KAL Cholestatin Phytosterol Complex by Nutraceutical Corp.

LIKELY EFFECTIVE

• Benign prostatic hyperplasia (BPH). Oral beta-sitosterol is beneficial for most symptoms of BPH. Details: Taking beta-sitosterol 60-130 mg orally in 2-3 divided doses daily for up to 18 months significantly improves urinary symptoms, increases maximum urinary flow, and decreases postvoid residual urine volume; however, it does not affect prostate size (5327,5328,5329,7195,7198,34975). Additionally, one study suggests that taking an enriched form of saw palmetto oil (Vispo) 200 mg containing 3% beta-sitosterol twice daily for 12 weeks seems to be more effective than standard saw palmetto oil containing 0.3% beta-sitosterol for reducing some measures of overall symptoms of BPH (104803). Although some preliminary research shows no benefit of beta-sitosterol on symptoms of BPH, the variability in doses used, the short duration of treatment, the small study sizes, and the differing severity of disease at baseline limit the reliability of these latter results (35124,96784).
• Hypercholesterolemia. Oral beta-sitosterol is beneficial for hypercholesterolemia. Details: Taking beta-sitosterol orally significantly reduces total and low-density lipoprotein (LDL) cholesterol levels, but has little or no effect on high-density lipoprotein (HDL) cholesterol levels. Beta-sitosterol 0.65-1.5 grams twice daily has been used, typically in conjunction with a low-fat diet (6668,7195,112081). The effects of combination formulations containing beta-sitosterol have also been evaluated in patients with hypercholesterolemia. Some preliminary clinical research in these patients shows that taking a combination of soy protein 8 grams plus beta-sitosterol 2 grams daily for 40 days lowers LDL cholesterol by 17-20 mg/dL, but does not improve triglyceride or HDL cholesterol levels, when compared to baseline (35013,35039). Other clinical research shows that taking a combination of beta-sitosterol 2.5 grams daily along with cholestyramine (Questran, Bristol Myer Squibb) 8 grams daily for 12 weeks reduces total cholesterol by about 23 mg/dL and LDL cholesterol by 15 mg/dL when compared to baseline, but is less effective than atorvastatin 10 or 80 mg daily (35100).

