CLINICAL APPLICATIONS

* Dyslipidemia

§ Hyperlipidemia (high cholesterol and triglycerides levels)

§ Hypercholesterolemia (high cholesterol levels)

§ Hypertriglyceridemia (high triglyceride levels)

* Dyslipidemia with obesity, diabetes mellitus, or fatty liver

 

WESTERN THERAPEUTIC ACTIONS

* Antihyperlipidemic effect to reduce plasma levels of cholesterol and triglycerides

* Antiobesity effect to reduce body weight and inhibit lipid accumulation

* Hypoglycemic effect to lower blood glucose levels to manage diabetes mellitus

* Prevents and treats fatty liver

 

CHINESE THERAPEUTIC ACTIONS

* Dissolves dampness

* Eliminates phlegm

* Invigorates blood circulation

* Clears heat

 

DOSAGE

Take 3 to 4 capsules three times daily on an empty stomach. For maximum effectiveness, take the last dose one hour before bedtime, as synthesis of cholesterol is most active at night. As a preventative formula, take 2 capsules twice daily on an empty stomach.

 

INGREDIENTS

Da Huang (Radix et Rhizoma Rhei)

Dan Shen (Radix et Rhizoma Salviae Miltiorrhizae)

Ge Gen (Radix Puerariae Lobatae)

Hai Zao (Sargassum)

Huang Qin (Radix Scutellariae)

Jue Ming Zi (Semen Cassiae)

Shan Zha (Fructus Crataegi)

Yin Chen (Herba Artemisiae Scopariae)

Yu Jin (Radix Curcumae)

Ze Xie (Rhizoma Alismatis)

 

BACKGROUND

Dyslipidemia is the elevation of cholesterol and/or triglycerides levels that contributes to the development of arteriosclerosis and atherosclerosis and increases the risks of coronary artery disorder. Causes of dyslipidemia may be primary (genetic) or secondary (including diet, obesity, and diabetes). Complications of dyslipidemia include atherosclerosis, arteriosclerosis, coronary artery disease, angina pectoris, hypertension and fatty liver. Optimal treatment requires dietary changes, exercise, and if necessary, use of herbs or drugs to lower lipids.

 

FORMULA EXPLANATION

According to traditional Chinese medicine, cholesterol and triglycerides are considered as excess accumulations of dampness (hyperglycemia) and phlegm in the blood vessels (dyslipidemia), liver (fatty liver), and body (obesity). To effectively reduce plasma levels of cholesterol and triglycerides, treat fatty liver, and reduce body weight, treatment must focus on dissolving dampness, eliminating phlegm, invigorating blood circulation, and clearing heat.

        In Cholisma (ES), Ze Xie (Rhizoma Alismatis) resolves dampness and Hai Zao (Sargassum) eliminates phlegm. Dan Shen (Radix et Rhizoma Salviae Miltiorrhizae), Yu Jin (Radix Curcumae), and Shan Zha (Fructus Crataegi) activate blood circulation and eliminate blood stasis; keeping the flow of blood smooth will prevent plaque buildup on the vessel walls and ensure a healthy cardiovascular system. In addition, the liver has a remarkable power to regenerate itself, and it does so even faster when blood movers are used to ensure the proper supply of nutrients and elimination of waste. Long-term stagnation of damp, phlegm, and blood will create heat. Therefore, several herbs are used to clear heat, such as Jue Ming Zi (Semen Cassiae), Da Huang (Radix et Rhizoma Rhei), Yin Chen (Herba Artemisiae Scopariae), Ge Gen (Radix Puerariae Lobatae) and Huang Qin (Radix Scutellariae). Yin Chen (Herba Artemisiae Scopariae) and Da Huang (Radix et Rhizoma Rhei) ensure the healthy function of the liver and gallbladder by promoting the secretion of bile, digestion of fat, and the dispelling of damp-heat accumulation in the Liver and Gallbladder.

        In summary, Cholisma (ES) is an excellent formula to treat individuals with an overall condition characterized by elevated cholesterol and triglyceride levels, accompanied by a fatty liver and obesity.

 

CAUTIONS & CONTRAINDICATIONS

* Cholisma (ES) is contraindicated during pregnancy.

