Phospholipid Complex 7,800 mg by NuMedica

POSSIBLY EFFECTIVE

• Ulcerative colitis. Limited clinical research shows that taking phosphatidylcholine products may improve clinical and remission scores in adults with ulcerative colitis. Details: Clinical research suggests that taking slow-release, phosphatidylcholine-rich phospholipids (Sterpur P-30 Granulat, Stern-Lecithin and Soja GmbH) improves symptoms and remission rate in patients with ulcerative colitis (68839,93389,93390,105728). A pooled analysis of 3 small randomized clinical trials in adults with chronic, active, ulcerative colitis at a single site shows that taking this specific form of phosphatidylcholine 1-4 grams daily for 3 months increases the odds of achieving clinical remission by 9.7 times when compared with placebo. Overall, 49% of the patients taking phosphatidylcholine achieved clinical remission. Taking phosphatidylcholine also improved quality of life and clinical improvement scores. In one study, this product also decreased the need for steroids, resulting in complete withdrawal of steroid therapy without exacerbation of disease in 80% of patients (93390). However, most patients in these studies were not treated with other standard therapies for ulcerative colitis, such as immunosuppressants and aminosalicylic acids. Subgroup analyses by dose suggest that the effective dose of this product is at least 1 gram daily; however, taking 3-4 grams daily may be more effective (93389,105728). In patients not responsive to mesalamine, some preliminary clinical research suggests taking LT-02 (Lipid Therapeutics GmbH), a modified-release formula of phosphatidylcholine, 3.2 grams daily for 12 weeks, improves symptoms of ulcerative colitis. Overall disease activity was improved by 52%, compared with 33% in those taking placebo. The effects on remission rate and mucosal healing were unclear; however, response rates were increased from 60% in the placebo group to 83% in the phosphatidylcholine group. In an 8-week follow-up, relapse was also less likely in patients treated with this product (93387).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Acne. Topical phosphatidylcholine has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research shows that applying a topical cream containing niacinamide and linoleic acid-rich phosphatidylcholine (4% niacinamide-phospholipidic; N-PHCL emulsion) once daily for 12 weeks improves skin hydration and reduce acne lesions and inflammation when compared with a 1% clindamycin cream or a carrier-only cream in patients 15 years and older with moderate acne (93388).
• Aging. Although there has been interest in using oral phosphatidylcholine for aging, there is insufficient reliable information about the clinical effects of phosphatidylcholine for this purpose.
• Alcohol-related liver disease. It is unclear if oral phosphatidylcholine is beneficial in patients with alcohol-related liver disease. Details: Preliminary clinical research in adults with acute alcoholic hepatitis shows that taking polyunsaturated phosphatidylcholine 6 grams orally daily for 24 months does not increase survival when compared with placebo (68843).
• Alzheimer disease. Although there has been interest in using oral phosphatidylcholine for Alzheimer disease, there is insufficient reliable information about the clinical effects of phosphatidylcholine for this purpose.
• Angina. Although there has been interest in using intravenous phosphatidylcholine for angina, there is insufficient reliable information about the clinical effects of phosphatidylcholine for this purpose.
• Anxiety. Although there has been interest in using oral phosphatidylcholine for anxiety, there is insufficient reliable information about the clinical effects of phosphatidylcholine for this purpose.
• Atherosclerosis. Although there has been interest in using intravenous phosphatidylcholine for atherosclerosis, there is insufficient reliable information about the clinical effects of phosphatidylcholine for this purpose.
• Atopic dermatitis (eczema). Although there has been interest in using oral phosphatidylcholine for atopic dermatitis, there is insufficient reliable information about the clinical effects of phosphatidylcholine for this purpose.
• Bipolar disorder. Although there has been interest in using oral phosphatidylcholine for bipolar disorder, there is insufficient reliable information about the clinical effects of phosphatidylcholine for this purpose.
• Dementia. It is unclear if oral phosphatidylcholine is beneficial in patients with dementia. Details: Population research in a sample of 1259 men in Finland suggests that high daily intake of phosphatidylcholine is associated with a 28% lower risk of developing dementia when compared with low daily intake, over a mean follow-up of about 22 years (103178).
• Fatty deposits. It is unclear if subcutaneous phosphatidylcholine is beneficial in patients with fatty deposits. Details: Very low quality clinical research shows that administering subcutaneous injections of phosphatidylcholine 125 mg-250 mg every 7-15 days can reduce localized fatty deposits on the chin, thigh, hips, abdomen, back, neck, and elsewhere, based on subjective visual assessments, when compared with baseline (15621,15625,15627). Improvements appear to last for 2-3 years or longer (15621,15627). In one study, phosphatidylcholine injections markedly or moderately reduce localized fatty deposits on the face in about 80% of patients for a period of up to 3 years based on subjective patient self-assessment (15621).
• Hepatic encephalopathy. It is unclear if oral phosphatidylcholine is beneficial in patients with hepatic encephalopathy. Details: Preliminary clinical research shows that taking polyunsaturated phosphatidylcholine 1050 mg daily for 6-8 weeks, either orally or through a nasogastric tube, does not improve recovery from encephalopathy compared with control in patients with acute or subacute liver failure. However, polyunsaturated phosphatidylcholine seems to reduce mortality compared to control in patients with subacute, but not acute, liver failure (68835).