POSSIBLY EFFECTIVE

• Coronary heart disease (CHD). The US Food and Drug Administration (FDA) has approved an authorized health claim for dietary plant sterols, when taken in doses of at least 3.4 grams daily as part of a diet low in saturated fat and cholesterol, for reducing the risk of CHD. Details: In 2010, the FDA authorized a health claim stating that consuming at least 3.4 grams of plant sterols daily, as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease (102365). This health claim is based on evidence showing that plant sterols can lower cholesterol levels. However, there is currently no evidence directly linking dietary intake of plant sterols with a reduced risk for developing CHD.
• Familial hypercholesterolemia. Oral beta-sitosterol, in combination with a cholesterol-lowering diet, seems to reduce low-density lipoprotein (LDL) cholesterol levels in patients with familial hypercholesterolemia. However, it doesn't seem to work as well as sitostanol or bezafibrate. Details: Preliminary clinical research shows that taking beta-sitosterol for 1-4 months while following a cholesterol-lowering diet reduces total cholesterol by 6% to 13% and LDL cholesterol by 6% to 20% in adult and pediatric patients with familial hypercholesterolemia. Beta-sitosterol 2.5-21.1 grams taken in up to three divided doses daily for 1-3 months has been used in adults. Beta-sitosterol 2-4 grams three times daily for 3 months has been used in children and adolescents (3889,5331,5332,5333,35067). Some research suggests that the optimal dose of beta-sitosterol is 6 grams daily; higher doses do not appear to be more effective (5333). However, some research in pediatric patients shows that beta-sitosterol can also decrease levels of high-density lipoprotein (HDL) cholesterol (5332) and that beta-sitosterol appears to be less effective for reducing LDL cholesterol when compared to sitostanol (3889). Furthermore, beta-sitosterol does not appear to improve triglyceride levels (5333). Some research has compared beta-sitosterol to cholesterol-lowering medication. In children with familial hypercholesterolemia, taking beta-sitosterol 1 grams three times daily in combination with the fibrate drug bezafibrate 200 mg once daily for 24 months reduces cholesterol as effectively as taking bezafibrate 200 mg twice daily. However, taking beta-sitosterol 2 grams three times daily is less effective for lowering LDL cholesterol when compared with bezafibrate 200 mg twice daily (5334).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Allergic rhinitis (hay fever). Although there is interest in using oral beta-sitosterol for allergic rhinitis, there is insufficient reliable information about the clinical effects of beta-sitosterol for this condition.
• Androgenic alopecia. Oral beta-sitosterol has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in males with androgenic alopecia shows that a combination of beta-sitosterol 50 mg plus saw palmetto extract 200 mg taken twice daily for an average of 4.6 months improves subjective scores of hair quantity and quality when compared with baseline (15550). The validity of this finding is limited by the lack of a comparator group.
• Asthma. Although there is interest in using oral beta-sitosterol for asthma, there is insufficient reliable information about the clinical effects of beta-sitosterol for this condition.
• Burns. Topical beta-sitosterol has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research shows that applying an ointment containing sesame oil, beta-sitosterol, berberine, and other plant ingredients (MEBO) is as effective as applying silver sulfadiazine dressing twice daily for healing burns and preventing bacterial infection (13526). Furthermore, this ointment appears to be more effective than povidone-iodine plus bepanthenol cream for reducing pain. The ointment can also shorten the hospital stay of these patients by almost one day when compared with povidone-iodine plus bepanthenol (35118). However, when used for second-degree facial burns, this ointment increases healing time by about 2 days and worsens pain and discomfort when compared with a specific dressing containing ionic silver (Aquacel Ag Hydrofiber) (35117). The ointment has been applied to partial-thickness burns as a thick layer every 4-12 hours for up to 18 days or until release from the hospital in patients aged 2 years and older (13526,35117,35118).
• Cancer. It is unclear if dietary beta-sitosterol is beneficial for cancer prevention. Details: A meta-analysis of population research has found that although the highest intake of plant sterols is associated with a reduced risk of having cancer when compared with the lowest intake, there is no association between beta-sitosterol itself and cancer risk (106084). Also, population research suggests that dietary intake of beta-sitosterol does not affect the risk of colon cancer (34993).
• Chronic prostatitis and chronic pelvic pain syndrome (CP/CPPS). Although there is interest in using oral beta-sitosterol for prostatitis, there is insufficient reliable information about the clinical effects of beta-sitosterol for this condition.
• Esophageal cancer. It is unclear if dietary beta-sitosterol intake influences the outcome of esophageal cancer. Details: In Chinese people with esophageal squamous cell carcinoma, the mortality rate does not seem to differ between those with the lowest versus the highest intake of dietary beta-sitosterol, measured five years before diagnosis (112082).
• HIV/AIDS. Although there is interest in using oral beta-sitosterol for HIV/AIDS, there is insufficient reliable information about the clinical effects of beta-sitosterol for this condition.
• Menopausal symptoms. Although there is interest in using oral beta-sitosterol for menopausal symptoms, there is insufficient reliable information about the clinical effects of beta-sitosterol for this purpose.
• Migraine headache. Although there is interest in using oral beta-sitosterol for migraine headache, there is insufficient reliable information about the clinical effects of beta-sitosterol for this condition.
• Obesity. It is unclear if oral beta-sitosterol is beneficial for obesity. Details: In Chinese adults, higher dietary intake of beta-sitosterol is inversely related to the risk of being overweight. The risk of central obesity specifically is linked to beta-sitosterol intake in males (112083).
• Psoriasis. Although there is interest in using oral beta-sitosterol for psoriasis, there is insufficient reliable information about the clinical effects of beta-sitosterol for this condition.
• Rheumatoid arthritis (RA). It is unclear if oral beta-sitosterol is beneficial for RA. Details: Preliminary clinical research shows that taking a specific supplement (Moducare) containing beta-sitosterol 20 mg and beta-sitosterol glucoside 0.2 mg three times daily for 24 weeks improves pain and symptoms in 28% to 85% of patients with RA when compared with baseline (35200). The validity of this finding is limited by the lack of a comparator group.
• Systemic lupus erythematosus (SLE). Although there is interest in using oral beta-sitosterol for SLE, there is insufficient reliable information about the clinical effects of beta-sitosterol for this condition.
• Thrombocytopenia. Although there is interest in using oral beta-sitosterol for thrombocytopenia, there is insufficient reliable information about the clinical effects of beta-sitosterol for this condition.
• Tuberculosis. It is unclear if oral beta-sitosterol is beneficial for tuberculosis. Details: A small clinical trial shows that taking beta-sitosterol orally as an adjunct to conventional treatment for tuberculosis can increase lymphocyte counts when compared with placebo; however, beta-sitosterol does not seem to decrease the time to cure based on negative sputum culture (5337).
• Upper respiratory tract infection (URTI). Although there is interest in using oral beta-sitosterol for upper respiratory infections such as bronchitis, common cold, exercise-induced respiratory infections, and influenza, there is insufficient reliable information about the clinical effects of beta-sitosterol for these conditions.
• Wound healing. Although there is interest in using topical beta-sitosterol for wound healing, there is insufficient reliable information about the clinical effects of beta-sitosterol for this purpose. More evidence is needed to rate beta-sitosterol for these uses.

