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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.

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LIKELY EFFECTIVE

• Dental caries. Using xylitol-containing products topically in the mouth seems to reduce the incidence of cavities. Details: Use of xylitol-containing products such as foods, chewing gum, candies, soluble dragees, and toothpaste that provide 1-20 grams of xylitol per day can marginally reduce the incidence of cavity formation in both adults and children (6815,6819,6822,95110,95114,95116,95117,95125,113324). Xylitol products appear to be more effective than products containing sorbitol for preventing cavity formation (6822,95690,113324). A scientific council of the American Dental Association states that chewing gum containing xylitol for 10-20 minutes after meals, or using lozenges providing xylitol 5-8 grams in divided doses daily, can reduce the incidence of coronal caries in adults and children 5 years or older (95690). However, these recommendations are based on only weak evidence. There is not enough evidence to recommend xylitol products for preventing caries in children under the age of 5 years (95124,95690,112858). In 2008, the US Food and Drug Administration (FDA) authorized a health claim for products containing xylitol. These products can state that although frequently eating foods high in sugars and starches as between-meal snacks can promote tooth decay, xylitol used to sweeten food does not promote tooth decay and may reduce the risk of dental caries (102364).

POSSIBLY EFFECTIVE

• Otitis media. Using xylitol-containing products topically in the mouth on a daily basis seems to reduce the risk of otitis media in preschool-aged children. Details: Giving a total daily dose of xylitol 8.4-10 grams as a chewing gum, lozenge, or syrup up to 5 times a day after meals to preschool children seems to reduce the risk of acute otitis media by about 25% when compared with a control containing sucrose alone or with low dose xylitol (6816,6817,95112). Xylitol gum and xylitol lozenges appear to be similarly effective for this indication; xylitol syrup might be slightly less effective than xylitol gum (95111,95112). Some research suggests that xylitol may also reduce the usage of antibiotics for acute otitis media, although results are conflicting (6816,6817,95112). However, a more recent clinical trial disagrees with these findings and shows that taking a syrup containing xylitol up to 5 times daily for 6 months does not reduce the risk of acute otitis media when compared with a control syrup containing sorbitol (113319). The reason for this discrepancy is unclear. However, the number of otitis media episodes was extremely low overall, with no episodes in the many children recruited during the COVID-19 pandemic. In addition, the average xylitol intake in this study was 3.7 grams daily, much lower than in the previous studies. However, xylitol 8.4-10 grams daily, administered at the onset of symptoms of an acute respiratory infection, does not seem to prevent acute otitis media (3846,95112). It is unclear whether xylitol reduces the risk of acute otitis media in children with recurrent acute otitis media. Limited clinical research shows that xylitol as gum or lozenges does not appear to reduce the risk of acute otitis media among otitis-prone healthy children (95112). However, preliminary clinical research in children aged 1-4 years shows that using a xylitol nasal spray 2-3 times daily for 3 months modestly reduces the number of episodes, as well as the number of episodes treated with systemic or topical antibiotics, when compared to the 3-month period before treatment (113323).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Coronavirus disease 2019 (COVID-19). It is unclear if intranasal xylitol is beneficial in patients with COVID-19. Details: Preliminary clinical research in adult outpatients with a positive COVID-19 test who are receiving standard treatment for symptoms lasting less than 3 days shows that using a nasal spray containing xylitol 11%, sodium chloride 0.85%, and grapefruit seed extract 0.2% in water, 2 sprays in each nostril every 3 hours while awake for 72 hours, then every 6 hours for a total of 14 days, does not affect time to symptom resolution or incidence of hospitalization when compared with a normal saline spray (109996).
• Cystic fibrosis. It is unclear if inhaled xylitol is beneficial in patients with cystic fibrosis. Details: Preliminary clinical research in patients hospitalized for an exacerbation of cystic fibrosis shows that administering 5 mL of xylitol 15% solution through a nebulizer twice daily for 2 weeks does not improve lung function, the density of sputum microbes, or quality of life when compared with hypertonic saline (103888).
• Dental plaque. There is some evidence that chewing xylitol gum reduces oral plaque in adults. It is unclear if topical xylitol solution helps to reduce dental plaque in children or adolescents. Details: A meta-analysis of 8 studies in adults shows that chewing sugar-free gum containing xylitol, sorbitol, or maltitol reduces oral plaque levels when compared with chewing sugar-containing gum or not chewing any gum (109997). One small clinical study in children aged 2-5 years shows that applying 40% xylitol solution using gauze once daily for 6 months does not suppress Streptococcus mutans count or reduce plaque accumulation when compared to baseline (95119). Conversely, a small clinical study in adolescents aged 14-17 years shows that rinsing with a solution containing xylitol, lysozyme, sea salt, and menthol (H2Ocean Sea Salt Mouthwash) twice daily for 3 months seems to reduce dental plaque and S. mutans levels when compared to baseline (105979). The validity of this finding is limited due to a lack of statistical comparison to the placebo group. Additionally, it is unclear if any effects are due to xylitol, other ingredients, or the combination.
