Psor-Rbs by Loomis Enzymes

POSSIBLY INEFFECTIVE

• Atopic dermatitis (eczema). Oral borage seed oil does not seem to improve symptoms of atopic dermatitis. Details: Taking borage seed oil orally 500-4000 mg daily for up to 24 weeks does not seem to improve symptoms of atopic dermatitis in adults or children (7632,7633,11341,36805,36824). Meta-analyses of clinical trials also indicate that borage oil and gamma-linolenic acid from borage and other sources do not significantly affect atopic dermatitis (13758,88185).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Acne. It is unclear if oral borage seed oil is beneficial for acne. Details: In patients with mild to moderate acne, preliminary clinical research shows that taking borage oil 2 grams providing gamma-linolenic acid levels of 400 mg daily for 10 weeks improves inflammatory and non-inflammatory acne lesion counts by 33% and 16%, respectively, when compared with baseline. Acne severity was also improved. These changes were significant when compared with a group receiving no treatment and were equivalent to patients taking 1000 mg each of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) (105842).
• Acute respiratory distress syndrome (ARDS). Enteral borage seed oil has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Borage seed oil, providing gamma-linolenic acid (GLA), has been investigated in combination with fish oil and antioxidants for improving outcomes in patients with ARDS. A meta-analysis of randomized controlled trials evaluating these ingredients, 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 sub-group 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 (105248,105249). Most studies included in these analyses investigated the use of Oxepa and found there was no effect on mortality when compared with control enteral formulas. However, studies investigating other sources of enteral or intravenous fish oil were also included in these analyses (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). Although most studies investigated the use of an enteral formula containing borage seed oil, fish oil was used alone or in combination in all included studies. Any benefit of borage seed oil alone is unclear from these meta-analyses.
• Alcoholism. Although there is interest in using oral borage seed oil for alcoholism, there is insufficient reliable information about the clinical effects of borage seed oil for this condition.
• Asthma. It is unclear if oral borage seed oil is beneficial for asthma. Details: Preliminary clinical research shows that taking borage seed oil containing gamma-linolenic acid levels of approximately 2 grams daily for 12 months does not improve asthma symptoms in patients with mild to moderate asthma when compared with placebo (36812).
• Attention deficit-hyperactivity disorder (ADHD). Although there is interest in using oral borage seed oil for ADHD, there is insufficient reliable information about the clinical effects of borage seed oil for this condition.
• Cardiovascular disease (CVD). Although there is interest in using oral borage seed oil for CVD prevention, there is insufficient reliable information about the clinical effects of borage seed oil for this purpose.
• Coronavirus disease 2019 (COVID-19). Oral borage seed oil has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small open label trial of patients in the intensive care unit (ICU) with severe COVID-19 infection shows that taking 5 mL of a syrup containing borage oil, providing gamma-linolenic acid 100 mg, plus extracts of lemongrass, yarrow, chamomile, and chicory daily for 5 days in combination with standard care reduces the length of ICU stay by around 1 day but does not improve mortality rates when compared with standard care alone (112147). The validity of these findings is limited by a lack of placebo control. Further, it is unclear if these findings are due to borage, other ingredients, or the combination.
• Diabetes. Although there is interest in using oral borage seed oil for diabetes, there is insufficient reliable information about the clinical effects of borage seed oil for this condition.
• Hangover. Although there is interest in using oral borage seed oil for symptoms of hangover, there is insufficient reliable information about the clinical effects of borage seed oil for this purpose.