(Read more about BETA-SITOSTEROL)

LIKELY EFFECTIVE

• Familial hypercholesterolemia. Oral plant sterols are beneficial for reducing levels of low-density lipoprotein (LDL) cholesterol when used in combination with a cholesterol-lowering diet in children and adults with familial hypercholesterolemia (FH). Details: A meta-analysis of results from clinical research in children and adults with FH shows that taking plant sterols while following a cholesterol-lowering diet reduces total cholesterol by an additional 12 mg/dL and LDL cholesterol by an additional 23 mg/dL when compared with following a cholesterol-lowering diet alone (90743). Individual clinical trials in adults and children 5 years and up show that consuming margarine spreads or yogurt enriched with plant sterol 1.6-2.3 grams daily for 4-26 weeks, sometimes in combination with statin therapy, reduces total cholesterol by up to 11% and LDL cholesterol by up to 14% in patients with FH (90726,90731,35037,35106). However, most clinical research shows that plant sterols do not reduce triglyceride levels or increase high-density lipoprotein (HDL) cholesterol levels in patients with FH (35037,35106,90743).
• Hypercholesterolemia. Oral plant sterols in doses of 2-3 grams daily are beneficial for reducing levels of low-density lipoprotein (LDL) cholesterol, but not triglycerides, when used in combination with a cholesterol-lowering diet. Details: Clinical research shows that taking plant sterols, alone or in combination with plant stanols, reduces total and LDL cholesterol levels in patients with hypercholesterolemia. Taking plant sterols daily while following a cholesterol-lowering diet reduces total cholesterol by about 3% to 8% and LDL cholesterol by about 5% to 15% when compared with dieting alone (5336,5437,7105,65749,90686,90720,90722,90723,90724,90734)(90741,90748,90752,106093). Plant sterols seem to have the most significant cholesterol-lowering effect in people who naturally produce a high amount of cholesterol (90742). When taken along with statin therapy, plant sterols can lower total cholesterol by about 12-22 mg/dL and LDL cholesterol by about 11-16 mg/dL when compared with statin therapy alone (90728,96272). Predictive modeling suggests that the cholesterol reduction from plant sterols can reduce the risk of cardiovascular disease over time. In English adults with hypercholesterolemia and no cardiovascular disease, replacing regular spreads with plant sterol -enriched spreads over a 20-year period could potentially prevent 69 cardiovascular events per 10,000 males and 40 events per 10,000 females (98449). Plant sterols, usually as esters, with or without plant stanols, 0.2-9 grams daily for up to one year have been used (5336,5437,5814,7105,14298,90686,90720,35034,90722,90723)(90724,90726,90730,90732,90733,90734,90741,90742,90744,90748)(90752,96272). However, the optimal dosage of plant sterols for reducing LDL cholesterol is about 2-3 grams daily taken with meals (5814,90733,90748). At this dosage, plant sterols seem to work as well as plant stanols but less effectively than taking policosanol 5-40 mg daily (14298,90730). When taken as fortified foods, plant sterols appear to be more effective when taken in dairy products than in breads or cereals (35034). No increased benefit is seen at dosages higher than 2-3 grams daily (90744). In post-menopausal females, a meta-analysis of 6 studies shows that plant sterols are most effective for reducing total and LDL cholesterol in patients with obesity, using a daily dose of plant sterols greater than 2 grams, and duration of treatment greater than 8 weeks (112081). Additionally, some clinical research shows that plant sterols might become less effective after about 2-3 months of treatment (90726). Results from most individual clinical studies show that plant sterols do not reduce triglyceride levels in patients with hypercholesterolemia (65749,90720,90732,96272,106093,112081). However, a meta-analysis of results from 12 clinical studies shows that taking plant sterols 0.8-4 grams daily reduces triglyceride levels by 6% in patients with hypercholesterolemia (90732). This suggests that plant sterols might modestly lower triglyceride levels in some patients, but more research in larger patient populations is needed to confirm this finding. There is also some evidence showing that plant sterols prepared as ester derivatives using fish oil rather than sunflower oil, olive oil, or rapeseed oil can moderately lower triglyceride levels when compared with placebo (90739). However, this benefit is likely due to the triglyceride-lowering activity of fish oil rather than plant sterols. Taking plant sterols does not improve levels of high-density lipoprotein (HDL) cholesterol (65749,90728,90732,96272,112081).

