Weight Loss Complements [Discontinued] by Swanson Complements

POSSIBLY EFFECTIVE

• Obesity. Oral Phaseolus vulgaris extract may reduce body weight and waist circumference in overweight and obese adults. Details: A meta-analysis of 6 small clinical studies shows that taking Phaseolus vulgaris extract daily for 4-12 weeks reduces body weight by around 1.6% when compared with placebo (107439). While some small studies show conflicting findings (12186,26158), most research in overweight and obese adults suggests that taking white kidney bean extract 800-1000 mg or cranberry bean extract 100 mg three times daily for 5-12 weeks reduces body weight by 1.5-4 kg, body mass index by about 0.7 kg/m2, and waist circumference by about 1.5-5 cm when compared with placebo or other control (26156,29926,93075,93077,104875). Specific products evaluated include Phase 2 (Pharmachem Labs; also marketed as Starchlite and Phaselite) (26156,29926); Carb Intercept with Phase 2 (Natrol LLC) (93075); and Beanblock (Indena S.p.A) (93077). Phaseolus vulgaris extract has also been evaluated in combination with other ingredients, with modestly positive results. These combination products include Blokcal (Pharmachem Labs) containing white kidney bean extract (Phase 2, Pharmachem Labs) 445 mg daily and elemental chromium 50-60 mcg daily for 30 days (15518); Suco-Bloc (Med-Eq), containing white kidney bean extract (Phaseolamin, Leuven Bioproducts) 200 mg, inulin from chicory root (Raftiline, Orafti SA) 200 mg, and garcinia extract 50 mg per tablet, 2 tablets three times daily with meals for 12 weeks (26157); Phaseolamin 1600 diet (Metabolic Inc.), containing the Phaseolus vulgaris constituent phaseolamin 750 mg with clove 200 mg, lysine 20 mg, arginine 20 mg, and alanine 20 mg, taken in two divided doses daily for 8 weeks (93076); and Bonvit (Indena), containing Phaseolus vulgaris extract 100 mg and artichoke 200 mg three times daily for 8 weeks (93080).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Colorectal cancer. It is unclear if oral Phaseolus vulgaris is beneficial for the prevention of colorectal cancer recurrence. Details: Observational research has found that dietary intake of several varieties of Phaseolus vulgaris, including baked beans, kidney beans, pinto beans, lima beans, and navy beans, is inversely associated with the risk of advanced colorectal adenoma recurrence. Results from the study show that the odds for advanced adenoma recurrence is 65% lower for patients who consume higher amounts of Phaseolus vulgaris when compared with those who consume lower amounts (29922).
• Diabetes. Small clinical studies suggest that oral Phaseolus vulgaris may not improve postprandial glucose levels in patients with type 2 diabetes. Details: While results from some small clinical studies in patients with type 2 diabetes suggest that taking Phaseolus vulgaris extract or consuming Phaseolus vulgaris beans can reduce postprandial glucose levels, most studies, including a meta-analysis of 6 small clinical trials, show that Phaseolus vulgaris does not significantly reduce postprandial glucose when compared with placebo or other control (93078,107439). Another small clinical study in patients with type 2 diabetes shows that taking 15 grams of a combination of Phaseolus vulgaris pod, white mulberry, and bilberry three times daily for 2 months decreases blood glucose by up to 24% when compared with baseline (33943). It is unclear if these findings are due to Phaseolus vulgaris, other ingredients, or the combination. Additionally, the validity of these findings is limited by the lack of a control group.
• Hypercholesterolemia. Oral Phaseolus vulgaris has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: One small, open-label clinical study in overweight and obese patients shows that taking Phaseolus vulgaris (white kidney bean) extract 300-600 mg plus carob gum extract 50-100 mg three times daily for 3-9 months modestly reduces total cholesterol levels and increases excretion of fat in the feces when compared to baseline (10633). The validity of these findings is limited by the lack of a comparator group.
• Kidney stones (nephrolithiasis). It is unclear if oral Phaseolus vulgaris extract is beneficial in patients with kidney stones. Details: A small clinical study in adults with small kidney stones shows that taking a Phaseolus vulgaris extract made from 250 grams of green beans three times a week for 6 weeks modestly reduces the size of kidney stones and lowers urinary calcium and oxalate levels when compared with a control group (104874).
• Lung cancer. It is unclear if oral Phaseolus vulgaris is beneficial for the prevention of lung cancer. Details: Observational research has found that consuming higher amounts of dietary phytoestrogens, such as isoflavones from Phaseolus vulgaris beans and soy, is associated with a 44% to 72% lower risk of developing lung cancer when compared with consuming lower amounts. The beneficial effect appears to be more pronounced in males than females (13190).
• Myocardial infarction (MI). Although there has been interest in using oral Phaseolus vulgaris for the prevention of MI, there is insufficient reliable information about the clinical effects of Phaseolus vulgaris for this purpose.
• Urinary tract infections (UTIs). Although there has been interest in using oral Phaseolus vulgaris for UTIs, there is insufficient reliable information about the clinical effects of Phaseolus vulgaris for this purpose. More evidence is needed to rate Phaseolus vulgaris for these uses.

