Phosphatidyl Choline Complex 1200 mg [Discontinued] by Country Life

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.

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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.

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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).

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