POSSIBLY EFFECTIVE

• Coronary heart disease (CHD). The US Food and Drug Administration (FDA) has approved an authorized health claim for dietary plant sterols, when taken in doses of at least 3.4 grams daily as part of a diet low in saturated fat and cholesterol, for reducing the risk of CHD. Details: In 2010, the US FDA authorized a health claim stating that consuming at least 3.4 grams of plant sterols daily, as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease (102365). This health claim is based on evidence showing that plant sterols can lower cholesterol levels. However, there is currently no evidence directly linking dietary intake of plant sterols with a reduced risk for developing CHD.

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Cancer. It is unclear if dietary plant sterols are beneficial for cancer prevention. Details: A meta-analysis of population research has found that the highest intake of plant sterols is associated with a 37% reduced risk of cancer when compared with the lowest intake (106084).
• Colorectal cancer. It is unclear if dietary plant sterols are beneficial for colorectal cancer prevention. Details: Population research has found that dietary intake of specific plant sterols, including campesterol, stigmasterol, or beta-sitosterol, is not associated with risk of developing colon cancer. Dietary intake of plant sterols also does not affect the risk of rectal cancer in females; however, in males, higher dietary intake of the plant sterols campesterol or stigmasterol is associated with an INCREASED risk of rectal cancer (34993).
• Esophageal cancer. It is unclear if dietary plant sterols influence the outcome of esophageal cancer. Details: In Chinese people with esophageal squamous cell carcinoma, the mortality rate does not seem to differ between those with the lowest versus the highest intake of dietary plant sterols, measured five years before diagnosis (112082).
• Gastric cancer. It is unclear if dietary plant sterols are beneficial for gastric cancer prevention. Details: Population research has found that consuming at least 82.5 mg of plant sterols daily as part of the diet is associated with moderately lower odds of developing gastric cancer when compared to those who consume less than 45.5 mg daily (34984).
• Impaired glucose tolerance (prediabetes). Although there is interest in using oral plant sterols for prediabetes, there is insufficient reliable information about the clinical effects of plant sterols for this condition.
• Metabolic syndrome. It is unclear if oral plant sterols are beneficial for metabolic syndrome; the available research is conflicting. Details: One clinical study shows that taking yogurt mini-drinks providing plant sterols 2 grams twice daily for 8 weeks reduces total cholesterol by about 16%, low-density lipoprotein (LDL) cholesterol by about 20%, and triglyceride levels by about 19% when compared with control yogurt drinks without plant sterols (90749). However, results from a much smaller study in patients with metabolic syndrome shows that taking plant sterols 2 grams daily for 8 weeks in breakfast cereal and margarine does not improve plasma lipids or other cardiovascular markers when compared with placebo foods (90745). Reasons for the discrepancy are not clear but might relate to the dose or formulation of plant sterol, or the lipid levels of the patients at baseline.
• Myocardial infarction (MI). It is unclear if dietary plant sterols are beneficial for MI prevention. Details: Population research has found that consuming approximately 340 mg of plant sterols daily is associated with a 29% lower risk of first myocardial infarction in males when compared with those who consume about 150 mg daily. However, dietary plant sterol intake is not associated with a reduced risk of first myocardial infarction in females (90740).
• Obesity. It is unclear if oral plant sterols are beneficial for obesity. Details: In Chinese adults, higher dietary intakes of beta-sitosterol, stigmasterol, and total plant sterols are inversely related to the risk of being overweight. The risk of central obesity is linked to stigmasterol intake in females, and to beta-sitosterol intake in males (112083). Preliminary clinical research in obese individuals shows that consuming rice bran snack bars fortified with a mixture of plant sterols and stanols 1.8 grams daily for 8 weeks while following a reduced calorie diet does not increase weight loss, reduce low-density lipoprotein (LDL) cholesterol, or improve blood glucose control when compared to dieting and consuming unfortified rice bran snack bars. However, the plant sterol-enriched rice bran snacks appear to decrease total cholesterol by about 10% more than unfortified rice bran snacks (90738). More evidence is needed to rate plant sterols for these uses.