* Jue Ming Zi (Semen Cassiae) and Da Huang (Radix et Rhizoma Rhei) may cause loose stool or diarrhea for those with sensitive gastrointestinal tracts. Should this occur, reduce the dosage to 2 to 3 capsules three times daily.

* The following warning statement is required by the State of California: “This product contains Da Huang (Radix et Rhizoma Rhei). Read and follow directions carefully. Do not use if you have or develop diarrhea, loose stools, or abdominal pain because Da Huang (Radix et Rhizoma Rhei) may worsen these conditions and be harmful to your health. Consult your physician if you have frequent diarrhea or if you are pregnant, nursing, taking medication, or have a medical condition.”

* This herbal formula contains herbs that invigorate blood circulation, such as Dan Shen (Radix et Rhizoma Salviae Miltiorrhizae). Therefore, patients who are on anticoagulant or antiplatelet therapies, such as Coumadin (warfarin), should use this formula with caution, or not at all, as there may be a higher risk of bleeding and bruising.[1]

 

CLINICAL NOTES

* Cholisma (ES) is specifically formulated to reduce blood cholesterol and triglyceride levels in individuals with fatty liver and/or obesity. Patients must take this herbal formula on a long-term basis for maximum results.

* The baseline cholesterol levels should be established before the initiation of herbal therapy; the first follow-up test should be done one month after the initiation of herbal therapy. Subsequent follow-ups can be done every two to three months to determine overall effectiveness. Cholesterol testing kits are available over-the-counter in most pharmacies. Results may vary from patient to patient. Lifestyle and dietary changes are also crucial for satisfactory result.

* Dyslipidemia has many secondary causes (obesity, diabetes, hypothyroidism, and use of drugs such as thiazides, beta-blockers, estrogen and progestins, and glucocorticoids) and multiple complications (atherosclerosis, arteriosclerosis, coronary artery disease, angina pectoris, hypertension and fatty liver). Therefore, optimal treatment must address both the causes and the complications. See Supplementary Formulas for more details.

 

Pulse Diagnosis by Dr. Jimmy Wei-Yen Chang:

* The overall general feel of the pulse is greasy. A greasy pulse is a pulse in which its border is not clear due to plaque built-up on the arterial wall. The more forceful and harder the pulse is, the worse the plaque built-up.

* Fatty liver: deep and forceful pulse on the left guan

 

SUPPLEMENTARY FORMULAS

* For high cholesterol and triglyceride levels without fatty liver or obesity, use Cholisma instead.

* For obese patients with an excess appetite, add Herbalite.

* For patients with diabetes mellitus, add Equilibrium.

* For deficient-type hypertension with dizziness or vertigo, combine with Gastrodia Complex.

* For excess-type hypertension with anger or flushed face, combine with Gentiana Complex.

* For coronary heart disorders, add Circulation.

* For excess heat everywhere in the body, add Gardenia Complex.

* For hepatitis or other liver dysfunction, add Liver DTX.

 

ACUPUNCTURE TREATMENT

Traditional Points:

* Hyperlipidemia:

§ Bleed Weizhong (BL 40) or wherever there is visible, dilated vein in the transverse crease of the popliteal fossa.

§ Taichong (LR 3), Xingjian (LR 2), Zusanli (ST 36), Quchi (LI 11), Fenglong (ST 40)

§ Alternate the following two sets of points:

    1) Sanyinjiao (SP 6), Zusanli (ST 36), and Neiguan (PC 6)

    2) Taibai (SP 3), Yanglingquan (GB 34), and Fenglong (ST 40)

* Obesity: Shenmen (HT 7), Liangqiu (ST 34), Gongsun (SP 4), Tianshu (ST 25), Daling (PC 7), Qihai (CV 6), Guanyuan (CV 4)

 

Classical Master Tung's Points:

* Hyperlipidemia: Fuding (T 44.04), Houzhi (T 44.05), Luotong (T 44.14), Zhitong (T 44.13), Xinling (T 33.17)*, Linggu (T 22.05), Jianzhong (T 44.06), Dizong (T 44.09)

* Obesity (general): Linggu (T 22.05), Huaguyi (T 55.02), Huagusi (T 55.05), Yizhong (T 77.05), Erzhong (T 77.06), Sanzhong (T 77.07), Zusanli (ST 36), Menjin (T 66.05), Liangqiu (ST 34), Renhuang (T 77.21), Tongguan (T 88.01), Tianhuangfu [Shenguan] (T 77.18), Mufu (T 88.38)*, Minghuang (T 88.12). Bleed SP and ST areas on the back and dark veins nearby Weizhong (BL 40), Sihuashang (T 77.08), Sihuazhong (T 77.09), Sihuaxia (T 77.11), Yizhong (T 77.05), Erzhong (T 77.06) and Sanzhong (T 77.07). Bleed before needling for best result.