(Read more about PHASEOLUS VULGARIS)

POSSIBLY EFFECTIVE

• Hypercholesterolemia. Several small studies suggest that oral safflower oil, as a substitute for coconut oil, butter, or other animal fats in the diet, may reduce total and low-density lipoprotein (LDL) cholesterol levels in patients with or without hypercholesterolemia. Details: Three small clinical studies in patients with or without hypercholesterolemia show that substituting coconut oil, butter, or other animal fats in the diet with safflower oil (36% of total daily calories) for 4-6 weeks can lower levels of total and LDL cholesterol, but has no beneficial effects on high-density lipoprotein (HDL) cholesterol or triglycerides (25391,25393,72310).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Coronary heart disease (CHD). Safflower oil, which is high in oleic acid, may be beneficial for reducing the risk of CHD when used to replace other dietary oils. Details: Some safflower oil products contain high quantities of oleic acid. In 2018, the US Food and Drug Administration (FDA) determined that it would allow a qualified health claim stating that consuming 1.5 tablespoons daily of oils containing at least 70% oleic acid may reduce the risk of CHD. In order to obtain any benefit, this oil must be used to replace fats and oils higher in saturated fat. However, the FDA has determined that this statement is based on supporting, rather than conclusive, evidence (98563).
• Cystic fibrosis. It is unclear if oral safflower oil is beneficial in children with cystic fibrosis. Details: A very small clinical study in children with cystic fibrosis shows that taking safflower oil 1 gram/kg daily for one year does not affect sweat chloride concentrations or disease severity when compared with age-matched controls (72281).
• Diabetes. Small clinical studies of oral safflower oil for improving glycemic control in patients with diabetes have yielded mixed results. Details: One very small clinical trial in patients with type 2 diabetes shows that taking safflower oil 10 grams daily for 3 weeks increases fasting blood glucose by 11% when compared to baseline. Insulin levels, insulin sensitivity, and lipid levels were not affected (13146). However, another small clinical study in obese, postmenopausal patients with type 2 diabetes shows that taking safflower oil 2 grams four times daily for 16 weeks decreases HbA1c by 0.64% and increases high-density lipoprotein (HDL) cholesterol by about 5 mg/dL when compared with conjugated linoleic acid (CLA) 2 grams four times daily. Insulin sensitivity and fasting blood glucose levels do not appear to be affected (94039). These differing outcomes may be due to the small study sizes and varied patient populations.
• Diabetic nephropathy. Small clinical studies suggest that intravenous safflower yellow, a component of safflower flower, might improve symptoms and markers of diabetic nephropathy. Details: A meta-analysis of 14 small and low-quality clinical studies in adults with diabetic nephropathy shows that intravenous administration of safflower yellow as an adjunct to conventional treatment reduces urinary albumin excretion rate, fasting blood glucose, serum creatinine, and blood urea nitrogen when compared with conventional treatment alone. Overall, patients receiving safflower yellow were more likely to experience a clinical improvement in symptoms when compared with conventional treatment alone (102381).
• Familial hypercholesterolemia. Small clinical studies suggest that substituting safflower oil in place of butter in the diet may modestly reduce cholesterol levels in patients with familial hypercholesterolemia. Details: Two very small clinical studies in patients with familial hypercholesterolemia show that substituting safflower oil in place of butter in the diet (contributing 36% of daily calories) for 3 weeks decreases total and low-density lipoprotein (LDL) cholesterol levels when compared with butter (72246,72267).
• Hepatitis C. Oral safflower oil has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small, open-label clinical study in patients with chronic hepatitis C shows that taking a specific combination product containing safflower, pumpkin seeds, plantain seeds, and Japanese honeysuckle (EH0202) 1 gram daily for 3 months modestly reduces general discomfort, abdominal bloating, nausea, and vomiting when compared to baseline. However, hepatitis C RNA and hepatitis C virus antibody levels are not affected (72238).