• Neurodermatitis. Although there is interest in using oral borage seed oil for neurodermatitis, there is insufficient reliable information about the clinical effects of borage seed oil for this condition.
• Obesity. It is unclear if oral borage seed oil is beneficial in patients with obesity. Details: A very small clinical trial in adults aged 30-46 years with obesity shows that taking 4 capsules of a specific borage seed oil (Barlean's Naturals), providing gamma-linolenic acid 880 mg total, daily for 6 weeks does not improve resting metabolic rate or body mass index when compared with placebo. Improvements in triglyceride and high-density lipoprotein cholesterol levels were observed when compared with baseline; however, patients had normal lipid profiles at baseline (108755). Due to its very small size, this study may have been inadequately powered to detect a difference between groups.
• Periodontitis. It is unclear if oral borage seed oil is beneficial for periodontitis. Details: Preliminary clinical research shows that taking borage seed oil 3 grams daily for 12 weeks improves gingival inflammation but does not reduce plaque in patients with periodontitis when compared with placebo (36804).
• Premenstrual syndrome (PMS). Although there is interest in using oral borage seed oil for PMS symptoms, there is insufficient reliable information about the clinical effects of borage seed oil for this purpose.
• Prematurity. It is unclear if formula containing borage seed oil is beneficial for neurodevelopment in premature infants. Details: Clinical research shows that giving infant formula supplemented with long-chain polyunsaturated fatty acids from borage oil and fish oil does not improve overall neurodevelopment at 9 or 18 months after term when compared with a control infant formula. However, in males, some but not all measures of neurodevelopment were modestly improved at 18 months. Additionally, length, but not weight, was improved in males, with no growth improvements in females. The infant formula in this study was supplemented with borage oil and fish oils to provide gamma-linolenic acid (GLA) 0.9 grams per 100 grams fat, as well as eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) 0.1 and 0.5 grams per 100 grams fat, respectively (13745).
• Pressure ulcers. Enteral borage seed oil has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: In patients with acute lung injury, preliminary clinical research shows that giving a specific enteral emulsion (Oxepa, Ross Laboratories) providing borage oil, 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 borage oil-containing formula was lower when compared with the control formula, these patients also seemed to have fewer pressure ulcers at baseline and no statistical comparison was conducted. The clinical significance of this finding is unclear (105252).
• Rheumatoid arthritis (RA). Small clinical studies suggest that borage seed oil may be beneficial for reducing symptoms of RA. Details: Some small clinical studies show that taking borage seed oil in combination with conventional analgesics or anti-inflammatory agents might help decrease symptoms of RA after 6 weeks of treatment, with improvements sustained for up to 24 weeks. In these studies, borage seed oil decreased the number of tender joints by 36%, the tender joint score by 45%, the number of swollen joints by 28%, and the swollen joint score by 41% when compared to baseline. Borage seed oil 4.5-7.2 grams daily for up to 24 weeks was used in these studies (1985,8458).
• Seborrheic dermatitis. Preliminary research suggests that topical borage seed oil is beneficial for infantile seborrheic dermatitis. Details: Small clinical studies suggest that topical application of borage seed oil 0.5 mL twice daily can lead to resolution of symptoms within 10-12 days. After discontinuation of topical borage seed oil application, symptoms recurred within 1 week (7630,13305). After lesion resolution, borage seed oil has been applied 2-3 times each week until 6-7 months of age without lesion recurrence (7630). The validity of these findings is limited by the small study sizes and lack of comparator groups.
• Stress. Although there is interest in using oral borage seed oil for stress, there is insufficient reliable information about the clinical effects of borage seed oil for this purpose. More evidence is needed to rate borage for these uses.

