Vitapak Program Whole Body - Bone, Beauty and Hormone Formula by GNC Women's

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Acne. Although there is interest in using topical burdock for acne, there is insufficient reliable information about the clinical effects of burdock for this purpose.
• Aging skin. It is unclear if topical burdock is beneficial for reducing wrinkles. Details: A very small study in females aged 39-65 years shows that applying an emulsion containing burdock fruit extract 1.2% to the face twice daily for 4 weeks slightly reduces skin wrinkles around the eyes when compared with placebo (37420).
• Atopic dermatitis (eczema). Although there is interest in using topical burdock for eczema, there is insufficient reliable information about the clinical effects of burdock for this condition.
• Breast cancer. Oral burdock root has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Population research in breast cancer patients has found that using a specific product containing burdock root, sheep sorrel, slippery elm bark, and Indian rhubarb (Essiac, Resperin Canada Limited) is not associated with improved quality of life when compared with no intervention (37419).
• Common cold. Although there is interest in using oral burdock for symptoms of the common cold, there is insufficient reliable information about the clinical effects of burdock for this condition.
• Diabetes. Although there is interest in using oral burdock for diabetes, there is insufficient reliable information about the clinical effects of burdock for this condition.
• Diverticulitis. It is unclear if oral burdock is beneficial in patients with diverticulitis. Details: A small open-label clinical study in patients with colonic diverticulitis shows that taking burdock tea (Ajikan, Co., Ltd.) providing 1.5 grams three times daily for a median of 26 months is associated with an acute diverticulitis recurrence rate of 11%, compared with 32% of those not taking burdock tea. Furthermore, the recurrence-free duration was increased by about 14 months. However, taking burdock tea for a median of 16 months does not prevent colonic diverticular bleeding recurrence (102696).
• Dry skin. Although there is interest in using topical burdock for dry skin, there is insufficient reliable information about the clinical effects of burdock for this purpose.
• Gout. Although there is interest in using oral burdock for gout, there is insufficient reliable information about the clinical effects of burdock for this condition.
• Hepatitis. Although there is interest in using oral burdock for hepatitis, there is insufficient reliable information about the clinical effects of burdock for this condition.
• Metabolic syndrome. It is unclear if oral burdock is beneficial in patients with metabolic syndrome. Details: A very small clinical study in patients with metabolic syndrome shows that drinking burdock extract 100 mL three times daily after meals for 16 weeks does not reduce body weight, abdominal fat, blood pressure, lipid levels, or glucose when compared with baseline or control (105667).
• Obesity. Although there is interest in using oral burdock for obesity, there is insufficient reliable information about the clinical effects of burdock for this condition.
• Urinary tract infections (UTIs). Although there is interest in using oral burdock for UTI, there is insufficient reliable information about the clinical effects of burdock for this condition.
• Vaginitis. Topical burdock has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Observational research in adults and children with vaginitis has found that applying a specific solution containing burdock, chamomile, and aloe (Zelesse, ITF Research Pharma S.L.U., Alcobendas) to the vaginal area once or twice daily for 5-20 days is associated with moderate improvements in symptoms such as pruritus, erythema, and discharge when compared with baseline (102695,102697). The validity of this finding is limited by its observational nature and the lack of a control group. More evidence is needed to rate burdock for these uses.

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POSSIBLY EFFECTIVE

• Diabetic neuropathy. Clinical research suggests that oral GLA may improve nerve function and symptoms of diabetic neuropathy in patients with type 1 and type 2 diabetes. Details: Two clinical trials in patients with type 1 or type 2 diabetes and diabetic neuropathy show that taking GLA 360-480 mg daily for 6-12 months improves measures of nerve function and symptoms of neuropathy, including muscle weakness, impaired tendon reflexes, and impaired sensation, when compared with placebo (1984,8926). GLA seems to be more effective in patients with better glucose control when compared with patients with poor glucose control (8926).

POSSIBLY INEFFECTIVE

• Atopic dermatitis (eczema). Most research suggests that oral GLA does not improve the symptoms or severity of atopic dermatitis in children and adults. Details: A meta-analysis of 11 small clinical studies in children and adults with atopic dermatitis shows that taking GLA from borage oil or evening primrose oil does not improve the severity of atopic dermatitis when compared with placebo oils. Adult doses in these studies ranged from 132-720 mg daily for 3-24 weeks. Child doses ranged from 90-480 mg daily for 3-16 weeks (13758). Also, a more recent clinical study in adults with mild-to-moderate atopic dermatitis shows that taking a food product containing GLA 200 mg daily for 12 weeks does not improve skin hydration, itching, or redness when compared with a control (92868). Conversely, one small open-label clinical trial in infants with atopic dermatitis shows that taking GLA 3 grams daily for 4 weeks might reduce redness, itching, and use of antihistamines when compared to baseline (51042). The validity of these findings is limited by a lack of placebo control.