• Hypertension. It is unclear if oral safflower oil is beneficial for reducing blood pressure; the available research is conflicting. Details: A very small clinical study in patients with hypertension shows that taking safflower oil 10 mL twice daily for 6-8 weeks reduces diastolic blood pressure when compared with placebo (72304). However, another small clinical study in patients with mild hypertension shows that taking safflower oil 30 mL daily for 6 weeks does not affect blood pressure when compared to baseline (72268).
• Low birth weight. It is unclear if oral safflower oil is beneficial in infants with low birth weight. Details: A small clinical study in low birth weight infants shows that fortifying formula or breast milk with a specific safflower oil product (Safola, Marico Industries Ltd.) does not improve weight gain or skin thickness when compared with coconut oil or unfortified formula or breast milk (72229).
• Metabolic syndrome. It is unclear if oral safflower oil is beneficial in patients with metabolic syndrome. Details: A small clinical study in patients with metabolic syndrome shows that taking safflower oil 2 grams four times daily for 12 weeks reduces waist circumference by 3.4 cm, systolic blood pressure by 7 mmHg, diastolic blood pressure by 3 mmHg, and fasting blood glucose by 8 mg/dL when compared with placebo. However, body weight, body mass index (BMI), and lipid levels were not affected (108889).
• Obesity. Although there has been interest in using oral safflower oil for obesity, there is insufficient reliable information about the clinical effects of safflower oil for this purpose.
• Myocardial infarction. Intravenous safflower yellow, a component of safflower flower, might improve outcomes when used as an adjunct to conventional therapy for the treatment of acute coronary syndrome (ACS). Details: A meta-analysis of 16 small, low-quality clinical trials in patients with ACS, including myocardial infarction and unstable angina, shows that intravenous administration of safflower yellow 20-40 mL daily for 10-15 days as an adjunct to conventional therapy improves clinical outcomes, electrocardiogram measures, and left ventricular ejection fraction when compared with placebo (108891).
• Phrynoderma. It is unclear if oral safflower oil is beneficial in patients with phrynoderma. Details: A small clinical study in patients with phrynoderma shows that taking 30 mL of safflower oil containing vitamin E 116 mg and linoleic acid 68% daily for more than 8 weeks can partially improve skin dryness and roughness when compared to baseline (72269). The validity of these findings is limited by the lack of a comparator group.
• Scarring. Topical safflower oil has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in patients with non-hypertrophic scars and striae shows that applying an oil containing safflower oil 55.9%, olive oil 42%, grapefruit oil 2%, and tocopherol 0.1% (Kneipp Bio Skin Oil, Kneipp GmbH) to the scars and striae twice daily for 8 weeks improves scores on the Patient Scar Assessment Scale (PSAS) by 20%, compared to a 6% improvement in untreated areas (95938).
• Stroke. Small clinical studies suggest that intravenous safflower yellow, a constituent of safflower flower, as an adjunct to conventional treatments, may improve neurological outcomes post-stroke. Details: A meta-analysis of seven small, low-quality clinical studies in Chinese patients with acute ischemic stroke shows that intravenous administration of safflower yellow 100-150 mg as an adjunct to conventional treatments, starting within 72 hours of stroke onset and continuing once daily for 14 days thereafter, increases the odds of neurological improvement by about 3-fold when compared with conventional treatments alone (94038).
• Unstable angina. Intravenous safflower yellow, a component of safflower flower, might improve outcomes when used as an adjunct to conventional therapy for the treatment of unstable angina. Details: A meta-analysis of seven low-quality clinical studies in Chinese patients with unstable angina shows that intravenous safflower yellow 50-150 mg daily for 14-15 days in addition to conventional treatment modestly improves electrocardiogram (ECG) measures and symptoms of angina when compared with conventional treatment alone (94041). Another meta-analysis of 16 small, low-quality clinical trials in patients with acute coronary syndrome (ACS), including unstable angina and myocardial infarction, shows that intravenous administration of safflower yellow 20-40 mL daily for 10-15 days as an adjunct to conventional therapy improves clinical outcomes, ECG measures, and left ventricular ejection fraction when compared with placebo (108891). More evidence is needed to rate safflower for these uses.