• Hepatitis A. It is unclear if oral phosphatidylcholine is beneficial in patients with hepatitis A. Details: Preliminary clinical research shows that taking phosphatidylcholine 900 mg orally daily for 12 weeks does not seem to reduce serum bilirubin or liver enzyme levels in patients with hepatitis A when compared with no intervention (5225).
• Hepatitis B. It is unclear if oral phosphatidylcholine is beneficial in patients with hepatitis B. Details: Preliminary clinical research in adults undergoing interferon treatment for hepatitis B shows that taking phosphatidylcholine 1.8 grams orally daily for 24 weeks improves clinical response when compared with placebo (5226). Other preliminary clinical research in patients with chronic active hepatitis B shows that taking phosphatidylcholine 3 grams orally improves histological disease scores when compared with control (5224).
• Hepatitis C. Oral phosphatidylcholine has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in adults undergoing interferon treatment for hepatitis C shows that taking phosphatidylcholine 1.8 grams orally daily for 24 weeks improves clinical response when compared with placebo (5226).
• Hypercholesterolemia. Although there has been interest in using intravenous phosphatidylcholine for hypercholesterolemia, there is insufficient reliable information about the clinical effects of phosphatidylcholine for this purpose.
• Hyperlipidemia. Although there has been interest in using oral phosphatidylcholine for hyperlipidemia, there is insufficient reliable information about the clinical effects of phosphatidylcholine for this purpose.
• Hyperlipoproteinemia. Oral phosphatidylcholine has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research shows that taking polyunsaturated phosphatidylcholine 1.8 grams daily for 28 days in combination with clofibrate does not significantly reduce total cholesterol, triglycerides, or phospholipids compared to clofibrate alone in patients with primary hyperlipoproteinemia of Fredrickson Types II or IV. However, taking the combination of polyunsaturated phosphatidylcholine plus clofibrate seems to significantly attenuate the relative increase in low-density lipoprotein (LDL) cholesterol when compared with clofibrate alone (68840).
• Infant development. It is unclear if oral phosphatidylcholine is beneficial for infant development. Details: Preliminary clinical research shows that taking phosphatidylcholine (PhosChol, Nutrasal) 5 grams daily, containing choline 750 mg daily, from 18 weeks' gestation to 90 days postpartum does not improve cognitive function in the infant at 10-12 months of age when compared with corn oil placebo (93386).
• Lipoma. It is unclear if subcutaneous phosphatidylcholine is beneficial in patients with lipoma. Details: An anecdotal report suggests that injecting a phosphatidylcholine solution directly into a lipoma can shrink the tumor by about 35%. However, in this report a major inflammatory reaction occurred, resulting in undesirable fibrotic changes to the tissue and eventual surgical excision of the lipoma (15622).
• Memory. It is unclear if oral phosphatidylcholine is beneficial for memory. Details: Preliminary clinical research shows that taking a single dose of phosphatidylcholine 25 grams (PC-55, TwinLab) orally can improve some measures of memory in healthy college students when compared with placebo (5228).
• Nonalcoholic fatty liver disease (NAFLD). It is unclear if oral phosphatidylcholine is beneficial in patients with NAFLD. Details: Preliminary clinical research shows that taking phosphatidylcholine 600 mg orally three times daily for 24 weeks qualitatively improves liver echogenicity and structure on an ultrasound scan, suggesting a reduction in hepatic steatosis, when compared to baseline. There is also a small decrease in liver function test values, but with considerable variability both at baseline and at 24 weeks (103176,103177). Preliminary clinical evidence also suggests that taking a combination of the milk thistle constituent silybin, phosphatidylcholine, and vitamin E (Realsil, Instituto Biochimico Italiano) orally twice daily for 12 months improves liver function tests (LFTs) and liver histology when compared with placebo in people with NAFLD (63244). It is unclear if this effect is due to phosphatidylcholine, other ingredients, or the combination.
• Periorbital fat pad herniation. It is unclear if subcutaneous phosphatidylcholine is beneficial in patients with periorbital fat pad herniation. Details: Preliminary clinical research shows that injecting phosphatidylcholine 20 mg subcutaneously every 2 weeks markedly reduces lower eyelid fat pads in people with bulging fat pads due to herniation when compared to baseline. In some people, benefits appeared to last for a period of 9 months to 2 years or longer (15623,15628).
• Peripheral arterial disease (PAD). Although there has been interest in using oral phosphatidylcholine for PAD, there is insufficient reliable information about the clinical effects of phosphatidylcholine for this purpose.
• Peritoneal dialysis. It is unclear if oral phosphatidylcholine is beneficial in patients with peritoneal dialysis. Details: Very preliminary clinical research shows that taking phosphatidylcholine 900 mg orally daily for 8 weeks does not improve ultrafiltration in peritoneal dialysis when compared to baseline (5222).
• Premenstrual syndrome (PMS). Although there has been interest in using oral phosphatidylcholine for PMS, there is insufficient reliable information about the clinical effects of phosphatidylcholine for this purpose.
• Tardive dyskinesia. It is unclear if oral phosphatidylcholine is beneficial in patients with tardive dyskinesia. Details: Preliminary clinical research taking phosphatidylcholine 30 grams orally daily for 6 weeks does not improve tardive dyskinesia symptoms when compared with placebo (5223). More evidence is needed to rate phosphatidylcholine for these uses.