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Acute respiratory distress syndrome (ARDS). Oral GLA has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A meta-analysis of randomized controlled trials evaluating GLA, fish oil, and antioxidants, provided as a specific enteral formula (Oxepa, Abbott Nutrition) or a combination supplement given as a bolus, shows that there is no effect on overall all-cause mortality or ventilator- or ICU-free days when compared with generally isonitrogenous and isocaloric control formulas. A subgroup analysis of lower quality research shows that there may be a modest benefit for patients with a higher risk of mortality (105250). Two more recent meta-analyses have yielded similar results. Although most of the studies included in these meta-analyses investigated the use of Oxepa, some studies investigating other sources of enteral or intravenous fish oil were also included (105248,105249). In one of these analyses, some low- to very low-quality evidence suggests that use of Oxepa modestly reduces mortality at 28 days, as well as ICU length of stay and duration of mechanical ventilation (105248). However, these benefits were not found in the second meta-analysis (105249). It is unclear if GLA, when used alone, is beneficial in patients with ARDS.
• Asthma. Oral GLA has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in patients with asthma shows that taking 10 grams of a medical food emulsion providing GLA 0.75 grams with eicosapentaenoic acid (EPA) 0.5 grams, or 15 grams of a medical food emulsion providing GLA 1.13 grams with EPA 0.75 grams, daily for 4 weeks does not improve self-reported overall symptoms of asthma and bronchodilator use at 2 or 4 weeks when compared with placebo. Another small clinical study shows that taking medical food EFF1009, providing GLA 0.75 grams and EPA 0.5 grams, daily for 4 weeks modestly reduces bronchodilator use and improves quality of life and symptoms such as wheezing when compared to baseline (105251). The validity of this finding is limited by the lack of a comparator group and a high dropout rate.
• Attention deficit-hyperactivity disorder (ADHD). Oral GLA has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in drug-naïve children ages 6 to 12 years with mild to moderate ADHD shows that taking GLA 60 mg in combination with eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) daily for 12 months results in some small beneficial effects on inattentive symptoms when compared with placebo. However, these changes are unlikely to be clinically useful. Also, there was no change in blood levels of fatty acids (111058). The effect of GLA itself is unclear from this study.
• Autism spectrum disorder. Although there has been interest in using oral GLA for autism spectrum disorder, there is insufficient reliable information about the clinical effects of GLA for this purpose.
• Back pain. Oral GLA has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: One clinical trial in patients with back pain due to compressive radiculopathy syndrome shows that taking GLA 360 mg and alpha-lipoic acid 600 mg daily for 6 weeks while undergoing rehabilitation therapy reduces pain intensity and improves disability status when compared with rehabilitation therapy alone (20489). It is unclear if these findings are due to GLA, alpha-lipoic acid, or the combination.
• Breast cancer. It is unclear if oral GLA is beneficial in patients with breast cancer. Details: A small clinical study in patients with various stages of endocrine-sensitive breast cancer shows that taking GLA 2.8 grams daily along with tamoxifen for 6 weeks seems to improve the response to tamoxifen when compared with tamoxifen alone (5902).
• Hyperlipidemia. Although there has been interest in using oral GLA for hyperlipidemia, there is insufficient reliable information about the clinical effects of GLA for this purpose.
• Hypertension. Oral GLA has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical trial in patients with modestly elevated diastolic blood pressure (DBP) shows that taking a combination of GLA 0.12 grams plus eicosapentaenoic acid (EPA) 0.48 grams does not reduce DBP when compared with olive oil (13771). However, another small clinical study in patients with hypertension shows that taking 4 grams of an oil preparation rich in GLA, EPA, and docosahexaenoic acid (DHA) daily for 6 weeks reduces DBP when compared with sunflower seed oil (51022). It is unclear if these findings are due to GLA, other ingredients, or the combination.
• Mastalgia. Oral GLA has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small preliminary clinical trial in patients with mastalgia shows that taking GLA 100 mg daily in combination with vitamin C and vitamin B12 as methylcobalamin for 12 weeks does not improve the proportion of patients with minimal or no pain when compared with taking placebo (111059).
• Menopausal symptoms. Although there has been interest in using oral GLA for menopausal symptoms, there is insufficient reliable information about the clinical effects of GLA for this purpose.
• Pressure ulcers. Oral GLA has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in patients with acute lung injury shows that taking a specific enteral emulsion (Oxepa, Ross Laboratories) providing GLA from borage oil along with fish oil and vitamins A, C and E for 7 days does not improve the healing of existing pressure ulcers when compared with a control enteral formula. Although the number of pressure ulcers in the group given the GLA-containing formula was lower when compared with the control formula, these patients also had fewer pressure ulcers at baseline and no statistical comparison was conducted. The clinical significance of this finding is unclear (105252).
• Psoriasis. Although there has been interest in using oral GLA for psoriasis, there is insufficient reliable information about the clinical effects of GLA for this purpose.
• Rheumatoid arthritis (RA). Although there has been interest in using oral GLA for RA, there is insufficient reliable information about the clinical effects of GLA for this purpose.
• Rosacea. It is unclear if oral GLA is beneficial in patients with rosacea. Details: A small clinical study in adults with rosacea shows that taking GLA (Evoprim) 320 mg daily along with minocycline 50 mg twice daily for 8 weeks improves patient satisfaction and measures of skin hydration and increases the rate of treatment success, defined as an investigator global assessment score of 1 or lower, indicating clear or minimal symptoms, by 2-fold when compared with placebo plus minocycline (107927).
• Scleroderma. It is unclear if oral GLA is beneficial in patients with scleroderma. Details: A small clinical study in patients with scleroderma shows that taking GLA (dose unknown) for 6 months does not reduce symptoms of scleroderma when compared with placebo (1977).
• Ulcerative colitis. Oral GLA has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in patients with ulcerative colitis shows that taking a combination of GLA 1.6 grams, eicosapentaenoic acid (EPA) 270 mg, and docosahexaenoic acid (DHA) 45 mg daily for 12 months does not reduce symptoms when compared with placebo (51013). More evidence is needed to rate GLA for these uses.