(Read more about PLANT STEROLS)

LIKELY SAFE ...when used orally and appropriately. Beta-sitosterol has been safely used at a dose of 130 mg daily for up to 18 months or a dose of up to 21.1 grams daily for up to 3 months (5327,5328,5329,5330,5331,5332,5333,5334,5336,5337) (7198,10638). There is insufficient reliable information available about the safety of beta-sitosterol when used topically.

CHILDREN: LIKELY SAFE
when used orally and appropriately. Beta-sitosterol has been safely used at a dose of 2-4 grams three times daily for up to 3 months (3889,5331,5332,5333,5334,35067).

PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.

(Read more about BETA-SITOSTEROL)

LIKELY SAFE ...when used orally and appropriately. Plant sterols have been safely used in studies lasting up to one year (35022,35037,90724,90726,90730,90732,90733,90734,90739,90742). Due to the unknown safety of plant sterol oxidation products, and the known production of these oxidation products during the heating of foods (106092), there is insufficient reliable information available about the safety of heat-treated foods containing added plant sterols.

CHILDREN: LIKELY SAFE
when used orally and appropriately. Plant sterols have been safely used in children in studies lasting for up to 6 months (35037,90722,90723,90726,90731,35106). PREGNANCY AND LACTATION: Insufficient reliable information available; avoid using.

(Read more about PLANT STEROLS)

(Read more about BETA-SITOSTEROL)

(Read more about PLANT STEROLS)

General ...Orally, beta-sitosterol is generally well tolerated. Topically, beta-sitosterol seems to be well tolerated.
Most Common Adverse Effects:
Orally: Constipation, diarrhea, gas, indigestion, and nausea.

Dermatologic ...Orally, beta-sitosterol can worsen acne when taken alone or in combination with saw palmetto (5331,15550).

Gastrointestinal ...Orally, beta-sitosterol can cause nausea, indigestion, gas, diarrhea, or constipation (5327,5328). Beta-sitosterol can also reduce the appetite (5334). There is a case report of acute pancreatitis thought to be associated with taking beta-sitosterol in a 57-year-old male. Symptoms started the first day of use, but did not return when he stopped taking beta-sitosterol (106080).
Single reports of reduced appetite, flatulence, and diarrhea have been reported for patients taking a combination of saw palmetto and beta-sitosterol (15550).

Genitourinary ...Orally, beta-sitosterol can cause erectile dysfunction and loss of libido (5327,5329).

(Read more about BETA-SITOSTEROL)

General ...Orally, plant sterols are generally well tolerated.

Dermatologic ...Acute dermatitis has been reported in a case report of a 51-year-old female who used a pharmacy-brand plant sterol supplement to lower cholesterol levels. The rash was widespread with lesions on the hands and feet and a red and swollen face. The patient was treated orally with prednisolone and topically with emollients for 2 weeks (90737). It is not entirely clear if this adverse effect was due to the plant sterol supplement or another contributing factor.

Endocrine ...Peripheral precocious puberty has been described in a 20-month-old boy who ingested about 15 grams daily of a chicken essence product containing the plant sterol avenasterol, also known as clerosterol or chondrillasterol. Signs and symptoms included elevated estradiol and testosterone levels, acne, hairiness, increased penis size, hoarse voice, and increased growth rate. These effects were reversed when the product was stopped (112084).

Gastrointestinal ...Abdominal discomfort has occurred in one child in a clinical trial of oral plant sterols (35106). Because plant sterols decrease cholesterol absorption in the gut, there is concern that they might produce some gastrointestinal symptoms like diarrhea and excess amounts of fat in the stool (steatorrhea), although these adverse effects have not been reported in clinical research.

(Read more about PLANT STEROLS)