(Read more about PHOSPHATIDYLCHOLINE)

POSSIBLY EFFECTIVE

• Coronary heart disease (CHD). The U.S. Food and Drug Administration (FDA) allows a qualified health claim stating that using high-oleic acid sunflower oil as a replacement for other dietary fats and oils higher in saturated fat may reduce the risk of CHD. Details: A meta-analysis of clinical studies shows that replacing 7.5% of energy from partially hydrogenated vegetable oils with high-oleic acid sunflower oil can reduce CHD risk by about 9% to 19%. Furthermore, analysis of results from observational studies found that replacing partially hydrogenated oil with high-oleic acid sunflower oil is associated with a 16% to 35% reduction in the risk of CHD events (95745). The FDA allows for a qualified health claim that replacing dietary fats and oils higher in saturated fat with high-oleic acid sunflower oil may reduce the risk of CHD. To achieve this benefit, the use of high-oleic acid sunflower oil should not increase total daily energy intake. The suggested daily dietary intake is about 20 grams (1.5 tbsp) of high-oleic sunflower oil in place of other fats and oils (98563). Sunflower oil that contains high amounts of linoleic acid rather than oleic acid does not appear to improve cholesterol levels or reduce the risk of cardiovascular events in patients with CHD (96205).
• Hypercholesterolemia. Consuming sunflower oil in the diet may reduce low-density lipoprotein (LDL) cholesterol levels in some patients. Details: There is evidence that using sunflower oil in the diet as 45-50 grams daily for up to 12 weeks is more effective than olive oil for decreasing LDL cholesterol and apolipoprotein B levels in healthy individuals (9780). Also, clinical research in patients with mild hyperlipidemia or moderate hypercholesterolemia shows that consuming specific brands of mid-oleic acid (NuSun) or high-oleic acid (Sunola, Meadow Lea Foods) sunflower oils as 15% to 20% of dietary calories for up to 5 weeks is more effective than olive oil or saturated fat for decreasing total cholesterol, LDL cholesterol, and apolipoprotein B levels (76697,76698). Also, consuming a high-oleic sunflower oil-rich diet for 3 weeks decreases total cholesterol levels to a greater extent than diets enriched with palm oil or medium-chain triglycerides in patients with mild hypercholesterolemia (67569). Other preliminary clinical research in patients with moderate hypercholesterolemia shows that consuming a diet rich in sunflower oil for 3 weeks decreases total cholesterol and LDL cholesterol levels when compared with baseline. However, levels of high-density lipoprotein (HDL) cholesterol appear to be lowered as well (76714). Despite these beneficial effects, sunflower oil might be less effective than some other dietary oils. Taking sunflower oil for 3 months appears to be less effective than rice bran oil for lowering cholesterol in patients with hypercholesterolemia (76699). Also, while consuming sunflower oil 45 grams daily, as part of the diet and as a supplement, for 12 weeks reduces levels of total cholesterol and LDL cholesterol when compared to baseline, it appears to be less effective at reducing total cholesterol levels than flaxseed oil in certain patients at risk for atherosclerosis (76696). In addition, taking sunflower oil 15.1 grams daily for 4 months does not appear to reduce levels of total or LDL cholesterol in patients with peripheral vascular disease (76691).