• Dry mouth. Oral xylitol has only been evaluated in combination with maltitol; its effect when used alone is unclear. Details: One small open-label clinical study in patients with gastroesophageal reflux disease who are experiencing dry mouth while taking omeprazole 40 mg daily shows that taking specific tablets (Xeros Dentaid, Dentaid) containing xylitol 422 mg and malic acid 28.6 mg 3 times daily after meals for 6 months seems to reduce the incidence of dry mouth and increase the buffering capacity of saliva when compared with no additional treatment (105982).
• Gingivitis. Topical xylitol has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study of patients with gingivitis shows that brushing with a toothpaste containing a combination of xylitol, extra virgin olive oil, and betaine anhydrous daily for 4 months decreases gingival bleeding and improves markers associated with gingival health when compared with placebo and commercial toothpaste (111372).
• Gulf war syndrome. It is unclear if intranasal xylitol is beneficial for improving respiratory symptoms in adults with Gulf war syndrome. Details: A small clinical study in patients with chronic rhinosinusitis and Gulf war syndrome shows that administering xylitol 5% solution intranasally via neti pot twice daily for 26 weeks in addition to standard care modestly improves nasal symptoms when compared with standard treatment alone. However, the improvement did not reach the pre-specified measure of clinical significance (105981).
• Hematopoietic stem cell transplant (HSCT). It is unclear if topical xylitol dental wipes help to prevent infections after HSCT. Details: One small open-label clinical trial in children and young adults undergoing HSCT shows that adding xylitol dental wipes 0.7 grams daily to standard care for oral hygiene, starting with ablative chemotherapy and continuing 28 days post-transplant, reduces the risk for bloodstream infections when compared with standard care alone. For every 4 patients treated with xylitol, one bloodstream infection was prevented (103890).
• Intranasal surgery. It is unclear if nasal irrigation with xylitol solution improves pain and obstruction after intranasal surgery. Details: Preliminary clinical research in patients undergoing endonasal endoscopic surgery shows that nasal irrigation with 60 mL of solution containing xylitol 1 gram in each nostril three times daily for 30 days, starting the second day after surgery, reduces pain and nasal obstruction when compared with saline nasal irrigation (103889).
• Obesity. It is unclear if oral xylitol is beneficial for obesity. Details: A small clinical trial in adults with obesity shows that taking xylitol daily for 5 weeks does not reduce abdominal fat or lipid levels or have beneficial effects on glucose tolerance or liver health when compared with no treatment. The xylitol dose in this study was 8 grams daily for 2 days, followed by 8 grams twice daily for 3 days, and then 8 grams 3 times daily for the remaining period (113320).
• Pain (acute). It is unclear if topical xylitol is beneficial for reducing dental injection pain in children. Details: A small clinical trial in children aged 5-7 years shows that applying xylitol 30% solution to the tongue for 2 minutes prior to topical anesthetic and dental injection modestly reduces pain associated with the injection compared with distilled water. Also, the xylitol solution was as effective as a 30% sucrose solution (113321).
• Postoperative ileus. It is unclear if chewing xylitol gum can reduce the development of postoperative ileus after various types of surgery. Details: An unblinded clinical study in adults undergoing colorectal resection for colon cancer shows that chewing xylitol gum for 15 minutes three times daily, starting on the first postoperative day, reduces the time to first flatus from 53 hours to 39 hours and the time to first defecation from 78 hours to 55 hours when compared with standard care alone (109998). A small clinical study in patients undergoing a Cesarean section shows that chewing xylitol gum for 15 minutes every 2 hours for 8-12 hours, starting 2 hours after surgery, does not reduce the time to first bowel sounds or first feeling of hunger when compared with chewing non-xylitol gum or not chewing any gum. The time to first defecation is 38, 44, and 45 hours, respectively, while times to hospital discharge are 46, 50, and 52 hours, respectively; it is unclear if these differences are statistically significant (109999).
• Rhinosinusitis. Small clinical studies suggest that intranasal rinses with xylitol solution may modestly improve nasal symptoms in patients with chronic rhinosinusitis. Details: Two small clinical studies in patients with chronic rhinosinusitis shows that nasal irrigation using 240 mL of solution containing xylitol 12 grams daily for up to 30 days reduces symptoms better than nasal irrigation with saline (95115,95122). Another small clinical study in patients with chronic rhinosinusitis and Gulf war syndrome shows that administering xylitol 5% solution intranasally via neti pot twice daily for 26 weeks in addition to standard care modestly improves nasal symptoms when compared with standard treatment alone. However, the improvement did not reach the pre-specified measure of clinical significance (105981).
• Upper respiratory tract infection (URTI). Although there is interest in using topical xylitol for URTI prevention in children, there is insufficient reliable information about the clinical effects of xylitol for this purpose. More evidence is needed to rate xylitol for these uses.

