| According to the American Heart Association, more | | | | 31 patients to receive 1,800 milligrams of red yeast rice |
| than 50 million Americans require some sort of | | | | twice per day, while the other 31 patients in this study |
| intervention to prevent or treat coronary artery | | | | received placebo (sugar) pills that looked identical to |
| disease, and another 15 million, or more, require | | | | the red yeast rice supplement pills. Neither the patients |
| medication in order to lower their cholesterol levels to a | | | | nor the researchers knew which patients were |
| safer range. | | | | receiving the red yeast rice and which patients were |
| Today, the statin class of drugs plays a dominant role | | | | receiving the placebo pills until after the study was |
| in the management of elevated cholesterol | | | | completed. All 62 patients were also enrolled in a |
| (hyperlipidemia), and these drugs are widely used to | | | | 12-week lifestyle and dietary modification program for |
| both prevent and treat coronary artery disease when | | | | patients with hyperlipidemia. |
| diet and exercise prove inadequate by themselves. | | | | This study was continued for 24 weeks, and blood |
| While the full spectrum and extent of the health | | | | levels of LDL, HDL, triglycerides, and liver enzymes |
| benefits of statin drugs continues to be the subject of | | | | were measured at the beginning of the study, as well |
| debate, there is ample high-level clinical research | | | | as 12 weeks and 24 weeks into the study. Additionally, |
| evidence that statins significantly reduce the risk of | | | | blood levels of creatinine phosphokinase (CPK), a |
| clinically significant coronary artery disease, heart | | | | muscle enzyme that is released when statin-induced |
| attack (myocardial infarction), and death in patients with | | | | rhabdomyolysis occurs, were also measured at these |
| elevated blood levels of "bad cholesterol" (LDL), and | | | | same time points. (All of these 62 patients had |
| even in patients who have normal LDL levels, but who | | | | previously discontinued statin therapy due to muscle |
| also have elevated C-reactive protein (CRP) levels. | | | | pain.) |
| (CRP is a protein that becomes elevated in the blood | | | | At the 12-week point, the average LDL levels of the |
| in the presence of inflammation.) | | | | patients in the red yeast rice group had declined by a |
| Unfortunately, as with all medications, the statins are | | | | very significant 43 milligrams per deciliter (mg/dl), |
| associated with potentially significant side effect. The | | | | compared to the 11 mg/dl reduction obtained in the |
| most serious side effects that have been associated | | | | placebo group with lifestyle and diet modification alone. |
| with statin drugs are muscle injury (rhabdomyolysis) | | | | At the 24-week point, a 35 mg/dl reduction in LDL |
| and liver injury. Based upon recent research data, | | | | levels was observed in the red yeast rice group |
| approximately 5 percent of patients taking statin drugs | | | | versus a 15 mg/dl average decrease in LDL levels at |
| will experience significant muscle pain and weakness, | | | | 24 weeks in the placebo pill group. (It is very important |
| requiring that they discontinue their statin medication. In | | | | to note, by the way, that even the "placebo group" of |
| severe cases, rhabdomyolysis can lead to permanent | | | | hyperlipidemia patients were able to reduce their |
| muscle injury and kidney failure. An additional 2 percent | | | | elevated LDL levels with diet and exercise alone!) |
| of patients may have to stop taking statins due to | | | | While LDL and total cholesterol levels were significantly |
| significant liver toxicity. Joint pain, peripheral nerve injury, | | | | reduced in the red yeast rice group, when compared |
| and memory loss have also been associated with the | | | | to the patients in the placebo group, blood levels of |
| use of some statin drugs, although the link between | | | | HDL, triglycerides, liver enzymes, and CPK did not |
| statins and these more uncommon side effects is less | | | | differ between the two groups of patients. Moreover, |
| clear than for rhabdomyolysis and liver injury. | | | | there were also no significant differences in weight |
| When diet and exercise alone fail to reduce elevated | | | | loss or the incidence of muscle pain between the two |
| LDL levels, particularly when there is a personal or | | | | patient groups following 24 weeks of red yeast rice |