(Read more about BORAGE)

LIKELY INEFFECTIVE

• Alzheimer disease. Lecithin does not improve daily functioning in patients with Alzheimer disease. Details: In patients with Alzheimer disease, taking various types of lecithin, 1.2-45 grams daily for up to 6 months, alone or in combination with various conventional medications, does not improve cognitive function or other measures of disease progression (5149,5151,5152,5156,14817,14823,14825,14837,14838).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Age-related cognitive decline. It is unclear if oral lecithin can slow age-related cognitive decline. Details: A small clinical crossover study in healthy adults aged 64 years and older shows that taking lecithin 26 grams orally daily, alone or in combination with physostigmine, for 5 weeks does not seem to improve memory when compared with placebo (19204).
• Anxiety. Although there is interest in using oral lecithin for anxiety, there is insufficient reliable information about the clinical effects of lecithin for this condition.
• Atopic dermatitis (eczema). Although there is interest in using oral lecithin for atopic dermatitis, there is insufficient reliable information about the clinical effects of lecithin for this condition.
• Bipolar disorder. It is unclear if oral lecithin is beneficial in patients with bipolar disorder. Details: A clinical study in six patients with mania shows that taking lecithin 10 mg three times daily improves symptoms of delusions, incoherent speech, and hallucinations when compared with placebo (14839).
• Dry skin. Although there is interest in using topical lecithin for dry skin, there is insufficient reliable information about the clinical effects of lecithin for this condition.
• Friedreich ataxia. Small clinical studies suggest that oral lecithin is not beneficial in people with Friedreich ataxia. Details: Preliminary clinical research shows that taking lecithin 25 grams orally daily for 1 month does not have any benefit in people with Friedreich ataxia (59298). Other preliminary clinical research shows that taking lecithin for a longer period of 6 months also does not improve performance (19211).
• Hyperlipidemia. Although lecithin may lower cholesterol in healthy people, it does not seem to improve cholesterol levels in people with hyperlipidemia. Details: Some clinical research shows that taking lecithin 20-30 grams daily for up to 11 months decreases cholesterol in healthy people (5147,14820). However, other clinical research shows that lecithin has no effect on low-density lipoprotein cholesterol or total cholesterol levels in people with hyperlipidemia (5148,14820).
• Parkinson disease. It is unclear if oral lecithin is beneficial in patients with Parkinson disease. Details: Preliminary clinical research in patients with Parkinson disease shows that taking lecithin 32 grams daily for 8 weeks does not improve symptoms when compared with placebo (19212).
• Postoperative pain. It is unclear if oral lecithin is beneficial for reducing postoperative pain. Details: Preliminary clinical research shows that taking lecithin 20 grams prior to surgery increases choline levels, but does not reduce postoperative pain after gynecological surgery, when compared with placebo (91231).
• Tardive dyskinesia. It is unclear if oral lecithin is beneficial in patients with tardive dyskinesia. Details: Two small clinical studies in patients with tardive dyskinesia shows that taking lecithin orally for 2 months, alone or in combination with lithium, does not improve symptoms when compared with placebo (14822,14824).
• TPN-associated hepatic steatosis. It is unclear if oral lecithin is beneficial in patients with hepatic steatosis associated with long-term total parenteral nutrition (TPN). Details: A small clinical study in patients on long-term TPN with low choline levels suggests that taking lecithin 20 grams orally twice daily for 6 weeks reduces the degree of hepatic steatosis, compared with no significant changes in those taking placebo (5140).
• Ulcerative colitis. Oral lecithin has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research shows that taking a disease-specific medical food (Profermin, Nordisk Rebalance) containing lecithin, fermented oats, barley malt, and lactobacillus plantarum, as 250 mL twice daily for 24 weeks, decreases disease activity by over 56% when compared with baseline and leads to remission in 46% of patients with mild-to-moderate ulcerative colitis (91228). Other preliminary clinical research in this population shows that taking Profermin 250 mL twice daily for 8 weeks improves disease activity and remission rate when compared with another medical food (Fresubin Original, Fresenius Kabi) (90271). The effects of lecithin alone are unclear. More evidence is needed to rate lecithin for these uses.

(Read more about LECITHIN)

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Celiac disease. Although there has been interest in using oral lipase for celiac disease, there is insufficient reliable information about the clinical effects of lipase for this purpose.
• Dyspepsia. It is unclear if oral lipase is beneficial for improving symptoms of postprandial distress syndrome. Details: A small clinical trial shows that taking a specific acid-resistant lipase (Amano Enzyme USA) 280 mg immediately before a high-fat meal does not reduce postprandial bloating and nausea when compared with placebo in individuals with postprandial distress syndrome (101900).
• Inflammatory bowel disease (IBD). Although there has been interest in using oral lipase for IBD, there is insufficient reliable information about the clinical effects of lipase for this purpose.
• Prematurity. It is unclear if adding a specific form of lipase, recombinant human bile salt-stimulated lipase (rhBSSL), to infant formula improves outcomes in premature infants. Some research suggests a potential increased risk for adverse effects. Details: Human breast milk contains rhBSSL, but it is inactivated when breast milk is pasteurized for donation. Clinical research in infants born before 32 weeks' gestation shows that adding rhBSSL as 8700 units per 100 mL formula or pasteurized breast milk, for 4 weeks does not increase growth velocity, body length, or head circumference over the next 12 months when compared with formula or pasteurized breast milk devoid of lipase. However, the infants who were small for gestational age (SGA), which made up approximately 15% of the study population, grew by an additional 1.9 grams/kg daily on average when compared with placebo (101940). More evidence is needed to rate lipase for these uses.