* Fatty liver: Ganmen (T 33.11), Minghuang (T 88.12), Huoquan (T 88.16). Bleed the LR area in the back wtih cupping. Bleed before needling for best result.

 

Master Tung’s Points by Dr. Chuan-Min Wang:

* Elevated cholesterol or triglyceride: Bleed Sihuashang (T 77.08), Sihuazhong (T 77.09), Sihuafu (T 77.10), Sihuaxia (T 77.11). Needle Qimen (T 33.01), Qijiao (T 33.02), Qizheng (T 33.03), Muliu (T 66.06), Mudou (T 66.07).

 

Balance Method by Dr. Richard Tan:

* Hyperlipidemia

§ Left side: Yinlingquan (SP 9), Xuehai (SP 10), Waiguan (TH 5)

§ Right side: Zusanli (ST 36), Fenglong (ST 40), Daling (PC 7), Laogong (PC 8)

§ Alternate sides from treatment to treatment.

* Obesity

§ Left side: Waiguan (TH 5), Hegu (LI 4), Yinlingquan (SP 9)

§ Right side: Zusanli (ST 36), Neiguan (PC 6)

§ Alternate sides from treatment to treatment.

* Fatty liver

§ Right side: ah shi points around Quze (PC 3) to Ximen (PC 4), Yanglingquan (GB 34)

§ Left side: Tianjing (TH 10), Shanglian (LI 9), Shousanli (LI 10), Xiguan (LR 7), Yinlingquan (SP 9)

§ Alternate sides from treatment to treatment.

 

Auricular Medicine by Dr. Li-Chun Huang:

* Obesity: Pituitary, Endocrine, Forehead, Exciting Point, Hunger Point, Thalamus, Sanjiao, Kidney, Large Intestine, Lung, areas that have fat deposit such as the Abdomen or Buttock

 

NUTRITION

* Increase the daily intake of cholesterol-lowering foods such as apples, bananas, carrots, cold-water fish, dried beans, garlic, grapefruit, olive oil, and fibers such as bran and oat.

* Advise the patients to consume large quantities of fresh fruits and vegetables.

* Decrease the intake of food that will raise cholesterol levels, including but not limited to: beer, wine, cheese, aged and cured meats, sugar, and greasy or fried foods. Avoid eating red meat, fatty foods, processed or fried foods, soda, pastries, pies, doughnuts, candy, and other sweets.

* Eat small, frequent meals throughout the day instead of a few large ones. Eat slowly and chew thoroughly.

* Increase the intake of niacin, which can lower total cholesterol levels by up to 18%, increase HDL cholesterol by up to 32%, and lower triglycerides by up to 26%. Slow release form of niacin is preferred to minimize side effects such as flushing and stomach pain.

* Other supplements that are beneficial are vitamin B5, vitamin C, vitamin E, chromium picolinate, lecithin, and coenzyme Q10.

* Avoid greasy, fatty, fried and oily foods. Seafood should also be reduced.

 

The Tao of Nutrition by Dr. Maoshing Ni and Cathy McNease:

* Make soup with diced artichoke hearts, sliced ginger, and 1/2 head of cabbage. Eat a bowl daily.

* Drink one glass daily of pureed asparagus juice, including the pulp; add one teaspoon of honey.

* Use white mushrooms and corn silk to make soup or tea regularly.

* Add rice bran to a grain dish everyday for at least two months.

* Incorporate pinto beans and other beans that are high in fiber and contain rich folate that lowers cholesterol into the diet regularly.

 

LIFESTYLE INSTRUCTIONS

* Drink tea on a daily basis, especially after meals, to decrease the absorption of fatty foods from the diet. Beneficial teas include pu-er, black, oolong or green tea.