| family history of cardiovascular disease, statins are | | | | supplementation. |
| generally the first line of treatment (in addition to aspirin, | | | | In summary, this was a small prospective, randomized, |
| if there are no contraindications to taking aspirin). | | | | placebo-controlled clinical research study involving |
| However, patients who do not tolerate statins have | | | | patients who had previously discontinued statin therapy |
| limited choices in terms of effective alternative | | | | due to muscle toxicity. In this study, which lasted for a |
| lipid-lowering therapy. | | | | relatively short duration of about 6 months, red yeast |
| Niacin, which is one of the oldest forms of therapy for | | | | rice supplementation (in addition to lifestyle and dietary |
| hyperlipidemia, is one alternative option , and although | | | | modifications) significantly reduced blood levels of LDL |
| not as effective as statins, this vitamin supplement, | | | | and total cholesterol. Throughout this research study, |
| when given in high enough doses, can not only reduce | | | | there was no clinical or laboratory evidence of liver or |
| LDL cholesterol, but also triglycerides (the predominant | | | | muscle toxicity associated with the use of red yeast |
| form of fat in the blood) as well. Additionally, niacin | | | | rice supplements. |
| therapy can also raise the "good cholesterol" (HDL) | | | | The results of this study are highly intriguing, although it |
| level in the blood. (By comparison, statins have only | | | | does leave some important questions unanswered. In |
| small effects on triglyceride levels, and minimal effects | | | | particular, it is not clear to what extent that |
| on HDL levels in the blood.) The biggest disadvantage | | | | naturally-occurring lovastatin, contained within in the red |
| of niacin therapy, however, is its tendency to cause | | | | yeast rice supplement used in this study, is responsible |
| severe flushing in about half of patients who take the | | | | for the LDL-lowering effects of red yeast rice that |
| standard form of this drug, as well as the abdominal | | | | were observed in this study (a small previous research |
| pain, nausea and vomiting that occurs in another 8 to | | | | study has suggested, but not proven, that the degree |
| 10 percent of patients. However, newer | | | | of LDL reduction observed with red yeast rice |
| extended-release preparations of niacin are much | | | | supplementation is greater than what would be |
| better tolerated, with an incidence of adverse side | | | | predicted by the actual lovastatin content of red yeast |
| effects of approximately 6 to 8 percent. (Fortunately, | | | | rice). |
| in most cases, flushing and the other adverse side | | | | Despite the very intriguing results of this small pilot |
| effects associated with niacin therapy will improve | | | | study, all readers should be reminded of some very |
| over time if patients continue to take this medication.) | | | | important caveats regarding the purchase and use of |
| As with statin drugs, however, there is a 1 or 2 percent | | | | red yeast rice supplements. Because of the variable |
| risk of liver toxicity associated with niacin therapy for | | | | but significant lovastatin content of many red yeast |
| hyperlipidemia, and most patients who take either statin | | | | rice dietary supplements, the Food and Drug |
| drugs or niacin for elevated LDL levels should be | | | | Administration (FDA) has recently sent warning letters |
| periodically monitored for elevations of liver enzymes in | | | | to several dietary supplement manufacturers, indicating |
| their blood. Long-term niacin therapy may also increase | | | | the Government's concern that red yeast rice contains |
| blood sugar (glucose) levels in patients with | | | | a known prescription-only drug and, therefore, that the |
| pre-diabetes or diabetes, and may also raise blood | | | | FDA's position is that such supplements should |
| levels of uric acid, which may, in turn, lead to the | | | | probably not be sold as over-the-counter dietary |
| development of gout in susceptible individuals. | | | | supplements. The variability of lovastatin content in |
| Therefore, fasting blood glucose levels and the level of | | | | various forms of red yeast rice also makes it difficult |
| uric acid in the blood should be monitored, as well, in | | | | for consumers to know how much lovastatin is |
| patients who are taking niacin for hyperlipidemia (these | | | | contained within these supplements, which may be a |
