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Hypercholesterolemia (literally: high blood cholesterol) is the presence of high levels of cholesterol in the blood. It is not a disease but a metabolic derangement that can be secondary to many diseases and can contribute to many forms of disease, most notably cardiovascular disease. It is closely related to the terms "Hyperlipidemia" (elevated levels of lipids) and "Hyperlipoproteinemia" (elevated levels of lipoproteins). more...

Hairy cell leukemia
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Signs and symptoms

Elevated cholesterol does not lead to specific symptoms unless it has been longstanding. Some types of hypercholesterolaemia lead to specific physical findings: xanthoma (thickening of tendons due to accumulation of cholesterol), xanthelasma palpabrum (yellowish patches around the eyelids) and arcus senilis (white discoloration of the peripheral cornea).

Longstanding elevated hypercholesterolemia leads to accelerated atherosclerosis; this can express itself in a number of cardiovascular diseases:

  • Angina pectoris, leading to PTCA or CABG
  • Myocardial infarction
  • Transient ischemic attacks (TIAs)
  • Cerebrovascular accidents/Strokes
  • Peripheral artery disease (PAOD)


When measuring cholesterol, it is important to measure its subfractions before drawing a conclusion on the cause of the problem. The subfractions are LDL, HDL and VLDL. In the past, LDL and VLDL levels were rarely measured directly due to cost concerns. VLDL levels are reflected in the levels of triglycerides (generally about 45% of triglycerides is composed of VLDL). LDL was usually estimated as a calculated value from the other fractions (total cholesterol minus HDL and VLDL); this method is called the Friedewald calculation; specifically: LDL ~= Total Cholesterol - HDL - (0.2 x Triglycerides).

Less expensive (and less accurate) laboratory methods and the Friedewald calculation have long been utilized because of the complexity, labor and expense of the electrophoretic methods developed in the 1970s to identify the different lipoprotein particles which transport cholesterol in the blood. As of 1980, the original methods, developed by research work in the mid-1970s cost about $5K, US 1980 dollars, per blood sample/person.

With time, more advanced laboratory analyses have been developed which do measure LDL and VLDL particle sizes and levels, and at far lower cost. These have partly been developed and become more popular as a result of the increasing clinical trial evidence that intentionally changing cholesterol transport patterns, including to certain abnormal values compared to most adults, often has a dramatic effect on reducing, even partially reversing, the atherosclerotic process. With ongoing research and advances in laboratory methods, the prices for more sophisticated analyses have markedly decreased, to less than $100, US 2004, by some labs, and with simultaneous increases in the accuracy of measurement for some of the methods.


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Congestive Heart Failure and Hypercholesterolemia - Alternative Therapies, part 2
From American Family Physician, 9/15/00 by Vincent Morelli

Natural supplements are widely used by the American public but, while claims of their therapeutic effects abound, medical research does not always support their effectiveness. Clinical trials using Q10 for the management of congestive heart failure have had conflicting results; hawthorn is prescribed in Germany for the treatment of this condition, but no trials have been conducted in the United States. Although initial research about the use of garlic in the management of hypercholesterolemia was encouraging, follow-up studies have failed to verify these results. Substituting soy protein for high-fat animal protein diets, however, does have a beneficial effect on serum lipid levels. So far, cholestin (a natural product containing several statins) has proved to be a cost-saving lipid-lowering medication, and fenugreek may offer modest improvement as well. Gugulipid is also promising but requires further research. (Am Fam Physician 2000;62:1325-30.)

In 1997, Americans spent more than $12 billion on natural supplements; a 1993 study showed that one third of Americans polled used some form of alternative medicine.(1) Family physicians must be aware of the widespread use of these products. We must be able to separate anecdotal from evidence-based benefits, and we must be aware of side effects and potential interactions between medications and herbs or supplements if we are to offer informed consultation to our patients.

American Family Physician has previously published articles that focus on herbal products and their side effects, as well as herb/drug interactions.(2,3) The first part of this article, published in the previous issue, reviewed the use of herbs and supplements in the management of diabetes, depression and obesity. This part of the article highlights the role that supplements can play in the management of two other conditions commonly encountered in the family physician's office: congestive heart failure and hypercholesterolemia. Table 1 summarizes information about the natural products discussed.