* Avoid the consumption of alcohol and exposure to tobacco. They increase cholesterol buildup and hardening of arteries.

* The importance of a regular exercise routine cannot be over-emphasized. Exercise will improve energy levels, normalize metabolic functions, reduce fat, and burn calories.

* Change dietary and exercise habits to avoid rebound weight gain.

* Do not lose weight drastically. Rapid weight loss may be hazardous and is more likely to lead to rebound weight gain.

 

CASE STUDY

* A 57-year-old female presented with an enlarged liver. She has a history of hepatitis and a cholecystectomy previously. Symptoms included shortness of breath, edema in the upper body and liver enzyme elevation. The TCM diagnosis was Spleen qi deficiency with phlegm. Liver DTX and Cholisma (ES) were both prescribed for five months. Her liver was normal in size without any discrete mass. As a result of taking the herbs, the patient's overall condition had improved. It was confirmed through another testing that her liver enzyme levels were back to normal. She hasn’t had any issues since. Submitted by H.C., Sydney, New York.

 

PHARMACOLOGICAL AND CLINICAL RESEARCH

Cholisma (ES) is formulated to treat dyslipidemia (hyperlipidemia, hypercholesterolemia and hypertriglyceridemia). This formula incorporates many herbs with excellent antihyperlipidemic effects to reduce plasma levels of cholesterol and triglycerides. Furthermore, Cholisma (ES) is also beneficial to treat related conditions and compilations, such as obesity, diabetes mellitus, and fatty liver.

        Cholisma (ES) contains many herbs with multiple mechanisms of actions to lower plasma cholesterols and triglycerides. Ze Xie (Rhizoma Alismatis) has a remarkable antihyperlipidemic effect, and has been shown in various clinical studies to effectively treat dyslipidemia, hypercholesterolemia, arteriosclerosis and fatty liver.[2],[3] Jue Ming Zi (Semen Cassiae) has multiple therapeutic benefits: it lowers low-density lipoproteins, increases high-density lipoproteins, and lowers blood pressure without any serious adverse effects.[4]^,[5],[6] Ge Gen (Radix Puerariae Lobatae) and Shan Zha (Fructus Crataegi) have both shown marked effectiveness for reduction of plasma cholesterol levels, with mechanisms of action attributed to enhancement of LDL-receptor activity, increased hepatic breakdown and decreased synthesis of cholesterol.[7]^,[8] Yu Jin (Radix Curcumae) has potent antioxidant and antihyperlipidemic functions, and demonstrates a comparable effect to that of Mevacor (lovastatin) to decrease plasma levels of cholesterol, triacylglycerol, and low-density lipoprotein cholesterol.[9] Lastly, Yu Jin (Radix Curcumae), Da Huang (Radix et Rhizoma Rhei) and Yin Chen (Herba Artemisiae Scopariae) are all effective in lowering plasma and liver content of cholesterols and triglycerides.[10]^,[11],[12] Clinical applications of these herbs include dyslipidemia, hypercholesterolemia, and coronary artery disease.[13]^,[14],[15]

        Clinically, many studies have been conducted to demonstrate the therapeutic benefits of these herbs to treat dyslipidemia. According to one clinical study, use of Jue Ming Zi (Semen Cassiae) effectively reduces cholesterol levels to normal within 6 weeks in 98 of 100 patients.[16] According to another clinical study, use of Jue Ming Zi (Semen Cassiae) in 48 patients is associated with reduction in blood cholesterol in 95.8% of the patients, reduction in triglycerides in 86.7%, and reduction of beta-lipoprotein in 89.5%.[17] Lastly, 30 patients with elevated cholesterol levels were treated with a 90% rate of effectiveness using an herbal formula that contained Shan Zha (Fructus Crataegi), Dan Shen (Radix et Rhizoma Salviae Miltiorrhizae) and Ge Gen (Radix Puerariae Lobatae).[18]