POSSIBLY INEFFECTIVE

• Hypertension. Oral sunflower oil does not seem to lower blood pressure. Details: Preliminary clinical research in adults with hypertension shows that taking sunflower oil 30-40 grams daily for one year is less effective than extra-virgin olive oil for reducing blood pressure (5091). Also, clinical research in elderly adults with hypertension shows that taking 60 grams of sunflower oil daily for 4 weeks is less effective than virgin olive oil for reducing systolic blood pressure (76692).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Atherosclerosis. It is unclear if oral sunflower oil is beneficial for atherosclerosis; some clinical research suggests that it may provide less benefit than other dietary oils. Details: Some preliminary clinical research in individuals with overweight and obesity shows that taking sunflower oil 30 mL (about 27 grams) daily for 90 days decreases carotid intima-media thickness (CIMT) by 3.5% when compared to baseline, but not when compared with olive oil or flaxseed oil. Sunflower oil also improves flow-mediated vasodilation by 73% when compared to baseline, compared with no improvement in those taking flaxseed oil or olive oil (99303). Other preliminary clinical research in individuals waiting for carotid endarterectomy shows that taking sunflower oil 6 grams daily for up to 189 days is less effective than the same dose of fish oil, and equivalent to control oil, for improving the status of atherosclerotic plaques (76688).
• Atopic dermatitis (eczema). Although there is interest in using topical sunflower oil for atopic dermatitis, there is insufficient reliable information about the clinical effects of sunflower oil for this condition.
• Child growth. It is unclear if topical sunflower oil is beneficial for early child growth. Details: A large preliminary clinical trial in newborn infants in India shows that exclusive topical application of 10 mL of high-linoleic acid sunflower oil, an average of 2.7 times daily for about one month, increases weight gain by 1.3 gram/kg daily when compared with a control group exclusively given traditional vigorous massage with mustard oil an average of 2.4 times daily. The increase in weight gain was highest for infants weighing less than 1500-2000 grams at birth (108141). However, it is unclear if any beneficial effects are due to the sunflower oil, the massage, their combination, or the lack of mustard oil.
• Dry mouth. It is unclear if rinsing the mouth with sunflower oil is beneficial for dry mouth. Details: Preliminary clinical research in adults with moderate dry mouth associated with medication use shows that using a sunflower oil mouth rinse and gargling for 5-8 minutes before spitting it out twice daily for 7 days improves dry mouth scores by 23% when compared to baseline. Sunflower oil also improves the ability to swallow and sleep with dry mouth, but not other dry mouth symptoms or saliva flow rate, when compared with control (105523). This study may have been inadequately powered to detect a difference between groups.
• Dry skin. It is unclear if topical sunflower oil is beneficial for dry skin in infants. Details: Preliminary clinical research in full-term, newborn infants shows that topical application of 4 drops of sunflower oil to each of three parts of the body twice daily for 4 weeks improves skin hydration, but not skin barrier function or the presence of redness or rash, when compared with not using topical oil. Furthermore, use of sunflower oil may impede the normal development of skin barrier function that occurs during the first four weeks of life (96144).