Congestive Heart Failure

Of the many adjunctive treatments for congestive heart failure (CHF), two of the most widely publicized in recent years are Q10 and hawthorn.

Ubiquinone: Q10

Q10 is a coenzyme found in all tissues of the body (hence its common name, ubiquinone). It is necessary for certain metabolic reactions, including oxidative respiration, and its concentration is increased in the heart, liver and pancreas. Its use in heart disease stems from its antioxidant effects, its stabilization of sodium- and potassium-activated adenosine triphosphate (NaK ATPase) and its effect on calcium channels.(4)

To date, the clinical benefits of Q10 supplementation have not been clearly proved. Two well-researched meta-analyses(5) have shown improved ejection fractions, stroke volume, cardiac output, cardiac index and end diastolic volume in patients taking Q10 supplement; each also suggested that Q10 may have a role in the treatment of CHF. However, the clinical significance of these findings has not yet been proved.

In clinical trials, a 1999 study(6) showed that 22 patients enrolled in a randomized, double-blind, placebo-controlled, crossover trial of Q10 experienced an increased stroke index at rest and at work and a decreased pulmonary capillary wedge at rest. The study concluded that patients with congestive heart failure may benefit from supplementation with Q10. Two other recent clinical trials(7,8) refuted this finding. A randomized, double-blind, placebo- controlled, crossover trial(7) evaluated 30 patients for three months and found no increase in resting systolic function despite plasma levels of Q10 that were twice the normal baseline values. Another randomized, double-blind, placebo-controlled, crossover study8 of 79 patients with CHF measured ejection fraction, exercise tolerance and quality of life. This study found a nonsignificant increase in ejection fraction and, possibly, a slightly increased exercise tolerance and slightly increased subjective quality of life in the subjects taking Q10

In light of the above evidence, it can be concluded that if Q10 has a beneficial role in the management of CHF, it is modest at best. These studies found no adverse side effects of Q10 at dosages of 100 mg daily for six years or 200 mg daily for one year.


The hawthorn plant contains pharmacologically active flavonoids that inhibit vasoconstriction and actively dilate blood vessels. One of these flavonoids has also been reported to block vasoconstriction by inhibiting angiotensin-converting enzyme. These actions, as well as in vitro increases in coronary circulation (from 20 to 140 percent) and inhibition of the adenosine 3',5'-cyclic monophosphate phosphodiesterase, give hawthorn its theoretic basis for use in congestive heart failure.(9)

As for its actual observed effect in human studies, a 1996 review(10) of German literature concludes that rigorous clinical trials have shown benefit in objective signs and subjective symptoms of stage II CHF. A multicenter, placebo-controlled, double-blind trial(11) studied 136 patients with stage II CHF. A clear improvement in the subjects receiving hawthorn was observed and documented as an improvement in the pressure-heart rate product, while the conditions of the subjects receiving placebo deteriorated. The hawthorn group also had a subjective improvement in quality of life and mental well-being. The study concluded that hawthorn was an effective, low-risk phytotherapeutic form of treatment in patients with stage II cardiac insufficiency.(11) Hawthorn is sold as a prescription medication in Europe and Asia. In Germany, it has been approved and is prescribed for mild cardiac insufficiency.

Despite studies mentioned in the German literature, we did not find that any double-blind, randomized, placebo-controlled, crossover trials had been performed in the United States, nor could we find any studies documenting echocardiographic improvements or improvements in exercise tolerance.

Because hawthorn may potentiate the action of cardiac glycosides and may interfere with digoxin or digoxin monitoring, it has been recommended that patients using digitalis or other cardiovascular drugs refrain from using hawthorn unless monitored by a physician. Neither we nor the authors of a 1998 review12 could find any clinical studies documenting this potential interaction.



Despite the many early promising studies and meta-analyses evaluating garlic's effect as a lipid-lowering agent, more recent, rigorous studies have failed to substantiate these benefits.(13-16) There is no current role for garlic as an antihyperlipidemic agent.