(Read more about LIPASE)

POSSIBLY SAFE ...when borage seed oil is used orally or topically and appropriately. Borage seed oil has been used with apparent safety in clinical trials at a dose of up to 4 grams daily for up to 12 weeks (7632,8458,11341,13305,36804,88185,5244).

LIKELY UNSAFE ...when products containing hepatotoxic pyrrolizidine alkaloids (PA) are used orally. Borage plant parts, such as the leaf, flower, and seed, can contain hepatotoxic PAs. Repeated exposure to low concentrations of hepatotoxic PAs can cause severe veno-occlusive disease. Hepatotoxic PAs might also be carcinogenic and mutagenic (12841,12842). Tell patients not to use borage preparations that are not certified and labeled as hepatotoxic PA-free.

CHILDREN: POSSIBLY SAFE
when borage seed oil is used orally and appropriately. Borage seed oil has been used with apparent safety at a dose of 2 grams daily for 12 weeks (11341).

CHILDREN: LIKELY UNSAFE
when products containing hepatotoxic PAs are used orally. Borage plant parts, such as the leaf, flower, and seed, can contain hepatotoxic PAs. Repeated exposure to low concentrations of hepatotoxic PAs can cause severe veno-occlusive disease. Hepatotoxic PAs might also be carcinogenic and mutagenic (12841,12842). Tell patients to avoid borage preparations that are not certified and labeled as hepatotoxic PA-free.

PREGNANCY AND LACTATION: LIKELY UNSAFE
when products containing hepatotoxic pyrrolizidine alkaloids (PA) are used orally. Borage plant parts, such as the leaf, flower, and seed, can contain hepatotoxic PAs. Repeated exposure to low concentrations of hepatotoxic PAs can cause severe veno-occlusive disease. Hepatotoxic PAs might also be carcinogenic, mutagenic, and teratogenic. These constituents are also excreted in breast milk (12841,12842). Tell patients to avoid borage preparations that are not certified and labeled as hepatotoxic PA-free. There is insufficient reliable information available about the safety of borage seed oil when used orally or topically during pregnancy or lactation.

(Read more about BORAGE)

LIKELY SAFE ...when used orally in amounts commonly found in foods. Lecithin has Generally Recognized As Safe (GRAS) status in the US (2619,105544). ...when used orally and appropriately in medicinal amounts. Lecithin has been used safely in doses of up to 30 grams daily for up to 6 weeks (5140,5149,5152,5156,14817,14822,14838,19212). ...when used topically (4914).

PREGNANCY AND LACTATION: LIKELY SAFE
when used orally in food amounts. Lecithin has Generally Recognized As Safe (GRAS) status in the US (105544). There is insufficient reliable information available about the safety of medicinal amounts of lecithin during pregnancy or lactation; avoid using.

(Read more about LECITHIN)

There is insufficient reliable information available about the safety of lipase.

CHILDREN: POSSIBLY UNSAFE
when recombinant human bile salt-stimulated lipase (rhBSSL) is used orally by premature infants. Adding rhBSSL to infant formula or pasteurized breast milk increases the risk for serious gastrointestinal adverse effects in premature infants (101940).

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

(Read more about LIPASE)

ANTICOAGULANT/ANTIPLATELET DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = B Theoretically, borage seed oil may increase the risk of bleeding if used with anticoagulant or antiplatelet drugs.  Details In healthy individuals, borage seed oil supplementation does not seem to affect platelet aggregation (36823). However, gamma-linolenic acid, a constituent of borage seed oil, seems to decrease platelet aggregation by 45% and increase the risk of bleeding by 40% in animal and clinical research (1979).

CYTOCHROME P450 3A4 (CYP3A4) INDUCERS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, taking borage with drugs that induce CYP3A4 might increase levels of pyrrolizidine alkaloid (PA) toxic metabolites.  Details Although borage seed oil contains little to no PAs, some borage plant parts, such as the leaf, flower, and seed, can contain hepatotoxic PAs. Hepatotoxic PAs are substrates of CYP3A4, which converts these chemicals into toxic metabolites (12841,12860). Tell patients to avoid borage preparations that are not certified and labeled as hepatotoxic PA-free.