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POSSIBLY EFFECTIVE

• Athletic performance. Regular consumption of whey protein in conjunction with exercise may improve muscle strength and performance. However, inconsistent consumption of whey protein, as well as intake of whey protein without concomitant exercise, may not be beneficial. Details: Most clinical research shows that taking whey protein 1.2-1.5 grams/kg or 30-33 grams daily in combination with strength training for 6-21 weeks can increase lean body mass, strength, and muscle hypertrophy in healthy young adults (16728,16729,16748,46552,85765,85910,91806,96025,102173). Higher doses of whey protein, such as 46-77 grams daily, have also been shown to increase strength when combined with athletic training (98886,98888). Some clinical research shows that whey protein hydrolysate (Lacprodan HYDRO.365, Arla Food Ingridiens Group P/S) twice daily for 1 week may slightly improve running speed (91793). However, less frequent intake or lower doses of whey protein do not seem to be beneficial for muscle strength. Some clinical research in middle-aged males shows that taking whey protein 35 grams three times weekly with resistance training for 14 weeks does not improve strength or muscle mass when compared with placebo (46736,85893). A small clinical study in trained males shows that taking whey protein 25 grams daily has no effect on body mass or strength after 2 weeks of detraining and 4 weeks of retraining when compared with maltodextrin (96021). Also, consuming whey protein without concomitant exercise does not seem to improve body composition or strength. Some clinical research shows that whey protein does not improve muscle mass or strength in obese postmenopausal patients who are losing weight through diet without exercise (98889). Some research has compared whey protein to other types of protein. A meta-analysis of preliminary clinical research, as well as individual clinical studies, show that whey protein is similarly beneficial to soy, beef, chicken, and dairy (casein with whey) protein for improving muscle strength (85941,98871,98888,105591). However, the validity of these findings is limited by the small size and high heterogeneity of the studies.

POSSIBLY INEFFECTIVE

• Chronic obstructive pulmonary disease (COPD). Oral whey protein does not seem to improve COPD symptoms. Details: Clinical research in adults with COPD shows that taking a specific whey protein supplement (ImuPower) 12 grams twice daily for 6 weeks can improve shortness of breath, but not lung function, exercise tolerance, or quality of life, when compared with placebo (86302). Other clinical research shows that taking a pressurized whey protein supplement 20 grams daily for 16 weeks, in combination with strength training for weeks 8-16, does not improve exercise tolerance, lung function, or muscle function when compared with placebo (86025).
• Osteoporosis. Oral whey protein does not seem to improve bone mineral density in older adults. Details: Clinical research shows that taking whey protein 30-45 grams daily for up to 2 years does not improve bone density when compared with a low-protein placebo in postmenopausal patients and males over 70 years of age (86074,91796). Taking whey protein 20-60 grams daily for 36 weeks also does not improve bone density when compared with an isoenergetic placebo in overweight or obese adults undergoing an exercise program (96027). The effect of whey protein in patients with osteoporosis has not been evaluated.