(Read more about SAFFLOWER)

POSSIBLY SAFE ...when used orally and appropriately. Most research has evaluated a specific Phaseolus vulgaris (white kidney bean) extract (Phase 2, Pharmachem Labs), which appears to be safe in doses of up to 3 grams daily for 2-3 months (12186,15518,26157,29926). Other Phaseolus vulgaris (white kidney bean) extracts also seem to be safe in doses of 0.9-2.4 grams daily when used for up to 3 months (10633,104875).

POSSIBLY UNSAFE ...when large amounts of fresh Phaseolus vulgaris husks are ingested. Raw Phaseolus vulgaris husks contain lectins that can cause gastrointestinal upset. Cooking destroys the lectins (18).

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

(Read more about PHASEOLUS VULGARIS)

LIKELY SAFE ...when safflower oil is used orally as part of the diet (6,13146,72238).

POSSIBLY SAFE ...when safflower oil is used topically for up to 8 weeks (95938). ...when safflower oil is administered intravenously in recommended doses by a health care professional. A specific safflower oil emulsion (Liposyn) 10% to 20% has been used intravenously for up to 2 weeks (72300,72301). ...when safflower yellow, a component of safflower flower, is administered intravenously and appropriately. Safflower yellow has been used with apparent safety in doses up to 150 mg daily for up to 5 weeks (94038,94041,102381).

CHILDREN: POSSIBLY SAFE
when safflower oil is administered intravenously in recommended doses by a healthcare professional. A specific safflower oil emulsion (Liposyn) 20% has been used intravenously in infants and children for up to 2 weeks (72284,72295). ...when safflower oil is used orally in medicinal amounts. Safflower oil 2.5 mL daily has been taken safely for 8 weeks (94042). There is insufficient reliable information available about the safety of safflower flower in children.

PREGNANCY: LIKELY SAFE
when safflower oil is used orally as part of the diet (6,13146,72238).

PREGNANCY: POSSIBLY SAFE
when safflower oil is administered intravenously in recommended doses by a healthcare professional (20529).

PREGNANCY: LIKELY UNSAFE
when safflower flower is used due to its abortifacient, menstrual stimulant, and uterine stimulant effects (11,12).

LACTATION: LIKELY SAFE
when safflower oil is used orally as part of the diet (6,13146,72238). There is insufficient reliable information available about the safety of safflower flower during lactation; avoid using.

(Read more about SAFFLOWER)

ANTIDIABETES DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, Phaseolus vulgaris might increase the risk of hypoglycemia when taken with antidiabetes drugs.  Details Small clinical studies suggest that Phaseolus vulgaris beans or bean pods, ingested alone or along with white mulberry leaf and bilberry, reduce blood glucose levels in some patients with diabetes (29921,29925,33943).