The precise mechanism by which soy proteins are thought to decrease serum lipid levels is unclear. Possible mechanisms include decreased cholesterol absorption, decreased bile reabsorption in the gut or possibly a change in endocrine status associated with biologically active substances such as isoflavones (phytoestrogens) or saponins present in soy.(17) Several well-conceived animal studies(18-20) have clearly shown a decrease in total cholesterol and low-density lipoprotein (LDL) levels when dietary soy protein was substituted for animal protein. Human observational studies, as well as human intervention trials, have also shown soy's beneficial effect on levels of total cholesterol and LDL.(21) A recent meta-analysis(22) also showed a trend toward decreased cholesterol levels and decreased LDL levels among subjects taking soy, with an average decrease of 9 percent in total cholesterol levels, 13 percent in LDL levels and 10 percent in triglyceride levels.

In 1998, Potter and associates(23) corroborated this meta-analysis and found that consumption of soy protein, substituted for animal fat, lowered total cholesterol levels an average of 6 percent and non-high-density lipoprotein cholesterol levels by 7 percent in postmenopausal women with hypercholesterolemia. In 1998, Wong and colleagues(24) demonstrated similar lipid-lowering effects in men with normal cholesterol levels and men with hypercholesterolemia.

In October 1999, the U.S. Food and Drug Administration approved a "health claim" labeling for soy products. It was concluded that, "Diets low in saturated fat and cholesterol that include 25 g of soy protein may reduce the risk of heart disease." To carry the health claim labeling, foods must contain at least 6.25 g of soy per serving and be low in fat, saturated fat and cholesterol. In reviewing all of the literature, consumption of at least 25 g of soy per day is needed to see a decrease in levels of cholesterol and LDL. Table 2 includes some of the more common sources of soy and their soy protein content.


Cholestin is a fermented product of rice on which red yeast is grown. This "red rice yeast product" has been used for centuries in China and contains starch, protein, fiber and at least eight statin compounds, which function as human menopausal gonadotropin coenzyme A (HMG CoA) reductase inhibitors.

Chinese studies claiming that this product decreased total cholesterol levels by 11 to 32 percent have recently been verified by U.S. studies. In a recent double-blind, placebo-controlled study(25-27) involving 83 patients with hypercholesterolemia, total cholesterol levels decreased by about 15 percent and LDL levels decreased by about 22 percent in the patients receiving cholestin. As expected, these results are similar to those obtained with commercially available "drug statins" because the active compounds are essentially the same.

Cholestin may be a cost-saving option for patients who require lipid-lowering medication but who are unable to afford the more expensive, commercially available medications. Although no adverse effects have been reported with the use of cholestin, it would be prudent to monitor liver function as well as creatine kinase just as would be done when administering commercially available statins.


Fenugreek, a legume sold as a dried seed, is native to Asia and southeastern Europe. It contains fiber and active steroid saponins that have been documented as having a hypoglycemic effect in mild cases of type 2 diabetes (formerly known as non-insulin-dependent diabetes).(28) The lipid-lowering potential of this product has also been proved in rats, dogs and humans.(29,30)

A recent study(28) of patients with coronary artery disease and type 2 diabetes showed a decrease in levels of total cholesterol and triglycerides with use of fenugreek. A 1990 double-blind, placebo-controlled study(31) of 10 patients with type 1 diabetes (formerly known as insulin-dependent diabetes) also showed a significant decrease in levels of total cholesterol, LDL and very-low-density lipoprotein (VLDL) in the patients receiving fenugreek. It is still too early to fully evaluate the lipid-lowering effects of this product, but some modest improvement is apparent. Well-designed clinical trials should be undertaken in the future.


Gugulipid (guggul gum) is widely used in India for the treatment of hypercholesterolemia. Two placebo-controlled studies(32,33) have been published in India. In one multicenter trial(34) with 205 subjects, gugulipid was found to reduce total cholesterol levels by 22 percent and triglyceride levels by 25 percent, compared with placebo, in 70 percent of patients. In the other study of 61 patients, gugulipid was found to decrease cholesterol levels by 11 percent, LDL levels by 12 percent and triglyceride levels by 12 percent.