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Age-related cognitive decline. It is unclear if oral whey protein is beneficial for age-related cognitive impairment. Details: Preliminary clinical research in older adults with subjective cognitive decline shows that taking whey peptide 1 gram for 12 weeks does not improve memory, executive functioning, or attention when compared with placebo. However, in a subgroup of patients with high levels of fatigue, whey peptide modestly improved memory (98885).
• Asthma. It is unclear if oral whey protein is beneficial in children with asthma. Details: A very small clinical study in children with asthma shows that taking a specific type of whey protein (HMS 90, Immunotec Inc.) 20 grams daily for 30 days does not improve lung function when compared to baseline (85833). The validity of this finding is limited by the lack of a comparator group.
• Atopic dermatitis (eczema). It is unclear if consuming infant formula containing whey protein reduces the risk of developing eczema. Details: A high-quality meta-analysis of small clinical studies shows that use of infant formula containing hydrolyzed whey protein for 4-6 months is no better than standard milk formula for reducing the risk of eczema (105585). This is in contrast to older meta-analyses that found benefit after consumption of fully or partially hydrolyzed whey protein (85987,86007,86048). However, these older publications had notable conflicts of interest and did not include small negative studies (105585). In 2011, the US Food and Drug Administration (FDA) allowed a qualified health claim in healthy infants with a family history of allergy who are not solely breastfed. It stated that feeding a formula of 100% partially hydrolyzed whey protein instead of formula containing intact cow's milk proteins from birth up to 4 months of age may reduce the risk of atopic dermatitis throughout 1-3 years of age. However, the FDA has concluded that there is very little scientific evidence to support this claim (102311).
• Atopic disease. It is unclear if consuming infant formula containing whey protein reduces the risk of developing atopic disease. Details: A high-quality meta-analysis of small clinical studies shows that use of infant formula containing hydrolyzed whey protein for 4-6 months is no different than standard milk formula for reducing the risk of atopic disease. However, there was a non-significant trend to reduced risk in the hydrolyzed whey protein group (105585). This finding conflicts with older meta-analyses which found benefit with hydrolyzed whey protein formula (85987,86007). However, these older publications had notable conflicts of interest and did not include small negative studies (105585).
• Cystic fibrosis. It is unclear if oral whey protein is beneficial for children or adults with cystic fibrosis. Details: A small clinical study in patients with cystic fibrosis shows that taking pressurized whey protein, 20 grams in children and 40 grams in adults, daily for 28 days, improves lung function in children, but not adults, when compared with baseline (85995). The validity of this finding is limited by the lack of a comparator group.
• Diabetes. It is unclear if oral whey protein is beneficial for improving glycemic control in people with type 2 diabetes. Details: A small clinical study in patients with well-controlled diabetes shows that consuming a 220 kcal drink containing whey protein concentrate 50 grams (Beit Haemek Advanced Technologies, Beit Haemek) before a meal lowers blood glucose levels by 28% and increases insulin levels in the first 3 hours after a meal when compared with drinking water (91795). However, whey protein does not seem to have long-term benefit on glycemic control when added to an exercise regimen. Another small clinical study in middle-aged males with type 2 diabetes shows that adding 20 grams of whey protein daily for 10 weeks to high-intensity mixed-mode interval training (MMIT) does not further improve glycemic control or body composition when compared to MMIT with placebo (98883).
• Exercise-induced asthma. It is unclear if oral whey protein is beneficial for exercise-induced asthma. Details: A small clinical study in patients with exercise-induced asthma shows that taking whey protein 30 grams daily for 10 days improves lung function when compared to baseline (85791). The validity of this finding is limited by the lack of a comparator group.
• Exercise-induced muscle damage. It is unclear if oral whey protein is beneficial for attenuating exercise-induced muscle damage; evidence is conflicting. Details: A meta-analysis of small heterogeneous clinical studies in trained and untrained adults shows that supplementation with a median dose of whey protein 25 grams (range 20-120 grams) given after and/or before exercise modestly improves muscle recovery measured over 3 days when compared with control (98881). Individual studies included in the analysis used whey protein 1.5 grams/kg daily for up to 2 weeks (86044), and whey protein isolate or whey protein hydrolysate (NatraPro or NatraBoost XR, MG Nutritionals) 25 grams three times in 24 hours (85915). Other small studies have not found benefit, but it is unclear if they were adequately powered. One small clinical study in healthy untrained males shows that taking whey protein 36.6 grams daily, starting 7 days before and continuing until 4 days after arm exercise, does not prevent muscle soreness over 5 days or attenuate reductions in strength (96024). Another small study in untrained healthy males shows that taking whey protein isolate (biPro, Eden Prairie) 0.3 grams/kg three times daily for 5 days does not reduce self-reported delayed onset muscle soreness, but may reduce creatine kinase, a biomarker of muscle damage, when compared with water (104758). Whey protein may not be beneficial for recovery from exercise in trained athletes. Small clinical studies show that consuming a whey protein beverage before or after exercise does not improve muscle recovery for trained adult and adolescent athletes when compared with a carbohydrate or non-caloric control (86303,91799,105592).