(Read more about PHASEOLUS VULGARIS)

ANTICOAGULANT/ANTIPLATELET DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = B High doses of safflower oil might increase the risk of bleeding when taken with anticoagulant or antiplatelet drugs.  Details Small clinical studies show that taking safflower oil, approximately 55 grams daily for 2-3 weeks, decreases platelet aggregation (72241,72303). However, taking lower doses of safflower oil, such as 5 grams daily for 4 weeks, does not seem to affect platelet function (66267). In one case report, a 74-year-old male stabilized on warfarin developed urinary tract bleeding and an elevated INR after taking a safflower extract 20 grams daily for 14 days (95939).

ANTIDIABETES DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = B Theoretically, safflower oil might alter the effects of antidiabetes drugs.  Details Some clinical research shows that taking safflower oil 10 grams daily for 3 weeks can increase fasting blood glucose in patients with type 2 diabetes (13146). However, clinical research in patients with metabolic syndrome with or without impaired glucose tolerance shows that taking safflower oil 8 grams daily for 12 weeks reduces fasting glucose levels by around 8 mg/dL (108889). Some clinical research also shows that taking safflower oil 8 grams daily for 16 weeks does not affect fasting glucose levels in patients with type 2 diabetes (94039).

WARFARIN Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, safflower oil might increase the risk of bleeding when taken with warfarin.  Details In one case report, a 74-year-old male stabilized on warfarin developed urinary tract bleeding and an elevated INR after taking a safflower extract 20 grams daily for 14 days (95939).

(Read more about SAFFLOWER)

General ...Orally, Phaseolus vulgaris extract seems to be well tolerated.
Most Common Adverse Effects:
Orally: Constipation, diarrhea, flatulence, nausea, stomach pain, and vomiting.
Serious Adverse Effects (Rare):
Orally: Hypersensitivity reactions, including anaphylaxis, in sensitive individuals.

Dermatologic ...Topically, Phaseolus vulgaris may cause contact dermatitis in sensitive individuals. A case of occupational contact dermatitis characterized by pruritus, erythema, eczema, and dyspnea has been reported for a 41-year-old farmer who handled the green parts of Phaseolus vulgaris (29920).

Gastrointestinal ...Orally, an extract of the Phaseolus vulgaris variety white kidney bean, as well as alpha-amylase inhibitors isolated from Phaseolus vulgaris, might cause nausea, vomiting, diarrhea, flatulence, constipation, satiety, and stomach pains (11265,18223,29925,104874). Also, white kidney bean extract, taken orally along with carob gum, may cause constipation, flatulence, soft stools, and reduced levels of vitamin B12 and folic acid (10633). Consuming large amounts of raw or undercooked Phaseolus vulgaris beans or extract can cause nausea, vomiting, diarrhea, and gastroenteritis due to the content of phytohaemagglutinin, a plant protein lectin (18223,29916,93082). Cooking usually destroys lectins (18).

Immunologic ...Orally, Phaseolus vulgaris may cause hypersensitivity reactions, including anaphylaxis, in sensitive individuals. A case of severe anaphylactic shock requiring epinephrine and steroid treatment has been reported for a 23-year-old following ingestion of cooked kidney beans, a variety of Phaseolus vulgaris. The causative agents were reported to be phaseolin (vicilin) and phytohaemagglutinin (29918). Also, a case of angioedema resulting from type I hypersensitivity has been reported for a one-year-old child following inhalation of vapors from or ingestion of cooked white beans, another variety of Phaseolus vulgaris (29919).

(Read more about PHASEOLUS VULGARIS)

General ...Orally and intravenously, safflower oil seems to be well tolerated.
Serious Adverse Effects (Rare):
Orally: Liver failure.

Dermatologic ...Intravenously, safflower yellow, a constituent of safflower flower, can cause skin rash (94038,94041). In one case, adjusting the rate of the drip improved the rash (94041).

Hepatic ...Orally, safflower oil has been associated with liver failure. There are at least 7 case reports of acute liver failure requiring liver transplant that are probably associated with over-use of safflower oil, usually for weight loss purposes. However, it is not clear what dose or duration of safflower use led to liver failure in these cases (99138).

Immunologic ...Safflower can cause an allergic reaction in individuals sensitive to the Asteraceae/Compositae family. Members of this family include ragweed, chrysanthemums, marigolds, daisies, and many other herbs.

(Read more about SAFFLOWER)