In each of these studies, side effects in the subjects receiving gugulipid were no different from those of the subjects receiving placebo, and the cost of gugulipid was markedly lower than that of the available statin drugs. The suggested dosage is the equivalent of 75 mg of guggulsterone per day.

In conclusion, although there were problems with the studies (e.g., short-term nature, no correlation with cardiovascular morbidity and mortality, data gathered from less than 200 patients), preliminary results indicate the need for further studies.


(1.) Eisenberg DM, Kessler RC, Foster C, Norlock FE, Calkins DR, Delbanco TL. Unconventional medicine in the United States. Prevalence, costs, and patterns of use. N Engl J Med 1993;328:246-52.

(2.) Cupp MJ. Herbal remedies: adverse effects and drug interactions. Am Fam Physician 1999;59:1239-45.

(3.) Zink T, Chaffin J. Herbal 'health' products: what family physicians need to know. Am Fam Physician 1998;58:1133-40 [Published erratum appears in Am Fam Physician 1999;59:540].

(4.) Ernster L, Dallner G. Biochemical, physiological and medical aspects of ubiquinone function. Biochim Biophys Acta 1995;1271:195-204.

(5.) Soja AM, Mortensen SA. Treatment of congestive heart failure with coenzyme Q10 illuminated by meta-analyses of clinical trials. Mol Aspects Med 1997;18(suppl):S159-68.

(6.) Munkholm H, Hansen HH, Rasmussen K. Coenzyme Q10 treatment in serious heart failure. Biofactors 1999;9:285-9.

(7.) Watson PS, Scalia GM, Galbraith A, Burstow DJ, Bett N, Aroney CN. Lack of effect of coenzyme Q on left ventricular function in patients with congestive heart failure. J Am Coll Cardiol 1999;33: 1549-52.

(8.) Hofman-Bang C, Rehnqvist N, Swedberg K, Wiklund I, Astrom H. Coenzyme Q10 as an adjunctive in the treatment of chronic congestive heart failure. The Q10 Study Group. J Card Fail 1995;1:101-7.

(9.) Schussler M, Holzl J, Fricke U. Myocardial effects of flavonoids from Crataegus species. Arzneimittelforschung 1995;45:842-5.

(10.) Weihmayr T, Ernst E. Therapeutic effectiveness of Crataegus. Fortschr Med 1996;114:27-9.

(11.) Weikl A, Assmus KD, Neukum-Schmidt A, Schmitz J, Zapfe G, Noh HS, et al. Crataegus Special Extract WS 1442. Assessment of objective effectiveness in patients with heart failure (NYHA II). Fortschr Med 1996;114:291-6.

(12.) Miller LG. Herbal medicinals: selected clinical considerations focusing on known or potential drug-herb interactions. Arch Intern Med 1998;158: 2200-11.

(13.) Silagy C, Neil A. Garlic as a lipid lowering agent--a meta-analysis. J R Coll Physicians Lond 1994;28: 39-45.

(14.) Neil HA, Silagy CA, Lancaster T, Hodgeman J, Vos K, Moore JW, et al. Garlic powder in the treatment of moderate hyperlipidaemia: a controlled trial and meta-analysis. J R Coll Physicians Lond 1996;30: 329-34.

(15.) Berthold HK, Sudhop T, von Bergmann K. Effect of a garlic oil preparation on serum lipoproteins and cholesterol metabolism: a randomized controlled trial. JAMA 1998;279:1900-2.

(16.) McCrindle BW, Helden E, Conner WT. Garlic extract therapy in children with hypercholesterolemia. Arch Pediatr Adolesc Med 1998;152: 1089-94.

(17.) Potter SM. Soy protein and serum lipids. Curr Opin Lipidol 1996;7:260-4.

(18.) Anthony MS, Clarkson TB, Hughes CL Jr, Morgan TM, Burke GL. Soybean isoflavones improve cardiovascular risk factors without affecting the reproductive system of peripubertal rhesus monkeys. J Nutr 1996;126:43-50.