• Fetal and premature infant mortality. It is unclear if topical sunflower oil is beneficial for preventing early mortality in premature infants. Details: A large clinical trial in newborn infants in India shows that exclusive topical application of 10 mL of high-linoleic acid sunflower oil, an average of 2.7 times daily for about one month, reduces infant mortality by 58% when compared to a control group exclusively given traditional vigorous massage with mustard oil an average of 2.4 times daily. A subgroup analysis of premature infants also shows a 52% reduction in mortality with the use of high-linoleic acid sunflower oil when compared with control (108143). However, it is unclear if any beneficial effects are due to the sunflower oil, the massage, their combination, or the lack of mustard oil.
• Prematurity. Small to moderate-sized clinical studies suggest that topical sunflower oil might increase body weight, reduce length of hospital stay, and improve skin hydration and skin integrity in preterm neonates. Details: Preliminary clinical research in preterm infants with low birth weight shows that massaging for 5-10 minutes using sunflower oil 10 mL/kg three times daily for 2 weeks increases weight gain by approximately 35% over 2 months when compared with massage using no oil. Sunflower oil massage does not appear to increase length or head circumference (96145). A small clinical study in premature infants in the intensive care unit (ICU) shows that a similar massage with sunflower oil three times daily for 5 days shortens ICU stay by about 5 days when compared with no massage. Furthermore, over the ICU stay, infants in the sunflower oil massage group gained an average of 15 grams, whereas infants in the control group experienced weight loss (98479). The effect of sunflower oil on skin hydration and integrity in preterm infants has also been assessed. A clinical trial of 90 preterm infants in a Turkish neonatal ICU shows that whole body skin treatment (not massage) with either sunflower oil or almond oil 4 mL/kg four times daily for 5 days improves measures of skin hydration and skin integrity when compared with control infants that did not receive oil treatment. The sunflower and almond oil treatments are equally effective (105524). Another clinical study in 90 infants (42% preterm) in a Turkish neonatal ICU shows that whole body skin treatment (not massage) with sunflower oil or liquid Vaseline 3-4 mL for preterm and 5-6 mL for full-term infants daily for 16 days improves measures of skin integrity when compared with control infants that did not receive any oil treatment. Skin integrity scores were better in the sunflower oil group than liquid Vaseline at some time points (111726).
• Psoriasis. Although there is interest in using topical sunflower oil for psoriasis, there is insufficient reliable information about the clinical effects of sunflower oil for this condition.
• Rheumatoid arthritis (RA). Although there is interest in using oral sunflower oil for RA, there is insufficient reliable information about the clinical effects of sunflower oil for this condition.
• Tinea pedis. It is unclear if topical sunflower oil is beneficial for tinea pedis. Details: Preliminary clinical research shows that topical application of a specific brand of ozonized sunflower oil (Oleozon) twice daily for 6 weeks is as effective as ketoconazole for curing athlete's foot (76687). More evidence is needed to rate sunflower oil for these uses.

(Read more about SUNFLOWER OIL)

POSSIBLY SAFE ...when used orally and appropriately. Large doses up to 30 grams per day for 6 weeks (5223) and smaller doses of up to 6 grams daily for up to 24 months have been well tolerated (68839,68843,105728). ...when used subcutaneously and appropriately, short-term. Some research suggests that subcutaneous injections of 0.2 mL to 5 mL of a 5% phosphatidylcholine solution do not cause significant serious adverse effects when doses are administered up to five times and spaced apart by 2-4 weeks (15621,15623,15624,15625). ...when used topically as an emulsion also containing niacinamide for up to 12 weeks (93388).