• Hepatitis. It is unclear if oral whey protein is beneficial for hepatitis. Details: A small clinical study in patients with chronic hepatitis B shows that taking a specific type of whey protein (Immunocal) 12 grams twice daily for 12 weeks can reduce liver transaminase levels and can increase glutathione (GSH) levels when compared with baseline. However, whey protein supplementation does not seem to improve liver function in patients with chronic hepatitis C (85687). The validity of these findings is limited by the lack of a comparator group.
• HIV/AIDS. It is unclear if oral whey protein is beneficial for improving immune function in children with HIV/AIDS. Details: One small clinical study in children with rapidly progressive HIV infection shows that taking whey protein at levels corresponding to 20% to 50% of total required protein for 4 months does not affect CD4 or CD8 cell count or the ratio of CD4+/CD8+ when compared with baseline. However, the occurrence of acute co-infections might be reduced with whey protein supplementation when compared with control (85781).
• HIV/AIDS-related wasting. Although oral whey is an adequate source of protein, it is unclear if it is better than other protein sources for reducing HIV/AIDs-related wasting. Details: A small open-label clinical study in malnourished patients with HIV shows that taking whey protein (dose unspecified) daily for 14 weeks increases muscle and fat mass when compared with baseline (85693). The validity of these findings is limited by the lack of a comparator group. Another small study in patients with HIV, stable weight, and a history of unintentional weight loss shows that taking whey protein 40 grams daily for 12 weeks does not affect weight or muscle mass when compared with taking an isocaloric control (85921). These study findings are limited because they cannot be generalized to patients with active weight loss or wasting. Another limitation is the higher dropout rate in the whey protein group due to gastrointestinal adverse events.
• Hyperlipidemia. It is unclear if oral whey protein is beneficial for lowering cholesterol levels. Details: A very small clinical study in overweight males with hyperlipidemia shows that taking whey protein 26.6 grams daily while participating in a resistance training program for 12 weeks reduces total cholesterol levels when compared with baseline but not when compared with placebo (85941). A meta-analysis of small heterogeneous clinical studies in healthy adults, as well as those with obesity and/or mild hypertension, shows that consuming whey protein alone or with other interventions seems to reduce lipid levels when compared with control (105586). However, most included studies were in patients without hyperlipidemia; it is unclear if whey protein is beneficial in patients with hyperlipidemia. Furthermore, these findings are limited by the variability in whey protein dosing, study duration, and patient population.
• Hypertension. It is unclear if oral whey protein reduces blood pressure. Details: Preliminary clinical research shows that drinking a beverage containing whey protein 2.6 grams daily for 12 weeks does not lower blood pressure in patients with mild hypertension when compared with placebo (85835). Also, taking whey protein 28 grams twice daily in water for 8 weeks reduces 24-hour systolic and diastolic blood pressure by 2.9 mm Hg and 2 mmHg, respectively, when compared with maltodextrin or casein in adults with mild hypertension and prehypertension. There were also improvements in endothelial function (96019).
• Mitochondrial myopathies. It is unclear if oral whey protein improves symptoms in patients with mitochondrial myopathies. Details: A small clinical study in individuals with mitochondrial diseases shows that taking a whey protein supplement 10 grams daily for one month does not improve muscle strength or quality of life when compared with placebo (85984).
• Nonalcoholic steatohepatitis (NASH). It is unclear if oral whey protein improves NASH. Details: A small clinical study in patients with untreated NASH shows that taking whey protein 20 grams daily for 12 weeks can reduce liver function tests, including alanine aminotransferase (ALT) and aspartate aminotransferase (AST), and reduce hepatic macrovesicular steatosis when compared with baseline (85961). The validity of these findings is limited by the lack of a comparator group.