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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.

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LIKELY SAFE ...when used orally in amounts commonly found in foods. Xylitol is an approved food additive in the US (17915).

POSSIBLY SAFE ...when used orally and appropriately in medicinal amounts as a chewing gum, candy, lozenge, toothpaste, or mouth rinse. Xylitol has been used with apparent safety in doses of 20-53 grams daily for up to 3 years (6815,6819,6821). ...when used as nasal irrigation 1-3 times daily for up to 30 days (95115,95122,103889,105981). ...when inhaled via nebulizer. 5 mL of xylitol 15% solution has been used with apparent safety twice daily for up to 2 weeks (103888).

POSSIBLY UNSAFE ...when used orally in very high doses, long-term. There is some concern that very high doses for extended periods of use can induce tumor growth (6815,6820). However, this effect has not yet been demonstrated in humans.

CHILDREN: POSSIBLY SAFE
when used orally and appropriately in medicinal amounts as a chewing gum, candy, lozenge, toothpaste, or mouth rinse. Xylitol has been used with apparent safety in doses up to 20 grams daily for up to three years (6815,6819,113319).

PREGNANCY AND LACTATION:
There insufficient reliable information available about the use of xylitol in medicinal amounts during pregnancy and lactation; avoid using.

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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.

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General ...Orally, xylitol is generally well tolerated in food amounts, although it may cause gastrointestinal discomfort at high doses. Topically, xylitol seems to be well tolerated.
Most Common Adverse Effects:
Orally: With high doses (30-40 grams), bowel sounds, diarrhea, flatulence.
Topically: Stinging of mucous membranes.

Cardiovascular ...Population research in adults at high risk for cardiovascular events suggests that the highest fasting blood levels of xylitol are associated with a 57% increased risk of major adverse cardiovascular events and a decreased incidence of event-free survival compared with lower levels (113318). As fasting blood levels are unrelated to consumption, it is unclear whether xylitol supplementation increases the risk of a major adverse cardiovascular event in this or any population. In healthy adults, a single dose of xylitol 30 grams increases blood levels of xylitol to levels capable of stimulating platelet aggregation in vitro (113318).

Endocrine ...Orally, high doses of xylitol can increase the risk of hyperuricemia. In a small study in healthy adults, taking a single dose of xylitol 35 grams in water increases levels of uric acid, while lower doses of xylitol did not have this effect (105980). Intravenous infusion of high doses of xylitol has been associated with hyperuricemia and acidosis, including lactic acidosis (6815).

Gastrointestinal ...Orally, acute administration of large amounts of xylitol (24 to 40 grams) can cause osmotic diarrhea, nausea, and flatulence (9,112857,113320). However, if the dose is increased gradually, tolerance to this effect can occur and prevent development of diarrhea and flatulence (9). Intranasally, flatulence and abdominal discomfort have been reported rarely (113323).

Hepatic ...Intravenous infusion of high doses has been associated with changes in liver function enzymes (6815).

Immunologic ...There are various cases of suspected allergic reactions to xylitol. In one case, an anaphylactic reaction to xylitol was reported in a 2-year-old. The allergy was confirmed based on a skin-prick test and basophil activation test (100173).

Pulmonary/Respiratory ...Following use of xylitol in nasal irrigation, minor stinging in the nose has been reported (95122,105981). Intranasally, a minor nosebleed and mild cough have been reported rarely (113323).

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