PREGNANCY: POSSIBLY SAFE
when used orally from 18 weeks of gestation at doses of up to 5 grams daily (93386)

LACTATION:
Insufficient reliable information available; avoid using.

(Read more about PHOSPHATIDYLCHOLINE)

LIKELY SAFE ...when used orally and appropriately in amounts commonly found in foods. When used as a substitute for other dietary oils, the recommended intake of high-oleic acid sunflower oil is 20 grams (1.5 tablespoons) daily (9780,98563). ...when used topically and appropriately, short-term. Sunflower oil has been applied to the skin twice daily for up to 6 weeks (76687). There is insufficient reliable information available about the safety of sunflower oil when used as an oral rinse.

CHILDREN: LIKELY SAFE
when used orally and appropriately in amounts commonly found in foods.

CHILDREN: POSSIBLY SAFE
when applied topically and appropriately, short-term. Sunflower oil has been applied to the skin of infants daily for up to 2 months (96144,96145,105524,108143). There is insufficient reliable information available about the safety of sunflower oil when used orally in larger amounts as medicine.

PREGNANCY AND LACTATION: LIKELY SAFE
when used orally and appropriately in amounts commonly found in foods. There is insufficient reliable information available about the safety of sunflower oil when used in amounts greater than those found in food.

(Read more about SUNFLOWER OIL)

(Read more about PHOSPHATIDYLCHOLINE)

ANTIDIABETES DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = B Theoretically, sunflower oil might decrease the effectiveness of antidiabetes medications.  Details A diet using sunflower oil as a fat source can cause increased fasting blood glucose levels in patients with type 2 diabetes (8132). Dose adjustments to diabetes medications might be necessary.

(Read more about SUNFLOWER OIL)

General ...Phosphatidylcholine is generally well tolerated when used orally, subcutaneously, or topically.
Most Common Adverse Effects:
Orally: Altered taste, bloating, diarrhea, itching, nausea, sweating, vomiting.
Subcutaneously: Bruising, burning, edema, erythema, hematoma, itching, pain at the injection site.
Serious Adverse Effects (Rare):
Subcutaneously: Lipoma.

Dermatologic ...When taken orally, phosphatidylcholine may increase sweating (5229) and itching (63244). When given subcutaneously, phosphatidylcholine can cause pain, burning, itching, tenderness to touch, bruising, edema, and erythema at the injection site. The pain, itching and erythema usually resolve within 2 days of treatment; however localized tenderness can last longer (15623,15624,15626,15627,15628). Edema and bruising usually resolve within 10 days of treatment (15621,15623,15625). Some people can also develop nodules or hematoma at the injection site. This usually resolves within 30 days (15627).

Gastrointestinal ...Ingesting large amounts of phosphatidylcholine (30 grams per day) can cause gastrointestinal upset and diarrhea (5223). However, bloating, diarrhea, altered taste, nausea, and vomiting have been reported with smaller doses (63244,68843,93389,93390,105728). Although moderate subcutaneous doses do not usually cause systemic side effects, high doses exceeding 1.2 grams of phosphatidylcholine can cause nausea and abdominal pain in some people (15624).

Musculoskeletal ...Injecting phosphatidylcholine directly into a lipoma can result in a significant inflammatory response and undesirable fibrotic tissue changes (15622).

(Read more about PHOSPHATIDYLCHOLINE)

General ...Orally and topically, sunflower oil is well tolerated.
Serious Adverse Effects (Rare):
Orally: Allergic reactions in sensitive individuals have been reported.

Immunologic ...Orally, sunflower oil 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. However, the protein content of sunflower oil is very low. In one case report, an allergic response to sunflower oil did not occur despite presenting with severe allergy and anaphylaxis to sunflower seed (108140).

(Read more about SUNFLOWER OIL)