• Obesity. It is unclear if oral whey protein is beneficial for weight loss when used without dietary modifications. Adding whey protein to a calorie-restricted diet or an exercise regimen does not seem to improve weight loss. Details: Most research in overweight and obese individuals shows that taking whey protein along with a low-calorie diet and/or in addition to an exercise program does not further increase weight loss when compared with the low-calorie diet or exercise alone (85897,86069,86130,91794,91798,91802,96027,102172). However, a small clinical study in patients who have regained weight after bariatric surgery shows that following a low-calorie diet and taking whey protein 0.5 grams/kg daily for 16 weeks reduces body weight by about 2 kg and fat mass by about 3 kg when compared with following a low-calorie diet alone (96022). When whey protein is taken without diet modifications, studies have yielded conflicting results. One small clinical study in overweight and obese adults shows that taking whey protein isolate 27 grams twice daily for 12 weeks does not reduce body weight when compared with a glucose control (86011). However, another small clinical study in overweight and obese adults shows that taking whey protein concentrate 52 grams daily for 23 weeks reduces weight by 1.8 kg and fat by 2.4 kg when compared with a carbohydrate control, but is no better than taking soy protein isolate 52 grams (86077). In contrast, a small clinical study in overweight males shows that taking whey protein concentrate 65 grams before lunch daily for 12 weeks decreases calorie intake and reduces weight by about 1 kg when compared with taking soy protein isolate 60 grams (91801). In contrast to adults, supplementation with whey protein might increase weight in adolescents. A clinical study in overweight adolescents shows that consuming 1 liter of a milk-based whey protein drink daily for 12 weeks increases weight and body mass index when compared with a water control (86144).
• Parkinson disease. It is unclear if oral whey protein improves symptoms of Parkinson disease. Details: Clinical research in a small group of patients shows that taking a specific type of whey protein isolate (HMS 90/Immunocal) 10 grams twice daily for 6 months does not improve symptoms of Parkinson disease when compared with placebo (96026). However, this study may have been inadequately powered to detect a difference between groups.
• Polycystic ovary syndrome (PCOS). It is unclear if oral whey protein improves symptoms and metabolic effects of PCOS. Details: One small clinical study in patients with PCOS shows that taking 240 kcal as a nutritional supplement containing pure whey protein 96% daily, in addition to a calorie-restricted diet for 2 months, reduces body weight, fat mass, and cholesterol and apolipoprotein B levels when compared with a simple sugar control supplement. However, the whey protein supplement does not improve glucose or insulin levels, and seems to decrease high-density lipoprotein (HDL) cholesterol levels (85912). The validity of this study is limited by its small size and a significant dropout rate.
• Polymyalgia rheumatica. It is unclear if oral whey protein improves muscle function in patients with polymyalgia rheumatica. Details: A small clinical study in patients with polymyalgia rheumatica shows that taking a whey protein-enriched dairy product twice daily for 8 weeks does not improve lower limb muscle function, walking speed, chair stand test performance, peak jump power, or peak jump force when compared with a regular dairy product (Play, Valio Ltd.) (86075).
• Psoriasis. It is unclear if oral whey protein improves psoriasis. Details: A small clinical study in patients with stable psoriasis shows that taking a specific whey protein extract product (Dermylex, Advitech, Inc.) 5 grams daily for 8 weeks modestly decreases symptom severity when compared with placebo (85885).
• Sarcopenia. Research on the use of oral whey protein in older adults with sarcopenia is conflicting. Details: Small clinical studies in trained older females show that consuming whey protein 35 grams three times weekly for 12 weeks, either before or after resistance training, modestly increases skeletal muscle mass, strength, and functional capacity when compared with resistance training and insufficient protein intake (98887,98890). Research on the use of whey supplementation without exercise is conflicting. A small clinical study in older adults with low muscle mass living in China shows that taking whey, or a whey-soy protein blend, 16 grams daily for 6 months slightly attenuates muscle loss when compared with no intervention (105603). However, a clinical study in healthy, active older adults living in Denmark shows that taking whey protein hydrolysate 20 grams twice daily does not increase muscle size or strength when compared with a carbohydrate control (105593). This finding may not be generalizable to frail adults or those with existing sarcopenia. Whey protein with or without exercise has shown benefit when used in combination with other nutrients. Specifically, whey protein 60 grams has been used with creatine 5 grams, calcium 800 mg, vitamin D 1000 IU, and omega-3 fatty acids 3 grams (Infinit Nutrition) for 6 weeks (96016). A beverage with leucine-enriched whey protein 20 grams has been used in combination with vitamin D 800 IU (Nutricia Advanced Medical Nutrition) daily for 6 weeks (96017). Another beverage containing whey protein 20 grams and vitamin D 800 IU has been used daily for 6 months (98882).
• Sepsis. It is unclear if oral whey protein is beneficial in children with sepsis. Details: A very small clinical study in long-term intensive care pediatric patients shows that taking a specific whey protein supplement (Beneprotein) 0.3 grams/kg daily for up to 28 days has a similar effect on the time to onset and the rate of hospital-acquired infection or sepsis when compared with taking a combination of zinc, selenium, glutamine, and metoclopramide. It is not clear how these results compare to patients receiving no supplementation (86095). More evidence is needed to rate whey protein for these uses.