| two latter complications of niacin therapy also appear | | | | problem for patients who are predisposed to liver, |
| to be less common when taking the newer | | | | muscle, or kidney toxicity associated with statin use. |
| extended-release niacin preparations.) | | | | Also, because lovastatin, and other potentially active |
| Other non-statin therapies are also available for the | | | | compounds in red yeast rice, can pass into both the |
| treatment of elevated LDL and triglyceride levels, but | | | | placenta and breast milk, women who are pregnant (or |
| they are seldom used, as they are not only less | | | | who may be pregnant), and women who are |
| effective than statins and niacin, but their side effects | | | | breastfeeding, should not be exposed to any |
| profiles are so significant that very few patients remain | | | | supplement or foods that contain red yeast rice. Finally, |
| compliant with these alternative lipid-lowering therapies. | | | | other compounds that may be toxic to the liver and |
| Red yeast rice (Monascus purpureus, for you botanists | | | | kidneys have previously been detected in some red |
| out there), has been used in China for at least 1,200 | | | | yeast rice preparations. |
| years. The yeast spores are typically grown on rice, | | | | Because of these various health-related concerns, I |
| from which this product gains its name. In addition to its | | | | want to make it very clear that I am not, at this time, |
| use, for centuries, as an herbal medication (mostly in | | | | advocating the routine use of red yeast rice for |
| East Asia) for stomach complaints and poor circulation, | | | | medicinal purposes. However, if you have failed all |
| Chinese food lovers will recognize the brick-red color | | | | other forms of lifestyle, dietary, and medical therapy |
| of red yeast rice whenever they eat Peking duck or | | | | for significant hyperlipidemia, then you may wish to |
| char siu. | | | | forward a link to this column to your Internist or |
| A handful of small previous research studies have | | | | Cardiologist. If they are open to the possibility of |
| suggested that red yeast rice may be as effective as | | | | incorporating red yeast rice into your lipid-lowering |
| some statins in reducing LDL and triglyceride levels | | | | regimen, and they are willing to closely monitor you for |
| when taken as a dietary supplement. This is not | | | | signs of toxicity (as well as unexpected pregnancy, for |
| surprising, as most pure preparations of red yeast rice | | | | fertile female patients), then this approach may be |
| actually contain naturally-occurring lovastatin, one of the | | | | something that you and your doctor may wish to |
| early statin drugs (and which, by the way, was first | | | | consider. However, I absolutely do not recommend that |
| isolated from aspergillus, which is another form of | | | | you begin taking red yeast rice supplements without |
| fungus). However, other compounds contained within | | | | the involvement and approval of your physician, |
| red yeast rice are also thought to additively contribute | | | | because of the health-related safety concerns that I |
| to the claimed LDL-lowering effects of this dietary | | | | have already discussed. |
| supplement, above and beyond the contribution of the | | | | Finally, I will close out this week's column by wishing all |
| small amount of lovastatin contained within many of | | | | of you other hard-working dads out there a very |
| these preparations. | | | | happy and warm Fathers Day. Among all of the |
| A new prospective, randomized, placebo-controlled | | | | blessings and fortunes that we might be lucky enough |
| clinical research study of red yeast rice strongly | | | | to acquire during our busy and often stressful lives |
| suggests that at least some forms of red yeast rice | | | | (and especially during these trying times), being a dad, |
| supplements may, indeed, be highly effective in | | | | and having the privilege of making such a tremendous |
| reducing elevated blood levels of LDL in patients who | | | | difference in the lives of our children, is surely one of |
| have been unable to tolerate standard statin | | | | the greatest gifts that we can receive. Please |
| medications. This study, which appears in the current | | | | remember to try to carve out some special time, |
| volume of the Annals of Internal Medicine, randomized | | | | everyday, to spend with your children. |