PHENOTHIAZINES Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, taking borage sed oil with phenothiazines might increase the risk of seizures.  Details Borage seed oil contains gamma-linolenic acid (GLA). There is concern that taking supplements containing GLA might cause seizures, or lower the seizure threshold, when taken with phenothiazines. This is based on limited data from two reports published in the 1980s. In one report, three patients with schizophrenia who had received phenothiazines developed EEG changes suggestive of temporal lobe epilepsy after starting treatment with evening primrose, another source of GLA. However, none experienced an actual seizure (21013). In the other report, two patients with schizophrenia who were stabilized on phenothiazines developed seizures when evening primrose 4 grams daily was added. One of these patients had a prior history of seizures (21010). It is unclear whether evening primrose had any additive epileptogenic effects with the phenothiazines, but there is no evidence that taking GLA-containing supplements alone can cause seizures (88187).

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General ...Orally, borage seed oil seems to be well tolerated. However, borage plant parts, such as the leaf, flower, and seed, that contain hepatotoxic pyrrolizidine alkaloid (PA) constituents should be avoided.
Most Common Adverse Effects:
Orally: Belching, bloating, diarrhea, and soft stools.
Serious Adverse Effects (Rare):
Orally: Borage plant parts that contain PA constituents can be hepatotoxic.

Gastrointestinal ...Orally, borage seed oil can cause soft stools, diarrhea, belching, and bloating (8013,11341).

Hepatic ...The pyrrolizidine alkaloid (PA) constituents of borage can cause significant hepatotoxicity (12841,12842). PAs can occur in borage leaf, flower, and seed; borage seed oil contains little to no PAs. Chronic exposure to other plants containing hepatotoxic PA constituents has been associated with veno-occlusive disease (VOD). Subacute VOD causes vague symptoms with persistent liver enlargement (4021). Symptoms of acute VOD include colicky pains in epigastrium, vomiting and diarrhea, and ascites within several days. Enlargement and induration of the liver occurs within a few weeks (12842).

Oncologic ...The pyrrolizidine alkaloid (PA) constituents of borage are potentially carcinogenic and mutagenic (12841,12842).

Pulmonary/Respiratory ...The pyrrolizidine alkaloid (PA) constituents of borage are potentially pneumotoxic (12841,12842).

(Read more about BORAGE)

General ...Orally, lecithin is well tolerated.
Most Common Adverse Effects:
Orally: Abdominal pain, diarrhea, fullness, and nausea.

Dermatologic ...Orally, lecithin can cause allergic skin reactions in people with egg or soy allergies (15705).

Gastrointestinal ...Orally, lecithin may cause abdominal pain, diarrhea, fullness, and nausea (5140,6243,14817,14822,14838,19204,59281).

Neurologic/CNS ...Orally, lecithin caused CNS complaints and agitation in one patient in a clinical trial (59261).

(Read more about LECITHIN)

General ...No adverse effects have been reported in adults. However, a thorough evaluation of safety outcomes has not been conducted.
Serious Adverse Effects (Rare):
Orally: Gastrointestinal adverse effects, such as necrotizing enterocolitis, when recombinant human bile salt-stimulated lipase is used in premature infants.

Gastrointestinal ...Orally, when added to the formula or pasteurized breast milk consumed by premature infants, recombinant human bile salt-stimulated lipase (rhBSSL) can cause gastrointestinal adverse effects, including abdominal distension, flatulence, constipation, colic, abdominal pain, gastroenteritis, vomiting, regurgitation, and rectal bleeding (101940). Premature infants receiving rhBSSL also had a slightly higher rate of necrotizing enterocolitis (NEC) when compared with those receiving placebo. After review by a panel of experts, it was determined that the rate of confirmed or suspected NEC in infants consuming rhBSSL was 3.3%, compared with 0.5% in those receiving placebo. Although this rate of NEC is lower than the historical rate of occurrence in premature infants (11%), a possible increased risk for NEC cannot be ruled out (101940).

(Read more about LIPASE)