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LIKELY SAFE ...when used in amounts commonly found in foods (12659,12660). Burdock root is commonly eaten as a vegetable (37422,92153,92154)

POSSIBLY SAFE ...when used topically, short-term. An emulsion containing burdock fruit extract 1.2% has been safely applied to the face twice daily for 4 weeks (37420). There is insufficient reliable information available about the safety of burdock when used orally in supplemental doses.

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

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POSSIBLY SAFE ...when used orally and appropriately. GLA appears to be safe when taken in oral doses of up to 2.8 grams daily for up to a year (1983,7701,7702,8926,107927).

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

(Read more about GAMMA-LINOLENIC ACID (GLA))

LIKELY SAFE ...when used orally and appropriately. Whey protein up to 30 grams has been safely used in clinical trials for up to 6 months (4930,16728,16729,105587).

CHILDREN: LIKELY SAFE
when used orally and appropriately as a dietary protein in food or infant formula. Hydrolyzed whey protein-based formula has been safely used in infants for up to 6 months in clinical trials (4927,105585,105594).

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

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ANTICOAGULANT/ANTIPLATELET DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, taking burdock with anticoagulant or antiplatelet drugs might increase the risk of bleeding.  Details In vitro research shows that lignans from burdock reduce rabbit platelet aggregation by inhibiting platelet activating factor (12619). This interaction has not been reported in humans.

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ANTICOAGULANT/ANTIPLATELET DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, GLA might increase the risk of bleeding when taken with anticoagulant or antiplatelet rugs.  Details Animal and human research suggests that GLA reduces platelet aggregation (1979).

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BISPHOSPHONATES Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = D Theoretically, whey protein might reduce the absorption of bisphosphonates.  Details Whey protein contains minerals such as calcium that bind bisphosphonates in the gut (9,12937). Advise patients to take bisphosphonates at least 30 minutes before whey protein, but preferably at a different time of day.

LEVODOPA Interaction Rating = Major Do not take this combination. Severity = High •  Occurrence = Probable •  Level of Evidence = D Theoretically, whey protein might decrease levodopa absorption.  Details Small clinical studies show that concomitant ingestion of protein or high doses of leucine or isoleucine (100 mg/kg) and levodopa can exacerbate tremor, rigidity, and the "on-off" syndrome in patients with Parkinson disease (3291,3292,3293,3294,4944).

QUINOLONE ANTIBIOTICS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = D Theoretically, whey protein might decrease quinolone absorption.  Details Whey protein contains minerals, such as calcium, that can bind to quinolones in the gut (9,10339). To avoid this interaction, advise patients to take oral quinolones at least 2 hours before or 4-6 hours after whey protein.

TETRACYCLINE ANTIBIOTICS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = D Theoretically, whey protein might decrease tetracycline absorption.  Details Whey protein contains minerals, such as calcium, that bind to tetracyclines in the gut (9,1843). To avoid this interaction, advise patients to take oral tetracyclines at least 2 hours before or 4-6 hours after whey protein.

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General ...Orally, burdock is well tolerated when consumed as a food. Although a thorough evaluation of safety outcomes is lacking, there has been long-standing historical use of burdock with few noted adverse effects.
Serious Adverse Effects (Rare):
All ROAs: Allergic reactions, including contact dermatitis and anaphylaxis.

Dermatologic ...Contact dermatitis has been reported secondary to burdock, especially after prolonged use of the root oil (37422). There are cases of allergic dermatitis secondary to using burdock plasters. Two males and a 14 year-old female developed erythematous and vesicular, pruritic, and exudative reactions in areas corresponding to the application of burdock root plasters (12667). Reactions occurred up to 7 days after initial use. Patch testing was positive for burdock sensitivity in all three patients and was nonreactive in matched controls.

