Therapeutic Lifestyle Changes and Supplements: Randomized Primary Prevention Trial" Authors: D.J. Becker, R.Y. Gordon, P.B. Morris, J. Yorko, Y.J. Gordon, M. Li, N. Iqbal