        Cholisma (ES) also has herbs to lower blood glucose to treat diabetes mellitus and reduce body weight to treat obesity, conditions commonly associated with dyslipidemia. Oral administration of Ge Gen (Radix Puerariae Lobatae) in herbal decoction has been shown to lower blood glucose levels.[19] In addition, administration of puerariafuran from Ge Gen (Radix Puerariae Lobatae) is associated with a preventative effect against diabetic complications, such as cataracts.[20] Yin Chen (Herba Artemisiae Scopariae) has an antiobesity effect, and has been shown to effectively reduce body weight and inhibit lipid accumulation, according to one study in subjects fed a high fat diet.[21] According to one clinical study, successful reduction of body weight was reported in 79 of 96 patients using a combination of herbal therapy, diet changes, and exercise regimens. The herbal formula contained Jue Ming Zi (Semen Cassiae), Ze Xie (Rhizoma Alismatis), Shan Zha (Fructus Crataegi) and others.[22]

        In summary, Cholisma (ES) is one of the best formulas to treat elevated cholesterol and triglyceride levels with complications such as fatty liver, obesity, and diabetes. The formula is most effective if combined with lifestyle and dietary changes as described above.

 

COMPARATIVE ANALYSIS

Dyslipidemia, obesity, and fatty liver are three conditions that are often closely linked to each others. Dyslipidemia is the accumulation of abnormally high levels of fats (cholesterols, triglycerides, or both) in the blood, fatty liver is the excess accumulation of fat in the liver cells, and obesity is the abnormal increase in body weight. If untreated, these conditions increase risk of diabetes, coronary artery disease, and cardiovascular and cerebrovascular disorders.

        In Western medicine, dyslipidemia is usually treated with HMG-CoA reductase inhibitors, a category of drugs that includes Lipitor (atorvastatin), Zocor (simvastatin), and Pravachol (pravastatin). Also known as “statin” drugs, these drugs reduce plasma cholesterol and triglyceride levels by reducing their synthesis in the liver. In most cases, these drugs are effective and are well tolerated. However, these drugs have been shown to cause serious and potentially life-threatening side effects in a small number of patients, such as rhabdomyolysis with kidney failure (0.5%), liver impairment (2.3%), and increased risk of liver cancer.[23] Furthermore, discontinuation of these drugs is frequently associated with a rebound increase of cholesterol and triglyceride levels. Given the potential risks versus benefits, it is important to take drugs only when necessary, and once on drug therapy, be monitored closely by the medical doctor so the drug can be discontinued immediately if these serious side effects begin to develop.

        Obesity, a common health problem that is quickly becoming an epidemic, has few treatment options available. There are only a few drugs approved by the Food and Drug Administration for long-term weight loss, and they have serious side effects. Xenical (orlistat) reduces body weight by blocking absorption of fat in the digestive tract. Because it interferes with the normal absorption process, this drug is known to cause many gastrointestinal side effects, such as fecal incontinence, fecal urgency, flatulence with discharge, increased defecation, oily evacuation, oily rectal leakage, steatorrhea, and projectile diarrhea. Meridia (sibutramine) is a stimulant agent that causes weight loss by increasing metabolism and suppressing appetite. Similar to many other stimulant weight-loss drugs, use of Meridia (sibutramine) may cause anorexia, anxiety, constipation, dizziness, headache, insomnia, irritability, nervousness, rhinitis, xerostomia, hypertension, congestive heart failure, arrhythmias, seizure and stroke.

        Fatty liver is a potentially serious condition that, if untreated, may lead to liver cirrhosis. Unfortunately, there is no drug treatment for fatty liver in Western medicine.

        Dyslipidemia, obesity, and fatty liver are all characterized by the presence of damp and phlegm affecting various parts of the body. Use of herbs has been shown to be extremely effective to slowly and steadily improve all three of these conditions.

        For treatment of dyslipidemia and obesity, drugs are more potent but have significantly more side effects, in comparison with herbs. However, the higher potency of the drugs is not necessary an advantage because these conditions are chronic in nature and require persistent and long-term treatment, not aggressive and short-term treatment. Therefore, long-term evaluation will often show comparable efficacy of both treatments. For fatty liver, herbal treatment is superior, especially since there are no treatment options available in Western medicine. Lastly, it is extremely important to remember there is no magic bullet. Without commitment to changing diet and lifestyles, use of either drugs or herbs will have limited effectiveness. The practitioners and patients must work together to achieve significant and sustainable clinical results.