Hematologic ...In one case report, a 38-year-old female developed immune-mediated thrombocytopenia after consuming a "cleansing" tea containing unknown amounts of burdock and yellow dock. The patient presented with bruising, mild weakness, and fatigue, which started 2-3 days after consuming the tea, and was found to have a platelet count of 5,000 per mcL. Symptoms resolved after platelet transfusion and treatment with oral dexamethasone (108971). It is unclear if these effects were caused by burdock, yellow dock, the combination, or other contributing factors.

Hepatic ...A case of idiosyncratic drug-induced liver disease (DILI) is reported in a 36-year-old female who presented with abdominal pain after 1 month of taking an herbal liver detox tea containing burdock and other ingredients. Remarkable laboratory values included elevated liver enzymes, alkaline phosphatase, and total bilirubin. The patient received a loading dose of N-acetylcysteine and was hospitalized for 12 days (112178). However, it is unclear if the adverse effect was due to burdock, other ingredients, or the combination.

Immunologic ...There is one case of anaphylactic shock secondary to eating boiled burdock. One hour after eating boiled burdock the patient presented with redness over the entire body and dyspnea. He was found to have low blood pressure and was treated with subcutaneous epinephrine 1 mg and intravenous lactated ringer's solution containing hydrocortisone 100 mg and dexamethasone 8 mg. The cause of anaphylactic shock was attributed to allergenicity to burdock based on positive skin prick test results. Previously, the patient had experienced urticaria after eating boiled burdock (12660).

Neurologic/CNS ...Anticholinergic reactions including dry mouth, dizziness, blurred vision, weakness, dilated pupils, inability to urinate, and bradycardia have been reported following the consumption of burdock products (12662,37421,37431,37434,37435). However, these anticholinergic reactions are believed result from contamination of burdock with belladonna alkaloids. Burdock itself does not contain atropine or other constituents that would be responsible for these reactions.

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General ...Orally, GLA seems to be well tolerated.
Most Common Adverse Effects:
Orally: Mild gastrointestinal adverse effects, including belching, bloating, diarrhea, dyspepsia, flatulence, nausea, and vomiting.

Gastrointestinal ...Orally, GLA may cause mild gastrointestinal effects such as dyspepsia, nausea, bloating, vomiting, soft stools, diarrhea, flatulence, and belching (7701,7702,8926,107927).

Hematologic ...Orally, GLA might prolong bleeding time (1979).

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General ...Orally, whey protein is generally well tolerated.
Most Common Adverse Effects:
Orally: Acne, bloating, cramps, diarrhea, fatigue, headache, nausea, reflux, reduced appetite, and thirst. Most adverse effects are dose-related.

Cardiovascular ...In one case report, use of an unclear quantity of whey protein over one month was thought to be probably responsible for the development of coronary embolism in three coronary arteries in a 33-year-old male with no history of atherosclerosis risk factors. The patient required treatment with intravenous glycoprotein IIb/IIIa inhibitor and heparin (96023).

Dermatologic ...Orally, whey protein has been reported to trigger the onset or worsening of acne. Multiple case reports in teenagers and young adults have associated intake of whey protein with the development of acne or the worsening of existing acneiform lesions. In these reports, the discontinuation of whey protein was typically associated with the clearance of acne lesions. In some cases, patients who were unresponsive to acne treatments while using whey protein became responsive after whey protein discontinuation (103965,103970,103971). Cow's milk, which is comprised of 20% whey protein, is also thought to exacerbate acne. It is theorized that this effect may be due to the growth factor and alpha-lactalbumin content of whey protein (103971,103982).

Gastrointestinal ...Orally, whey protein, especially in higher doses of 2. 3-6.5 grams/kg daily, may cause increased bowel movements, nausea, thirst, bloating, esophageal reflux, cramps, and reduced appetite (2640,85961,85702,86043,86074,86075,86084,86089,86095).

Hepatic ...In two case reports, acute cholestatic liver injury occurred after consumption of the combination of whey protein and creatine supplements (46701,90319).

Musculoskeletal ...In one case report, a 26-year-old male experienced fasciitis, or swelling of the forearms, hands, and legs, after consuming the supplement Pure Whey (85895).

Neurologic/CNS ...Orally, high doses of whey protein may cause tiredness or fatigue and headache (2640). Mild drowsiness has also been reported (86089,86092,86124).

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