(19.) Balmir F, Staack R, Jeffrey E, Jimenez MD, Wang L, Potter SM. An extract of soy flour influences serum cholesterol and thyroid hormones in rats and hamsters. J Nutr 1996;126:3046-53.

(20.) Fernandez ML, Wilson TA, Conde K, Vergara-Jimenez M, Nicolosi RJ. Hamsters and guinea pigs differ in their plasma lipoprotein distribution when fed diets varying in animal protein, soluble fiber, or cholesterol content. J Nutr 1999;129:1323-32.

(21.) Potter SM, Bakhit RM, Essex-Sorlie DL, Weingartner KE, Chapman KM, Nelson RA, et al. Depression of plasma cholesterol in men by consumption of baked products containing soy protein. Am J Clin Nutr 1993;58:501-6.

(22.) Anderson JW, Johnstone BM, Cook-Newell ME. Meta-analysis of the effects of soy protein intake on serum lipids. N Engl J Med 1995;333:276-82.

(23.) Potter SM, Baum JA, Teng H, Stillman RJ, Shay NF, Erdman JW. Soy protein and isoflavones: their effects on blood lipids and bone density in postmenopausal women. Am J Clin Nutr 1998;68: 1375S-9S.

(24.) Wong WW, Smith EO, Hachey DL, Heird WC, Pownell HJ. Cholesterol-lowering effect of soy protein in normocholesterolemic and hypercholesterolemic men. Am J Clin Nutr 1998;68:1385S-9S.

(25.) Heber D. Dietary supplement or drug? The case for cholestin [Letter]. Am J Clin Nutr 1999;70:106-8.

(26.) Havel RJ. Dietary supplement or drug? The case of cholestin [Editorial]. Am J Clin Nutr 1999;69:175-6.

(27.) Heber D, Yip I, Ashley JM, Elashoff DA, Elashoff RM, Go VL. Cholesterol-lowering effects of a proprietary Chinese red-yeast-rice dietary supplement. Am J Clin Nutr 1999;69:231-6.

(28.) Bordia A, Verma SK, Srivastava KC. Effect of ginger (Zingiber officinale Rosc.) and fenugreek (Trigonella foenumgraecum L.) on blood lipids, blood sugar and platelet aggregation in patients with coronary artery disease. Prostaglandins Leukot Essent Fatty Acids 1997;56:379-84.

(29.) Petit PR, Sauvaire YD, Hillaire-Buys DM, Leconte OM, Baissac YG, Ponsin GR, et al. Steroid saponins from fenugreek seeds: extraction, purification, and pharmacological investigation on feeding behavior and plasma cholesterol. Steroids 1995;60:674-80.

(30.) Valette G, Sauvaire Y, Baccou JC, Ribes G. Hypocholesterolaemic effect of fenugreek seeds in dogs. Atherosclerosis 1984;50:105-11.

(31.) Sharma RD, Raghuram TC, Rao NS. Effect of fenugreek seeds on blood glucose and serum lipids in type I diabetes. Eur J Clin Nutr 1990;44:301-6.

(32.) Nityanand S, Srivastava JS, Asthana OP. Clinical trials with gugulipid. A new hypolipidaemic agent. J Assoc Physicians India 1989;37:323-8.

(33.) Agarwal RC, Singh SP, Saran RK, Das SK, Sinha N, Asthana OP, et al. Clinical trial of gugulipid--a new hypolipidemic agent of plant origin in primary hyperlipidemia. Indian J Med Res 1986;84:626-34.

(34.) Singh RB, Niaz MA, Ghosh S. Hypolipidemic and antioxidant effects of Commiphora mukul as an adjunct to dietary therapy in patients with hypercholesterolemia. Cardiovasc Drugs Ther 1994;8: 659-64.

This is Part II of a two-part article on alternative therapies. Part I, on alternative therapies for depression, diabetes and obesity appeared in the last issue (Am Fam Physician 2000; 62:1051-60.)

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